Alternative Clinical Trial Designs and Methods for Assessing Treatment Effects Incorporating Real-World Data - Juniper Publishers

 Biostatistics and Biometrics - Juniper Publishers

Abstract

Traditional parallel group double-blind controlled trial design is the preferred approach to provide substantial evidence to support a new drug application. To elevate trial efficiency to a new level, the pharmaceutical industry and the health regulatory authorities continuously make great effort to propose the applications of innovative designs to new drug developments. These designs include the branching out group sequential design, a variety of adaptive designs and platform designs. Moreover, to overcome the challenge of patient recruitment and reduce trial sample size particularly in rare disease areas, Bayesian design and patient matching approach are often applied by incorporating historical or real-world data for statistical inference. In addition, for ethical or practical considerations, single arm or open label randomized controlled designs may also be utilized to evaluate treatment effects. In this paper, we discuss these designs and their applicability in different scenarios, in the context of proposing a new pseudo randomized controlled design where patients ‘randomized’ to control will be under standard of care and therefore may not need to consent for the interventional trial procedures and need only agreeing the use of their data which are closer to real-world data. This new design improves upon the single arm design, while featuring part of the open label randomized controlled designs; thus, inherit some of their key features as we summarize in the paper. Therefore, this new design may have its value in some trial settings through providing improved controlled Real-World Data..

Keywords: Bayesian Design; Historical Data Borrowing; Single Arm Design; Open Label Randomized Design; Real-World Evidence; Pseudo Randomized Controlled Design

Introduction

Currently, with the cost of developing a new medicine continuously increases, paradigm for clinical research has changed over time. New ideas for a variety of innovative clinical trial designs steadily emerge. Regulatory agencies also start to accept some of these designs [1] for the purpose of accelerating the availabilities of more innovative, safe and effective therapies to patients. Nonetheless, we should still open our mind to think of and embrace all other possible clinical trial designs. In this paper, we will discuss the key features of some these designs, motivating us to propose a new design: pseudo randomized controlled design, which could be considered as a design improving upon the traditional single arm design and open label randomized controlled design. The new design can also leverage Real-World Data while address selection biases and comparability concerns. With the layout of all the design options, it will be convenient for the practitioners to compare and evaluate the choices for a specific clinical study.

Randomized Double-Blind Controlled Trial Designs

The traditional randomized double-blind controlled trial design is considered as the ‘gold standard’ design. In this design, the sponsor first prepares a study protocol which details the objectives/hypotheses, the sample size, the study population (inclusion/exclusion criteria), the study duration, the number of visits, the treatments which include the control, the methods of endpoint measurements, the other study procedures and the approaches for data analysis (e.g., the model, the estimand and the way for handling missing data). Then the sponsor selects study centers from different countries based on the feasibility of timely recruiting patients and the regional sample size requirements from the regional health authorities [2-4]. Often after a run-in period, patients are randomized to treatment or control after consent and go through the study procedures specified in the protocol. Trial results are subsequently derived after data base lock. The common perception is that trial results with such a design are ‘unbiased’ for ‘certain measures, estimands and purposes.

Actually, trial results even from a trial with such a ‘gold standard’ design are still trial specific with the limitation for the particular population via the country or site selections and protocol inclusion/exclusion criteria. They are unbiased only within this population as well as the study procedures described in the protocol including perhaps the inclusion of the run-in qualification period. To have the evidence of a robust (beyond this narrow study population) treatment effect, the sponsors are often required to conduct two pivotal studies (or a large single trial with an extremely small p-value) at different study centers/countries. Both studies should confirm the treatment effect to demonstrate the reproducibility. Additional evidence could be provided through trials for additional related indications. Moreover, post-marketing bridging studies may be conducted in new countries to extrapolate the treatment effect to different/broader patient populations. Real-world or post-marketing observational studies may also be conducted to get real-world evidence in a real-world setting. Even though study centers are not randomly selected globally, results derived from a random effect model treating study center as a random effect with the incorporation of between-center variability should be more generalizable than those from a fixed effect model [5-7]. Nonetheless, we seldom see the application of the random effect model to multi-center trials or multi-regional trials. Subgroup analyses need also being performed to assess the consistency of treatment effects across different subpopulations.

Within the broad traditional randomized controlled design category, there are further subtypes of designs. They include the fixed design, group sequential design, sequential parallel comparison design, platform design, adaptive design, the regular parallel group design and crossover design. Different designs have their own advantages under their corresponding assumptions and circumstances. For example, owing to many unknowns before the initiation of a study, we have the desire to modify the study based on either the blinded or unblinded internal data of the study obtained during the trial monitoring process to increase the chance of trial success. We then can apply the adaptive design which provides us many flexibilities [8]. We can stop the trial early due to futility or unexpectedly strong treatment effect. We can revise the sample size for the targeted conditional power. We can select dose(s) and enrich patient population(s) for the later stages of the trial. We can even determine for the final analysis whether we want to only assess the non-inferiority or go further to assess the superiority if there is the hope based on the interim data. The power for superiority assessment will be no larger than the significance level if there is truly no between-treatment difference regardless of the magnitude of the sample size. If the interim data show no or very small treatment effect, we had better just go for the noninferiority assessment so that we can complete the study early and save valuable resource [9].

Given the limitation of the trial results from the traditional randomized controlled trials revealed above, we are motivated to explore other possible alternative trial designs. One ideal scenario is to find all patients without applying the extensive inclusion/exclusion criteria and randomize them to treatment and control. Even though the trial results (the focus should be on estimation rather hypothesis testing with the huge sample size) are the results of one specific realization of the randomization and another similar trial cannot be conducted after (almost) all patients have been studied (unless another trial is conducted in newly diagnosed patients subsequent to the first trial), the trial results should be applicable to another randomization of the same scheme due to the huge scale of the trial. Thus, the results should be more generalizable compared to those of the traditional randomized controlled trials with limited sample sizes. Clearly, such a design is not realistic as we cannot really include all (currently diagnosed) patients in one single study. In any case, we should keep in mind that trial results from a larger trial are always more desirable and interpretable than those of a relatively smaller trial [10]. The size of a trial should be determined not merely for enough power for hypothesis testing of the primary efficacy endpoint but more for appropriate and robust quantitative evaluation of the treatment effects measured broadly by other endpoints including those for safety assessments. As discussed below, other considerations can trigger the applications of alternative designs given the infeasibility of the various traditional randomized controlled trial in some circumstances.

Single Arm Design

It is sometimes unethical or practical to include a (placebo) control in a clinical study particularly exposing a large number of patients to ineffective/inappropriate placebo control. In addition, patients may not have the motivation to participate in such placebo-controlled trial if alternative treatments are available in the disease area which makes recruitment very challenging. Then a single arm design will often be the option for the study. EMA recently issued a draft reflection paper on establishing efficacy based on single-arm trials [11]. The reflection paper clearly outlines the description and specific characteristics of single-arm trials. It also provides general considerations for single-arm trial designs including the choice of endpoints, target and trial population, role of external information, statistical principles, sources of bias and potential mitigation. As there is no internal control, the endpoints must be able to isolate treatment effects undoubtedly caused by the treatment rather than the selection of trial population or some prognostic factors. The assessment of treatment effect may be through the evaluation of the within-treatment effect; for example, measured by mean change from baseline at a specific time point for a continuous endpoint and compared to a threshold.

This threshold often depends on the treatment effect of the standard of care (SOC) (measured using historical data). Notice that the treatment effect of the standard of care can improve or change over time along with the continuous advancement of innovative medical technology and the availability of more effective treatments or other prior or concomitant medical interventions. It may also depend on the population and the regions of conducting the study as the standard of care can vary substantially long with the health care system and even the human development index [12] across countries. In addition, if the threshold is a constant without any variability, the study should be sized with certain level of precision based on confidence interval for the assessment of treatment effect. Clearly, the determination of a relevant threshold is not straightforward, and the interpretation of the trial result may rely on something that is not measured within the study. Such studies therefore are more limited to rare diseases and oncological studies [13], where the effect of ‘current standard of care’ is usually quite low with small variabilities. For binary, count data, time to event and other study endpoints, the within-treatment event rate, cumulative event rate curve and the other summary statistics may be used to evaluate the within-treatment effect.

Rather than comparing the within-treatment effect to a constant threshold, we may directly leverage external historical control data or Real-World Data (RWD) (potentially concurrent standard of care control) using a synthetic control for statistical inference of a single arm trial in order to consider the data variability (rather than just the use of the point estimate as the threshold). But the results will still be uninterpretable if we fail to account for known and unknown confounding factors when comparing the results to an external control [13]. Thus, when external data are borrowed to form a control group, for the validity of the analysis outcome, we need to ascertain some key assumptions which include the consistency of patient population, medical practices, and treatment regimens. If individual patient data from the external source are available, propensity score estimated from individual patients’ covariates can be applied to match and select patients from the external source [14]. Thus, patients of the single arm trial and the selected patients from the external source are comparable at least by some measures believed to be relevant or predictive of ‘disease progression’. If individual patient data from multiple RWD sources are not simultaneously accessible due to data privacy policy, aggregated data in the form of special summary statistics may be requested in order to perform the appropriate data matching analysis [15,16]. Further research in this area is of great critical needs.

As for the other open label studies, to mitigate potential bias, for a single-arm trial, the statistical analysis plan should be finalized before the initiation of the study. Theoretically, during the trial, there should be no unplanned trial modifications including the target population, the sample size, the threshold, the approach for analysis and the source of external information. Any amendment is considered potentially data driven.

Historical Data Borrowing Design and Pseudo Randomized Controlled Design

Obviously, there are some challenging issues associated with the traditional single arm design in the alternative design category as alluded to previously. We attempt here to address the issue of better generating and incorporating valid internal/external control data to ameliorate the design deficiency of single arm studies.

Bayesian Design

Bayesian design allows the leveraging of historical/external information through the application of an informative prior distribution. The design may borrow treatment effect information (both the active treatment and control data) or borrow just the control data from the historical studies so that the total sample size of the current study can be reduced to make the study more feasible particularly for a trial in a rare disease area where recruiting patients is very challenging. If only the historical control data will be borrowed, a full sample size for the experimental treatment arm, but a reduced sample size for the control arm could be used. Different from the single arm trials, the study with a Bayesian design has both comparative arms even though the sample size for the control arm may be relatively smaller. Thus, the design can sometimes be treated as the hybrid of single arm and controlled design with the borrowing of external data. Only when internal data are available can we assess the consistency between the historical and current data. Consistency has two aspects. One is the consistency in study setting regarding patient population definition/identification, study endpoint definition/specification, study procedures and similar study centers [17].

This consistency is the prerequisite for the validity of the design. Another aspect is the consistency in the study endpoint value across the historical and current studies. To prevent the excessive amount of data borrowing, even when the study characteristics of the historical and current studies are largely similar, a dynamic data borrowing procedure may still be implemented so that the amount of data borrowing depends on the observed level of consistency in endpoint value (e.g., the observed mean values of the endpoint) of the two datasets [18,19]. The amount of data borrowing is reflected in the adjustment on the variance of the prior distribution or the effective sample size. There is no impact on the mean of the prior distribution in this dynamic historical data borrowing process. If baseline covariates could impact the value of the study endpoint, to make the patients of the historical data comparable to the concurrent patients, we can first do patient matching and selection using propensity score and then apply the Bayesian dynamic approach to regulate the amount of data borrowing.

