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Do preparticipation clinical exams reduce morbidity and mortality for athletes?
Though clinical preparticipation exams (PPE) are recommended by experts and required in most states, we found no medium- or better-quality evidence that demonstrates they reduce mortality or morbidity. PPEs detect only a very small percentage of cardiac abnormalities among athletes who subsequently die suddenly (strength of recommendation [SOR]: C, case series study). PPEs are also unable to accurately identify athletes with exercise-induced bronchospasm (SOR: C, small cross-sectional study) and are poorly predictive of which athletes are at increased risk of orthopedic injuries (SOR: C, cross-sectional study).
Evidence summary
A systematic review of the literature on PPE identified 310 studies of athletes age <36 years. The authors searched multiple electronic databases and reviewed the bibliographies of retrieved articles but did not perform hand searches of journals or contact authors directly. The review did not find any prospective cohort or randomized trials addressing the effectiveness of clinical PPE. The 5 studies that assessed the format of the PPE concluded that it is not adequately standardized, does not consistently address the American Heart Association (AHA) recommendations for cardiovascular screening and exam, and is administered by a variety of health care professionals, some without proper training.1
Sudden cardiac death is defined as a nontraumatic, nonviolent, unexpected event resulting from sudden cardiac arrest within 6 hours of a previously witnessed state of normal health.2 Such events occur in about 1 in 200,000 high school athletes per academic year (about 16 deaths in the US annually). Detection of cardiovascular abnormalities that may cause morbidity or mortality is difficult. A case series reviewed 158 sudden deaths that occurred in trained athletes in the US from 1985 to 1995. The athletes were identified from news accounts, the National Center for Catastrophic Sports Injury Registry, and informal communications and reports. The authors interviewed families, witnesses, and coaches, and they analyzed postmortem information. Of the 115 athletes who had a standard preparticipation medical evaluation, only 4 (3%) were suspected of having cardiovascular disease. The cardiovascular abnormality responsible for sudden death was prospectively identified in only 1 athlete.3
PPE does not accurately identify student athletes with exercise-induced bronchospasm (EIB). Of the studies on EIB, the best was a prospective cross-sectional study of 352 adolescents from 3 suburban Washington state schools. The students completed a 14-item EIB questionnaire, had a physical exam, and underwent a 7-minute exercise challenge spirometry. Complete data were available for 256 of the students. EIB was diagnosed by spirometry in 9.4% of the athletes. No student had EIB detected solely by physical exam. Using a cutoff of 2 positive questions, the questionnaire had a sensitivity of 71% and a specificity of 47%, with a negative and positive predictive value of 6% and 12%, respectively. This study concluded that EIB occurs frequently in adolescent athletes, but screening by physical exam and medical history does not accurately detect it.4
PPEs are not able to predict which student athletes will experience an orthopedic injury, and no controlled studies have been done to determine whether PPE prevents or reduces the severity of orthopedic injuries. A study surveyed 1204 student athletes (aged 13–20 years) from Richmond County, Georgia, who had a standardized PPE before participating in sports. The questionnaire was administered via mail or telephone and inquired about injuries sustained after the PPE. The response rate to the survey was 56%. The study found that a history of knee or ankle injury and abnormal findings on exam in male athletes slightly increased the likelihood of repeated injury of the same joint. However, the sensitivities of history or physical exam for ankle or knee injuries were all <25%.5
Recommendations from others
The AHA recommends a national standard for PPE and that screening should be mandatory for all high school and college athletes before participation in organized sports, with screening repeated every 2 years, and an interim history obtained during the intervening years. Specific items are given in the TABLE.6
In 2004, the American Academy of Family Physicians, along with the American Academy of Pediatrics, American College of Sports Medicine, American Medical Society for Sports Medicine, American Orthopedic Society for Sports Medicine, and the American Osteopathic Academy of Sports Medicine, published recommendations for PPEs. They suggested a detailed history (consisting of a 16-point questionnaire incorporating AHA recommendations for cardiovascular screening), limited medical exam, and a detailed musculoskeletal exam evaluating strength, flexibility, and stability of major joints.7
TABLE
AHA recommendations for preparticipation exams
| CARDIOVASCULAR SCREENING QUESTIONS |
|
| CARDIOVASCULAR SCREENING EXAM |
|
| CARDIAC FINDINGS REQUIRING FURTHER EVALUATION |
|
The PPE provides us an opportunity to address preventive health issues
Beth Anne Fox, MD, MPH
East Tennessee State University, Kingsport Family Medicine Residency, Kingsport, Tennessee
Most physicians involved in screening athletes recognize the limitations of PPEs in detecting those at risk for sports-related morbidity and mortality. The history is the most important part of the examination for identifying athletes who might be at risk and should be thorough. Prepared PPE forms such as those endorsed by the AAFP and ACSM can assist in obtaining this history. Because this may be the only occasion for the athlete to see a physician, the examination is best performed by a primary care provider who can use the opportunity to address preventive health issues such as tobacco, alcohol, and drug use, depression and suicidality, sexuality, nutrition, and accident prevention. This kind of counseling is difficult to do in a group format.
1. Wingfield K, Matheson GO, Meeuwisse WH. Preparticipation evaluation: an evidence-based review. Clin J Sport Med 2004;14:109-122.
