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Fiore MC, Bailey WC, Cohen SJ. Smoking Cessation. Rockville (MD): Agency for Health Care Policy and Research (AHCPR); 1996 Apr. (AHCPR Clinical Practice Guidelines, No. 18.)

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  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

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Smoking Cessation.

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3Evidence

Background

The recommendations summarized in Chapter 2 are the result of a review and analysis of the extant tobacco cessation literature. Chapter 3 reports the results of this review and analysis and describes the efficacy of various treatments, assessments, and strategies for their implementation. This chapter, therefore, addresses such questions as: Does the professional discipline of the treatment clinician make a difference in the efficacy of the intervention? Are physicians, nurses, dentists, psychologists, and health educators all effective in delivering interventions? Similarly, are minimal interventions, such as clinician advice to quit smoking, effective or are more intensive interventions required? Does the duration of an intervention in weeks or the number of treatment sessions substantially influence efficacy? Which screening strategies result in the reliable identification of smokers? Are pharmacologic interventions effective, and if so, which ones? In short, which treatments or assessments are efficacious and how should they be implemented?

The panel examined the relation between outcomes and 12 major assessment or treatment characteristics or strategies. These 12 characteristics or strategies, and the categories within each, are listed in Table 3. Type of outcome varied across the different strategies being analyzed. For instance, in the analysis of strategies for screening for tobacco use, one outcome was the percent of smokers identified, whereas in the analysis of treatment strategies, the outcome was long-term smoking cessation (cessation for 5 months or more). The panel analyzed treatment or assessment strategies that seemed rationally related to efficacy and that constituted distinct approaches that exist in current clinical practice.

Table 3. Analyzed treatment and assessment strategies.

Table

Table 3. Analyzed treatment and assessment strategies.

The panel chose categories within strategies according to three major concerns. First, some categories reflected generally accepted dimensions or taxonomies. An example of this is the categorical nature of the clinician types (physician, psychologist, and so on). Second, information on the category had to be available in the published literature. Many questions of theoretical interest had to be abandoned simply because the requisite information was not available. Third, the category had to occur with sufficient frequency to permit meaningful statistical analysis. For example, the cut-points of some continuous variables (e.g., Intensity of Person-to-Person Contact, Duration of Treatment) were determined so that relevant studies were apportioned appropriately for statistical analysis. Information on the coding of articles according to these dimensions is located in the technical report.

In ideal circumstances, the panel could evaluate each category by consulting randomized controlled trials relevant to the category in question. Unfortunately, with the exception of pharmacologic interventions, very few or no randomized controlled trials are specifically designed to address the effects of the various categories within these treatment or assessment strategies. Moreover, strategy categories are frequently confounded with one another. For example, comparisons among clinicians are almost always confounded with the content, format, and intensity of the interventions. Psychologists tend to deliver relatively intensive, psychosocial interventions, often in a group format, whereas physicians tend to deliver brief advice to individuals. More intensive interventions may result in higher cessation rates, such that psychologists appear to be more effective in promoting smoking cessation than do physicians, when in fact, the intensity of the intervention rather than the type of clinician may result in higher cessation rates. Therefore, direct, unconfounded comparisons of categories within a particular strategy were often impossible. These strategies were nevertheless analyzed because of their clinical importance and because it was possible to reduce confounding by careful selection of studies and by statistical control of confounding factors.

Panel meta-analyses were used as the primary source of data for evaluating most strategies. For two topics, however, pharmacotherapies and interventions for pregnant smokers, high-quality published meta-analyses already existed and were the primary source of data. Individual articles from these analyses were evaluated whenever necessary. Details of the meta-analytic techniques can be found in the technical report.

Some meta-analyses were conducted to evaluate strategies with respect to the population under study and the type of outcome data used in the study. The relative efficacy of various treatment characteristics was largely unaffected by differences in the population under study (i.e., all-comers vs. self-selected analyses) and the type of outcome data (i.e., intent-to-treat vs. other studies and studies with vs. without biochemical confirmation).

The following sections of Chapter 3 address the 12 treatment and assessment strategies outlined in Table 3. For each strategy analyzed, background information, clinical recommendations, and the evidentiary basis for those recommendations are provided.

Screen for Tobacco Use

Recommendation: All patients should be asked if they use tobacco and should have their tobacco-use status documented on a regular basis. (Strength of Evidence = A)

Recommendation: Clinic screening systems such as expanding the vital signs to include smoking status, or the use of smoking status chart stickers, are essential for consistent assessment and documentation of smoking. (Strength of Evidence = B)

The panel conducted meta-analyses to determine the impact of systems that screen for smoking on two outcomes: the rate of smoking cessation intervention by clinicians and the rate of cessation by patients who smoke.

