Interventions for preventing weight gain after smoking cessation

Jamie Hartmann-Boyce, Annika Theodoulou, Amanda Farley, Peter Hajek, Deborah Lycett, Laura L. Jones, Laura Kudlek, Laura Heath, Anisa Hajizadeh, Marika Schenkels, Paul Aveyard

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    Abstract

    Background: Most people who stop smoking gain weight. This can discourage some people from making a quit attempt and risks offsetting some, but not all, of the health advantages of quitting. Interventions to prevent weight gain could improve health outcomes, but there is a concern that they may undermine quitting. Objectives: To systematically review the effects of: (1) interventions targeting post-cessation weight gain on weight change and smoking cessation (referred to as 'Part 1') and (2) interventions designed to aid smoking cessation that plausibly affect post-cessation weight gain (referred to as 'Part 2'). Search methods: Part 1 - We searched the Cochrane Tobacco Addiction Group's Specialized Register and CENTRAL; latest search 16 October 2020. Part 2 - We searched included studies in the following 'parent' Cochrane reviews: nicotine replacement therapy (NRT), antidepressants, nicotine receptor partial agonists, e-cigarettes, and exercise interventions for smoking cessation published in Issue 10, 2020 of the Cochrane Library. We updated register searches for the review of nicotine receptor partial agonists. Selection criteria: Part 1 - trials of interventions that targeted post-cessation weight gain and had measured weight at any follow-up point or smoking cessation, or both, six or more months after quit day. Part 2 - trials included in the selected parent Cochrane reviews reporting weight change at any time point. Data collection and analysis: Screening and data extraction followed standard Cochrane methods. Change in weight was expressed as difference in weight change from baseline to follow-up between trial arms and was reported only in people abstinent from smoking. Abstinence from smoking was expressed as a risk ratio (RR). Where appropriate, we performed meta-analysis using the inverse variance method for weight, and Mantel-Haenszel method for smoking. Main results: Part 1: We include 37 completed studies; 21 are new to this update. We judged five studies to be at low risk of bias, 17 to be at unclear risk and the remainder at high risk. An intermittent very low calorie diet (VLCD) comprising full meal replacement provided free of charge and accompanied by intensive dietitian support significantly reduced weight gain at end of treatment compared with education on how to avoid weight gain (mean difference (MD) −3.70 kg, 95% confidence interval (CI) −4.82 to −2.58; 1 study, 121 participants), but there was no evidence of benefit at 12 months (MD −1.30 kg, 95% CI −3.49 to 0.89; 1 study, 62 participants). The VLCD increased the chances of abstinence at 12 months (RR 1.73, 95% CI 1.10 to 2.73; 1 study, 287 participants). However, a second study found that no-one completed the VLCD intervention or achieved abstinence. Interventions aimed at increasing acceptance of weight gain reported mixed effects at end of treatment, 6 months and 12 months with confidence intervals including both increases and decreases in weight gain compared with no advice or health education. Due to high heterogeneity, we did not combine the data. These interventions increased quit rates at 6 months (RR 1.42, 95% CI 1.03 to 1.96; 4 studies, 619 participants; I2 = 21%), but there was no evidence at 12 months (RR 1.25, 95% CI 0.76 to 2.06; 2 studies, 496 participants; I2 = 26%). Some pharmacological interventions tested for limiting post-cessation weight gain (PCWG) reduced weight gain at the end of treatment (dexfenfluramine, phenylpropanolamine, naltrexone). The effects of ephedrine and caffeine combined, lorcaserin, and chromium were too imprecise to give useful estimates of treatment effects. There was very low-certainty evidence that personalized weight management support reduced weight gain at end of treatment (MD −1.11 kg, 95% CI −1.93 to −0.29; 3 studies, 121 participants; I2 = 0%), but no evidence in the longer-term 12 months (MD −0.44 kg, 95% CI −2.34 to 1.46; 4 studies, 530 participants; I2 = 41%). There was low to very low-certainty evidence that detailed weight management education without personalized assessment, planning and feedback did not reduce weight gain and may have reduced smoking cessation rates (12 months: MD −0.21 kg, 95% CI −2.28 to 1.86; 2 studies, 61 participants; I2 = 0%; RR for smoking cessation 0.66, 95% CI 0.48 to 0.90; 2 studies, 522 participants; I2 = 0%). Part 2: We include 83 completed studies, 27 of which are new to this update. There was low certainty that exercise interventions led to minimal or no weight reduction compared with standard care at end of treatment (MD −0.25 kg, 95% CI −0.78 to 0.29; 4 studies, 404 participants; I2 = 0%). However, weight was reduced at 12 months (MD −2.07 kg, 95% CI −3.78 to −0.36; 3 studies, 182 participants; I2 = 0%). Both bupropion and fluoxetine limited weight gain at end of treatment (bupropion MD −1.01 kg, 95% CI −1.35 to −0.67; 10 studies, 1098 participants; I2 = 