A Meta-analysis of the Efficacy of Over-the-counter Nicotine Replacement

Overview

Journal Tob Control

Specialty Psychiatry

Date 2003 Mar 4

PMID 12612357

Citations 71

Authors

J R Hughes

S Shiffman

P Callas

J Zhang

Affiliations

Soon will be listed here.

Abstract

Objective: To determine whether over-the-counter (OTC) nicotine replacement therapy (NRT) is pharmacologically efficacious, whether it produces abstinence rates similar to those in prescription settings, and to estimate the long term (that is, greater than six month) abstinence rate with OTC NRT.

Method: Systematic literature review.

Data Sources: Medline, Psych Abstracts, bibliographies, requests of scientists.

Study Selection: Studies comparing OTC NRT versus OTC placebo or studies comparing OTC NRT versus prescription NRT that reported abstinence rates and for which a full study report was available.

Data Extraction: Two of the authors independently reviewed studies and compared results.

Data Synthesis: Meta-analysis was performed by first testing for homogeneity across studies, then combining odds ratios (ORs) weighting by inverse variance and proportions weighting by study sample size.

Results: One OTC NRT versus OTC placebo nicotine gum study was excluded due to small sample size and different setting. The four remaining studies were randomised trials of nicotine versus placebo patch with ORs of 2.1-3.2. These outcomes were homogenous and when combined resulted in an OR favouring NRT of 2.5 (95% confidence interval (CI) 1.8 to 3.6). Among the two randomised and two non-randomised trials of OTC NRT versus prescription NRT, one small study had an OR of 0.3, two others had ORs of 1.0 and 1.4, and a fourth study had an OR of 3.6. These results were not homogenous; however, when combined via a random effects model the estimated OR was not less than 1.0--that is, OR 1.4 (95% CI 0.6 to 3.3). The long term (that is, greater than six months) quit rates for OTC NRT was 1% and 6% in two studies and 8-11% in five other studies. These results were not homogenous; however, when combined the estimated OR was 7% (95% CI 4% to 11%).

Conclusions: OTC NRT is pharmacologically efficacious and produces modest quit rates similar to that seen in real world prescription practice.

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References

Hays J, Croghan I, Schroeder D, Offord K, Hurt R, Wolter T . Over-the-counter nicotine patch therapy for smoking cessation: results from randomized, double-blind, placebo-controlled, and open label trials. Am J Public Health. 1999; 89(11):1701-7. PMC: 1508975. DOI: 10.2105/ajph.89.11.1701. View

Dey P, Foy R, Woodman M, Fullard B, Gibbs A . Should smoking cessation cost a packet? A pilot randomized controlled trial of the cost-effectiveness of distributing nicotine therapy free of charge. Br J Gen Pract. 1999; 49(439):127-8. PMC: 1313349. View

. State medicaid coverage for tobacco-dependence treatments--United States, 1998 and 2000. MMWR Morb Mortal Wkly Rep. 2001; 50(44):979-82. View

Hughes J . Comorbidity and smoking. Nicotine Tob Res. 2002; 1 Suppl 2:S149-52; discussion S165-6. DOI: 10.1080/14622299050011981. View

Thorndike A, Biener L, Rigotti N . Effect on smoking cessation of switching nicotine replacement therapy to over-the-counter status. Am J Public Health. 2002; 92(3):437-42. PMC: 1447095. DOI: 10.2105/ajph.92.3.437. View

. Biochemical verification of tobacco use and cessation. Nicotine Tob Res. 2002; 4(2):149-59. DOI: 10.1080/14622200210123581. View

Shiffman S, Rolf C, Hellebusch S, Gorsline J, Gorodetzky C, Chiang Y . Real-world efficacy of prescription and over-the-counter nicotine replacement therapy. Addiction. 2002; 97(5):505-16. DOI: 10.1046/j.1360-0443.2002.00141.x. View

Pierce J, Gilpin E . Impact of over-the-counter sales on effectiveness of pharmaceutical aids for smoking cessation. JAMA. 2002; 288(10):1260-4. DOI: 10.1001/jama.288.10.1260. View

Shiffman S, Gorsline J, Gorodetzky C . Efficacy of over-the-counter nicotine patch. Nicotine Tob Res. 2003; 4(4):477-83. DOI: 10.1080/1462220021000018416. View

10.

Schneider N, Jarvik M, Forsythe A, Read L, Elliott M, Schweiger A . Nicotine gum in smoking cessation: a placebo-controlled, double-blind trial. Addict Behav. 1983; 8(3):253-61. DOI: 10.1016/0306-4603(83)90020-5. View

11.

Cohen S, Lichtenstein E, Prochaska J, Rossi J, Gritz E, CARR C . Debunking myths about self-quitting. Evidence from 10 prospective studies of persons who attempt to quit smoking by themselves. Am Psychol. 1989; 44(11):1355-65. DOI: 10.1037//0003-066x.44.11.1355. View

12.

Hughes J, Wadland W, Fenwick J, Lewis J, Bickel W . Effect of cost on the self-administration and efficacy of nicotine gum: a preliminary study. Prev Med. 1991; 20(4):486-96. DOI: 10.1016/0091-7435(91)90046-7. View

13.

Johnson R, Hollis J, Stevens V, Woodson G . Patterns of nicotine gum use in a health maintenance organization. DICP. 1991; 25(7-8):730-5. DOI: 10.1177/106002809102500705. View

14.

Johnson R, Stevens V, Hollis J, Woodson G . Nicotine chewing gum use in the outpatient care setting. J Fam Pract. 1992; 34(1):61-5. View

15.

Velicer W, Prochaska J, Rossi J, Snow M . Assessing outcome in smoking cessation studies. Psychol Bull. 1992; 111(1):23-41. DOI: 10.1037/0033-2909.111.1.23. View

16.

Lichtenstein E, Hollis J . Patient referral to a smoking cessation program: who follows through?. J Fam Pract. 1992; 34(6):739-44. View

17.

Hughes J, Gulliver S, Fenwick J, Valliere W, Cruser K, Pepper S . Smoking cessation among self-quitters. Health Psychol. 1992; 11(5):331-4. DOI: 10.1037//0278-6133.11.5.331. View

18.

Russell M, Stapleton J, Feyerabend C, Wiseman S, Gustavsson G, Sawe U . Targeting heavy smokers in general practice: randomised controlled trial of transdermal nicotine patches. BMJ. 1993; 306(6888):1308-12. PMC: 1677738. DOI: 10.1136/bmj.306.6888.1308. View

19.

Pierce J, Gilpin E, Farkas A . Nicotine patch use in the general population: results from the 1993 California Tobacco Survey. J Natl Cancer Inst. 1995; 87(2):87-93. DOI: 10.1093/jnci/87.2.87. View

20.

Cinciripini P, Lapitsky L, Seay S, Wallfisch A, Kitchens K, Van Vunakis H . The effects of smoking schedules on cessation outcome: can we improve on common methods of gradual and abrupt nicotine withdrawal?. J Consult Clin Psychol. 1995; 63(3):388-99. DOI: 10.1037//0022-006x.63.3.388. View