Clinical evaluation of a new AS mouth wash 881010 as an antismoking agent:a placebo-controlled double-blind trial

Objective: The objective of this study was to assess the effectiveness of a new antismoking (A.S.) preparation manufactured by the Arab Pharmaceutical Manufacturing (APM) Company as an aid to smoking cessation. Subjects. mate rial and methods: The design of this clinical study involved 137 Jordanian healthy male smokers. Seventy-foul male smokers were given the A.S. mouth w ash (active ingredient 0.5% silver nitrate) and 63 male smokers received th e placebo solution in a double-blind fashion. Mouth wash solutions were adm inistered three times daily by gargling for one minute and for a period of two weeks. The daily number of cigarettes smoked by volunteers, nicotine, a nd cotinine concentrations in saliva, plasma, and urine were considered in this study as markers of smoking cessation. Results: Means +/- SD of the nu mber of cigarettes smoked before treatment (zero time) were 21.45 +/- 8.21, and 22.49 +/- 9.50 cigarettes in A.S. mouth wash- and placebo-treated grou ps, respectively. As compared to placebo, the A.S. mouth wash resulted in a significant (p < 0.05) reduction in the number of daily cigarettes smoked by volunteers during and after treatment. Means +/- SD of the number of cig arettes smoked by A.S. mouth wash-treated volunteers were 8.68 +/- 7.55, 7. 87 +/- 6.80, and 10.14 +/- 8.29 cigarettes, and in placebo-treated individu als were 15.91 +/- 8.21, 15.70 +/- 9.58 and 17.03 +/- 9.06 cigarettes, one week, two weeks after treatment, and four weeks after stopping treatment, r espectively. Furthermore, a significant number of volunteers either totally stopped or reduced smoking cigarettes after treatment with the A.S. mouth wash. Concerning nicotine and cotinine levels in biological fluids, a trend of a decrease in their levels was observed bur it was found not statistica lly significant. Apart from reversible brownish to blackish discoloration o f teeth and gums, no other side-effects were observed after treatment with the A.S. mouth wash. Conclusion: In conclusion, the A.S, mouth wash 881010 is generally safe, easy to administer, and effective as an aid to smoking c essation.