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The Efficacy of Berberine-Containing Quadruple Therapy on Helicobacter Pylori Eradication in China: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

ABSTRACT: Background:Berberine-containing quadruple therapy (adding berberine to the standard triple therapy) is being used to treat Helicobacter pylori infection, but the effects in randomized controlled trials (RCTs) are still controversial. Therefore, a meta-analysis is needed to estimate the efficacy and safety of berberine-containing quadruple therapy on Helicobacter pylori eradication. Methods:Ten databases were searched to find the available literature. RCTs about the efficacy and safety of berberine-containing quadruple therapy on Helicobacter pylori eradication were included. The data of Helicobacter pylori eradication rate, peptic ulcer healing rate, relieving rate of clinical symptoms and adverse events were extracted to appraise the net change with a fixed or randomized effect model. Results:A total of 13 articles were included in the analysis. Pooled results showed that the addition of berberine in standard triple therapy significantly improved Helicobacter pylori eradication rate (RR 1.22; 95% CI 1.16 to 1.27; I2 = 12%), increased the peptic ulcer healing rate (RR 1.15; 95% CI 1.10 to 1.19; I2 = 44%), relieved the clinical symptoms (RR 1.11; 95% CI 1.06 to 1.17; I2 = 44%) and reduced the incidence of side events (RR 0.65; 95% CI 0.53 to 0.80; I2 = 58%) comparing to the standard triple therapy. Conclusions:The analysis showed that the addition of berberine in standard triple therapy could improve Helicobacter pylori eradication rate and clinical symptom remission rate, accelerate ulcer healing, and reduce adverse events, which is very beneficial to clinical work in China.

SUBMITTER: Hu Q

PROVIDER: S-EPMC7010642 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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The Efficacy of Berberine-Containing Quadruple Therapy on Helicobacter Pylori Eradication in China: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

Hu Qian Q Peng Ze Z Li Lingli L Zou Xin X Xu Lijun L Gong Jing J Yi Ping P

Frontiers in pharmacology 20200204

<h4>Background</h4>Berberine-containing quadruple therapy (adding berberine to the standard triple therapy) is being used to treat <i>Helicobacter pylori</i> infection, but the effects in randomized controlled trials (RCTs) are still controversial. Therefore, a meta-analysis is needed to estimate the efficacy and safety of berberine-containing quadruple therapy on <i>Helicobacter pylori</i> eradication.<h4>Methods</h4>Ten databases were searched to find the available literature. RCTs about the e ...[more]

PMID: 32116685

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Project description:ObjectiveTo assess the effects and safety of berberine combined with triple therapy on Helicobacter pylori (H. pylori) eradication in adults.MethodsPubMed, MEDLINE, EMBASE, Cochrane Library, and Chinese databases including China National Knowledge Infrastructure (CNKI), Wanfang data, Chinese Technology Journal Full-text Database (VIP), and China biomedical literature database (CBM) were searched to obtain the eligible studies published up to October 10, 2017. The primary outcome was eradication rate of H. pylori. The secondary outcome was incidence of adverse effects. Data analysis was conducted by RevMan5.2 and Stata V.9.0 software. Trial sequential analysis (TSA) was performed to assess the risk of random error and the validity of conclusion with TSA program version 0.9 beta.ResultsThe meta-analysis results indicated berberine combined with triple therapy could improve the eradication rates of H. pylori (urea breath test subgroup: RR=1.18, 95%CI=(1.12,1.24), P < 0.00001, biopsy subgroup: RR=1.23, 95%CI=(1.13,1.34), P < 0.00001) and reduce the total occurrence of adverse effects (OR=0.59, 95%CI(0.46, 0.75), P < 0.0001) when compared with only using triple therapy. Besides, the incidence of nausea (OR=0.59, 95%CI(0.41, 0.86), P < 0.05) and diarrhea (OR=0.41, 95%CI(0.24, 0.71) was remarkably lower in experimental group while that of abdominal distention (OR=0.64, 95%CI(0.40,1.04), P > 0.05) and vomiting (OR=0.65, 95%CI(0.37, 1.15), P > 0.05) had no significant change. TSA of H. pylori eradication rates and adverse effects incidence illustrated that the cumulative value of Z-curve went across the conventional boundary value, trial sequential monitoring boundary for benefit, and required information size, suggesting the results were stable.ConclusionEvidence from meta-analysis suggested that berberine combined with triple therapy can be an option for increasing H. pylori eradication rates and reducing overall therapy-related adverse effects incidence, particularly nausea and diarrhea, whereas more randomized controlled trials designed according to CONSORT statement are demanded to support the efficacy in further studies.

