| Objective: To evaluate the clinical effect of xiaopi pill in the treatment of refractory functional dyspepsia.Methods: A randomized,double-blind,placebo-controlled trial was conducted to randomly divide 66 patients with refractory functional dysphasia(postpranpranal discomfort syndrome)into the treatment group and the treatment group,with 33 patients in each group.The treatment group was given xiaopi pill prescription free decoction granules,and the placebo group was given xiaopi pill prescription simulated placebo granules.The course of treatment was 4 weeks.The outcome indexes were clinical symptom total score,single clinical symptom score,TCM syndrome total score,single TCM syndrome score and quality of life score.The main efficacy index was the total effective rate of clinical symptoms,the secondary efficacy index was the single clinical effective rate of symptoms,the total effective rate of TCM syndromes,the single effective rate of TCM syndromes and the quality of life score.The efficacy was analyzed using Full analysis set(FAS)and Per protocol set(PPS).P<0.05 was considered statistically significant.Results: A total of 66 patients were enrolled in this study,including 33 patients in the treatment group and 33 patients in the placebo group.There were 6 cases of abscission and 3 cases in each group.(Ⅰ)Comparison of total score of clinical symptoms(1)PPS analysis: the total effective rate of clinical symptoms was 66.7% in the treatment group and 36.7% in the placebo group(P=0.02).(2)FAS analysis: the total effective rate of clinical symptoms in the treatment group and the placebo group was 66.7% and 36.4%,respectively(P=0.014).(Ⅱ)Comparison of single clinical symptom scores 496/5000(1)PPS analysis: the disappearance rates in the treatment group and the placebo group were 36.7% and 10.0% respectively(P=0.030),and the improvement rates were 0.555 0.412 and 0.316 0.446(P=0.035).The early satiety rate was 39.1% in the treatment group and 8.7% in the placebo group(P=0.035),and the improvement rate was 0.527 0.457 and 0.275 0.357(P=0.024),respectively.In the treatment group and the placebo group,the disappearance rates were 41.7% and 10.0%,respectively(P=0.039),and the improvement rates were 0.560 0.545 and 0.254 0.382,respectively(P=0.040).(2)FAS analysis: the disappearance rate in the treatment group and the placebo group was 33.3% and 9.1%,respectively(P=0.033),and the improvement rate was 0.498 0.410 and 0.267 0.485,respectively(P=0.041).Early satiety,the rate of disappearance was 36.0% in the treatment group and 8.0% in the placebo group(P=0.017),and the rate of improvement was 0.497 0.451 and 0.267 0.347(P=0.048),respectively.The disappearance rate in the treatment group and the placebo group was 46.2% and 14.3%,respectively(P=0.028),and the improvement rate was 0.528 0.334 and 0.290 0.406,respectively(P=0.032).(Ⅲ)Comparison of total scores of TCM syndromes(1)PPS analysis: the total effective rates of clinical symptoms in the treatment group and the placebo group were 56.7% and 50.0% respectively(P>0.05).(2)FAS analysis: the total effective rate of clinical symptoms in the treatment group and the placebo group was 60.6% and 45.5%,respectively(P>0.05).(Ⅳ)Comparison of single TCM syndrome points(1)PPS analysis: the disappearance rate of early satiety was 39.1% in the treatment group and 8.7% in the placebo group(P=0.035),and the improvement rate was 0.358 0.463 and 0.114 0.264(P=0.042),respectively.The disappearance rates in the treatment group and the placebo group were 40.0% and 0%,respectively(P=0.017),and the improvement rates were 0.333 0.488 and 000 0.000,respectively(P=0.021).(2)FAS analysis: the rate of early satiety was 36.0% in the treatment group and 8.0% in the placebo group(P=0.017),and the rate of improvement was 0.324 0.454 and 0.118 0.258(P=0.060),respectively.The disappearance rate was 33.3% in the treatment group and 0% in the placebo group(P=0.035),and the improvement rate was 0.278 0.461 and 000 0.000(P=0.023),respectively.(Ⅴ)Comparison of life quality points(1)PPS analysis: the improvement rates of total quality of life scores in the treatment group and the placebo group were 0.098 0.116 and 0.083 0.140,respectively(P>0.05).In the field of "food and beverage" in each single field,the improvement rates of the scores in the treatment group and the placebo group were 0.107 0.158 and 0.040 0.087,respectively(P=0.047),and there was no statistical difference in the improvement rates of the scores in other single fields between the two groups.(2)FAS analysis: the improvement rates of total quality of life scores in the treatment group and the placebo group were 0.089 0.114 and 0.075 0.135,respectively(P>0.05).In the field of "food and beverage" in each single field,the improvement rates of scores in the treatment group and the placebo group were 0.080 0.152 and 0.011 0.120,respectively(P=0.048),and there was no statistical difference in the improvement rates of scores in other single fields between the two groups.(Ⅵ)Adverse eventsThere were 3 adverse events in the placebo group and no adverse events in the treatment group,with no statistically significant difference between the two groups(P>0.05).It is suggested that xiaopi pill has better safety.Conclusion: Xiaopi pill can effectively improve the clinical symptoms and TCM symptoms of refractory functional dyspepsia(postpranital discomfort syndrome),with good safety,and it is worthy of further promotion and application in clinical practice. |
PDF Full Text Request