基于四君子汤的疗法治疗功能性（非溃疡性）消化不良的疗效和安全性：一项随机对照试验的荟萃分析。
Efficacy and safety of Si-Jun-Zi-Tang-based therapies for functional (non-ulcer) dyspepsia: a meta-analysis of randomized controlled trials.
机构信息
School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, China.
Guangzhou Institute of Cardiovascular Disease, the Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
出版信息
BMC Complement Med Ther. 2021 Jan 6;21(1):11. doi: 10.1186/s12906-020-03176-z.
BACKGROUND
The traditional Chinese medicine formula Si-Jun-Zi-Tang (SJZT) has a long history of application in the treatment of functional dyspepsia (non-ulcer dyspepsia, FD)-like symptoms. SJZT-based therapies have been claimed to be beneficial in managing FD. This study aimed to assess the efficacy and safety of SJZT-based therapies in treating FD by meta-analysis.
METHODS
Systematic searches for RCTs were conducted in seven databases (up to February 2019) without language restrictions. Data were analyzed using Cochrane RevMan software version 5.3.0 and Stata software version 13.1, and reported as relative risk (RR) or odds ratio (OR) with 95% confidence intervals (CIs). The primary outcome was response rate and the secondary outcomes were gastric emptying, quality of life, adverse effects and relapse rate. The quality of evidence was evaluated according to criteria from the Cochrane risk of bias.
RESULTS
A total of 341 potentially relevant publications were identified, and 12 RCTs were eligible for inclusion. For the response rate, there was a statically significant benefit in favor of SJZT-based therapies (RR = 1.23; 95% CI 1.17 to 1.30). However, the benefit was limited to modified SJZT (MSJZT). The relapse rate of FD patients received SJZT-based therapies was lower than that of patients who received conventional medicines (OR = 0.23; 95% CI 0.10 to 0.51). No SJZT-based therapies-related adverse effect was reported.
CONCLUSION
SJZT-based prescriptions may be effective in treating FD and no serious side-effects were identified, but the effect on response rate appeared to be limited to MSJZT. The results should be interpreted with caution as all the included studies were considered at a high risk of bias. Standardized, large-scale and strictly designed RCTs are needed to further validate the benefits of SJZT-based therapies for FD management.
TRIAL REGISTRATION
Systematic review registration: [PROSPERO registration: CRD42019139136 ].
背景
中药方剂四君子汤（SJZT）在治疗功能性消化不良（非溃疡性消化不良，FD）样症状方面具有悠久的应用历史。SJZT 为基础的治疗方法已被证明对治疗 FD 有益。本研究旨在通过荟萃分析评估 SJZT 为基础的疗法治疗 FD 的疗效和安全性。
方法
系统检索了 7 个数据库（截至 2019 年 2 月）的 RCT 文献，无语言限制。使用 Cochrane RevMan 软件版本 5.3.0 和 Stata 软件版本 13.1 对数据进行分析，并以相对风险（RR）或比值比（OR）及其 95%置信区间（CI）表示。主要结局是应答率，次要结局是胃排空、生活质量、不良反应和复发率。根据 Cochrane 偏倚风险标准评估证据质量。
结果
共确定了 341 篇潜在相关文献，其中 12 项 RCT 符合纳入标准。对于应答率，SJZT 为基础的疗法具有显著的获益（RR=1.23；95%CI 1.17 至 1.30）。然而，这种获益仅限于改良 SJZT（MSJZT）。接受 SJZT 为基础的疗法治疗的 FD 患者的复发率低于接受常规药物治疗的患者（OR=0.23；95%CI 0.10 至 0.51）。未报告与 SJZT 为基础的疗法相关的不良反应。
结论
SJZT 为基础的方剂可能对治疗 FD 有效，且未发现严重的副作用，但对应答率的影响似乎仅限于 MSJZT。由于所有纳入的研究均被认为存在高偏倚风险，因此应谨慎解释这些结果。需要进行标准化、大规模和严格设计的 RCT 以进一步验证 SJZT 为基础的疗法治疗 FD 的益处。
试验注册
系统评价注册：[PROSPERO 注册：CRD42019139136]。
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