Abstract
Background. Chinese herbal medicine (CHM) has been used in China and elsewhere to treat patients with functional dyspepsia (FD). However, controlled studies supporting the efficacy of such treatment are lacking. Objective. To assess the efficacy and safety of modified Ban xia xie xin decoction in patients with FD of cold and heat in complexity syndrome. Methods. We performed a randomized, double-blind, placebo-controlled trial involving patients from five centers. Patients with FD of cold and heat in complexity syndrome (n = 101) were randomly assigned to groups given either CHM modified Ban Xia Xie Xin decoction or placebo in a 2 : 1 ratio. Herbal or placebo granules were dissolved in 300 mL of boiled water cooled to 70°C. Patients in both groups were administered 150 mL (50°C) twice daily. The trial included a 4-week treatment period and a 4-week followup period. The primary outcomes were dyspepsia symptom scores, measured by the total dyspepsia symptom scale and the single dyspepsia symptom scale at weeks 0, 1, 2, 3, 4, and 8. Results. Compared with patients in the placebo group, patients in the CHM group showed significant improvements according to the total and single dyspepsia symptom scores obtained from patients (P < 0.01) and investigators (P < 0.01). Conclusions. CHM modified Ban Xia Xie Xin decoction appears to offer symptomatic improvement in patients with FD of cold and heat in complexity syndrome. Trial Registration. Chinese Clinical Trial Registry (ChiCTR): ChiCTR-TRC-10001074.
Highlights
Functional dyspepsia (FD) is a common functional gastrointestinal disorder characterized by chronic or recurrent upper abdominal fullness, epigastric pain, eructation, bloating, early satiety, nausea, vomiting, regurgitation, burning, loss of appetite, and other symptoms
We studied the distribution of the different syndromes in 565 patients with functional dyspepsia (FD) and found that “cold and heat in complexity” is one of the most common syndromes of FD [15]
The available evidence of the efficacy of these formulas is inadequate. This multicenter, randomized, double-blind, placebocontrolled study indicated that modified Ban Xia Xie Xin decoction is effective in the management of symptoms associated with FD
Summary
Chinese herbal medicine (CHM) has been used in China and elsewhere to treat patients with functional dyspepsia (FD). To assess the efficacy and safety of modified Ban xia xie xin decoction in patients with FD of cold and heat in complexity syndrome. Patients with FD of cold and heat in complexity syndrome (n = 101) were randomly assigned to groups given either CHM modified Ban Xia Xie Xin decoction or placebo in a 2 : 1 ratio. Herbal or placebo granules were dissolved in 300 mL of boiled water cooled to 70∘C. Patients in both groups were administered 150 mL (50∘C) twice daily. CHM modified Ban Xia Xie Xin decoction appears to offer symptomatic improvement in patients with FD of cold and heat in complexity syndrome.
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