Outline
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Abstract^
In a systematic review of the efficacy of interventions intended to help people stop smoking, data have been analyzed from 188 randomized controlled trials.Following personal advice and encouragement to stop smoking given by physicians during a single routine consultation, an estimated 2% (95% confidence limits, 1%, 3%; P<.001) of all smokers stopped smoking and did not relapse up to 1 year as a direct consequence of the advice. The effect is modest but cost-effective: the cost of saving a life is about $1500. Supplementary interventions (follow-up letters or visits, demonstration of spirometry, etc) have an additional effect--variable in extent. Advice and encouragement are particularly effective for smokers at special risk--pregnant women (efficacy, 8%) and patients with ischemic heart disease. Behavior modification techniques (relaxation, rewards and punishment, avoiding "trigger" situations, etc), in group or individual sessions led by a psychologist, have an effect that is statistically significant (P=.05) but no greater than simple advice by a physician (2%); yet, these techniques are several times more expensive. The effect of hypnosis is unproved (no trials have used biochemical markers). Nicotine replacement therapy is effective in an estimated 13% of smokers who seek help in cessation; the effect is greater in those who are nicotine-dependent. Other pharmacological treatments are not of proven efficacy, and acupuncture is ineffective. Sudden cessation or gradual reduction in smoking are similar in their efficacy on average. Physicians should take time to advise all their patients who smoke to quit. Smokers who are intent on stopping should be given additional support and encouraged to use nicotine replacement therapy.
(Arch Intern Med. 1995;155:1933-1941)
Many interventions have been developed to help people stop smoking. We present a systematic review of their efficacy, by analyzing data from 188 trials that we classified according to the nature of the intervention into five major categories. We have examined only randomized controlled trials to ensure the avoidance of bias and, with specified exceptions, only trials in which the duration was 6 months or more since short-term trials may overestimate the full effect.
METHODS^
Randomized controlled trials of smoking cessation
interventions were identified [1-120] by using
MEDLINE and Index Medicus, by scrutinizing the citations in each trial and in
review articles, and by consulting with experts. Randomization was by
individual or by defined groups of smokers. We identified and analyzed, as a
subgroup, 88 trials that measured biochemical markers to verify claims of
stopping smoking (carbon monoxide, thiocyanate, or cotinine). In trials of some
interventions, all available smokers were recruited irrespective of their
interest in stopping smoking, while other trials recruited self-referred
smokers--usually those responding to local advertisements to participate in a
trial. Motivation is likely to be greater in the self-referred smokers
[120]. Some trials tested more than one
intervention through multiple treatment arms or factorial design. In general,
we included only trials in which the duration of follow-up was at least 6
months because of the high rate of early relapse: the difference in cessation
rates between treated and control subjects is typically greatest in the first
week, and it lessens in the subsequent 6 months or so but then remains
reasonably stable (as illustrated by trials of nicotine replacement therapy in
the Figure 1. Shorter trials of some specified
interventions were included as they were judged informative despite this
problem.
Figure 1. Difference (95% confidence limits) in prevalence of smoking
between treated and control groups in 14 trials of nicotine replacement
therapy, reporting follow-up at 1, 3, 6, and 12 months (according to Hurt et al
[89] and references 5, 10, 11, 13, 15, 24, 26,
30, 34, 35, 37 through 39 in the review by Tang et al [120]). At 1 and 3 months, the differences are significantly
greater (P<.001) than at 12 months; at 6 months, there is no significant
difference
We used as the principal measure of effect the difference between the percentages of the treated and control subjects who stopped smoking. This provided a direct estimate of the proportion of all treated subjects who stopped smoking as a result of the intervention. (Using the ratio--a relative rate--instead of the difference yielded similar conclusions.) Where available, we used the point prevalence of smoking cessation in preference to sustained cessation during a period because the former could be verified by biological markers. The data were analyzed on an "intention-to-treat" basis, assuming that all subjects (treated and control) who did not complete the trial had not given up smoking. We calculated the weighted averages of the difference in cessation rates between the treated and control groups in combinations of trials that tested similar interventions, weighting each trial by the inverse of the square of its SE. For some of the less standardized interventions, there was statistically significant heterogeneity between trials in their estimates of effect; the method of DerSimonian and Laird [121] provided a best estimate of the average effect, but we attempted to account for the heterogeneity.
To conclude that an antismoking intervention was effective, we made two stipulations: (1) a statistically significant measure of effect from combining all the randomized trials of the intervention and (2) support for the overall result from trials in which smoking cessation was confirmed by biochemical markers. Biochemical markers were not needed to support a conclusion that an intervention was ineffective; this was based on the upper 95% confidence limit of the combined estimate of effect from all trials.
