Association between use of lubiprostone and headache: A systematic review and meta-analysis of randomized controlled trials.

IF 3 3区医学 Q2 PHARMACOLOGY & PHARMACY

British journal of clinical pharmacology Pub Date : 2025-10-02 DOI:10.1002/bcp.70305

Satoru Mitsuboshi, Makoto Morizumi, Shungo Imai, Satoko Hori, Kazumasa Kotake

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引用次数: 0

Abstract

Aims: Lubiprostone and its active metabolite may activate prostaglandin receptors, raising concerns about an increased risk of headache. We performed a systematic review and meta-analysis to identify whether lubiprostone increases the risk of headache.

Methods: To identify all relevant randomized controlled trials (RCTs), we comprehensively searched MEDLINE (via PubMed), ClinicalTrials.gov website and the Cochrane Central Register of Controlled Trials. The search focused on studies comparing lubiprostone vs. placebo or other laxatives. A DerSimonian-Laird random-effects model was utilized to estimate risk ratios (RRs) and 95% confidence intervals (CIs). A fixed-effect method based on the Mantel-Haenszel method was employed for analyses with 3 or fewer studies. Heterogeneity was assessed using the I² statistic, and the certainty of evidence was rated using the GRADE approach.

Results: Twenty-six studies were examined in the analysis. The incidence of headache was 5.3% for lubiprostone and 3.2% for placebo or other laxatives. Lubiprostone increased the risk of headache (RR 1.32, 95% CI 1.02-1.71, I² = 0%, 6265 patients, 26 RCTs, moderate certainty) relative to placebo or other laxatives. The risk of headache seemed to be consistently increased in both adults (RR 1.23, 95% CI 0.93-1.62, I² = 0%, 5390 patients, 24 RCTs, moderate certainty) and children (RR 3.07, 95% CI 1.67-5.63, I² = 84.4%, 875 patients, 2 RCTs, very low certainty).

Conclusion: The results of this meta-analysis suggest that lubiprostone treatment increases the risk of headache in adults.

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使用鲁比前列酮与头痛之间的关系：随机对照试验的系统回顾和荟萃分析。

目的：卢比前列素及其活性代谢物可能激活前列腺素受体，引起人们对头痛风险增加的担忧。我们进行了一项系统回顾和荟萃分析，以确定lubiprostone是否会增加头痛的风险。方法：我们综合检索MEDLINE（通过PubMed）、ClinicalTrials.gov网站和Cochrane Central Register of controlled trials，以确定所有相关的随机对照试验（RCTs）。这项研究的重点是比较卢比前列酮与安慰剂或其他泻药的研究。采用dersimonan - laird随机效应模型估计风险比（rr）和95%置信区间（ci）。3项及以下研究的分析采用基于Mantel-Haenszel方法的固定效应法。使用I2统计量评估异质性，使用GRADE方法评估证据的确定性。结果：26项研究纳入分析。鲁比前列酮组头痛发生率为5.3%，安慰剂或其他泻药组为3.2%。与安慰剂或其他泻药相比，卢比前列酮增加了头痛的风险（RR 1.32, 95% CI 1.02-1.71, I2 = 0%， 6265例患者，26项随机对照试验，中等确定性）。在成人（RR 1.23, 95% CI 0.93-1.62, I2 = 0%， 5390例患者，24项随机对照试验，中等确定性）和儿童（RR 3.07, 95% CI 1.67-5.63, I2 = 84.4%， 875例患者，2项随机对照试验，极低确定性）中，头痛的风险似乎持续增加。结论：本荟萃分析的结果表明，鲁比前列酮治疗增加了成人头痛的风险。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

British journal of clinical pharmacology 医学-药学

CiteScore

6.30

自引率

8.80%

发文量

419

审稿时长

1 months

期刊介绍： Published on behalf of the British Pharmacological Society, the British Journal of Clinical Pharmacology features papers and reports on all aspects of drug action in humans: review articles, mini review articles, original papers, commentaries, editorials and letters. The Journal enjoys a wide readership, bridging the gap between the medical profession, clinical research and the pharmaceutical industry. It also publishes research on new methods, new drugs and new approaches to treatment. The Journal is recognised as one of the leading publications in its field. It is online only, publishes open access research through its OnlineOpen programme and is published monthly.