Identifying Smokers: Impact on Clinical Intervention

Nine studies met selection criteria and were analyzed using a random-effects meta-analysis to assess the impact of screening systems on the rate of smoking cessation intervention by clinicians. The results of this meta-analysis are shown in Table 4. Implementing clinic systems designed to increase the assessment and documentation of smoking status markedly increases the rate at which clinicians intervene with their patients who smoke.

Table 4. Impact of having a smoking status identification system in place on rates of clinician intervention with their patients who smoke (n = 9 studies).

Table

Table 4. Impact of having a smoking status identification system in place on rates of clinician intervention with their patients who smoke (n = 9 studies).

Identifying Smokers: Impact on Smoking Cessation

Three studies met selection criteria and were analyzed using a random-effects meta-analysis to assess the impact of identifying smokers on actual rates of smoking cessation. The results of this meta-analysis are shown in Table 5. These results suggest that having a clinic system in place that identifies smokers results in higher rates of smoking cessation, although this finding was not statistically significant and was based on a small number of studies.

Table 5. Impact of having a smoking status identification system in place on the rates of cessation among patients who smoke (n = 3 studies).

Table

Table 5. Impact of having a smoking status identification system in place on the rates of cessation among patients who smoke (n = 3 studies).

Evidence

The following statements support the above recommendations:

  • Screening systems that systematically identify and document smoking status result in higher rates of smoking cessation interventions by clinicians. (Strength of Evidence = A)
  • Screening systems that systematically identify and document smoking status appear to result in higher quit rates among patients who smoke. (Strength of Evidence = C)

Strategy 1 for the Primary Care Clinician and Strategy 1 for Health Care Administrators, Insurers, and Purchasers detail an approach for including tobacco-use status as a new vital sign. This approach is designed to produce consistent assessment and documentation of tobacco use. Evidence from randomized controlled trials shows that this approach increases the probability that tobacco use is consistently assessed and documented (Fiore, Jorenby, Schensky, et al., 1995; Robinson, Laurent, and Little, 1995).

Advice To Quit Smoking

Recommendation: All physicians should strongly advise every patient who smokes to quit. (Strength of Evidence = A)

Recommendation: All clinicians should strongly advise their patients who smoke to quit. Although studies have not independently addressed the impact of advice to quit by all types of nonphysician clinicians, it is reasonable to believe that such advice is effective. (Strength of Evidence = C)

Nine studies met selection criteria for assessing the efficacy of clinician advice to quit smoking. For the purpose of this analysis, advice was defined as clinical intervention lasting 3 minutes or less. Seven of these studies examined the impact of physician advice, a number sufficient to assess this variable using meta-analytic techniques. The meta-analysis was unable to address the impact of advice to quit by other nonphysician clinicians, because only two studies addressed this issue and were limited to pregnant patients. Results of the meta-analysis are shown in Table 6. Given the large number of smokers who visit a clinician each year, the potential public health impact of universal advice to quit is substantial.

Table 6. Efficacy of advice to quit by a clinician (n = 7 studies).

Table

Table 6. Efficacy of advice to quit by a clinician (n = 7 studies).

Evidence

The following statements support the above recommendations:

  • Physician advice to quit smoking increases quit rates compared with the absence of such advice. (Strength of Evidence = A)
  • Insufficient data exist to assess the efficacy of advice to quit smoking when the advice is given by nonphysician clinicians. However, it is likely that such advice is efficacious. Therefore, all clinicians should advise their patients who smoke to quit. (Strength of Evidence = C)

Specialized Assessment

Recommendation: Clinicians should routinely assess both the smoking status of all of their patients and the appropriateness of cessation interventions such as nicotine replacement therapy. (Strength of Evidence = A)

Recommendation: Cessation treatment is effective without specialized assessments. Clinicians, therefore, should intervene with every patient who smokes even if specialized assessments are not available. (Strength of Evidence = A)

Recommendation: Clinicians may engage in specialized assessments in order to gauge potential for successful quitting. (Strength of Evidence = C)

Every individual entering a health care setting should receive an assessment that determines his or her smoking status and interest in quitting. Such an assessment is a necessary first step in treatment. In addition, every patient should be assessed for physical or medical conditions that may affect the use of planned treatments (e.g., nicotine replacement therapy).

The clinician may also wish to perform specialized assessments of individual and environmental attributes that provide information for tailoring treatment. Specialized assessments refer to the use of formal instruments (e.g., questionnaires, clinical interviews, or physiologic indices such as carbon monoxide, serum nicotine/cotinine levels, and/or pulmonary function) that may be associated with cessation outcome. Some of the variables targeted in specialized assessments that are associated with differential cessation rates are listed in Table 7.

