Safety and efficacy of Viva QS for smoking cessation

Abstract

Nicotine dependence is a life threatening disorder and efforts have been focused to identify new mechanisms to assist smokers to quit. The need to find new interventions is vital. The use of herbals as alternative to current treatments is limited and most studies were without randomized control trial (RCT). To our knowledge, this is the first study in Malaysia using randomized, double-blind, placebo-controlled trial to study herbal medication for smoking cessation. Viva® was first introduced in Malaysia to help drug addicts managed withdrawal symptoms. Distaste for cigarettes were noticed in patients undergoing treatment - which led to development of Viva QS® for smoking cessation. Viva QS® is a preparation with twelve herbs from Korea and China.The objectives of the study were to determine the efficacy and safety of Viva QS® for quit smoking. A mobile smoking cessation programme (MSCP) was employed to reach smokers at workplaces. Workers who attended smoking cessation talk and fulfilled study criteria were enrolled upon written consent. Demographic and smoking history information, modified Fagerstrom test for nicotine dependence (FTND) score and carbon monoxide (CO) level were obtained at baseline. Follow-up were conducted by phone calls and/or face-to-face meetings at week 4, 12 and 24. During follow-up, subjects also received brief counselling to continuously promote cessation. Viva QS® and placebo were supplied for 24 weeks. Self-reported abstinence at week 24 was verified using saliva or urine cotinine test in addition to CO test.Biochemically verified 7-days point prevalence demonstrated Viva QS® significantly increased quit rate vs. placebo; 42.7% vs. 26.2% (p = 0.038) at week 4, 32.0% vs. 16.7% {p = 0.031) at week 12 and 30.7% vs. 13.9% (p = 0.015) at week 24. Adverse events reported were similar between groups (p > 0.05). The most frequently reported adverse events were sore throat and dry mouth (36.6% and 17.8%, respectively for Viva QS® vs. 28.8% and 16.9% for placebo). For non-quitters, results showed reduction in the number of daily cigarettes smoked in both groups but there was no significant difference between both arms (p > 0.05). We suggested Viva QS® is safe and effective for smoking cessation.