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Melatonin may slow disease progression in amyotrophic lateral sclerosis: Findings from the Pooled Resource Open‐Access ALS Clinic Trials database
Author(s) -
Bald Elizabeth M.,
Nance Christopher S.,
Schultz Jordan L.
Publication year - 2021
Publication title -
muscle and nerve
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.025
H-Index - 145
eISSN - 1097-4598
pISSN - 0148-639X
DOI - 10.1002/mus.27168
Subject(s) - melatonin , amyotrophic lateral sclerosis , hazard ratio , medicine , database , proportional hazards model , confidence interval , clinical trial , vital capacity , disease , oncology , physical therapy , lung function , lung , computer science , diffusing capacity
Abstract Introduction We utilized the Pooled Resource Open‐Access Clinical Trials (PRO‐ACT) database to investigate whether melatonin use among patients with amyotrophic lateral sclerosis (ALS) was associated with slower disease progression and prolonged survival. Methods This retrospective analysis of the PRO‐ACT database addresses the impact of melatonin on progression and overall survival of ALS. A Cox proportional hazards ratio model was performed to investigate the effect that melatonin had on time to death. For secondary outcome measures, linear mixed effects regression models were used to ascertain the effect of melatonin on change in standardized ALS Functional Rating Scale (sALSFRS) and percentage predicted forced vital capacity (FVC) scores. Results Melatonin users had a significantly decreased annualized hazard death rate compared with the non–melatonin users (hazard ratio, 0.241; 95% confidence interval, 0.088‐0.659; P = .0056). The melatonin users also had a slower rate of decline in sALSFRS score ( t = 2.71; P = .0069) and change in percent predicted FVC score ( t = 2.94; P = .0035) compared with the non–melatonin users. Discussion Our findings suggest that melatonin may be beneficial for patients with ALS. Due to the nature of this database, our results are solely intended to be hypothesis‐generating and no strong associations can be made. Given the low cost and favorable safety profile of melatonin, the hypotheses generated warrant further investigation.