Trial reportHealth and quality of life outcomes2010
Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials.
Trial report in Health and quality of life outcomes, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 43 papers, 9 of them syntheses that pooled 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.
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.
A Multi-center, Open, One-arm Study to Investigate the Safety and Efficacy of Daily Oral Administration of T00660AA for the Treatment of Endometriosis Over 52 Weeks (Follow-up to Study 307041)
Randomized Clinical Trial the Use of Levonorgestrel-releasing Intrauterine System Versus Etonogestrel Implant in Pelvic Pain Control in Women With Endometriosis
Who cites it
43 citing papers in PubMed, 9 syntheses or guidelines pooled it, 126 citations in OpenAlex.
- Impact of combined oral contraceptives and progestin-only pills on psychological and sexual well-being of women with endometriosis: A systematic review.Acta obstetricia et gynecologica Scandinavica · 2026Pooled it
- Effectiveness of Multidisciplinary Treatment Compared to Single Discipline Treatment of Female Chronic Pelvic Pain: A Systematic Review and Meta-Analyses.BJOG : an international journal of obstetrics and gynaecology · 2025Pooled it
- Vitamin D for primary dysmenorrhea and endometriosis-related pain - A systematic review of registered RCTs.PloS one · 2025Pooled it
- Comparative effectiveness of exercise interventions for primary dysmenorrhea: a systematic review and network meta-analysis.BMC women's health · 2024Pooled it
- Pooled it
- Exercise for dysmenorrhoea.The Cochrane database of systematic reviews · 2019Pooled it
- A Comparison of Treatment Effects for Nonsurgical Therapies and the Minimum Clinically Important Difference in Knee Osteoarthritis: A Systematic Review.JBJS reviews · 2019Pooled it
- Efficacy of phloroglucinol for treatment of abdominal pain: a systematic review of literature and meta-analysis of randomised controlled trials versus placebo.European journal of clinical pharmacology · 2018Pooled it
- Treatment of endometriosis in different ethnic populations: a meta-analysis of two clinical trials.BMC women's health · 2012Pooled it
- Radiofrequency Versus Myofascial Therapy in Women With Myofascial Chronic Pelvic Pain: A Randomized Clinical Trial.International urogynecology journal · 2026Trial
- Catheter-Based Sacral Nerve Block Versus Pudendal Nerve Block in the Treatment of Pudendal Neuralgia: A Randomized Double-Blinded Controlled Trial.European journal of pain (London, England) · 2026Trial
- Effects of Diaphragmatic Breathing in Primary Dysmenorrhea: A Randomized Controlled Trial.Pain research & management · 2026Trial
- Alkalinised lidocaine as an anaesthetic before onabotulinumtoxinA injections. a randomised trial.BJU international · 2025Trial
- A randomized trial assessing the efficacy of Silymarin on endometrioma-related manifestations.Scientific reports · 2022Trial
- Pain Reduction With an Immersive Digital Therapeutic Tool in Women Living With Endometriosis-Related Pelvic Pain: Randomized Controlled Trial.Journal of medical Internet research · 2022Trial
- Practical issues encountered while determining Minimal Clinically Important Difference in Patient-Reported Outcomes.Health and quality of life outcomes · 2020Trial
- Deep Dyspareunia One Year After Nerve-Sparing Endometriosis Surgery: An Observational Study Highlighting Undesirable Outcomes.Journal of personalized medicine · 2026Article
- Combined pelvic floor training and hormonal therapy for endometriosis pain recurrence: a propensity score-matched study.Frontiers in medicine · 2026Article
- Ultrasound-guided percutaneous cryoablation under local anesthesia: a promising treatment method for symptomatic adenomyosis.Quantitative imaging in medicine and surgery · 2025Article
- Good long-term results of sacral neuromodulation for endometriosis related chronic pelvic pain.BMC women's health · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWhen comparing active treatments, a non-inferiority (or one-sided equivalence) study design is often used. This design requires the definition of a non-inferiority margin, the threshold value of clinical relevance. In recent studies, a non-inferiority margin of 15 mm has been used for the change in endometriosis-associated pelvic pain (EAPP) on a visual analog scale (VAS). However, this value was derived from other chronic painful conditions and its validation in EAPP was lacking.
methodsData were analyzed from two placebo-controlled studies of active treatments in endometriosis, including 281 patients with laparoscopically-confirmed endometriosis and moderate-to-severe EAPP. Patients recorded EAPP on a VAS at baseline and the end of treatment. Patients also assessed their satisfaction with treatment on a modified Clinical Global Impression scale. Changes in VAS score were compared with patients' self-assessments to derive an empirically validated non-inferiority margin. This anchor-based value was compared to a non-inferiority margin derived using the conventional half standard deviation rule for minimal clinically important difference (MCID) in patient-reported outcomes.
resultsAnchor-based and distribution-based MCIDs were-7.8 mm and-8.6 mm, respectively.
conclusionsAn empirically validated non-inferiority margin of 10 mm for EAPP measured on a VAS is appropriate to compare treatments in endometriosis.
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Registered trials
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.