2. Lyznicki JM, Nielsen NH, Schneider JF. Cardiovascular screening of athletes. Am Fam Physician 2000;62:765-774.Erratum in: Am Fam Physician, 2001; 63:2332.
3. Maron BJ, Shirani J, Poliac LC, Mathenge R, Roberts WC, Mueller FO. Sudden death in young competitive athletes. Clinical, demographic, and pathological profiles. JAMA 1996;276:199-204.
4. Hallstrand TS, Curtis JR, Koepsell TD, et al. Effectiveness of screening examinations to detect unrecognized exercise-induced bronchoconstriction. J Pediatr 2002;141:343-348.
5. DuRant RH, Pendergrast RA, Seymore C, Gaillard G, Donner J. Findings from the preparticipation athletic examination and athletic injuries. Am J Dis Child 1992;146:85.-
6. Maron BJ, Thompson PD, Puffer JC, et al. Cardiovascular preparticipation screening of competitive athletes. A statement for health professionals from the Sudden Death Committee (clinical cardiology) and Congenital Cardiac Defects Committee (cardiovascular disease in the young), American Heart Association. Circulation 1996;94:850-856.
7. Smith DM. American Academy of Family Physicians, Preparticipation Physical Evaluation Task Force. Preparticipation Physical Evaluation. 3rd ed. Minneapolis: McGraw-Hill Healthcare; 2004.
Though clinical preparticipation exams (PPE) are recommended by experts and required in most states, we found no medium- or better-quality evidence that demonstrates they reduce mortality or morbidity. PPEs detect only a very small percentage of cardiac abnormalities among athletes who subsequently die suddenly (strength of recommendation [SOR]: C, case series study). PPEs are also unable to accurately identify athletes with exercise-induced bronchospasm (SOR: C, small cross-sectional study) and are poorly predictive of which athletes are at increased risk of orthopedic injuries (SOR: C, cross-sectional study).
Evidence summary
A systematic review of the literature on PPE identified 310 studies of athletes age <36 years. The authors searched multiple electronic databases and reviewed the bibliographies of retrieved articles but did not perform hand searches of journals or contact authors directly. The review did not find any prospective cohort or randomized trials addressing the effectiveness of clinical PPE. The 5 studies that assessed the format of the PPE concluded that it is not adequately standardized, does not consistently address the American Heart Association (AHA) recommendations for cardiovascular screening and exam, and is administered by a variety of health care professionals, some without proper training.1
Sudden cardiac death is defined as a nontraumatic, nonviolent, unexpected event resulting from sudden cardiac arrest within 6 hours of a previously witnessed state of normal health.2 Such events occur in about 1 in 200,000 high school athletes per academic year (about 16 deaths in the US annually). Detection of cardiovascular abnormalities that may cause morbidity or mortality is difficult. A case series reviewed 158 sudden deaths that occurred in trained athletes in the US from 1985 to 1995. The athletes were identified from news accounts, the National Center for Catastrophic Sports Injury Registry, and informal communications and reports. The authors interviewed families, witnesses, and coaches, and they analyzed postmortem information. Of the 115 athletes who had a standard preparticipation medical evaluation, only 4 (3%) were suspected of having cardiovascular disease. The cardiovascular abnormality responsible for sudden death was prospectively identified in only 1 athlete.3
PPE does not accurately identify student athletes with exercise-induced bronchospasm (EIB). Of the studies on EIB, the best was a prospective cross-sectional study of 352 adolescents from 3 suburban Washington state schools. The students completed a 14-item EIB questionnaire, had a physical exam, and underwent a 7-minute exercise challenge spirometry. Complete data were available for 256 of the students. EIB was diagnosed by spirometry in 9.4% of the athletes. No student had EIB detected solely by physical exam. Using a cutoff of 2 positive questions, the questionnaire had a sensitivity of 71% and a specificity of 47%, with a negative and positive predictive value of 6% and 12%, respectively. This study concluded that EIB occurs frequently in adolescent athletes, but screening by physical exam and medical history does not accurately detect it.4
PPEs are not able to predict which student athletes will experience an orthopedic injury, and no controlled studies have been done to determine whether PPE prevents or reduces the severity of orthopedic injuries. A study surveyed 1204 student athletes (aged 13–20 years) from Richmond County, Georgia, who had a standardized PPE before participating in sports. The questionnaire was administered via mail or telephone and inquired about injuries sustained after the PPE. The response rate to the survey was 56%. The study found that a history of knee or ankle injury and abnormal findings on exam in male athletes slightly increased the likelihood of repeated injury of the same joint. However, the sensitivities of history or physical exam for ankle or knee injuries were all <25%.5
Recommendations from others
The AHA recommends a national standard for PPE and that screening should be mandatory for all high school and college athletes before participation in organized sports, with screening repeated every 2 years, and an interim history obtained during the intervening years. Specific items are given in the TABLE.6
In 2004, the American Academy of Family Physicians, along with the American Academy of Pediatrics, American College of Sports Medicine, American Medical Society for Sports Medicine, American Orthopedic Society for Sports Medicine, and the American Osteopathic Academy of Sports Medicine, published recommendations for PPEs. They suggested a detailed history (consisting of a 16-point questionnaire incorporating AHA recommendations for cardiovascular screening), limited medical exam, and a detailed musculoskeletal exam evaluating strength, flexibility, and stability of major joints.7
TABLE
AHA recommendations for preparticipation exams
| CARDIOVASCULAR SCREENING QUESTIONS |
|
| CARDIOVASCULAR SCREENING EXAM |
|
| CARDIAC FINDINGS REQUIRING FURTHER EVALUATION |
|
The PPE provides us an opportunity to address preventive health issues
Beth Anne Fox, MD, MPH
East Tennessee State University, Kingsport Family Medicine Residency, Kingsport, Tennessee
Most physicians involved in screening athletes recognize the limitations of PPEs in detecting those at risk for sports-related morbidity and mortality. The history is the most important part of the examination for identifying athletes who might be at risk and should be thorough. Prepared PPE forms such as those endorsed by the AAFP and ACSM can assist in obtaining this history. Because this may be the only occasion for the athlete to see a physician, the examination is best performed by a primary care provider who can use the opportunity to address preventive health issues such as tobacco, alcohol, and drug use, depression and suicidality, sexuality, nutrition, and accident prevention. This kind of counseling is difficult to do in a group format.
