American Journal of Epidemiology Copyright O 1997 by The Johns Hopkins University School of Hygiene and Public Health All rights reserved Vol. 145, No. 4 Printed In U.SA. Nicotine Patches in Smoking Cessation: A Randomized Trial among Over-the-Counter Customers in Denmark Jette Sonderskov, 1 Jom Olsen, 1 - 2 Svend Sabroe, 1 Lucette Meillier, 1 and Kim Overvad 1 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. Am J Epidemiol 1997;145:309-18. drug administration routes; drugs, non-prescription; nicotine; placebo effect; randomized controlled trials; smoking cessation Cigarette smoking is the single most important pre- ventable cause of cancer and premature death (1), and 20 percent of all deaths in developed countries are presently attributed to tobacco smoking (2). Conse- quently, smoking cessation has a high priority in pre- ventive health; and several strategies have been ap- plied, such as public information campaigns on health consequences of smoking and suggestions concerning change in smoking behavior, high taxation on ciga- rettes, restriction on tobacco advertising and promo- tional activities, enforced prohibition on sale of to- bacco products to underaged youth, tobacco-free Received for publication June 16, 1995, and accepted for pub- lication October 2, 1996. 1 Department of Epidemiology and Social Medicine, University of Aarhus, Aarhus, Denmark. 2 Danish Epidemiology Science Centre, Aarhus, Denmark. Reprint requests to Dr. Jom Olsen, Department of Epidemiology and Social Medicine, University of Aarhus, Norrebrogade 44, Build- ing 2C, DK-8000 Aarhus C, Denmark. schools and workplaces, and tobacco education pro- grams in schools. Several types of individual interven- tions have been implemented, e.g., self-help manuals and advice/therapy or group programs in smoking cessation clinics or at workplaces headed by physi- cians or psychologists; and these interventions have had varying success (3-9). From the 1920s to the 1940s, several investigators assumed that nicotine was responsible for the compulsive use of tobacco among smokers (10), and additional data supported this the- ory (10). From the 1950s, the health consequences of smoking were documented (11-16); however, a phar- macologic aid in smoking cessation, nicotine gum, was not launched until 1973 (17). Since then, other nicotine replacement methods (10, 18-22) have been developed to relieve nicotine withdrawal symptoms, such as nicotine gum, patches, and nasal sprays. During the late 1980s and the early 1990s, the efficacy of nicotine replacement therapy compared 309 Downloaded from https://academic.oup.com/aje/article-abstract/145/4/309/69028 by guest on 25 December 2017
Transcript
American Journal of EpidemiologyCopyright O 1997 by The Johns Hopkins University School of Hygiene and Public HealthAll rights reserved
Vol. 145, No. 4Printed In U.SA.
Nicotine Patches in Smoking Cessation: A Randomized Trial amongOver-the-Counter Customers in Denmark
Jette Sonderskov,1 Jom Olsen,1-2 Svend Sabroe,1 Lucette Meillier,1 and Kim Overvad1
The authors examined the effect of 24-hour nicotine patches in smoking cessation among over-the-countercustomers in Denmark, based on a randomized double-blind placebo-controlled trial. Participants wereconsecutive customers to whom nicotine patches were offered as the only treatment. Forty-two pharmaciesin the areas of Aarhus and Copenhagen in Denmark participated in the trial, and 522 customers who smoked10 or more cigarettes per day were randomized to either nicotine patches or placebo from January to March1994. 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 morecigarettes per day started on a dose of 21-mg/day patches. Customers who smoked less started on patchesof 14 mg/day; and for all of the participants, the dose was gradually reduced to 7-mg/day patches during thestudy period. Smoking behavior and compliance were recorded by means of self-administered questionnairesand telephone interviews. Smoking status was recorded in intervals of 4 weeks, which was fixed to be atreatment period, and 26 weeks after inclusion. There was a significant increase in smoking cessation ratesafter 8 weeks of follow-up but only among smokers who started on 21-mg/day patches. There was a markedplacebo effect at each time of contact during the trial, especially in those smoking fewer than 20 cigarettes perday. Although the noncompliance rate was high overall due to discontinuation in the use of patches byrelapsed smokers, noncompliance among successful quitters was low. More side effects were seen in thenicotine group than in the placebo group, but none of the reported side effects were serious. It appears thatregular healthy smokers who were customers of nonprescribed nicotine patches and who received 21-mg/daynicotine patches benefited from the active treatment (44.1% stopped smoking after 4 weeks), but almost asmany stopped smoking in the placebo group (37.3% after 4 weeks). No significant differences in smokingcessation rates were seen among smokers who started with the low-dose nicotine or placebo patches. Am JEpidemiol 1997;145:309-18.
