Effectiveness of a Cognitive Orientation Program With and Without Nicotine Replacement Therapy in Stopping Smoking in Hospitalised Patients

IntroductionWe have analyzed the effectiveness of high-intensity cognitive-behavioral intervention initiated during hospitalization, compared with minimal intervention. We have also analyzed whether the combination of intervention with nicotine replacement therapy (NRT) can increase smoking abstinence rates after 12 months of follow-up.MethodsWe studied 2,560 active smokers during their hospital stays. Of these, 717 smokers declined to participate in the study, and after minimal intervention they were asked for permission to telephone them one year later to ask if they continued to smoke. The remaining 1,843 smokers received high-intensity cognitive therapy and were randomized to receive NRT or not. The follow-up after hospital discharge was completed either in the outpatient consultation or by telephone sessions.ResultsOne year later, 7% of the patients who declined to participate in the study maintained smoking abstinence, compared with 27% of those who did participate in the study (p<0.001). There were significant differences between the group that only received behavioral treatment (21% abstinence) compared with the group that also received NRT (33% abstinence; p = 0.002). In this last group, there were significant differences (p = 0.03) between those who attended outpatient consultation (39% abstinence) and those who had telephone sessions (30%). In the multivariate analysis, the predictors for abstinence 12 months later were: having used NRT (OR 12.2; 95% CI, 5.2-32; p = 0.002) and a higher score on the Richmond test (OR 10.1; 95% CI, 3.9-24.2; p = 0.01).ConclusionsCognitive orientation interventions initiated in hospitalized smokers increase 12-month abstinence rates compared with minimal intervention, and said rates increase significantly when NRT is added.     

Effect of nicotine, silver acetate, and ordinary chewing gum in combination with group counselling on smoking cessation.

Four hundred and ninety six smokers participated in a randomised comparison of the effect of silver acetate, nicotine, and ordinary chewing gum on smoking cessation. All were motivated to stop smoking abruptly and all had smoked at least 10 cigarettes a day for at least five years. Side effects and taste acceptability were related to outcome after six months. The participants attended nine meetings over a year, at which lectures, support, and advice about stopping smoking were given. Tobacco abstinence was confirmed by measurement of carbon monoxide in expired air. The chewing gums were used for 12 weeks. After 12 weeks there was a trend towards more abstainers in the nicotine group (59%) than in the silver acetate (50%) and ordinary (45%) chewing gum groups that was not quite significant (p = 0.07). At 26 and 52 weeks the number of cigarette abstainers was similar in the three treatment groups. Subjects in the nicotine chewing gum group had a longer mean time before relapse than those in the silver acetate and ordinary chewing gum groups. Mean success rates for all subjects combined at 12, 26, and 52 weeks were 52.8%, 39.7%, and 23.3%. The side effects of nicotine and silver acetate chewing gum were generally mild and transient, and unimportant except for mouth irritation from silver acetate, which had a negative effect on outcome, and the low taste acceptability of nicotine, which had a strong negative influence on the success rate. The results suggest a short term effect on nicotine chewing gum on smoking cessation, but the abstinence rates after one year were generally disappointing.     

Controlled trial of three weeks nicotine replacement treatment in hospital patients also given advice and support

