| Objective:To estimate efficacy and safety of patent Chinese medicine Liuwei Anxiao capsules (LAC) for treating functional dyspepsia (FD).Method:Randomized controlled trials on LAC use in adolescent and adult FD patients compared with placebo or conventional medicine were searched from MEDLINE, EMBASE, CENTRAL, AMED, CBM, CNKI, VIP, Wanfang Database, Chinese and international Clinical Trial Registry website and hand-searching. Only studies published up to April 2014 were included. Total and individual symptom effective rates after treatment were primary outcomes, whilst gastric empty rate and safety were secondary outcomes. Data extraction and quality assessment followed Cochrane systematic review methods. The meta-analysis was performed by RevMan 5.3.5. The report on overall quality of the evidence and strength of recommendation were carried out using GRADE profiler 3.6 software.Results:Twenty-four studies with a total of 2,573 participants were included in the analysis. Our meta-analysis showed that patients treated with LAC alone (risk ratio [RR]= 1.16,95%confidence interval [CI] 1.06 to 1.27, I2=73%) or LAC plus western medicine (RR= 1.22,95% CI 1.14 tol.32) had higher total effective rates than those treated with western medicine alone. Individual symptom effective rates between patients treated with LAC and prokinetic drugs were compared:LAC increased the rates by 17% in early satiation (RR=1.17,95% CI 1.04 to 1.32) and by 18% in epigastric pain (RR= 1.18,95% CI 1.06 to 1.31). Moreover, there were superior WMD values of 2.16 (95%CI 0.26 to 4.07) and 7.39 (95%CI 2.86 to 11.92) in accelerating gastric empty rate when using LAC alone or LAC combined with western medicine than using western medicine alone. There was no serious adverse event reported. The heterogeneity was found when total effective rates were compared between LAC alone and western medicine alone; however, the result showed stable and reliable according to the sensitivity analysis. The differences in prokinetic drugs used and treatment durations were observed in subgroup analysis; these differences might explain the heterogeneity among trials. LAC had a better total therapeutic effect than domperidone and metoclopramide (dopaminergic drugs) (RR=1.23,95%CI 1.13 to 1.34, I2=0% and RR=1.90,95%CI 1.54 to 2.35, I2=0%), whereas the four-week treatment had a higher total effective rate compared with the two-week treatment. There was no serious adverse event reported. The quality of evidence was shown to be medium to very low. Hence, the level of recommendation was weak.Conclusion:Our study demonstrates the advantages of LAC over western medicine in treating FD patients. The total efficacy became better when adding LAC to the conventional medicine. However, the results are insufficient to draw the definitive conclusion. Given the low quality of included trials, the level of recommendation of using LAC for treating FD remains weak. This warrants the need of additional rigorous studies on LAC effectiveness and its long-term safety. |
PDF Full Text Request