Cigarette smoking is the single most important pre-ventable cause of cancer and premature death (1), and20 percent of all deaths in developed countries arepresently attributed to tobacco smoking (2). Conse-quently, smoking cessation has a high priority in pre-ventive health; and several strategies have been ap-plied, such as public information campaigns on healthconsequences of smoking and suggestions concerningchange in smoking behavior, high taxation on ciga-rettes, restriction on tobacco advertising and promo-tional activities, enforced prohibition on sale of to-bacco products to underaged youth, tobacco-free
Received for publication June 16, 1995, and accepted for pub-lication October 2, 1996.
1 Department of Epidemiology and Social Medicine, University ofAarhus, Aarhus, Denmark.
2 Danish Epidemiology Science Centre, Aarhus, Denmark.Reprint requests to Dr. Jom Olsen, Department of Epidemiology
and Social Medicine, University of Aarhus, Norrebrogade 44, Build-ing 2C, DK-8000 Aarhus C, Denmark.
schools and workplaces, and tobacco education pro-grams in schools. Several types of individual interven-tions have been implemented, e.g., self-help manualsand advice/therapy or group programs in smokingcessation clinics or at workplaces headed by physi-cians or psychologists; and these interventions havehad varying success (3-9). From the 1920s to the1940s, several investigators assumed that nicotine wasresponsible for the compulsive use of tobacco amongsmokers (10), and additional data supported this the-ory (10). From the 1950s, the health consequences ofsmoking were documented (11-16); however, a phar-macologic aid in smoking cessation, nicotine gum,was not launched until 1973 (17). Since then, othernicotine replacement methods (10, 18-22) have beendeveloped to relieve nicotine withdrawal symptoms,such as nicotine gum, patches, and nasal sprays.
During the late 1980s and the early 1990s, theefficacy of nicotine replacement therapy compared
309
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310 Sonderskov et al.
with placebo treatment has been examined in a numberof trials. Meta-analyses evaluating the potency of nic-otine gum showed a decrease in efficacy over timewhen used in low-intervention smoking cessation pro-grams, such as programs implemented in a generalpractice setting (23, 24). Efficacy was greater whencombined with intensive programs in specializedsmoking cessation clinics (24, 25).
Nicotine gum does have unpleasant side effects(20), and so as an alternative delivery system, thenicotine patch was developed in 1984. Absorption ofnicotine from the patches is transdermal, and contraryto the nicotine gum, the plasma level of nicotine isconstant during the period of use. Better compliance isexpected because it is easier to use (18-20).
The effect of nicotine patches has been evaluated inrandomized placebo-controlled trials in volunteers re-cruited by public advertisements or by invitation. Ingeneral, the method appears to work independently ofthe trial settings (26-28), even with little counseling(28, 29).
Until recently, nicotine patches were sold only byprescription in most countries. However, over-the-counter sale has been permitted in Denmark sinceDecember 1991. Studies estimating the value of nic-otine patches in an over-the-counter situation areneeded, especially since use without counseling orsupport could be applied on a large scale.
The first objective of the present study was to esti-mate short-term smoking cessation rates among con-secutively selected customers of nicotine patches at anumber of pharmacies in Denmark. The intention wasto evaluate smoking cessation by means of nicotinepatches as close to a real-life situation of over-the-counter use as possible. No additional smoking cessa-tion methods or use of biomarkers to determine smok-ing status were applied.
The second objective of the study was to evaluatesmoking cessation on a long-term basis.
MATERIALS AND METHODS
The study was a randomized double-blind placebo-controlled trial aimed at obtaining two groups, eachwith approximately 250 customers. The trial was car-ried out in collaboration with the Department of Epi-demiology and Social Medicine, University of Aarhus,Denmark, and Ciba-Geigy, Inc., Denmark. The De-partment of Epidemiology and Social Medicine wasresponsible for collecting, analyzing, and reporting thedata; and Ciba-Geigy monitored the study at the phar-macies.
