Evidence map›Paper›PMID 20559296›Full record

Trial reportObesity (Silver Spring, Md.)2011

Weight loss with naltrexone SR/bupropion SR combination therapy as an adjunct to behavior modification: the COR-BMOD trial.

Thomas A Wadden, John P Foreyt, Gary D Foster, James O Hill, Samuel Klein, Patrick M O'Neil, Michael G Perri, F Xavier Pi-Sunyer, Cheryl L Rock, Janelle S Erickson and 3 more

2 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Obesity (Silver Spring, Md.), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 219 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
219citing papers in PubMed, 15 pooled it
20.8field-weighted citation impact, top 1% 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.

NCT00456521 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Naltrexone Sustained Release (SR)/Bupropion SR and Placebo in Subjects With Obesity Participating in a Behavior Modification Program

TypeinterventionalSponsorOrexigen Therapeutics, IncRan2007 to 2008Enrolled793ConditionsObesity, OverweightArmsNaltrexone SR 32 mg/ bupropion SR 360 mg/ day, Placebo, Intensive group lifestyle modification counseling
NCT02627105 nacompletednot on this mapstarted 2015, after this paper: background citation

The Beef WISE Study: Beef's Role in Weight Improvement, Satisfaction, and Energy

TypeinterventionalSponsorUniversity of Colorado, DenverRan2015 to 2016Enrolled120ConditionsWeight LossArmsBeef group, Non-beef group
3 · Its place in the literature

Who cites it

219 citing papers in PubMed, 15 syntheses or guidelines pooled it, 538 citations in OpenAlex.

  1. Guideline
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Obesity in South and Southeast Asia-A new consensus on care and management.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2023
    Guideline
  6. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
  7. Long-term effects of weight-reducing drugs in people with hypertension.The Cochrane database of systematic reviews · 2021
    Pooled it
  8. Pooled it
  9. Guideline
  10. Pooled it
  11. Guideline
  12. Food cue reactivity and craving predict eating and weight gain: a meta-analytic review.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2016
    Pooled it
  13. European Guidelines for Obesity Management in Adults.Obesity facts · 2015 · on this map
    Guideline
  14. Pooled it
  15. Pooled it
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

159 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 10 institutions in 1 country.

Thomas A WaddenDepartment of Psychiatry, Center for Weight and Eating Disorders, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA. wadden@mail.med.upenn.edu
John P Foreyt
Gary D Foster
James O Hill
Samuel Klein
Patrick M O'Neil
Michael G Perri
F Xavier Pi-Sunyer
Cheryl L Rock
Janelle S Erickson
Holly N Maier
Dennis D Kim
Eduardo Dunayevich
VistaGen Therapeutics (United States) · USClinical Solutions · USMedical University of South Carolina · USSt. Luke's-Roosevelt Hospital Center · USTemple University · USUniversity of California, San Diego · USUniversity of Colorado Denver · USUniversity of Florida · USUniversity of Pennsylvania · USWashington University in St. Louis · US

Funding

RESEARCH TRAININGP30DK026687 · NIDDK · ST. LUKE'S-ROOSEVELT INST FOR HLTH SCIS · PI Anthony W Ferrante, DYMPNA GALLAGHER · 1986 to 2026
$33.0M
Washington University Nutrition Obesity Research CenterP30DK056341 · NIDDK · WASHINGTON UNIVERSITY · PI Dominic N Reeds · 1999 to 2026
$30.2M
University of Florida Older Americans Independence Center (OAIC)P30AG028740 · NIA · UNIVERSITY OF FLORIDA · PI Stephen D Anton · 2007 to 2026
$22.8M
NIA NIH HHS P30 AG028740NIDDK NIH HHS P30 DK026687NIDDK NIH HHS P30 DK056341
6 · The paper itself

Abstract

This 56-week, randomized, placebo-controlled trial examined the efficacy and safety of naltrexone plus bupropion as an adjunct to intensive behavior modification (BMOD). A total of 793 participants (BMI = 36.5 ± 4.2 kg/m²) was randomly assigned in a 1:3 ratio to: (i) placebo + BMOD (N = 202); or (ii) naltrexone sustained-release (SR, 32 mg/day), combined with bupropion SR (360 mg/day) plus BMOD (i.e., NB32 + BMOD; N = 591). Both groups were prescribed an energy-reduced diet and 28 group BMOD sessions. Co-primary end points were percentage change in weight and the proportion of participants who lost ≥5% weight at week 56. Efficacy analyses were performed on a modified intent-to-treat population (ITT; i.e., participants with ≥1 postbaseline weight while taking study drug (placebo + BMOD, N = 193; NB32 + BMOD, N = 482)). Missing data were replaced with the last observation obtained on study drug. At week 56, weight loss was 5.1 ± 0.6% with placebo + BMOD vs. 9.3 ± 0.4% with NB32 + BMOD (P < 0.001). A completers analysis revealed weight losses of 7.3 ± 0.9% (N = 106) vs. 11.5 ± 0.6% (N = 301), respectively (P < 0.001). A third analysis, which included all randomized participants, yielded losses of 4.9 ± 0.6 vs. 7.8 ± 0.4%, respectively (P < 0.001). Significantly more NB32 + BMOD- vs. placebo + BMOD-treated participants lost ≥5 and ≥10% of initial weight, and the former had significantly greater improvements in markers of cardiometabolic disease risk. NB32 + BMOD was generally well tolerated, although associated with more reports of nausea than placebo + BMOD. The present findings support the efficacy of combined naltrexone/bupropion therapy as an adjunct to intensive BMOD for obesity.

Indexed as

Behavior TherapyAdultAntidepressive AgentsBupropionChemotherapy, AdjuvantCombined Modality TherapyDelayed-Action PreparationsDouble-Blind MethodDrug CombinationsFemaleHumansMaleMiddle AgedNaltrexoneNarcotic AntagonistsObesityAntidepressive AgentsBupropionDelayed-Action PreparationsDrug CombinationsNaltrexoneNarcotic AntagonistsPlacebos

Identifiers

PMID20559296
PMCPMC4459776
OpenAlexW1997115741

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.