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A U.S. Public Health Service Clinical Practice Guideline June 2000 Treating Tobacco Use andTreating Tobacco Use and Dependence Dependence PHSPHS Introduction PHSPHS PHSPHS Smoking in Perspective Kills more than 430,000 Americans each year 25% of adult Americans smoke 3,000 children and adolescents become regular tobacco users every day Causes cancer, heart disease, stroke, pulmonary disease, and adverse pregnancy outcomes Adds $50 billion in direct health costs each year One-third of all tobacco users in U.S. will die prematurely PHSPHS Opportunity for Intervention 70% of smokers have made at least one unsuccessful quit attempt 46% try to quit each year More than 70% of smokers visit a health care setting each year Effective treatments exist which produce long-term or permanent abstinence PHSPHS Barriers to Treating Tobacco Use and Dependence Inadequate institutional support for routine assessment and treatment Clinicians lack of knowledge of: How to identify and treat tobacco users Which treatments are efficacious Chronic nature of nicotine addiction Time constraints in clinical practice PHSPHS Tobacco Dependence as a Chronic Disease Tobacco dependence demonstrates features of a chronic disease: 0 Long-term disorder 0 Periods of relapse and remission 0 Requires ongoing rather than acute care PHSPHS Treating Tobacco Use and Dependence PHS Clinical Practice Guideline Sponsored by a consortium of 7 nonprofit and Government agencies: Agency for Healthcare Research and Quality Centers for Disease Control and Prevention National Cancer Institute National Heart, Lung, and Blood Institute National Institute on Drug Abuse Robert Wood Johnson Foundation University of Wisconsin Medical Schools Center for Tobacco Research and Intervention PHSPHS Goals for Developing the Guideline Identify effective treatments for tobacco use and dependence Translate the evidentiary findings into specific strategies for addressing tobacco use and dependence: 0Brief interventions 0Intensive interventions 0Systems interventions Methodology PHSPHS PHSPHS Methodology Literature search and review of 6,000 articles published between 1975 and 1999 Articles reviewed for possible inclusion in meta-analyses 192 articles met criteria for inclusion in a meta -analysis Additional 500+ articles examined by Guideline Expert Panel Draft reviewed by more than 70 external peer reviewers prior to final PHSPHS Major Findings and Recommendations PHSPHS Development of Recommendations Guideline Expert Panel reviewed evidence, including meta-analyses then: Developed recommendations via consensus Assigned a Strength of Evidence rating, A, B, or C, to each Wrote guideline strategies and supporting text translating the findings into practice PHSPHS Major Findings and Panel Recommendations 1. Tobacco dependence is a chronic condition that often requires repeated intervention. However, effective treatments exist that can produce long-term or even permanent abstinence. PHSPHS Major Findings and Panel Recommendations 2. Because effective tobacco dependence treatments are available, every patient who uses tobacco should be offered one or more of these treatments. PHSPHS Major Findings and Panel Recommendations 3. It is essential that clinicians and health care delivery systems (including administrators, insurers, and purchasers) institutionalize the consistent identification, documentation, and treatment of every tobacco user seen in a health care setting. PHSPHS Major Findings and Panel Recommendations 4. Brief tobacco dependence treatment is effective, and every patient who uses tobacco should be offered at least brief treatment. PHSPHS Major Findings and Panel Recommendations 5. There is a strong dose-response relation between the intensity of tobacco dependence counseling and its effectiveness. Treatments involving person-to-person contact (via individual, group, or proactive telephone counseling) are consistently effective, and their effectiveness increases with treatment intensity (e.g., minutes of contact). PHSPHS Major Findings and Panel Recommendations 6. Three types of counseling and behavioral therapies were found to be especially effective and should be used with all patients attempting tobacco cessation: Provision of practical counseling (problem-solving/skills training) Provision of social support as part of treatment (intra-treatment social support) Help in securing social support outside of