Setting and study participants
Recruitment of customers took place at 42 pharma-cies in the areas of Aarhus and Copenhagen (equiva-lent to about 20 percent of all pharmacies in Denmark)from January to March 1994. No public announcementof the trial was made; and to minimize talk about thestudy among people, it was decided to spread the firstday of inclusion for the participating pharmacies overa 3-week period. Furthermore, only a few participantswere included from sparsely populated areas. All 18-year-old or older customers at the pharmacy who haddecided to buy 24-hour nicotine patches and whosmoked at least 10 cigarettes per day (inclusion crite-ria) were asked to join the study, and they were offeredthe patches free of charge. Information about potentialparticipants was obtained by self-reported medical his-tory. Pregnant or breastfeeding women and customerswith cardiovascular disease, endocrine disease, diabe-tes, peptic ulcer, or reduced kidney or liver functionwere excluded from the trial (exclusion criteria).
Potential candidates were asked to give oral andwritten consent and to refrain from using any othernicotine products during the trial, in accordance withtrial conditions set forth by the Danish National Boardof Health. Among the 573 registered customers whofulfilled the inclusion criteria, 522 gave informed con-sent and were randomized by means of randomizedsequential treatment packages. Details of the studypopulation and the outcome of randomization are de-scribed in table 1.
For practical reasons, four employees from Ciba-Geigy, Inc., provided instructions concerning the trialprocedure for the staff at the participating pharmaciesand distributed trial patches to the participating phar-macies. A Ciba-Geigy employee was in contact withthe participating pharmacies at least once a week.Selected pharmacists at each participating pharmacywere responsible for recruiting and dispensing thepatches to trial members.
Treatment
Twenty-four-hour nicotine patches (Nicotinell)were provided for a 12-week period equivalent to threetreatment periods. Customers who smoked 20 ciga-rettes or more per day were randomized to use one21-mg/day patch per day during the first 4 weeksequivalent to one treatment period (active patchesrelease 21 mg of nicotine in 24 hours), 14-mg/daypatches (14 mg of nicotine/24 hours) during the sec-ond 4-week treatment period, and 7-mg/day patches (7mg of nicotine/24 hours) during the final 4 weeks.Smokers of fewer than 20 cigarettes per day used14-mg/day patches during the first two treatment pe-
Am J Epidemiol Vol. 145, No. 4, 1997
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46.2
56.3
48.1
38
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46.1
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48.3
53.8
43
.75
1.9
49
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53.9
51
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62.5
(ran
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19.5
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61 75 50 42
44 41 57 37 2 9
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52.7
39
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57.1
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312 Sonderskov et al.
nods (8 weeks), and 7-mg/day patches during the finaltreatment period. To ensure that the nicotine and pla-cebo patches were identical in terms of color and odor,the placebo patches contained a pharmacologicallynegligible amount of nicotine.
Randomization was selected within the two smok-ing levels. Instructions for proper use of patches weregiven orally and in writing at the pharmacies. Partic-ipants were asked to change the application site of thepatch every day, and patches were handed out in4-week packages equivalent to one treatment period inthis study.
Three patch sizes constituted the dose treatment ofNicotinell patches available in public sale in Denmarkat that time. The routine treatment procedure wasrecommended by the pharmaceutical firm and subse-quently tested and used in the trial.
Data
Each customer completed a questionnaire at thepharmacy on the day of randomization. Subsequentquestionnaires were mailed from the Department ofEpidemiology and Social Medicine to the participantsin weeks 3 and 7 of the 12-week treatment period andreturned in closed envelopes to the pharmacies inweeks 4 and 8, when participants collected patches forthe next treatment period. The questionnaires wereimmediately mailed to the Department of Epidemiol-ogy and Social Medicine. Telephone interviews wereconducted by two trained interviewers in weeks 12 and26 or whenever participants dropped out of the trial orreported any side effects.
Data on sociodemographic characteristics, numberof previous quit attempts, smoking history, and nico-tine dependency (estimated by Fagerstrom's ToleranceQuestionnaire) (30) were collected at the time of ran-domization. Information was collected at each point ofcontact throughout the trial period on smoking statusduring the trial, smoking while using the patches, otherkinds of intervention, side effects, and continuous andinterrupted use of patches.
