ABSTRACT
This systematic review aims to evaluate the efficacy and safety of Huoxiang Zhengqi formulas in treating gastrointestinal type cold. Seven electronic databases,including CNKI, WanFang Data, Vip, SinoMed, PubMed, Cochrane Library, Embase will be searched from the inception of the study until March 2017.All randomized controlled trials that evaluate the treatment of Huoxiang Zhengqi formulas for gastrointestinal type cold will be eligible. The methodological quality will be assessed using the Cochrane risk of bias tool for randomized clinical trials and Review Manager 5.3 software is used for analyzing the data.The results are： eight RCTs and 680 patients are included .Meta-analysis are performed according to the stratification of the treatment strategy. Eight studies report clinical efficacy, among them four studies show Huoxiang Zhengqi formulas are better than western medicine(RR and 95%,1.2[1.08, 1.33]), another four studies showHuoxiang Zhengqi formulas in conjunction with conventional treatment are better than conventional treatment(RR and 95%, 1.32[1.20,1.46]).About symptom remission rate, one study shows the treatment group effect is better than the control group from the following clinical symptoms：chills,fever,bowel diarrhea,the effect of treating sore throat itchy is same with western medicine treatment.No adverse reactions are found about Huoxiang Zhengqi formulas in this study.Current evidence shows that Huoxiangzhengqi formulas are better than Western medicine group and western medicine routine treatment group from clinical efficacy. Limited by the quantity and quality of studies, more large-scale and rigorously designed randomised controlled trials with large sample size are warranted to clarify the conclusions.
ABSTRACT
Objective To evaluate the efficacy and safety of Modified Huoxiang Zhengqi Soft Capsule in treatment of gastrointestinal type cold with exogenous wind-cold and endogenous damp stagnation syndrome.Methods A multi-center and double-blind double-dummy randomized controlled trial was conducted.440 patients of gastrointestinal type cold with exogenous wind-cold and endogenous damp stagnation syndrome were enrolled from Januarary to July 2013.They were randomly divided into two groups,the trial group of 330 cases and the control group of 110 cases.The trial group was given Modified Huoxiang Zhengqi Soft Capsule and Huoxiang Zhengqi Soft Capsule analogue three times a day for 3 days.The control group received Huoxiang Zhengqi Soft Capsule and Modified Huoxiang Zhengqi Soft Capsule analogue three times a day for 3 days.Clinical symptoms,signs and symptoms and adverse effect were observed and blood test,routine urine and stool test,feces occult blood,hepatorenal function and electrocardiogram were examined before and after treatment.Results In terms of traditional Chinese medicine syndrome and efficacy after treatment,the clinical healing rates of the trial group and the control group were 50.000％,35.455％ for full analysis set and50.464％,35.780％ for per protocol set.The overall effective rates were 94.848％,76.364％ for full analysis set and 96.285％,77.064％ for per protocol set.There were significant differences between the two groups (P ＜ 0.05).In addition,there were significant differences in clinical healing rates and overall effective rates of symptoms including diarrhea,nausea and vomiting,rhinobyon and rhinorrhea,fullness and oppression in the chest and diaphragm and abdominal swelling and pain between two groups (P ＜ 0.05).However,the difference in overall effective rates of headache and lightheadedness symptom were significant (P ＜ 0.05) except for clinical healing rate.No adverse effects were found in the trial.Conclusion Modified Huoxiang Zhengqi Soft Capsule is effective and safe in treatment of gastrointestinal type cold with exogenous wind-cold and endogenous damp stagnation syndrome and its effect is better than that of Huoxiang Zhengqi Soft Capsule.