A Bayesian design is considered as a Complex Innovative Design (CID) per the FDA guidance [6]. CIDs are designs that have rarely or never been used to date to provide substantial evidence of effectiveness in new drug applications or biological license applications. Based on the guidance, extensive simulation should be performed to demonstrate the frequentist operating characteristics of the Bayesian design in terms of type I error probability and power. Rather than just claiming the significance of the treatment effect and providing the point estimate of the treatment effect, the advantage of the Bayesian design and analysis is that it provides the flexibility to make probabilistic statement regarding the true treatment effect through the posterior distribution. Particular attention should be paid to any historical borrowing methods. With the improvement of the standard of care, placebo effect may vary and change over time, and the treatment effect may attenuate over time. Therefore, the borrowing of historical control data may create bias in favor of the superiority claim but against the non-inferiority claim [20]. Simulation will be helpful to quantify the range of bias.

Pseudo Randomized Controlled Design

One of the underlying deficiencies with the above single arm or Bayesian design is the usage of ‘historical’ control data which are subject to drift over time, and therefore potentially non-comparable to current medical practices, endpoints measurements, study procedures and patient populations. The question is whether we can and how to potentially address this challenge (at least in part). Let’s now modify the traditional randomized controlled open label trial in the following way. In selected countries/sites, patients who meet the protocol criteria will be virtually ‘randomized’ to the treatment or control in a pseudo trial. There is no need for the patients to know they are randomized in this ‘pseudo’ trial at this point of time. Those who are ‘randomized’ to the control will be followed with the standard clinical practice procedure or standard of care, in this case, without the need of consent. By nature of this randomization scheme, this ‘control’ group is (concurrent and) comparable to the future ‘treatment’ group and serves as the basis of creating ‘unbiased’ comparisons. Among the patients who are ‘randomized’ to the treatment, we ask for their informed consent to participate in an open label single arm trial. Those who consent to participate in the pseudo randomized and ‘single treatment arm’ study will take the study medication and be followed according to the protocol while the other patients who do not consent will be followed like those ‘randomized’ to the control, i.e., under the standard of care. (Figure 1) provides the flow chart of this design which has the following features.
i.It can be considered as a design with a single treatment arm plus a ‘randomized’ concurrent rather than historical control arm. Therefore, this design is somewhere between the single arm uncontrolled or historical controlled design and the regular open label randomized controlled design. Note that the traditional single arm trial does not have a randomization step and therefore has no randomized ‘unbiased’ concurrent control. The issues associated with the traditional single arm trials have been discussed in Section 3. This design improves upon the traditional single arm trial by providing a comparable concurrent control group and yielding ‘unbiased’ treatment effect estimates.
ii.Note further that patients are ‘randomized’ first and then consent next for those randomized to ‘treatment’, or consent to provide Real World data for those randomized to ‘control/placebo’. In the traditional randomized controlled trials, patients consent first then are randomized later, those who do not consent are not randomized and not included in either the treatment arm or control arm. The proposed new design could therefore be applicable to situations where traditional randomized, placebo-controlled trials are not ethical or practical.
iii.The control is the real open label standard of care control rather than a placebo control (with the exclusion of certain concomitant medications). Due to the open label nature, if a placebo was used, there should be no extra placebo effect (Figure 1).

We next address the question of how to perform data analysis and interpret the results; moreover, how to use the data from patients who are randomized to ‘treatment’ but do not consent. First, for those patients randomized to treatment, we need to assess the comparability between those who consent and do not consent to participate in the study based on their characteristics (In traditional trials, we cannot assess this. It is nice to have this information). In the case where they are very similar, we can infer that if the patients who are randomized to the control were also asked to consent, likely, those who consent and those who do not consent might also be similar. Actually, no matter whether they consent or not, they all should realize that they will all have the same standard of care. Thus, the comparison between the treated patients and all the patients in the control arm should be justifiable. Patients who are randomized to treatment, but do not consent have no on-treatment data. If the intent-to-treat principle is applied and include all randomized patients in the analysis, clearly, the treatment effect will be substantially underestimated. As the missing data mechanism is more likely to be independent with the missing endpoint data and therefore is missing at random. The analysis based on a likelihood approach with non-consent patients excluded is therefore valid [21,22] particularly if the key baseline covariates are included in the analysis model. On the other hand, in case where the consent and none consent patients are different in terms of their characteristics, propensity score can be used for patient matching and selection from the controlled patients for the eventual treatment effect evaluation [14]. Since the control is concurrent real-world control and ‘randomization’ is performed, the between treatment comparison should be less biased and we should have more confidence with this analysis compared to the analysis with historical control.

Note that in order to include patients in data analysis, we need to obtain their agreement or ‘consent’ to use their data. This ‘consent’ is a light consent (e.g., signing a HIPPA release form with appropriate de-identification measures) for those who are randomized to the control as they do not need going through interventional study procedures. We just need their endpoint being measured at specific timepoints, which can be considered as a part of the treatment procedures even under the standard of care. Since the safety profile of the standard of care should be well known, patients in the ‘control’ group also do not need to take the cumbersome safety endpoint measurements. The safety of the experimental drug can be evaluated by the within treatment assessment approach using the concurrent background safety profile as the reference. Moreover:
i.For efficacy: we likely only have measures of the primary endpoint (survival or clinical outcome) at certain timepoints. Study design should consider such SOC practices, so we avoid any design or data measurement bias (e.g, more frequent measures in treatment group, creating ascertainment biases). For some secondary endpoints, we may not have data from the control group.
ii.For safety, again, we need to avoid data collection biases: if we have more frequent clinical visits in the treatment group, we may collect more ‘routine’ adverse events or have more lab abnormalities detected via frequent central labs. Therefore, we should focus more on serious adverse events, or assess lab out of ranges (exceeding multiple times of the upper limits of normal) only at timepoints of SOC practice.

If all patients are required to formally consent and go through the formal study procedures according to the trial protocol, the pseudo randomized design can be replaced by a traditional randomized open label-controlled design. (Table 1) provides the summary of the comparative features of different designs. Besides those discussed in (Table 1), for the pseudo randomized trial design, trial procedures could be simplified at least for the patients in the control group to save cost. Moreover, there will be less issues of patients’ dropping out from the ‘study’ for those randomized to the control (Table 1).

Discussion

As discussed, there are many different clinical trial designs for us to select for a specific trial in a given context. The suitability of a design will depend on the disease area, the objectives of the trial, the nature of the new treatment, the study population, the acceptability by the health authorities, the timeline and cost considerations. Some of the designs including the traditional randomized double-blind controlled design and single arm design are widely used. Nonetheless, they may not always be applicable efficient or feasible for some scenarios. Thus, innovative designs are proposed in literature and are being used in practice. Clearly, some of these designs may need additional assumptions for the results to be valid such as the consistency assumption for the use of the Bayesian design with historical data borrowing. Some of the assumptions can be verified via observed data when performing data analysis. Based on the comparison in (Table 1), the pseudo randomized controlled design may be a suitable option when blinding is not possible, and we need a concurrent control to provide valid comparable data in a real-world setting where patients can have more flexibility and at the same time cost for the study can be reduced. There is one drawback compared to traditional single arm trials: because of the ‘pseudo randomization,’ we do ‘lose’ some patients who refuse to consent to be treated.

Even though there may be some sound rationale and considerations behind any new designs, to fully understand and appreciate the features of the design, we need to further evaluate and share our experience obtained from real trial practice. Sometimes, performing simulation for a specific trial setting is also necessary per the regulatory guidance. In terms of the pseudo randomized single treatment arm concurrent controlled design discussed in Section 4.2, we do not have much experience regarding when and why a patient would consent or not consent to participate in the active treatment group of the study. Patients’ behavior may depend on the availability of alternative medicines in the market even though a patient can always drop out from the study and switch medication any time during the study if the study treatment apparently has no effect. In addition, a patient may consent to take the active treatment and participate in the study for the purpose of saving medical cost and getting the needed care at the same time. Then the behavior will be ‘social-economic’ related and the associated prognostic covariates will need being incorporated in the analysis model to reduce bias. If such a design can be deployed, we will have data to assess the differences (if any) between consent and none-consent patient subgroups and evaluate the differences between the concurrent control group and any historical control data (if available). We welcome readers to consider and further enhance this new design proposal.

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Infantile Ocular Cystinosis: About Two Family Casesy - Juniper Publishers

 Ophthalmology - Juniper  Publishers

Abstract

Cystinosis is a metabolic pathology characterized by the accumulation of cystine in lysosomes, essentially damaging the eyeball and the kidney. It is characterized by a cystine transport defect due to a mutation in the CTNS gene. Our objective was to report two familial cases of cystinosis with ocular manifestation. It involved a 7-year-old girl (Case 1) and her 18-month-old little brother (Case 2), followed in nephropediatrics for cystinosis and referred to our department for an eye assessment. Rickets resistant to vitamin D supplementation were noted . They presented with Fanconi syndrome and renal ultrasound was normal in both. At the slit lamp we found superficial punctate keratitis and a deposit of refractive microcrystals scattered over the entire extent of the cornea, with a Gahl score of 3.00 in both patients. A homozygous CNTS mutation was revealed by molecular biology. The asymptomatic parents presented the same mutation in the heterozygous state. They benefited from treatment based on vitamin A in ophthalmic ointment and correction of hydro-electrolyte disorders and vitamin D supplementation. Cystinosis is a rare genetic pathology. It is to be looked for in the presence of corneal crystals associated with a delay in height and weight growth. The diagnosis is made by measuring intra leukocyte cystine. Cysteamine, orally and ocularly, has significantly improved the prognosis. Genetic counseling is of paramount importance.

Keywords: Cystinosis, Corneal crystals, Fanconi syndrome, Cysteamine

Introduction

Cystinosis is a lysosomal, autosomal recessive pathology caused by mutation of the CTNS gene encoding cystinosin. This membrane transport protein allows the efflux of cystine from lysosomes to the cytoplasm, where it is degraded into cysteine. The intralysosomal accumulation of cystine induces the formation of insoluble crystals responsible for progressive multi-organ failure, particularly in the kidneys, pancreas, thyroid and eyes. Several ocular locations of this crystal accumulation have been described and can jeopardize the quality of life of affected patients, possibly creating visual impairment and even blindness [1]. Our objective was to report two familial cases of cystinosis with ocular manifestation.

Case Description

It involved a 7-year-old girl (Case 1) and her 18-month-old little brother (Case 2), respectively from a family of four children, the result of second-degree parental consanguinity. They were followed by a nephropediatrician for cystinosis and referred to our department for an eye assessment. Pediatric examination revealed rickets resistant to vitamin D supplementation, marked by failure to thrive (-2 standard deviations). In Case 1, an epiphyseal bulge at the ankles and wrists, a genu valgum, was noted. On laboratory examination, they presented Fanconi syndrome marked by polyuria, hypocalcemia, hypokalemia, hyponatremia, hypophosphatemia, hypovitaminosis D and elevated β 2-microglobinuria. Renal ultrasound was normal, well differentiated in both.

The ophthalmological examination showed distance visual acuity assessed according to the Léa scale at 0.2 at OD and 0.4 at OG in Case 1. It was difficult to assess in Case 2, who presented good light tracking at 2 eyes. At the slit lamp, there was superficial punctate keratitis and a deposit of refractive microcrystals scattered over the entire extent of the cornea, with a Gahl score of 3.00 in both patients (Figures 1 and 2). The remainder of the examination was normal in both Cases. The ophthalmological examination of both parents was unremarkable. Molecular biology allowed us to make the diagnosis of cystinosis in the 2 Cases, revealing a homozygous mutation of the CNTS (c.614A>G) (Figure 3). The asymptomatic parents presented the same mutation in the heterozygous state (Figure 4). The other 2 children of the siblings were unaffected by the mutation. They benefited from treatment based on vitamin A in ophthalmic ointment and correction of hydro-electrolyte disorders and vitamin D supplementation.