Records were kept when dropouts either were ab-sent at the expected time of collecting patches at thepharmacies or reported discontinued use of patches inthe questionnaire. It was documented when a partici-pant dropped out because of relapse, discontinued useof the patches, or reported side effects or a lack ofperceived effect of the treatment. At the time of thedropout, current smoking status was recorded, andnonsmokers were contacted in week 26 to collectinformation on smoking behavior.
Successful smoking cessation was defined in theprotocol as 1) no reported smoking during a 4-weektreatment period; or 2) one episode of slip, which was
defined as less than 6 days of smoking within a 4-weekperiod (31). After each 4-week period of follow-up,the point prevalence of smoking was measured.
Relapse was defined as 7 consecutive days of smok-ing one or more cigarettes (31). Compliance was usedto indicate the extent to which the recommended treat-ment procedure was followed.
Analyses
The results were analyzed according to the "inten-tion to treat" principle and by means of the x2 test andthe Mantel-Haenszel trend test (16). Bivariate, sur-vival, and logistic regression analyses were conductedin SPSS/PC + advanced statistics 4.0. The level ofstatistical significance was set at 0.05 and all confi-dence intervals as 95 percent. The blinding procedurewas not broken until all main results were tabulated.Participants lost to follow-up (n = 19) were classifiedas smokers.
RESULTS
The main results of the study are presented in table2. In the nicotine patch group, more smokers stoppedsmoking than in the placebo group; however, the dif-ference was statistically significant only among par-ticipants who started on 21-mg/day patches and onlyafter 8 weeks of follow-up. In combined analyses, thepoint prevalence of nonsmokers decreased from 50percent after 4 weeks to 17 percent after 26 weeks inthe nicotine group; the corresponding values in theplacebo group were 44 percent and 11 percent, respec-tively.
When similar analyses were made using total absti-nence to classify nonsmokers, the prevalence of non-smokers in the combined group decreased for thenicotine treated from 22 percent after 4 weeks to 8percent after 26 weeks, compared with 17 percent and5 percent in the placebo group. The relative smokingcessation prevalence proportions were 1.27 (95 per-cent confidence interval 0.89-1.81) after 4 weeks and1.83 (0.92-3.65) after 26 weeks.
In table 3 can be seen a statistically significant andmoderately better treatment effect among participantstreated with 14-mg/day nicotine patches who had 11 ormore previous quit attempts. No effect of nicotinetreatment can also be seen in relation to duration ofprevious smoking, daily cigarette consumption, and ahigh nicotine dependency score ("FTQ score") regard-less of starting dose. Furthermore, no differences insmoking cessation rates among men and women ac-cording to starting dose and treatment were found. Ina combined analysis of the treatment groups, a mod-
Am J Epidemiol Vol. 145, No. 4, 1997
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Nicotine Patches in Smoking Cessation 313
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erately better treatment effect among women was ob-served, albeit not statistically significant.
As shown in table 4, poor compliance in both groups(less than half used the patches as scheduled in theprotocol) was mainly due to the fact that relapsedsmokers stopped using the patches. Noncomplianceamong the remaining nonsmoking trial members wasmuch smaller throughout the treatment period, 11.4and 12.0 percent in the nicotine and placebo groups,respectively. Compliance results according to initialtreatment dose do not differ from the combined resultin table 4.
During each 4-week treatment period, skin reactionsand minor central nervous system reactions (sleepdisturbance, headache, dizziness) were more frequentin the nicotine group (table 5). Skin reactions in-creased with time, but none of the side effects wereserious or led to hospitalization. Side effects were,however, one of the main reasons reported for drop-ping out in the nicotine group (apart from no perceivedeffect of treatment and relapse); this was not seen inthe placebo group (table 6).