treatment (extra-treatment social support) PHSPHS Major Findings and Panel Recommendations 7. Numerous effective pharmacotherapies for smoking cessation now exist. Except in the presence of contraindications, these should be used with all patients attempting to quit smoking. Five first-line pharmacotherapies were identified that reliably increase long-term smoking abstinence rates: Bupropion SR Bupropion SR Nicotine gum Nicotine gum Nicotine inhaler Nicotine inhaler Nicotine nasal spray Nicotine nasal spray Nicotine patch Nicotine patch PHSPHS Major Findings and Panel Recommendations 7. Continued Two second-line pharmacotherapies were identified as efficacious and may be considered by clinicians if first-line pharmacotherapies are not effective Clonidine Nortriptyline Over-the-counter nicotine patches are effective relative to placebo, and their use should be encouraged PHSPHS Major Findings and Panel Recommendations 8. Tobacco dependence treatments are both clinically effective and cost-effective relative to other medical and disease prevention interventions. As such, insurers and purchasers should ensure that: All insurance plans include as a reimbursed benefit the counseling and pharmacotherapeutic treatments identified as effective in this Guideline Clinicians are reimbursed for providing tobacco dependence treatment just as they are reimbursed for treating other chronic conditions PHSPHS Results PHSPHS Treatment and Assessment Strategies Analyzed Screen for tobacco use Advice to quit Intensity of person-to- person clinical contact Type of clinician Formats of psychosocial interventions Self-help interventions Types of counseling and behavioral therapies Pharmacologic interventions Combination NRT Over-the-counter pharmacotherapy PHSPHS Impact of Physicians Advice to Quit (n = 7 studies) AdviceAdvice Odds RatioOdds Ratio (95%) CI(95%) CI No advice to quit No advice to quit (reference group)(reference group) Physician advicePhysician advice to quitto quit 7.9%7.9%1.01.0 10.2%10.2%1.31.3 (1.1-1.6)(1.1-1.6) EstimatedEstimated Abstinence RateAbstinence Rate PHSPHS Efficacy of Interventions Delivered by Various Types of Clinicians (n = 29 Studies) Type of ClinicianType of Clinician Estimated Estimated Abstinence RateAbstinence Rate Odds RatioOdds Ratio (95%) CI(95%) CI No clinician No clinician (reference group)(reference group) 10.2%10.2%1.01.0 19.9%19.9%2.22.2 (1.5-3.2)(1.5-3.2) Self-helpSelf-help Non-physicianNon-physician clinicianclinician Physician clinicianPhysician clinician 10.9%10.9% 15.8%15.8% 1.71.7 (1.3-2.1)(1.3-2.1) 1.11.1 (0.9-1.3)(0.9-1.3) PHSPHS Efficacy of Treatment Delivery Format (n = 58 studies) FormatFormat Estimated Estimated Abstinence RateAbstinence Rate Odds RatioOdds Ratio (95%) CI(95%) CI No format No format (reference group)(reference group) 10.8%10.8% 1.01.0 13.9%13.9% 1.31.3 (1.1-1.6)(1.1-1.6) Self-helpSelf-help Proactive phoneProactive phone counselingcounseling Group counselingGroup counseling 12.3%12.3% 13.1%13.1% 1.21.2 (1.1-1.4)(1.1-1.4) 1.21.2 (1.02-1.3)(1.02-1.3) Individual counselingIndividual counseling16.8%16.8%1.71.7 (1.4-2.0)(1.4-2.0) PHSPHS Efficacy of Various Intensity Levels of Person-to-Person Contact (n = 43 Studies) Level of ContactLevel of Contact Odds RatioOdds Ratio (95%) CI(95%) CI No contact No contact (reference group)(reference group) 10.9%10.9%1.01.0 22.1%22.1%2.32.3 (2.0-2.7)(2.0-2.7) Minimal counselingMinimal counseling ( 10 minutes)( 10 minutes) 13.4%13.4% 16.0%16.0% 1.61.6 (1.2-2.0)(1.2-2.0) 1.31.3 (1.01-1.6)(1.01-1.6) Estimated Estimated Abstinence RateAbstinence Rate PHSPHS Efficacy of Various types of Counseling and Behavioral Therapies (n = 62 Studies) Type of Counseling orType of Counseling or Behavioral TherapyBehavioral Therapy Estimated Estimated Abstinence RateAbstinence Rate Odds RatioOdds Ratio (95%) CI(95%) CI No therapyNo therapy (reference group)(reference group) 11.2%11.2%1.01.0 11.2%11.2%1.0 (0.8-1.3)1.0 (0.8-1.3) Relaxation/breathingRelaxation/breathing Contingency contractingContingency contracting Weight/dietWeight/diet 10.8%10.8% 11.2%11.2%1.0 (0.7-1.4)1.0 (0.7-1.4) 1.0 (0.7-1.3)1.0 (0.7-1.3) Cigarette fadingCigarette fading11.8%11.8%1.1 (0.8-1.5)1.1 (0.8-1.5) Negative affectNegative affect 1.2 (0.8-1.9)1.2 (0.8-1.9) 13.6%13.6% PHSPHS Efficacy of Various Types of Counseling and Behavioral Therapies (n = 62 Studies) (Cont) Type of Counseling orType of Counseling or Behavioral TherapyBehavioral Therapy Estimated Estimated