Nicotine Patches in Smoking Cessation: A Randomized Trial among Over-the-Counter Customers in Denmark

Abstract

The authors examined the effect of 24-hour nicotine patches in smoking cessation among over-the-counter customers in Denmark, based on a randomized double-blind placebo-controlled trial. Participants were consecutive customers to whom nicotine patches were offered as the only treatment. Forty-two pharmacies in the areas of Aarhus and Copenhagen in Denmark participated in the trial, and 522 customers who smoked 10 or more cigarettes per day were randomized to either nicotine patches or placebo from January to March 1994. Customers with chronic diseases and pregnant or breastfeeding women were excluded from the trial. Twenty-four-hour patches were offered free of charge during a 3-month period. Those smoking 20 or more cigarettes per day started on a dose of 21-mg/day patches. Customers who smoked less started on patches of 14 mg/day; and for all of the participants, the dose was gradually reduced to 7-mg/day patches during the study period. Smoking behavior and compliance were recorded by means of self-administered questionnaires and telephone interviews. Smoking status was recorded in intervals of 4 weeks, which was fixed to be a treatment period, and 26 weeks after inclusion. There was a significant increase in smoking cessation rates after 8 weeks of follow-up but only among smokers who started on 21-mg/day patches. There was a marked placebo effect at each time of contact during the trial, especially in those smoking fewer than 20 cigarettes per day. Although the noncompliance rate was high overall due to discontinuation in the use of patches by relapsed smokers, noncompliance among successful quitters was low. More side effects were seen in the nicotine group than in the placebo group, but none of the reported side effects were serious. It appears that regular healthy smokers who were customers of nonprescribed nicotine patches and who received 21-mg/day nicotine patches benefited from the active treatment (44.1% stopped smoking after 4 weeks), but almost as many stopped smoking in the placebo group (37.3% after 4 weeks). No significant differences in smoking cessation rates were seen among smokers who started with the low-dose nicotine or placebo patches.

Nicotine replacement therapy

“…Smokers may intuitively understand that there is little point in continuing patch treatment if they fail to stop early on, in keeping with findings that smoking within the first week of attempted cessation predicts later failure to quit. 7,[18][19][20] Intermittent use may also be the result of improper instruction or inadequate provider counseling. However, in this study, all participants attended a session with research staff where they were instructed in proper use of the patch.…”

“…Swartz et al, 6 surveying nicotine patch users identified through pharmacy records, showed that persons who used patch daily (as opposed to less frequently) were more likely to be abstinent during patch use, and had 1.6 greater odds of successfully quitting 9 to 12 months later. Sonderskov et al 7 reported that among pharmacy customers in Denmark, adherence to free nicotine patch was 45%, 33%, and 38% at 4, 8, and 12 weeks, respectively, among motivated smokers, and did not differ according to treatment dose. Even when the patch is used, smokers often continue to smoke.…”

Community pharmacy interventions for public health priorities: a systematic review of community pharmacy-delivered smoking, alcohol and weight management interventions

“…There were two alcohol interventions, 46,48 12 smoking cessation interventions, 44,45,[49][50][51][52][53][55][56][57][58][59][60]63 five weight-loss interventions 39,[64][65][66][67] and five multicomponent interventions that included pharmacotherapy and lifestyle changes in participants with comorbidities including dyslipidaemia (n = 1 study), 71 hypertension 72 and type 2 diabetes mellitus (n = 3 studies). [68][69][70] Four studies had multiple publications, one smoking cessation study had an English 63 and a Danish 73 publication; another smoking cessation study 49 had two additional publications including a paper on cost-effectiveness 51 and a paper on shorter-term follow-up. 50 Another smoking cessation study 60 had an additional publication on cost-effectiveness.…”

Efetividade da terapia cognitivo-comportamental na terapêutica do tabagista

“…A recaída deve ser vista diferente do "slip" ou "escorregada", ocasião em que o participante pode "dar uma tragada" aleatória, não se configurando volta à adicção (Sonderskov et al, 1997;Presman et al, 2005).…”

“…Na verdade, não sabia quem eu seria, sem o cigarro na mão". Quando o fumante fica pelo menos um ano abstinente, passa a ser considerado como tendo tido sucesso total no tratamento (Sonderskov et al, 1997;Presman et al, 2005). Assim sendo, nesta amostra, o período de abstinência de pelo menos dez meses e a constatação de que alguns participantes do grupo conseguiram ficar um ano sem fumar, é um resultado muito promissor.…”