Background
Electronic cigarettes (ECs) are handheld electronic vaping devices which produce an aerosol formed by heating an e‐liquid. People who smoke report using ECs to stop or reduce smoking, but ...some organisations, advocacy groups and policymakers have discouraged this, citing lack of evidence of efficacy and safety. People who smoke, healthcare providers and regulators want to know if ECs can help people quit and if they are safe to use for this purpose. This review is an update of a review first published in 2014.
Objectives
To evaluate the effect and safety of using electronic cigarettes (ECs) to help people who smoke achieve long‐term smoking abstinence.
Search methods
We searched the Cochrane Tobacco Addiction Group's Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO for relevant records to January 2020, together with reference‐checking and contact with study authors.
Selection criteria
We included randomized controlled trials (RCTs) and randomized cross‐over trials in which people who smoke were randomized to an EC or control condition. We also included uncontrolled intervention studies in which all participants received an EC intervention. To be included, studies had to report abstinence from cigarettes at six months or longer and/or data on adverse events (AEs) or other markers of safety at one week or longer.
Data collection and analysis
We followed standard Cochrane methods for screening and data extraction. Our primary outcome measures were abstinence from smoking after at least six months follow‐up, AEs, and serious adverse events (SAEs). Secondary outcomes included changes in carbon monoxide, blood pressure, heart rate, blood oxygen saturation, lung function, and levels of known carcinogens/toxicants. We used a fixed‐effect Mantel‐Haenszel model to calculate the risk ratio (RR) with a 95% confidence interval (CI) for dichotomous outcomes. For continuous outcomes, we calculated mean differences. Where appropriate, we pooled data from these studies in meta‐analyses.
Main results
We include 50 completed studies, representing 12,430 participants, of which 26 are RCTs. Thirty‐five of the 50 included studies are new to this review update. Of the included studies, we rated four (all which contribute to our main comparisons) at low risk of bias overall, 37 at high risk overall (including the 24 non‐randomized studies), and the remainder at unclear risk.
There was moderate‐certainty evidence, limited by imprecision, that quit rates were higher in people randomized to nicotine EC than in those randomized to nicotine replacement therapy (NRT) (risk ratio (RR) 1.69, 95% confidence interval (CI) 1.25 to 2.27; I2 = 0%; 3 studies, 1498 participants). In absolute terms, this might translate to an additional four successful quitters per 100 (95% CI 2 to 8). There was low‐certainty evidence (limited by very serious imprecision) of no difference in the rate of adverse events (AEs) (RR 0.98, 95% CI 0.80 to 1.19; I2 = 0%; 2 studies, 485 participants). SAEs occurred rarely, with no evidence that their frequency differed between nicotine EC and NRT, but very serious imprecision led to low certainty in this finding (RR 1.37, 95% CI 0.77 to 2.41: I2 = n/a; 2 studies, 727 participants).
There was moderate‐certainty evidence, again limited by imprecision, that quit rates were higher in people randomized to nicotine EC than to non‐nicotine EC (RR 1.71, 95% CI 1.00 to 2.92; I2 = 0%; 3 studies, 802 participants). In absolute terms, this might again lead to an additional four successful quitters per 100 (95% CI 0 to 12). These trials used EC with relatively low nicotine delivery. There was low‐certainty evidence, limited by very serious imprecision, that there was no difference in the rate of AEs between these groups (RR 1.00, 95% CI 0.73 to 1.36; I2 = 0%; 2 studies, 346 participants). There was insufficient evidence to determine whether rates of SAEs differed between groups, due to very serious imprecision (RR 0.25, 95% CI 0.03 to 2.19; I2 = n/a; 4 studies, 494 participants).
