Adjuvant use of melatonin for pain management in endometriosis-associated pelvic pain-A randomized double-blinded, placebo-controlled trial.
Study Goal
The researchers aimed to determine whether 20 mg of melatonin as an adjuvant therapy could provide analgesic effects for endometriosis-associated pain compared to placebo.
Results Summary
The study found no statistically or clinically significant difference in pain reduction between the melatonin and placebo groups. No adverse effects were observed with melatonin use.
Population
Women aged 18-50 with endometriosis and severe dysmenorrhea, with or without chronic pelvic pain.
Effective Dosage
20 mg orally daily
Duration
Two consecutive menstrual cycles or months
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
20 mg melatonin as an adjuvant therapy | no change | endometriosis-associated pain | women with endometriosis-associated pain | 2.9 (SD 1.9) in the melatonin group and 3.3 (SD 2.0) in the placebo group, p = 0.45 | showed to be non-significant statistically as well as clinically | #1 |
20 mg of melatonin given orally at bedtime | no change | endometriosis-associated pain | women with endometriosis-associated pain | - | could not show that ... had better analgesic effect | #2 |
20 mg Melatonin | no change | adverse effects | women with endometriosis and severe dysmenorrhea with or without chronic pelvic pain | - | No adverse effects were observed | #3 |
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. 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 on the 11-point numeric rating scale, a difference of 1.3 units was considered clinically significant. Clincaltrials.gov nr NCT03782740. 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, 2.9 (SD 1.9) in the melatonin group and 3.3 (SD 2.0) in the placebo group, p = 0.45. 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 compared with placebo. No adverse effects were observed.