Abstinence RateAbstinence Rate Odds RatioOdds Ratio (95%) CI(95%) CI IntraIntra-treatment-treatment social supportsocial support 14.4%14.4% 1.3 (1.1-1.6)1.3 (1.1-1.6) 16.2%16.2%1.5 (1.3-1.8)1.5 (1.3-1.8) Extra-treatmentExtra-treatment social supportsocial support ProblemsolvingProblemsolving/ / skills trainingskills training 16.2%16.2%1.5 (1.1-2.1)1.5 (1.1-2.1) Other aversive smoking Other aversive smoking17.7%17.7%1.7 (1.04-2.8)1.7 (1.04-2.8) Rapid smokingRapid smoking2.0 (1.1-3.5)2.0 (1.1-3.5)19.9%19.9% No therapyNo therapy (reference group)(reference group) 11.2%11.2% 1.01.0 PHSPHS Efficacy of Bupropion SR (n = 2 Studies) PharmacotherapyPharmacotherapy Odds RatioOdds Ratio (95%) CI(95%) CI Placebo Placebo (reference group)(reference group) 17.3%17.3% 1.01.0 Bupropion SRBupropion SR 30.5%30.5%2.12.1 (1.5 - 3.0)(1.5 - 3.0) EstimatedEstimated Abstinence RateAbstinence Rate PHSPHS Efficacy of Nicotine Gum (n = 13 Studies) PharmacotherapyPharmacotherapy Odds RatioOdds Ratio (95%) CI(95%) CI Placebo Placebo (reference group)(reference group) 17.1%17.1% 1.01.0 Nicotine gumNicotine gum 23.7%23.7%1.51.5 (1.3 - 1.8)(1.3 - 1.8) EstimatedEstimated Abstinence Rate Abstinence Rate PHSPHS Efficacy of Nicotine Inhaler (n = 4 Studies) PharmacotherapyPharmacotherapy Odds RatioOdds Ratio (95%) CI(95%) CI Placebo Placebo (reference group)(reference group) 10.5%10.5% 1.01.0 Nicotine inhalerNicotine inhaler 22.8%22.8%2.52.5 (1.7 - 3.6)(1.7 - 3.6) EstimatedEstimated Abstinence RateAbstinence Rate PHSPHS Efficacy of Nicotine Nasal Spray (n = 3 Studies) PharmacotherapyPharmacotherapy Odds RatioOdds Ratio (95%) CI(95%) CI Placebo Placebo (reference group)(reference group) 13.9%13.9% 1.01.0 Nicotine nasalNicotine nasal sprayspray 30.5%30.5%2.72.7 (1.8 - 4.1)(1.8 - 4.1) EstimatedEstimated Abstinence Rate Abstinence Rate PHSPHS Efficacy of Nicotine Patch (n = 27 Studies) PharmacotherapyPharmacotherapy Odds RatioOdds Ratio (95%) CI(95%) CI Placebo Placebo (reference group)(reference group) 10.0%10.0% 1.01.0 Nicotine patchNicotine patch 17.7%17.7%1.91.9 (1.7 - 2.2)(1.7 - 2.2) EstimatedEstimated Abstinence RateAbstinence Rate PHSPHS Psychosocial Psychosocial InterventionsInterventions PHSPHS Identification Documenting tobacco use status at every clinic visit will increase rates of clinician intervention and can increase abstinence rates Identification guides effective and appropriate intervention based on patients tobacco use status and willingness to quit PHSPHS Vital Signs Stamp VITAL SIGNSVITAL SIGNS Pulse:Pulse: TemperatureTemperature: : Respiratory Rate:Respiratory Rate: (circle one)(circle one) CurrentCurrentFormerFormerNeverNeverTobacco Use:Tobacco Use: Blood Pressure:Blood Pressure: WeightWeight: : PHSPHS Providers Treatment by a variety of clinicians increases abstinence rates Treatment by more than one type of clinician is more effective than by a single type of clinician Therefore, all clinicians (physicians and nonphysicians) should provide smoking cessation intervention PHSPHS Format The following treatment formats were found to be particularly effective: 0Individual counseling 0Group counseling 0Proactive telephone counseling Interventions delivered in multiple formats improve abstinence rates PHSPHS Self-Help Use of self-help material either alone or as an adjuvant does not significantly improve clinical abstinence rates Guideline self-help analyses are limited in that they did not examine particular forms or uses of self-help, e.g. tailored self-help PHSPHS Brief Advice Brief advice by a physician (approximately 3 minutes or less) increases long-term abstinence rates significantly Any clinician can and should offer brief advice Goal: Every tobacco user is identified and offered at least a brief intervention at each clinical visit PHSPHS Intensity of Treatment Interventions Dose-response relationship: higher success rates with increasing treatment intensity Optimal cessation interventions include: 0Four or more sessions 0Longest individual session 10 minutes 0Total person-to-person contact time 30 minutes Appropriate for any tobacco user willing to participate PHSPHS Counseling and Behavioral Therapies 3 types of therapies were found to be especially effective: 0Providing smokers with practical counseling (problemsolving and skills training) 0Providing social support as part of treatment (intra-treatment social support) 0Helping smokers obtain social support outside of treatment (extra-treatment social support) PHSPHS