Though clinical preparticipation exams (PPE) are recommended by experts and required in most states, we found no medium- or better-quality evidence that demonstrates they reduce mortality or morbidity. PPEs detect only a very small percentage of cardiac abnormalities among athletes who subsequently die suddenly (strength of recommendation [SOR]: C, case series study). PPEs are also unable to accurately identify athletes with exercise-induced bronchospasm (SOR: C, small cross-sectional study) and are poorly predictive of which athletes are at increased risk of orthopedic injuries (SOR: C, cross-sectional study).
Evidence summary
A systematic review of the literature on PPE identified 310 studies of athletes age <36 years. The authors searched multiple electronic databases and reviewed the bibliographies of retrieved articles but did not perform hand searches of journals or contact authors directly. The review did not find any prospective cohort or randomized trials addressing the effectiveness of clinical PPE. The 5 studies that assessed the format of the PPE concluded that it is not adequately standardized, does not consistently address the American Heart Association (AHA) recommendations for cardiovascular screening and exam, and is administered by a variety of health care professionals, some without proper training.1
Sudden cardiac death is defined as a nontraumatic, nonviolent, unexpected event resulting from sudden cardiac arrest within 6 hours of a previously witnessed state of normal health.2 Such events occur in about 1 in 200,000 high school athletes per academic year (about 16 deaths in the US annually). Detection of cardiovascular abnormalities that may cause morbidity or mortality is difficult. A case series reviewed 158 sudden deaths that occurred in trained athletes in the US from 1985 to 1995. The athletes were identified from news accounts, the National Center for Catastrophic Sports Injury Registry, and informal communications and reports. The authors interviewed families, witnesses, and coaches, and they analyzed postmortem information. Of the 115 athletes who had a standard preparticipation medical evaluation, only 4 (3%) were suspected of having cardiovascular disease. The cardiovascular abnormality responsible for sudden death was prospectively identified in only 1 athlete.3
PPE does not accurately identify student athletes with exercise-induced bronchospasm (EIB). Of the studies on EIB, the best was a prospective cross-sectional study of 352 adolescents from 3 suburban Washington state schools. The students completed a 14-item EIB questionnaire, had a physical exam, and underwent a 7-minute exercise challenge spirometry. Complete data were available for 256 of the students. EIB was diagnosed by spirometry in 9.4% of the athletes. No student had EIB detected solely by physical exam. Using a cutoff of 2 positive questions, the questionnaire had a sensitivity of 71% and a specificity of 47%, with a negative and positive predictive value of 6% and 12%, respectively. This study concluded that EIB occurs frequently in adolescent athletes, but screening by physical exam and medical history does not accurately detect it.4
PPEs are not able to predict which student athletes will experience an orthopedic injury, and no controlled studies have been done to determine whether PPE prevents or reduces the severity of orthopedic injuries. A study surveyed 1204 student athletes (aged 13–20 years) from Richmond County, Georgia, who had a standardized PPE before participating in sports. The questionnaire was administered via mail or telephone and inquired about injuries sustained after the PPE. The response rate to the survey was 56%. The study found that a history of knee or ankle injury and abnormal findings on exam in male athletes slightly increased the likelihood of repeated injury of the same joint. However, the sensitivities of history or physical exam for ankle or knee injuries were all <25%.5
Recommendations from others
The AHA recommends a national standard for PPE and that screening should be mandatory for all high school and college athletes before participation in organized sports, with screening repeated every 2 years, and an interim history obtained during the intervening years. Specific items are given in the TABLE.6
In 2004, the American Academy of Family Physicians, along with the American Academy of Pediatrics, American College of Sports Medicine, American Medical Society for Sports Medicine, American Orthopedic Society for Sports Medicine, and the American Osteopathic Academy of Sports Medicine, published recommendations for PPEs. They suggested a detailed history (consisting of a 16-point questionnaire incorporating AHA recommendations for cardiovascular screening), limited medical exam, and a detailed musculoskeletal exam evaluating strength, flexibility, and stability of major joints.7
TABLE
AHA recommendations for preparticipation exams
| CARDIOVASCULAR SCREENING QUESTIONS |
|
| CARDIOVASCULAR SCREENING EXAM |
|
| CARDIAC FINDINGS REQUIRING FURTHER EVALUATION |
|
The PPE provides us an opportunity to address preventive health issues
Beth Anne Fox, MD, MPH
East Tennessee State University, Kingsport Family Medicine Residency, Kingsport, Tennessee
Most physicians involved in screening athletes recognize the limitations of PPEs in detecting those at risk for sports-related morbidity and mortality. The history is the most important part of the examination for identifying athletes who might be at risk and should be thorough. Prepared PPE forms such as those endorsed by the AAFP and ACSM can assist in obtaining this history. Because this may be the only occasion for the athlete to see a physician, the examination is best performed by a primary care provider who can use the opportunity to address preventive health issues such as tobacco, alcohol, and drug use, depression and suicidality, sexuality, nutrition, and accident prevention. This kind of counseling is difficult to do in a group format.
