Efficacy and Safety of Drug Combinations for Chronic Pelvic Pain: Protocol for a Systematic Review

Mohammed Mohiuddin, Rex Park, Ursula Wesselmann, Caroline F. Pukall, Keith Jarvi, Curtis Nickel, R. Christopher Doiron, Ian Gilron
In: JMIR Research Protocols · 2021 · vol. 10(5) , pp. e21909 · doi:10.2196/21909 · PMID:33999006 · PMC8167620 · W3153392486
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⚙ AI-generated summary by claude@2026-06, 2026-06-10 ⓘ

This systematic review protocol outlines the methodology to evaluate the efficacy and safety of drug combinations for chronic pelvic pain by analyzing randomized controlled trials.

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⚙ AI-generated deep summary by claude@2026-06, 2026-06-10 ⓘ

This paper presents a protocol for a systematic review on the efficacy and safety of drug combinations for chronic pelvic pain, structured according to the PRISMA-P 2015 checklist, using a planned PICO framework with defined eligibility criteria, interventions/comparators, and outcomes. It outlines intended information sources (e.g., electronic databases, grey literature and/or trial registers), a draft repeatable search strategy, and procedures for managing records, selecting studies, and extracting data (including planned processes for confirming data). The key finding is not applicable because the paper is a protocol rather than a completed review, and the main limitation explicitly implied by the document type is that no results are yet available. Relevance to endometriosis: chronic pelvic pain is a core condition in which endometriosis and adenomyosis commonly present, though this protocol text (as provided) does not explicitly name endometriosis or adenomyosis.

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Abstract

BACKGROUND: Chronic pelvic pain with various etiologies and mechanisms affects men and women and is a major challenge. Monotherapy is often unsuccessful for chronic pelvic pain, and combinations of different classes of medications are frequently prescribed, with the expectation of improved outcomes. Although a number of combination trials for chronic pelvic pain have been reported, we are not aware of any systematic reviews of the available evidence on combination drug therapy for chronic pelvic pain. OBJECTIVE: We have developed a protocol for a systematic review to evaluate available evidence of the efficacy and safety of drug combinations for chronic pelvic pain. METHODS: This systematic review will involve a detailed search of randomized controlled trials investigating drug combinations to treat chronic pelvic pain in adults. The databases searched will include the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and EMBASE from their inception until the date the searches are run to identify relevant studies. The primary outcome will be pain relief measured using validated scoring tools. Secondary outcomes, where reported, will include the following: adverse events, serious adverse events, sexual function, quality of life, and depression and anxiety. Methodological quality of each included study will be assessed using the Cochrane Risk of Bias Tool. RESULTS: The systematic review defined by this protocol is expected to synthesize available good quality evidence on combination drug therapy in chronic pelvic pain, which may help guide future research and treatment choices for patients and their health care providers. CONCLUSIONS: This review will provide a clearer understanding of the efficacy and safety of combination pharmacological therapy for chronic pelvic pain. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews CRD42020192231; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=192231. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/21909.

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Condition tags

chronic_pelvic_pain

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