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. 2021 Apr;63(4):572-576.
doi: 10.1002/mus.27168. Epub 2021 Jan 24.

Melatonin may slow disease progression in amyotrophic lateral sclerosis: Findings from the Pooled Resource Open-Access ALS Clinic Trials database

Elizabeth M Bald  1 , Christopher S Nance  2 , Jordan L Schultz  3
Affiliations

Melatonin may slow disease progression in amyotrophic lateral sclerosis: Findings from the Pooled Resource Open-Access ALS Clinic Trials database

Elizabeth M Bald et al. Muscle Nerve. 2021 Apr.

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.

Keywords: ALS; PRO-ACT; disease progression; melatonin; survival.

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Conflict of interest statement

Disclosure of Conflicts of Interest: None of the authors has any conflict of interest to disclose.

Figures

Figure 1:
Figure 1:. Flow diagram of included and excluded participants
sALSFRS0 = standardized amyotrophic lateral sclerosis functional rating scale BMI = body mass index
Figure 2:
Figure 2:. Unmatched and matched results of primary and secondary outcomes
(A) Annualized hazard death rate between melatonin users and non-users without propensity score matching (B) Annualized hazard death rate between melatonin users and non-users with propensity score matching (C) Change in sALSFRS over time between melatonin users and non-users without propensity score matching (D) Change in sALSFRS over time between melatonin users and non-users with propensity score matching (E) Change in % predicted FVC scores between melatonin users and non-users without propensity score matching (F) Change in % predicted FVC scores between melatonin users and non-users with propensity score matching sALSFRS = standardized amyotrophic lateral sclerosis functional rating scale FVC % Predicted = percentage of predicted of forced vital capacity
See this image and copyright information in PMC

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