1. Wingfield K, Matheson GO, Meeuwisse WH. Preparticipation evaluation: an evidence-based review. Clin J Sport Med 2004;14:109-122.
2. Lyznicki JM, Nielsen NH, Schneider JF. Cardiovascular screening of athletes. Am Fam Physician 2000;62:765-774.Erratum in: Am Fam Physician, 2001; 63:2332.
3. Maron BJ, Shirani J, Poliac LC, Mathenge R, Roberts WC, Mueller FO. Sudden death in young competitive athletes. Clinical, demographic, and pathological profiles. JAMA 1996;276:199-204.
4. Hallstrand TS, Curtis JR, Koepsell TD, et al. Effectiveness of screening examinations to detect unrecognized exercise-induced bronchoconstriction. J Pediatr 2002;141:343-348.
5. DuRant RH, Pendergrast RA, Seymore C, Gaillard G, Donner J. Findings from the preparticipation athletic examination and athletic injuries. Am J Dis Child 1992;146:85.-
6. Maron BJ, Thompson PD, Puffer JC, et al. Cardiovascular preparticipation screening of competitive athletes. A statement for health professionals from the Sudden Death Committee (clinical cardiology) and Congenital Cardiac Defects Committee (cardiovascular disease in the young), American Heart Association. Circulation 1996;94:850-856.
7. Smith DM. American Academy of Family Physicians, Preparticipation Physical Evaluation Task Force. Preparticipation Physical Evaluation. 3rd ed. Minneapolis: McGraw-Hill Healthcare; 2004.
1. Wingfield K, Matheson GO, Meeuwisse WH. Preparticipation evaluation: an evidence-based review. Clin J Sport Med 2004;14:109-122.
2. Lyznicki JM, Nielsen NH, Schneider JF. Cardiovascular screening of athletes. Am Fam Physician 2000;62:765-774.Erratum in: Am Fam Physician, 2001; 63:2332.
3. Maron BJ, Shirani J, Poliac LC, Mathenge R, Roberts WC, Mueller FO. Sudden death in young competitive athletes. Clinical, demographic, and pathological profiles. JAMA 1996;276:199-204.
4. Hallstrand TS, Curtis JR, Koepsell TD, et al. Effectiveness of screening examinations to detect unrecognized exercise-induced bronchoconstriction. J Pediatr 2002;141:343-348.
5. DuRant RH, Pendergrast RA, Seymore C, Gaillard G, Donner J. Findings from the preparticipation athletic examination and athletic injuries. Am J Dis Child 1992;146:85.-
6. Maron BJ, Thompson PD, Puffer JC, et al. Cardiovascular preparticipation screening of competitive athletes. A statement for health professionals from the Sudden Death Committee (clinical cardiology) and Congenital Cardiac Defects Committee (cardiovascular disease in the young), American Heart Association. Circulation 1996;94:850-856.
7. Smith DM. American Academy of Family Physicians, Preparticipation Physical Evaluation Task Force. Preparticipation Physical Evaluation. 3rd ed. Minneapolis: McGraw-Hill Healthcare; 2004.
Evidence-based answers from the Family Physicians Inquiries Network
What interventions can help patients stop using chewing tobacco?
Nicotine replacement therapy (NRT), including gum and patches, decreases cravings and short-term abstinence rates, but does not improve long-term abstinence (strength of recommendation [SOR]: B, meta-analysis of small randomized controlled studies [RCT]).
It is unclear if bupropion has an effect on cessation rates (SOR: B, small RCTs with conflicting results). Behavioral interventions increase abstinence rates for smokeless tobacco users (SOR: B, meta-analysis of small RCTs).
Evidence summary
Use of smokeless tobacco can lead to nicotine dependence and cause periodontal disease, leukoplakia, cancer, and possibly cardiovascular disease.1-3 Patients who abruptly stop using smokeless tobacco may experience withdrawal symptoms similar to that observed in smokers.3
Nicotine gum
A small double-blind study randomized 79 male smokeless tobacco users to chew nicotine gum (0 mg, 2 mg, or 4 mg) for 5 days.4 Sixty patients completed the study. No significant differences in withdrawal symptoms, including cravings, concentration, or restlessness, were noted among the 3 groups (P>.05). However, further analysis demonstrated that patients with high blood levels of cotinine who received nicotine gum 2 mg experienced decreased cravings compared with placebo (P<.001), and a trend towards decreased cravings with 4 mg gum was noted (P<.06). Limitations of this study: quit rates were not reported, participants did not have to be motivated to quit smokeless tobacco in order to enroll, and it is not known if patients were counseled about the appropriate “chew and park” technique for nicotine gum.
