Reporting of harms in systematic reviews focused on naltrexone: a cross-sectional study

Research output: Contribution to conferencePosterpeer-review


Background: Naltrexone is a commonly used pharmacologic intervention for Alcohol Use Disorder (AUD), Opioid Use Disorder (OUD), and several off label indications. Due to its popular use, it is important for both benefits and harms of naltrexone therapy to be adequately assessed within the medical literature. Systematic reviews (SR) often provide physicians with up-to-date information regarding the safety profile of a given therapy. Therefore, we sought to assess the completion of harms reporting in SRs related to naltrexone, the methodological quality of included systematic reviews, and primary study overlap among included systematic reviews.

Methods: Our study searched MEDLINE (Pubmed and Ovid), EMBASE, Epistemonikos, and Cochrane Database for Systematic Reviews. We included SRs assessing naltrexone for both FDA-approved and off-label uses. Screening and data extraction were performed in a masked, duplicate fashion. Overlapping primary studies among included SRs were assessed using the corrected cover area (CCA). Additionally, we appraised each included SR using the AMSTAR-2 checklist.

Results: Out of the 87 included SRs, one study used a grade or severity scale to assess harms (86/87, 99.0%) and 4 studies used terminology to describe harms from naltrexone therapy (4/87, 4.6%). Additionally, AMSTAR-2 appraised 72 SRs as “critically low” (72/87, 82.8%) and 2 SRs as “high” (2/87, 2.3%). A Kruskal-Wallis test showed a significant relationship between studies graded “critically low” via AMSTAR-2 and harms reporting completeness (P=.0486), as well as studies that specified harms as a secondary outcome and completeness of harms reporting (P=.0001). Our study found 4 pairs of included SRs had a “high” (>50%) overlap of primary studies.

Conclusions: Our study demonstrates that underreporting of harms is prevalent among SRs on naltrexone therapy. We suggest implementing changes to improve harms reporting within medical literature which will aid physicians in better interpreting a study’s results.
Original languageAmerican English
StatePublished - 14 Feb 2023
EventOklahoma State University Center for Health Sciences Research Week 2023 - Oklahoma State University Center for Health Sciences, 1111 W. 17th street, Tulsa, United States
Duration: 13 Feb 202317 Feb 2023


ConferenceOklahoma State University Center for Health Sciences Research Week 2023
Country/TerritoryUnited States
Internet address


  • Naltrexone
  • cross-sectional analysis
  • systematic reviews
  • harms


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