中药复方治疗功能性消化不良：一项随机、双盲、 安慰剂对照试验的Meta分析

Traditional Chinese medicine compounds for the treatment of functional dyspepsia: an updated meta-analysis of randomized, double-blind, placebo-controlled trials

    摘要
  • 摘要:
    目的评价中药复方治疗功能性消化不良 (FD) 的有效性与安全性。
    方法计算机检索 PubMed, Embase, Cochrane Library, Web of Science, CBM, Wanfang Data, CNKI 和 VIP 数据库，搜集有关中药复方治疗 FD 的随机、双盲、安慰剂对照试验，检索时限均为建库至2021年3月2日。由2名研究者独立筛选文献, 提取资料并评价纳入研究的偏倚风险后，采用 RevMan 5.4 软件进行Meta分析。
    结果共纳入23项临床试验，包括2 898例患者。Meta分析结果显示：中药复方治疗FD总体缓解率明显高于安慰剂 (73.8% vs 46.2%) ［RR ＝ 1.50, 95% CI (1.29，1.76), P < 0.000 01］。各单项症状中，中药复方对上腹痛［MD ＝− 0.99, 95% CI (− 1.37, − 0.61), P < 0.000 01］, 上腹烧灼感［MD ＝− 0.32，95% CI (− 0.59，− 0.05), P = 0.02］, 餐后饱胀不适［MD ＝− 1.59，95% CI (− 1.96，− 1.21), P < 0.000 01］, 早饱症状［MD ＝− 0.93, 95% CI (− 1.32, − 0.54), P < 0.000 01］的改善均优于安慰剂。与安慰剂相比，中药复方治疗可明显改善FD患者中医证候［MD ＝− 5.58，95% CI (− 7.55，− 3.61), P < 0.000 01］, 胃排空率［MD ＝ 12.22，95% CI (8.90，15.55), P < 0.000 01］，有助于提高患者生活质量［MD ＝11.27, 95% CI (0.10，22.43), P = 0.05］。中药复方治疗与安慰剂均未见严重不良事件报道，两组不良反应发生情况无显著差异［RR ＝ 1.34, 95% CI (0.91, 1.96), P = 0.14］。
    结论当前证据表明，中药复方治疗能显著缓解FD症状，有效改善FD患者胃排空，有助于提高患者生活质量，临床应用未见严重不良反应。受纳入研究数量和质量的限制，上述结论尚待更多高质量研究予以验证。

     

    Abstract:
    ObjectiveTo evaluate the efficacy and safety of traditional Chinese medicine (TCM) compounds for the treatment of functional dyspepsia (FD).
    MethodsThe PubMed, Embase, Cochrane Library, Web of Science, Chinese Biomedical Database (CBM), Wanfang Data, China National Knowledge Infrastructure (CNKI), and China Science and Technology Journal Database (VIP) were searched to collect randomized, double-blind, and placebo-controlled trials of FD treated with TCM compounds. The search duration was from the establishment of the database to March 2, 2021. After two researchers independently screened the literature, extracted the data, and evaluated the bias risk included in the study, they used RevMan 5.4 software for meta-analysis.
    ResultsA total of 23 clinical trials were included, including 2 898 patients. Meta-analysis showed that the overall remission rate of FD treated with TCM compounds was significantly higher than that of placebo (73.8% vs. 46.2%) RR = 1.50, 95% CI (1.29, 1.76), P < 0.000 01. Among the single symptoms, TCM compounds were superior to the placebo in improving epigastric pain MD =﹣0.99, 95% CI (﹣1.37,﹣0.61), P < 0.000 01, epigastric burning sensation MD =﹣0.32, 95% CI (﹣0.59,﹣0.05), P = 0.02, postprandial fullness discomfort MD = ﹣1.59, 95% CI (﹣1.96, ﹣1.21), P < 0.000 01, and early satiety symptoms MD = ﹣0.93, 95% CI (﹣1.32, ﹣0.54), P < 0.000 01. Compared with the placebo, TCM compounds treatment can obviously improve TCM syndrome in patients with FD MD = ﹣5.58, 95% CI (﹣7.55,﹣3.61), P < 0.000 01, gastric emptying rate MD = 12. 22, 95% CI (8.90, 15.55), P < 0.00001, and helped to improve patients' quality of life MD = 11.27, 95% CI (0.10, 22.43), P = 0.05. No severe adverse events were reported between the two groups RR = 1.34, 95% CI (0.91, 1.96), P = 0.14.
    ConclusionOur results showed that TCM compounds treatment could significantly alleviate FD symptoms, improve gastric emptying in FD patients, and help to improve their quality of life. No severe adverse reactions have been reported in clinical applications. Due to the limitation of the quantity and quality of the included studies, the above conclusions need to be verified by more high-quality studies.

     

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