Table 7. Variables associated with lower cessation rates [a].

Table

Table 7. Variables associated with lower cessation rates [a].

Several considerations should be kept in mind regarding the use of specialized assessments. First, there was little strong or consistent evidence that a smoker's status on a specialized assessment predicted the relative efficacy of the various interventions. The one exception is that persons high in nicotine dependence may benefit more from 4 mg as opposed to 2 mg of nicotine gum (see section in Chapter 3, Smoking Cessation Pharmacotherapy). More importantly, the panel found that, regardless of their standing on specialized assessments, all smokers have the potential to benefit from cessation interventions. Therefore, delivery of cessation interventions should not depend on specialized assessments. Finally, little consistent research evidence shows how treatment should be tailored based on the results of these assessments. However, the panel recognizes that some effective interventions such as general problem solving (see section in Chapter 3, Content of Smoking Cessation Interventions) entail treatment tailoring based on a systematic assessment of individual patient characteristics.

The reviewed evidence suggested that treatment is effective despite the presence of risk factors for relapse (e.g., severe previous withdrawal, depression, other smokers in the home), but quit rates in smokers with these characteristics tend to be lower than rates in those without these characteristics.

Interventions

Type of Clinician

Recommendation: Smoking cessation interventions delivered by a variety of clinicians and health care personnel increase cessation rates. Clinician involvement in smoking cessation interventions should be based on factors such as access to smokers, level of training, and interest rather than on membership in a specific professional discipline. (Strength of Evidence = A)

Recommendation: All health care personnel and clinicians should repeatedly and consistently deliver smoking cessation interventions to their patients. Smoking cessation interventions should be delivered by as many clinicians and types of clinicians as is feasible given available resources. (Strength of Evidence = A)

There were 41 studies that met selection criteria for analyses examining the effectiveness of various types of providers of smoking cessation interventions. These analyses compared the efficacy of interventions delivered by specific types of providers and by multiple providers with interventions where there was no provider (e.g., where there was no intervention or intervention consisted of self-help materials only). Please note that "multiple providers" refers to the number of different types of providers, not the number of total providers regardless of type. The latter information was rarely, if ever, available from the study reports. Results are shown in Table 8.

Table 8. Efficacy of and estimated cessation rates for interventions delivered by various types of providers (n = 41 studies).

Table

Table 8. Efficacy of and estimated cessation rates for interventions delivered by various types of providers (n = 41 studies).

Evidence

The following statements support the above recommendations:

  • Smoking cessation interventions delivered by any single type of health care provider or by multiple providers increase cessation rates relative to interventions where there is no provider (e.g., self-help interventions). Results are consistent across diverse provider groups, with no clear advantage to any single provider type. (Strength of Evidence = A)
  • Smoking cessation interventions delivered by the following types of providers or clinicians have been shown to increase cessation rates relative to interventions where there is no provider: physician provider (e.g., primary care physician, cardiologist), nonphysician medical health care provider (e.g., dentist, nurse, health counselor, pharmacist), and nonmedical health care provider (e.g., psychologist, social worker, counselor). (Strength of Evidence = A)
  • Smoking cessation interventions delivered by multiple types of providers markedly increase cessation rates relative to those produced by interventions where there is no provider. (Strength of Evidence = A)

Treatment Formats

Recommendation: To be most effective, smoking cessation interventions should include either individual or group counseling/contact. (Strength of Evidence = A)

Twenty-five studies met selection criteria and were included in the analysis comparing different types of formats for smoking cessation interventions. Results of this analysis are shown in Table 9.

Table 9. Efficacy of and estimated cessation rates for various formats (n = 25 studies).

Table

Table 9. Efficacy of and estimated cessation rates for various formats (n = 25 studies).

Evidence

The following statements support the above recommendation:

  • Smoking cessation interventions delivered by means of self-help materials appear to increase cessation rates relative to no intervention. However, their impact is smaller and less certain than that of individual or group counseling. (Strength of Evidence = B)
  • Smoking cessation interventions delivered by means of individual counseling (involving person-to-person contact) increase cessation rates relative to no intervention. (Strength of Evidence = A)
  • Smoking cessation interventions delivered by means of group counseling/contact increase cessation rates relative to no intervention. (Strength of Evidence = A)

There is insufficient evidence to assess telephone counseling/contact. Telephone counseling/contact was defined as proactive clinician-initiated telephone calls. (Compare with "hotline/helpline" [Table 10], which involves patient-initiated telephone calls.)

Efficacy of Self-Help Treatment Alone

Recommendation: Where feasible, smokers should be provided with access to support through a telephone hotline/helpline as a self-help intervention. (Strength of Evidence = B)

Types of Self-Help Intervention

In general, smoking cessation interventions delivered by means of self-help materials may increase cessation rates relative to no intervention (Curry, 1993). However, their impact is smaller and less certain than that of individual or group counseling.

