Silver acetate gum as a deterrent to smoking. Effects of a 2.5-mg silver acetate lozenge on initial and long-term smoking cessation. Effect of nicotine, silver acetate, and ordinary chewing gum in combination with group counselling on smoking cessation. The effect of nicotine, silver acetate, and placebo chewing gum on the cessation of smoking. The influence of smoking type and nicotine dependence. The impact of pharmaceutical company funding on results of randomized trials of nicotine replacement therapy for smoking cessation: a meta-analysis. High-dose nicotine patch therapy. Percentage of replacement and smoking cessation. [Randomized clinical trial: effectiveness of the cognitive-behavioral approach and the use of nicotine replacement transdermal patches for smoking cessation among adults in Rio de Janeiro, Brazil]. Effectiveness of a nurse-managed, lay-led tobacco cessation intervention among ohio appalachian women. A randomized trial of nicotine-replacement therapy patches in pregnancy.
Silver acetate chewing gum, a nonprescription medication, produces an unpleasant metallic taste in the mouth of individuals who consume tobacco products in conjunction with this smoking deterrent. Use of the product leads to self-induced aversive conditioning. In the present double-blind controlled study, subjects using silver acetate for three weeks of treatment had a smoking cessation rate of 15 out of 136 (11 percent, p = 0.02). Placebo subjects had a smoking cessation rate of 6 out of 146 (4 percent, p = .102). Without further treatment, the group using silver acetate demonstrated a 7 percent nonsmoking rate at four months compared with a 3 percent nonsmoking rate for the placebo group. Silver acetate demonstrated a modest benefit over placebo as a smoking deterrent in a minimal intervention and highly cost-effective treatment setting. Silver acetate over-the-counter products, such as gum, lozenge, and spray, produce an aversive metallic taste when combined with cigarette smoke. Hence, they hold promise of serving as an effective smoking deterrent, one that may be used on a self-help basis.
                Five hundred adult smokers, male and female, were assigned randomly to one of two experimental conditions, 2.5-mg silver acetate lozenge and placebo lozenge. A double-blind study of the effects of a 2.5-mg silver acetate lozenge on initial (3 weeks) and long-term (12 months) smoking cessation was carried out.
                About 90% of the subjects (n = 500) reported using the lozenge (silver acetate or placebo) for smoking cessation, and they used about five lozenges per day. Over 70% of the quitters (n = 70) reported using the lozenge on an as-needed basis for relapse prevention. The overall objectively verified quit rates for subjects assigned to the silver acetate and placebo conditions at Visit 3 (3 weeks) were 17% (n = 42) and 11% (n = 28), respectively, a difference which approached statistical significance (P = 0.071). When the analysis was restricted to subjects who used the product, a statistically significant difference (P < 0.05) in initial smoking cessation emerged (26%, n = 37 vs 16%, n = 23) for subjects assigned to the silver acetate and placebo conditions. At 12 months follow-up, 26% (n = 11) of initial quitters in the silver acetate condition and 32% (n = 9) of the quitters in the placebo condition were abstinent. This difference was not statistically significant.
                The study demonstrated modest efficacy for the effect of the 2.5-mg silver acetate lozenge on initial smoking cessation for the subset of subjects who used the product as recommended. We failed to demonstrate efficacy of the lozenge for long-term relapse prevention. Additional research on the efficacy of the 2.5-mg silver acetate lozenge and long-term abstinence in general appears warranted. Four hundred and ninety six smokers participated in a randomised comparison of the effect of silver acetate, nicotine, and ordinary chewing gum on smoking cessation. All were motivated to stop smoking abruptly and all had smoked at least 10 cigarettes a day for at least five years. Side effects and taste acceptability were related to outcome after six months. The participants attended nine meetings over a year, at which lectures, support, and advice about stopping smoking were given. Tobacco abstinence was confirmed by measurement of carbon monoxide in expired air. The chewing gums were used for 12 weeks. After 12 weeks there was a trend towards more abstainers in the nicotine group (59%) than in the silver acetate (50%) and ordinary (45%) chewing gum groups that was not quite significant (p = 0.07). At 26 and 52 weeks the number of cigarette abstainers was similar in the three treatment groups. Subjects in the nicotine chewing gum group had a longer mean time before relapse than those in the silver acetate and ordinary chewing gum groups. Mean success rates for all subjects combined at 12, 26, and 52 weeks were 52.8%, 39.7%, and 23.3%. The side effects of nicotine and silver acetate chewing gum were generally mild and transient, and unimportant except for mouth irritation from silver acetate, which had a negative effect on outcome, and the low taste acceptability of nicotine, which had a strong negative influence on the success rate. The results suggest a short term effect on nicotine chewing gum on smoking cessation, but the abstinence rates after one year were generally disappointing. The effects of nicotine (NI), silver acetate (SA), and ordinary (PL) chewing gum on the cessation of smoking were compared through ratings on six smoking types and physiological nicotine dependence (F-score) in a placebo-controlled and randomized study that included 496 smokers in a group-support setting. Results were evaluated after 26 weeks. Ratings on smoking types 1, 3, 4, 5, and 6 and F-score were related to success rates. The effect of NI was superior to SA in smokers with high type 1 ratings, the effects of NI and SA were almost equal and superior to PL in smokers with high type 4 and 6 ratings, and the effect was independent of the F-score. Treatment of smokers with NI and SA should be restricted to smoking types in which an effect superior to PL is documented, and research should be performed to find support for smoking types where SA and NI have a clear effect. To assess whether source of funding affected the results of trials of nicotine replacement therapy (NRT) for smoking cessation.
