Adjuvant use of melatonin for pain management in endometriosis-associated pelvic pain - a randomized double-blinded, placebo-controlled trial

SND-ID: 2023-28

Creator/Principal investigator(s)

Lena Marions - Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset

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

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Language

Swedish

Research principal, contributors, and funding

Research principal

Karolinska Institutet

Responsible department/unit

Ki SÖS

Contributor(s)

Ylva Böttiger - University of Linköping, Department of Biomedical and Clinical Sciences

Hans Järnbert-Pettersson - Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset

Måns Edlund - Karolinska Institutet, Department of Women's and Children's Health

Protection and ethical review

Data contains personal data

Yes

Sensitive personal data

Yes

Type of personal data

pseudonymised

Code key exists

Yes

Ethics Review

Stockholm - Ref. 2017/1177-21/2

Method and time period

Population

Fyrtio kvinnor, 18-50 år med endometrios och svår mensvärk

Study design

Double-blind randomised trial

Geographic coverage

Geographic spread

Geographic location: Sweden

Publications
Dataset
Adjuvant use of melatonin for pain management in endometriosis-associated pelvic pain - a randomized double-blinded, placebo-controlled trial

Associated documentation

Description

The dataset consists of a csv fil (RCT_mel_endo.csv) with responses from the survey.

Version 1

Citation

Lena Marions. Karolinska Institutet (2023). Adjuvant use of melatonin for pain management in endometriosis-associated pelvic pain - a randomized double-blinded, placebo-controlled trial. Swedish National Data Service. Version 1. https://doi.org/10.48723/875f-ma81

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Data format / data structure

Numeric

Creator/Principal investigator(s)

Lena Marions - Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset

Data collection

  • Mode of collection: Self-administered questionnaire
  • Time period(s) for data collection: 2019-08-21–2021-06-27
  • Instrument: RedCap (Technical instrument(s))
  • Sample size: 40

Number of individuals/objects

40

Published: 2023-03-24
Last updated: 2023-03-24