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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 Shea
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