A double-blind, randomized controlled trial of duloxetine for pain in Parkinson's disease

Hirotaka Iwaki; Rina Ando; Satoshi Tada; Noriko Nishikawa; Tomoaki Tsujii; Yuki Yamanishi; Noriyuki Miyaue; Hayato Yabe; Masahiro Nagai; Masahiro Nomoto

doi:10.1016/j.jns.2020.116833

A double-blind, randomized controlled trial of duloxetine for pain in Parkinson's disease

J Neurol Sci. 2020 Jul 15:414:116833. doi: 10.1016/j.jns.2020.116833. Epub 2020 Apr 9.

Authors

Affiliations

¹ Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Laboratory of Neurogenetics, National Institute on Aging, National Institute of Health, MD, USA; Data Tecnica International, MD, USA.
² Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.
³ Department of Neurology, National Center Hospital of Neurology and Psychiatry, Tokyo, Japan.
⁴ Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Department of Neurology, Saiseikai Matsuyama Hospital, Ehime, Japan.
⁵ Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Department of Neurology, Saiseikai Imabari Hospital, Ehime, Japan. Electronic address: nomoto1492@nifty.com.

PMID: 32299024
DOI: 10.1016/j.jns.2020.116833

Abstract

Background: Duloxetine proved effective for treating pain in people with Parkinson's disease in a single-arm, open-label study.

Objective: To evaluate the efficacy of duloxetine in a double-blind, randomized, placebo-controlled trial.

Methods: We randomly assigned 46 patients with Parkinson's disease with pain to either the duloxetine 40 mg/day arm or the placebo arm. After 10 weeks, we tested the change from baseline in 24-hour average pain severity measured by a visual analogue scale.

Results: We could not confirm the effect of duloxetine on pain. Exploratory analyses indicated that treatment with duloxetine was associated with improved scores on the Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39.

Conclusions: The study failed to provide evidence for the use of duloxetine for treating pain in people with Parkinson's disease.

Keywords: Duloxetine hydrochloride; Pain; Parkinson's disease; Randomized controlled trial.

Publication types

Randomized Controlled Trial

MeSH terms

Dopamine Agents* / therapeutic use
Double-Blind Method
Duloxetine Hydrochloride* / therapeutic use
Humans
Pain* / drug therapy
Pain* / etiology
Parkinson Disease* / complications
Parkinson Disease* / drug therapy
Treatment Outcome

Substances

Dopamine Agents
Duloxetine Hydrochloride