Adjuvant use of melatonin for pain management in dysmenorrhea - a randomized double-blinded, placebo-controlled trial.
Study Goal
The researchers aimed to determine if 10 mg of melatonin administered during the menstrual week could effectively reduce pain in women with severe dysmenorrhea without endometriosis, compared to placebo.
Results Summary
The study found no clinically significant difference in pain reduction between melatonin and placebo, though a statistically insignificant higher mean pain score was observed in the melatonin group. No adverse effects were reported.
Population
Women with severe dysmenorrhea but no signs of endometriosis (40 participants, 19 in melatonin group, 18 in placebo group).
Effective Dosage
10 mg daily at bedtime during the menstrual week.
Duration
One menstrual week.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
10 mg melatonin daily | decrease | level of pelvic pain | women with endometriosis | - | has previously been shown to reduce | #1 |
10 mg of melatonin given orally at bedtime during the menstrual week | no change | dysmenorrhea | women with dysmenorrhea but without any signs of endometriosis | - | could not show that ... had better analgesic effect | #2 |
melatonin | increase | pain measured with numeric rating scale (NRS) | participants with severe dysmenorrhea | mean NRS 3.18 in melatonin group vs 2.45 in placebo group | proved to be statistically, although not clinically significant | #3 |
melatonin | no change | adverse effects | participants with severe dysmenorrhea | - | no adverse effects were observed | #4 |
PURPOSE: Dysmenorrhea is a common, recurring, painful condition with a global prevalence of 71%. The treatment regime for dysmenorrhea includes hormonal therapies and NSAID, both of which are associated with side effects. A dose of 10 mg melatonin daily has previously been shown to reduce the level of pelvic pain in women with endometriosis. We chose to investigate how this regime, administered during the week of menstruation, would affect women with dysmenorrhea but without any signs of endometriosis, as adjuvant analgesic treatment. METHODS: Forty participants with severe dysmenorrhea were randomized to either melatonin or placebo, 20 in each group. Our primary outcome was pain measured with numeric rating scale (NRS); a difference of at least 1.3 units between the groups was considered clinically significant. Secondary outcomes were use of analgesics, as well as absenteeism and amount of bleeding. Mixed model was used for statistical analysis. RESULTS: Eighteen participants completed the study in the placebo group and 19 in the melatonin group. Mean NRS in the placebo group was 2.45 and 3.18 in the melatonin group, which proved to be statistically, although not clinically significant. CONCLUSION: This randomized, double-blinded, placebo-controlled trial could not show that 10 mg of melatonin given orally at bedtime during the menstrual week had better analgesic effect on dysmenorrhea as compared with placebo. However, no adverse effects were observed. CLINICAL TRIALS: NCT03782740 registered on 17 December 2018.