Efficacy and safety of Sijunzi Decoction for peptic ulcers: A systematic review and meta-analysis

摘要

ObjectiveTo investigate the therapeutic efficacy and safety ofSijunziDecoction (SJZD) for peptic ulcers (PUs) through the assessment of randomized controlled trials (RCTs).MethodsFive English and four Chinese databases were systematically searched to identify eligible RCTs that investigated the effect of SJZD for PUs. SJZD was used either independently or concomitantly with routine anti-ulcer treatments and compared with no intervention, placebo, or conventional therapy. Outcomes evaluated included ulcer healing, symptom improvement,Helicobacter pylori(Hp) eradication, ulcer recurrence, and adverse reactions. Statistical analysis and risk of bias was evaluated by Revman 5.3.ResultsFourteen trials involving 1476 participants fulfilled the selection criteria. All trials were presented with a high risk of bias. Analyses showed that modified SJZD had significant benefit on ulcer healing compared with ranitidine and sucralfate and triple therapy with omeprazole, amoxicillin and clarithromycin. Compared with this omeprazole triple therapy and therapy using pantoprazole, the addition of modified SJZD was superior. Regarding symptom improvement, modified SJZD was significantly better than ranitidine and sucralfate and had an added benefit when supplemented with either of two omeprazole triple therapies (omeprazole, amoxicillin and clarithromycin, and omeprazole, levofloxacin and furazolidone) or pantoprazole. Furthermore, modified SJZD had a favorable effect on Hp eradication compared with cimetidine and additional benefit was noted when complemented with either of the two omeprazole triple therapies or therapy consisting of omeprazole and amoxicillin. Modified SJZD was superior at reducing ulcer recurrence among healed patients compared with cimetidine. Modified SJZD with triple-drug regimen comprising omeprazole, amoxicillin and clarithromycin was also found to be more effective at reducing ulcer relapse compared with the triple therapy alone. No serious adverse events were reported.ConclusionModified SJZD, used independently or as a complementary treatment to conventional ulcer-healing treatments, promoted PU healing, alleviated symptoms, eradicated Hp, and reduced ulcer relapse. Modified SJZD was relatively safe. However, rigorous randomized controlled trials are required to provide further support for these effects because of the high risk of bias and limited sample size of the included trials.