RESULTS^
Table 1summarizes the data necessary to
judge each intervention--the overall statistical significance, the combined
estimate of efficacy with 95% confidence limits, whether there was significant
heterogeneity of effect between trials, and whether the subgroup of trials with
biochemical confirmation of smoking cessation confirmed the result. Expressing
efficacy as the difference between the proportions of treated and control
subjects who stopped smoking estimated the percentage of all treated subjects
who stopped smoking as a result of the intervention. Table 2through Table 6list data
from individual trials of the more important or controversial interventions;
similar tables for trials of the other interventions are available from the
authors on request.
Table 1. Summary Estimates From Randomized Controlled Trials of
Interventions to Help People Stop Smoking
Table 2. Trials of Advice and Encouragement by a Physician During a
Routine Consultation
Table 6. Trials of Clonidine Hydrochloride
Advice and Encouragement to Stop
Smoking^
By a Physician Once During a Routine Consultation. All
smokers who were consulting a physician were randomized to receive personal
advice and encouragement to stop smoking or no advice. The advice was simple
and usually standardized. It could include simple strategies, such as agreeing
to a date on which the smoker would stop, discussion of previous difficulties
in stopping, and giving smokers a booklet. Typical duration was less than 5
minutes, and follow-up visits were not arranged. Of 17 trials, 14
[2,4-11,13-17] were based in family practice, and
three were based in hospital clinics [1,3,12].
Table 2lists the results of individual trials and the combined estimate of efficacy. About 2% of all smokers who received advice stopped smoking as a direct consequence of it (P<.001). There was no significant heterogeneity among the results of the 17 trials, and the six trials [1-6] that measured biochemical markers of tobacco smoke intake recorded a similar result that was also statistically significant.
With Additional Encouragement and Support. Ten trials tested strategies that were intended to provide additional encouragement or support in addition to brief advice by a physician once. Different trials tested demonstration of spirometry [18] or exhaled carbon monoxide [10], additional visits [19,20] or letters [21], continued encouragement after initially stopping smoking [22,23], or combinations of these [24,25]. The trials lacked statistical power to assess any specific additional intervention, but the overall estimate of efficacy of 5% from the 10 trials (with support from biochemical markers in seven) was statistically significant Table 1. The more striking result, however, was the high degree of heterogeneity among the 10 trials (chi squared (chi2)9 =42.0, P<.001); efficacy ranged from -0.5% [23] to 29% [24]. The variation in the nature of the supplementary interventions was not likely to account fully for the heterogeneity, and as these interventions were relatively nonstandardized, investigators may have conveyed more enthusiasm for stopping smoking in some trials than in others through a personal effect of individual investigators that is not generalizable. Nonetheless, the result suggests that further encouragement and support do convey additional benefit on average.
By Nurses in Health Promotion Clinics. In two trials [26,27] of advice and encouragement by nurses in health promotion clinics in family practices, the combined estimate of efficacy was inconclusive; this was consistent both with the same effect as advice from physicians or with no effect.
By Supportive Group Sessions. Eight trials [13,28-34] tested supportive group sessions for smokers that were led by a health care professional. The groups met on several occasions, providing information on the health consequences of smoking and fostering mutual support and encouragement in stopping smoking and a discussion of problems that were encountered. The combined estimate of efficacy was not statistically significant Table 1.
In Pregnancy. Table 3shows the results of nine trials [35-43] that tested three interventions in pregnancy. Efficacy was statistically significant and confirmed by biochemical markers in five trials [38-42]. The effect of the interventions in pregnancy was greater than that of the same interventions in healthy nonpregnant subjects: the combined result of the seven trials [36,38-43] of self-help manuals in pregnancy (9.0%) significantly exceeds that of the 11 trials [12,14,28,29,34,60-65] in nonpregnant subjects Table 5 (P=.01).
Table 3. Trials of Antismoking Interventions in Pregnancy
Table 5. Behavior Modification Therapy: Trials of Nonspecific Approaches
In Men at High Risk of Ischemic Heart Disease. In a trial [44] of advice and encouragement to stop smoking given by hospital physicians to men with myocardial infarction, efficacy was as high as 35%; uncontrolled studies have confirmed pronounced efficacy [122]. Table 4lists the results of this trial and of four trials [45-48] of advice and encouragement in healthy men with relatively high levels of risk factors for ischemic heart disease. Additional interventions were tested in three trials [46-48]; encouragement not to smoke was the only intervention in one [45]. The excess risk of ischemic heart disease was discussed, and the smokers were given repeated advice and encouragement to stop smoking and support after they had stopped. Overall efficacy was 21% (P<.001); the heterogeneity among the four trials was partly owing to a less intensive intervention in one trial [48] and to the recording of a change from cigarettes to other tobacco as a success in another [47,123]. Biochemical markers were lacking in all of these trials.