Discussion

Cystinosis is an autosomal recessive disease that is caused by an accumulation of cystine in lysosomes. This concerns cells of all tissues and organs with greater sensitivity on the part of kidney tissue. It is the absence of cystinosine, a cystine transporter located in the lysosome membrane, which is responsible for this accumulation, with cystine no longer being transported out of the lysosome [2]. Found in all ethnic groups, this disease has a prevalence of between one birth in 200,000 and one birth in 100,000 depending on the country [3]. These were the first cases found in our department.

Ninety-five percent of people with cystinosis have the infantile nephropathic form. Three clinical forms of cystinosis (infantile, juvenile and ocular) have been described depending on the age of onset and the severity of symptoms. In the infantile form, the most common, the first signs appear after 3 months, marked by a polyuro-polydipsic syndrome and significant growth retardation, secondary to a generalized proximal tubular syndrome (Toni-Debré-Fanconi syndrome) with disturbances. hydro electrolytes severe.

The accumulation of cystine in different organs is responsible for hypothyroidism, insulin-dependent diabetes, hepatosplenomegaly with portal hypertension, muscle damage and brain damage. Ocular damage, secondary to cystine deposits in the cornea and conjunctiva, leads to tearing and photophobia. The disease gradually progresses after the age of 6 to end-stage renal failure. The juvenile form appears after the age of 8 years and presents a clinical picture of intermediate severity, with end-stage renal failure occurring after the age of 15 years [2-4]. Finally, there is the non-nephropathic or pure ocular form , which appears in adulthood . The 2 patients reported presented with infantile cystinosis.

The severity of the disease is essentially based on kidney damage which can be life-threatening. Cystinotic nephropathy manifests itself by weight loss, Fanconi syndrome, damage to the renal glomerulus and manifestations affecting other organs. The extrarenal involvement is essentially ocular and mainly causes photophobia and blepharospasm. Corneal damage is constant, appears from 12 months, and consists of deposits of birefringent spindle crystals which accumulate over time in the corneal stroma, and progress from the anterior stroma towards the endothelium. The appearance is scintillating and multicolored on biomicroscopic examination. Superficial punctate keratitis and strip keratitis are often associated, and the corneal endothelium is spared. In more advanced stages, limbal corneal neovascularization can be found [5,6]. The severity of corneal damage can be assessed by the Gahl biomicroscopic score (0 to 3) and by OCT of the anterior segment [6]. Confocal microscopy makes it possible to analyze and quantify corneal crystals, assess the infiltration of inflammatory cells and look for nerve damage [7].

Cystinotic retinopathy is rarer. Crystal deposits are sometimes noted throughout the retina. Depigmentation of the retinal periphery associated with pigment deposits is possible, which can progress to retinal atrophy [5,8]. The crystals can also be located on the conjunctiva, the iris, the ciliary body, the anterior lens capsule, the choroid or the optic nerve and cause complications such as angle closure glaucoma, posterior synechiae, edema. macular, choroidal neovascularization [6,8]. Our patients did not present any localization other than corneal involvement.

The biochemical diagnosis is based on the intra-leukocyte cystine dosage which is the gold standard. It is a sensitive and precise examination for the confirmation of the disease [5]. It is not available in our context.

The molecular diagnosis is confirmed by the presence of mutations in the CTNS gene coding for cystinosine located on chromosome 17. There are genotype and phenotype correlations explaining the variability of the symptoms [3]. This genetic study is necessary to confirm the diagnosis and carry out family studies with a view to genetic counseling. In our case, it made it possible to confirm the genetic mutation in the 2 children and in the parents.

Treatment with cysteamine has improved the prognosis of the disease. Its aim is to deplete lysosomes of cystine [1,3]. Its early administration makes it possible to delay the age of onset of end-stage renal failure and prevent late complications. To achieve effective corneal concentrations, topical administration of cysteamine in the form of ophthalmic gel is required [1]. This requires an increased dosage which can make treatment compliance difficult. As cysteamine is not marketed in Senegal, patients received symptomatic treatment with vitamin A ointment and hydro electrolytic and vitamin supplementation.

Conclusion

Cystinosis is a rare genetic pathology whose main manifestation is Fanconi syndrome. It is to be looked for in the presence of corneal crystals associated with a delay in height and weight growth. The diagnosis is made by measuring intra leukocyte cystine. Cysteamine, orally and ocularly, has significantly improved the prognosis. Genetic counseling is of paramount importance.

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Understanding the Concept of “Nutraceutical” - Juniper Publishers

 Pharmacy & Pharmaceutical Sciences - Juniper Publishers

Abstract

Nutraceuticals, a portmanteau of “nutrition” and “pharmaceutical,” represent a rapidly growing and evolving field in the realm of health and wellness. This term refers to products that combine the benefits of both nutrition and pharmaceuticals, as they aim to promote health and prevent or manage diseases. Nutraceuticals encompass a wide range of substances, including vitamins, minerals, herbs, dietary supplements, functional foods, and bioactive compounds. The core concept behind nutraceuticals is their potential to deliver therapeutic effects beyond basic nutrition. They are designed to bridge the gap between dietary insufficiencies and pharmaceutical interventions. Nutraceuticals may enhance overall well-being, support specific physiological functions, or alleviate symptoms associated with various medical conditions.

The appeal of nutraceuticals lies in their natural origins and the premise of fewer side effects compared to traditional pharmaceuticals. These products often contain bioactive compounds with antioxidant, anti-inflammatory, or immune-boosting properties, such as omega-3 fatty acids, probiotics, and plant polyphenols. The nutraceutical industry has witnessed exponential growth due to the increasing awareness of preventive healthcare and the desire for more natural treatment options. However, it also faces challenges related to regulation and quality control, as the boundaries between food and medicine can be blurred.

Keywords: Antioxidants; Disease modifiers; Herbal nutraceuticals; Nutraceutical products; Nutraceuticals, Oxidative stress

Introduction

The original concept in these concepts goes back three thousand years. Hippocrates (460-377 BC), the nicely recognized father of current medication, said “let food be thy medicine and medicine be thy meals” to expect the courting among suitable ingredients for fitness and their therapeutic benefits. The truth in this saying is broadly regarded nowadays. The idea of nutraceuticals is not new, although it has evolved substantially over the years. in the early 1900s, meal producers inside the u.s. started out adding iodine to salt so that you can save your goiter, representing one of the first attempts at creating a functional issue through fortification. these days researchers have identified hundreds of compounds with useful characteristics, and they preserve to make discoveries surrounding the complex advantages of phytochemicals (non-nutritive plant chemical compounds which have protecting or sickness-preventative houses) in meals. In Japan, England, and other countries, nutraceuticals have already got grown to be a part of the nutritional landscape. Client hobby in the relationship between food plan and fitness has elevated the demand for data on nutraceuticals. speedy advances in technological know-how and era, growing fitness care prices, modifications in meals legal guidelines affecting label and product claims, a growing older population, and a rising hobby in reaching wellness via food regimen are among the elements fueling U.S. interest in nutraceuticals. Credible scientific research indicates many capacity fitness benefits from meal components. These blessings should expand the fitness claims now accredited to be diagnosed using the food and Drug administration [1-3].

Approximately 2000 years ago, Hippocrates efficaciously emphasized “let meals be your medication and remedy be your meals”. presently there is an improved worldwide interest due to the recognition that “nutraceuticals” play a major position in fitness enhancement. The term “Nutraceutical” was coined by combining the terms “vitamins” and “Pharmaceutical” in 1989 via Dr. Stephen De Felice, Chairman of the inspiration for Innovation in medicinal drugs. “Nutraceutical” is a marketing term evolved for a nutritional complement that is offered to treat or save your sickness and thus has no regulatory definition. Therefore a “nutraceutical” is any substance that can be taken into consideration as food or part of meals and affords scientific or fitness benefits, encompassing, the prevention and treatment of sicknesses. Such merchandise might also vary from isolated vitamins, nutritional dietary supplements, and diets to genetically engineered “clothier” ingredients, herbal products, s and processed ingredients which include cereals, soups, and liquids. Currently, over 470 nutraceutical and functional food products are to be had with documented health advantages. “Nutraceuticals and useful foods have received huge interest due to their presumed safety and capability dietary and therapeutic results”. The nutraceutical and practical meals industry is in a unique position to capitalize on clients’ hobbies. Be it a multinational pharmaceutical organization, a nutritional organization, a large meals multinational, or a small diet-promoting company, all of them apprehend the converting tendencies and are aware of the extra health-seeking consumer fashion. there may be, hence, a proliferation of this cost-delivered merchandise aimed toward no longer only maintaining oneself wholesome but also prevention/remedy of numerous illnesses ranging from coronary heart illnesses to cancer [4,5].

As referred to in advance, purposeful foods contain larger profit margins than conventional ingredients (30 to 500 percent better). the worldwide marketplace size is anticipated between 30 and 60 billion US$, with Japan, US, and Europe occupying the most important share. By way of 2010, the nutraceutical call is forecast to touch $197 billion. There are lots of misunderstandings regarding the terminologies like “nutraceuticals”, “functional meals”, “nutritional supplements” “clothier meals”, “scientific foods”, “pharma foods”, “phytochemicals” etc. There appears to be a thin dividing line in their interchangeable utilization using oneof- a-kind humans on one-of-a-kind events. “Prescription drugs” can be taken into consideration as tablets used especially to treat sicknesses, even as “nutraceuticals” are the ones which might be intended to save you from sicknesses.

The above difference between prescription drugs and nutraceuticals is lovable, however superficial and inaccurate. prescription drugs are materials that have (or have had) patent protection because of expensive trying out to conform to the specifications of respective Governments. However, many vitamins may in no way get hold of authorities’ approval on account that no person could justify the cost of testing requirements for materials that cannot be blanketed via patent laws. Each prescription drug and vitamin can cure and save your ailment(s), but the best prescription drugs have governmental sanctions [6-8]. Many prescription drugs have their origin in plant life and animals and aren’t any much less “natural” than vitamins. A classic instance of vitamins is synthetic vitamins. Nutraceuticals from time to time referred to as “functional ingredients”, have induced heated debate because they blur the conventional dividing line between meals and medication. When food is being cooked or prepared with the usage of “medical intelligence” without or with the know-how of the way or why its miles getting used, then the meals are known as “functional meals.” for that reason, purposeful food provides the body with the required quantity of nutrients, fat, proteins, carbohydrates important for healthful survival. whilst practical meals aid within the prevention and/or remedy of ailment(s)/ ailment(s) other than deficiency conditions like anemia it’s miles called a “nutraceutical”. Consequently, useful food for one patron can act as a nutraceutical for any other. Examples of nutraceuticals include fortified dairy products (milk as such is a nutrient and its product casein is a pharmaceutical) and citrus result (orange juice is a nutrient and its constituent ascorbic acid is a pharmaceutical).

