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% (P gt;0.05), respectively. For TCM syndromes, the total efficacy rates of the two groups were 45.6% and 42.34% (P gt;0.05), respectively. The two drugs were equivalent by the equivalent test (P lt;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.
Citation： HUANG Jihan,ZHENG Qingshan,GAO Rui,TU Xiuhua,XU Fengqin,SUN Ruiyuan. Clinical Equivalence Evaluation on the Efficacy and Safety of Niuhuangjiangya Tablets and Pills in the Treatment of Patients with Primary Hypertension ( Overabundant Liver-Fire ). Chinese Journal of Evidence-Based Medicine, 2004, 04(4): 249-254. doi: Copy