Twelve studies met selection criteria for evaluations of specific types of self-help materials. These studies involved self-help treatments used by themselves (with no non-self-help treatment modality). To estimate the effect of various types of self-help, we included all 12 studies in a single meta-analysis using a random-effects model (Table 10). In this analysis, the various types of self-help interventions were compared with a control condition or reference group in which subjects received no treatment.

Table 10. Efficacy of and cessation rates for various types of self-help formats when used alone (n = 12 studies).

Table

Table 10. Efficacy of and cessation rates for various types of self-help formats when used alone (n = 12 studies).

Evidence

The following statements support the above recommendation:

  • Written self-help materials (pamphlets/booklets/manuals) when used alone do not increase cessation rates relative to no self-help materials. (Strength of Evidence = A)
  • Videotapes and audiotapes when used alone do not increase cessation rates relative to no self-help materials. However, these methods deserve further examination because very few studies addressed these types of self-help materials. (Strength of Evidence = B)
  • Provision of a list of community programs when used alone does not increase cessation rates relative to no self-help materials. (Strength of Evidence = B)
  • Hotlines/helplines (patient-initiated telephone calls for cessation counseling or aid) when used alone increase smoking cessation rates relative to no self-help materials. (Strength of Evidence = B)

No randomized clinical trials that addressed the efficacy of computer programs for smoking cessation met our selection criteria. Further research should be done on such innovative approaches to self-help (e.g., computerized, personalized interventions) (Strecher, Kreuter, Den Boer, et al., 1994).

Multiple Types of Self-Help Materials

An additional random-effects model assessed the efficacy of multiple types of self-help interventions versus no self-help, as shown in Table 11. These results are based on the 12 self-help studies, 6 of which contained at least one treatment arm in which subjects received multiple types of self-help materials (e.g., audiocassette, television program).

Table 11. Efficacy of multiple types of self-help materials (n = 12 studies).

Table

Table 11. Efficacy of multiple types of self-help materials (n = 12 studies).

Evidence

The results suggest an increasing effect with an increase in the number of types of self-help interventions. However, the estimate for combining three different types of self-help materials is based on a single study. (Strength of Evidence = C)

Intensity of Person-to-Person Clinical Intervention

Recommendation: There is a strong dose-response relationship between the intensity of person-to-person contact and successful cessation outcome. Intensive interventions are more effective and should be used when resources permit. (Strength of Evidence = A)

Recommendation: Every smoker should be offered at least a minimal or brief intervention whether or not the smoker is referred to an intensive intervention. (Strength of Evidence = B)

Fifty-six studies met selection criteria for comparisons among various intensity levels of person-to-person contact. Whenever possible, intensity was defined based on the amount of time the clinician spent with a smoker in a single contact. Minimal-contact interventions were defined as 3 minutes or less, brief counseling was defined as greater than 3 minutes to less than or equal to 10 minutes, and counseling/psychosocial interventions were defined as greater than 10 minutes. Intense interventions could involve multiple patient-clinician contacts. These levels of person-to-person contact were compared with a no-contact reference group involving study conditions where subjects received no person-to-person contact (e.g., self-help-only conditions). Results are shown in Table 12.

Table 12. Efficacy of and cessation rates for various intensity levels of person-to-person contact (n = 56 studies).

Table

Table 12. Efficacy of and cessation rates for various intensity levels of person-to-person contact (n = 56 studies).

Evidence

The following statements support the above recommendations:

  • As the intensity level of person-to-person contact increases, efficacy also increases. (Strength of Evidence = A)
  • Smoking cessation interventions utilizing counseling/psychosocial interventions (sessions lasting more than 10 minutes) markedly increase cessation rates relative to no-contact interventions. (Strength of Evidence = A)
  • Smoking cessation interventions utilizing brief counseling (sessions lasting 3-10 minutes) increase cessation rates over no-contact interventions. (Strength of Evidence = A)
  • Smoking cessation interventions utilizing minimal contact (sessions lasting less than 3 minutes) increase cessation rates over no-contact interventions. (Strength of Evidence = B)

Content of Smoking Cessation Interventions

Recommendation: Smoking cessation interventions should help smokers recognize and cope with problems encountered in quitting (problem solving/skills training) and should provide social support as part of treatment. (Strength of Evidence = B)

Recommendation: Smoking cessation interventions that use some type of aversive smoking procedure (rapid smoking, rapid puffing, other aversive smoking) increase cessation rates and may be used with smokers who desire such treatment or who have been unsuccessful using other interventions. (Strength of Evidence = B)

Primary Content Types

Thirty-nine studies met selection criteria for analyses examining the effectiveness of interventions utilizing various types of content. Results are shown in Table 13.