Another study randomized 234 male smokeless tobacco users to receive group behavioral treatment plus nicotine gum 2 mg (B/NRT); group behavioral treatment plus placebo (B/Pl); minimal contact plus nicotine gum 2 mg (MC/NRT); or minimal contact plus placebo (MC/Pl).5
Group behavioral treatment consisted of 8 group counseling sessions 45 to 60 minutes in length; minimal contact involved 4 brief one-on-one sessions with a nurse. Patients chewed a minimum of 6 pieces of nicotine or placebo gum per day.
At 4 weeks, point prevalence abstinence rates were as follows: B/NRT, 63.6%; B/Pl, 66%; MC/NRT, 35.3%; and MC/Pl, 48.1% (P<.01). Abstinence rates remained significantly different at 1 and 6 month follow-ups, but not at 12 months. Post-hoc logistic regression favored group behavioral therapy plus NRT at 6 months. Moreover, survival analysis of continuous prevalence rates demonstrated that the least effective treatment was minimal contact plus NRT.
The authors theorized that nicotine gum may actually worsen risk of relapse in smokeless tobacco users due to behavioral similarities associated with use, but that behavioral treatment may help regain abstinence after a lapse. Gum users experienced lessened withdrawal symptoms including cravings, irritability, anxiety, and difficulty concentrating (P<.01). Results indicate that behavioral interventions may be more effective than NRT; however, low doses of nicotine gum were used.
Nicotine transdermal patches
A randomized double-blind study examined nicotine transdermal patches in smokeless tobacco users.6 Researchers recruited 422 participants from a Minnesota college campus and surrounding metropolitan area through advertisements; they were randomly assigned to nicotine patch plus mint snuff (a nicotine-free product), nicotine patch and no mint snuff, placebo patch plus mint snuff, or placebo patch and no mint snuff. The patch was dosed as 21-mg patch for 6 weeks, 14-mg patch for 2 weeks, and 7-mg patch for 2 weeks. All patients participated in 8 weekly individual 10-minute sessions with a therapist.
Continuous 10-week abstinence rates were 69% for nicotine patch and mint snuff, 58% for nicotine patch and no mint snuff, 46% for placebo patch and mint snuff, and 51% for placebo patch and no mint snuff (P=.002). After 15 weeks the abstinence rates were no longer different between the treatment groups. Patch users experienced lower total withdrawal scores (P=.002) as well as decreased craving (P<.001), irritability (P<.001), and restlessness (P=.019). Total withdrawal scores were not improved for mint snuff users; however, subsets of total withdrawal scores were lower for cravings (P=.005), irritability (P=.046), and anxiety (P=.012).
Meta-analysis
The Cochrane Database of Systematic Reviews published a meta-analysis of 6 studies that examined NRT or bupropion in smokeless tobacco users.3 The primary outcome for the meta-analysis was tobacco abstinence 6 months or more after the intervention. Neither nicotine patches (odds ratio [OR]=1.16; 95% confidence interval [CI], 0.88–1.54) nor nicotine gum (OR=0.98; 95% CI, 0.59–1.63) were shown to improve abstinence over placebo at 6 months. The authors highlight the need for larger studies that compare different NRT products, doses, and duration.
One small randomized trial of bupropion was included, but it found no effect on tobacco abstention (OR=1.00; 95% CI, 0.23–4.37). Another small RCT found an effect; however, it was excluded from the meta-analysis because subjects were followed for only 3 months. The meta-analysis also concluded that behavioral interventions appear to be effective for increasing tobacco abstinence rates. Results were heterogeneous, and study quality was mixed. One post-hoc finding appeared to show that most effective behavioral interventions were coupled with an oral exam with direct feedback.
Recommendations from others
The United States Department of Health and Human Services recommends that smokeless tobacco users should be treated with the same counseling and interventions utilized for smokers, but commented that evidence is currently insufficient to suggest that NRT increases long-term abstinence.7 British guidelines concluded that no evidence clearly shows that nicotine gum or patches are effective cessation aids for smokeless tobacco users.2
NRT not recommended for smokeless users; try bupropion, behavioral therapy
Patrick O. Smith, PhD
Professor, Family Medicine, University of Mississippi Medical Center
Smokeless tobacco users are a special tobacco user population with a limited research base. Although it seems counterintuitive, nicotine replacement therapy (nicotine gum and the nicotine patch) is not recommended for this population. Using the tobacco use and quit history, treatment may include bupropion while employing standard behavioral therapies: intra-treatment social support, extra-treatment social support, and problem solving skills training. After setting a quit date, prepare the patient for the quit, and following the quit attempt focus on relapse prevention. Frequent follow-up visits provide intra-treatment social support and promotes development of extra-treatment (eg, telephone or computer based quit lines or individuals) social support while providing practical problem solving.
1. Severson HH, Hatsukami D. Smokeless tobacco cessation. Prim Care 1999;26:529-551.
2. West R, McNeill A, Raw M. Smokeless tobacco cessation guidelines for health professionals in England. Br Dent J 2004;196:611-618.
3. Ebbert JO, Rowland LC, Montori V, et al. Interventions for smokeless tobacco use cessation. Cochrane Database Syst Rev 2005;1:130.-
4. Hatsukami D, Anton D, Keenan R, Callies A. Smokeless tobacco abstinence effects and nicotine gum dose. Psychopharmacology 1992;106:60-66.
