EVALUATION OF THE EFFECTIVENESS OF FREE NICOTINE PATCH THERAPY IN A CHARITY CLINIC FOR SMOKING CESSATION

Email: wali@ksu.edu.sa ABSTRACT The purpose of this study was to evaluate the efficacy of a free nicotinepatch therapy for smoking cessation in Saudi smokers. A single centered prospective study was carried out in a charity clinic for smoking cessation in Riyadh, Saudi Arabia. A total of 31 subjects who attended the smoking cessation clinic from June 2014 to August 2014 were studied. All participants were male and their mean age was 31.1±6.4 years. The duration of history of smoking was 12.9±6.8 years. The nicotinepatch therapy outcomes were measured at baseline and at 6 weeks after using nicotinepatch therapy. At base line the number of cigarettes per day was 27±10 and carbon monoxide (CO) level was 20.2±8.3. The analyzed statistics revealed that there were significant decreased in the number of cigarette per day (p=0.001) and Carbon Monoxide (CO) level (p=0.001) over 6 weeks of nicotinepatch therapy. After 6 weeks of therapy, abstinence rate was 58 % (verified by CO level) and no serious adverse reactions were documented. The most common side effects were nausea, headache and local irritation sings. In addition, our finding revealed that smokers were likely to suffer from withdrawal symptoms following trying to quit. These withdrawal symptoms include sleep disturbance, loss of concentration and weight gain as well as irritability. Results of this study show that free nicotine-patch therapy is an effective measure for smoking cessation in Saudi population.


INTRODUCTION
Smoking is major public health problem and a condition that leads to increase morbidity and mortality (Fiore et al., 2008).The World Health Organization (WHO) statistics showed more than 5 million of people killed per year due to tobacco use (WHO, 2014).It has been postulated that the number of tobacco-related deaths worldwide in the year 2020 could increase to 8.4 million (Al-Rifi, 2004).Complications related to smoking are cancer, heart disease, stroke, and chronic obstructive pulmonary disease (Preechawong et al., 2011).
Smoking in Saudi Arabia influenced by cultural and environment; the country has history of smoking more than 50 years (Al-Rifi, 2004).Patterns of smoking in Saudi population include cigarette and other smoking pastemixture such as Jurake and mehassel (Al-Arifi et al., 2006) .Consequently, smoking is major public health issue in Saudi Arabia, as it has been estimated that 2.4 -52.4% of Saudi Arabia are smoker (Bassiony, 2009).Among adolescents, the prevalence of current smoking ranges from 15%-30%.(Jarallah et al., 1996;Lam et al., 2005).In addition, smoking is not only dangerous to people but contributing to be social cost.Saudi Arabia spends around $315 million for purchasing tobacco every year (Bassiony, 2009).
The most effective intervention of reducing serious complications in smokers is to quit smoking (Lam et al., 2005).Nicotine-patch therapy is an effective pharmacological assist for smokers attempting to quit, and it has been evidenced as first line treatment for smoking cessation (Xiao et al., 2014).However, limited smoking cessation studies established in Asian populations have been established in China, and Taiwan (Lam et al., 2005;Hsueh et al., 2010, Xiao et al., 2014).In addition, there is little data from the Middle East namely Kingdom of Saudi Arabia focusing on ethnic differences in tobacco dependence, smoking cessation and behavioral aspects of quitting smoking.
Free nicotine patch program has shown significant impact in helping certain ethnicity to quit smoking achieving an abstinence rate of 26.7% in 4 months follow-up period among Asian American population in the United States (Shelley et al., 2010).Several charity and free smoking cessation programs and clinics are available in Saudi Arabia; however, to best of our knowledge, no study was conducted to evaluate the efficacy, safety and tolerability of nicotine-patch therapy programs.Therefore, this study was done to investigate the effectiveness of a free nicotine-patch therapy for smoking cessation in Saudi Arabia.

MATERIAL AND METHODS
The current study was a single centered prospective study to evaluate the efficacy of a free nicotine-patch therapy in Saudi smokers through the period from June 2014 to August 2014.In addition to the efficacy, the safety of nicotine patch was assessed.The subjects were enrolled from a charity clinic for smoking cessation in Riyadh, Saudi Arabia.Any Saudi smoker who ages 18 years or older and smokes at least 10 cigarettes per day was included in the study.Subjects were excluded if subjects: (1) were using tobacco-containing products other than cigarettes;(2) were pregnant women; (3) had cardiovascular diseases; (4) used nicotine NRT within 6 months; (5) had a level of carbon monoxide less than 10 parts per million (ppm); (5) were diagnosed with psychiatric condition.Data collected included: socio-demographic data, physical examination, medical history and vital signs assessed by the clinic physicians, and analysis of an expired carbon monoxide (CO) sample.All these date were taken from patient's profile.

Intervention
The smoking cessation program was a 6week program of free nicotine-patch therapy.Every subject received 21mg per day during the first and second week, 14 mg per day during the third and fourth week and 7mg per day during the fifth and sixth week.Proper application and usage of nicotine patch were delivered to all our study's subjects.The ethical approval was obtained from King Saud University College of Pharmacy.
All participants were informed and briefed on the study.Then, they signed a written consent and scheduled for a medical screening examination.

Measures
Subjects attended the clinic weekly.Evaluations were done at baseline before the intervention of nicotine -patch therapy and at the sixth week visit after completing the treatment regimen.At baseline, data on number of cigarettes per day, CO levels, smoking history and patients' demographic data were obtained.The data collections were repeated after 6 weeks of receiving nicotine-patch therapy.The outcome of the nicotine-patch therapy was measured as changes in the number of cigarettes per day, the CO level, and abstinence rates.In addition, the adverse events were assessed by interviewing the participants.