BACKGROUND: Smoking is a major public health issue, estimated as causing 120 000 deaths in the UK per year. Smoking cessation is an important aspect of the treatment of many diseases. Nicotine replacement therapy (NRT) has been shown to increase cessation rates among healthy volunteers and in general practice, but it is not clear whether it has an effect in hospital patients. METHODS: Patients referred by their hospital doctor to the smoking cessation counsellor and who agreed to participate in the study were randomised to receive either NRT given as a nicotine patch daily and a nicotine inhalator on an as needed basis plus advice and support (AS+NRT), or to receive just advice and support (AS). Claims of smoking cessation were validated at 1 week, 3 months, 6 months, and 1 year by carbon monoxide (CO) breath testing. RESULTS: A total of 245 patients were randomised, 136 AS+NRT and 109 AS. There were no significant demographic differences between the two groups at baseline. At 1 year 35 (14%) had sustained cessation confirmed by a CO breath test, 20/136 (15%) AS+NRT and 15/109 (14%) AS, p=0.857. One hundred and ten patients gave up smoking for at least 1 week, 54% AS+NRT and 33% AS (p<0.001). By 6 months there was no significant difference between the two groups (22/136 (16%) AS+NRT and 15/109 (14%) AS). CONCLUSION: In hospital patients NRT, given as regular daily patches plus an inhalator to be used as needed, did not add to the smoking cessation rate achieved at 1 year by regular advice and support, despite significantly increasing the cessation rate at 1 week.     

The efficacy of a smoking cessation programme in patients undergoing elective surgery – a randomised clinical trial

It is known that smokers constitute an important risk group of patients undergoing surgery. It is unknown how smoking cessation intervention initiated 4 weeks prior to elective surgery affects the probability of permanent cessation. We randomly assigned 117 patients, scheduled to undergo elective orthopaedic and general surgery, to smoking cessation intervention and control group. The intervention group underwent a programme initiated, on average, 4 weeks prior to surgery with weekly meetings or telephone counselling and were provided with free nicotine replacement therapy (NRT). The control group received standard care. As a result, 20/55 (36%) patients the intervention group vs 1/62 (2%) in the control group became completely abstinent throughout the peri-operative period (p < 0.001). After 1 year, those in the intervention group was most likely to be abstinent (18/55 (33%) vs 9/62 (15%) of the controls (p = 0.03). Level of nicotine dependence and obesity seemed to be a predictor of long-term abstinence (p = 0.02).     

Efficacy of bupropion in the indigenous Maori population in New Zealand

BACKGROUND: Smoking rates are high in indigenous populations and contribute to their poor health. In New Zealand the indigenous Maori population has a high rate of smoking, with around 50% of adults being smokers compared with 20% of the adult European population. A study was undertaken to determine whether bupropion is effective in the treatment of smoking cessation in the indigenous Maori population in New Zealand. METHODS: A randomised, placebo controlled, double blind, parallel group study was performed in 134 Maori smokers aged 16-70 years who smoked more than 10 cigarettes per day. The main outcome measures were continued abstinence from smoking at 3 and 12 months. RESULTS: At each time point continued abstinence was better for the subjects allocated to bupropion, with a risk ratio for abstinence over all time points of 2.44 (95% CI 1.22 to 4.88). The rates of continued abstinence in the bupropion and placebo groups at 3 months were 44.3% and 17.4%, respectively, with a risk ratio of 2.54 (95% CI 1.30 to 5.00). The corresponding figures at 12 months were 21.6% and 10.9%, respectively, with a risk ratio of 1.99 (95% CI 0.79 to 5.00). CONCLUSION: Bupropion is an effective treatment for smoking cessation in the indigenous Maori population in New Zealand.     

Is nicotine replacement therapy for smoking cessation effective in the “real world”? Findings from a prospective multinational cohort study