Compared to behavioural support only/no support, quit rates were higher for participants randomized to nicotine EC (RR 2.50, 95% CI 1.24 to 5.04; I2 = 0%; 4 studies, 2312 participants). In absolute terms this represents an increase of six per 100 (95% CI 1 to 14). However, this finding was very low‐certainty, due to issues with imprecision and risk of bias. There was no evidence that the rate of SAEs varied, but some evidence that non‐serious AEs were more common in people randomized to nicotine EC (AEs: RR 1.17, 95% CI 1.04 to 1.31; I2 = 28%; 3 studies, 516 participants; SAEs: RR 1.33, 95% CI 0.25 to 6.96; I2 = 17%; 5 studies, 842 participants).
Data from non‐randomized studies were consistent with RCT data. The most commonly reported AEs were throat/mouth irritation, headache, cough, and nausea, which tended to dissipate over time with continued use. Very few studies reported data on other outcomes or comparisons and hence evidence for these is limited, with confidence intervals often encompassing clinically significant harm and benefit.
Authors' conclusions
There is moderate‐certainty evidence that ECs with nicotine increase quit rates compared to ECs without nicotine and compared to NRT. Evidence comparing nicotine EC with usual care/no treatment also suggests benefit, but is less certain. More studies are needed to confirm the degree of effect, particularly when using modern EC products. Confidence intervals were wide for data on AEs, SAEs and other safety markers. Overall incidence of SAEs was low across all study arms. We did not detect any clear evidence of harm from nicotine EC, but longest follow‐up was two years and the overall number of studies was small.
The main limitation of the evidence base remains imprecision due to the small number of RCTs, often with low event rates. Further RCTs are underway. To ensure the review continues to provide up‐to‐date information for decision‐makers, this review is now a living systematic review. We will run searches monthly from December 2020, with the review updated as relevant new evidence becomes available. Please refer to the Cochrane Database of Systematic Reviews for the review's current status.
Background
Heated tobacco products (HTPs) are designed to heat tobacco to a high enough temperature to release aerosol, without burning it or producing smoke. They differ from e‐cigarettes because ...they heat tobacco leaf/sheet rather than a liquid. Companies who make HTPs claim they produce fewer harmful chemicals than conventional cigarettes. Some people report stopping smoking cigarettes entirely by switching to using HTPs, so clinicians need to know whether they are effective for this purpose and relatively safe. Also, to regulate HTPs appropriately, policymakers should understand their impact on health and on cigarette smoking prevalence.
Objectives
To evaluate the effectiveness and safety of HTPs for smoking cessation and the impact of HTPs on smoking prevalence.
Search methods
We searched the Cochrane Tobacco Addiction Group's Specialised Register, CENTRAL, MEDLINE, and six other databases for relevant records to January 2021, together with reference‐checking and contact with study authors and relevant groups.
Selection criteria
We included randomised controlled trials (RCTs) in which people who smoked cigarettes were randomised to switch to exclusive HTP use or a control condition. Eligible outcomes were smoking cessation, adverse events, and selected biomarkers. RCTs conducted in clinic or in an ambulatory setting were deemed eligible when assessing safety, including those randomising participants to exclusively use HTPs, smoke cigarettes, or attempt abstinence from all tobacco. Time‐series studies were also eligible for inclusion if they examined the population‐level impact of heated tobacco on smoking prevalence or cigarette sales as an indirect measure.
Data collection and analysis
We followed standard Cochrane methods for screening and data extraction. Our primary outcome measures were abstinence from smoking at the longest follow‐up point available, adverse events, serious adverse events, and changes in smoking prevalence or cigarette sales. Other outcomes included biomarkers of harm and exposure to toxicants/carcinogens (e.g. NNAL and carboxyhaemoglobin (COHb)). We used a random‐effects Mantel‐Haenszel model to calculate risk ratios (RR) with 95% confidence intervals (CIs) for dichotomous outcomes. For continuous outcomes, we calculated mean differences on the log‐transformed scale (LMD) with 95% CIs. We pooled data across studies using meta‐analysis where possible.
Main results
We included 13 completed studies, of which 11 were RCTs assessing safety (2666 participants) and two were time‐series studies. We judged eight RCTs to be at unclear risk of bias and three at high risk. All RCTs were funded by tobacco companies. Median length of follow‐up was 13 weeks.