A dietary supplement is a product that is intended to supplement the diet that bears or includes one or extra substances like nutrition, mineral, herb, an amino acid or pay attention, metabolite, constituent, extract or mixtures of those. “Medical meals” are a particular class of therapeutic sellers which are meant for the nutritional management of a specific ailment. An example of clinical meals is formulations intended to control sufferers with inborn mistakes in amino acid metabolism. more modern medical ingredients are designed to manipulate hyperhomocysteinemia, pancreatic exocrine insufficiency, inflammatory situations, most cancers cachexia, and other illnesses. The usage of nutraceuticals, as an attempt to accomplish applicable healing outcomes with decreased facet outcomes, compared with different therapeutic dealers has met with amazing monetary success [9,10]. The desire for the discovery and manufacturing of nutraceuticals over prescription drugs is nicely appreciated by pharmaceutical and biotechnology agencies. some popular nutraceuticals consist of glucosamine (for arthritis), lutein (for macular degeneration), ginseng (for cold), echinacea (anti-immune), folic acid, cod liver oil pills, and so on. The most popular functional food and beverage products include omega-3 eggs, omega-three enriched yogurts, calcium-enriched orange juice, and inexperienced tea to mention some. Most of the nutraceuticals do own a couple of healing benefits, however in the gift overview, plenty of attempts have been dedicated to decentralizing them based on their sicknessspecific essential indication. Nutraceuticals was claimed to have a physiological advantage or offer protection in opposition to the subsequent sicknesses (and/or observed to act as):

i. Cardiovascular dealers

ii. Antiobese sellers

iii. Antidiabetics

iv. Anticancer dealers

v. Immune boosters

vi. persistent inflammatory problems

vii. Degenerative sicknesses

viii. Neuro degenerative diseases [11]

Nutraceuticals vs Other Terminologies

There is a lot of bewilderment concerning the terminologies like nutraceuticals, useful meals, dietary supplements, fashion designer foods, clinical foods, pharma foods, phytochemicals, and so on. “Prescribed drugs” can be taken into consideration as pills used specifically to deal with sicknesses, at the same time as “nutraceuticals” are those that are supposed to save you illnesses. inside ecu drugs law a nutraceutical can be described as a remedy for two motives: it may be used for the prevention, remedy, or remedy of a condition or sickness or be administered so that you can restore, correct, or enhance physiological functions in human beings. Each prescription drug and vitamin can treat and save your disease(s), but the best-prescribed drugs have the governmental sanction. capsules are concerned with an approval process before marketing. To be accredited, a drug should exhibit safety and efficacy for its supposed use. Nutraceuticals aren’t capsules without a doubt due to the fact they have no longer long passed via an approval system. Many prescribed drugs have their starting place in plants and animals and are not any much less “natural” than nutrients. A conventional instance of nutrients is synthetic vitamins. “Medical foods” are a specific class of healing agents that can be meant for the dietary control of a selected ailment. An instance of scientific meals is formulations meant to manipulate patients with inborn errors in amino acid metabolism. More recent scientific meals are designed to manage hyperhomocysteinemia, pancreatic exocrine insufficiency, inflammatory conditions, cancer cachexia, and other illnesses. meals are usually diagnosed as secure whereas Nutraceuticals may additionally contain materials that might be “herbal” but won’t be formally recognized as safe [12-14].

Nutraceuticals occasionally referred to as “purposeful foods”, have induced heated debate due to the fact they blur the conventional dividing line between meals and medication. Nutraceuticals barely range from useful foods. When food is being cooked or prepared the usage of “medical intelligence” with or without an understanding of the way or why its miles getting used, the food is called useful food. Hence, functional food provides the body with the specified quantity of vitamins, fats, proteins, carbohydrates, etc. Wanted for its healthful survival. Whilst practical meals aid within the prevention and/or treatment of ailment(s) and/or disorder(s) other than anemia, it is known as Nutraceutical. (Because maximum of the useful foods act in a few ways or the opposite as anti-anemic, the exception to anemia is considered to have a clear distinction between the 2 phrases, functional meals, and nutraceutical.) Examples of nutraceuticals consist of fortified dairy merchandise (e.g., milk) and citrus culmination (e.g., orange juice) and veggies. us nutritional complement fitness and training Act (DHSEA), defined “nutritional supplement” as the usage of numerous criteria. A nutritional supplement is a product (aside from tobacco) that is supposed to supplement the weight-reduction plan that bears or consists of one or greater of the subsequent dietary components: a vitamin, a mineral, an herb, or a different botanical, an amino acid, a dietary substance to be used through man to complement the weight loss plan through increasing the overall daily consumption, or a concentrate, metabolite, constituent, extract, or combos of those substances [15].

A dietary supplement: is meant for ingestion tablet, pill, pill, or liquid shape. isn’t represented to be used as a conventional food or as the sole object of a meal or eating regimen. is labeled as a “nutritional supplement.” consists of products together with an accepted new drug-certified antibiotic, or licensed biologic that was advertised as a dietary complement or food before approval, certification, or license.

for this reason, nutraceuticals vary from nutritional dietary supplements within the following components: Nutraceuticals ought to not only complement the weight-reduction plan but must also resource in the prevention and/or ailment. Nutraceuticals are requested for use as a traditional food or as the sole object of a meal or diet. Nutraceuticals are manufactured to strict requirements and are regulated beneath food safety and satisfactory control regulations [16]. A ray of “treatment desire” in the mind of commonplace patients revolves around nutraceuticals due to their false notion that ‘all herbal medicines are true.” also, the excessive cost of prescription drugs and the reluctance of a few coverage businesses to cowl the expenses of medicine helps nutraceuticals solidify their presence inside the worldwide marketplace of healing procedures and therapeutic marketers [17].

Type of Nutraceuticals

Nutraceuticals are labeled based on various chemical constituents present in herbal flowers. desk 1 suggests the listing of numerous nutraceuticals, their additives, supply, and their capacity blessings. Discussion nowadays, nutraceuticals have obtained high hobbies because of their capacity dietary, and safety profile, aside from healing capability. Pharmaceutical and dietary groups are aware of the converting traits that are due to the advantages of these compounds. most nutraceuticals possess more than one therapeutic advantage. The prevailing examines devoted to a better understanding of nutraceuticals primarily based on their pharmaceutical and therapeutic warning signs. It has to be noted that there might be numerous confusions associated with the terminology of nutraceuticals, including phytochemicals, pharma foods, medical meals, practical foods, nutritional supplements, clothier ingredients, and so forth., there may be a thin dividing line between their interchangeable usage with the aid of distinct humans on one-of-a-kind activities. prescribed drugs are ordinarily taken into consideration as medications that are used especially to treat illnesses, but nutraceuticals are the substances that are often considered to prevent illnesses.

This difference between prescribed drugs and nutraceuticals may be very erroneous and superficial. pharmaceuticals and nutraceuticals each can remedy and save you sickness(s) however, the best pharmaceuticals have governmental sanction. prescribed drugs are compounds that typically own patent safety due to high-priced testing. However, nutraceuticals no longer want those checking out documents.

Scientific foods or medicinal foods are a particular category of healing marketers that might be taken into consideration for the nutritional control of a specific ailment. as an instance, medicinal foods are designed to manage inflammatory situations, most cancers, hyperhomocysteinemia, pancreatic exocrine insufficiency, and other diseases. They also play significant protection against numerous age-related or continual illnesses. Natural drug treatments which are used as a nutrient are considered in this category. Nutraceuticals are in many results and vegetables are answerable for health advantages. because of these health blessings of nutraceuticals, they could often be taken to treat or lessen the risk elements together with excessive LDL cholesterol, excessive blood strain, and diabetes. several of the most popular nutraceutical products marketed these days are botanicals which include ginseng, ginkgo biloba, St. John’s wort, and echinacea. [The list of nutraceuticals being studied is changing usually and reflects ongoing marketplace developments, research, and consumer interest. With rapidly increasing interest in nutraceutical intake, sizeable research is important to warrant the nutraceuticals utilization secure and powerful. The mechanistic actions of nutraceuticals aren’t clean. However, they are probably concerned with a wide type of biological techniques, including activation of signal transduction pathways, antioxidant defenses, gene expression, cellular proliferation, differentiation, and upkeep of mitochondrial integrity

Classification of nutraceuticals: (Table 1-3)

Research Methods

Research on nutraceuticals usually involves a multidisciplinary approach.

Literature review

A thorough review of the controlled articles, including research articles, reviews, and supervisory directions, was conducted to consider the various facets of nutraceuticals.

Data collection

Data were collected through surveys, interviews with specialists, and analyses of nutraceutical production labels and additives. The market dossier was also asked to recognize the current situation.

Data analysis

A qualitative study was used to categorize and compile judgments from brochures, surveys, and interviews. A quantitative dossier, if available, was resolved to recognize the flows and advantages.

Results

Definition and classification of nutraceuticals

Nutraceuticals are products that come from fair beginnings or are fortified with accompanying bioactive compounds that support fitness benefits and provide further basic food. They can be classified into various types, including working snacks, digestive supplements, and herbaceous products.

Key active ingredients

Common life factors of nutraceuticals include vitamins, minerals, antioxidants, probiotics, prebiotics, and phytochemicals. These ingredients are well known for their potential to enhance well-being and prevent illness.

Consumer perspectives

Research shows that purchasers turn to nutraceuticals for a variety of reasons, including common well-being and wellness, ailment prevention, and addressing health concerns. Consumer priorities are frequently affected by perceptions of ease and security.

Regulatory framework

The supervisory foundation of nutraceuticals varies from country to country. In many domains, distinguishing directions and controlling product quality standards guarantee device security and efficacy. Compliance with these requirements is essential for display access.

Market trends

Nutraceuticals have endorsed meaningful developments in recent years, compelled by the growing strength of knowledge among shoppers. Key currents include the rise of working foods, embodied food, and an increasing emphasis on tenable and unaffected sourcing of pieces.

Discussion

Nutraceuticals are complex and are evolving. They maintain a singular slot in food and health activities, contributing to the promise of improved comfort and health support. However, challenges related to experimental confirmation, product quality control, and regulatory agreements remain. Moreover, as manufacturing continues to evolve, it securely and efficiently balances innovation and service choice. Researchers, managers, and industry partners must agree to guarantee that nutraceuticals meet their potential while addressing these challenges.

Conclusion

Many nutraceuticals, functional ingredients, and occurring compounds that had been investigated and reported in diverse research found that these products are extraordinarily active, have a profound effect on cellular metabolism, and frequently have a little unfavorable impact. It’s far natural that human beings’ consciousness is moving to an effective method for the prevention of illnesses to stay healthy. Nutraceuticals are clinical vicinity generated everywhere around the globe. in many cases, nutraceuticals provide a bonus over the synthetic capsules beneath improvement by way of the prescribed drugs enterprise.

It is a novel pharmacological interest which has become exciting in its feasible scientific use and for that reason helps in the prevention and therapeutic of numerous illnesses. maximum of the pharmaceutical companies frequently lacks the motivation to pursue those difficulties in acquiring patents. its miles hope that government groups and research facilities will provide a guide for similar studies in nutraceuticals [18-20].

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On Influence of Zhou Gong on the Political Thoughts of Huang School - Juniper Publishers

 Archaeology & Anthropology - Juniper Publishers

Abstract

It is well known that thoughts and administration measures of Zhou Gong (Duke of Zhou)周公 are the source of Confucianism. However, Huang School is good at learning from other Schools, and has absorbed the administration methods and political thoughts when Zhou Gong ruled the adherents of Shang Dynasty. With the study of existing and excavated documents, the paper conveys the idea that the virtue-punishment thought of Huang School learns from the Zhou Gong’s thought of “illustrate his virtue and be careful in the use of punishments.” he put forward the idea of learning from and following the administration methods of former ancient emperors of Shang Dynasty. He regarded former wise emperors of Yin as models of governance. He knew the history of Xia and Shang Dynasty, and learned from their experience, and values the natural law. He used the methods of Shang Dynasty to make enfeoffment, rites and calendar. These measures achieve great effects. His thoughts and measures have great influence on the political thoughts of Huang School. Of course, Huang School prevailed in the Warring States of Period, and some thoughts did not exist in Zhou Gong’s period.