BACKGROUND: Increasing smoking cessation rates is an important goal in preventing lung cancer and chronic obstructive pulmonary disease. Nicotine replacement therapy (NRT) has been found in clinical trials to improve the chances of success at stopping, but recent cross-sectional survey data have raised doubts as to whether it is effective when used by smokers making quit attempts unsupervised outside clinical trials. Because of biases inherent in cross-sectional surveys, this issue can only be adequately addressed using longitudinal studies. This paper reports the first study of its kind to examine the issue. METHODS: The ATTEMPT cohort is a multinational cohort study with data collection by the internet which recruited smokers of > or = 5 cigarettes per day aged 35-65 years who were intending to stop smoking within the next 3 months. Phase 1 began in spring 2003 and involved 2009 smokers from the USA, UK, Canada and France. Phase 2 involved 3645 smokers and included the same countries plus Spain. Follow-up assessments were carried out every 3 months. 492 smokers who made a quit attempt without formal behavioural support or bupropion in the first 3-month follow-up period were identified from phase 1, 357 of whom were followed up for a further 6 months. The phase 2 sample involved 906 smokers making quit attempts, 732 of whom were followed up. At baseline, demographic characteristics, smoking history and nicotine dependence were assessed. Smokers who made quit attempts were questioned on methods used to aid them. The main outcome measure was self-report of complete abstinence throughout both the 3-month periods following the quit date. RESULTS: 35.6% of smokers followed up in phase 1 and 29.6% of those followed up in phase 2 used NRT. The odds ratios comparing abstinence for 6 months in those using and those not using NRT, adjusting for nicotine dependence, were 3.0 (95% CI 1.2 to 7.5) for the phase 1 sample and 2.1 (95% CI 1.0 to 4.1) for the phase 2 sample. The difference in success rates between those using NRT and those not using it, adjusted for the Fagerstrom test for nicotine dependence (FTND) score, was 6% in the phase 1 sample and 3.7% in the phase 2 sample. The improved odds of success were not explicable in terms of motivation to use some form of aid to cessation or differential loss to follow-up. CONCLUSION: NRT use by smokers making self-initiated quit attempts without formal behavioural support is associated with improved long-term abstinence rates.     

Interventions for smoking cessation in hospitalised patients: a systematic review

BACKGROUND: An admission to hospital provides an opportunity to help people stop smoking. Individuals may be more open to help at a time of perceived vulnerability, and may find it easier to quit in an environment where smoking is restricted or prohibited. Providing smoking cessation services during hospitalisation may help more people to attempt and sustain an attempt to quit. The purpose of this paper is to systematically review the effectiveness of interventions for smoking cessation in hospitalised patients. METHODS: We searched the Cochrane Tobacco Addiction Group register, CINAHL, and the Smoking and Health database for studies of interventions for smoking cessation in hospitalised patients. Randomised and quasi-randomised trials of behavioural, pharmacological, or multi-component interventions to help patients stop smoking conducted with hospitalised patients who were current smokers or recent quitters were included. Studies of patients admitted for psychiatric disorders or substance abuse, those that did not report abstinence rates, and those with follow up of less than 6 months were excluded. Two of the authors extracted data independently for each paper, with assistance from others. RESULTS: Intensive intervention (inpatient contact plus follow up for at least 1 month) was associated with a significantly higher cessation rate compared with controls (Peto odds ratio (OR) 1.82, 95% CI 1.49 to 2.22). Any contact during hospitalisation followed by minimal follow up failed to detect a statistically significant effect on cessation rate, but did not rule out a 30% increase in smoking cessation (Peto OR 1.09, 95% CI 0.91 to 1.31). There was insufficient evidence to judge the effect of interventions delivered only during the hospital stay. Although the interventions increased quit rates irrespective of whether nicotine replacement therapy (NRT) was used, the results for NRT were compatible with other data indicating that it increases quit rates. There was no strong evidence that clinical diagnosis affected the likelihood of quitting. CONCLUSIONS: High intensity behavioural interventions that include at least 1 month of follow up contact are effective in promoting smoking cessation in hospitalised patients.     

A programme for reducing smoking in pre-operative surgical patients: randomised controlled trial

We assessed the efficacy of a comprehensive programme for stopping smoking in 210 smokers scheduled for surgery, before admission and 3 months after attending a pre-operative clinic. Participants were randomly allocated to receive an intervention incorporating nicotine replacement therapy for patients smoking more than 10 cigarettes per day ("dependent smokers"), or to a control group to receive usual care. Dependent smokers allocated to the intervention group were more likely to report abstinence before surgery than those allocated to receive usual-care (63 (73%) vs. 29 (56%), respectively; OR 2.2 (95% CI 1.0-4.8)), and 3 months after attendance (16 (18%) vs. 3 (5%), respectively; OR = 3.9 (95% CI 1.0-21.7).     