5. Hatsukami D, Jensen J, Allen S, Grillo M, Bliss R. Effects on behavioral and pharmacological treatment on smokeless tobacco users. J Consult Clin Psychol 1996;64:153-161.
6. Hatsukami DK, Grillo M, Boyle R, et al. Treatment of spit tobacco users with transdermal nicotine system and mint snuff. J Consult Clin Psychol 2000;68:241-249.
7. Treating tobacco use and dependence: a clinical practice guideline. Rockville, Md: US Department of Health and Human Services, Public Health Service. Last updated 2000. Available at: guidelines.gov/summary/summary.aspx?doc_id=2360&nbr=158 6&string=tobacco. Accessed on March 4, 2005.
Nicotine replacement therapy (NRT), including gum and patches, decreases cravings and short-term abstinence rates, but does not improve long-term abstinence (strength of recommendation [SOR]: B, meta-analysis of small randomized controlled studies [RCT]).
It is unclear if bupropion has an effect on cessation rates (SOR: B, small RCTs with conflicting results). Behavioral interventions increase abstinence rates for smokeless tobacco users (SOR: B, meta-analysis of small RCTs).
Evidence summary
Use of smokeless tobacco can lead to nicotine dependence and cause periodontal disease, leukoplakia, cancer, and possibly cardiovascular disease.1-3 Patients who abruptly stop using smokeless tobacco may experience withdrawal symptoms similar to that observed in smokers.3
Nicotine gum
A small double-blind study randomized 79 male smokeless tobacco users to chew nicotine gum (0 mg, 2 mg, or 4 mg) for 5 days.4 Sixty patients completed the study. No significant differences in withdrawal symptoms, including cravings, concentration, or restlessness, were noted among the 3 groups (P>.05). However, further analysis demonstrated that patients with high blood levels of cotinine who received nicotine gum 2 mg experienced decreased cravings compared with placebo (P<.001), and a trend towards decreased cravings with 4 mg gum was noted (P<.06). Limitations of this study: quit rates were not reported, participants did not have to be motivated to quit smokeless tobacco in order to enroll, and it is not known if patients were counseled about the appropriate “chew and park” technique for nicotine gum.
Another study randomized 234 male smokeless tobacco users to receive group behavioral treatment plus nicotine gum 2 mg (B/NRT); group behavioral treatment plus placebo (B/Pl); minimal contact plus nicotine gum 2 mg (MC/NRT); or minimal contact plus placebo (MC/Pl).5
Group behavioral treatment consisted of 8 group counseling sessions 45 to 60 minutes in length; minimal contact involved 4 brief one-on-one sessions with a nurse. Patients chewed a minimum of 6 pieces of nicotine or placebo gum per day.
At 4 weeks, point prevalence abstinence rates were as follows: B/NRT, 63.6%; B/Pl, 66%; MC/NRT, 35.3%; and MC/Pl, 48.1% (P<.01). Abstinence rates remained significantly different at 1 and 6 month follow-ups, but not at 12 months. Post-hoc logistic regression favored group behavioral therapy plus NRT at 6 months. Moreover, survival analysis of continuous prevalence rates demonstrated that the least effective treatment was minimal contact plus NRT.
The authors theorized that nicotine gum may actually worsen risk of relapse in smokeless tobacco users due to behavioral similarities associated with use, but that behavioral treatment may help regain abstinence after a lapse. Gum users experienced lessened withdrawal symptoms including cravings, irritability, anxiety, and difficulty concentrating (P<.01). Results indicate that behavioral interventions may be more effective than NRT; however, low doses of nicotine gum were used.
Nicotine transdermal patches
A randomized double-blind study examined nicotine transdermal patches in smokeless tobacco users.6 Researchers recruited 422 participants from a Minnesota college campus and surrounding metropolitan area through advertisements; they were randomly assigned to nicotine patch plus mint snuff (a nicotine-free product), nicotine patch and no mint snuff, placebo patch plus mint snuff, or placebo patch and no mint snuff. The patch was dosed as 21-mg patch for 6 weeks, 14-mg patch for 2 weeks, and 7-mg patch for 2 weeks. All patients participated in 8 weekly individual 10-minute sessions with a therapist.
Continuous 10-week abstinence rates were 69% for nicotine patch and mint snuff, 58% for nicotine patch and no mint snuff, 46% for placebo patch and mint snuff, and 51% for placebo patch and no mint snuff (P=.002). After 15 weeks the abstinence rates were no longer different between the treatment groups. Patch users experienced lower total withdrawal scores (P=.002) as well as decreased craving (P<.001), irritability (P<.001), and restlessness (P=.019). Total withdrawal scores were not improved for mint snuff users; however, subsets of total withdrawal scores were lower for cravings (P=.005), irritability (P=.046), and anxiety (P=.012).
Meta-analysis
The Cochrane Database of Systematic Reviews published a meta-analysis of 6 studies that examined NRT or bupropion in smokeless tobacco users.3 The primary outcome for the meta-analysis was tobacco abstinence 6 months or more after the intervention. Neither nicotine patches (odds ratio [OR]=1.16; 95% confidence interval [CI], 0.88–1.54) nor nicotine gum (OR=0.98; 95% CI, 0.59–1.63) were shown to improve abstinence over placebo at 6 months. The authors highlight the need for larger studies that compare different NRT products, doses, and duration.
