Efficacy of a Chinese Herbal Proprietary Medicine (Hemp Seed Pill) for Functional Constipation
Efficacy of a Chinese Herbal Proprietary Medicine (Hemp Seed Pill) for Functional Constipation
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DOI：
10.1038/ajg.2010.305
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发表时间：
2011-01-01
影响因子：
9.8
通讯作者：
Sung, Joseph J. Y.
中科院分区：
文献类型：
--
作者：
Cheng, Chung-Wah;Bian, Zhao-Xiang;Sung, Joseph J. Y.
目的：功能性便秘是一种常见的临床主诉。尽管缺乏确凿的证据，但中草药已成为治疗这种疾病的一种流行的替代疗法。本研究的目的是通过严格设计的研究来评估中药中成药--麻籽丸(HSP)在最佳剂量下治疗FC的有效性和安全性。方法：本研究由两部分组成：试验I为剂量决定研究，试验II为安慰剂对照临床研究。在试验I中，首先从三种剂量(2.5、5.0和7.5g，b.i.d)中确定热休克蛋白的最佳剂量。试验II是一项随机双盲研究，将HSP治疗中医理论定义为实证的FC患者(罗马III标准)的疗效和安全性与安慰剂进行比较。试验中的所有参与者都经历了为期2周的磨合、8周的治疗和8周的随访。主要终点是治疗期间完全自发排便(CSBM)的有效率。与他们的基线相比，CSBM和GT；平均增加1/周的参与者被定义为应答者。次要结果测量包括随访期间的应答率、个人和总体症状评估以及报告的不良反应(AEs)。结果：剂量7.5g，tid。治疗效果优于2.5、5.0g，两次/d。在试验I的96名受试者中(每组32人)，因此在试验II中被选为与安慰剂比较。在试验II中，120名受试者被随机分成两组(每组60人)。治疗期间HSP组和安慰剂组的有效率分别为43.3%和8.3%，随访期分别为30.0%和15.0%(P
OBJECTIVES: Functional constipation (FC) is a common clinical complaint. Despite a lack of consolidated evidence, Chinese herbal medicine (CHM) has become a popular alternative treatment for this condition. The aim of this study was to assess, with a rigidly designed study, the efficacy and safety of a CHM proprietary medicine, Hemp Seed Pill (HSP), in optimal dosage for treating FC.METHODS: This study comprised two parts: trial I, a dose determination study, and trial II, a placebo-controlled clinical study. In trial I, the optimal dosage of HSP was first determined from among three doses (2.5, 5.0, and 7.5 g b.i.d.). In trial II, a randomized double-blind study, the efficacy and safety of HSP for FC patients (Rome III criteria) in excessive syndrome as defined by traditional Chinese medicine (TCM) theory were compared with placebo. All participants in trials underwent a 2-week run-in, an 8-week treatment, and an 8-week follow-up. The primary end point was the responder rate for complete spontaneous bowel movement (CSBM) during treatment. Participants with a mean increase of CSBM >= 1/week compared with their baselines were defined as responders. Secondary outcome measures included responder rate during follow-up, individual and global symptom assessments, and reported adverse effects (AEs).RESULTS: The dose of 7.5 g b.i.d. showed better therapeutic effect than that of 2.5 and 5.0 g b.i.d. among 96 subjects (32 per arm) in trial I and was therefore selected for comparison with placebo in trial II. In trial II, 120 subjects were randomized into two arms (60 per arm). Responder rates for the HSP and placebo groups were 43.3 and 8.3% during treatment and 30.0 and 15.0% in the follow-up period, respectively (P