Shanmugham Suresh, Zuber Mohammed, Chan Jia En, Kumar Suresh, Ching Siew Mooi, Lee Yeong Yeh, Vadakkechalil Harsha, Veettil Sajesh K
Department of Pharmacy Practice, School of Pharmacy, IMU University, 57000, Kuala Lumpur, Malaysia.
Clinical and Administrative Pharmacy, College of Pharmacy, University of Georgia, Athens, GA, USA.
Indian J Gastroenterol. 2025 Feb;44(1):24-34. doi: 10.1007/s12664-024-01648-5. Epub 2024 Aug 24.
The beneficial effects of using antidepressants in improving functional dyspepsia (FD) symptoms have been reported in previous meta-analyses; however, the results have not been conclusive. The aim was to perform an updated meta-analysis coupled with trial sequential analysis (TSA) to assess the efficacy of the use of any antidepressants in the treatment of FD in adults.
Electronic databases were searched up to March 2024 for randomized controlled trials (RCTs) recruiting adults with FD. Data of overall symptoms improved between the antidepressants and placebo groups was pooled to obtain risk ratio (RR) employing the random-effects model. The effect of random errors was evaluated with TSA. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess the certainty of evidence. Analyses were performed using STATA version 16.0.
Nine RCTs with 924 patients met the eligible criteria. The RRs of FD symptoms improving with any antidepressants, tricyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors were (n = 9, RR = 1.30 [95% CI, 1.02-1.67]), (n = 5, RR = 1.41 [95% CI, 1.07-1.85]) and (n = 2, RR = 0.97 [95% CI, 0.72-1.29]), respectively. TSA demonstrated conclusive evidence for the beneficial effect of TCAs. The number needed to treat (NNT) with any depressants and TCAs were 11 (95% CI, 7-36) and 6 (95% CI, 4-15), respectively. The certainty of the evidence for an effect of TCAs was that of moderate GRADE quality. The benefit, however, was limited to the western population (n = 3, RR = 1.43 [95% CI, 1.04-1.96]) and did not extend to the Asian population (n = 2, RR = 1.32 [95% CI, 0.75-2.32]). Conversely, antidepressant-using patients experienced adverse events more frequently. However, no statistically significant association was found between TCAs and any adverse events (n = 3; RR = 1.36 [95% CI, 0.91-2.04]).
Evidence was obtained suggesting TCAs can be an effective alternative in the treatment of FD, but more evidence from high-quality large trials is required to support their use, especially in the Asian population.
先前的荟萃分析报道了使用抗抑郁药改善功能性消化不良（FD）症状的有益效果；然而，结果尚无定论。本研究旨在进行一项更新的荟萃分析并结合试验序贯分析（TSA），以评估使用任何抗抑郁药治疗成人FD的疗效。
检索截至2024年3月的电子数据库，查找招募成年FD患者的随机对照试验（RCT）。汇总抗抑郁药组和安慰剂组总体症状改善的数据，采用随机效应模型获得风险比（RR）。用TSA评估随机误差的影响。采用推荐分级评估、制定与评价（GRADE）方法评估证据的确定性。使用STATA 16.0版进行分析。
9项RCT（共924例患者）符合纳入标准。使用任何抗抑郁药、三环类抗抑郁药（TCA）和选择性5-羟色胺再摄取抑制剂使FD症状改善的RR分别为（n = 9，RR = 1.30 [95% CI，1.02 - 1.67]）、（n = 5，RR = 1.41 [95% CI，1.07 - 1.85]）和（n = 2，RR = 0.97 [95% CI，0.72 - 1.29]）。TSA证明TCA具有有益效果的确凿证据。使用任何抗抑郁药和TCA的治疗所需人数（NNT）分别为11（95% CI，7 - 36）和6（95% CI，4 - 15）。TCA有疗效的证据确定性为中等GRADE质量。然而，这种益处仅限于西方人群（n = 3，RR = 1.43 [95% CI，1.04 - 1.96]），未扩展至亚洲人群（n = 2，RR = 1.32 [95% CI，0.75 - 2.32]）。相反，使用抗抑郁药的患者不良事件发生频率更高。然而，未发现TCA与任何不良事件之间存在统计学显著关联（n = 3；RR = 1.36 [95% CI，0.91 - 2.04]）。
有证据表明TCA可作为治疗FD的有效替代药物，但需要更多来自高质量大型试验的证据来支持其使用，尤其是在亚洲人群中。
