Importance: There are no known effective treatments for painful chemotherapy-induced peripheral neuropathy.
Objective: To determine the effect of duloxetine, 60 mg daily, on average pain severity.
Design, Setting, And Patients: Randomized, double-blind, placebo-controlled crossover trial at 8 National Cancer Institute (NCI)-funded cooperative research networks that enrolled 231 patients who were 25 years or older being treated at community and academic settings between April 2008 and March 2011. Study follow-up was completed July 2012. Stratified by chemotherapeutic drug and comorbid pain risk, patients were randomized to receive either duloxetine followed by placebo or placebo followed by duloxetine. Eligibility required that patients have grade 1 or higher sensory neuropathy according to the NCI Common Terminology Criteria for Adverse Events and at least 4 on a scale of 0 to 10, representing average chemotherapy-induced pain, after paclitaxel, other taxane, or oxaliplatin treatment.
Interventions: The initial treatment consisted of taking 1 capsule daily of either 30 mg of duloxetine or placebo for the first week and 2 capsules of either 30 mg of duloxetine or placebo daily for 4 additional weeks.
Main Outcome Measures: The primary hypothesis was that duloxetine would be more effective than placebo in decreasing chemotherapy-induced peripheral neuropathic pain. Pain severity was assessed using the Brief Pain Inventory-Short Form "average pain" item with 0 representing no pain and 10 representing as bad as can be imagined.
Results: Individuals receiving duloxetine as their initial 5-week treatment reported a mean decrease in average pain of 1.06 (95% CI, 0.72-1.40) vs 0.34 (95% CI, 0.01-0.66) among those who received placebo (P = .003; effect size, 0.513). The observed mean difference in the average pain score between duloxetine and placebo was 0.73 (95% CI, 0.26-1.20). Fifty-nine percent of those initially receiving duloxetine vs 38% of those initially receiving placebo reported decreased pain of any amount.
Conclusion And Relevance: Among patients with painful chemotherapy-induced peripheral neuropathy, the use of duloxetine compared with placebo for 5 weeks resulted in a greater reduction in pain.
Trial Registration: clinicaltrials.gov Identifier: NCT00489411.
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http://dx.doi.org/10.1001/jama.2013.2813 | DOI Listing |
J Am Acad Child Adolesc Psychiatry
January 2025
University Medical Center Groningen, Groningen, The Netherlands.
Objective: To examine the association between newer generation antidepressants and insomnia as an adverse event (AE) in the treatment of children and adolescents with major depressive disorder (MDD).
Method: A systematic search was performed in major databases (inception to August 31, 2023) to retrieve double-blind, placebo-controlled, randomized controlled trials (RCTs) evaluating the safety of 19 antidepressants in the acute treatment (initial 6 to 12 weeks) of children and adolescents aged ≤ 18 years with MDD (primary analyses). RCTs in anxiety disorders and obsessive-compulsive disorder (OCD) were retrieved from a recent meta-analysis and included in complementary analyses.
J Clin Epidemiol
January 2025
Adult Psychiatry Department, Rennes University Hospital, Rennes, France; Centre for Population Neuroscience and Stratified Medicine (PONS), Department of Psychiatry and Clinical Neuroscience, Charité Universitätsmedizin Berlin, Berlin, Germany. Electronic address:
Objective: Relying on published data alone might be insufficient for meta-analyses to be reliable and trustworthy since selective outcome reporting is common, especially for adverse events. We investigated the existence of selective reporting and its potential for bias in a case study exploring adverse events of duloxetine in adults.
Study Design And Setting: We systematically searched all previous meta-analyses/pooled analyses on duloxetine published on PubMed for 7 indications approved by the American and European health authorities.
Int J Clin Pharm
January 2025
Department of Medicine, Evangelical University of Goiás, Avenida Universitária Km 3.5, Cidade Universitária, Anápolis, GO, 75083-515, Brazil.
Background: Recent studies suggest that duloxetine administration before non-laparoscopic surgery may reduce postoperative pain and analgesic requirement without increasing adverse event occurrence.
Aim: To perform a systematic review and meta-analysis of randomized controlled trials (RCTs) on preoperative administration of duloxetine versus placebo for postoperative pain relief in adults undergoing laparoscopic surgery, assessing efficacy- and safety-related outcomes.
Method: We systematically searched MEDLINE, Embase, and Cochrane Library, covering all records up to July 19, 2024.
BMJ Open
December 2024
Institute for Musculoskeletal Health, Sydney Local Health District, Sydney, New South Wales, Australia.
Introduction: Sciatica is a debilitating condition that often becomes chronic, and for which there are few effective treatment options. Treatments such as the anti-depressant duloxetine have shown promise, but the evidence is inconclusive. We are describing a high quality, definitive trial to investigate the efficacy, safety and cost-effectiveness of duloxetine in chronic sciatica.
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