Randomized controlled clinical trial of Shaohuang laxative mixture in the treatment of intestinal gas stagnation constipation
10.13699/j.cnki.1001-6821.2017.05.009
- VernacularTitle:芍黄通便合剂治疗肠道气滞型便秘的随机对照临床试验
- Author:
Dan WANG
1
;
Yong-Hua YUAN
;
Jin HE
;
Lin LI
;
Ting-Dong GUO
;
Xiao-Yan HU
;
Si-Biao PEI
;
Da-Cheng REN
Author Information
1. 重庆医科大学药学院
- Keywords:
Shaohuang laxative mixture;
Muxiang Binlang pill;
intestinal gas stagnation constipation;
traditional Chinese medicine syndrome score
- From:
The Chinese Journal of Clinical Pharmacology
2017;33(5):415-417,422
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the clinical efficacy and safety of Shaohuang laxative mixture in the treatment of intestinal gas stagnation constipation.Methods A total of 144 patients with intestinal gas stagnation constipation were randomly divided into treatment group and control group,each group 72 cases.Patients in treatment group were orally administration Shaohuang laxative mixture,20 mL each time,tid.Patients in control group were orally given Muxiang Binlang pill 6 g each time,tid.Once the defecate free,stopping the medication,and followed up for 7 d to observe the defecating awareness,frequency,stool shape (according to Bristol stool from scale),time,amount,accompanying symptoms (including defecation pain,abdominal distension,defecation difficulties,exhaust,etc.),the main related signs,physical and chemical indicators.Besides,the adverse drug reactions were recorded during the treatment.Results After treatment,the total effective rate in treatment group was 91.94% (57/62 cases),had no significant difference with that in control group,which was 90.16% (55/61 cases,P > 0.05).After treatment,the scores of desire to defecate,defecation frequency,defecation quality,defecation time,defecation volume,defecation difficulty level,abdominal distension and pain,belching,Xiongxie fullness and borborygrmi in treatment group were 4.81 ±0.80,4.19 ±0.78,4.91 ±0.76,5.11 ±0.92,4.25 ±0.61,4.20 ±0.77,5.11 ±0.68,5.06 ±0.79,3.73 ±0.61,4.40 ±0.64 in treatment group,had no significant difference with those in control group,which were 4.65 ± 0.74,4.26 ± 0.84,4.81 ± 0.88,5.02 ± 0.99,4.12 ± 0.54,4.19 ± 0.81,5.02 ±0.76,5.00 ±0.75,3.87 ±0.66,4.33 ±0.51 (P >0.05),but had significant difference with those before treatment (P < 0.05).The adverse reactions in treatment group and control group were nausea and diarrhea,and the incidences of adverse drug reactions in treatment group and control group were 3.23% (2/62 cases) and 4.92% (3/61 cases),with no significant difference (P > 0.05).Conclusion Shaohuang laxative mixture and aplotaxis auriculata compound pill have similar efficacy in treatment of intestinal gas stagnation constipation.Shaohuang laxative mixture is safe and effective in the treatment of intestinal gas stagnation.