Table 13. Efficacy of and cessation rates for various types of content relative to no-contact arms (n = 39 studies).

Table

Table 13. Efficacy of and cessation rates for various types of content relative to no-contact arms (n = 39 studies).

Evidence

Three specific content categories yield statistically significant increases in cessation rates relative to no contact (e.g., untreated control conditions). These categories follow:

  1. Smoking cessation interventions including content on general problem solving (problem solving/skills training/relapse prevention/stress management) increase cessation rates. (Strength of Evidence = B)
  2. Smoking cessation interventions including a supportive component administered during a smoker's direct contact with a clinician (intratreatment social support) increase cessation rates. Please note that this refers only to support delivered during direct contact with a clinician and does not refer to a social support component implemented outside of this contact, such as attempting to increase social support in the smoker's environment. (Strength of Evidence = B)
  3. Smoking cessation interventions including aversive smoking procedures (rapid smoking, rapid puffing, other smoking exposure) increase cessation rates. (Strength of Evidence = B)

The strength of evidence for the various content categories did not warrant an "A" rating for several reasons. First, smoking cessation interventions rarely used a particular content in isolation. Second, various types of content tended to be correlated with other treatment characteristics. For instance, some types of content were more likely to be delivered using a greater number of sessions across longer time periods. Third, it must be noted that all of these contents were being compared with no-contact/control conditions. Therefore, the control conditions in this meta-analysis did not control for nonspecific or placebo effects of treatment. This further restricted the ability to attribute efficacy to particular contents, per se.

Smoking cessation counseling interventions that included two content areas (general problem solving/skills training and intratreatment social support) were significantly associated with higher smoking cessation rates. General Strategies 1 and 2 outline elements of problem solving and supportive treatments to help the clinician using these treatment components. It must be noted, however, that these two treatment labels are nonspecific and include heterogeneous treatment elements. The third content area associated with superior outcomes was aversive smoking. This involves sessions of guided smoking where the patient smokes intensively, often to the point of discomfort or malaise. Some aversive smoking techniques, such as rapid smoking, may constitute a health risk and should be conducted only with appropriate medical screening and supervision. Aversive smoking interventions have largely been replaced by nicotine replacement strategies.

Other Content Types—Negative Affect, Cue Exposure, Hypnosis, Acupuncture

The content areas of acupuncture, hypnosis, negative affect, and cue exposure were examined separately because too few studies met selection criteria for inclusion in the primary meta-analysis Table 13 The efficacy of treatments directed at reduction of negative affect (three studies) and treatments utilizing cue exposure (four studies) was assessed through a direct review of relevant studies.

Psychiatric comorbidity and negative affect are risk factors for relapse. Preliminary but insufficient evidence suggested that cessation rates can be improved by treatments specifically addressing these issues.

Cue exposure treatment is intended to reduce smoking motivation through repeated exposure to smoking cues without the opportunity to smoke. None of the four cue exposure studies found this treatment superior to comparison treatments. However, these studies all suffered from methodological problems and were based on small samples. Hence, at present it would be premature to evaluate cue exposure/extinction interventions.

Separate meta-analyses were conducted for the content categories of hypnosis and acupuncture. Only three acceptable studies examined hypnosis. Because the studies were of poor quality and their results were inconsistent, the evidence was insufficient to assess the effectiveness of hypnosis.

Similarly, evidence was inadequate to support the efficacy of acupuncture as a smoking cessation treatment. The acupuncture meta-analysis comparing "active" acupuncture with "control" acupuncture revealed no difference in efficacy between the two types of procedures, and the odds ratio for active acupuncture was actually smaller than that of control acupuncture. These results suggest that any effect of acupuncture might be produced by factors such as positive expectations about the procedure.

The six studies included in the analysis of acupuncture were examined individually in order to explore acupuncture efficacy further. Of these six studies, five involved nonacupuncture control conditions. Two of these showed acupuncture to be more effective than control conditions, and three showed no difference. Therefore, active acupuncture was not consistently more effective than either placebo/control acupuncture or nonacupuncture control conditions. The panel concluded that there was relatively little evidence available regarding acupuncture and that the existing evidence was inconclusive.