                We reviewed all randomized controlled trials included in the Cochrane review. There were insufficient non-industry trials of the newer products for these to be included. We included 90 trials of either the nicotine gum (52) or nicotine patch (38). They comprised 18 238 treatment and 16 235 control participants. Forty-nine showed evidence of industry support (18 gum, 31 patch).
                Industry (31 of 49, 63%) compared with non-industry (seven of 41, 17%, P < 0.001) supported a higher proportion of nicotine patch studies and had larger sample sizes (479 versus 268, P = 0.04). Twenty-five (51%) industry trials reported statistically significant (P < 0.05) results, compared with nine (22%) non-industry trials (OR = 3.70, 95% CI = 1.46-9.35). This difference was not explained by trial characteristics. Industry-supported trials had a pooled odds ratio of 1.90 (1.67-2.16), compared with 1.61 (1.43-1.80) for other studies (chi(2) = 3.6, P = 0.058). There was evidence of funnel-plot asymmetry among industry trials (t = 4.35, P < 0.001), but not among other trials, indicating that several small null-effect industry trials may not have reached publication. After imputation adjustment, the odds ratio for industry trials reduced to 1.64 (1.43-1.89) and the overall NRT odds ratio reduced from 1.73 (1.60-1.90) to 1.62 (1.49-1.77).
                Compared with independent trials, industry-supported trials were more likely to produce statistically significant results and larger odds ratios. These differences persisted after adjustment for basic trial characteristics. Although we had no data on the amount of funding for each trial, it is possible that more resources led to higher treatment compliance and therefore greater efficacy in industry-supported trials. Differences can also possibly be explained by publication bias with several small, null-effect industry studies not having reached publication. After adjustment for this possible bias, results for industry trials were lower and similar to non-industry results. Similarly, the overall estimate of the net effect for these products reduces to about 5% attributable 1-year successes. This remains of considerable public health benefit. Registration of clinical trials has become mandatory in many countries since most of the trials considered here were conducted, and this should reduce the potential for publication bias in future. To assess the level of nicotine replacement, evidence of nicotine toxicity, and withdrawal symptom relief with placebo and 11-, 22-, and 44-mg/d doses of transdermal nicotine. A secondary objective was to assess short- and long-term smoking cessation rates.
                Randomized, double-blind, placebo-controlled inpatient/outpatient trial.
                Seventy-one cigarette smokers stratified according to light (n = 23), moderate (n = 24), and heavy (n = 24) smoking rates.
                After baseline measures were obtained, subjects were randomly assigned to placebo or an 11-, 22-, or 44-mg/d dose of transdermal nicotine and admitted to a special hospital unit for intensive inpatient treatment of nicotine dependence. During the 6-day inpatient stay, daily nicotine and cotinine levels were determined from trough and peak blood samples. Outpatient patch therapy continued for 7 weeks following the hospital stay, and those initially assigned to placebo were randomly assigned to 11 or 22 mg/d. At week 4, the dosage of those initially assigned to 44 mg/d was reduced to 22 mg/d.
                Percentage of replacement of cotinine was calculated by dividing the steady-state levels attained during patch therapy by the corresponding baseline levels. Abstinence from smoking was verified by expired air carbon monoxide. Withdrawal symptoms and nicotine toxicity were assessed daily through questionnaires during the inpatient stay. Follow-up visits were at 3, 6, 9, and 12 months.
                There was a statistically significant relationship between baseline smoking rate and baseline trough and peak blood cotinine levels (rs = 0.39, rs = 0.45; P < .001 in both instances). A dose-response relationship was observed with higher patch doses, which produced a higher percentage of cotinine replacement and better withdrawal symptom relief. Only one subject (a light smoker assigned to the 44-mg dose) developed signs of nicotine toxicity. There was a positive association between the week 2 patch dose and the biochemically confirmed abstinence at the end of patch therapy (P = .007) but not for subsequent follow-up times. A higher percentage of cotinine replacement was associated with the higher 8-week smoking abstinence rate (P = .03), an association not found at long-term follow-up.
