Adjuvant use of melatonin for pain management in endometriosis-associated pelvic pain - a randomized double-blinded, placebo-controlled trial
SND-ID: 2023-28-1. Version: 1. DOI: https://doi.org/10.48723/875f-ma81
Associated documentation
Citation
Creator/Principal investigator(s)
Lena Marions - Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset
Research principal
Karolinska Institutet
- Ki SÖS
Description
Purpose: 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.
Methods: 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.
Clincaltrials.gov nr NCT03782740.
Results: 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.
Conclusion: This ra
Methods: 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.
Clincaltrials.gov nr NCT03782740.
Results: 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.
Conclusion: 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.
The dataset consists of a csv fil (RCT_mel_endo.csv) with responses from the survey. Show less..
Data contains personal data
Yes
Sensitive personal data
Yes
Type of personal data
pseudonymised
Code key exists
Yes
Language
Population
Fyrtio kvinnor, 18-50 år med endometrios och svår mensvärk
Study design
Double-blind randomised trial
Number of individuals/objects
40
Data format / data structure
Geographic spread
Geographic location: Sweden
Responsible department/unit
Ki SÖS
Contributor(s)
Måns Edlund - Karolinska Institutet, Department of Women's and Children's Health
Hans Järnbert-Pettersson - Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset
Ylva Böttiger - University of Linköping, Department of Biomedical and Clinical Sciences
Ethics Review
Stockholm - Ref. 2017/1177-21/2
Research area
Obstetrics, gynaecology and reproductive medicine (Standard för svensk indelning av forskningsämnen 2011)
Keywords
Soderman, 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
DOI:
https://doi.org/10.1371/journal.pone.0286182
SwePub:
oai:DiVA.org:liu-196852
