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Alternative remedies for insomnia: a proposed method for personalized therapeutic trials

Authors Romero K, Goparaju B, Russo K, Westover MB, Bianchi MT

Received 18 November 2016

Accepted for publication 9 February 2017

Published 17 March 2017 Volume 2017:9 Pages 97—108

DOI https://doi.org/10.2147/NSS.S128095

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Colin Mak

Peer reviewer comments 2

Editor who approved publication: Professor Steven A Shea


Kate Romero,1,2 Balaji Goparaju,1,2 Kathryn Russo,1,2 M Brandon Westover,1 Matt T Bianchi1,2

1Neurology Department, Massachusetts General Hospital, 2Division of Sleep Medicine, Harvard Medical School, Boston, MA, USA

Abstract: Insomnia is a common symptom, with chronic insomnia being diagnosed in 5–10% of adults. Although many insomnia patients use prescription therapy for insomnia, the health benefits remain uncertain and adverse risks remain a concern. While similar effectiveness and risk concerns exist for herbal remedies, many individuals turn to such alternatives to prescriptions for insomnia. Like prescription hypnotics, herbal remedies that have undergone clinical testing often show subjective sleep improvements that exceed objective measures, which may relate to interindividual heterogeneity and/or placebo effects. Response heterogeneity can undermine traditional randomized trial approaches, which in some fields has prompted a shift toward stratified trials based on genotype or phenotype, or the so-called n-of-1 method of testing placebo versus active drug in within-person alternating blocks. We reviewed six independent compendiums of herbal agents to assemble a group of over 70 reported to benefit sleep. To bridge the gap between the unfeasible expectation of formal evidence in this space and the reality of common self-medication by those with insomnia, we propose a method for guided self-testing that overcomes certain operational barriers related to inter- and intraindividual sources of phenotypic variability. Patient-chosen outcomes drive a general statistical model that allows personalized self-assessment that can augment the open-label nature of routine practice. The potential advantages of this method include flexibility to implement for other (nonherbal) insomnia interventions.

Keywords: insomnia, over the counter, alternative remedy, herbal, supplement

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