Evidence map›Paper›PMID 31918448›Full record

SynthesisBritish journal of clinical pharmacology2020

Naltrexone-bupropion (Mysimba) in management of obesity: A systematic review and meta-analysis of unpublished clinical study reports.

Igho J Onakpoya, Joseph J Lee, Kamal R Mahtani, Jeffrey K Aronson, Carl J Heneghan

Erratum issuedOpen access · bronzeAbstract readMeta-AnalysisSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in British journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 25 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 3 pooled it
5.3field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 3 syntheses or guidelines pooled it, 76 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. The 'Obesity First' approach: Redefining the future of healthcare.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2026
    Review
  6. Review
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  10. Article
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  15. Review
  16. Review
  17. Article
  18. The Effect of KSK-94, a Dual Histamine HPharmaceuticals (Basel, Switzerland) · 2024
    Article
  19. Review
  20. Naltrexone-bupropion for weight loss.Canadian family physician Medecin de famille canadien · 2023
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Igho J OnakpoyaCentre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, Radcliffe Observatory Quarter, University of Oxford, Oxford, UK.ORCID 0000-0002-2420-0811
Joseph J LeeCentre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, Radcliffe Observatory Quarter, University of Oxford, Oxford, UK.
Kamal R MahtaniCentre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, Radcliffe Observatory Quarter, University of Oxford, Oxford, UK.
Jeffrey K AronsonCentre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, Radcliffe Observatory Quarter, University of Oxford, Oxford, UK.ORCID 0000-0003-1139-655X
Carl J HeneghanCentre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, Radcliffe Observatory Quarter, University of Oxford, Oxford, UK.
University of Oxford · GB

Funding

National Institute for Health Research School for Primary Care Research (NIHR-SPCR) 390
6 · The paper itself

Abstract

aimsTo compare the benefits and harms of naltrexone-bupropion using evidence from clinical study reports.

methodsWe searched Food and Drug Administration and European Medicines Agency websites, PubMed, and Clinicaltrials.gov (May 2016) to identify pivotal trials; we then sent a freedom of information request to the European Medicines Agency (July 2016). We included pivotal, phase III placebo-controlled trials. We assessed the risks of bias using the Cochrane criteria, and the quality of the evidence using GRADE. We used a random-effects model for meta-analyses.

resultsOver a 27-month period (July 2016 to August 2018), we received 31 batches of clinical study report documents containing over 65 000 pages of data from 4 pivotal trials (n = 4536). Significantly more participants who took naltrexone-bupropion achieved ≥5% reduction in body weight: risk ratio (RR) = 2.1 (95% confidence interval 1.35-3.28), P = .001, GRADE = low, number needed to treat (NNT) to benefit = 5 (3-17); this represents a 2.53 kg (1.85-3.21) reduction in baseline body weight compared with placebo. Naltrexone-bupropion had significantly beneficial effects on other cardiovascular risk factors; however, the true effect sizes for these are uncertain because of incomplete outcome data. Naltrexone-bupropion significantly increased the risk of adverse events: RR = 1.11 (1.05-1.18, P = .0004, GRADE = low, NNT to harm = 12 7-27); serious adverse events: RR = 1.70 (1.38-2.1, P < .00001, GRADE = moderate, NNT to harm = 21 13-38); and discontinuation because of adverse events: RR = 1.92 (1.65-2.24, P < .00001, GRADE = moderate, NNT to discontinue treatment = 9 8-13).

conclusionsNaltrexone-bupropion significantly reduces body weight by a small amount but significantly increases the risk of adverse events. A rigorous process of postmarketing surveillance is required.

Indexed as

BupropionNaltrexoneDrug CombinationsHumansObesityBupropionbupropion hydrochloride, naltrexone hydrochoride drug combinationDrug CombinationsNaltrexoneclinical study reportmeta-analysisnaltrexone-bupropionobesitysystematic review

Identifiers

PMID31918448
PMCPMC7098870
OpenAlexW3000659570

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.