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Clinical evaluation of a new A.S. mouth wash 881010 as an antismoking agent: a placebo-controlled double-blind trial. 1999

S Zmeili, and A Salhab, and K Shubair, and M Gharaibeh, and N Suliman, and A Al-Kayed, and M Shubair, and N Abu Hijleh, and M Abu Jbara
Department of Pharmacology, Faculty of Medicine, University of Jordan, Amman.

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. 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. CONCLUSIONS In conclusion, the A.S. mouth wash 881010 is generally safe, easy to administer, and effective as an aid to smoking cessation.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D009067 Mouthwashes Solutions for rinsing the mouth, possessing cleansing, germicidal, or palliative properties. (From Boucher's Clinical Dental Terminology, 4th ed) Mouth Bath,Mouth Rinse,Mouth Wash,Bath, Mouth,Baths, Mouth,Mouth Baths,Mouth Rinses,Rinse, Mouth,Rinses, Mouth,Wash, Mouth
D009538 Nicotine Nicotine is highly toxic alkaloid. It is the prototypical agonist at nicotinic cholinergic receptors where it dramatically stimulates neurons and ultimately blocks synaptic transmission. Nicotine is also important medically because of its presence in tobacco smoke. Nicotine Bitartrate,Nicotine Tartrate
D010919 Placebos Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol. Sham Treatment
D002849 Chromatography, Gas Fractionation of a vaporized sample as a consequence of partition between a mobile gaseous phase and a stationary phase held in a column. Two types are gas-solid chromatography, where the fixed phase is a solid, and gas-liquid, in which the stationary phase is a nonvolatile liquid supported on an inert solid matrix. Chromatography, Gas-Liquid,Gas Chromatography,Chromatographies, Gas,Chromatographies, Gas-Liquid,Chromatography, Gas Liquid,Gas Chromatographies,Gas-Liquid Chromatographies,Gas-Liquid Chromatography
D003367 Cotinine The N-glucuronide conjugate of cotinine is a major urinary metabolite of NICOTINE. It thus serves as a biomarker of exposure to tobacco SMOKING. It has CNS stimulating properties. Scotine
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults

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