Does smoking cessation improve quality of life in patients with coronary heart disease?

OBJECTIVE: To evaluate whether smoking cessation after a coronary event improves quality of life, and to assess whether quality of life is a predictor of smoking cessation. DESIGN: Health-related quality of life at baseline and at 12 months follow up were measured in a randomised smoking cessation trial of 240 smokers aged under 76 years admitted for myocardial infarction, unstable angina or coronary bypass surgery. At 12 months follow up 101 had managed to give up smoking (quitters), and 117 were smokers (sustained smokers). RESULTS: The quitters and sustained smokers had similar improvements in all quality of life domains from baseline to 12 months follow up. Further, after adjustment for differences in baseline characteristics, the quality of life was not significantly different in the quitters compared to the sustained smokers neither at baseline nor at 12 months follow up. CONCLUSIONS: Smoking cessation did not improve quality of life compared to sustained smoking after a coronary event in a 12 month follow up. Quality of life was not a significant predictor of smoking cessation.     

Peri-operative tobacco cessation interventions: a systematic review and meta-analysis

Tobacco smoking is associated with a substantially increased risk of postoperative complications. The peri-operative period offers a unique opportunity to support patients to stop tobacco smoking, avoid complications and improve long-term health. This systematic review provides an up-to-date summary of the evidence for tobacco cessation interventions in surgical patients. We conducted a systematic search of randomised controlled trials of tobacco cessation interventions in the peri-operative period. Quantitative synthesis of the abstinence outcomes data was by random-effects meta-analysis. The primary outcome of the meta-analysis was abstinence at the time of surgery, and the secondary outcome was abstinence at 12 months. Thirty-eight studies are included in the review (7310 randomised participants) and 26 studies are included in the meta-analysis (5969 randomised participants). Studies were pooled for subgroup analysis in two ways: by the timing of intervention delivery within the peri-operative period and by the intensity of the intervention protocol. We judged the quality of evidence as moderate, reflecting the degree of heterogeneity and the high risk of bias. Overall, peri-operative tobacco cessation interventions increased successful abstinence both at the time of surgery, risk ratio (95%CI) 1.48 (1.20–1.83), number needed to treat 7; and 12 months after surgery, risk ratio (95%CI) 1.62 (1.29–2.03), number needed to treat 9. More work is needed to inform the design and optimal delivery of interventions that are acceptable to patients and that can be incorporated into contemporary elective and urgent surgical pathways. Future trials should use standardised outcome measures.     

Effectiveness of bupropion as an aid to stopping smoking before elective surgery: a randomised controlled trial

Smoking is a risk factor for complications during and after surgery, but most smokers are unable to quit before elective surgery. We tested the efficacy of bupropion in improving smoking cessation rates in this setting by enrolling 47 patients from the elective surgery waiting list in a double-blind randomised controlled trial. Patients receiving bupropion had a lower daily cigarette consumption at the time of hospital admission, median (IQR) cigarettes per day: 6 (2-7) vs. 15 (9-20), p = 0.046. They also had a reduction in end-expired carbon monoxide (p = 0.004), a known contaminant of cigarette smoke, and increased arterial oxygen saturation on pulse oximetry (p = 0.011). They were more likely to have stopped smoking at the 3-week visit (p = 0.036), but not at the 6-week visit (p = 0.25) or at the time of hospital admission for surgery (p > 0.99). This study found that smokers waiting for elective surgery are more likely to reduce or stop smoking when treated with bupropion.     

Feasibility and pilot efficacy of a brief smoking cessation intervention delivered by vascular surgeons in the Vascular Physician Offer and Report (VAPOR) Trial

Background

This study determined the feasibility and potential efficacy of an evidence-based standardized smoking cessation intervention delivered by vascular surgeons to smokers with peripheral arterial disease.

