Objective To assess the effect and safety of Dalitong Granule in the treatment of the Piman syndrome (functional dyspepsia).
Method The double-blind, double-dummy and randomized controlled method was adopted. 120 patients were randomized to the treatment group (n=90, Dalitong Granule 6 g, tid) and the control group (n=30, treated with cisapride 5 mg, tid). The therapeutic course for both groups was 2 weeks.
Results All the results were analyzed on the basis of intention-to-treat and per-protocol population. In the treatment group, the markedly effective rates were 62.37% and 64.45% respectively. The effective rates were 99.55% and 96-67% respectively. In the control group, the markedly effective rates were 58-08% and 60.00% respectively. The effective rates were 90.33% and 93.33% respectively. There was no significant difference between two groups (P gt;0.05). For effects on Piman syndrome, in the treatment group, the markedly effective rates were 53.76% and 55.56% respectively. The effective rates were 86.02% and 88.89% respectively. In the control group, the markedly effective rates were 48.38% and 50.00% respectively. The effective rates were 80.64% and 83.33% respectively. The results showed no statistical significance difference between two groups (P gt;0.05). For effects on gastric emptying function (PP population), in the treatment group, the markedly effective rate and effective rate were 72.42% and 79.32%. In the control group those were 64.28% and 64.28%. There was no significant difference between the two groups (P gt;0.05). ITT and PP analysis revealed similar results. No adverse effect was found in the observation.
Conclusions Dalitong granule has the same clinical effect as cisapride with no obvious toxic-adverse effects.
Citation： WANG Lei,LI Tingqian,ZHANG Ruiming,MAO Bing,CHANG Jing,ZHANG Ying. Double-Blind Randomized Controlled Trial of Dalitong Granule in the Treatment of Piman Syndrome (Functional Dyspepsia). Chinese Journal of Evidence-Based Medicine, 2004, 04(4): 239-243. doi: Copy