                A 44-mg/d dose of nicotine patch therapy appears to be safe for use in heavy smokers. Cigarette smoking rates can be used to estimate the initial nicotine patch dose. Monitoring blood cotinine levels at baseline and steady state can be used for assessing the adequacy of nicotine replacement. Withdrawal symptom relief can be improved with more complete nicotine replacement. Achieving a greater percentage of nicotine replacement may increase the efficacy of nicotine patch therapy. Randomized clinical trial carried out to investigate the effectiveness of the cognitive-behavioral approach and nicotine replacement therapy with nicotine patches for smoking cessation. Participated 1,199 adults, volunteers, in Rio de Janeiro, Brazil, randomly assigned to 10 different groups: intensive brief counseling group (GB), with 1 or 2 sessions (G1-G2), and with 3 or 4 sessions (G3-G4), with/without nicotine replacement therapy (NRT). Abstinence proportions were estimated during 12 months. These proportions among participants not assigned to NRT were 20% (GB), 17% (G1-G2), and 23% (G3-G4); and among assigned NRT groups were 30% (GBA), 34% (G1A-G2A), and 33% (G3A-G4A). After multiple adjustments, the abstinence proportions ratios seemed to follow a "dose-response" pattern: compared to GB, the ratios were 0.85 (G1-G2), 1.13 (G3-G4), 1.51 (GBA), 1.66 (G1A-G2A), and 1.75 (G3A-G4A). The results suggest that use of NRT increases the abstinence proportion for cessation. The "dose-response" pattern suggests that cognitive-behavioral could be the reasonable option in the smoking cessation therapy. The purpose of this study was to evaluate a nurse-managed, lay-led tobacco cessation intervention delivered to adult women in Ohio Appalachia.
                A randomized controlled experimental design included intervention participants (n = 147) enrolled in a nurse-managed, lay-led protocol that incorporated nicotine replacement and behavioral counseling. Control participants (n = 155) received a personalized letter from their clinic physician, who advised them to quit smoking and requested they schedule a clinic appointment to discuss cessation.
                Self-reported and cotinine-validated quit rates were significantly higher among intervention group participants compared with control group participants at 3-and 6-month follow-up (P < 0.02). At 12 months, self-reported abstinence was 19.1% (intervention group) and 9.0% (control group), with cotinine-validated rates of 12.2% and 7.1%, respectively (P = 0.13). Prolonged abstinence rates were significantly different between groups at 3, 6, and 12 months (P < 0.02). Logistic regression analyses indicated adjusted odds of cotinine-validated quitting was associated with cigarette consumption per day (odds ratio, 0.94; 95% confidence interval, 0.89-0.99) and Center for Epidemiologic Studies Depression Scale score > or = 16 (odds ratio, 0.39; 95% confidence interval, 0.17-0.90).
                A lay-led approach that is managed by a nurse may serve as an effective cessation strategy among this high-risk population. Additional efforts are needed to sustain long-term abstinence, even after intensive intervention. Nicotine-replacement therapy is effective for smoking cessation outside pregnancy and its use is widely recommended during pregnancy. We investigated the efficacy and safety of nicotine patches during pregnancy.
                We recruited participants from seven hospitals in England who were 16 to 50 years of age with pregnancies of 12 to 24 weeks' gestation and who smoked five or more cigarettes per day. Participants received behavioral cessation support and were randomly assigned to 8 weeks of treatment with active nicotine patches (15 mg per 16 hours) or matched placebo patches. The primary outcome was abstinence from the date of smoking cessation until delivery, as validated by measurement of exhaled carbon monoxide or salivary cotinine. Safety was assessed by monitoring for adverse pregnancy and birth outcomes.
                Of 1050 participants, 521 were randomly assigned to nicotine-replacement therapy and 529 to placebo. There was no significant difference in the rate of abstinence from the quit date until delivery between the nicotine-replacement and placebo groups (9.4% and 7.6%, respectively; unadjusted odds ratio with nicotine-replacement therapy, 1.26; 95% confidence interval, 0.82 to 1.96), although the rate was higher at 1 month in the nicotine-replacement group than in the placebo group (21.3% vs. 11.7%). Compliance was low; only 7.2% of women assigned to nicotine-replacement therapy and 2.8% assigned to placebo used patches for more than 1 month. Rates of adverse pregnancy and birth outcomes were similar in the two groups.
                Adding a nicotine patch (15 mg per 16 hours) to behavioral cessation support for women who smoked during pregnancy did not significantly increase the rate of abstinence from smoking until delivery or the risk of adverse pregnancy or birth outcomes. However, low compliance rates substantially limited the assessment of safety. (Funded by the National Institute for Health Research Health Technology Assessment Programme; Current Controlled Trials number, ISRCTN07249128.).
Existing trials show little evidence for a specific effect of silver acetate in promoting smoking cessation. The confidence intervals for the ratio are quite wide. However, the upper limit of the confidence intervals for a positive effect equates to an absolute increase in the smoking cessation rate of about 4%. Any effect of this agent is therefore likely to be smaller than nicotine replacement therapy. The lack of effect of silver acetate may reflect poor compliance with a treatment whose rationale is to create an unpleasant stimulus.