3%); (fluoxetine MD −1.01 kg, 95% CI −1.49 to −0.53; 2 studies, 144 participants; I2 = 38%; low- and very low-certainty evidence, respectively). There was no evidence of benefit at 12 months for bupropion, but estimates were imprecise (bupropion MD −0.26 kg, 95% CI −1.31 to 0.78; 7 studies, 471 participants; I2 = 0%). No studies of fluoxetine provided data at 12 months. There was moderate-certainty that NRT reduced weight at end of treatment (MD −0.52 kg, 95% CI −0.99 to −0.05; 21 studies, 2784 participants; I2 = 81%) and moderate-certainty that the effect may be similar at 12 months (MD −0.37 kg, 95% CI −0.86 to 0.11; 17 studies, 1463 participants; I2 = 0%), although the estimates are too imprecise to assess long-term benefit. There was mixed evidence of the effect of varenicline on weight, with high-certainty evidence that weight change was very modestly lower at the end of treatment (MD −0.23 kg, 95% CI −0.53 to 0.06; 14 studies, 2566 participants; I2 = 32%); a low-certainty estimate gave an imprecise estimate of higher weight at 12 months (MD 1.05 kg, 95% CI −0.58 to 2.69; 3 studies, 237 participants; I2 = 0%). Authors' conclusions: Overall, there is no intervention for which there is moderate certainty of a clinically useful effect on long-term weight gain. There is also no moderate- or high-certainty evidence that interventions designed to limit weight gain reduce the chances of people achieving abstinence from smoking.

    Original languageEnglish
    Article numberCD006219.pub4
    JournalCochrane Database of Systematic Reviews
    Volume2021
    Issue number10
    Early online date6 Oct 2021
    DOIs
    Publication statusPublished - 6 Oct 2021

    Funder

    Funding Information: Dr Benowitz has served as a consultant to pharmaceutical companies, including Pfizer, which markets smoking cessation medications, and has been a paid expert witness in litigation against tobacco companies. Dr Pipe has served as a consultant to pharmaceutical companies that market smoking cessation medications, including Pfizer, and has received research funding from Pfizer for conduct of this study and from Johnson & Johnson. Dr West is a consultant to Pfizer, Johnson & Johnson, and GlaxoSmithKline and has received research funding from Pfizer and Johnson & Johnson; Dr West’s salary is funded by Cancer Research UK. Dr Hays has received research support from Pfizer for the conduct of this study. Dr Tonstad has received honoraria for lectures and consulting for Pfizer. Drs McRae, Lawrence, and St Aubin are employees and stockholders of Pfizer. Dr Anthenelli reports his university receiving grants from Pfizer and Alkermes, and providing consulting and/or advisory board services to Pfizer, Arena Pharmaceuticals, and Cerecor; Dr Anthenelli’s contributions to this article were supported, in part, by National Institute on Alcohol Abuse and Alcoholism grants U01 AA013641 and R01 AA019720, and National Institute on Drug Abuse/Veterans Affairs Cooperative Studies 1031 and 1032. Funding Information: “This study was supported by a grant from the Department of Defense Peer Review Medical Research Program of the Office of the Congressionally Directed Medical Research Programs, Grant Number W81XWH-05-2-0015. The opinions expressed herein and the interpretation and reporting of these data are the responsibility of the authors and in no way should be seen as an official recommendation, interpretation, or policy of the National Institutes of Health, the Department of Health and Human Services, the Department of Defense, or the U.S. Government.” Funding Information: "Financial Disclosures: Dr Jorenby reported receiving research support from Pfizer, Nabi Biopharma-ceutical, Sanofi-Aventis and consulting fees from Nabi Biopharmaceutical. Dr Hays reported receiving a research grant from Pfizer. Dr Rigotti reported receiving research grant funding and consulting fees from GlaxoSmithKline, which markets smoking cessation medications, and Pfizer and Sanofi-Aventis, which are developing smoking cessation medications. Dr Rigotti also reported receiving consulting fees from Merck, which is developing smoking cessation medications. Funding Information: Prolonged abstinence at 6 and 12 months (validation: CO ≤ 8 ppm, or urinary cotinine < 15µg/L) Mean (SD) weight change (kg) at EOT, 6 and 12 months "This research was supported by grant R01 DA 04174 from the National Institute on Drug Abuse (Dr Marcus). Dr Levine’s effort was partially supported by grant K01DA15396 from the National Institute on Drug Abuse (Dr Levine). GlaxoSmithKline provided bupropion hydrochloride SR, 150 mg, and matching placebo oral administration free of charge." Funding Information: This work was supported by the Australian National Health and Medical Research Council (NHMRC project grant numbers 569210 and 1009351) and the Commonwealth Department of Health and Ageing Funding Information: "This study was supported by GlaxoSmithKline Consumer Healthcare, Parsippany, NJ" Funding Information: "This study was supported by a research grant provided by Elan Pharmaceutical Research Corporation, Gainesville, Ga, and Athlone, Ireland" Funding Information: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr. Ebbert