Person-to-Person Treatment: Duration and Number of Sessions

Recommendation: In general, the greater the number of weeks over which person-to-person counseling or treatment is delivered, the more effective it is. Therefore, the duration of smoking cessation interventions should last as many weeks as is feasible given available resources. (Strength of Evidence = A)

Recommendation: Person-to-person treatment delivered over four to seven sessions appears especially effective in increasing cessation rates. Therefore, if available resources permit, clinicians should strive to meet at least four times with quitting smokers. (Strength of Evidence = A)

Duration of Treatment

Fifty-five studies met selection criteria for the analysis addressing the duration of smoking cessation interventions. Duration of treatment was categorized as less than 2 weeks, 2 weeks to less than 4 weeks, 4 weeks to 8 weeks, and greater than 8 weeks. Less than 2 weeks was used as the reference group. Results are shown in Table 14.

Table 14. Efficacy of and cessation rates for various durations of person-to-person treatment (n = 55 studies).

Table

Table 14. Efficacy of and cessation rates for various durations of person-to-person treatment (n = 55 studies).

Because the duration of treatment was associated with the intensity of person-to-person contact (length of treatment sessions), an additional analysis examined the effect of duration after controlling for intensity of person-to-person contact. The trend for increasing efficacy with increasing duration remained after controlling for the intensity of person-to-person contact, but only the longest duration showed a significant effect (data not shown).

Evidence

The efficacy of a smoking cessation intervention increases with longer duration of treatment. The duration of treatment independently contributes to the efficacy of smoking cessation interventions over and above the contribution of the intensity of person-to-person contact. (Strength of Evidence = A)

Number of Treatment Sessions

Fifty-five studies involving at least some person-to-person contact met selection criteria for the analysis addressing the impact of number of treatment sessions. The number of treatment sessions was categorized as one or fewer sessions, two to three sessions, four to seven sessions, and greater than seven sessions. One or fewer sessions was used as the reference group. Results are shown in Table 15.

Table 15. Efficacy of and cessation rates for number of person-to-person treatment sessions (n = 55 studies).

Table

Table 15. Efficacy of and cessation rates for number of person-to-person treatment sessions (n = 55 studies).

Because number of treatment sessions was associated with the intensity of person-to-person contact (length of treatment sessions), an additional analysis that examined the effect of the number of sessions after controlling for intensity of person-to-person contact was also conducted. Only four to seven sessions remained statistically significant after controlling for the intensity of person-to-person contact.

Evidence

Multiple treatment sessions increase smoking cessation rates over those produced by one or fewer sessions. The evidence suggests that four to seven sessions may be the most effective range. These results also suggest that the number of treatment sessions, at least four to seven sessions, contributes to the efficacy of smoking cessation interventions over and above the contribution of the intensity of person-to-person contact. (Strength of Evidence = A)

Smoking Cessation Pharmacotherapy

Evaluation of various pharmacotherapies for smoking cessation was conducted using several sources of information. For transdermal nicotine and nicotine gum, several high-quality published meta-analyses were available. For clonidine, sources of information were an existing published meta-analysis, a meta-analysis conducted by guideline staff, and examination of individual studies. For all other pharmacotherapies, the source of information was examination of individual studies.

Recommendation: Patients should be encouraged to use nicotine replacement therapy (patch or gum) for smoking cessation except in the presence of special circumstances (see General Strategies 3 and 5). (Strength of Evidence = A)

Recommendation: Transdermal nicotine (the nicotine patch) is an efficacious smoking cessation treatment that patients should be encouraged to use. The nicotine patch is effective across diverse settings and populations and when used with a variety of psychosocial interventions. (Strength of Evidence = A)

Recommendation: Nicotine gum is an efficacious smoking cessation treatment that patients should be encouraged to use. (Strength of Evidence = A)

Transdermal Nicotine (the nicotine patch)

Five meta-analyses of the efficacy of the nicotine patch have been published (Fiore, Smith, Jorenby, et al., 1994; Gourlay, 1994; Po, 1993; Silagy, Mant, Fowler, et al., 1994; Tang, Law, and Wald, 1994). The primary results of these meta-analyses are summarized in Table 16. Suggestions regarding clinical use of the nicotine patch are provided in General Strategies 3 and 4. General Strategy 4suggests criteria for the use of nicotine replacement therapy.

Table 16. Summary of nicotine patch meta-analyses efficacy results (n = 5 meta-analyses).

Table

Table 16. Summary of nicotine patch meta-analyses efficacy results (n = 5 meta-analyses).

