Dept of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
KBH, Karolinska Institutet, Stockholm, Sweden.
Eur J Clin Pharmacol. 2022 Feb;78(2):191-196. doi: 10.1007/s00228-021-03234-6. Epub 2021 Oct 20.
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.
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.
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.
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.
NCT03782740 registered on 17 December 2018.
痛经是一种常见的、反复出现的、疼痛的疾病，全球患病率为 71%。痛经的治疗方案包括激素治疗和 NSAID，两者都有副作用。先前的研究表明，每天 10 毫克褪黑素可以降低子宫内膜异位症女性盆腔疼痛的程度。我们选择研究这种在月经周期期间给药的方案如何作为辅助镇痛治疗，对没有任何子宫内膜异位症迹象的痛经女性产生影响。
40 名严重痛经的参与者被随机分为褪黑素组或安慰剂组，每组 20 名。我们的主要结局是用数字评分量表（NRS）测量的疼痛；两组之间至少相差 1.3 个单位被认为具有临床意义。次要结局是使用镇痛药以及缺勤和出血量。采用混合模型进行统计分析。
安慰剂组有 18 名参与者完成了研究，褪黑素组有 19 名参与者完成了研究。安慰剂组的平均 NRS 为 2.45，褪黑素组为 3.18，尽管没有统计学意义，但证明具有临床意义。
这项随机、双盲、安慰剂对照试验未能表明在月经周期期间睡前口服 10 毫克褪黑素对痛经的镇痛效果优于安慰剂。然而，没有观察到不良反应。
NCT03782740 于 2018 年 12 月 17 日注册。
