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Melatonin treatment in patients with atypical facial pain: A randomized, double-blind, placebo-controlled clinical trial

Tahereh Nosratzehi

Medicina Clínica Práctica, 2024

Abstract

Background: The present study was carried out to evaluate the effect of melatonin and placebo in the patients with atypical facial pain (AFP). Method: Thisdoubleblind randomized controlled studywascarriedouton30patientswhoweresuffering from AFP. During this period, patients were divided in 2 study and control groups. Then, they were treated with melatonin. Melatonin group used four 3-mg daily and placebo group received 4 placebo which were similar in size, shape,colorwithmelatoninuntiltheendoftreatment,andthentheseverityofburningsensationwasmeasured by physician. Sleep quality was measured using the visual analog scale using the Petersburg questionnaire. Result: The results of thepresent study show that theuseofmelatoninand placebo inpatientswith AFPreduces sensation and improves their sleep quality, although it may not reduce it completely. In this study, severity of burning was 5.71±1.42 after treatment in the study group and 5.93±2.65 in the control group, which was notstatisticallysigni fi cant( p =.46).The mean scoreof sleep beforetreatment wasnotsigni fi cantlydifferent be-tween the study (9±1.23) and the control (8±1.56) groups. The mean score of sleep after treatment between the study group (8±1.45) and the control group (7±1.23) was not signi fi cantly different ( p =.43). Conclusion: According to the result of the study, melatonin was not superior placebo in treatment of AFP. © 2024 Published by Elsevier España, S

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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.

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