Smoking cessation in patients: two further studies by the British Thoracic Society. Research Committee of the British Thoracic Society.

The effects of various smoking cessation strategies were studied in two multicentre trials with new patients attending hospital or a chest clinic because of a smoking related disease. In the first trial (study A, 1462 patients) the effect of the physician's usual advice to stop smoking was compared with the effect of the same advice reinforced by a signed agreement to stop smoking by a target date within the next week, two visits by a health visitor in the first six weeks, and a series of letters of encouragement from the physician. The second trial (study B, 1392 patients) compared (1) advice only, (2) advice supplemented by a signed agreement, (3) advice supplemented by a series of letters of encouragement, and (4) advice supplemented by a signed agreement and a series of letters of encouragement. Patients were reviewed at six months and those claiming to have stopped smoking were seen again at 12 months. Claims of abstinence were checked by carboxyhaemoglobin measurement. In study A 9% of the intervention group had succeeded in stopping smoking at six months compared with 7% of the "advice only" patients (p = 0.17). In study B success rates were 5.2%, 4.9%, 8.5%, and 8.8% respectively. The signed agreement did not influence outcome, whereas postal encouragement increased the effect of the physician's advice. In both studies patients reviewed clinically between the initial and the six month visit were more likely to stop smoking than those not reviewed. Success rates increased with age and men tended to do better than women. The studies suggest that physician's advice alone will persuade 5% of outpatients with a smoking related disease to stop smoking. Subsequent postal encouragement will increase the cessation rate by more than half as much again. Such small improvements in success rates are worth while, especially if they can be achieved cheaply and on a wide scale.     

The effect of pre-operative counselling on smoking patterns in patients undergoing forefoot surgery

BackgroundSmoking contributes to higher surgical complication rates. Previous studies assessing smoking cessation interventions examined the provision of comprehensive packages. The use of surgery as an incentive to complement brief advice has not been fully evaluated.MethodsSmokers were counselled and referred to their general practitioners for specific cessation strategies. Smoking status was recorded prior to surgery, on admission and in post-operative clinics. A telephone survey at a mean of 12 months post-operation ascertained long-term behavioural changes.ResultsNinety-seven patients underwent surgery with twenty-five recorded as smokers. Sixteen stopped smoking pre-operatively; a further four reduced their intake, as a direct consequence of counselling. No patients were previously aware of the detrimental effects of smoking associated with foot surgery.ConclusionsSurgery provides an incentive for smoking cessation, maintained post-operatively. Although forefoot fusions and arthrodeses were used in our study, the results are transferable to other branches of orthopaedic surgery.     

Do cigarette smokers with erectile dysfunction benefit from stopping?: a prospective study

OBJECTIVE: To assess whether stopping smoking can improve erectile dysfunction (ED) in smokers, as cigarette smoking is a known risk factor for ED. PATIENTS AND METHODS: Smokers who requested nicotine replacement therapy (NRT) and complained of ED were first evaluated for hypertension, dyslipidaemia, diabetes, psychiatric disorders and drug history. The grade of ED in smokers with none of these risk factors was then determined using the five-item version of the International Index of Erectile Function (IIEF-5) before NRT, and the grading repeated after 1 year of follow-up. The correlation between the exposure to smoking (pack-years) and severity of ED was assessed before the follow-up. The ED status between patients who stopped smoking after NRT and those who continued during the follow-up was then compared before and after the follow-up. RESULTS: The severity of ED correlated significantly with the level of exposure to smoking. Age and ED status before the follow-up were not significantly different between 118 patients who stopped (ex-smokers) and 163 who continued smoking (current smokers). After 1 year the ED status improved in > or = 25% of ex-smokers but in none of the current smokers; 2.5% of ex-smokers and 6.8% of current smokers had a deterioration in ED. Ex-smokers had a significantly better ED status after the follow-up (P = 0.009). Among ex-smokers, patients with advanced ED and those who were older had less improvement. CONCLUSION: There is a strong association between the intensity of cigarette smoking and degree of ED. Stopping cigarette smoking can improve ED in a considerable proportion of smokers. Age and the severity of ED before stopping are inversely related to the chance of improvement.     