Safety
The adverse events were assessed by interviewing the participants during their weekly visits.The researchers also reviewed the patient records to determine any adverse events Efficacy Abstinence rates: Smoking abstinence was determined by self-reported cigarette use and verified with a CO level lower than 10 ppm.The assessment of quit smoking included point-prevalence abstinence.The pointprevalence rate of abstinence measured at the 6th-week right after the treatment.Pointprevalence abstinence refers to the percentage of individuals who were not smoking during the previous 7 days (Chen et al., 2002).
CO levels: The CO levels were assessed by having subjects take a deep breath and hold it for 15 seconds before exhaling into a CO monitor (Bedfont Micro Smokerlyzer).Levels lower than 10 ppm was indicator of abstinence.

Statistical analysis
All the data were transferred to the spreadsheet of SPSS version 21 for analysis.Descriptive data were presented as numbers, frequencies, percentages, means and standard deviations.Wilcoxon test was used to analyse the significance of variations before and after intervention.

Baseline characteristics
A total of 31 smokers who fulfilled the inclusion criteria were included in the study.The characteristics of participants are shown in Table I.All participants were male.The mean age of participants was 31.1±6.4years.The duration of history of smoking was 12.9±6.8years.The number of cigarettes per day was 27±10.The CO level was 20.2±8.3.

The outcomes of nicotine patch The number of cigarettes per day
Reduction of the amount of cigarette smoking per day over the 6 weeks period summarized (Table II).The mean number of cigarette at baseline was 27 cigarette per day (SD=10) and at 6 weeks was 12.3(SD=16.3).There was significant reduction in the number of cigarette per day at base line and 6 weeks (p=0.001)from the intervention.

CO level
The CO level is an important measure of the efficacy of nicotine-patch therapy.The mean scores of the CO level pre-intervention and after the intervention was 20.2(SD=8.3),11.1(SD=12.6)respectively (Table II).There was significant reduction in CO level after inter-vention of nicotine-patch therapy (p=0.001).

Abstinence rates
The point-prevalence rates of abstinence from smoking, as verified by CO levels showed that subjects were abstinent at 58 % at 6 weeks (18 of 31 subjects).

Adverse reactions
The majority of adverse reactions reported during the period of study were headache (19.3%), followed by itching (16.1) and redness (12.9).Table 3 shows others adverse reactions were reported.In addition only one participant of non quit smokers had adverse reaction namely headache.
The present study evaluated the effectiveness and safety of nicotine-patch therapy in a population of Saudi Arabia.To our knowledge this was first smoking cessation carried out in Saudi Arabia smokers.The finding of this study revealed that nicotinepatch therapy for smoking cessation appeared to be safe and effective.These findings were consistent with a study evaluated the efficacy a free nicotine-patch program among Chinese American smokers living in New York City (Shelley et al., 2010).A total of 375 subjects from two community-based organizations were enrolled to receive free nicotine patch therapy.Baseline and 4-months follow-up survey were used to determine the abstinence rate.The abstinence rate at 4 months was 26.7%.One of the main outcomes of smoking cessation is abstinence rate.The abstinence rate of this study was 58% at 6 weeks.The abstinence rate had a high effect in smoking cessation through 6 weeks period of nicotine-patch therapy.Our higher abstinence rate was consistent with other studies (Chou et al., 2004;Paoletti et al., 1996), suggesting that the nicotine patch approach promoted smoking cessation in Saudi pupation.This study found positive reduction in the number of cigarettes over 6 weeks.This demonstrated that nicotine patch therapy significantly reduce the daily cigarettes smoking.In addition, the significant reduction in CO level supported the reduction in daily cigarette smoking.The result supports the outcomes of previous studies that nicotinepatch therapy was effective in smoking reduction verified by reduction in CO level s and number of cigarette smoking per day (Joseph et al., 1996;Chou et al., 2004;Batra et al., 2005;Xiao et al., 2014).
This study confirmed the safety of nicotine -patch therapy amongst the Saudi smokers as reflected from the low prevalence of mild symptoms tolerated by Saudi smokers.This study reported 32.2% of side effect including systemic events (headache, nausea) and dermatitis disorders.However, our finding are much lower than those reported (50%) in USA (Transdermal Nicotine Study Group, 1991).Moreover, a similar study was carried out in china aimed to assess safety of nicotine patch in Chinese smokers reported that 26.3 % of subjects had gastrointestinal side effects (Xiao et al., 2014).This study showed that the most common withdrawal symptoms were sleep disturbance, loss of concentration, weight gain and irritability.All these withdrawal symptoms are consistent with several previous  et al.,1984;Hajek et al.,1989;Zhang et al., 2006;Tomson et al., 2006).
Although the findings of study are promising, the efficacy and safety of nicotine patch therapy in Saudi population, it has some limitations.One of the limitations is the participation was restricted to male smokers and limited by small size who attended the Naqa Charity Clinic.Therefore, the results of this study could only represent the situation in Riyadh city.Another limitation is the shortterm follow-up of the smoking cessation and reducing rates.Thus, an extended time followup may be needed to demonstrate longitudinal benefits from the nicotine-patch therapy.

CONCLUSION
This study reported initial data on the safety and efficacy of nicotine patch therapy in Saudi population.The main contribution of this study showed that nicotine patch therapy can be an important adjunct to smoking cessation in Saudi smokers.Six -week abstinence rate showed higher effect after the use of nicotinepatch therapy.

Table I .
The characteristics of participants(n = 31)

Table II .
The outcomes of nicotine patch therapy(n = 31)

Table IV .
Numbers of participants reporting withdrawal symptoms of smoking