Abstract：
This study aimed to evaluate the efficacy and safety of Biling Weitong Granules in the treatment of stomach ache disorder. Randomized controlled trial(RCT) of Biling Weitong Granules in the treatment of digestive diseases with stomach ache disorder as the primary symptom was retrieved from Chinese and English electronic databases and trial registration platforms from database inception to June 10, 2022. Two investigators conducted literature screening and data extraction according to the screening criteria. The Cochrane risk-of-bias tool(v 2.0) was used to assess the risk of bias in the included studies. Analyses were performed using RevMan 5.4 and R 4.2.2, with summary estimates measured using fixed or random effects models. The primary outcome indicators were the visual analogue scale(VAS) scores and stomach ache disorder symptom scores. The secondary outcome indicators were clinical recovery rate, Helicobacter pylori(Hp) eradication rate, and adverse reaction/events. Twenty-seven RCTs were included with a sample size of 2 902 cases. Meta-analysis showed that compared with conventional western medicine treatments or placebo, Biling Weitong Granules could improve VAS scores(SMD=-1.90, 95%CI[-2.18,-1.61], P<0.000 01), stomach ache disorder symptom scores(SMD=-1.26, 95%CI[-1.71,-0.82], P<0.000 01), the clinical recovery rate(RR=1.85, 95%CI[1.66, 2.08], P<0.000 01), and Hp eradication rate(RR=1.28, 95%CI[1.20, 1.37], P<0.000 01). Safety evaluation revealed that the main adverse events in the Biling Weitong Granules included nausea and vomiting, rash, diarrhea, loss of appetite, and bitter mouth, and no serious adverse events were reported. Egger\'s test showed no statistical significance, indicating no publication bias. The results showed that Biling Weitong Granules in the treatment of digestive system diseases with stomach ache disorder as the primary symptom could improve the VAS scores and stomach ache disorder symptom scores of patients, relieve stomach ache disorder, and improve the clinical recovery rate and Hp eradication rate, with good safety and no serious adverse reactions. However, the quality of the original studies was low with certain limitations. Future studies should use unified and standardized detection methods and evaluation criteria of outcome indicators, pay attention to the rigor of study design and implementation, and highlight the clinical safety of the medicine to provide more reliable clinical evidence support for clinical application.
摘要：
本研究旨在评价碧灵胃痛颗粒治疗胃痛症的疗效和安全性。从数据库开始至2022年6月10日，从中英文电子数据库和试验注册平台中检索出必灵胃痛颗粒治疗以胃痛为主要症状的消化系统疾病的随机对照试验（RCT）。两名研究者根据筛选标准进行文献筛选和数据提取。Cochrane偏倚风险工具（v2.0）用于评估纳入研究的偏倚风险。使用RevMan5.4和R4.2.2进行分析，并使用固定或随机效应模型测量汇总估计值。主要结局指标为视觉模拟评分(VAS)评分和胃痛障碍症状评分。次要转归指标为临床恢复率,幽门螺杆菌(Hp)根除率,和不良反应/事件。纳入27个RCT，样本量为2902例。Meta分析结果显示,与常规西药治疗或安慰剂治疗相比,碧灵胃痛颗粒可改善VAS评分（SMD=-1.90，95CI[-2.18，-1.61]，P<0.00001)，胃痛障碍症状评分（SMD=-1.26，95CI[-1.71，-0.82]，P<0.00001)，临床恢复率(RR=1.85，95CI[1.66，2.08]，P<0.00001)，和Hp根除率（RR=1.28，95CI[1.20，1.37]，P<0.00001)。安全性评价显示，碧灵胃痛颗粒的主要不良事件包括恶心和呕吐，皮疹,腹泻,食欲不振,和苦涩的嘴，未报告严重不良事件.艾格检验无统计学意义，表明没有出版偏见。结果表明，碧灵胃痛颗粒治疗以胃痛障碍为首发症状的消化系统疾病，可提高患者的VAS评分和胃痛障碍症状评分，缓解胃痛，提高临床治愈率和Hp根除率，安全性好，无严重不良反应。然而,原始研究的质量较低,存在一定的局限性.未来研究应采用统一、规范的检测方法和结果指标评价标准,注意研究设计和实施的严谨性，并突出该药的临床安全性,为临床应用提供更可靠的临床证据支持。