reports grants from Pfizer, Orexigen and JHP Pharmaceuticals and personal fees from GlaxoSmithKline during the conduct of the study. Dr. Hughes reports personal fees from Alere/ Free and Clear, Equinox, GlaxoSmithKline, Healthwise, Pfizer, Embera, Selecta, DLA Piper, Dorrffer-meyer, Nicoventures, Pro Ed, Publicis, Cicatelli, and non-financial support from Swedish Match, outside the submitted work. Dr. West reports grants, personal fees and non-financial support from Pfizer, GlaxoSmithKline, and Johnson & Johnson outside the submitted work. Dr. Rennard reports personal fees from Almirall, Novartis, Nycomed, Pfizer, A2B Bio, Dalichi Sankyo, APT Pharma/Britnall, As-traZeneca, Boehringer Ingelheim, Chiesi, Decision Resource, Dunn Group, Easton Associates, Gerson, GlaxoSmithKline, Roche, Theravance, Almirall, CSL Behring, MedImmune, Novartis, Pearl, Takeda, Forest, CME Incite, Novis, PriMed, Takeda, grants from AstraZeneca, Novartis, Otsuka, Boehringer Ingel-heim, GlaxoSmithKline, and Johnson & Johnson, outside the submitted work. Dr. Russ, Dr. McRae, Ms. Treadow, Dr. Yu, Dr. Dutro, and Dr. Park are employees and stock holders of Pfizer Inc. Funding Information: "This study was supported by a grant from Pharmacia & Upjohn, Helsingborg, Sweden (Dr Wiklund)" Funding Information: "We thank the Medical Research Council and the Imperial Cancer Research fund for financial support; (…) Kabi Pharmacia Therapeutics AB for supplying the nasal sprays, and their representative, Dr Mikael Franzon" Funding Information: This study was supported by CTSA grant number UL1 TR000135 from the National Center for Advancing Translational Sciences (NCATS), a component of the National Institutes of Health (NIH). Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NIH. Funding for this study was also provided by a Mayo Clinic NIH-relief award, and a small grant award from the Department of Psychiatry and Psychology. Funding Information: “This project has received funding from the European Union’s Horizon 2020 research and innovation programme, under Grant Agreement No. 680995. Aflofarm Pharma Poland provided cytisine (Desmox-an) and placebo free of cost for the trial; however, they have no role in the trial conduct, its analysis or dissemination of results.” Funding Information: “This study was funded by Arena Pharmaceuticals, Inc. and Eisai, Inc.” Funding Information: “The work reported in this manuscript was funded by the Department of Veterans Affairs Office of Rural Health (Project number 12-CR6). The Office of Rural Health played no role in the design or conduct of the study, the interpretation of the results, or the preparation of the manuscript.” Funding Information: “J.R. received funding from Philip Morris International, Altria, JUUL Labs. He discloses consulting with Philip Morris International and Revive Therapeutics LLC. He obtained patent purchase agreement in 2011 with Philip Morris International for nicotine inhalation system. J.R.’s privately funded projects are limited to the development and evaluation of reduced-risk tobacco products. J.M.D. received funding from Pfizer Inc. and Axsome Therapeutics Inc. J.M.D. privately funded projects are limited to evaluation of programs or development of drugs designed to treat tobacco use.” “Subjects will be reimbursed up to $417.42 for attending seven study visits and one follow up visit. There will be a payment of $40 per study visit attended. In addition, subjects will receive a payment of $10 for each of the 7 sessions attended in which they return their completed take-home forms (brief questionnaires which describe withdrawal symptoms and record smoking behavior and medication use). Subjects will also receive additional compensation up to $7.42 (per Sherry McKee protocol) for completing the laboratory session (P2). Subjects who do not complete each visit will still receive payment for the sessions attended. Thus, subjects who attend seven visits and hand in their take-home forms each time will receive a total payment of $350 plus the amount earned in the P2 laboratory session. Subjects who come back for a follow up session six months after their Quit Day will receive an additional $60. Subjects will not be compensated for the screening session.” Funding Information: "This research was supported by National Institute on Drug Abuse Grant DA04174." Funding Information: All participants received a total of 6 x 15 - 20 mins health education counselling by trained counsellors at weeks 0, 1, 3, 7 in person and weeks 5 and 16 by telephone and a culturally-targeted smoking cessation guide developed for African-American light smokers (Kick It at Swope: Stop smoking Guide) 1. Mean (SD) weight change (kg) at EOT (7 weeks) and 6 months in abstainers (cotinine-verified 7-day point prevalence) "This work was supported by the National Cancer Institute at the National Institutes of Health (CA 091912 to L.S.C.). This work was also supported in part by the National Institute for Minority Health and Disparities (1P60MD003422 to J.S.A.). Support was also provided by the Centre for Addiction and Mental Health and by a Canada Research Chair in Pharmacogenetics (to R.F.T.)" Funding Information: "This research