Keywords:Zhou Gong; Huang School; Political thoughts; Adaptation

Introduction

Throughout the ages, the systematic thoughts and theories all experience the development from birth to completeness. After a long time of practice, accumulation and assimilation, some learned from others’ strong points to offset their weakness as time advanced and things changed. It gradually becomes systematic, develops into a metaphysical aspect, and eventually forms a complete systematic theory including metaphysical theory and practice after continuous improvement. It is true for both Confucianism and Taoism. After the development of the pre-Qin period, Han, Wei, Jin, North and South Dynasties, Sui, Tang, Song, Yuan, Ming and Qing Dynasty, Confucianism has absorbed different thoughts to have rich contents, and become the mainstream in Chinese culture [1]. Taoism is no exception. It has the complete metaphysical theory and practice that have great influence on Chinese history. A theory will have great or small influence on other theories, politic, economy, society, academy, art and history in different aspects. Meanwhile, these mutual influences can be positive or negative [2]. In the whole humanistic society, all factors interplay.

Issues and Academic Contributions of this Paper

This paper mainly solves a problem: as Zhou Gong, who has an important influence on Chinese traditional culture and has an important position, in addition to having an important influence on Confucianism, he also has a great influence on the pre-Qin Taoism, especially his influence on the Huang School. Huang School is one of the Huang Lao School. The Huang and Lao have the same and different ideas. Scholars often confuse the two. However, if you read the related texts in pre-Qin and Han dynasties carefully, you will find that there is a difference between Huang School and Lao School. This article is to explore the influence of Zhou Gong on Huang school’s thought. The author has checked relevant papers at home and abroad in China, and almost none of them have devoted to this. This article discusses the influence of Zhou Gong on Huang School, one fills the space of Zhou Gong’s research, and the other distinguishes the internal differences in Huang Lao School, which is quite innovative in academic research.

In terms of politics including politicians and political events, Zhou Gong is an important figure in the early of Zhou Dynasty¹.

He has thoughts in politic, society, ethic and military. As the founder of Chinese culture and pre-Qin theory [3], he established the social ethic, individual morality and concept of land under Heaven, advocated rule by rites, virtue and civilization, and worshiped Hou-ji and emperor Wen. His words and deeds have great influence on the future academic theory, politic and political system. He has influence on not only Confucianism but other theories including Huang School.

Every systematic theory is good at learning from others’ strong points and offset their weakness to better its own theory, improve its level and strengthen its depth, which is also true for Taoism. It has absorbed different theories especially in political theory, and doesn’t neglect the influential figures in history. When scholars explore the origin of Huang School, Zhou Gong should not be neglected. Weihua, Runtian [4] think that Huang School originated from the legend related to the Yellow Emperor in the Spring and Autumn Period. Xi [5] believes that the study of Huang-Lao is related to Fan Li. Xi and Kangsheng [6] both believe that the study of Huang-Lao originated from Laozi. During the development of Huang-Lao political theory, it has many theory origins. Author believes that some Zhou Gong’s theory should be one of the origins of political theory of Huang School, which it has absorbed [7]. The paper will talk about the influence of Zhou Gong’s words and deeds and administration on political theory of Huang School, and provide a new perspective for the origin of Huang School and origin of Confucianism and Taoism.

Methods

Before the political theory of Huang School is talked about, the relations among Taoism, Huang School and Lao Thoughts should be discussed. Generally, Taoism refers to the school and group that express their academic purpose, including Huang-Lao School, but Huang-Lao School can’t cover Taoism fully [8]². Huang-Lao School is the general term for Huang School and Lao Thoughts. They are two schools of Taoism in pre-Qin and have different and similar thoughts. Scholars believe that lost ancient Lao Zi, Jing Fa or Four Classics of Hunag Emperor (hereinafter referred as Four Classics) are the important classics of Huang School. The Huang School in the paper is quoted only from this book. According to the study, it is hard to tell which came first. They have similar thought on Taoism, but have difference in applying Tao into society and politic. Lao Zi emphases that “It should keep to the role of the female” [9] and “The submissive and weak will overcome the hard and strong” (1982:53). Four Classics advocates “discriminating between feminine and masculine conduct” (Chang et al., 1998:163). Lao Zi talks about the Tao not laws, and emphases that “The way never acts yet nothing is left undone” [9]. The chapter of Tao and Laws emphases that “It is out of Tao that the law come into being [10], and no success comes without struggle, and values laws. Lao Zi values nature, and believes that it should “keep people innocent of knowledge and free from desire” [9]. Four Classics acknowledges the effect of human, and believes that human can conform to nature to change it. Four Classics values judging status, while Lao Zi doesn’t [11].

Although there are similarities and difference between Huang School and Lao School, they care called together as Huang-Lao School. There are two reasons for this. The first one is they are not differentiated from each other in The Grand Scribe’s Records. The second one is that Lao is used to replace Huang, and books of Huang School are not available. From generation to generation, it is not being corrected (1989:152).

Besides, because of the close relation between Zhou Gong and political theory of Huang School, the paper will introduce the political theory of Huang Thought first. Scholars believe that the Tao in the “On Principle of Six Schools³” written by Sima Tan refers to Huang School [12]. The Huang School he talked about is concise and clear:

“The doctrine of Taoism proclaims that people should concentrate their attention on activities and take action with empty forms, and meanwhile the essence is to nurture the nature of all things on the earth. Besides a reference to what Yin-Yang says about the seasonal alteration, Taoism has found its way to obtain the merits of Confucianism and Mo Tzu (Mo Zi), to extract the essence of Ming Chia (Ming Jia) and Fa Chia (Fa Jia) and to evolve compatible with the current situation. Therefore, the creed of Taoism can easily exert its force on almost everything with a good understanding of the simple intention so that a minimal effort can produce a maximal effect [13].”

“The term “Wu Wei” is rendered in Taoism as “doing nothing” and “Wu Bu Wei” as “accomplishing everything”. Although the notion of the two terms is too profound to comprehend, what it advocates is easy to implement. The theoretical foundation of Taoism is emptiness so that it has neither external forms nor constant state, which will enable it to explore the reasonable nature of all things only if it applies itself in a practical way and obeys the nature law. This kind of emptiness is depicted as the Tao, which can be the governing principle of all things, because it neither surpasses everything nor lags behind. The rules within the Tao are not postulated but cater to the needs of situation and the dimension of the Tao should contain the varied forms of all things. So, the reason why the achievements of the sage are indelible in spite of the elapsing time is that they accomplish things in tune with times. Emptiness is the eternal rule of the Tao and the adaptation of times is the elementary step for an emperor to tackle the national affairs. The emperor should have a clear idea about the distinction between honest courtiers and sycophantic ones. A person is lively with ardent spirit that resides in the physical form of the body. The overuse of spirit will make it exhausted and the overwork of the physical body will cause it collapsing. What’s worse, an isolation of spirit from the physical body means death. Once the isolation takes effect, it cannot be restored to its original state just as the dead cannot come to life again, so the sage has paid great attention to both the spirit and the body. In this regard, the physical form supports life while spirit is the fundamental force that endows life with vitality. Without the mental and physical tranquility, it is a hollow and preposterous to say that “I have an efficient way to manage the world.” But how can you start without spirit and body to rely on?” (2004:6338).

¹Most of the documents in the early Zhou Dynasty are related to Shangshu: Book of Zhou. Scholars also call it as Dagao, Kanggao, Jiugao, Zicai, Zhaogao, Luogao, Duoshi, Wuyi, Junshi, Duofang and Lizheng, which directly record the words and deeds of Zhou Gong. For more details, please refer to Gu Jiegang, Liu Qihua, On the Annotation and Translation of Shangshu, Beijing, Zhonghua Book, 2005; Du Yong, Study on Eight Admonitions of the Early Zhou Dynasty, Beijing, China Social Sciences Press, 1998, pp. 8-91.

²More discussions about Taoism, please refer to Creel HG (1956) What is Taoism. Journal of the American oriental Society (JAOS) 76(3): 139- 152.

³Smith K (1992) in “The Concept of ‘Six Schools’ Created by Sima Tan” (Chinese Culture, No. 2) points out that for the first time in the history of Chinese thought, Sima Tan used “家” to refer to different schools. Taoism is a new comprehensive category.

In the essay, Sima Tan mainly talks about political theory. He believes that Huang School has the merits of Confucianism, Mo Tzu (Mo Zi), Ming Chia (Ming Jia), Fa Chia (Fa Jia) and Yin Yang. Its thoughts are as followed.

First, “emptiness” and “action with empty forms”. “Emptiness” refers to the objective laws and rules. “Action with empty forms” means that all activities (cultivation, behavior and administration) of emperors should conform to the objective laws including natural law. Emperors should consider the natural law as the foundation of social order and rule the country [14]. Emperors need not add or reduce their own desire, but could nurture the nature of all things on the earth. This involves the relation among emperors’ administration learning from natural law, the concept of “three talents” and politic [15].

Second, “Adaptation”. Therefore, the creed of Taoism can easily exert its force on almost everything with a good understanding of the simple intention so that a minimal effort can produce a maximal effect. The wise emperors should follow the objective laws, but as the things (time and objective things) change, it applies itself in a practical way and obeys the nature law. Emperors should conform to the objective situations in action. Emperors should change as the situation changes, enable to explore the reasonable nature of all things, master the nature of all things, comply with the changes of everything and take “adaptation as the foundation. So, the adaptation of times is the elementary step for an emperor to tackle the national affairs. Adaptation is the important content of Taoism. Huang School emphasizes that in administration, the emperor should do nothing, and the subjects should do their duties, and the emperor should own the rights of reward and punishment. The emperor should have a clear idea about the distinction between honest courtiers and sycophantic ones. The subjects should do their own duties and show their talents. The emperor needs reward the virtuous and talented people and punish the mediocre and the disloyal. This is the Thought of Emperor Judges and subjects work and the thought of reward and punishment [15].

Third, keep the spirit and physical body. “The purpose of this is to make the emperor rest the spirit and body. A person is lively with ardent spirit that resides in the physical form of the body. The overuse of spirit will make it exhausted and the overwork of the physical body will cause it collapsing. What’s worse, an isolation of spirit from the physical body means death. Once the isolation takes effect, it cannot be restored to its original state just as the dead cannot come to life again, so the sage has paid great attention to both the spirit and the body.” In this regard, the physical form supports life while spirit is the fundamental force that endows life with vitality. The emperor understands that the goal of politic is to ensure the rest of his spirit and body without much overuse. So, Huang School puts forward the theory of keeping the spirit and body of the emperor [15].

So, for the political theory of Huang School, Sima Tan believed that the emperor should comply with the natural law and master the objective situation to conform to the changes, and use “adaptation” to ensure the rest of spirit and body. This is the key points of political theory of Huang School [16].

