Abstract
BackgroundFunctional constipation is a common clinical complaint. Although the effectiveness of Ma Zi Ren Wan for alleviating functional constipation symptoms has been proven in a previous randomized placebo-controlled study, further evidence is needed to make clinical recommendations about Chinese herbal medicine. In particular, a comparison with conventional western medicine for functional constipation patients is needed.Methods/DesignThis is a prospective, double-blinded, double dummy, randomized, controlled trial. After a 2-week run-in period, eligible patients (Rome III) with excessive traditional Chinese medicine syndrome will randomly be assigned to the Chinese medicine arm (Ma Zi Ren Wan and western medicine placebo), western medicine arm (senna and Chinese medicine placebo) or placebo arm (Chinese medicine placebo and western medicine placebo). Patients will undergo an 8-week treatment and an 8-week follow-up. The primary outcome is the responder rate for complete spontaneous bowel movement (CSBM) during treatment. Patients with a mean increase of CSBM ≧1/week in comparison with their baselines are defined as responders. The secondary outcomes include responder rate during follow-up, changes of colonic transit as measured with radio-opaque markers, individual and global symptom assessments, and reported adverse effects.DiscussionThis study is the first study to compare a Chinese Herbal Medicine (Ma Zi Ren Wan) with a laxative that is commonly used in the clinical practice of western medicine, and with a placebo. This study will complete the investigation of Ma Zi Ren Wan for functional constipation, and should, therefore, suggest recommendations for clinical practice. Furthermore, the process of first conducting a systematic review, then implementing a dose determination study followed by a placebo-control trial, and finally, comparing traditional Chinese medicine with an active conventional medicine in a controlled trial can be a reference to other researches on Chinese medicine interventions in the future.Trial registrationNCT01695850
Highlights
Functional constipation is a common clinical complaint
The process of first conducting a systematic review, implementing a dose determination study followed by a placebo-control trial, and comparing traditional Chinese medicine with an active conventional medicine in a controlled trial can be a reference to other researches on Chinese medicine interventions in the future
Constipation affects a substantial portion of the population, involving an estimated 12% to 19% of Americans [1], 14% of Asians [2], and up to 27% of the global population, depending on demographic factors, sampling, and definition [3]
Summary
Functional constipation is a common clinical complaint. the effectiveness of Ma Zi Ren Wan for alleviating functional constipation symptoms has been proven in a previous randomized placebo-controlled study, further evidence is needed to make clinical recommendations about Chinese herbal medicine. The patent formula Ma Zi Ren Wan (MZRW) was first recorded in the TCM classic, ‘Discussion of Cold-induced Disorders’ (ShangHanLun) [6], and this formula has been commonly used for excessive constipation in China and other Asian countries for more than two thousand years since the Han Dynasty (A.D. 200). It comprises six herbs: Semen Cannabis Sativae, Semen Pruni Armeniacae, Radix Paeoniae, Fructus Immaturus Citri Aurantii, Cortex Magnoliae and Radix et Rhizoma Rhei. Based on modern pharmaceutical studies, MZRW can stimulate intestinal mucosa, increase secretion, accelerate intestinal peristalsis and decrease water absorption [10,11]
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