was supported in part by US Public Health Service grant DA-04986 from the National Institute on Drug Abuse and by research grants from Kabi Pharmacia AB and Parke-Davis" Funding Information: "This study was supported in part by The Patrick and Catherine Weldon Donaghue Foundation, The University of Connecticut Center on Aging, and NIH grants R01 DA13334, and M01 RR06192 (University of Connecticut General Clinical Research Center) and P50AA15632. Glaxo-SmithKline Pharmaceuticals donated nicotine and placebo patches" Funding Information: "This study was funded by Pfizer, Inc" Funding Information: “This research was funded by the H2020 European Commission research and innovation program (grant agreement 681120) as part of the SmokeFreeBrain project (www.smokefreebrain.eu).” Funding Information: "By Transdisciplinary Tobacco Use Research Center grant P5084718 from the National Cancer Institute and the National Institute on Drug Abuse and Public Health Services Research grant M01-RR0040 from the National Institutes of Health. Dr. Lerman was supported by the Abramson Cancer Center and An-nenberg Public Policy Center. Dr. Benowitz was supported by Public Health Services grants DA02277, DA12393, and CA078703, as well as the University of California, San Francisco, Comprehensive Cancer Center. Nicotine nasal spray (Nicotrol) was provided by Pharmacia and Upjohn, Helsingborg, Sweden" Funding Information: DL has received hospitability from manufacturers of smoking cessation products, Pfizer, Tadworth, UK. DL’s institution during the active phase of the trial has received smoking cessation products for use in a clinical trial from Johnson & Johnson, New Brunswick, New Jersey, USA. DL has received Slimming World membership vouchers for use in this trial. DL has received expenses and consultancy fees from the NHS and Universities for teaching about cessation-related weight gain. DL has received grant funding from UKCTCS and the NIHR-SPCR for research relating to cessation-related weight gain. PA is an NIHR senior investigator and is funded by NIHR Biomedical Research Centre and the CLAHRC, Oxford. AF is an NIHR Senior Investigator and receives funding from NIHR Oxford Biomedical Research Centre. AL has received hospitality from Weight Watchers. In the last 5 years, MM has received grant funding from Pfizer and varenicline, for research purposes. Funding Information: Mean (SD) weight change (kg) in prolonged abstainers at end of treatment (email communication) and 12m (email communication) (validation: CO < 10 ppm) "This study was funded by Pharmacia AB, who also supervised and monitored procedures and data collection in the practices. We thank the MRC and Imperial Cancer Research Fund for financial support of the Health Behaviour Unit. The Unit`s staff designed the study, analysed and wrote up the results, and assayed saliva cotinine concentrations" Funding Information: “This study was funded by a grant from the National Institute on Drug Abuse (P50-DA027840).” Funding Information: This work was supported by funding of the salary for DL, provided by a fellowship from the NIHR-SPCR during the active trial period. Additional funds to set up the trial and buy equipment were provided by the NIHR-SPCR and UKCTCS. The UKCTCS is one of five UK Public Health Research Centres of Excellence. We also gratefully acknowledge funding from the British Heart Foundation, Cancer Research UK, the Economic and Social Research Council, Medical Research Council and the Department of Health, under the auspices of the UK Clinical Research Collaboration. AL’s salary was paid by NIHR-SPCR during the trial period, and the salaries of AF, MM and PA were paid by their respective institutions. PA is an NIHR senior investigator and funded by NIHR Oxford Biomedical Research Centre and CLAHRC. All funding is gratefully acknowledged. Funding Information: "This study was entirely funded by grant 7RT-0033 from the California Tobacco-Related Disease Research Program,Oakland, Calif" Funding Information: "This study was supported by a grant from Kabi Pharmacia AB, Helsingborg, Sweden" Funding Information: "The authors report the following potential conflicts of interest for the last 5 years: Dr Smith has received research support from Elan Corporation. Dr Baker has served as an investigator on research projects sponsored by pharmaceutical companies, including Sanofi-Synthelabo, Pfizer Inc, and Nabi Biopharmaceuticals. Dr Jorenby has received research support from the National Institute on Drug Abuse, the National Cancer Institute, Pfizer Inc, Sanofi-Synthelabo, and Nabi Biopharmaceuticals. He has received support for educational activities from the National Institute on Drug Abuse and the Veterans Administration and consulting fees from Nabi Biopharmaceuticals. Dr Fiore has received honoraria from Pfizer. He has served as an investigator on research studies at the University of Wisconsin that were funded by Pfizer, Sanofi-Synthelabo, GlaxoSmithKlein, and Nabi Biopharmaceuticals. In 1998, the University of Wisconsin appointed Dr Fiore to a named chair funded by an unrestricted gi, to University of Wisconsin from Glaxo Wellcome. All authors had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis." Funding