Results and Discussion

The above-mentioned is the political theory of Huang School, which has been influenced by Zhou Gong. Generally, scholars believe that Taoism and Jiang Ziya are closely related, and Zhou Gong has a close relation with Confucianism, which can be seen from the opinions of Ban Gu. The category of Taoism in Han Zhi has recorded 237 essays. Ban Gu considered Tai Gong as one of the Taoist [17]. Historical Records has recorded that “when T’aikung arrived at his state, he cultivated administration, adapted their social customs, simplified their social codes” [13]. And it also has recorded that Jiang Ziya said: “I simplified the ritual codes between the lord and his vassals. I followed its customs in governing” (2004:2287). It is obvious that “adapting their social customs” and “following its customs” are the important measures of Jiang Ziya’s administration, which are also vital contents of political theory of Taoism. During his administration, he valued “adaptation”, and this is why Ban Gu considered him as one of the Taoist. So, it is seen that Ban Gu believed that “adaptation” is an important part of Taoism.

In fact, Zhou Gong’s words and deeds have great influence on the political theory of Huang School. The paper will discuss about it from the following aspects.

Influence of Zhou Gong’s thought of “illustrate virtue and be careful in the use of punishments” on the virtue and punishment of Huang School

Zhou Gong’s thought of “illustrate virtue and be careful in the use of punishments”

“Illustrating virtue and be careful in the use of punishments” is the important content of Zhou Gong’s political thoughts. It is in the chapter of “The Announcement of Kangshu”. In this essay, Zhou Gong warned Kang Shu that “Your father, great and bright King Wen, advocated moral education, cautiously employed punishments but he did not bully and oppressed those who were helpless, he employed those who might be employed, respected those who might be respected, and threatened those who might be threatenable, it was his rule to respect and love people” [18]. Scholars have different explanation of “illustrate virtue and be careful in the use of punishments”. In the Spring and Autumn Period, Sheng Gong thought that it meant that the monarch should not have sexual conduct [19]. Shangshu quoted Zi Xia’s words to explain that “be careful in the use of punishments” meant that the monarch should think about the punishment really carefully [20]. Pseudo-Confucius Biography believed that putting virtuous one in an important position was as vital as being careful in the use of punishments (2011:647). Kong Yingda [21] thought “illustrating virtue” as “using virtue”, which meant the virtuous ones. Sun Xingyan [22] and Wang Xianqian [20] regarded “be careful in the use of punishments” as probation. Modern scholars such as Jianhua [23] and Yubo [24] think that “illustrate virtue” requires that the emperor needs to improve moral cultivation, and “valuing virtue” is for protecting people. All these opinions are different from the original meaning of “illustrating virtue and be careful in the use of punishments”.

When scholars discuss about the virtue in “illustrate virtue”, they always stick to morality. In fact, the meaning of virtue has a development process in pre-Qin Period. In Shang Dynasty, it meant following, gain, behavior, regulation and laws. In Western Zhou, it meant the God will-emperor-people relation, moral conduct and good thoughts. In the Spring and Autumn Period, it meant the virtuous men, morality rules, external criterion, ritual culture, culture and education, national destiny, and good diplomatic relations (Zhao-gui, Year? 243-253)⁴.

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When Zhou Gong put forward the thought of “illustrate virtue and be careful in the use of punishments”, he opposed the virtue and punishment. Virtue meant to do someone a favor and soften someone. “Illustrate virtue” was Zhou Gong’s ruling measure of winning people over, and didn’t mean his virtue and morality cultivation. Punishment was the opposite if virtue, which meant the compulsory punishing measures. In the chapter “The Announcement of Kangshu”, Zhou Gong put forward the principles and implementing guideline of punishment, including being careful in the use of punishment, opposing punishment to kill the innocent, heavy sentence to criminals that commit crimes on purpose and recidivists and light sentence to the criminals with negligence and causal offenders, abolishing collective punishment and cruel torture, opposing random punishment and killing, and advocating proper punishment.

Zhou Gong’s virtue and punishment thought was still used in the Spring and Autumn Period. They often compared the virtue and punishment. In “Twenty-Fifth Year of Duke Xi” in Zuo Zhuan, it is said that “It is virtue by which the people of the Middle State are cherished; it is by severity that the wild tribes around are awed.” In “Twelfth Year of Duke Xuan” in Zuo Zhuan it is said that “when it submitted, be forgave it－his kindness and justice were established. There was the justice of punishment in the attack of revolt; there was the kindness of virtue in the gentle dealing with submission. Both these things were shown” [19]. Virtue and punishment are two aspects of political principles in the Spring and Autumn Period, which was called virtue-punishment principle [25].

Zhou Gong valued virtue and illustration. Book of Zhou records that Zhou Gong liked to use illustration, such as “illustrate virtue”, “show a great discrimination”, “give them bright distinction”, “the enlightener and sustainer”, and “shines brightly” there are also some in Chinese bronze inscriptions, such as “illustrate regulations”, illustrate virtue, “show Heart”, “illustrate punishment” and “shines brightly” [26]⁵. It also uses “illustrate punishment” in Huang Men [27]. In Mister Lv’s Spring and Autumn Annals, it says that illustration exists because of ration [28]. Zhou Gong used the “Ming” frequently. He emphasized the human’s ration and the ability of ration, and distinguished his thought and administration measures from that of Yin people to emphasize the importance of the thought of “illustrate virtue and be careful in the use of punishments” to rule country and suppress rebellion in the critical period [29]. Besides, in the documents of Qin and Han Dynasty, “Ming” has the religious meaning, and maybe reflects the ancient worship of light. Zhou Gong emphasized the destiny of Heaven and valued the “illustrate virtue”. In Heaven, “de” was called “virtue of Heaven”, and on earth, it was called “illustrate virtue” [30]. “Virtue of Heaven” meant that people were endowed with “virtue of Heaven”, which was a religious and political words [31]. Obviously, Zhou Gong transformed the “illustrate virtue” from a religious word to a political word, and granted it with new meaning.

⁴On the development of the connotation of “Virtue” in the pre-Qin Dynasty, please refer to Fulin C (2005) The Origin and Development of the Concept of “Virtue” in Pre-Qin Period. China Social Sciences, 4. Delong L (2013) A Study of the Origin of “Virtue” in Pre-Qin Period (PhD’s thesis).Jilin University.

⁵For more information, please refer to The Anthology of Bronze Inscriptions of Yin and Zhou Dynasties. Beijing: Zhonghua Book Company, 1984.

Besides, the punishment in “be careful in the use of punishments” should include penalty. In the chapter “The Announcement of Kangshu”, it says that “you must see that those punishments, as well as the penalty of death, be righteous”, which means the rational punishment and penalty of death [32]. In the chapter “No Ease”, it says that “(your ministers will imitate you) so the correct laws of the former emperors, both small and great, will be changed and disordered”. In Pseudo-Confucius Biography, it explains the punishment as law [21]. Liu Qihua [18] believed that punishment and penalty were the same. In a word, the meaning of “illustrate virtue and be careful in the use of punishments” is to not only benefit people, but also be careful when using the punishments and laws. Different methods need be adapted in the administration of Yin people.

Combination of virtue and punishment of Huang School

Political theory of Huang School advocates the combination of virtue and punishment, and appreciation of civil and military. Four Classics advocates handling their relation from the theory of Yin and Yang, and believes that they supplement each other. In the chapter “Investigation”, it says that “Instead, rectify affairs with punishments and rewards (by bestowal of benefits). Spring and summer are the seasons for reward; autumn and winter are the seasons for punishment. Give priority to virtue over punishment in order to nourish life…So brilliantly evident are punishment and reward as are the sun and moon set in turn to illuminate according to the brilliance proper to each, and to wax [and wane] without error…the ruler above and the subjects below will be in great harmony and both will satisfy their ambitions. Heaven will complete (these) in accordance with (their natural tendencies). Nourishing the affairs of people according to the right timing, and giving priority to reward rather than punishment, are following Heaven” [11]. In the chapter “Contention of Clans”, there are similar words, saying that “The supreme measures of rectification are punishment and reward. So, manifests are punishment and reward that they are like the sun and the moon calling on each other (in coordinated complementarity) …Manifest as the reward of Heaven is, it cannot function without punishment. Awesome as the punishment of Heaven is, it will lose its efficacy without reward. Punishment and reward nourish one another and thereby the distinction between compliance and rebelliousness is established” (1989:300). Four Classics puts the virtue and punishment together, showing that they are the ruling tools. Virtue is the opposite meaning punishment, which is reward in chapter “Er Bing” of Han Fei Zi. It points out that “what virtue and punishment are? Killing is punishment and reward is virtue. Subjects are afraid of punishment but enjoy virtue. So, when emperors are good at using virtue and punishment, the subjects will fear his power and respect him” [33]. Han Feizi was influenced by Huang-Lao School. The virtue and punishment are important concepts of Huang School, and it is an important method for emperors to rule their subjects. Huang School advocates virtue before punishment, and virtue over punishment.

Besides the combination of virtue and punishment, Huang School also advocate the appreciation of “wen” and “wu”. In the chapter “Correct emperorship”, it defines the meaning of “wen” and “wu”. It says that following the vitality of life ordained by Heaven to nourish life is called wen (governing by civil administration). “Following the (destiny) of death ordained by Heaven to administer the severe sanction of death to those who should be killed is called wu (governing by coercive administration). If both [wen] and wu function well, then all-under-Heaven will obey the ruler” [11]. “Wen” means that people can get a rest and emperor should promote the policies of benefiting people. “Wu” refers to the armed suppression and attack. And it means that the emperor should overthrow the evil government with righteous power. The emperor should use both, overthrowing the evil government with force to expand his lands and promoting people-benefit policies to win people’s support. And in this way can he rule all the lands. “If one is performing the ways of wen and wu carefully, one will gain the allegiance of all peoples under Heaven” (1989:251). “Wen” and “wu” are two methods for an emperor to rule all the lands.

During the relation between virtue, and punishment and “wen” and “wu”, “wen” is the manifestation of virtue, and “wu” is the representation of punishment, so the relation between “wen” and “wu” is dominated by the relation between virtue and punishment [11]. According the above-mentioned, “wen” refers to the people-benefit policies and conciliation policy, and “wu” refers to the armed form of suppressing rebellion and overthrowing evil government. “Wen” and “wu” are the two methods of governance and ruling all lands. So, the meaning of “wen” and “wu” is larger than that of virtue and punishment.

Influence of Zhou Gong’s thought of “illustrate virtue and be careful in the use of punishments” on the combination of virtue and punishment of Huang School

According to the above-mentioned, the virtue in thought of “illustrate virtue and be careful in the use of punishments” has the same meaning as the virtue in Huang School. Both refer to the conciliating reward measures adapted by emperors. Zhou Gong’s thought of “illustrate virtue and be careful in the use of punishments” has direct influence on the combination of virtue and punishment of Huang School.

Besides, from the development of virtue’s meaning, the influence of Zhou Gong’s thought of virtue on Huang School can be seen. The meaning of Zhou Gong’s virtue includes original virtue, emperor virtue, people virtue, ancestor virtue, etiquette, and people’s mind and thoughts (Zhao-gui, Year:253-266). In summary, virtue includes politics, religion, society and selfcultivation. Zhou Gong implemented these virtues in order to consolidate the emperorship given by Heaven, so he put forward the thought of “illustrate virtue and be careful in the use of punishments” in the hope of getting the support of Zhou people and Shang people to secure the emperorship [34]. Four Classics was written in the Warring States Period, and the thought of virtue was affected. Besides inheriting and developing Zhou Gong’s thought of “illustrate virtue and be careful in the use of punishments”, it has both metaphysical theory and practice. Metaphysical theory means that virtue falls on everything from its nature - Tao. This is a basic common recognition that Taoism in pre-Qin Period has for virtue.