No studies reported smoking cessation outcomes.
There was insufficient evidence for a difference in risk of adverse events between smokers randomised to switch to heated tobacco or continue smoking cigarettes, limited by imprecision and risk of bias (RR 1.03, 95% CI 0.92 to 1.15; I2 = 0%; 6 studies, 1713 participants). There was insufficient evidence to determine whether risk of serious adverse events differed between groups due to very serious imprecision and risk of bias (RR 0.79, 95% CI 0.33 to 1.94; I2 = 0%; 4 studies, 1472 participants). There was moderate‐certainty evidence for lower NNAL and COHb at follow‐up in heated tobacco than cigarette smoking groups, limited by risk of bias (NNAL: LMD −0.81, 95% CI −1.07 to −0.55; I2 = 92%; 10 studies, 1959 participants; COHb: LMD −0.74, 95% CI −0.92 to −0.52; I2 = 96%; 9 studies, 1807 participants). Evidence for additional biomarkers of exposure are reported in the main body of the review.
There was insufficient evidence for a difference in risk of adverse events in smokers randomised to switch to heated tobacco or attempt abstinence from all tobacco, limited by risk of bias and imprecision (RR 1.12, 95% CI 0.86 to 1.46; I2 = 0%; 2 studies, 237 participants). Five studies reported that no serious adverse events occurred in either group (533 participants). There was moderate‐certainty evidence, limited by risk of bias, that urine concentrations of NNAL at follow‐up were higher in the heated tobacco use compared with abstinence group (LMD 0.50, 95% CI 0.34 to 0.66; I2 = 0%; 5 studies, 382 participants). In addition, there was very low‐certainty evidence, limited by risk of bias, inconsistency, and imprecision, for higher COHb in the heated tobacco use compared with abstinence group for intention‐to‐treat analyses (LMD 0.69, 95% CI 0.07 to 1.31; 3 studies, 212 participants), but lower COHb in per‐protocol analyses (LMD −0.32, 95% CI −1.04 to 0.39; 2 studies, 170 participants). Evidence concerning additional biomarkers is reported in the main body of the review.
Data from two time‐series studies showed that the rate of decline in cigarette sales accelerated following the introduction of heated tobacco to market in Japan. This evidence was of very low‐certainty as there was risk of bias, including possible confounding, and cigarette sales are an indirect measure of smoking prevalence.
Authors' conclusions
No studies reported on cigarette smoking cessation, so the effectiveness of heated tobacco for this purpose remains uncertain. There was insufficient evidence for differences in risk of adverse or serious adverse events between people randomised to switch to heated tobacco, smoke cigarettes, or attempt tobacco abstinence in the short‐term. There was moderate‐certainty evidence that heated tobacco users have lower exposure to toxicants/carcinogens than cigarette smokers and very low‐ to moderate‐certainty evidence of higher exposure than those attempting abstinence from all tobacco. Independently funded research on the effectiveness and safety of HTPs is needed.
The rate of decline in cigarette sales accelerated after the introduction of heated tobacco to market in Japan but, as data were observational, it is possible other factors caused these changes. Moreover, falls in cigarette sales may not translate to declining smoking prevalence, and changes in Japan may not generalise elsewhere. To clarify the impact of rising heated tobacco use on smoking prevalence, there is a need for time‐series studies that examine this association.
Background
A number of treatments can help smokers make a successful quit attempt, but many initially successful quitters relapse over time. Several interventions have been proposed to help prevent ...relapse.
Objectives
To assess whether specific interventions for relapse prevention reduce the proportion of recent quitters who return to smoking.
Search methods
We searched the Cochrane Tobacco Addiction Group trials register, clinicaltrials.gov, and the ICTRP in May 2019 for studies mentioning relapse prevention or maintenance in their title, s, or keywords.