Information: “This research was supported by the National Institute on Aging (NIA), grant AG18239. NIA had no other role other than financial support.” Funding Information: Mean (SD) weight change (kg) in continuous abstainers at end of treatment and 12 m (validation: CO < 10 ppm) "This trial was supported by a grant from the Swiss National Science Foundation (SNSF 3200-067085). Other funders: Swiss National Science Foundation" Funding Information: Mean (SD) weight change (kg) in continuous abstinent smokers at EOT (validation: CO ≤ 7 ppm) Adverse events at EOT (reported narratively) "Supported by a grant awarded to Dr. Klesges and Dr. Meyers (HL-3932) by the National Heart, Lung, and Blood Institute (Bethesda, Md.). Support was also received from a Centers of Excellence grant awarded to the Department of Psychology, Memphis State University, by the state of Tennessee. Scher-ing-Plough Corporation provided both the phenylpropanolamine and the placebo gum for this investigation." Funding Information: Mean (SD) weight change (kg) in point prevalence abstainers at EOT (email communication) and 12m (email communication) (validation: ≤ 20 ng/ml cotinine) "This study was funded by grants from NHLBI (#R01 HL 61779 and #K24-HL04440), the NIH General Clinical Research Centers Program (#M01-RR-01066) and an unrestricted research grant from Glax-oSmithKline, Inc (GSK). GSK provided free drug and placebo and an unrestricted research grant to permit data collection to be completed when NHLBI funds were exhausted" Funding Information: Dr George has received investigator-initiated and contract research support from Pfizer, served as a consultant to Novartis, and received honoraria from National Institutes of Health (NIH) and American College of Neuropsychopharmacology. Funding Information: "Andrea King is part of the advisory board and is a consultant for Lundbeck and the US Food and Drug Administration. Dingcai Cao is part of the advisory board and is a consultant for the US Food and Drug Administration. Stephanie S. O'Malley received research support from NABI Biopharmaceuticals, Pfizer Inc; is part of the advisory board and is a consultant for the American College of Neuropsychophar-macogy workgroup, the Alcohol Clinical Trial Initiative Group; is sponsored by Alkermes, Abbott Laboratories, Eli Lilly & Company, GlaxoSmithKline, Johnson & Johnson Pharmaceuticals, Lundbeck, Scher-ing Plough, Pfizer, and Gilead Pharmaceuticals. Dr O'Malley was an inventor on a patent on naltrexone for smoking cessation held by Yale University, which has been abandoned. Henry R. Kranzler is part of the advisory board and is a consultant for the American College of Neuropsychopharmacogy Alcohol Clinical Trial Initiative Group, Lundbeck, GlaxoSmithKline, Alkermes, Gilead, Roche, Pfizer, and Lilly. Dr Kranzler received grants from Merck. Harriet deWit received grants from Unilever. Dr deWit is part of the advisory board and is a consultant for the US Food and Drug Administration. Alicia K. Matthews is part of the advisory board and is a consultant for US Food and Drug Administration. Xiaochen Cai and Ryan J. Stachoviak report no financial conflicts of interest." Funding Information: "This study was supported through grant CE1198/0101 from the Cancer Research Campaign (now Cancer Research UK) to the authors" Funding Information: "This research was conducted at the University of Wisconsin–Madison and was supported by grant P50 DA019706 from the National Institute on Drug Abuse and by grant M01 RR03186 from the General Clinical Research Centers Program of the National Center for Research Resources. Dr Piper was supported by an Institutional Clinical and Translational Science Award, University of Wisconsin–Madison (KL2 grant 1KL2RR025012-01). Medication was provided to patients at no cost under a research agreement with GlaxoSmithKline" Funding Information: "This study was supported by two grants (HL45057, HL46352) awarded by the National Heart, Lung, and Blood Institute. We also appreciate the financial support from Schering-Plough Corporation and for providing the placebo and PPA gum. Support was also received from a Centers of Excellence grant awarded to the Department of Psychology, Memphis State University, by the state of Tennessee." Funding Information: We thank the Cochrane Tobacco Addiction Review Group for their support and advice. Specifically the content of the table of included studies in part two of this review is mainly populated by data extracted by the authors of the parent reviews (Lindsay Stead, Kate Cahill, Michael Ussher) with statistical advice given by Rafael Perera. We also thank Cynthia Pomerleau and colleagues, and Michael Ussher, for reading and commenting on earlier drafts of this protocol. We would also like to thank the many authors of the primary studies that responded to our requests for data. For previous versions of the review, we thank the following authors for their contributions: Mujahed Shraim (MS) wrote and submitted the review protocol, and extracted data for Part 1 studies. Jennie Inglis (JS) extracted data for Part 2 studies. Both contributed to the first version of the review only, published in 