To compare the efficacy of two kinds of Zhizhu pills in the treatment of functional dyspepsia of spleen-deficiency and qi-stagnation syndrome:a randomized group sequential comparative trial

BMC Gastroenterology

Research Article

Shengsheng Zhang¹  Hongxin Cao²  Xinyue Wang³  Youhua Yu⁴  Zhong Wang⁵  Zhiwei Jing⁵  Yanan Yu⁵  Yongyan Wang⁵  Hongli Wu⁵  Luqi Huang⁶  Xudong Tang⁷ 

[1] Beijing Traditional Chinese Medicine Hospital, Capital Medical University, No.5 Meishuguan Back Street, 100010, Dongcheng District, Beijing, China;China Academy of Chinese Medical Sciences, No. 16 Nanxiaojie, 100700, Dongzhimen nei, Beijing, China;Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, No.5 Haiyuncang, Dongcheng District, 100700, Beijing, China;Experimental Research Center, China Academy of Chinese Medical Sciences, No. 16 Nanxiaojie, 100700, Dongzhimen nei, Beijing, China;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No. 16 Nanxiaojie, 100700, Dongzhimen nei, Beijing, China;Institute of Chinese Material Medica, China Academy of Chinese Medical Sciences, No. 16 Nanxiaojie, 100700, Dongzhimen nei, Beijing, China;Xiyuan Hospital of China Academy of Chinese Medical Sciences, No.1 Xiyuan playground, Haidian District, 100091, Beijing, China;

关键词: Traditional Chinese Medicine;    Functional Dyspepsia;    Naringin;    Hesperidin;    Herbal Medication;   

DOI  :  10.1186/1471-230X-11-81

 received in 2009-12-21, accepted in 2011-07-15,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundIn Traditional Chinese Medicine (TCM) theory, functional dyspepsia (FD) can be divided into different syndromes according to different clinical symptoms and signs, and the most common one is spleen-deficiency and qi-stagnation syndrome that can be treated by Chinese traditional patent medicine ---- two kinds of Zhizhu pills, between which the primary difference in ingredients is that one contains immature orange fruit of Citrus aurantium L.(IFCA) and the other contains that of Citrus sinensis Osbeck (IFCS). The trial's objective was to compare the efficacy of two kinds of Zhizhu pills on symptom changes in patients with FD of spleen-deficiency and qi-stagnation syndrome.MethodsA randomized, group sequential, double-blinded, multicenter trial was conducted in patients with FD of spleen-deficiency and qi-stagnation syndrome at 3 hospitals in Beijing between June 2003 and May 2005. Participants were randomly allocated into two groups (IFCA group and IFCS group) in a 1:1 ratio, and respectively took one of the two kinds of Zhizhu pills orally, 6 g each time, 3 times a day, for 4 weeks. Statistical analysis was performed with use of a group sequential method, the triangular test (TT).ResultsA total of 163 patients were randomized, and 3 patients were excluded from analysis because of early dropouts, leaving 160 patients (IFCA group: n = 82; IFCS group: n = 78) for statistical analysis. Three interim analyses were done after 62, 116, and 160 patients had completed their 4-week treatment, respectively. At the third interim analysis, the sample path crossed the upper boundary and the trial was stopped, the cure-markedly effective rates were 45% for IFCS group and 67% for IFCA group, respectively, the one-sided p-value was 0.0036, the median unbiased estimate of the odds ratio (OR) for the benefit of IFCA relative to IFCS was 2.91 with 95%CI: 1.40 to 6.06.No adverse events were observed in the two groups.ConclusionsZhizhu pills containing IFCA was superior to Zhizhu pills containing IFCS in the treatment of FD of spleen-deficiency and qi-stagnation syndrome. The application of group sequential analysis in clinical trials of TCM may offer some financial and ethical benefits.Trial RegistrationChinese Clinical Trial Registry (ChiCTR): ChiCTR-TRC-00000485

【 授权许可】

Unknown   
© Wu et al; licensee BioMed Central Ltd. 2011. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.