Selection criteria
Randomised or quasi‐randomised controlled trials of relapse prevention interventions with a minimum follow‐up of six months. We included smokers who quit on their own, were undergoing enforced abstinence, or were participating in treatment programmes. We included studies that compared relapse prevention interventions with a no intervention control, or that compared a cessation programme with additional relapse prevention components with a cessation programme alone.
Data collection and analysis
We used standard methodological procedures expected by Cochrane.
Main results
We included 81 studies (69,094 participants), five of which are new to this update. We judged 22 studies to be at high risk of bias, 53 to be at unclear risk of bias, and six studies to be at low risk of bias. Fifty studies included abstainers, and 30 studies helped people to quit and then tested treatments to prevent relapse. Twenty‐eight studies focused on special populations who were abstinent because of pregnancy (19 studies), hospital admission (six studies), or military service (three studies). Most studies used behavioural interventions that tried to teach people skills to cope with the urge to smoke, or followed up with additional support. Some studies tested extended pharmacotherapy.
We focused on results from those studies that randomised abstainers, as these are the best test of relapse prevention interventions. Of the 12 analyses we conducted in abstainers, three pharmacotherapy analyses showed benefits of the intervention: extended varenicline in assisted abstainers (2 studies, n = 1297, risk ratio (RR) 1.23, 95% confidence interval (CI) 1.08 to 1.41, I2 = 82%; moderate‐certainty evidence), rimonabant in assisted abstainers (1 study, RR 1.29, 95% CI 1.08 to 1.55), and nicotine replacement therapy (NRT) in unaided abstainers (2 studies, n = 2261, RR 1.24, 95% Cl 1.04 to 1.47, I2 = 56%). The remainder of analyses of pharmacotherapies in abstainers had wide confidence intervals consistent with both no effect and a statistically significant effect in favour of the intervention. These included NRT in hospital inpatients (2 studies, n = 1078, RR 1.23, 95% CI 0.94 to 1.60, I2 = 0%), NRT in assisted abstainers (2 studies, n = 553, RR 1.04, 95% CI 0.77 to 1.40, I2 = 0%; low‐certainty evidence), extended bupropion in assisted abstainers (6 studies, n = 1697, RR 1.15, 95% CI 0.98 to 1.35, I2 = 0%; moderate‐certainty evidence), and bupropion plus NRT (2 studies, n = 243, RR 1.18, 95% CI 0.75 to 1.87, I2 = 66%; low‐certainty evidence). Analyses of behavioural interventions in abstainers did not detect an effect. These included studies in abstinent pregnant and postpartum women at the end of pregnancy (8 studies, n = 1523, RR 1.05, 95% CI 0.99 to 1.11, I2 = 0%) and at postpartum follow‐up (15 studies, n = 4606, RR 1.02, 95% CI 0.94 to 1.09, I2 = 3%), studies in hospital inpatients (5 studies, n = 1385, RR 1.10, 95% CI 0.82 to 1.47, I2 = 58%), and studies in assisted abstainers (11 studies, n = 5523, RR 0.98, 95% CI 0.87 to 1.11, I2 = 52%; moderate‐certainty evidence) and unaided abstainers (5 studies, n = 3561, RR 1.06, 95% CI 0.96 to 1.16, I2 = 1%) from the general population.
Authors' conclusions
Behavioural interventions that teach people to recognise situations that are high risk for relapse along with strategies to cope with them provided no worthwhile benefit in preventing relapse in assisted abstainers, although unexplained statistical heterogeneity means we are only moderately certain of this. In people who have successfully quit smoking using pharmacotherapy, there were mixed results regarding extending pharmacotherapy for longer than is standard. Extended treatment with varenicline helped to prevent relapse; evidence for the effect estimate was of moderate certainty, limited by unexplained statistical heterogeneity. Moderate‐certainty evidence, limited by imprecision, did not detect a benefit from extended treatment with bupropion, though confidence intervals mean we could not rule out a clinically important benefit at this stage. Low‐certainty evidence, limited by imprecision, did not show a benefit of extended treatment with nicotine replacement therapy in preventing relapse in assisted abstainers. More research is needed in this area, especially as the evidence for extended nicotine replacement therapy in unassisted abstainers did suggest a benefit.