2009. MS and Amanda Parsons (AP) carried out searches for the first part of the review and AP, Deborah Lycett (DL), MS and JI independently identified relevant studies and extracted data. AP drafted the review. DL, Paul Aveyard and Peter Hajek gave conceptual and editorial support. For this update, we acknowledge the help of Min Gao in screening a paper published in Chinese and James Schulte for statistical support. We would also like to gratefully acknowledge and thank the following study authors who responded to our requests and provided additional data: Professor Amanda Baker and Associate Professor Terry J. Lewin, Assistant Professor Erika Litvin Bloom, Professor Bonnie Spring and Dr Harold Javitz, Professors Fridtjof Thomas and Karen Chandler Johnson, Dr Eli Heggen, Professor Andrea King, Professor Mark J. Eisenberg, Professor Kevin M. Gray, Dr Ashley Vena, Dr Nikos Ioakeimidis, and Associate Professor Natalie Walker. We thank Henri-Jean Aubin, Universit? Paris-Saclay, Inserm, CESP, AP-HP. Villejuif, France and Serena Tonstad, Oslo University Hospital, Norway, for providing peer review. We thank Charles Vicary for providing consumer review. The National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC) Diet and Obesity provided funding to support this update. The views expressed are those of the review author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.? Funding Information: "This project was supported in part through grants K07CA01757 and R29CA59660 from the National Cancer Institute, Bethesda, Md, and an R29CA59660 supplementary grant from the Office of Research on Women’s Health, National Institutes of Health, Bethesda, Md (Dr Marcus)" Funding Information: "This study was supported by Pfizer Inc, which provided funding, study drug and placebo, and monitoring" Funding Information: "Drs Hurt and Croghan and Mr Offord have worked on clinical research studies funded in part by Lederle Laboratories, Elan Pharmaceutical Research Corporation, Burroughs-Wellcome, and Kabi. Dr Hurt has received honoraria for educational activities from Ciba Geigy Corporation, Marion Merrell Dow, Inc, and McNeil Pharmaceuticals. Mr Offord has received honoraria for educational activities from Elan Pharmaceutical Research corporation" Funding Information: "Pfizer Inc. funded the study and was involved with its design, analysis and writing the manuscript. All authors had complete access to all relevant data. Dahlia Garza and Simon Davies are employees of Pfizer Inc., and therefore hold shares in the company. Editorial support was provided by Aideen Young, PhD, of UBC Scientific Solutions and funded by Pfizer Inc. None of the other authors hold shares in any companies. Chen Wang and Dan Xiao are affiliated with the WHO Collaborating Centre for Tobacco or Health. WHO had no role in the study’s funding, design, analysis or write-up." Funding Information: Funding for the study was provided by EU-FP7 and ICMR. Professor S K Sharma was supported by the JC Bose Fellowship (No. SB/SB2/JCB-04/2013) of the Ministry of Science & Technology, Govt. of India. Funding Information: Role of the Sponsors: NIH and Pfizer had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication" "All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Ebbert reports serving as an investigator for clinical trials funded by Pfizer, receipt of consultancy fees from GlaxoSmithKline, research support from Pfizer, and research support from Orexigen and JHP Pharmaceuticals outside of the current study. Dr Hatsukami reports receipt of research support from Nabi Biopharmaceuticals outside of the current study. Dr Hays reports serving as an investigator for clinical trials funded by Pfizer. Dr Hurt reports receipt of consulting fees from Pfizer, an unrestricted grant from Pfizer Medical Education Group, and provision of expert testimony in Florida tobacco litigation cases. The other authors report no disclosures" Funding Information: "This study was supported by grants from the National Institute of Drug Abuse/the National Institutes of Health (R01-DA016834), CTSA Grant Number ULI-RR024999 from the National Center for Advancing Translational Sciences (its contents are solely the responsibility of the authors and do not necessarily Funding Information: "This study was supported by grant #DA 03893and training grant T 32 DA 07209from the National Institute on Drug Abuse to Dr. Stitzer. We gratefully acknowledge the support of Marion Merrell Dow, Inc. in providing the nicotine gum for this study" Funding Information: “The author(s) disclosed receipt of the following financial support for the research, authorship, and/ or publication of this article: The study was funded by the American Heart Association, Grant-in-Aid awarded to Dr White.” Funding Information: Burke 1993: “This study was supported by Ciba-Geigy Pharmaceuticals, who also supplied the nicotine and placebo patches. We thank Ciba-Geigy for help in conducting the study and for ensuring that it met the sandards set by the Declaration of Helsinki and the “Good clinical practice” guidelines. We thank Ciba-geigy for undertaking the time consuming tasks of packaging and data entry. The central oxford ethics committee gave