DISCUSSION
Most smoking cessation trials using transdermalpatches have been implemented in clinical and generalpractice settings among volunteers recruited throughlocal advertisements; most of these trials have shownbetter effects from nicotine than placebo patches (18,32-41). In general, the difference in abstinence ratesbetween the nicotine and the placebo-treated groups atthe end of the treatment period is more pronounced inclinical trials than in general practice trials due to astronger placebo effect in trials carried out in generalpractice (18, 28, 32-41). The previously publishedresults indicate that nicotine patches are effective insmoking cessation in clinical settings. These studiesdo not provide information on the effectiveness ofpatches when used in public health. One survey with a6-month follow-up period and self-reported data con-ducted among a large "real-world" population of el-derly, low-income transdermal nicotine users whofilled prescriptions through the Pennsylvania Pharma-ceutical Assistance Plan tried to describe the pattern ofuse and outcome of transdermal nicotine therapy inrelation to other types of intervention. The resultsindicated that a comprehensive support system andproper patient instruction in patch use were needed toobtain a higher rate of quitters in the population (42).
The present study was designed to evaluate theefficacy of nicotine patches in an over-the-counterenvironment without additional support. For that rea-son, no biomarkers or diaries were used to estimate
Am J Epidemiol Vol. 145, No. 4, 1997
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Nicotine Patches in Smoking Cessation 315
TABLE 4. Compliance according to treatment among pharmacy customers who made over-the-counterpurchases In Aarhus and Copenhagen, Denmark, January to March 1994
TABLE 5. Side effects according to treatment of pharmacy customers who made over-the-counter purchases in Aarhus andCopenhagen, Denmark, January to March 1994
Type ofskJeeffectet
ReactJon after 4 weeksSkinGastrointestinalCentral nervous systemCardiac
Reaction after 8 weeksSkinGastrointestinalCentral nervous systemCardiac
Reaction after 12 weeksSkinGastrointestinalCentral nervous systemCardiac
No.*
255
156
96
Nicotine patch
Stated side effects
75 (29.4)7(2.7)
19(7.5)1 (0.4)
61 (39.1)1 (0.6)4 (2.6)1 (0.6)
42 (43.8)4 (4.2)
11 (11.5)2(2.1)
Placebo patch
^ + Stated side effects
26749(18.4)
9 (3.4)7 (2.6)4(1.5)
15434(22.1)5 (3.2)2(1.3)2(1.3)
9731 (32.0)
4(4.1)1 (1.0)1 (1.0)
PPR§
1.600.812.840.26
1.770.201.970.44
1.371.01
11.12.02
95%CI§
1.17-2.20*0.31-2.151.22-6.65*0.03-2.33
1.24-2.53*0.02-1.670.37-10.620.05-5.39
0.93-1.970.26-3.921.46-84.39*0.19-21.92
• p < 0.05.t Reactions are categorized as follows: skin—Itching, erythema, skin eruption, allergic reaction; gastrointestinal—nausea, vomiting,
diarrhea, constipation, flatulence, abdominal pain, dry mouth, abnormalities of salivation and taste; central nervous system—sleepdisturbance, headache, dizziness; cardiac—palpitation, chest pain.
X Number of trial members at the beginning of the period.§ PPR, prevalence proportion ratio; Cl, confidence Interval.
smoking status, and no psychological or behavioralsupport was added to the pharmacologic treatment.
Our results concerning smoking cessation amongsmokers treated with nicotine patches were similar tothose in previous papers (18, 28, 32-35, 38-41), butthe placebo effect in the present study was strongerthan in most other studies (28, 32, 37), especially forthose who smoked fewer than 20 cigarettes per day atinclusion. Smokers participating in our study wereprobably highly motivated since trial members werepotential customers who had decided to invest in anexpensive treatment (in Denmark, a 1-month supply ofNicotinell patches costs $120), which perhaps couldexplain the high placebo effect. In contrast to othertrials in this field, there were no advertisements forpotential trial candidates, and the fact that the patcheswere provided free of charge was not announced inadvance to avoid less motivated customers in the trial.
The lack of effect, especially in the group thatstarted on the low-dose treatment, might be due to
insufficient nicotine supply to meet their nicotineneed. The distribution of the Fagerstrom's ToleranceQuestionnaire score (30) showed substantial overlapbetween those who started on the 21- and the 14-mg/day doses. Of those who started on the 14-mg/daydose, 40 percent had a Fagerstrom's Tolerance Ques-tionnaire score (30) of more than 6 (figure 1), perhapsdue to an unintended underreporting of smoking at thebeginning of the trial or to a recently reduced dailycigarette consumption. Nicotine dependency estimatedby the Fagerstrom Tolerance Questionnaire may per-haps be a better way of allocating smokers to theproper treatment level than asking for the daily num-ber of cigarettes at the time of trial inclusion.