Zhou Gong put forward the thought of “careful punishment”, which meant the principles and criterion of using punishments and. Penalty and punishment had the same meaning. In Er Ya, it says that punishment is law, so law and punishment have same meaning. Huang-Lao School in pre-Qin period values punishment, and one of contents of punishment is law. Huang School also value law, emphasizing that law is born from Tao. In the chapter “Tao and Laws”, it says that “It is out of Tao that the law come into being. These laws, prescribed according to calculus of gains and losses, are yardsticks to measure and to distinguish what is correct from what is incorrect” [10]. Law is metaphysical and scared, and transcends politic and times to have independence, transcendence and fairness. “Laws and regulations represent the supreme rectitude” (1998:112). With law, the right and wrong can be told. “The distinction between right and wrong should be determined by laws. One should be empty and quiet (to be able) to listen carefully so as to accord with the laws” (1998:143). If everything conforms to the law and fairness, emperors and lawexecutors are very important. So, in Law, it emphasizes that “those who formulate laws and regulations are not allowed to create confusion (in given priority)” (1998:112)，and “only one who is (devoted to) the common good without selfishness and can see and know without confusion” (1998:142). “Only when the law is executed fairly without selfish desire can the country be ruled effectively. Only when pure impartiality without self-interest (is given priority), and all punishments and rewards are fully carried out” (1998:112). So, Huang School on law has inherited the Zhou Gong’s thought of “careful punishment”.

Influence of Zhou Gong’s administration measure on political thought of Huang School

The paper will talk about influence of Zhou Gong’s administration measures on the politic.

Zhou Gong learns from the ruling experience of emperors of Shang Dynasty, studies its law, and critically accepts its traditions

Wei district was the old capital of Shang Dynasty, and its adherents lived here. It was hard to rule them. Zhou Gong enfeoffed his brother, Kangshu, to this land. Before leaving, he warned him carefully. Besides putting forward the thought of “illustrate virtue and be careful in the use of punishments”, he also required Kangshu to learn from Shang Dynasty’s experience. “Now your management of the people will depend on your reverently following your father Wen; --do you carry out his virtuous words which you have heard, and clothe yourself with them. Moreover, where you go, seek out among the traces of the former wise emperors of Yin what you may use in protecting and regulating their people. Again, you must more remotely study the old accomplished men of Shang, that you may establish your Heart, and know how to instruct the people. Further still, you must seek out besides what is to be learned of the wise emperors of antiquity, and employ it in tranquillizing and protecting the people. Finally, enlarge your thoughts to the comprehension of all Heavenly principles, and virtue will be richly displayed in your person, so that you will not render nugatory the emperor’s charge.” Zhou Gong requires Kangshu to use the people of Shang Dynasty, listen to their suggestion of ruling country, and seek the governance of ancient wise emperors to gain the method of protecting people. In this way, the people in Wei district can live a happy life and the emperor’s order will not be neglected.

Zhou Gong regarded former wise emperors of Yin as models of governance. He said, “When I think clearly of the people, I see that they are to be led to happiness and tranquility. I think of the virtue of the former wise emperors of Yin, whereby they tranquillized and regulated the people, and rouse myself to realize it. Moreover, the people now were sure to follow a leader. If one do not lead them, he could not be said to exercise a government in their State” [35]. He emphasized that whether the life of people is improved, they all must study and master the way of ruling people like the former wise emperors of Yin and use them successfully. Tang was the one he needs to learn from. In the chapter “An Announcement for Many Countries”, Zhou Gong praised Tang that “he paid careful attention to the essential virtue of a sovereign, in order to stimulate the people, and they on their part imitated him, and were stimulate” (1991:498). He praised that Tang is careful in the use of punishment, and people were moved and learn to do good deeds. He punished the criminals and people were afraid and try do good deeds. In the chapter “The Establishment of Governmental Institute”, Zhou Gong praised that Tang used three talented subjects and the virtuous ones. “Tang employed to fill the three high positions those who were equal to those positions; and those who were called possessors of the three grades of ability could display that ability. He then studied them severely and greatly imitated them, use the utmost of them in their three positions and with their three grades of ability. The people in the cities of Shang were thereby all brought to harmony, and those in the different quarters of the empire were brought greatly under the influence of the virtue thus displayed” (1991:512-513). He praises that Tang can use the three talented subjects and other virtuous ones, so that he can “rule with folded hands”. Emperors rules using the right ones, the subjects take their responsibilities, and everyone is on his own duty. This is the ideal politic of Confucianism and Taoism.

Zhou Gong knew history and valued tradition including the tradition of Shang and Zhou Dynasty. In the chapter “The Announcement of Banning Wine”, it says that “let the young also Hearken diligently to the constant lessons of their fathers.

Let them look at virtuous actions whether great or small in the same light” (1991:403). He demanded Kangshu to remember the lessons from ancient generations, and promote all traditional virtues. He valued the tradition of Zhou clan and had a critical attitude to the tradition from Yin clan. Zhou Dynasty replaced the Shang Dynasty, and they could not only follow the political tradition of Yin clan, but also promote policies to rule the Yin people. One feature of politic in Shang Dynasty is valuing law and punishment. In the Book of Rites, it says that Yin people respect the god and lead its people to serve the god; the ghost is before the rite and punishment before reward. This show that Shang Dynasty values law and punishment. In the chapter “The Announcement of Kangshu”, Zhou Gong emphasizes that “in things beyond your immediate jurisdiction, have laws set forth which the officers may observe; and those should be the panel laws of Yin, which be right-ordered” (1991:390), and “in setting forth the business of the laws, the punishments will be determined by the regular laws of Yin. But you must see that those punishments, as well as the penalty of death, be righteous” (1991:391). This requires that when Kang Shu handles the cases, besides the regular law of Shang Dynasty, he needs to take the reasonable law and punishment. The reason that Zhou Gong values the law of Shang Dynasty is because he wanted to master the key points of laws of Shang Dynasty and learn its advantages to transform laws of Shang Dynasty into the laws of Zhou Dynasty. This is his smartness.

Zhou Gong’s administration measure of following the tradition of Shang Dynasty

Zhou Gong followed the tradition of Shang Dynasty of enfeoffment

After overthrowing the Shang Dynasty, Zhou Gong relocated the Yin clan to different enfeoffment areas. Their clan groups and orders were not collapsed but kept. In Zuo Zhuan, Zi-yu talked about the enfeoffment:

When emperor Woo had subdued Shang, emperor Ch’ing completed the establishment of the new dynasty, and chose and appointed [the princes of] intelligent virtue, to act as bulwarks and screens to Chow (Zhou). Hence it was that the duke of Chow gave his aid to the royal House for the adjustment of all the emperordom, he being most dear and closely related to Chow. To the duke of Loo (Pih-K’in, the duke of Chow’s son) there were given －a grand chariot, a grand flag with dragons on it, the hwangstone of the sovereigns of Hea (Xia), and the [great bow], Fan-Joh of Fung-foo. [The Heads of ] six clans of the people of Yin,－the Teaou, the Sea, the Senou, the Soh, the Chang-choh, and the Wechoh, were ordered to lead the chiefs of their kindred, to collect their branches, the remoter as well as the near, to conduct the multitude of their connexions, and to repair with them to Chow, to receive instructions and laws of the duke of Chow. They were then charged to perform duty in Loo, which thus the brilliant virtue of the duke of Chow might be made illustrious. Lands [also] were apportioned [to the duke of Loo] on an enlarged scale, with priests, superintendents of the ancestral temple, diviners, historiographers, all the appendages of State, the tablets of historical records, the various officers and the ordinary instruments of their offices. The people of Shang-yen were also attached, and a charge was given to Pih-K’in, and the old capital of Shaou-Haou was assigned as the centre of his State. To K’ang Shuh (The first marquis of Wei) there were given a grand carriage, four flags,－of various colored silks, of red, of plain silk, and ornamented with feathers,－and [bell], Ta-leu, with seven clans of the people of Yin,－the T’aou, the She, the Po, the E, the Fan, the Ke, and the Chung-k’wei. The boundaries of his territory extended from Woo-foo southwards to the north of Poo-teen. He received a portion of the territory of Yew-yen, that he might discharge his duty to the emperor, and a portion of the lands belonging to the eastern capital of Seang-t’oo, that he might be able the better to attend at the emperor’s journeys to the east. Tan Ke delivered to him the land, and T’sou Shuh the people. The charge was given to him, as contained in the ‘Announcement to K’ang,’ and the old capital of Yin was assigned as the centre of his State. Both in Wei and Loo they were to commence their govt. according to the principles of Shang, but their boundaries were defined according to the rules of Chow (Zhou). To T’ang Shuh (The first lord of Tsin) there were given a grand carriage, the drum of Meihseu, the Keueh-kung mail, the bell Koo-seen, 9 clans of the surname Hwae, and five presidents over the different departments of office. The charge was given to him, as contained in the ‘Announcement of T’ang (New lost),’ and the old capital of Hea (Xia) was assigned as the centre of his State. He was to commence his govt. according to the principles of Hea (Xia), but his boundaries were defined by the rules of the Jung. Those three princes were all younger brothers, but they were possessed of excellent virtue, and they were therefore distinguished by those grants of territory and other things [35].”

Zhou Gong made the enfeoffment of Lu, Wei, and Tang country, and granted them with lands, positions, and people of Yin sixth clan and seventh clan that are skilled one, craftsmen and people of Huai clan, cars, religion things, weapons, and jade objects. These the Yin clan moved as a whole. Shirakawa Shizuka [36] pointed out that this Yin clan still kept their form and order, and pronounced the ruling policies that “they were to commence their govt. according to the principles of Shang, but their boundaries were defined according to the rules of Chow (Zhou).” Xu Zhuoyun [37] has the same opinion. He believed that Zhou Dynasty used the combination of Zhou Dynasty, Shang Dynasty and oriented old groups as the basic principles of administration, and they use the policies of Xia, Shang, and Jung to humour the local culture. Author agrees with Chao Yuepei’s opinion. He said that “(Both in Wei and Loo) they were to commence their govt. according to the principles of Shang, but their boundaries were defined according to the rules of Chow (Zhou).” And “he was to commence his govt. according to the principles of Hea (Xia), but his boundaries were defined by the rules of the Jung.” That “their boundaries were defined according to the rules of Chow (Zhou)” means that in terms of land management, they adapted the agricultural production methods of Zhou Dynasty and following their production and operation methods instead of changing their long-standing living habits. That “he was to commence his govt. according to the principles of Hea (Xia)” is to adapt the living habits of Jung in the early of Dynasty and keep the order. The rules of Zhou and Jung are different land rules, namely agriculture and stock farming. Tang Shu promoted the rule of Jung to respect the living habits of nomadism [38].

When Zhou Gong made the enfeoffment, he followed the tradition of Shang Dynasty. Besides the clan groups, he also let them have their own faith, like altar of Poh in Lu country. In 496 BC, “Yang Hoo imposed another covenant on the duke and the 8 Hwan clans at the altar of Chow (Zhou)) and one upon the people at the altar of Poh” [35]. He aimed to gain the support of Yin people [39]. So, we can see that from the early of Zhou Dynasty to the end, Yin people in State of Lu still had their clan group and faith.