advice and formal consent to the trial, and Professor Nicholas Wals and colleagues at St Bartholomew’s Medical College, London, carried out the cotinine measurements.” Lycett 2011: “The original trial and 8-year follow-up was funded by Cancer Research UK. Deborah Lycett has a PhD studentship funded by UK Centre for Tobacco Control Studies (UKCTCS), a UKCRC Public Health Research: Centre of Excellence. Funding from British Heart Foundation, Cancer Research UK, Economic and Social Research Council, Medical Research Council, and the Department of Health, under the auspices of the UK Clinical Research Collaboration, is gratefully acknowledged. Paul Aveyard is funded by National Institute of Health Research (NIHR)." Paul Aveyard has conducted consultancy work on smoking cessation for Pfizer, McNeil and Xenova Biotechnology. Marcus Munafò has received fees for invited lectures from the National Health Service, GlaxoSmithKline, Novartis, the Moffitt Cancer Research Center and the Karolinska Institutet, and received benefits in kind (hospitality, etc.) from various pharmaceutical companies. He has received research and travel support from the European Research Advisory Board, GlaxoSmithKline, Pfizer Consumer Healthcare and Novartis. Consultancy has been provided to the European Commission, The American Institutes for Research, the National Audit Office and G-Nostics Ltd. Elaine Johnstone has received consultancy income from European Network for Smoking Prevention. Michael Murphy has received consultancy income from the European Network for Smoking Prevention and has provided scientific consultancy services through the University of Oxford ISIS Innovation to the National Audit Office and G-NosticsLtd. Funding Information: "This study was funded by Pfizer Inc. Editorial support for the development of this manuscript was provided by Alexandra Bruce, PhD, of UBC Scientific Solutions and was funded by Pfizer Inc." "Drs Rigotti, Pipe, Benowitz, and Tonstad have consulted for Pfizer. Dr Rigotti has been the site principal investigator for clinical trials of smoking cessation medications funded by Pfizer, sanofi-aventis, and Nabi Biopharmaceuticals. Dr Pipe has received educational and research support in the past from Bristol Myers Squibb, Johnson & Johnson, GlaxoSmithKline, and Merrell Dow. Drs Benowitz and Ton-stad served on the scientific planning committee for this study and have been paid consultants to Pfizer and other pharmaceutical companies that are developing and/or marketing smoking cessation medications. Dr Benowitz has been a paid expert witness in litigation against tobacco companies. At the time of the study, his family owned a small amount of Pfizer stock, but no longer does. Dr Tonstad has been the site principal investigator for clinical trials of smoking cessation medication and other medications funded by Pfizer and other pharmaceutical companies. Dr Arteaga is a statistical director at Pfizer Inc, supporting the varenicline studies. Dr Garza is a senior medical director of clinical research and development at Pfizer Inc, and the medical monitor for this study. The other authors report no conflicts." Funding Information: "KEW, KRR, and CBB are employees of Pfizer and have stock or stock options in Pfizer. RN has received consulting fees from Pfizer, GlaxoSmithKline, Sanofi-Aventis, Merck, Constella, and LLC. DEJ has received consulting fees from Nabi Biopharmaceutical and receives research support from Pfizer, Nabi Biopharmaceutical, and Sanofi-Aventis. FTL serves on speakers’ bureaus for Pfizer and Merck and is a consultant on an advisory panel with Pfizer. JTH received grant support from Pfizer. JEP received grant support from Merck, DepoMed, Pfizer, Novartis, Takeda, Sanofi-Aventis, Symbollon, TAP, and Glax-oSmithKline. Editorial support was provided by Ray Beck, Jr, PhD of Envision Pharma and was funded by Pfizer, Inc. The ClinicalTrials.gov registration number is NCT00150228" Funding Information: "The work described in this article was supported in part by National Institutes of Health Grants HL52577 and HL63307 and a Veterans Affairs Merit Review Award to Bonnie Spring." Funding Information: "This study was supported by a grant from Lederle Laboratories, Pear River, NY" Funding Information: "Drs. Tsai and Cho have been members of Pfizer-sponsored advisory panels and, together with Drs. Cheng, Kim, and Hsueh, were investigators for a Pfizer-sponsored clinical trial. Editorial assistance was provided by Christopher Grantham, PhD, of Envision Pharma, Horsham, United Kingdom, and funded by Pfizer Inc., New York, New York." Funding Information: "This study was supported by a grant from Pharmacia & Upjohn Consumer Healthcare, Helsingborg, Sweden" Funding Information: "This study was funded by Pfizer Inc. Role of sponsors: Editorial support for the development of this manuscript was provided by Brenda Smith, PhD, and administrative support was provided by Sue Francis, both of UBC Scientific Solutions with funding from Pfizer Inc." "Dr Tashkin received grant support from Pfizer Inc and Nabi Pharmaceuticals and fees for attending advisory board meetings from Pfizer Inc. Dr Hays received a research grant from Pfizer Inc for