Evidence map›Paper›PMID 41339844›Full record

SynthesisBMC women's health2025

Clinical impacts of botulinum toxin type A injections for provoked vestibulodynia: insights from randomized controlled trials.

Zhengyu Gao, Luoman Hu, Chuanjian Yi, Chengfei Gao

Abstract readSystematic ReviewMeta-Analysis
In one paragraph

Synthesis in BMC women's health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Zhengyu GaoDepartment of Rehabilitation Medicine, the Affiliated Hospital of Qingdao University, No. 16 Jiangsu Road, Qingdao, Shandong Province, 266003, China.
Luoman HuDepartment of Rehabilitation Medicine, the Affiliated Hospital of Qingdao University, No. 16 Jiangsu Road, Qingdao, Shandong Province, 266003, China.
Chuanjian YiDepartment of Rehabilitation Medicine, the Affiliated Hospital of Qingdao University, No. 16 Jiangsu Road, Qingdao, Shandong Province, 266003, China.
Chengfei GaoDepartment of Rehabilitation Medicine, the Affiliated Hospital of Qingdao University, No. 16 Jiangsu Road, Qingdao, Shandong Province, 266003, China. gaocf@qduhospital.cn.

Funding

Natural Science Foundation of Shandong Province ZR2021QH062
6 · The paper itself

Abstract

backgroundProvoked vestibulodynia (PVD) is a chronic vulvar pain condition often associated with pelvic floor muscle hypertonicity. Botulinum neurotoxin type A (BoNT-A), a neuromuscular transmission blocker, has been proposed as a potential treatment to alleviate PVD-related symptoms. However, its clinical efficacy and safety remain uncertain.

objectiveTo systematically assess the efficacy and safety of BoNT-A injections in women with PVD through a meta-analysis of randomized controlled trials (RCTs).

methodsWe conducted a systematic review and meta-analysis following PRISMA guidelines. A comprehensive search of MEDLINE, Embase, and Cochrane Library databases was performed up to March 2025 to identify RCTs comparing BoNT-A injections with placebo. Pooled effect sizes were calculated using standardized mean differences (SMDs) or weighted mean differences (WMDs), with 95% confidence intervals (CIs), based on fixed- or random-effects models depending on heterogeneity.

resultsFour RCTs involving 244 women (BoNT-A: n = 143; placebo: n = 101) were included. BoNT-A treatment did not significantly reduce pain (SMD = - 0.13; 95% CI: - 0.39 to 0.13; p = 0.80), nor did it improve sexual function (WMD = - 0.09 points on the FSFI; 95% CI: - 6.42 to 6.25; p = 0.98) or sexual distress (WMD = 0.15 points on the FSDS; 95% CI: - 9.35 to 9.64; p = 0.98). No serious adverse events were reported, and minor injection-site discomfort was the most common adverse effect.

conclusionsWhile BoNT-A appears to be well tolerated, current evidence from randomized trials does not consistently support its efficacy in relieving pain or improving sexual function in women with PVD. The limited number of studies and variability in intervention protocols warrant cautious interpretation of these findings.

trial registrationCRD420251024448.

Indexed as

Botulinum Toxins, Type ANeuromuscular AgentsVulvodyniaAdultFemaleHumansRandomized Controlled Trials as TopicTreatment OutcomeBotulinum Toxins, Type ANeuromuscular AgentsBotulinum neurotoxin type AMeta-analysisPainProvoked vestibulodyniaSexual function

Identifiers

PMID41339844
PMCPMC12676762

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.