Efficacy Evalution Of Qinghua Hewei Tablet In Treating Postprandial Distress Syndrome

ObjectTo evaluate the efficacy and safety of Qinghua Hewei tablet in the treatment of patients with postprandial distress syndrome(PDS).Method1.This was a randomized,double-blinded,placebo-controlled clinical trial. Patients were enrolled according to Rome III criteria for PDS with block random method.Also the patients with PDS alone were recorded.2. The treatment group were given Qinghua Hewei tablet three times a day,while the control group were given placebo three times a day.The treatment courses of both groups were4weeks.3.Visits were scheduled on preliminary diagnosis (before treatment),2weeks and4weeks after treatment. The score of main symptom severity,TCM syndrome score and SF36scale were recorded.4. We analyzed the score change of main symptom severity,every single symptom (such as postprandial fullness, upper abdominal bloating and early satiation, epigastric pain and epigastric burning),TCM syndromes and SF36scale in PDS.We also analyzed the score change of main symptom severity, every single symptom (such as postprandial fullness, upper abdominal bloating and early satiation) and TCM syndromes in PDS alone.We analyzed the score change of main symptom severity,TCM syndromes for every TCM syndrome.5. The outcomes of security check were recorded before and after treatment. Adverse events were monitored during and after treatment.6.The data was analyzed by SAS9.2software and it was considered to have statistical significance if P<0.05. Result1.A total of110patients with PDS were enrolled in the trial;55patients were randomized to the treatment and control groups respectively.56patients with PDS alone were enrolled with26patients in the treatment group and30patients in the control group.There was no statistical difference between treatment group and control group on sex,age and BMI before treatment.2.Both treatment group and control group have improvement in the total scores of main symptom severity,every single symptom (such as postprandial fullness, upper abdominal bloating and early satiation, epigastric pain and epigastric burning)and TCM syndromes after treatment. Treatment group was superior to control group in the improvement of the total scores of main symptom severity, every single symptom and TCM syndromes (P<0.05). Both treatment group and control group have improvement on health-related quality of life according to Short Form-36(SF36) questionnaire after treatment, which includes eight domains measureing physical,mental and social aspects of quality of life,but there was no significant difference between treatment group and control group (P>0.05).The total effective rate in treatment group for main symptom severity was89.09%, while control group was36.36%; it was obvious that treatment group was superior to control group(P<0.05). The total effective rate in treatment group for TCM syndromes was83.64%, while control group was38.18%; it was obvious that treatment group was superior to control group(P<0.05).3.The patients with PDS alone which were in both treatment group and control group have improvement in the total scores of main symptom severity(such as postprandial fullness, upper abdominal bloating and early satiation) and TCM syndromes after treatment. There was significant difference between treatment group and control group in the total scores of main symptom severity, every single symptom and TCM syndromes (P<0.05). The total effective rate in treatment group for main symptom severity was84.62%, while control group was36.67%; it was obvious that treatment group was superior to control group(P<0.05).The total effective rate in treatment group for TCM syndromes was80.77%, while control group was36.67%; it was obvious that treatment group was superior to control group(P<0.05).4.Both treatment group and control group have improvement in the total scores of main symptom severity and TCM syndromes for liver-qi stagnation syndrome,deficiency of spleen-qi and stomach-qi syndrome, incoordination between liver and stomach syndrome and dampness-heat of spleen and stomach syndrome; treatment group was superior to control group in the total scores of main symptom severity for all TCM syndromes (P<0.05);also treatment group was superior to control group in the total scores of TCM syndromes for deficiency of spleen-qi and stomach-qi syndrome and dampness-heat of spleen and stomach syndrome (P<0.05);but there was no significant difference between treatment group and control group in the total scores of TCM syndromes for liver-qi stagnation syndrome and incoordination between liver and stomach syndrome.5.There was not specific adverse event and laboratory test concerned to research drugs happened.Conclusion:Qinghua Hewei tablet was effective and safe in treating PDS in clinical trials. Qinghua Hewei tablet thus represents a beneficial new drug for the treatment of PDS.