Pharmacotherapy PHSPHS Pharmacotherapeutic Interventions All patients attempting to quit smoking should be encouraged to use pharmacotherapy except under special circumstances such as: 0Medical contraindications 0Smoking fewer than 10 cigarettes/day 0Pregnant/breastfeeding women 0Adolescents PHSPHS First-Line Pharmacotherapies The following pharmacotherapies were found to be safe and effective: 0Bupropion SR 0Nicotine gum 0Nicotine inhaler 0Nicotine nasal spray 0Nicotine patch FDA has approved the use of these medications for the treatment of tobacco dependence PHSPHS Second-Line Pharmacotherapies Both of these pharmacotherapies were also found to be effective: 0Clonidine 0Nortriptyline FDA has not approved the use of these medications for tobacco dependence These medicines have more significant side effects than the first-line pharmacotherapies PHSPHS Combination Nicotine Replacement Therapy Combining the nicotine patch and a self- administered NRT (either nicotine gum or nicotine nasal spray) is more efficacious than a single form of NRT PHSPHS Over-the-Counter Nicotine Patch Therapy Over-the-counter nicotine patch therapy is effective relative to placebo PHSPHS Factors to Consider When Choosing a Pharmacotherapy Clinician familiarity with the medications Contraindications for selected patients Patient preference Previous patient experiences with a specific agent (positive or negative) Patient characteristics (concern about weight gain, history of depression) PHSPHS Bupropion SR Doubles abstinence rates vs. placebo Only non-nicotine medication approved by FDA for smoking cessation treatment Marketed as Zyban for smoking cessation or Wellbutrin SR for depression Mechanism: presumably blocks neural reuptake of dopamine and/or norepinephrine PHSPHS Bupropion SR Available by prescription only (USA) Dosing: Start 1-2 weeks before quit date 150 mg orally once daily x 3 day 150 mg orally twice daily x 7-12 weeks No taper necessary at end of treatment Maintenance: consider as a maintenance therapy for up to 6 months post-cessation PHSPHS Nicotine Replacement Therapy (NRT) Nicotine is active ingredient Supplied as steady dose (patch) or self- administered (gum, inhaler, nasal spray) Self-administered products should be used on scheduled basis initially before tapered to ad lib use and eventual discontinuation PHSPHS Nicotine Replacement Therapy No evidence of increased cardiovascular risk with NRT except with acute disease Medical contraindications: Immediate myocardial infarction ( 2 weeks) Serious arrhythmia Serious or worsening angina pectoris Accelerated hypertension PHSPHS Pharmacotherapy Cost per Day (April 2000, USA Retail Chain Pharmacy) Bupropion SR Nicotine gum Nicotine inhaler Nicotine nasal spray Nicotine patch $3.33 for 150 mg bid $6.25 for 10 2 mg pcs $6.87 for 10 4 mg pcs $10.94 for 10 crtrdgs $5.40 for 12 doses $4.22 for 24 hr $4.51 for 16 hr PHSPHS Pharmacotherapy NOT Recommended in PHS Guideline SSRI and tricyclic antidepressants (other than nortriptyline) Anxiolytics, benzodiazapines, beta-blockers Silver acetate Mecamylamine PHSPHS Pharmacotherapy for Special Populations Bupropion SR or NRTs, specifically nicotine gum, should be considered for patients concerned about weight gain Bupropion SR and nortriptyline should be considered in patients with a history of depression PHSPHS Multiple Pharmacotherapy Bupropion SR may be combined with any of the NRTs Combination NRT Patch + gum or patch + nasal spray is more efficacious than a single NRT Encourage in patients unable to quit using single agent Caution patients on risk of nicotine overdose Combined NRT not currently FDA approved PHSPHS Pharmacotherapy for Light Smokers Consider reducing dose of first-line pharmacotherapies Bupropion SR may be prescribed at full strength (150 mg orally twice daily) PHSPHS Extended Use of Pharmacotherapy First-line tobacco dependence medications may be considered for extended use, especially in patients with persistent withdrawal symptoms Evidence shows that a minority of patients continue ad libitum NRT agents Does not present known health risks FDA has approved bupropion SR for a long- term maintenance indication PHSPHS Special Findings PHSPHS Special Populations In general, treatments found to be effective in the guideline should be used with all populations Some special populations may have concerns that can be addressed within the context of tre
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