Aims
We used data from a recent systematic review to investigate weight regain after behavioural weight management programmes (BWMPs, sometimes referred to as lifestyle modification programmes) and ...its impact on quality‐of‐life and cost‐effectiveness.
Materials and Methods
Trial registries, databases and forward‐citation searching (latest search December 2019) were used to identify randomized trials of BWMPs in adults with overweight/obesity reporting outcomes at ≥12 months, and after programme end. Two independent reviewers screened records. One reviewer extracted data and a second checked them. The differences between intervention and control groups were synthesized using mixed‐effect, meta‐regression and time‐to‐event models. We examined associations between weight difference and difference in quality‐of‐life. Cost‐effectiveness was estimated from a health sector perspective.
Results
In total, 155 trials (n > 150 000) contributed to analyses. The longest follow‐up was 23 years post‐programme. At programme end, intervention groups achieved –2.8 kg (95%CI –3.2 to –2.4) greater weight loss than controls. Weight regain after programme end was 0.12‐0.32 kg/year greater in intervention relative to control groups, with a between‐group difference evident for at least 5 years. Quality‐of‐life increased in intervention groups relative to control at programme end and thereafter returned to control as the difference in weight between groups diminished. BWMPs with this initial weight loss and subsequent regain would be cost‐effective if delivered for under £560 (£8.80‐£3900) per person.
Conclusions
Modest rates of weight regain, with persistent benefits for several years, should encourage health care practitioners and policymakers to offer obesity treatments that cost less than our suggested thresholds as a cost‐effective intervention to improve long‐term weight management.
Registration
The review is registered on PROSPERO, CRD42018105744.
Background
By reducing the amount of nicotine that reaches the brain when a person smokes a cigarette, nicotine vaccines may help people to stop smoking or to prevent recent quitters from relapsing.
...Objectives
The aims of this review are to assess the efficacy of nicotine vaccines for smoking cessation and for relapse prevention, and to assess the frequency and type of adverse events associated with the use of nicotine vaccines.
Search methods
We searched the Cochrane Tobacco Addiction Review Group specialised register for trials, using the term 'vaccine' in the title or , or in a keyword (date of most recent search April 2012). To identify any other material including reviews and papers potentially relevant to the background or discussion sections, we also searched MEDLINE, EMBASE, and PsycINFO, combining terms for nicotine vaccines with terms for smoking and tobacco use, without design limits or limits for human subjects. We searched the Annual Meeting s of the Society for Research on Nicotine and Tobacco up to 2012, using the search string 'vaccin'. We searched Google Scholar for 'nicotine vaccine'. We also searched company websites and Google for information related to specific vaccines. We searched clinicaltrials.gov in March 2012 for 'nicotine vaccine' and for the trade names of known vaccine candidates.
Selection criteria
We included randomized controlled trials of nicotine vaccines, at Phase II and Phase III trial stage and beyond, in adult smokers or recent ex‐smokers. We included studies of nicotine vaccines used as part of smoking cessation or relapse prevention interventions.
Data collection and analysis
We extracted data on the type of participants, the dose and duration of treatment, the outcome measures, the randomization procedure, concealment of allocation, blinding of participants and personnel, reporting of outcomes, and completeness of follow‐up.
Our primary outcome measure was a minimum of six months abstinence from smoking. We used the most rigorous definition of abstinence, and preferred cessation rates at 12 months and biochemically validated rates where available. We have used the risk ratio (RR) to summarize individual trial outcomes. We have not pooled the current group of included studies as they cover different vaccines and variable regimens.
