BACKGROUND: Whether the association between smoking and erectile dysfunction is causal is uncertain. No RCTs have been previously conducted on cessation counseling and additional nicotine replacement therapy (NRT) adherence counseling among smokers with erectile dysfunction. PURPOSE: The aim of the study was to determine if smoking-cessation counseling in conjunction with NRT increases quitting and NRT adherence compared to usual care, and if stopping smoking would improve erectile function among Chinese erectile dysfunction patients who smoke. DESIGN: An RCT was conducted. Data were collected in 2004-2007 and analyzed in 2008. SETTING/PARTICIPANTS: The sample included 719 Chinese adult erectile dysfunction patients who smoked at least 1 cigarette per day, intended to quit smoking within the next 7 days, and would use NRT. INTERVENTIONS: Group A1 received 15-minute smoking-cessation and 3-minute NRT adherence counseling at baseline, 1 week, and 4 weeks with free NRT for 2 weeks. Group A2 received the same treatment, except for the adherence counseling. Group B received 10 minutes of quitting advice. All subjects received a self-help quitting booklet at first contact. MAIN OUTCOME MEASURES: Self-reported 7-day tobacco abstinence at 6 months, 4-week NRT adherence at 1 month, and improvement in erectile dysfunction condition at 6 months. RESULTS: The intervention groups (A1+A2) achieved higher rates of abstinence, both self-reported (23% vs 12.8%, RR=1.79, 95% CI=1.22, 2.62) and biochemically validated (11.4% vs 5.5%, RR=2.07, 95% CI=1.13, 3.77), than the control group. The NRT adherence rate did not differ between Groups A1 and A2 (13.7% vs 12.7%, RR=1.08, 95% CI=0.69, 1.69). An improvement in erectile dysfunction status from baseline to 6 months was associated with self-reported quitting at 6 months but not with intervention status. CONCLUSIONS: Although quitting smoking was associated with improvement in erectile dysfunction, this study found significant outcome differences among the means used to achieve smoking cessation. TRIAL REGISTRATION: ISRCTN13070778. 2010 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.
RCT Entities:
BACKGROUND: Whether the association between smoking and erectile dysfunction is causal is uncertain. No RCTs have been previously conducted on cessation counseling and additional nicotine replacement therapy (NRT) adherence counseling among smokers with erectile dysfunction. PURPOSE: The aim of the study was to determine if smoking-cessation counseling in conjunction with NRT increases quitting and NRT adherence compared to usual care, and if stopping smoking would improve erectile function among Chinese erectile dysfunctionpatients who smoke. DESIGN: An RCT was conducted. Data were collected in 2004-2007 and analyzed in 2008. SETTING/PARTICIPANTS: The sample included 719 Chinese adult erectile dysfunctionpatients who smoked at least 1 cigarette per day, intended to quit smoking within the next 7 days, and would use NRT. INTERVENTIONS: Group A1 received 15-minute smoking-cessation and 3-minute NRT adherence counseling at baseline, 1 week, and 4 weeks with free NRT for 2 weeks. Group A2 received the same treatment, except for the adherence counseling. Group B received 10 minutes of quitting advice. All subjects received a self-help quitting booklet at first contact. MAIN OUTCOME MEASURES: Self-reported 7-day tobacco abstinence at 6 months, 4-week NRT adherence at 1 month, and improvement in erectile dysfunction condition at 6 months. RESULTS: The intervention groups (A1+A2) achieved higher rates of abstinence, both self-reported (23% vs 12.8%, RR=1.79, 95% CI=1.22, 2.62) and biochemically validated (11.4% vs 5.5%, RR=2.07, 95% CI=1.13, 3.77), than the control group. The NRT adherence rate did not differ between Groups A1 and A2 (13.7% vs 12.7%, RR=1.08, 95% CI=0.69, 1.69). An improvement in erectile dysfunction status from baseline to 6 months was associated with self-reported quitting at 6 months but not with intervention status. CONCLUSIONS: Although quitting smoking was associated with improvement in erectile dysfunction, this study found significant outcome differences among the means used to achieve smoking cessation. TRIAL REGISTRATION: ISRCTN13070778. 2010 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.
Authors: T P Thompson; C J Greaves; R Ayres; P Aveyard; F C Warren; R Byng; R S Taylor; J L Campbell; M Ussher; S Michie; R West; A H Taylor Journal: Trials Date: 2016-10-27 Impact factor: 2.279