Ensaio clínico duplo-cego randomizado e placebocontrolado com naltrexona e intervenção breve no tratamento ambulatorial da dependência de álcool

Castro, Luís André; Laranjeira, Ronaldo

doi:10.1590/s0047-20852009000200002

Cited by 9 publications

(1 citation statement)

References 14 publications

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“…The assessment of the risk of bias is reported in Additional file 1: Figure S1. One article was published in Portuguese [50]. Several studies were unpublished: data of 2 unpublished nalmefene RCTs (CPH-101-0399, CPH-101-0701) were provided by access to the document service of the EMA, and data of 3 naltrexone RCTs were recovered from ClinicalTrials.gov (NCT00667875, NCT01625091, and NCT00302133).…”

Section: Resultsmentioning

confidence: 99%

Vibration of effects from diverse inclusion/exclusion criteria and analytical choices: 9216 different ways to perform an indirect comparison meta-analysis

Palpacuer

Hammas

Duprez

et al. 2019

BMC Med

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Background Different methodological choices such as inclusion/exclusion criteria and analytical models can yield different results and inferences when meta-analyses are performed. We explored the range of such differences, using several methodological choices for indirect comparison meta-analyses to compare nalmefene and naltrexone in the reduction of alcohol consumption as a case study. Methods All double-blind randomized controlled trials (RCTs) comparing nalmefene to naltrexone or one of these compounds to a placebo in the treatment of alcohol dependence or alcohol use disorders were considered. Two reviewers searched for published and unpublished studies in MEDLINE (August 2017), the Cochrane Library, Embase, and ClinicalTrials.gov and contacted pharmaceutical companies, the European Medicines Agency, and the Food and Drug Administration. The indirect comparison meta-analyses were performed according to different inclusion/exclusion criteria (based on medical condition, abstinence of patients before inclusion, gender, somatic and psychiatric comorbidity, psychological support, treatment administered and dose, treatment duration, outcome reported, publication status, and risk of bias) and different analytical models (fixed and random effects). The primary outcome was the vibration of effects (VoE), i.e. the range of different results of the indirect comparison between nalmefene and naltrexone. The presence of a “Janus effect” was investigated, i.e. whether the 1st and 99th percentiles in the distribution of effect sizes were in opposite directions. Results Nine nalmefene and 51 naltrexone RCTs were included. No study provided a direct comparison between the drugs. We performed 9216 meta-analyses for the indirect comparison with a median of 16 RCTs (interquartile range = 12–21) included in each meta-analysis. The standardized effect size was negative at the 1st percentile (− 0.29, favouring nalmefene) and positive at the 99th percentile (0.29, favouring naltrexone). A total of 7.1% (425/5961) of the meta-analyses with a negative effect size and 18.9% (616/3255) of those with a positive effect size were statistically significant (p < 0.05). Conclusions The choice of inclusion/exclusion criteria and analytical models for meta-analysis can result in entirely opposite results. VoE evaluations could be performed when overlapping meta-analyses on the same topic yield contradictory result. Trial registration This study was registered on October 19, 2016, in the Open Science Framework (OSF, protocol available at https://osf.io/7bq4y/).

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Section: Resultsmentioning

confidence: 99%