Main results
There are no nicotine vaccines currently licensed for public use, but there are a number in development. We found four trials which met our inclusion criteria, three comparing NicVAX to placebo and one comparing NIC002 (formerly NicQbeta) to placebo. All were smoking cessation trials conducted by pharmaceutical companies as part of the drug development process, and all trials were judged to be at high or unclear risk of bias in at least one domain. Overall, 2642 smokers participated in the included studies in this review. None of the four included studies detected a statistically significant difference in long‐term cessation between participants receiving vaccine and those receiving placebo. The RR for 12 month cessation in active and placebo groups was 1.35 (95% Confidence Interval (CI) 0.82 to 2.22) in the trial of NIC002 and 1.74 (95% CI 0.73 to 4.18) in one NicVAX trial. Two Phase III NicVAX trials, for which full results were not available, reported similar quit rates of approximately 11% in both groups. In the two studies with full results available, post hoc analyses detected higher cessation rates in participants with higher levels of nicotine antibodies, but these findings are not readily generalisable. The two studies with full results showed nicotine vaccines to be well tolerated, with the majority of adverse events classified as mild or moderate. In the study of NIC002, participants receiving the vaccine were more likely to report mild to moderate adverse events, most commonly flu‐like symptoms, whereas in the study of NicVAX there was no significant difference between the two arms. Information on adverse events was not available for the large Phase III trials of NicVAX.
Vaccine candidates are likely to undergo significant changes before becoming available to the general public, and those included in this review may not be the first to reach market; this limits the external validity of the results reported in this review in terms of both effectiveness and tolerability.
Authors' conclusions
There is currently no evidence that nicotine vaccines enhance long‐term smoking cessation. Rates of serious adverse events recorded in the two trials with full data available were low, and the majority of adverse events reported were at mild to moderate levels. The evidence available suggests nicotine vaccines do not induce compensatory smoking or affect withdrawal symptoms. No nicotine vaccines are currently licensed for use in any country but a number are under development.
Further trials of nicotine vaccines are needed, comparing vaccines with placebo for smoking cessation. Further trials are also needed to explore the potential of nicotine vaccines to prevent relapse. Results from past, current and future research should be reported in full. Adverse events and serious adverse events should continue to be carefully monitored and thoroughly reported.
Objective
The aim of this study was to develop a shortened Oxford Food and Activity Behaviors (OxFAB) questionnaire to identify the cognitive and behavioral strategies used by individuals during ...weight‐management attempts.
Methods
This study reduced an existing 117‐item questionnaire (the original OxFAB questionnaire) through identifying clusters of techniques from the responses of 278 people living with obesity and, within those clusters, identifying the most representative question or questions. Questions were rephrased to cover multiple strategies at the domain level, with several alternative phrasings developed for new questions. Face validity was tested through think‐aloud interviews with 12 people living with obesity. Questions were rephrased accordingly and tested using test‐retest (n = 172). Prevalence‐ and bias‐adjusted κ (PABAK) were calculated, and questions with PABAK < 0.41 were rewritten and evaluated in a new test‐retest sample (n = 130).
Results
OxFAB20 consists of 20 questions covering diet, physical activity, and cognitive strategies for weight management. Test–retest resulted in a mean PABAK score of 0.56 (SD = 0.14). Questions were revised where appropriate. The questionnaire is available for use via a CC‐BY license.
Conclusions
The OxFAB20 questionnaire provides a practical tool for researchers to identify the cognitive and behavioral strategies used by individuals during attempts at weight control.
Objective
Evidence on the effectiveness of behavioral weight management programs often comes from uncontrolled program evaluations. These frequently make the assumption that, without intervention, ...people will gain weight. The aim of this study was to use data from minimal intervention control groups in randomized controlled trials to examine the evidence for this assumption and the effect of frequency of weighing on weight change.
Methods
Data were extracted from minimal intervention control arms in a systematic review of multicomponent behavioral weight management programs. Two reviewers classified control arms into three categories based on intensity of minimal intervention and calculated 12‐month mean weight change using baseline observation carried forward. Meta‐regression was conducted in STATA v12.