Recovery of intraoperative microbicidal and inflammatory functions of alveolar immune cells after a tobacco smoke-free period

BACKGROUND: Tobacco smoking inhibits alveolar macrophage function, but cessation of smoking markedly reduces the risk of postoperative pulmonary complications. The authors therefore evaluated the effect of nonsmoking duration on both antimicrobial and inflammatory functions of alveolar macrophages during anesthesia and surgery. METHODS: The authors studied 15 patients who had never smoked, 15 current smokers, and 41 former smokers, all of whom underwent general anesthesia. Former smokers were further allocated to one of three groups depending on their smoke-free periods: 2 months (n = 13), 3-5 months (n = 13), and 6-12 months (n = 15). Alveolar immune cells were collected by bronchoalveolar lavage immediately after induction of anesthesia, at 2 and 4 h after induction of anesthesia, and at the end of surgery. Opsonized and nonopsonized phagocytosis were measured. Microbicidal activity was determined as the ability of the macrophages to kill Listeria monocytogenes directly. Finally, we determined the expression of proinflammatory cytokines, including interleukin 1beta, interleukin 8, interferon gamma, and tumor necrosis factor alpha, and of antiinflammatory cytokines (interleukin 4 and 10) by semiquantitative polymerase chain reaction. RESULTS: Nonopsonized and opsonized phagocytosis and microbicidal activity of alveolar macrophages (antimicrobial functions) decreased 20-50%, and the expression of genes for all proinflammatory and antiinflammatory cytokines increased 3-30-fold over time in all groups. Starting 4 h after induction of anesthesia, the decreases in antimicrobial functions were 1.5-3 times greater in current and former smokers (2 months' abstinence) than in patients who had never smoked. Starting 4 h after anesthesia, the increase in expression of all cytokines, except interleukin 8, was twofold to fivefold less in current and former smokers (2-6 months' abstinence) than in patients who had never smoked. CONCLUSION: Our data suggest that former smokers may have a limited ability to mount effective pulmonary immune defenses for long as 6 months after stopping cigarette use.     

Prospective study on the effect of smoking and nicotine substitution on leucocyte blood counts and relation between blood leucocytes and lung function

BACKGROUND: The influence of smoking and of nicotine substitution on the counts of total blood leucocytes and leucocyte subsets and the relations between the counts and lung function was investigated. METHODS: The study was a combined cross sectional and prospective study of 298 smokers and 136 non-smokers. Forced expiratory volume in one second (FEV1) was measured in all participants at baseline and six months after quitting smoking in 160 ex-smokers (quitters) and 138 persons with smoking relapse. Blood samples were obtained from all participants at baseline and from 160 quitters and 30 continuing smokers two, six, 12, and 26 weeks after smoking cessation and from 92 quitters one year after the cessation of smoking. RESULTS: Blood leucocyte counts and leucocyte subsets were all higher in smokers than in non-smokers. In cigarette smokers total leucocyte, neutrophil, and lymphocyte blood counts showed a dose dependent relationship with the daily cigarette consumption and pack years consumption. In smokers the neutrophil blood count was independently associated negatively with FEV1 residuals. After quitting smoking total leucocyte, neutrophil, and lymphocyte blood counts decreased during the first 26 weeks and after one year lymphocyte blood counts were higher than in non-smokers. In quitters substituted with nicotine chewing gum (2 mg) the accumulated number of pieces of chewing gum used in the 12 weeks had an inverse relationship with the decrease in the total lymphocyte blood count at 12 weeks after smoking cessation. CONCLUSIONS: Leucocyte blood counts are raised in smokers and decrease after smoking cessation. Neutrophil blood counts had an inverse relationship with lung function and nicotine may increase lymphocyte blood counts in smokers.     

