Abstract
This study presents a meta-analysis of the influence of several potentially biasing factors (eg industry support, extrapyramidal side effects) on efficacy of studies comparing second-generation antipsychotic (SGA) with first-generation antipsychotic (FGA) medications. We used the dataset from our previously published meta-analysis of 124 randomized controlled trials (RCTs) comparing SGAs with FGAs, to evaluate whether certain possible biases could influence the actual outcome on the total score of the Positive and Negative Syndrome Scale (PANSS), Brief Psychiatric Rating Scale (BPRS), and Clinical Global Impressions (CGI) scores. Industry sponsorship was determined by contact with authors or publication statement. We calculated whether (1) industry sponsorship, (2) study quality, (3) extrapyramidal symptoms (EPS) properties, or (4) prophylactic antiparkinsonian medications influenced SGA vs FGA efficacy for each drug and averaged overall by two Hedges and Olkin-based meta-analyses. The analysis found that none of the factors was significantly associated with a particular outcome. While industry-sponsored articles may conclude their medication to be more favorable than that of a competitor in an RCT, we found that the observed efficacy was not influenced by sponsorship. Many attribute the finding that SGAs appears to be more efficacious than FGAs to be a result of EPS-decreasing efficacy (or its measurement). We were unable to confirm that the drug's EPS properties or antiparkinsonian management altered actual efficacy.
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Acknowledgements
This study was supported in part by National Institute of Mental Health Grant No. 1 P01MH68580-01 CFDA #93.242.
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DISCLOSURE/CONFLICT OF INTEREST
John Davis and Nancy Chen have no financial conflict of interest and have not received or anticipate receiving any monetary support from the pharmaceutical industry including compensation for professional services, research support, honorarium, speaker's fees, royalties, stock or stock options, consultantship and reimbursement for travel expenses, over the past 5 years. Ira Glick, over the past 5 years, either has served on advisory boards, received research support, or been on speakers’ bureaus for Solvay, Shire, Glaxo, Janssen, Lilly, AstraZeneca, Pfizer, BMS-Otsuka, and the NIMH. Dr Glick also has stock in Johnson & Johnson and Forrest Laboratories.
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Davis, J., Chen, N. & Glick, I. Issues that May Determine the Outcome of Antipsychotic Trials: Industry Sponsorship and Extrapyramidal Side Effect. Neuropsychopharmacol 33, 971–975 (2008). https://doi.org/10.1038/sj.npp.1301493
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DOI: https://doi.org/10.1038/sj.npp.1301493
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