Objective To assess the reporting quality of noninferiority and equivalence randomized controlled trials (RCTs) related to Traditional Chinese Medicine (TCM). Methods The noninferiority and equivalence RCTs related to TCM were searched, and the quality of the included RCTs was identified in accordance with the extended version of CONSORT statement which refers to the reporting standard of noninferiority and equivalence RCTs. Results A total of 13 noninferiority and equivalence RCTs were included. Except for the common questions of RCTs in reporting quality, some contents related to noninferiority and equivalence trials in reporting were not enough: a) The title of RCTs did not reflect the most important content of the literature; b) The introduction of background was quite simple. The rationale about noninferiority and equivalence trials, and the effectiveness of positive control were not clearly defined; c) All literatures did not indicate whether the subjects, interventions and outcomes in the noninferiority and equivalence trials were identical or similar to those in previous trials of defining the effectiveness of control treatment; d) Most literatures did not define the critical value of noninferiority and equivalence, and did not estimate the sample size; e) Only half of literature described the statistical methods of noninferiority test and equivalence test; and f) Some literature had mistakes in noninferiority and equivalence conclusion. Conclusion The researchers still need deeper understanding of the theoretical basis of noninferiority and equivalence trials. The reference to the extended version of CONSORT statement, which refers to the reporting standard of noninferiority and equivalence RCTs, is helpful for researchers to identify the key points of the design, performance and reporting of the noninferiority and equivalence RCTs, to lay stress on the related contents of noninferiority and equivalence trial reporting, and to radically improve the reporting quality of such clinical trials.
Objective To evaluate the efficacy and safety of Niuhuangjiangya tablets (NT) on mild to moderate primary hypertension (overabundant liver-fire) in comparison with Niuhuangjiangya pills (NP). Method The double-dummy and randomized controlled method was adapted to assess 240 patients (overabundant liver-fire) who were divided into the treatment group (n =120, treated with NT 2 tablets, twice a day) and the control group (n =120, treated with NP 1 pill, twice a day).The duration of treatment for both groups was 4 weeks. Results Blood pressure began to decline in the first week of treatment. After 4 weeks, the mean diastolic and systolic blood pressure dropped 7.51 and 12.16 mmHg, respectively, in the treatment group; 7.53 and 12.45 mmHg dropped respectively in the control group. For diastolic blood pressure, the total efficacy rates of the two groups were 50.8% and 54.9% (Pgt;0.05), respectively. For TCM syndromes, the total efficacy rates of the two groups were 45.6% and 42.34% (Pgt;0.05), respectively. The two drugs were equivalent by the equivalent test (Plt;0.05). No adverse effect was found in the study. Conclusions Niuhuangjiangya tablets have confirmed that the effects on mild to moderate hypertension has few side effects. The efficacy of the two drugs is equivalent by the equivalence test. placebo=controlled trials are required.