Tolerability and Efficacy of Duloxetine Compared to Amitriptyline in Women With Chronic Pelvic Pain Syndrome: Findings From a Clinical Trial

IF 1.5 4区医学 Q3 UROLOGY & NEPHROLOGY

LUTS: Lower Urinary Tract Symptoms Pub Date : 2025-07-27 DOI:10.1111/luts.70023

Maede Mohseni, Rojan Ghaderzadeh, Kimia Bakhtiari, Maryam Zamanirafe, Mona Doostizadeh, Aliasghar Tabatabaeii Mohammadi, Kiumarth Amini, Maryam Mehrpooya

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引用次数: 0

Abstract

Objectives

Duloxetine has demonstrated efficacy in treating various types of chronic pain conditions. A double-blind clinical trial was conducted to assess the effectiveness and tolerability of duloxetine compared to amitriptyline in women suffering from chronic pelvic pain (CPP) syndrome.

Methods

Sixty-nine eligible women diagnosed with CPP syndrome were randomly assigned to receive either duloxetine or amitriptyline. Duloxetine was initiated at 30 mg/day and amitriptyline at 25 mg/day, with dosages increased to 60 mg/day for duloxetine and 50 mg/day for amitriptyline after the first week and maintained throughout weeks 2 to 8 of the treatment phase. The effectiveness of the treatment was assessed using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) and its domain scores at weeks 4 and 8 after treatment. The safety and tolerability of the study medications were assessed using an antidepressant side effect checklist and spontaneous participant reports of adverse effects. All analyses were conducted on an Intention-to-Treat (ITT) analysis data set.

Results

Patients undergoing both medications experienced similar improvements in their total NIH-CPSI scores at weeks 4 and 8. The proportions of patients achieving a response, defined as at least a 6-point reduction in the total NIH-CPSI score at both weeks 4 and 8, were also comparable between the duloxetine and amitriptyline treatments. Further, at the end of the study period, a similar proportion of subjects reported marked or moderate overall symptom improvements with both treatments. However, in the analysis of NIH-CPSI domain scores, duloxetine-treated patients exhibited lower pain domain scores at both study endpoints, while amitriptyline-treated patients achieved better scores in the urinary symptoms domain. Regarding quality of life domain scores, no significant differences were observed between the groups. In terms of safety and tolerability, duloxetine demonstrated more favorable outcomes, with fewer patients experiencing adverse effects and a lower withdrawal rate due to adverse effects compared to amitriptyline.

Conclusions

These findings suggest that duloxetine is as effective as amitriptyline for managing CPP syndrome in women, with the added advantage of a more favorable safety profile.

Trial Registration

The trial was registered at the Iranian Registry of Clinical Trials (identifier code: IRCT20120215009014N457). Registration date: 2023-01-10

查看原文本刊更多论文

与阿米替林相比，度洛西汀对女性慢性盆腔疼痛综合征的耐受性和疗效：来自一项临床试验的发现

目的：度洛西汀治疗多种慢性疼痛的疗效已得到证实。进行了一项双盲临床试验，以评估度洛西汀与阿米替林在慢性盆腔疼痛（CPP）综合征妇女中的有效性和耐受性。方法69例确诊为CPP综合征的女性患者随机分为度洛西汀组和阿米替林组。度洛西汀起始剂量为30 mg/天，阿米替林起始剂量为25 mg/天，第一周后剂量增加至度洛西汀60 mg/天，阿米替林50 mg/天，并在治疗期的第2至8周保持。在治疗后第4周和第8周，使用美国国立卫生研究院慢性前列腺炎症状指数（NIH-CPSI）及其域评分来评估治疗的有效性。研究药物的安全性和耐受性通过抗抑郁药物副作用检查表和参与者自发报告的不良反应进行评估。所有分析均在意向治疗（ITT）分析数据集上进行。结果接受两种药物治疗的患者在第4周和第8周的NIH-CPSI总评分有相似的改善。达到缓解的患者比例（定义为在第4周和第8周NIH-CPSI总评分至少降低6分）在度洛西汀和阿米替林治疗之间也具有可比性。此外，在研究期结束时，相似比例的受试者报告两种治疗均显著或中度改善整体症状。然而，在NIH-CPSI结构域评分分析中，度洛西汀治疗的患者在两个研究终点均表现出较低的疼痛结构域评分，而阿米替林治疗的患者在泌尿系统症状领域得分较高。在生活质量领域得分方面，两组间无显著差异。在安全性和耐受性方面，与阿米替林相比，度洛西汀表现出更有利的结果，出现不良反应的患者较少，不良反应引起的停药率更低。这些发现表明，度洛西汀与阿米替林在治疗女性CPP综合征方面同样有效，并且具有更有利的安全性。试验在伊朗临床试验注册中心注册（识别码：IRCT20120215009014N457）。报名日期：2023-01-10

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来源期刊

LUTS: Lower Urinary Tract Symptoms UROLOGY & NEPHROLOGY-

CiteScore

3.00

自引率

7.70%

发文量

审稿时长

>12 weeks

期刊介绍： LUTS is designed for the timely communication of peer-reviewed studies which provides new clinical and basic science information to physicians and researchers in the field of neurourology, urodynamics and urogynecology. Contributions are reviewed and selected by a group of distinguished referees from around the world, some of whom constitute the journal''s Editorial Board. The journal covers both basic and clinical research on lower urinary tract dysfunctions (LUTD), such as overactive bladder (OAB), detrusor underactivity, benign prostatic hyperplasia (BPH), bladder outlet obstruction (BOO), urinary incontinence, pelvic organ prolapse (POP), painful bladder syndrome (PBS), as well as on other relevant conditions. Case reports are published only if new findings are provided. LUTS is an official journal of the Japanese Continence Society, the Korean Continence Society, and the Taiwanese Continence Society. Submission of papers from all countries are welcome. LUTS has been accepted into Science Citation Index Expanded (SCIE) with a 2011 Impact Factor.