An effect of the nicotine patch was observed amongparticipants treated with 21-mg/day nicotine patcheswho had a Fagerstrom's Tolerance Questionnairescore between 7 and 11 points, whereas no effect ofthe nicotine patches was observed among participantstreated with 14 mg/day and a similar Fagerstrom's
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316 Sonderskov et al.
TABLE 6. Reasons for leaving the smoking cessation study according to treatment of phannacycustomers who made over-the-counter purchases In Aarhus and Copenhagen, Denmark, January toMarch 1994
Reason
0-4 weeksStarted to smokeNo perceived need for treatmentSide effectNo perceived effect of treatmentOther reasonNo stated reasonAll
5-8 weeksStarted to smokeNo perceived need for treatmentSide effectNo perceived effect of treatmentOther reasonNo stated reasonAll
9-12 weeksStarted to smokeNo perceived need for treatmentSide effectNo perceived effect of treatmentOther reasonNo stated reasonAll
Tolerance Questionnaire score. The randomization ap-parently produced two comparable groups, and only19 randomized customers were lost to follow-up.
Logistic regression controlling for gender, age,Fagerstrom's Tolerance Questionnaire score, phar-macy effect, age when started smoking, starting dose,
a
11
20 cm • 3 0 cm'FIGURE 1. Fagerstrom's score for the Nicotinell group, Aarhus and Copenhagen, Denmark, January to March 1994.
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Nicotine Patches in Smoking Cessation 317
school and vocational education was done but did notchange the point estimate toward a significant resultinasmuch as the analysis showed an odds ratio of 1.32(95 percent confidence interval 0.82-1.64).
All attempts were made to blind the treatment dur-ing the trial and in the analyses. However, of theplacebo-treated participants, more than expected ac-cording to the null hypothesis guessed the type oftreatment at the end of the treatment period (table 7).The effect of such a blinding failure would probablybe a reduction of the placebo effect.
The low compliance in our study was expected sinceno one encouraged the relapsed smokers to continueuse of the patches. On the contrary, they were warnedagainst getting too much nicotine, and they had topromise at entry not to use additional nicotine productswhile using the patches.
Our data on smoking are probably reliable sincesmoking status was recorded in self-administeredquestionnaires, by telephone interviews conducted by"neutral" interviewers, and without any social pressureto provide specific answers. Furthermore, the use ofbiomarkers would not eliminate the impact of nondif-ferential misclassification since these methods have arather low sensitivity (43, 44). Furthermore, smokingis socially more acceptable in Denmark than in mostother countries, and different studies of smoking be-havior among Danes have shown reliable self-reportedsmoking data (45-47).
This trial suggests that transdermal nicotine treat-ment in an over-the-counter situation should probablybe allocated according to a nicotine dependency score.The trial also indicates that the success rate of over-the-counter use of patches was better than expected,especially among the placebo-treated; however, thedifference in outcome between the two treatmentgroups was smaller than in most other trials withnicotine patches. Transdermal nicotine treatment ap-pears to be relatively safe when used in a populationwithout any contraindication, and the current study
TABLE 7. Evaluation* of the blinding procedure In asmoking cessation study of pharmacy customers who madeover-the-counter purchases In Aarhus and Copenhagen,Denmark, January to March 1994
Guesst
Nicotine patchPlacebo patchDo not know
Actual
Nicotine patch
No.
759773
%
30.639.629.8
use
Placebo patch
No.
4713971
%
18.354.127.6
*p= 0.001; df = 2.t Self-reported guessing of which treatment study participants
received according to actual treatment.
indicates that it is possible to administer this treatmentin a pharmacy setting.
ACKNOWLEDGMENTS
This study was partly funded by Ciba-Geigy, which alsosupplied the nicotine and placebo patches.
The authors thank Gitte Bj0rn0 and Annemette Chris-tensen, who conducted the interviews; Annemette Chris-tensen, who coordinated data collection and prepared themanuscript; and Marianne Godt Hansen, who was respon-sible for language revision of the manuscript.
The study was approved by the Regional Ethics Commit-tee in the County of Aarhus and by the National Board ofHealth, and it met the standards set by the Declaration ofHelsinki and the Good Clinical Practice Guidelines.
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