Clinical evaluation of a new A.S. 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, MATERIAL AND METHODS: The design of this clinical study involved 137 Jordanian healthy male smokers. Seventy-four male smokers were given the A.S. mouth wash (active ingredient 0.5% silver nitrate) and 63 male smokers received the placebo solution in a double-blind fashion. Mouth wash solutions were administered three times daily by gargling for one minute and for a period of two weeks. The daily number of cigarettes smoked by volunteers, nicotine, and cotinine concentrations in saliva, plasma, and urine were considered in this study as markers of smoking cessation.

RESULTS

Means +/- SD of the number 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 groups, 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 cigarettes 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 individuals 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, respectively. 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 but it was found not statistically significant. Apart from reversible brownish to blackish discoloration of 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 cessation.