Project description:Background and aimsPotassium-Competitive Acid Blockers (P-CABs) have been used in Helicobacter pylori (H. pylori) eradication therapies in recent years. However, the efficacy and safety of P-CABs compared to Proton-Pump Inhibitors (PPIs) in this setting remain controversial.MethodsThe efficacy and safety of P-CABs and PPIs for H. pylori eradication were compared in a meta-analysis based on a systematic literature search of major electronic databases for relevant Randomized Controlled Trials (RCTs).ResultsSeven studies and 1,168 patients were included. The pooled eradication rate determined by Intention-To-Treat (ITT) analysis was 90.2% for P-CAB-based and 75.5% for PPI-based triple therapy (pooled RR [95% CI] = 1.17 [1.08-1.28], p < 0.001). The Per-Protocol (PP) analysis also demonstrated significant superiority of P-CABs (pooled eradication rate = 92.4% vs. 77.8%; pooled RR [95% CI] = 1.14 [1.03-1.26], p < 0.01). In a subgroup evaluation, P-CABs were significantly better than PPIs as a first-line eradication therapy, in both the ITT analysis (pooled eradication rate = 91.8% vs. 76.4%; pooled RR [95% CI] = 1.18 [1.10-1.28], p < 0.0001) and the PP analysis (pooled eradication rate = 93.0% vs. 78.6%; pooled RR [95% CI] = 1.13 [1.02-1.26], p < 0.05). However, P-CABs were not superior to PPIs when administered as salvage therapy, as determined in the ITT (75.0% vs. 66.0%, pooled RR [95% CI] = 1.11 [0.69-1.78], p = 0.66) and PP (85.7% vs. 70.0%, pooled RR [95% CI] = 1.20 [0.82-1.75], p = 0.34) analyses. In a subgroup analysis limited to Japanese patients, both the ITT analysis (pooled eradication rate = 89.6% vs. 73.9%; RR [95% CI] = 1.21 [1.14-1.29], p < 0.01) and the PP analysis (pooled eradication rate = 92.0% vs. 75.7%; RR [95% CI] = 1.18 [1.06-1.32], p < 0.01) showed that P-CABs were significantly superior compared to PPIs as triple eradication therapy. However, in the subgroup analysis of patients from other countries, there was no significant difference in either the ITT analysis (pooled eradication rate = 93.8% vs. 85.2%; RR [95% CI] = 1.10 [0.99-1.22], p = 0.07) or PP analysis (pooled eradication rate = 95.0% vs. 90.8%; RR [95% CI] = 1.05 [0.98-1.14], p = 0.17). The incidence of adverse events associated with the two regimens did not significantly differ (P-CABs vs. PPIs: 33.6% vs. 40.0%; RR [95% CI] = 0.84 [0.71‒1.00], p = 0.05). The incidence of serious adverse events and dropout rate due to adverse events also did not differ (p = 0.44 and p = 0.67, respectively).ConclusionsThe efficacy of P-CAB-based triple therapy is superior to that of PPI-based triple therapy as a first-line approach to H. pylori eradication, particularly in Japanese patients. As salvage therapy, the efficacy of the two treatments did not significantly differ. The tolerability of P-CAB-based and PPI-based triple therapy was comparable, as was the incidence of adverse events.

Dataset Information

The Efficacy of Berberine-Containing Quadruple Therapy on Helicobacter Pylori Eradication in China: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

Publications

The Efficacy of Berberine-Containing Quadruple Therapy on Helicobacter Pylori Eradication in China: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

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