{"paper_id":"a0b1373d-ccaa-4507-b599-e994ac8b37b2","body_text":"Adjuvant use of melatonin for pain management in endometriosis-associated pelvic pain - a randomized double-blinded, placebo-controlled trial\nhttps://doi.org/10.48723/875f-ma81\nPurpose: Considering the pharmacological treatment options for endometriosis-associated pain are confined to hormonal therapy and analgesics, we studied the analgesic effect of 20 mg melatonin as an adjuvant therapy in women with endometriosis-associated pain.\nMethods: This randomized double-blinded, placebo-controlled trial was conducted at the Research Center for Womens’ Health at Södersjukhuset, a university hospital in Stockholm, Sweden. Forty women from 18 to 50 years of age with endometriosis and severe dysmenorrhea with or without chronic pelvic pain were given 20 mg Melatonin or placebo orally daily for two consecutive menstrual cycles or months. The level of pain was recorded daily via questionnaire on the 11-point numeric rating scale. A difference of 1.3 units was considered clinically significant.\nClincaltrials.gov nr NCT03782740.\nResults: Sixteen participants completed the study in the placebo group and 18 in the melatonin group. The difference in endometriosis-associated pain between the groups showed to be non-significant statistically as well as clinically.\nConclusion: This randomized, double-blinded, placebo-controlled trial could not show that 20 mg of melatonin given orally at bedtime had better analgesic effect on endometriosis-associated pain as compared with placebo. However, no adverse effects were observed.\nThe dataset consists of a csv fil (RCT_mel_endo.csv) with responses from the survey.\nDocumentation files\nDocumentation files\nCitation and access\nCitation and access\nData access level:\nCreator/Principal investigator(s):\nResearch principal:\nData contains personal data:\nYes\nType of personal data:\npseudonymised\nCode key exists:\nYes\nSensitive personal data:\nYes\nCitation:\nLanguage:\nMethod and outcome\nMethod and outcome\nPopulation:\nFyrtio kvinnor, 18-50 år med endometrios och svår mensvärk\nStudy design:\n- Double-blind randomised trial\n- Randomised controlled trial (RCT)\n- Experimental study\nNumber of individuals/objects:\n40\nData format/data structure:\nData collection - Self-administered questionnaire\nData collection - Self-administered questionnaire\nMode of collection:\nSelf-administered questionnaire\nTime period(s) for data collection:\n2019-08-21 - 2021-06-27\nSample size:\n40\nInstrument\nInstrument\nName:\nRedCap\nType:\nTechnical instrument(s)\nGeographic coverage\nGeographic coverage\nGeographic location:\nAdministrative information\nAdministrative information\nResponsible department/unit:\nDepartment of Clinical Science and Education, Södersjukhuset [S1]\nContributor(s):\n- Måns Edlund – Karolinska Institutet - Department of Women's and Children's Health\n- Hans Järnbert-Pettersson – Karolinska Institutet - Department of Clinical Science and Education, Södersjukhuset\n- Ylva Böttiger – University of Linköping - Department of Biomedical and Clinical Sciences\nEthical Review\nEthical Review\nReviewer:\n- Stockholm Ethical Review Board\nRegistration number:\n2017/1177-21/2\nTopic and keywords\nTopic and keywords\nSwedish Standard Classification of Research Subjects 2025:\nKeywords:\nPublications\nPublications\nCitation:\nSoderman, L., Böttiger, Y., Edlund, M., Jaernbert-Pettersson, H., & Marions, L. (2023). Adjuvant use of melatonin for pain management in endometriosis-associated pelvic pain-A randomized double-blinded, placebo-controlled trial. In PLOS ONE (Vol. 18, Issue 6). https://doi.org/10.1371/journal.pone.0286182\nSwePub:\nMetadata\nMetadata\nVersion 1","source_license":"CC0","license_restricted":false}