Abstract
BackgroundFunctional dyspepsia (FD) is characterized by a high prevalence rate and no standard conventional treatments. Alternative therapies, such as herbal formulas, are widely used to treat FD. However, there are inadequate evidences regarding the safety and efficacy of these formulas. Moreover, the mechanisms by which herbal formulas act in the gastrointestinal tract are controversial. In traditional Korean medicine, Banha-sasim-tang has long been one of the most frequently prescribed herbal formulas for treating dyspepsia. The current study is designed to evaluate the efficacy and safety of Banha-sasim-tang for FD patients and to examine whether there will be a significant correlation between cutaneous electrogastrography recordings and dyspeptic symptoms in FD patients, and between changes in gastric myoelectrical activity and improvement in dyspeptic symptoms during Banha-sasim-tang administration.MethodsThis randomized, double-blind, placebo-controlled trial will be performed at two centers and will include a Banha-sasim-tang group and placebo group. Each group will consist of 50 FD patients. Six weeks of administration of Banha-sasim-tang or placebo will be conducted. During the subsequent 2 months, follow-up observations of primary and secondary outcomes will be performed. The primary outcomes are differences as measured on the gastrointestinal symptom scale, and the secondary outcomes are differences as measured on the visual analogue scale for dyspepsia and on the questionnaire for FD-related quality of life. All outcomes will be measured at baseline, at 2, 4, and 6 weeks of treatment, and at the 1 and 2 month follow-up. Cutaneous electrogastrography will be performed and assessed at baseline and at 6 weeks.DiscussionThis trial will provide evidence of the safety and efficacy of Banha-sasim-tang for the treatment for FD. Furthermore, based on the assessment of the relationship between cutaneous electrogastrography recordings and dyspeptic symptoms in this trial, the possibility of clinical applications of cutaneous electrogastrography in the treatment of FD will be elucidated.Trial RegistrationCurrent Controlled Trials (ISRCTN 51910678); Clinical Trials.gov Identifier: NCT00987805
Highlights
Functional dyspepsia (FD) is characterized by a high prevalence rate and no standard conventional treatments
Functional dyspepsia (FD) is characterized by chronic or relapsing dyspeptic symptoms in the absence of structural lesions that can be identified with clinically available tests [1,2]
(2) In patients with FD or FD subtypes according to the Rome III criteria, there will be a significant correlation between the degree of dyspeptic symptoms and cutaneous EGG recordings and 6 weeks of oral administration of BST can improve the abnormal frequency and power parameters on cutaneous EGG
Summary
Functional dyspepsia (FD) is characterized by a high prevalence rate and no standard conventional treatments. Alternative therapies, such as herbal formulas, are widely used to treat FD. The current study is designed to evaluate the efficacy and safety of Banha-sasim-tang for FD patients and to examine whether there will be a significant correlation between cutaneous electrogastrography recordings and dyspeptic symptoms in FD patients, and between changes in gastric myoelectrical activity and improvement in dyspeptic symptoms during Banha-sasim-tang administration. Many researchers have used cutaneous EGG, which suggests that this technique may be useful in the evaluation of gastric motor function in FD patients [7]. The relationship between dyspeptic symptoms and cutaneous EGG recordings remains a controversial topic in FD
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