Table 4. Trials of Advice and Encouragement by a Physician in Men at
High Risk of Dying of Ischemic Heart Disease
Behavior Modification Therapy^
Nonspecific Approaches. In these trials, combinations
of relatively nonspecific behavioral techniques were tested. These included the
following techniques: (1) relaxation as an alternative to smoking; (2) rewards
and punishments--a treat if targets were met, or a chore or forfeiting money if
they were not; (3) visualizing unpleasant consequences of smoking (nausea,
dizziness, etc), and then the avoidance of such consequences by refusal to
smoke; (4) identifying situations or stimuli that commonly trigger the urge to
smoke, and avoiding them or finding substitute activities; and (5) emphasizing
the positive reasons for stopping smoking.
There were three types of settings: (1) individual sessions with a psychologist who was experienced in introducing the above techniques to smokers, (2) group sessions that were led by a psychologist, and (3) a self-help manual in which the techniques were outlined in simple language, but with no personal contact.
The results of the 30 trials [12-14,28-30,32-34,49-65] in this category are shown in Table 5. The combined estimate of efficacy was 2% (0.4%, P=.05), and it was confirmed by the results of the 14 trials with biochemical markers. There was significant heterogeneity of effect among all 30 trials, and among the 14 trials of group sessions that were led by a psychologist and the 11 trials of the use of a self-help manual. The heterogeneity may again suggest a personal effect of some investigators that is not generalizable, or variation between the subjects in different trials in the difficulty they experienced in attempting to quit.
Aversion. Various forms of aversion therapy have been used in smoking cessation, including, for example, the delivery of electric shocks as the aversive stimulus [124]. Two forms of aversion have been evaluated in randomized controlled trials.
Rapid or Satiation Smoking. Subjects were instructed either to take one puff every 6 seconds from each cigarette that they smoked, about five times the usual rate (rapid smoking), or to smoke a daily minimum of at least twice their usual number of cigarettes (satiation smoking). The aim was to induce symptoms of mild nicotine toxicity (nausea, giddiness, etc) that would produce an aversion to smoking. The combined estimate of efficacy from 14 trials of rapid or satiation smoking [32,33,54,55,58,66-73] of 14% was statistically significant (P<.001), but it was not supported by the two trials [54,55] that measured biochemical markers, so efficacy was unproved. Rapid and satiation smoking are now little used, because of the potential hazards in smokers with coronary artery disease and other diseases [125], and because many regarded the treatment as undesirable on general grounds.
Silver Acetate (Gum or Mouth Spray). Silver interacts with cigarette smoke to produce a noxious metallic taste--an aversive stimulus. In the four trials [74-77], all placebo-controlled with biochemical markers, the combined estimate of efficacy was not statistically significant. The upper confidence limit indicates that an efficacy greater than 8% is unlikely. Even this may be too high because the duration of follow-up was only 3 to 4 months in two [74,77] of the four trials, and short-term trials may overestimate the long-term effect (Figure).
Sensory Deprivation. Typically smokers lay on a bed in a dark soundproof chamber for up to 24 hours, and antismoking advice or other interventions were delivered. The sensory deprivation was supposed to increase persuadability and responsiveness to external cues [78]. The three randomized trials [78-80] suggested that the technique is ineffective.
Hypnosis. In the 10 randomized trials of hypnosis [31,57,70,81-86], the combined estimate of efficacy of 23% was statistically significant (P<.001), but no trials measured biochemical markers of tobacco smoke intake to confirm verbal claims of having stopped smoking (often given by telephone), so the effect is unproved. There was also significant heterogeneity between the results. Older uncontrolled studies of hypnosis and smoking cessation have often reported high abstinence rates after 6 to 12 months (some exceeding 50%) [126], but again, these rates were not confirmed by biochemical markers.
Pharmacological Treatments to Allay
Withdrawal Symptoms^
Nicotine Replacement Therapy. These trials have
recently been reviewed by us and others [120,127,128]. All forms of nicotine replacement therapy are
effective aids for nicotine-dependent smokers who seek help in stopping.
