Objectives: 

Tricyclic antidepressants (TCAs) are commonly used to treat disorders of gut-brain interaction (DGBI). However, these medications are often associated with side effects that lead to early treatment discontinuation. Research in other chronic medical conditions suggests that many TCA side effects may be caused by nocebo (negative placebo) effects. The current study tests a brief, verbal intervention aimed at improving tolerance of TCAs in DGBI by providing education about nocebo effects.

Materials and Methods: 

This pilot randomized controlled trial was performed in a tertiary care gastroenterology clinic. Participants with DGBI were randomized “standard information,” describing the benefits and risks of TCAs, or “augmented information,” which included an additional <30-second education about nocebo effects. Two weeks after their visit, participants were emailed a survey evaluating the number and bothersomeness of side effects, adequate relief, global improvement, and treatment satisfaction.

Results: 

Thirty-one patients were randomized and 22 responded to the survey. The average age was 40% and 59% were women. Although not statistically significant, the augmented group attributed nominally fewer symptoms to TCAs than the standard group, with a medium effect size (1.5 vs. 4.2, effect size d=0.56, P=0.212) and reported being significantly less bothered by those symptoms (13.4 vs. 38.1, P=0.037). A nominally larger percentage of the augmented group reported adequate relief of symptoms after 2 weeks of treatment compared with the standard group (55% vs. 27%, respectively).

Conclusions: 

This pilot study demonstrates that a brief (≈30 s) clinical intervention addressing nocebo effects may improve tolerance of TCAs. These findings provide support for future, fully powered studies to evaluate the impact of framing on clinical outcomes, especially in chronic conditions.

中文翻译：

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改善药物耐受性：三环类抗抑郁药治疗肠脑相互作用障碍的初步研究

目标： 

三环类抗抑郁药（TCA）通常用于治疗肠-脑相互作用障碍（DGBI）。然而，这些药物通常会产生副作用，导致治疗提前停止。对其他慢性疾病的研究表明，许多 TCA 副作用可能是由反安慰剂（负面安慰剂）效应引起的。目前的研究测试了一种简短的口头干预，旨在通过提供有关反安慰剂效应的教育来提高 DGBI 对 TCA 的耐受性。

材料和方法： 

这项随机对照试验是在一家三级护理胃肠病诊所进行的。患有 DGBI 的参与者被随机分配“标准信息”，描述 TCA 的益处和风险，或“增强信息”，其中包括关于反安慰剂效应的额外 <30 秒教育。访问两周后，参与者收到了一份调查电子邮件，评估副作用的数量和麻烦程度、充分缓解、整体改善和治疗满意度。

结果： 

31 名患者被随机分配，22 名患者对调查做出回应。平均年龄为 40%，其中 59% 为女性。虽然没有统计学意义，但增强组名义上归因于 TCA 的症状比标准组少，效应大小为中等（1.5 对比 4.2，效应大小d = 0.56，P = 0.212），并且据报告明显较少受这些症状困扰（ 13.4 与 38.1，P = 0.037）。与标准组相比，名义上更大比例的增强组在治疗 2 周后报告症状得到充分缓解（分别为 55% 和 27%）。

结论： 

这项试点研究表明，针对反安慰剂效应的简短（约 30 秒）临床干预可能会提高 TCA 的耐受性。这些发现为未来的、充分有力的研究提供了支持，以评估框架对临床结果的影响，特别是在慢性疾病中。