the conduct of the clinical trial described in this manuscript. In the past 3 years, Dr Rennard has been a consultant or a member of an advisory board for Able Associates, Adelphi Research, Almirall/Prescott, APT Pharma/Britnall, Aradigm, AstraZeneca, Boehringer Ingelheim, Chiesi, CommonHealth, Consult Complete, COPDForum, Data Monitor, Decision Resources, Defined Health, Dey, Dunn Group, Eaton Associates, Equinox, Gerson, GlaxoSmithKline, Infomed, KOL Connection, M Pankove, MedaCorp, MDRx Financial, Mpex, Novartis, Nycomed, Oriel Therapeutics, Otsuka, Pennside Partners, Pfizer Inc (varenicline), Pharma Ventures, Pharmaxis, Price Waterhouse, Propagate, Pulmatrix, Reckner Associates, Recruiting Resources, Roche, Schlesinger Medical, SciMed, Sudler and Hennessey, TargeGen, Theravance, UBC, Uptake Medical, and VantagePoint Management. Dr Rennard has lectured for the American Thoracic Society, AstraZeneca, Boehringer Ingelheim, California Allergy Society, Creative Educational Concept, France Foundation, Information TV, Network for Continuing Ed, Novartis, Pfizer, and SOMA and has received industry-sponsored grants from AstraZeneca, Biomarck, Centocor, Mpex, Nabi Pharmaceuticals, Novartis, and Otsuka. Ms Ma and Drs Lawrence and Lee are all employees of Pfizer Inc, own Pfizer Stock, and have Pfizer stock options" Funding Information: NW, CB, MV, GL, ML, and VP report grants from the Health Research Council of New Zealand, during the conduct of the study. NW, CB, MV, and VP report grants from Pfizer, outside of the submitted work. GL chairs the organisation End Smoking New Zealand, which advocates for harm reduction approaches to tobacco control. E-cigarettes were purchased from a New Zealand e-cigarette online retailer (NZVA-POR, https://www.nzvapor.com/), e-liquid was purchased from Nicopharm, Australia (www.nicophar-m.com.au/), and nicotine patches were supplied by the New Zealand Government via their contract with Novartis (Sydney, Australia). NZVAPOR also provided, at no cost to participants, on-line and phone support regarding use of the e-cigarettes. Neither NZVAPOR nor Nicopharm have links with the tobacco industry. None of the above parties had any role in the design, conduct, analysis, or interpretation of the trial findings, or writing of this publication. Funding Information: "This work was supported by Local Departmental Resources, including provision of varenicline. Tine AB, Kavli Holding AS, Lantmä nen Cerealia AS, and the Norwegian Meat and Poultry Council sponsored study meals. These companies had no role in the conduct, writing or interpretation of the trial" Funding Information: The National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC) Diet and Obesity provided funding to support this update. The views expressed are those of the review author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. Funding Information: "Dr Shiffman provides consulting to GlaxoSmithKline Healthcare on matters relating to smoking control, and was compensated for his work on this project. Dr Shiffman also has an interest in a novel nicotine replacement product that is not addressed by this article. Dr Hajek has provided consulting to and received research funding from pharmaceutical companies, including GlaxoSmithKline Consumer Healthcare and Pharmacia Consumer Healthcare, Peapack, NJ. Drs Dresler, Gilburt, and Strahs and Mr Targett are employed by GlaxoSmithKline Consumer Healthcare" Funding Information: Was funded by the Arizona Biomedical Research Commission (formerly theArizona Disease Control Research Commission), Grant # 7014. Funding Information: “K.S. received a research grant from Pfizer (2015–2017) to study the effect of varenicline (a smoking cessation medicine) on waterpipe smoking cessation. E.K. received payment from pharmaceutical companies providing smoking cessation medications for clinical studies, educational and consultation activities. Funding Information: “This work was supported by the National Institute on Drug Abuse [grant number K23 DA019950] awarded to Ana M. Abrantes, PhD.” Funding Information: “The National Institute of Mental Health (NIMH) of the NIH, under award R21MH087928 (Dr Chengappa), provided the main funding for this study. Pfizer provided drug/placebo and an investigator-initiated grant, WS-515343 (Dr Chengappa). These monies channeled through the University of Pittsburgh were used to offset costs of study procedures, participant payments, and a percentage of the time and effort of research staff and faculty salaries. Role of the sponsor: Neither the NIMH of the NIH nor Pfizer had a role in the conduct or the publication of the study. As part of the letter of agreement with Pfizer, they reviewed the original manuscript that was submitted but did not request changes to the content.” “Dr Turkin has served on the speaker’bureau of Forest, Sunovion, and Otsuka; and owns shares of Pfizer stock. Funding Information: "This research was supported by National Institutes of Health grants CA84724-05 and DA0197-06" Publisher Copyright: Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

    ASJC Scopus subject areas

    • Pharmacology (medical)

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