Table 1reproduces our previously published
summary estimates from the trials of 2-mg gum [120], and it updates the analysis of the nicotine transdermal
patch with the inclusion of six recently published trials
[87-91]. The 2-mg nicotine gum and the nicotine
patch are comparable in their efficacy, but the patch offers greater
convenience and minimal need for instruction in its use. Efficacy was greater
(11% to 13%) in trials of self-referred smokers than in trials that recruited
all successive smokers (3% to 4%), confirming the greater motivation of
self-referred smokers. By using a simple questionnaire to quantify nicotine
dependence, the 2-mg nicotine gum was useful in the more dependent smokers
(efficacy, 27% in self-referred smokers) but not in the less dependent smokers
(efficacy, 0%) [120]. Efficacy of the nicotine
patch was less clearly related to nicotine dependence. It may have little
efficacy in the most highly dependent smokers (smoking within 5 minutes of
waking in the morning), possibly because it cannot reproduce the "surge" in
plasma nicotine gained after smoking a cigarette [120]. In these smokers, the 4-mg gum may be an effective form
of replacement therapy and could enable about one third of self-referred highly
dependent smokers to stop [120]. Nasal spray may
also be useful [129]. Among the majority of
smokers with less marked degrees of nicotine dependence, the nicotine patch
would enable an estimated 13% of smokers who seek help in stopping smoking to
give up the habit.
Clonidine Hydrochloride. Clonidine is an alpha2 -adrenergic agonist that was developed as an antihypertensive drug. It was found to reduce symptoms of opiate withdrawal. Cigarette smoking increases plasma endorphin levels, and these increased levels might be partly responsible for the habituation, so clonidine might reduce nicotine withdrawal symptoms.
The results of the trials of clonidine therapy in smoking cessation are shown in Table 6. All trials are shown irrespective of duration of follow-up, as only two of the 10 trials published 6-month follow-up data. The estimate of efficacy was greater (P=.06) in the four trials [98-101] that did not use a biochemical marker to confirm smoking cessation (19.9%, P<.001) than in the six trials [92-97] that did (6.6%, P=.11). This result from the more reliable trials, together with the general observation that trials of less than 6 months' duration overestimate the long-term effect (Figure), indicates that clonidine is unlikely to be effective in smoking cessation.
Tranquilizers and Other Agents. Tranquilizers (meprobamate, 400 mg/d, and diazepam, 7.5 mg/d) have not helped smokers to stop [30,100] Table 1. Trials that have tested buspirone hydrochloride, a serotonin uptake inhibitor that is used to allay anxiety [102,103], and naloxone, an opiate antagonist that is used like clonidine because smoking increases endorphin levels [104], have suggested a possible short-term effect, but the follow-up was limited to a few weeks.
Miscellaneous Treatments. Eight randomized trials of acupuncture [59,81,105-110] have not shown significant efficacy, either overall Table 1 or in separate comparisons with no acupuncture or with acupuncture at points that were considered ineffective. Nonrandomized studies of acupuncture also have shown no evidence of efficacy [130].
Cimetidine was found not to decrease the rate of elimination of nicotine from the body despite earlier evidence that it may, and it did not assist smoking cessation [111]. Trials of a citric acid aerosol [112,113] that was intended to provide a similar sensation of "satisfaction" in the throat as does cigarette smoke have suggested a possible short-term effect.
Gradual Reduction in Nicotine
Intake^
Three techniques for gradually reducing the nicotine
content of inhaled cigarette smoke have been compared with sudden cessation in
trials. These are (1) a series of graduated filters that remove progressively
more nicotine from inhaled cigarette smoke [114],
(2) a series of brand changes to cigarettes of successively lower nicotine
yield [69,115,116], or (3) gradually reducing the
number of cigarettes smoked daily [71,117-119].
The overall difference of 5% (confidence limits, -2%, 11%) was consistent with
an advantage for gradual cessation, but the difference was not statistically
significant.
COMMENT^
Advice and Encouragement^
People stop smoking as a result of brief, unsolicited
advice from their family practitioner. An estimated 2% of consecutive smokers
who were given such advice stopped smoking and did not relapse up to 1 year as
a direct consequence of the advice. Although the effect is modest, it is
cost-effective. About one third of smokers die of a disease caused by their
smoking, and the advice takes about 5 minutes of a family practitioner's time,
costing about $10 in America or (pound sterling)4 in Great Britain. The cost of
saving a life through routine advice to all smokers to stop smoking is about
$1500 (($10/2%)x3), or (pound sterling)600. Few procedures in medicine carry so
small a cost of saving a life. In smokers who do not quit immediately, the
advice may contribute to future cessation of smoking by reinforcing messages
from other sources [122].
