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A Controlled Trial of Sustained-Release Bupropion, a Nicotine Patch, or Both for Smoking Cessation. Smoking is the silent killer of the 20 th century more people died from smoking and smoking related illness in the past hundred years than in all the major wars. The situation used to be one of ignorance people did not realise the ill-effects of their habit on their health and the health of those around them. Today the situation has changed most realise the danger but many are addicted and find it extremely difficult to quit. Nicotine is a drug and like most is highly addictive it is a craving for this nicotine which makes it difficult to suddenly stop smoking, hence the introduction of nicotine replacement therapy. The release of nicotine or some similar substance delivers the nicotine to the body without the harmful tar of smoke inhalation hence relieving some of the craving intensity.
Use of such nicotine-replacement therapies is thought to help people quit smoking. The study detailed above was undertaken to determine the effectiveness of such nicotine replacement therapies on smoking subjects, and monitor side effects (if any). The study combines nicotine release patches with an antidepressant bupropion (a combination now used pharmaceutical ly). Jornby et al. (1) conducted a double-blind, placebo-controlled comparison of sustained-release bupropion, a nicotine patch, bupropion and a nicotine patch, and placebo for smoking cessation. They excluded smokers with any clinical depression. Treatment consisted of nine weeks of bupropion (150 mg a day for the first three days, and then 150 mg twice daily) or placebo, as well as eight weeks of nicotine-patch therapy (21 mg per day during weeks 2 through 7, 14 mg per day during week 8, and 7 mg per day during week 9) or placebo.
The target day for quitting smoking was usually day 8. They used 893 people (from an original 1182) who each smoked at least 15 cigarettes per day, recruited through media and allocated randomly to the relevant group. 244 subjects received sustained release bupropion 244 subjects received a nicotine patch 245 subjects received bupropion and a nicotine patch 160 subjects received a placebo The study deals with both the immediate cessation of smoking and also makes measure of levels of depression (directly linked to likelihood of smoking resumption) (Hurt et al (2) showed conclusively that bupropion administered exclusively resulted in a 23 % long term success rate, hence linking affect or mood to probability of success. ) The portion of the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV), concerning mood disorders was used to assess whether subjects had mood disorders. The Beck Depression Inventory (3) assesses the severity of depression. This was astutely combined with measures of insomnia, dizziness, dream abnormalities, nausea, and such to determine any side effects and their contribution to either aid or increase difficulty of quitting. Secondary outcome measures included withdrawal symptoms, body weight, and Beck Depression Inventory scores. Guidelines for classification of having quit smoking were required and these were the same used by Hurt et al (2); Subjects were considered to be abstinent if they reported not smoking since the preceding clinic visit and had an expired carbon monoxide concentration of 10 ppm or less.
A total of 311 subjects (34. 8 percent) discontinued one or both medications. Seventy-nine subjects stopped treatment because of adverse events: 6 in the placebo group, 16 in the nicotine-patch group, 29 in the bupropion group, and 28 in the combined-treatment group. The most common adverse events were insomnia and headache. The results obtained were measured until the end of 12 months to measure long term abstinence. The abstinence rates at 12 months were 15. 6 percent in the placebo group, as compared with 16. 4 percent in the nicotine-patch group, 30. 3 percent in the bupropion group, and 35. 5 percent in the group given bupropion and the nicotine patch. In terms of the secondary outcome measures, the following was observed: By week 7, subjects in the placebo group had gained an average of 2. 1 kg, as compared with a gain of 1. 6 kg in the nicotine-patch group, a gain of 1. 7 kg in the bupropion group, and a gain of 1. 1 kg in the combined-treatment group.
Hence weight gain at seven weeks was significantly less in the combined-treatment group than in the bupropion group and the placebo group. The fundamental ideas of the study were statistically demonstrated, and were consistent with previous similar studies. They found that treatment with sustained-release bupropion alone or in combination with a nicotine patch resulted in significantly higher long-term rates of smoking cessation than use of either the nicotine patch alone or placebo. Abstinence rates were higher with combination therapy than with bupropion alone, but the difference was not statistically significant. Treatment with both bupropion and the nicotine patch was not significantly better than treatment with bupropion alone. As compared with the use of placebo, treatment with the nicotine patch, the nicotine patch and bupropion, and bupropion alone all resulted in less severe withdrawal symptoms and less weight gain after smoking cessation.
Hurt et al (2) also proved that bupropion and nicotine-replacement therapies can reduce weight gain after smoking cessation. The study details expected results close to the anticipated results based on previous studies of similar nature (including Hurt et al and previous Jornby et al). The study falls short I believe in its failure to include different methods of nicotine delivery including nicotine release chewing gum and nicotine inhalation via nasal inhaler spray. Both of these methods are used extensively and they are a relevant a means of nicotine delivery as trans-dermal nicotine patches. All members of the study were recruited through media and were all volunteers, which means that they may not represent a true spectrum of the smoking population. It was also found that statistically the levels of long term abstinence did not differ considerably between the bupropion and nicotine / bupropion combination groups but that secondary outcome measures between these two groups differed significantly.
This could lead to complications arising from long term use of either or both in combination and should be investigated. One curious result is the odds ratio for the final comparison between the nicotine patch therapy and placebo group at the end of one year was 1. 1, similar to values reported in previous work (Hurt et al (2) ). However, statistical analysis of point-prevalence data clearly shows no significant differences at all between the placebo and nicotine patch during follow-up period. It is unclear as to why the nicotine patch would have produced a weak effect according to the statistical point-prevalence analysis. This study draws heavily on previous study; Fiore MC, Bailey WC, Cohen SC, et al. Smoking cessation.
Clinical practice guideline no. 18 (5) according to which 70 - 80 percent of smokers who use nicotine substitutes resume smoking in the long term. This is the predominant basis for the inclusion of the antidepressant bupropion in this study and is the same basis for the results obtained by Hurt et al (2) on their use of an antidepressant, the liberal use of such antidepressants raise ethical issues like the possible long term addiction or abuse of these substances once made largely available, their availability, and the regulation of their distribution all need to be thoroughly considered before they are released to the public, lest we run the risk of trading one addiction for another. References 1. Jornby, Douglas E. ; Leischow, Scott J. ; Nides, Mitchell A, et al. ; A Controlled Trial of Sustained-Release Bupropion, a Nicotine Patch, or Both for Smoking Cessation. The New England Journal of Medicine; Volume 340 (9) 4 March 1999 pp 685 - 691 2.
Hurt RD, Sachs DPL, Glover ED, et al. A comparison of sustained-release bupropion and placebo for smoking cessation. N Engl J Med 1997; 337: 1195 - 202. 3. Beck AT, Steer RA.
Beck Depression Inventory. Philadelphia: Center for Cognitive Therapy, 1978 4. Diagnostic and statistical manual of mental disorders, 4 th ed. : DSM-IV. Washington, D. C. : American Psychiatric Association, 1994. 5. Fiore MC, Bailey WC, Cohen SC, et al.
Smoking cessation. Clinical practice guideline no. 18. Rockville, Md. : Agency for Health Care Policy and Research, April 1996. (AHCPR publication no. 96 - 0692. )
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