The State of Qi is considered as the one to use the method of following tradition. The Grand Scribe’s Records has recorded that when Jiang Ziya arrived at the State of Qi, he followed the tradition, simplified the etiquette, developed industry and provided convenience for the fish and salt industry. People preferred the State of Qi [13]. The following tradition means to keeping the custom and habits of original residents. Simplifying the etiquette means keeping their rite system instead of promoting the rites of Zhou Dynasty. Oriented area has old clans. State of Qi followed its customs and habit of inheriting the family name, and organized the mixed ruling powers [37]. Obviously, the administration of Jiang Ziya followed the customs of original residents, which is the same in principle as State of Lu’s commencing his govt. according to the principles of Shang, and State of Jin’s commence his govt. according to the principles of Xia.

hou Gong knew that promoting the method of following tradition could help them gain their positions and achieve better governance. Shuo Yuan recorded the words that Zhou Gong warned his son -- Bo Qin in State of Lu with much meaning of Taoism. He said that it is noble for the ones in high positions that could protect the humble, it is smart for the majority to protect the fear ones, and it is reasonable for the smart ones to protect the fool. All these are the virtue of modesty. And he quoted from the chapter “Khien” in the Book of Change that “it is the way of Heaven to diminish the full and augment the humble. It is the way of earth to overthrow the full and replenish the humble. Spiritual and beings inflict calamity on the full and bless the humble. It is the way of men to hate the full and love the humble” [40]. The “Khien” is a work in the Warring State Period [41]. The words are quoted from the Khien by later generation to show that Zhou Gong valued modesty. Modesty is valued by Confucianism and Taoism, and they have similar origin of that. This also shows the influence of Zhou Gong’s thought on Taoism.

Zhou Gong’s other measures of ruling Yin people

Besides the above-mentioned measures of following Shang Dynasty’s rules in his administration, Zhou Gong also followed Shang Dynasty’s rule in other aspects to achieve success. Zhou Gong appointed some nobility of Shang Dynasty, and in the chapter “The Announcement of Kangshu”, it says that “from the Hou, Teen, Nan, Ts’ae, and Wei domains, the various officers stimulated this harmony of the people, and introduced them to the business there was for Chow (Zhou). The duke of Chow (Zhou) encouraged all to diligence.” “Bo min” refers to the Yin people relocating to City of Luo and they take positions in the government. In the chapter “The Announcement of Zhaogong”, it says that “after seven days, on Kea-tsze, in the morning, from his written specifications he gave their several charges to the people of Yin, and to the chiefs of the States from the Hou, Teen and Nan tenures. When the people of Yin had thus received their orders, they arose with vigor to do their work” [35]. Zhou Gong appointed the emperors of Hou, Teen, and Nan as the Dukes with the same positions. Some Yin people were appointed as presbyters wearing the formal clothes of Shang Dynasty. In the “Wen Wang” of The Book of Poetry, it says that “the officers of Yin, admirable and alert, Assist at the libations in (our) capital;--They assist at the libations, Always wearing the hatchets on their lower garment and their peculiar cap. O ye royal ministers of the emperor, ever think of your ancestor!” (1991:430). Yin people were selected as the presbyters wearing the formal clothes of Shang Dynasty, which shows that Zhou Dynasty respects the customs of Shang Dynasty’s nobility [42].

Zhou Dynasty still used some rites of Shang Dynasty. In the chapter “The Announcement about the City of Luo”, it said that “the emperor’s guests, on occasion of the killing of the victims and offering the sacrifice, all made their appearance” [35]. Wang Guowei explained that “杀” means killing the animals and “禋” means offering the sacrifice. In the Rites of Zhou Dynasty, it offers the sacrifice to Hao Tian Emperor, Sun, Moon, Sizhong, Siming, Fengshi and Yushi. They burn wood to cause smoke that goes up. They also use this to offers the sacrifice to ghost. In Wu Cheng, it says that it happens in temples, which shows that in the early of Zhou Dynasty, the Shang Dynasty’s rite of offering the sacrifice are still used.

esides, in the early, Zhou Dynasty used the calendar of Shang Dynasty. In the chapter “The Announcement of Kangshu”, Zhou Gong told Kang Shu that “in examining the evidence in criminal cases, reflect upon it for five or six days, yea for ten days or three months. You may then boldly carry your decision into effect in such cases” [35]. The system of Ten days belonged to Shang Dynasty. They divided a month into three Ten days, and at the beginning of the week, a month was divided into four part. This essay was used by Zhou Gong to tell Kang Shu to follow and use the system of Shang Dynasty. Zhou Gong used the calendar system of Shang Dynasty. Calendar played an important role in ancient politic and economy.

So, we can see that when Zhou Gong ruled the country, he valued the “following the tradition” and achieved great results.

Relation between administration measures of Zhou Gong and “adaptation” of Huang School

Huang School values the “adaptation”. “Adaptation” is one of the cores of Huang School and political theory of Four Classics. In the “On Principle of Six Schools”, Sima Tan has emphasized the adaptation of times is the elementary step for an emperor to tackle the national affairs, and pointed out that Huang Thought used the adaptation of times. Adaptation means the changes in accordance with the changes of things, so adaptation also values time. Four Classics values adaptation and puts forward the adaptation of Heaven, earth and people after seeing the achievement of Zhou Gong’s adaptation administration. They will be talked about next.

The chapter “Cheng” puts forward the thought of following Heaven and says that “a sage is never the first one to act; nor is he obstinate. He does not make decisions before the opportunities are at hand. He does not acquire things (for his own purpose); (on the other hand,) he does not refuse good fortune. Accordingly, he follows the principles of Heaven. If one loses the support of Heaven, he will die. If one deceives his lord, he will likewise suffer death. If one does not treat his superior with respect, he will be in danger” [10]. A sage doesn’t act first or be obstinate, but waits for the right time and chance to act so that he will not lose the fortune. The wise emperor should follow the natural law, or his rule will be in danger. So, it is important for the emperor to value natural law and take the timing. The chapter “Cheng” also says that “if (a naturally suitable) opportunity to achieve something is not yet at hand, one should not be eager to do it prematurely. (So also) if a proper time is not yet at hand, one should not enjoy the honor (of high position and great wealth)” (1998:189). It means that plants cannot grow against the natural law to bloom, which emphasizes the importance of timing. Its meaning is expanded. The wise emperor should seize the timing in time instead of early or late, so when the time is right, everything can be successful, or it will fail. The chapter “Guan” says that “The ruler of people should restrain himself from the three pleasures, he ought not to create disorder in people’s affairs, nor should he go against the timing of Heaven. In so doing, the five grains will abundantly bear fruit, people (will) multiply, the ruler above and the subjects below will be in great harmony and both will satisfy their ambitions. Heaven will complete (these) in accordance with (their natural tendencies)” (1998:150). The wise emperor should arrange proper time for agriculture and military, and military should be avoided in the planting seasons. In this way can agriculture be developed, emperor and his subjects be harmonious, people live affluently, and Heaven bless them.

The chapter “The Four Principles” points out “timeliness of Heaven”. It says that “according to the timeliness of Heaven, launching a punitive expedition against (countries) that are suffering destruction ordained by Heaven is called wu. If the military sword (of control) is followed by wen, then success will be achieved. He who utilizes two measures of wen and one measure of wu will become a king” (1998:126). It emphasizes that the wise emperor should comply with the law of Heaven and he can overthrow the country that is bound to destruction. After the success with force, the wise emperor should pacify his people so that he can rule all the lands. So, we can see the importance of timing in the military. The chapter “The Function of an Army” also values the importance of timing. It says that “the reason the sage succeeds is because he (knows how to) seize the opportunity in time and make use of it. (If one can) follow up the timely (opportunity) and seize…one will surely succeed. The sage never rescinds punishment when it is due, nor does he break contracts. Instead, he abides by the proper timing of Heaven and makes decisions accordingly. When a decision should be made, and yet not fails to make it, then one will suffer disasters caused by himself” (1998:166). As long as the wise emperor is good at taking advantage of timing and following the timing and chances, he will be successful. Otherwise, he will suffer disaster.

In terms of adapting earth and people, the chapter “Aphorisms” says that “according to what the earth provides, one must replenish one’s (military) supplies, and, relying on (the support of) people, one must recruit a new army. If one does not follow (the natural course of events), he will not attain good fortune” (1998:188). Besides following the natural law, emperors need to act in accordance with the earth and people to succeed. Otherwise, if emperors crave for greatness and success and fight against natural law with his people, his country will be in danger. The chapter “The Function of an Army” says that “in the midst of confusion and disturbance, they will exploit the strength of people to rebel against the ultimate of Heaven. If they still achieve something by doing so, their country will be in jeopardy, their state will be in chaos and actually nothing will be achieved. Even if an achievement is celebrated, it cannot be enjoyed (because the name falls short of the reality and the country will suffer turmoil). This is the Tao of Heaven” (1998:167).

It is obvious that Four Classics believes that wise monarchs should apply adaptation to politic, military, and agriculture, and can have a good result. Adaptation is one of core concepts of politic of Huang School. Chen Ligui [12] says that the seeming negative Huang and Lao Thoughts contain tenacity to achieve the positive results, and the key is adaptation.

That Zhou Gong’s administration measures emphases adaptation has great influence on the adaptation of Huang School. His administration measures are in politic, including founding of a nation, requiring dukes to study and follow Yin emperor’s administration method, keep and respect customs, religion and organization of Yin clan. It is the same as Huang School, which believe that monarchs arrange staff and they should follow the rules and their duty [16]. Of course, Zhou Gong’s adaptation is mainly used on the administration measures, and his other measures are not following adaptation. The adaptation of Huang School has broad meaning, and is expanded and improved by Zhou Gong’s adaptation. It also includes requiring monarchs to follow Yin and Yang and respect the nature laws, and putting the society and politic into the category of adaptation. Huang Thoughts emphases that theoretical foundation of adaptation is emptiness and it is supported by Taoism. Zhou Gong emphases “illustrate virtue and be careful in the use of punishments”. The virtue he talks about is closely related to the Heaven and God will, but the God will is different from the Tao of Huang School. God will is from God, while Tao means nature law. Huang School has a Tao theory including the theory of universal formation, and it talks about the political theory based on that universal formation theory. This is what Zhou Gong doesn’t have.

Conclusion

Confucius said, “The Dynasty has followed the regulations of Yin; wherein it took from or added to them may be known.” From the development of the ritual culture of Shang and Zhou Dynasty, Confucius pointed out that ritual culture in Zhou Dynasty has inherited and selected from the ritual culture in Shang Dynasty [43]. In fact, from Zhou Gong’s administration measures, we can see his “adaptation” method [44]. The reason he uses “adaptation” method is because that Zhou Dynasty is just founded, and its power is not strong. Zhou Dynasty couldn’t rule Yin people by force. Zhou Gong had a good understanding of the history of Xia and Shang Dynasty. He learnt from their experience and emphases that the government should rule its people with virtue, and it is destiny that Zhou Dynasty replaces the Shang Dynasty because of its emperor’s virtue. Zhou Gong won people over in his administration measure, unites with neighboring countries, reduced rebellion and inherited critically the culture of Shang Dynasty. Zhou Gong put forward the thought of “illustrate virtue and be careful in the use of punishments” and implemented measures to rule Yin people to achieve great effects. His thoughts and methods have great influence on the birth of Huang School in the Warring States Period. Huang School prevailed in the Warring States of Period, and has the ideas of Taoism like valuing natural law and emphasizing Yin and Yang. These thoughts did not exist in Zhou Gong’s period. During its development, Huang School learned from others’ strong points. As an important figure, Zhou Gong’s thoughts and politic should be valued and absorbed by Huang School. The relation between them is obvious.

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