Additional interventions that are supplementary to simple advice on one occasion by a physician, such as extra visits or letters and support in the early stages after stopping smoking, show marked effect in some trials but not others. The heterogeneity of effect suggests a personal effect of some investigators in conveying enthusiasm and commitment for stopping smoking that is not generalizable. Nevertheless, the supplementary interventions can be recommended despite this uncertainty as, on average, they have conveyed some additional effect in the trials, confirmed by biochemical markers, and they are brief and cheap.
The effect of health promotion clinics (usually run by nurses) is unknown: the two trials lack power. However, advice by physicians during a consultation sought by the patient may be seen as personal and individualized and, hence, more effective than standardized advice that is given in health promotion clinics. Also, a "white coat effect" has been identified: in one study [131], more smokers responded to the investigator's advice to stop smoking on occasions when he was wearing a white coat than when he was not. Supportive small-group sessions in volunteers that were led by a health care professional, if effective at all, are no more effective than simple advice by a physician; yet, such sessions cost considerably more.
Advice and other antismoking interventions are particularly effective in patients at particular risk of the harmful effects of smoking. Interventions were significantly more effective in pregnant women Table 3 than in low-risk people, with biochemical confirmation of the greater effect. Trials also indicate that intensive advice, encouragement, and support to stop smoking are particularly effective in patients at high risk of death from ischemic heart disease Table 4. The magnitude of the effect must remain uncertain in view of the absence of biochemical markers in these trials and the heterogeneity of effect; however, given the biochemical validation of an effect in healthy low-risk people and of a greater effect in one higher-risk group, the importance of advice and support in this group cannot be denied.
Behavior Modification Therapy^
The findings from randomized trials do not support the
use of behavior modification therapy in helping people to stop smoking. The 30
trials of nonspecific approaches Table 5
demonstrated a statistically significant effect that was confirmed by
biochemical markers, but the average size of the effect (2%) is no greater than
that of simple unsolicited advice from physicians--even though these trials
recruited volunteers who were likely to be more strongly motivated to stop
smoking. The degree of personal contact in these interventions is longer
(self-help manuals apart), making them several times more expensive than simple
advice; thus, they cannot be recommended on the grounds of cost-effectiveness.
Rapid or satiation smoking has not been shown to be effective in trials with
biochemical confirmation; the approach is now little used because of hazards
[121], and the general approach is undesirable.
Sensory deprivation is ineffective. The effect of hypnosis is unproved, since
biochemical confirmation is lacking, and again, the highly significant
heterogeneity of effect suggested a personal effect of certain investigators
that is not generalizable.
Treatment to Allay Withdrawal^
Nicotine replacement therapy is effective and
worthwhile; it should be offered to all but the least nicotine-dependent
smokers who seek help in stopping. However, no other pharmacological treatment
to help people stop smoking can be justified by the results of published
randomized controlled trials. Acupuncture is ineffective.
CONCLUSIONS^
Clinicians should take the time to give a brief period
of advice on quitting smoking to all their patients who smoke
[122]. In terms of saving lives, such advice
constitutes a cost-effective use of their time. Additional encouragement, and
support through the early stages after stopping smoking, improve the likelihood
of success on average, although the extent to which this occurs depends in part
on the individual approach of the physician.
Advice and encouragement to stop smoking are particularly important in patients at higher risk of the adverse effects of smoking, notably in pregnant women and in patients with ischemic heart disease. Nicotine replacement therapy should be offered to smokers who are intent on stopping. The transdermal patch is the most convenient preparation; the 4-mg gum or the nasal spray may be more effective in the most highly nicotine-dependent smokers. Other interventions to help people stop smoking are ineffective or unproved. Essential features of future trials that will test unproved interventions (such as hypnosis) should include biochemical confirmation of stopping smoking and a duration of at least 6 months.
Accepted for publication March 9, 1995.
We thank the Department of Health, London, England, for financial support, although the views are our own.
Correspondence to Department of Environmental and Preventive Medicine, Wolfson Institute of Preventive Medicine, The Medical College of St Bartholomew's Hospital, Charterhouse Square, London, England EC1M 6BQ (Dr Law).
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Behavior Therapy; Clonidine; Counseling; Hypnosis; Myocardial Ischemia; Nicotine Replacement Agents; Pregnancy; Smoking Cessation; Substance Withdrawal Syndrome; Tranquilizing Agents
Copyright (c) 1999 Ovid
Technologies, Inc.
Version: 4.1.0 source ID 1.4582.1.135, Revision:
1.405.1.4