Abstract
This study evaluated the efficacy and safety of Banha-sasim-tang (BST) in patients with functional dyspepsia (FD). BST (Banxia-xiexin-tang in traditional Chinese medicine and Hange-shashin-to in Kampo medicine) is traditionally prescribed for the treatment of dyspepsia with epigastric stiffness and gastric fullness in China, Japan, and Korea. Patients with FD were randomly administered an oral dose (10 g) of BST syrup or placebo, twice a day for 4 weeks. The primary outcome was the symptom checklist part of the Nepean dyspepsia index (NDI). The secondary outcomes were the quality of life (QoL) part of the NDI, functional dyspepsia-related QoL (FD-QoL), and visual analog scale (VAS). A total of 60 patients with FD were screened, and 50 were randomized into BST group (n = 25) and placebo group (n = 25). Two patients in the placebo group withdrew before the start of the treatment. Administration of BST syrup resulted in improvement in the symptom-related NDI score in the BST group compared with that in the control group; however, the difference was not significant. BST syrup significantly improved “fullness after eating” index of NDI at follow-up time point (2.88 ± 2.65 vs 4.78 ± 2.69, p = 0.0081). In the total score of the QoL section of the NDI and FD-QoL scales, there was no significant improvement in the BST group compared to that in the placebo group. With regard to improvement in overall FD symptoms, the VAS scale showed improvement in both groups, but the difference was not significant. Interestingly, follow-up investigation showed a significantly beneficial effect of BST on FD symptoms, when compared to placebo. Significant improvement observed in VAS score (39.60 ± 22.29 vs 52.17 ± 20.55, p = 0.048). This indicated that the effect of BST lasted even after the completion of the medication regimen. Overall, our data suggest that while BST showed no significant improvement in the symptom-related NDI score and the QoL related scores in NDI and FD-QoL after 4 weeks of treatment, it effectively improved the VAS score and fullness after eating-related symptoms in the follow-up visit.Clinical Trial Registration:https://cris.nih.go.kr; Identifier KCT 0002013
Highlights
Functional dyspepsia (FD) refers to the presence of gastrointestinal symptoms, such as postprandial fullness, early satiety, epigastric discomfort, bloating, and nausea (Lacy et al, 2013)
Epidemiological studies have shown that 15–20% of the population in Western countries has dyspepsia in the course of 1 year (Tack et al, 2004)
A survey study showed that 36.7% of the patients with functional gastrointestinal disorders used herbal drugs herbal drugs as an alternative or complementary medicine (Lahner et al, 2013; Ottillinger et al, 2013)
Summary
Functional dyspepsia (FD) refers to the presence of gastrointestinal symptoms, such as postprandial fullness, early satiety, epigastric discomfort, bloating, and nausea (Lacy et al, 2013). These symptoms are non-life-threatening and FD is not related to an increase in mortality, relapsing-remitting symptoms of FD cause impairment in the quality of life (QoL), and the symptoms cause decreased productivity and activity in the workplace (Mahadeva and Goh, 2006; Talley and Ford, 2015). According to TCM pattern diagnosis, individuals may show different symptoms and signs depending on their physical conditions and health status even though they may suffer from the same disease. Different symptoms and signs are classified into several “patterns” (called “Zeung” in Chinese), which have been used as diagnostic tools and for prescribing medicinal herbs and acupoints in TCM (Jiang, 2005; Berle et al, 2010; van der Greef et al, 2010; Zhang et al, 2012)
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