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An open label study investigating the efficacy of hypericum perforatum special extract (ze117), nicotine patches and combination (ze117)/nicotine patches for smoking cessation

机译:一项开放标签研究,研究贯叶连翘特殊提取物(ze117),尼古丁贴片和组合(ze117)/尼古丁贴片对戒烟的疗效

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摘要

Introduction: Nicotine addiction has become one of the largest international health problems, increasing the risk of cardiovascular disease, cancers, and respiratory diseases. There are several treatments available for smoking cessation with the most common transdermal nicotine replacement and anti-depressants. However current treatments are only mildly efficacious and have side effects which lead to a decrease in their effectiveness. Additional treatments for smoking cessation with lower side effects are required. Methods: We examined the efficacy of Remotiv ® (Hypericum perforatum Special Extract - ZE117) compared to Nicabate ® CQ Nicotine Replacement Therapy (NRT) and combination ZE117/NRT for smoking cessation over a treatment time of 10 weeks. Given the different pharmacological profiles of Ze117 and NRT it was expected that a combination treatment would be most efficacious for smoking cessation than the other two treatments alone. Sixty smokers aged between 18 and 60 years were enrolled in the study. Smoking status was assessed using CO levels measured by the Bedfont Smokerlyzer (primary outcome measure). Secondary outcome measures of anxiety, DSM-IV nicotine dependence and Fagerström craving and symptoms were also recorded. Results: A significant main effect of reduction in the number of smokers over the course of the study was observed although there were no significant differences between any of the treatment groups on this variable after 14 weeks. Conclusions: These results indicate that the three treatment options are equally efficacious for smoking cessation. Interestingly the Ze117 treatment significantly reduced the amount of craving over the treatment duration of the study compared to the other two treatments indicating a possible mechanism by which Ze117 may assist in smoking cessation.
机译:简介:尼古丁成瘾已成为国际上最大的健康问题之一,增加了心血管疾病,癌症和呼吸道疾病的风险。有几种最常用的经皮尼古丁替代品和抗抑郁药可用于戒烟。然而,当前的治疗仅是中等有效的并且具有导致其有效性降低的副作用。需要更多的戒烟方法,以减少副作用。方法:我们比较了Remotiv®(贯叶连翘特有提取物-ZE117)与Nicabate®CQ尼古丁替代疗法(NRT)和ZE117 / NRT组合在10周治疗时间内戒烟的功效。鉴于Ze117和NRT的不同药理学特征,预计与单独的其他两种治疗方法相比,联合治疗对戒烟最有效。这项研究招募了60名年龄在18至60岁之间的吸烟者。使用Bedfont Smokerlyzer测量的一氧化碳水平(主要结果指标)评估吸烟状况。还记录了焦虑,DSM-IV尼古丁依赖和Fagerström渴望和症状的次要结局指标。结果:在研究过程中,观察到吸烟者数量减少的显着主要效果,尽管14周后在该变量上各治疗组之间均无显着差异。结论:这些结果表明,三种治疗方法对于戒烟同样有效。有趣的是,与其他两种疗法相比,Ze117疗法在研究的整个治疗期间显着减少了渴望的数量,这表明Ze117可能有助于戒烟。

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