Efficacy of modified LiuJunZi decoction on functional dyspepsia of spleen-deficiency and qi-stagnation syndrome: a randomized controlled trial

Abstract

BackgroundChinese herbal medicine (CHM) has been used in China and some other countries for the treatment of patients with functional dyspepsia (FD). However, controlled studies supporting the efficacy of such treatments in patients with FD are lacking. In this trial, we aimed to assess the efficacy and safety of modified LiuJunZi decoction in patients with FD of spleen-deficiency and qi-stagnation syndrome.MethodsWe performed a randomized, double-blind, placebo-controlled trial with patients from five centers. Patients with FD of spleen-deficiency and qi-stagnation syndrome (n = 160) were randomly assigned to groups given CHM modified LiuJunZi 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 follow-up 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. The secondary outcome was the change of radiopaque barium markers emptied from the stomach between week 0 and week 4 of treatment.ResultsCompared with patients in the placebo group, patients in the CHM group showed significant improvements according to the scores of total dyspepsia symptoms and single dyspepsia symptoms obtained from patients (P < 0.01) and investigators (P < 0.01). They also showed an improvement in the number of radiopaque barium markers emptied from the stomach (P < 0.05).ConclusionsCHM modified LiuJunZi decoction appears to offer symptomatic improvement in patients with FD of spleen-deficiency and qi-stagnation syndrome.Trial registrationChinese Clinical Trial Registry (ChiCTR): http://ChiCTR-TRC-10001074

Effects of a Herbal Medicine, Yukgunja-Tang, on Functional Dyspepsia Patients Classified by 3-Dimensional Facial Measurement: A Study Protocol for Placebo-Controlled, Double-Blind, Randomized Trial

“…A previous study demonstrated 1.57 points of improvement ( μ c − μ t = δ ) in the TDS scale for FD after 4 weeks of YGJT treatment compared with that after the placebo treatment [17]. The study indicated a mean standard deviation (SD = σ ) of 2.148.…”

“…The subjects will be randomly assigned to the treatment or control group in a 2 : 1 ratio using block randomization method. This ratio is chosen because it will be more ethical to assign twice the number of subjects who will take placebo to the treatment group than to allocate equal number of subjects to each group [17]. Random numbers will be generated using the PROC PLAN of SAS 9.4 (SAS Institute Inc., Cary, NC, USA) by the independent statistician.…”

“…The TDS scale comprises 8 items (postprandial fullness and bloating, early satiety, epigastric pain, epigastric burning, nausea, vomiting, belching, and other symptoms), with a 4-point Likert scale [17, 32]. The TDS score is the total score of 8 items.…”

“…The SDS scale comprises three aspects of four principal symptoms of FD with a 4-point Likert scale [17, 32]. The symptoms are epigastric pain, epigastric burning, postprandial fullness and bloating, and early satiety.…”

“…These effects improve gastric accommodation and emptying [12–16]. Some randomized controlled trials have been conducted to investigate the effect of YGJT on FD [17–21]. However, YGJT significantly improves only some symptoms of FD [18, 20].…”