One small randomized trial of bupropion was included, but it found no effect on tobacco abstention (OR=1.00; 95% CI, 0.23–4.37). Another small RCT found an effect; however, it was excluded from the meta-analysis because subjects were followed for only 3 months. The meta-analysis also concluded that behavioral interventions appear to be effective for increasing tobacco abstinence rates. Results were heterogeneous, and study quality was mixed. One post-hoc finding appeared to show that most effective behavioral interventions were coupled with an oral exam with direct feedback.
Recommendations from others
The United States Department of Health and Human Services recommends that smokeless tobacco users should be treated with the same counseling and interventions utilized for smokers, but commented that evidence is currently insufficient to suggest that NRT increases long-term abstinence.7 British guidelines concluded that no evidence clearly shows that nicotine gum or patches are effective cessation aids for smokeless tobacco users.2
NRT not recommended for smokeless users; try bupropion, behavioral therapy
Patrick O. Smith, PhD
Professor, Family Medicine, University of Mississippi Medical Center
Smokeless tobacco users are a special tobacco user population with a limited research base. Although it seems counterintuitive, nicotine replacement therapy (nicotine gum and the nicotine patch) is not recommended for this population. Using the tobacco use and quit history, treatment may include bupropion while employing standard behavioral therapies: intra-treatment social support, extra-treatment social support, and problem solving skills training. After setting a quit date, prepare the patient for the quit, and following the quit attempt focus on relapse prevention. Frequent follow-up visits provide intra-treatment social support and promotes development of extra-treatment (eg, telephone or computer based quit lines or individuals) social support while providing practical problem solving.
Nicotine replacement therapy (NRT), including gum and patches, decreases cravings and short-term abstinence rates, but does not improve long-term abstinence (strength of recommendation [SOR]: B, meta-analysis of small randomized controlled studies [RCT]).
It is unclear if bupropion has an effect on cessation rates (SOR: B, small RCTs with conflicting results). Behavioral interventions increase abstinence rates for smokeless tobacco users (SOR: B, meta-analysis of small RCTs).
Evidence summary
Use of smokeless tobacco can lead to nicotine dependence and cause periodontal disease, leukoplakia, cancer, and possibly cardiovascular disease.1-3 Patients who abruptly stop using smokeless tobacco may experience withdrawal symptoms similar to that observed in smokers.3
Nicotine gum
A small double-blind study randomized 79 male smokeless tobacco users to chew nicotine gum (0 mg, 2 mg, or 4 mg) for 5 days.4 Sixty patients completed the study. No significant differences in withdrawal symptoms, including cravings, concentration, or restlessness, were noted among the 3 groups (P>.05). However, further analysis demonstrated that patients with high blood levels of cotinine who received nicotine gum 2 mg experienced decreased cravings compared with placebo (P<.001), and a trend towards decreased cravings with 4 mg gum was noted (P<.06). Limitations of this study: quit rates were not reported, participants did not have to be motivated to quit smokeless tobacco in order to enroll, and it is not known if patients were counseled about the appropriate “chew and park” technique for nicotine gum.
Another study randomized 234 male smokeless tobacco users to receive group behavioral treatment plus nicotine gum 2 mg (B/NRT); group behavioral treatment plus placebo (B/Pl); minimal contact plus nicotine gum 2 mg (MC/NRT); or minimal contact plus placebo (MC/Pl).5
Group behavioral treatment consisted of 8 group counseling sessions 45 to 60 minutes in length; minimal contact involved 4 brief one-on-one sessions with a nurse. Patients chewed a minimum of 6 pieces of nicotine or placebo gum per day.
At 4 weeks, point prevalence abstinence rates were as follows: B/NRT, 63.6%; B/Pl, 66%; MC/NRT, 35.3%; and MC/Pl, 48.1% (P<.01). Abstinence rates remained significantly different at 1 and 6 month follow-ups, but not at 12 months. Post-hoc logistic regression favored group behavioral therapy plus NRT at 6 months. Moreover, survival analysis of continuous prevalence rates demonstrated that the least effective treatment was minimal contact plus NRT.
The authors theorized that nicotine gum may actually worsen risk of relapse in smokeless tobacco users due to behavioral similarities associated with use, but that behavioral treatment may help regain abstinence after a lapse. Gum users experienced lessened withdrawal symptoms including cravings, irritability, anxiety, and difficulty concentrating (P<.01). Results indicate that behavioral interventions may be more effective than NRT; however, low doses of nicotine gum were used.
Nicotine transdermal patches
A randomized double-blind study examined nicotine transdermal patches in smokeless tobacco users.6 Researchers recruited 422 participants from a Minnesota college campus and surrounding metropolitan area through advertisements; they were randomly assigned to nicotine patch plus mint snuff (a nicotine-free product), nicotine patch and no mint snuff, placebo patch plus mint snuff, or placebo patch and no mint snuff. The patch was dosed as 21-mg patch for 6 weeks, 14-mg patch for 2 weeks, and 7-mg patch for 2 weeks. All patients participated in 8 weekly individual 10-minute sessions with a therapist.
