Both melatonin and meloxicam improved sleep and pain in females with primary dysmenorrhea—results from a double-blind cross-over intervention pilot study
Up to 25% of ovulating women suffer from primary dysmenorrhea, a condition associated with pain and transient-reduced quality of life, along with greater irritability and impaired sleep. In the present study, we asked whether and if so to what extent melatonin and meloxicam can improve subjective and objective sleep and reduce pain among women with primary dysmenorrhea (PD). To this end, we conducted a double-blind cross-over clinical trial lasting for three menstrual cycles. A total of 14 women (mean age M = 27.5 years) with primary dysmenorrhea took part in the study. At baseline, that is, during the first menstruation, they completed a visual analogue scale to rate pain; sleep continuity was assessed via actigraphs, and overall sleep quality was assessed with the Pittsburgh Sleep Quality Index (PSQI). Next, participants were randomly assigned to one of two conditions, either melatonin during the second, and meloxicam during the third menstruation, or meloxicam during the second, and melatonin during the third menstruation. Neither participants nor investigators were aware of participants’ study assignment. During the second and third menstruations, the assessments described above were repeated. At baseline, sleep assessed both objectively and subjectively was impaired, and pain was high. Subjective sleep improved and pain decreased during the second and third menstruations irrespective of whether melatonin or meloxicam was administered first or second. Likewise, objective sleep efficiency increased and objective sleep latency shortened. The efficacy of melatonin was superior to that of meloxicam. The present pattern of results suggests that both melatonin and meloxicam are suitable to treat pain and PD-related sleep complaints among women with primary dysmenorrhea.
KeywordsPrimary dysmenorrhea Pain Sleep Melatonin Meloxicam
We thank Nick Emler (University of Surrey, Surrey, UK) for proofreading the manuscript.
FK, FM, SB, DSB, FA, HK, and MRG designed the study.
FK, FM, DSB, FA, HK, and MRG wrote the proposal for the ethical committee.
FK, FM, FA, HK, and MRG were highly involved in the recruitment of patients, the assessments, and interventions.
SB, DSB, and MRG performed the statistical analysis.
DSB, SB, and MRG wrote the draft of the manuscript.
DSB and SB integrated the co-authors’ comments.
DSB, SB, HK, and MRG completed the final version of the manuscript and submitted it.
Compliance with ethical standards
All procedures were approved by the institutional ethics committee of the KUMS, and performed in accordance with the rules laid down in the Declaration of Helsinki (Iranian Registry of Clinical Trials: IRCT2015031521475N1).
Conflict of interest
The authors declare that they have no conflicts of interests.
The entire study was performed without external funding.
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