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Bupropion ist ein Wirkstoff aus der Gruppe der Antidepressiva und wird in den USA seit 1989 zur Behandlung von PatientInnen mit depressiven Störungen eingesetzt. Da Bupropion darüber hinaus eine Behandlung von Menschen mit Amphetamin-Konsumstörungen unterstützen könnte, haben Bakouni et al. nun eine Übersichtsarbeit und Metaanalyse über die Wirksamkeit von Bupropion zur Therapie entsprechender Abhängigkeitserkrankungen vorgelegt.
Bupropion ist ein Wirkstoff aus der Gruppe der Antidepressiva und wird in den USA seit 1989 zur Behandlung von PatientInnen mit depressiven Störungen eingesetzt. Da Bupropion darüber hinaus eine Behandlung von Menschen mit Amphetamin-Konsumstörungen unterstützen könnte, haben Bakouni et al. nun eine Übersichtsarbeit und Metaanalyse über die Wirksamkeit von Bupropion zur Therapie entsprechender Abhängigkeitserkrankungen vorgelegt.
ImportanceDifferences in treatment effects between men and women may be important across diverse interventions and diseases.ObjectiveWe aimed to evaluate claims of sex-based differences in treatment effects across published meta-analyses.Data SourcesPubMed (searched up to January 17, 2024).Study SelectionPublished meta-analyses of randomized controlled trials (RCTs) that had any mention of sex (male/female) subgroup or related analysis in their abstract.Data Extraction and SynthesisWe determined how many meta-analyses had made claims of sex-based differences in treatment effects. These meta-analyses were examined in depth to determine whether the claims reflected sex-treatment interactions with statistical support or fallacious claims and categorized the frequency of different fallacies. For claims with statistical support, we examined whether they were considered and discussed in UpToDate. Whenever possible, we re-analyzed the p-value for sex-treatment interaction.Main Outcomes and MeasuresNumber of claims with statistical support and fallacious claims; clinical implications of subgroup differences.Results216 meta-analysis articles fulfilled the eligibility criteria. Of them, 99 stated in the abstract that that there was no sex-based difference, and 20 mentioned a sex-based subgroup analysis without reporting results in the abstract. 97 meta-analyses made 115 claims of sex-based differences. Of them, 27 claims across 21 articles had statistical support at p<0.05. 4/27 claims were mentioned in UpToDate, but none led to different recommendations for men and women. 35 articles had 39 fallacious claims where the sex-treatment interaction was not statistically significant (significant effects in one sex (29 claims in 25 articles), larger effects in one sex (7 claims in 7 articles), other (3 claims in 3 articles)). Another 44 articles made claims based on potentially fallacious methods (39 based on meta-regression of percentage of one group and 5 providing the results of only one group), but proper data were unavailable to assess statistical significance.Conclusions and relevanceFew meta-analyses of RCTs make claims of sex-based differences in treatment effects and most of these claims lack formal statistical support. Statistically significant and clinically actionable sex-treatment interactions may be rare.
Background and aimsA 12‐week placebo‐controlled, sequential parallel Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder (ADAPT‐2) trial evaluated the effects of extended‐release injectable naltrexone plus extended‐release oral bupropion (NTX + BUPN) on methamphetamine (MA) use over two stages. This study reports on the previously unpublished stage 2 MA use in participants randomized at stage 1 to receive NTX + BUPN through both stages compared with those assigned to placebo.DesignThis is a secondary analysis of the US National Institute on Drug Abuse (NIDA) ADAPT‐2 network trial.SettingThe parent ADAPT‐2 trial was carried out across multiple NIDA Clinical Trials Network (CTN) sites in the United States.ParticipantsThis analysis includes 403 people with MA use disorder who participated in the ADAPT‐2 CTN trial.Intervention and comparatorNTX + BUPN was compared with placebo over the course of the trial.MeasurementMA use was measured by urine drug screens conducted twice weekly for 12 weeks, then once in week 13 and once in week 16 post‐treatment follow‐up.FindingsParticipants on NTX + BUPN in stage 1 showed an additional 9.2% increase [95% confidence interval (CI), 0.09%–17.9%, P = 0.038] during stage 2 in their probability of testing negative for MA, with a total increase of 27.1% (95% CI, 13.2%–41.1%, P < 0.001) over the full 12 weeks of treatment. In contrast, participants on placebo in both stages increased in probability of testing MA‐negative by a total of 11.4% (95% CI, 4.1%–18.6%, P = 0.002) over all 12 weeks. The 12‐week increase among participants on NTX + BUPN was significantly greater—by 15.8% (95% CI, 4.5%–27.0%, P = 0.006)—than the increase among those on placebo.ConclusionFor people with methamphetamine (MA) use disorder receiving treatment with extended‐release injectable naltrexone plus extended‐release oral bupropion (NTX + BUPN), continued treatment with NTX + BUPN after 6 weeks is associated with additional reductions in MA use up to 12 weeks.
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