Year 2025 / Volume 117 / Number 12
Original
Fluoxetine in functional constipation with somatic symptom disorder ‒ Efficacy and safety from a propensity score-matched cohort study

737-744

DOI: 10.17235/reed.2025.11434/2025

Bin Yang, Xiangying Feng, Qinxian Huang, Xuzhao Li, Xue Jiang, Weihong Fu, Qingchuan Zhao, Zhifeng Zhao,

Abstract
Introduction: functional constipation (FC) is often accompanied by somatic symptom disorder (SSD), especially in refractory conditions. In such patients, constipation manifestations often appear to reflect heightened somatic symptoms rather than bowel dysfunction such as excessive preoccupation to defecation. Therefore, we conducted a cohort study to evaluate the efficacy and safety of fluoxetine in patients with FC and comorbid SSD. Methods: the cohort study involved 316 FC patients with somatic symptoms. Among them, 161 patients received fluoxetine, while 155 were treated with polyethylene glycol (PEG). Using propensity scores, patients were matched into 77 pairs for comparative analysis. The primary outcome was the proportion who achieved ≥ 3 completely spontaneous bowel movements (CSBMs) per week at six-months. Secondary outcomes included the assessment of bowel symptom, mental scale, and treatment satisfaction. Safety was evaluated by adverse events. Results: at six months, 40.26 % of the fluoxetine group achieved the primary endpoint compared to 22.08 % in the PEG group (p = 0.009). Significant improvements were noted in secondary outcomes, including frequency of CSBMs, bowel symptom severity, GAD-9 score, and patient satisfaction. Key factors contributing to treatment effectiveness included baseline GAD-9 scores > 9 (OR = 5.01; p < 0.01). Adverse events occurred in 16 cases (9.9 %) of the fluoxetine group, with most being mild life-affecting. Conclusion: fluoxetine appears to be a safe and effective therapeutic option over a six-month period for patients with FC and SSD, exerting dual benefits in alleviating both constipation and associated psychological symptoms.
Lay Summary
A substantial proportion of patients with functional constipation (FC) experience both difficulty in defecation and marked anxiety and preoccupation with bowel habits, features characteristic of somatic symptom disorder (SSD). In this cohort, fluoxetine, an established SSD therapy, achieved significantly greater clinical improvement than the standard laxative polyethylene glycol (PEG) and was associated with a favorable safety profile.
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Yang B, Feng X, Huang Q, Li X, Jiang X, Fu W, et all. Fluoxetine in functional constipation with somatic symptom disorder ‒ Efficacy and safety from a propensity score-matched cohort study. 11434/2025


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Publication history

Received: 25/06/2025

Accepted: 09/07/2025

Online First: 30/07/2025

Published: 12/12/2025

Article Online First time: 35 days

Article editing time: 170 days


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