Results
Thirty studies met the inclusion criteria, twenty‐nine of which had usable data, representing 5,963 participants allocated to control arms. Control arms were categorized according to intensity, as offering leaflets only, a single session of advice, or more than one session of advice from someone without specialist skills in supporting weight loss. Mean weight change at 12 months across all categories was −0.8 kg (95% CI −1.1 to −0.4). In an unadjusted model, increasing intensity by moving up a category was associated with an additional weight loss of −0.53 kg (95% CI −0.96 to −0.09). Also in an unadjusted model, each additional weigh‐in was associated with a weight change of −0.42 kg (95% CI −0.81 to −0.03). However, when both variables were placed in the same model, neither intervention category nor number of weigh‐ins was associated with weight change.
Conclusions
Uncontrolled evaluations of weight loss programs should assume that, in the absence of intervention, their population would weigh up to a kilogram on average less than baseline at the end of the first year of follow‐up.
Abstract Weight loss can reduce the health risks associated with being overweight or obese. However, the most effective method of weight loss remains unclear. Some programs emphasize physical ...activity, others diet, but existing evidence is mixed as to whether these are more effective individually or in combination. We aimed to examine the clinical effectiveness of combined behavioral weight management programs (BWMPs) targeting weight loss in comparison to single component programs, using within study comparisons. We included randomized controlled trials of combined BWMPs compared with diet-only or physical activity-only programs with at least 12 months of follow-up, conducted in overweight and obese adults (body mass index ≥25). Systematic searches of nine databases were run and two reviewers extracted data independently. Random effects meta-analyses were conducted for mean difference in weight change at 3 to 6 months and 12 to 18 months using a baseline observation carried forward approach for combined BWMPs vs diet-only BWMPs and combined BWMPs vs physical activity-only BWMPs. In total, eight studies were included, representing 1,022 participants, the majority of whom were women. Six studies met the inclusion criteria for combined BWMP vs diet-only. Pooled results showed no significant difference in weight loss from baseline or at 3 to 6 months between the BWMPs and diet-only arms (–0.62 kg; 95% CI –1.67 to 0.44). However, at 12 months, a significantly greater weight-loss was detected in the combined BWMPs (–1.72 kg; 95% CI –2.80 to –0.64). Five studies met the inclusion criteria for combined BWMP vs physical activity-only. Pooled results showed significantly greater weight loss in the combined BWMPs at 3 to 6 months (–5.33 kg; 95% CI –7.61 to –3.04) and 12 to 18 months (–6.29 kg; 95% CI –7.33 to –5.25). Weight loss is similar in the short-term for diet-only and combined BWMPs but in the longer-term weight loss is increased when diet and physical activity are combined. Programs based on physical activity alone are less effective than combined BWMPs in both the short and long term.
Background
Rapid weight gain is common with antipsychotic medication. Lost confidence, low mood and medication non‐adherence often follow. Yet, the dynamic interactions between the physical and ...psychological consequences of weight gain, and implications for intervention, are unknown.
Objectives
We examined first‐person accounts of weight gain to identify preferences for weight change interventions.
Design
A qualitative design was used to explore patients’ experiences of weight change in the context of psychosis.
Method
Semi‐structured interviews, analysed using grounded theory, were conducted with 10 patients with psychosis. Sample validation was conducted with peer researchers with lived experience of psychosis.
Results
Patients described that initially the extent and speed of weight gain was overshadowed by psychotic experiences and their treatment. This led to a shocking realisation of weight gain. The psychological impact of weight gain, most strikingly on the self‐concept, was profound. Loss of self‐worth and changed appearance amplified a sense of vulnerability. There were further consequences on mood, activity and psychotic experiences, such as voices commenting on appearance, that were additional obstacles in the challenging process of weight loss. Sedative effects of medication also contributed. Unsuccessful weight loss left little hope and few preferences for interventions. Early information about common weight gain trajectories and working with experts‐by‐experience were valued. Rebuilding self‐confidence, efficacy and worth may be a necessary first step.
Conclusions
The journey of weight gain in patients with psychosis is characterised by loss of self‐worth, agency and hope. There are multiple stages in the journey, each with different psychological reactions, that may need different treatment responses.
PDF