Evidence

The following statements are based on published meta-analyses and panel opinion:

  • Transdermal nicotine approximately doubles 6- to 12-month abstinence rates over those produced by placebo interventions. Five meta-analyses have concluded that the nicotine patch is a highly effective aid to smoking cessation. (Strength of Evidence = A)
  • Transdermal nicotine is consistently more efficacious than placebo treatment regardless of the intensity of any adjuvant psychosocial interventions. However, intensive psychosocial interventions increase absolute abstinence rates among individuals given either placebo or active patch treatment. (Strength of Evidence = A)
  • Patients are more likely to comply with transdermal nicotine instructions than with nicotine gum instructions. (Strength of Evidence = C)

Nicotine Gum

More than 50 studies on the efficacy of nicotine gum have been published, making nicotine gum by far the most extensively investigated pharmacologic treatment for smoking cessation. This body of research has now been summarized by four major meta-analyses (Cepeda-Benito, 1993; Lam, Sze, Sacks, et al., 1987; Silagy, Mant, Fowler, et al., 1994; Tang, Law, and Wald, 1994). Primary results of the three most recent nicotine gum meta-analyses are summarized in Table 17.

Table 17. Summary of nicotine gum meta-analyses [a] (n = 3 meta-analyses) [b].

Table

Table 17. Summary of nicotine gum meta-analyses [a] (n = 3 meta-analyses) [b].

Evidence

The following statements are based on published meta-analyses and panel opinion:

  • Nicotine gum improves smoking cessation rates by approximately 40-60 percent compared with control interventions through 12 months of followup.
  • Three meta-analyses found the gum to be efficacious in assisting smokers to quit, and this improvement is observed in both self-referred and unselected populations. (Strength of Evidence = A)
  • Nicotine gum is consistently more efficacious than control interventions regardless of the intensity of any adjuvant psychosocial intervention, although efficacy is greater when combined with an intensive psychosocial intervention. (Strength of Evidence = B)
  • The 4-mg gum is more efficacious than the 2-mg gum as an aid to smoking cessation in highly dependent smokers. (Strength of Evidence = B)

Although nicotine chewing gum is an efficacious smoking cessation treatment, problems with compliance, ease of use, social acceptability, and unpleasant taste have been noted by investigators. Because transdermal nicotine replacement is not associated with these problems, the patch may be more acceptable for most smokers. General Strategy 4contains guidelines for the differential recommendation of the nicotine patch and nicotine gum.

Most side effects of gum use are relatively mild and transient, and many can be resolved by simply correcting the user's chewing technique. Some patients may desire to continue nicotine replacement therapy for periods longer than usually recommended. For instance, studies suggest that when patients are given free access to nicotine gum, 15-20 percent of successful abstainers continue to use the gum for a year or longer (Hajek, Jackson, and Belcher, 1988; Hughes, Wadland, Fenwick, et al., 1991). Although weaning should be encouraged, continued use of nicotine replacement is clearly preferable to a return to smoking with respect to health consequences. This is because, unlike smoking, nicotine replacement products do not (a) contain nonnicotine toxic substances (e.g., "tar"), (b) produce dramatic surges in blood nicotine levels, and (c) produce strong dependence (Henningfield, 1995). Suggestions regarding the clinical use of nicotine gum are provided in General Strategy 5.

Other Nicotine Replacement Interventions

Two new nicotine replacement interventions, a nicotine nasal spray and a nicotine inhaler, have been developed and tested. Published data on these products are limited, but studies demonstrate a significant benefit compared with placebo interventions (Hjalmarson, Franzon, Westin, et al., 1994; Sutherland, Stapleton, Russell, et al., 1992; Tonnesen, Norregaard, Mikkelsen, et al., 1993). At present, these products are not licensed for prescription use in the United States, and there are limited data regarding their use. Therefore, the panel drew no conclusions about their efficacy and made no recommendations regarding their use. [As this guideline went to press, nicotine nasal spray was approved for use in the United States by the FDA.]

Over-the-Counter Nicotine Replacement Therapy

The FDA approved nicotine gum for over-the-counter (OTC) use in April 1996, and the nicotine patch may be approved for OTC use by the end of 1996. Although the OTC status of these medications will no doubt increase their availability, this does not reduce the clinician's essential responsibility to intervene with smokers. Once OTC nicotine replacement products are available, the clinician will also continue to have specific responsibilities regarding these products, such as encouraging their use when appropriate, providing counseling, and offering instruction on appropriate use. In addition, the clinician may advise patients regarding the use of an OTC product versus a non-OTC product such as a new nicotine replacement treatment or antidepressant therapy.

Clonidine

Evidence for the efficacy of clonidine as a smoking cessation intervention was derived from an examination of individual studies, a published meta-analysis, and a fixed-effect meta-analysis conducted by guideline staff that examined clonidine use in women only. The use of a fixed-effects model, opposed to a random-effects model, is a departure from the typical guideline analytic strategy. The fixed-effects meta-analysis was used because of the very small number of studies available for analysis and the different statistical assumptions of the two models (see the technical report).