Effect of smoking, abstention, and nicotine patch on epidermal healing and collagenase in skin transudate

Delayed wound healing may explain postoperative tissue and wound dehiscence in smokers, but the effects of smoking and smoking cessation on the cellular mechanisms remain unclear. Suction blisters were raised in 48 smokers and 30 never smokers. The fluid was retrieved and the epidermal roof was excised. Transepidermal water loss (TEWL) was measured after 2, 4, and 7 days. Then, the smokers were randomized to continuous smoking or abstinence with a transdermal nicotine patch or a placebo by concealed allocation. The sequence was repeated after 4, 8, and 12 weeks in all smokers and abstainers and in 6 never smokers. Matrix metalloproteinase (MMP)-8 and MMP-1 levels in suction blister fluid were assessed by an enzyme-linked immunosorbent assay. Random-effects models for repeated measurements were applied and p ≤0.05 was considered significant. One week after wounding the TEWL was 17.20 (14.47–19.92) g/cm² hour (mean, 95% CI) in smokers and 13.89 (9.46–18.33) in never smokers ( p <0.01). In abstinent smokers TEWL was 18.95 (15.20–22.70)( p <0.01, when compared with smokers). In smokers, MMP-8 was 36.4 (24.3–48.5) ng/mL (mean, 95% CI) and 15.2 (1.4–30.2) ng/mL in never smokers ( p <0.01). Abstinent smokers' MMP-8 level was 21.2 ng/mL (6.6–43.0) ( p =0.02, when compared with smokers). MMP-1 was unaffected by smoking and abstention. Transdermal nicotine patch did not affect any parameter. We conclude that smoking attenuates epidermal healing and may enhance extracellular matrix degradation. Three months of abstinence from smoking does not restore epidermal healing, whereas 4 weeks of abstinence normalizes suction blister MMP-8 levels. These findings suggest sustained impaired wound healing in smokers and potential reversibility of extracellular matrix degradation.     

Weekly versus basic smoking cessation support in primary care: a randomised controlled trial

BACKGROUND: There is insufficient and conflicting evidence about whether more intensive behavioural support is more effective than basic behavioural support for smoking cessation and whether primary care nurses can deliver effective behavioural support. METHODS: A randomised controlled trial was performed in 26 UK general practices. 925 smokers of >or=10 cigarettes per day were randomly allocated to basic or weekly support. All participants were seen before quitting, telephoned around quit day, and seen 1 and 4 weeks after the initial appointment (basic support). Participants receiving weekly support had an additional telephone call at 10 days and 3 weeks after the initial appointment and an additional visit at 2 weeks to motivate adherence to nicotine replacement and renew quit attempts. 15 mg/16 h nicotine patches were given to all participants. The outcome was assessed by intention to treat analyses of the percentage confirmed sustained abstinence at 4, 12, 26 and 52 weeks after quit day. RESULTS: Of the 469 and 456 participants in the basic and weekly arms, the numbers (%) who quit and the percentage difference were 105 (22.4%) vs 102 (22.4%), 0.1% (95% CI -5.3% to 5.5%) at 4 weeks, 66 (14.1%) vs 52 (11.4%), -2.6% (95% CI -6.9% to 1.7%) at 12 weeks, 50 (10.7%) vs 40 (8.8%), -1.9% (95% CI -5.7% to 2.0%) at 26 weeks and 36 (7.7%) vs 30 (6.6%), -1.1% (95% CI -4.4% to 2.3%) at 52 weeks. CONCLUSIONS: The absolute quit rates achieved are those expected from nicotine replacement alone, implying that neither basic nor weekly support were effective. Primary care smoking cessation treatment should provide pharmacotherapy with sufficient support only to ensure it is used appropriately, and those in need of support should be referred to specialists.