OBJECTIVE: To determine the effectiveness and safety of the novel nicotine polyestex gum for smoking cessation, along with its impact on the quality of life (QOL). MATERIAL AND METHOD: A double-blind, placebo-controlled, randomized clinical trial was conducted on 43 smokers. All of them received either nicotine gum or placebo. Only those who could quit completely and continuously by the end of 3 months were considered total abstinence. QOL was also measured using WHO questionnaires. RESULTS: Treatment with nicotine polyestex gum resulted in significantly greater abstinence rate at 3 months compared with placebo (50% vs. 9%; p = 0.003). Adverse events were modest and not encountered more often than those seen in the placebo group. QOL at 3-months improved in both groups, but there was no statistically significant difference between the groups. CONCLUSION:Nicotine polyestex gum is effective and safe for smoking cessation. It is also associated with significant improvement in the QOL.
RCT Entities:
OBJECTIVE: To determine the effectiveness and safety of the novel nicotine polyestex gum for smoking cessation, along with its impact on the quality of life (QOL). MATERIAL AND METHOD: A double-blind, placebo-controlled, randomized clinical trial was conducted on 43 smokers. All of them received either nicotine gum or placebo. Only those who could quit completely and continuously by the end of 3 months were considered total abstinence. QOL was also measured using WHO questionnaires. RESULTS: Treatment with nicotine polyestex gum resulted in significantly greater abstinence rate at 3 months compared with placebo (50% vs. 9%; p = 0.003). Adverse events were modest and not encountered more often than those seen in the placebo group. QOL at 3-months improved in both groups, but there was no statistically significant difference between the groups. CONCLUSION:Nicotine polyestex gum is effective and safe for smoking cessation. It is also associated with significant improvement in the QOL.