Evidence

There is little support for the use of clonidine either as a primary or as an adjunctive pharmacologic treatment for smoking cessation. (Strength of Evidence = B)

Seven clinical trials on clonidine were identified in the initial literature review, but only two fulfilled selection criteria for meta-analysis. Based on these two studies, the guideline meta-analysis suggested that clonidine may be effective with female patients (odds ratio = 3.0, 95 percent C.I. = 1.5-5.9). However, no recommendations were made with respect to clonidine because of the following concerns. First, of the seven trials examining the effectiveness of clonidine for smoking cessation, only two provided adequate long-term followup information. Second, only three of the seven clonidine studies presented results by gender, and only two of these three met meta-analytic selection criteria. Thus, the success of clonidine among women may be the reason for the presentation of results by gender in these studies; that is, there may be a selection bias. Finally, side effects are common with clonidine use, and as many as 25 percent of patients may discontinue clonidine therapy for this reason.

Antidepressants

Smoking is significantly more prevalent among individuals with a history of depression, and these individuals have more difficulty quitting smoking than do smokers without a history of depression (Anda, Williamson, Escobedo, et al., 1990; Breslau, Kilbey, and Andreski, 1992; Glassman, Helzer, Covey, et al., 1990). Some trials have investigated the use of antidepressants for smoking cessation, but no published articles met selection criteria for review. Because of a paucity of data, the panel drew no conclusions about antidepressant therapy for smoking cessation.

Anxiolytics/Benzodiazepines

A few trials have evaluated anxiolytics as a treatment for smoking cessation. Individual trials of propranolol (a beta-blocker) and diazepam did not reveal a beneficial effect for these drugs compared with control interventions. Only one study using an anxiolytic (buspirone) revealed evidence of efficacy in smoking cessation. Because of a lack of data, no conclusion was drawn regarding the efficacy of anxiolytics in smoking cessation.

Silver Acetate

The three randomized clinical trials of silver acetate that met selection criteria revealed no beneficial effects for smoking cessation.

Evidence. The use of silver acetate as either a primary or an adjunctive treatment for smoking cessation was not supported. (Strength of Evidence = B)

Followup Assessment and Procedures

Recommendation: All patients who receive an intervention should be assessed for abstinence at the completion of treatment or during subsequent clinic visits. (1) for abstinent patients, all should receive relapse prevention treatment (see section in Chapter 4, Relapse Prevention). (2) For patients who have relapsed, assess their willingness to quit (Strength of Evidence = C):

All patients should be assessed with respect to their smoking status at least at the completion of treatment. Additional assessments within the first 2 weeks of quitting should also be considered (Kenford, Fiore, Jorenby, et al., 1994). Abstinent patients should receive relapse prevention treatment (see General Strategy 8) including reinforcement for their decision to quit, congratulations on their success at quitting, and encouragement to remain abstinent. Clinicians should also inquire about current and future threats to abstinence and provide appropriate suggestions for coping with these threats.

Patients who have relapsed should be assessed for their willingness to quit. Patients who are currently motivated to make another quit attempt should be provided with an intervention (see section in Chapter 3, Interventions). Clinicians may wish to increase the intensity of psychosocial treatment at this time or refer the patient to a smoking cessation specialist/program for a more intensive treatment if the patient is willing. In addition, nicotine replacement should be offered to the patient. If the previous cessation attempt included nicotine replacement, the clinician should review whether the patient used these medications in an effective manner and consider use of another form (see General Strategies 3 and 5).

Patients who are unwilling to quit at the current time should receive a brief intervention designed to promote the motivation to quit (see General Strategy 6).

Reimbursement for Smoking Cessation Treatment

Recommendation: Smoking cessation treatments (both pharmacotherapy and counseling) should be provided as paid services for subscribers of health insurance/managed care. (Strength of Evidence = C)

Recommendation: Clinicians should be reimbursed for delivering effective smoking cessation treatments. (Strength of Evidence = C)

Primary care clinicians frequently cite insufficient insurance reimbursement as a barrier to the provision of preventive services such as smoking cessation treatment (Henry, Ogle, and Snellman, 1987; Orleans, Schoenbach, Salmon, et al., 1989.). Insurance coverage has been shown to increase rates of cessation services utilization and therefore increase rates of quitting. For example, the presence of prepaid or discounted prescription drug benefits increases patients' receipt of nicotine gum, the duration of gum use (Johnson, Hollis, Stevens, et al., 1991), and smoking cessation rates (Cox and McKenna, 1990; Hughes, Wadland, Fenwick, et al., 1991). In addition, an 8-year insurance industry study found that reimbursing physicians for provision of preventive care resulted in reported increases in exercise, seat belt use, and weight loss, as well as decreased alcohol use and a trend (because of small sample size) toward decreased smoking Logsdon, Lazaro, and Meier, 1989).

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