Continuous 10-week abstinence rates were 69% for nicotine patch and mint snuff, 58% for nicotine patch and no mint snuff, 46% for placebo patch and mint snuff, and 51% for placebo patch and no mint snuff (P=.002). After 15 weeks the abstinence rates were no longer different between the treatment groups. Patch users experienced lower total withdrawal scores (P=.002) as well as decreased craving (P<.001), irritability (P<.001), and restlessness (P=.019). Total withdrawal scores were not improved for mint snuff users; however, subsets of total withdrawal scores were lower for cravings (P=.005), irritability (P=.046), and anxiety (P=.012).
Meta-analysis
The Cochrane Database of Systematic Reviews published a meta-analysis of 6 studies that examined NRT or bupropion in smokeless tobacco users.3 The primary outcome for the meta-analysis was tobacco abstinence 6 months or more after the intervention. Neither nicotine patches (odds ratio [OR]=1.16; 95% confidence interval [CI], 0.88–1.54) nor nicotine gum (OR=0.98; 95% CI, 0.59–1.63) were shown to improve abstinence over placebo at 6 months. The authors highlight the need for larger studies that compare different NRT products, doses, and duration.
One small randomized trial of bupropion was included, but it found no effect on tobacco abstention (OR=1.00; 95% CI, 0.23–4.37). Another small RCT found an effect; however, it was excluded from the meta-analysis because subjects were followed for only 3 months. The meta-analysis also concluded that behavioral interventions appear to be effective for increasing tobacco abstinence rates. Results were heterogeneous, and study quality was mixed. One post-hoc finding appeared to show that most effective behavioral interventions were coupled with an oral exam with direct feedback.
Recommendations from others
The United States Department of Health and Human Services recommends that smokeless tobacco users should be treated with the same counseling and interventions utilized for smokers, but commented that evidence is currently insufficient to suggest that NRT increases long-term abstinence.7 British guidelines concluded that no evidence clearly shows that nicotine gum or patches are effective cessation aids for smokeless tobacco users.2
NRT not recommended for smokeless users; try bupropion, behavioral therapy
Patrick O. Smith, PhD
Professor, Family Medicine, University of Mississippi Medical Center
Smokeless tobacco users are a special tobacco user population with a limited research base. Although it seems counterintuitive, nicotine replacement therapy (nicotine gum and the nicotine patch) is not recommended for this population. Using the tobacco use and quit history, treatment may include bupropion while employing standard behavioral therapies: intra-treatment social support, extra-treatment social support, and problem solving skills training. After setting a quit date, prepare the patient for the quit, and following the quit attempt focus on relapse prevention. Frequent follow-up visits provide intra-treatment social support and promotes development of extra-treatment (eg, telephone or computer based quit lines or individuals) social support while providing practical problem solving.
1. Severson HH, Hatsukami D. Smokeless tobacco cessation. Prim Care 1999;26:529-551.
2. West R, McNeill A, Raw M. Smokeless tobacco cessation guidelines for health professionals in England. Br Dent J 2004;196:611-618.
3. Ebbert JO, Rowland LC, Montori V, et al. Interventions for smokeless tobacco use cessation. Cochrane Database Syst Rev 2005;1:130.-
4. Hatsukami D, Anton D, Keenan R, Callies A. Smokeless tobacco abstinence effects and nicotine gum dose. Psychopharmacology 1992;106:60-66.
5. Hatsukami D, Jensen J, Allen S, Grillo M, Bliss R. Effects on behavioral and pharmacological treatment on smokeless tobacco users. J Consult Clin Psychol 1996;64:153-161.
6. Hatsukami DK, Grillo M, Boyle R, et al. Treatment of spit tobacco users with transdermal nicotine system and mint snuff. J Consult Clin Psychol 2000;68:241-249.
7. Treating tobacco use and dependence: a clinical practice guideline. Rockville, Md: US Department of Health and Human Services, Public Health Service. Last updated 2000. Available at: guidelines.gov/summary/summary.aspx?doc_id=2360&nbr=158 6&string=tobacco. Accessed on March 4, 2005.
1. Severson HH, Hatsukami D. Smokeless tobacco cessation. Prim Care 1999;26:529-551.
2. West R, McNeill A, Raw M. Smokeless tobacco cessation guidelines for health professionals in England. Br Dent J 2004;196:611-618.
3. Ebbert JO, Rowland LC, Montori V, et al. Interventions for smokeless tobacco use cessation. Cochrane Database Syst Rev 2005;1:130.-
4. Hatsukami D, Anton D, Keenan R, Callies A. Smokeless tobacco abstinence effects and nicotine gum dose. Psychopharmacology 1992;106:60-66.
5. Hatsukami D, Jensen J, Allen S, Grillo M, Bliss R. Effects on behavioral and pharmacological treatment on smokeless tobacco users. J Consult Clin Psychol 1996;64:153-161.
6. Hatsukami DK, Grillo M, Boyle R, et al. Treatment of spit tobacco users with transdermal nicotine system and mint snuff. J Consult Clin Psychol 2000;68:241-249.
7. Treating tobacco use and dependence: a clinical practice guideline. Rockville, Md: US Department of Health and Human Services, Public Health Service. Last updated 2000. Available at: guidelines.gov/summary/summary.aspx?doc_id=2360&nbr=158 6&string=tobacco. Accessed on March 4, 2005.
Evidence-based answers from the Family Physicians Inquiries Network