Efficacy And Safety Evaluation In The Treatment Of Functional Dyspepsia With Weikangning Party

Objective:The purpose of this study was to evaluate efficacy and safety of Weikangning decoction in functional dyspepsia patients with cold and heat mixed Syndrome, and the influence of Weikangning decoction in gastric emptying.Methods:This study was a random, double-blind, placebo-controlled clinical study. 105 cases of FD patients were recruited from Wangjing Hospital on 2015 July to 2016 March. This study included 41 males and 64females (male to female ratiol:1.56).Inclusion criteria:Western Roman III reference standards, reference 2009 TCM Chinese Medical Association Professional Committee of Medical stomach disease functional dyspepsia Chinese medical consensus opinion, Chinese medicine clinical research guidelines Edition 2002 in the Chinese medicine treatment ruffian full clinical research guidelines.Patients were divided into the treatment group(70 cases) and control group(35 cases).The treatment group was given Weikangning (ginger Pinellia 9g, skullcap 9g, Kawatsure 5g, ginger9g, licorice 9g, fried white peony 15g, wide turmeric 9g, thick Park 9g, vinegar Xuan Hu 10g, Bupleurum 9g, rhubarb 6g, fried almonds 9g, Amomum 6g,Codonopsis 15g, jujube 4),the control group was given the placebo. Treatment course of both group were 4 weeks. Health education, diet guidance and psychological counseling were given to all patients before treatment.Evaluation of efficacy:The score of TCM and west medicine symptoms of baseline, the second week,4thweek was assessed,The gastric emptying,safety evaluation of baseline and the 4th week was evaluated. SPSS 19.0 was used to analysis.Results:A total of 102 patients completed the clinical observation,70 patients in Chinese medicine group and 32 patients in control group.3 patient lost to follow-up in control group was not included in statistical analysis.l. Symptom scores evaluation:(1)Compared to baseline data:demographic data,basic vital signs, the score of TCM and west medicine symptoms of the two groups had no statistical difference(P>0.05).(2) The effective evaluation:TCM symptoms integrate in treatment and controls were 2 weeks(57.1%VS34.3%),4 weeks(94.3%VS62.5%),west medicine symptoms integrate in treatment and controls were 14 days(70%VS21.8%), 28days(94.3%VS68.7%),The both difference were statistically significant(P<0.05).(3) TCM symptoms evaluation:For two groups, total symptom scores at all observation time points had improved compared with the scores before treatment(P<0.05),but no statistical difference between the treatment and control group(P>0.05). Scores of abdominal fullness and distention,dry mouth with bitter taste, tiredness and fecal discharge difficulty syndrome of improvement is better than the control group,and the symptom scores had significant improvement(P<0.05); (4) West medicine symptoms evaluation:For two groups, total symptom scores and each single symptom score at all observation time points had improved compared with the scores before treatment(P<0.05), and the treatment group were statistical better than the control group after four weeks treatment(P<0.05).Scores of early satiety syndrome of improvement is significant better than the control group(P<0.05).2.The safety evaluation:102 cases of security checks before and after treatment inpatients with non-specific changes, to prove Weikangning was safe and reliable.3.Comparison of gastric emptying:There were 53 cases (51.9%) with delayed gastric emptying.40 cases (39.2%) in treatment group and 13(12.7%) cases in the control;49 cases (48.1%)with normal gastric emptying,30 cases (29.4%) in treatment group and 19(18.6%) cases in the control.(1)Compared to baseline data:demographic data,basic vital signs,the total TCM symptom score,each single symptom score and the total west medicine symptoms score of the two groups had no statistical difference(P>0.05). Scores of postprandial fullness and belching in delayed gastric emptying were more than the normal group,the difference had statistical significance (P<0.05).(2) Compared to gastric emptying:For both treatment and control groups, gastric emptying had improved compared to the score before treatment(P<0.05),but no statistical difference between the treatment and control group(P>0.05), divided into delayed gastric emptying and normal group according to 50% for the standard, both group’s gastric emptying had improved compared with the score before treatment(P<0.05),but no statistical difference between the treatment and control group in normal group(P>0.05). However, in delayed gastric emptying group,the gastric emptying of improvement of the treatment group is significant better than the control group (P<0.05).(3) Correlation analysis:the gastric emptying was associate with the scroe of abdominal fullness and distention (r=0.209, P=0.03), pantothenic acid (r=0.192, P=0.05), total west medicine symptoms score (r=0.176, P=0.03), postprandial fullness (r=0.237, P=0.02). The changes of gastric emptying rate was associate with the changes of the score of abdominal fullness and distention, stomach ache, chest distress, Constipation, fecal discharge difficulty, preference for sighing, pantothenic acid, postprandial full, nausea and Emesis.Conclusions:1.Weikangning decoction treatment on patients with cold and heat mixed type of functional dyspepsia was effective and safe.2.Weikangning decoction could Effectively improve the symptoms of traditional Chinese medicine and western medicine in patients with FD in cold and heat syndromes,and improve the symptoms of abdominal fullness and distention,dry mouth with bitter taste, tiredness and fecal discharge difficulty, early satiety especially.3.The placebo have certain efficacy to treat FD patient and can accelerated gastric emptying4. Part of FD patients had gastric emptying delayed. The gastric emptying was associate with the scroe of abdominal fullness and distention, pantothenic acid, total west medicine symptoms score, postprandial fullness.5. Weikangning decoction could improve the gastric emptying function of FD patients with delayed gastric emptying.The changes of gastric emptying rate was associate with the changes of the score of abdominal fullness and distention, stomach ache, chest distress, Constipation, fecal discharge difficulty, preference for sighing, pantothenic acid, postprandial full, nausea and Emesis.