Abstract Background and Aims A combination of behavioural and pharmacological support is judged to be the optimal approach for assisting smoking cessation. Allen Carr's Easyway (ACE) is a single‐session pharmacotherapy‐free programme that has been in operation internationally for 38 years. We compared the effectiveness of ACE with specialist behavioural and pharmacological support delivered to the national standard in England. Design A two‐arm, parallel‐group, single‐blind, randomized controlled trial. Setting London, UK, between February 2017 and May 2018. Participants A total of 620 participants (310 in ACE and 310 in the combined behavioural and pharmacological support condition) were included in the analysis. Adult (≥ 18 years) smokers wanting to quit were randomized in a 1 : 1 ratio. Mean age for the total sample was 40.8 years, with 53.4% being male. Participant baseline characteristics (ethnicity, educational level, number of previous quit attempts, nicotine dependence) were evenly balanced between treatment groups. Intervention and comparator The intervention was the ACE method of stopping smoking. This centres on a 4.5–6‐hour session of group‐based support, alongside subsequent text messages and top‐up sessions if needed. It aims to make it easy to stop smoking by convincing smokers that smoking provides no benefits for them. The comparator was a specialist stop smoking service (SSS) providing behavioural and pharmacological support in accordance with national standards. Measurements The primary outcome was self‐reported continuous abstinence for 26 weeks from the quit/quit re‐set date verified by exhaled breath carbon monoxide measurement < 10 parts per million (p.p.m.). Primary analysis was by intention to treat. Secondary outcomes were: use of pharmacotherapy, adverse events and continuous abstinence up to 4 and 12 weeks. Findings A total of 468 participants attended treatment (255 ACE versus 213 SSS, P < 0.05). Of those who did attend treatment, 100 completed 6‐month measures (23.7% ACE versus 20.7% SSS). Continuous abstinence to 26 weeks was 19.4% (60 of 310) in the ACE intervention and 14.8% (46 of 310) in the SSS intervention [risk difference for ACE versus SSS 4.5% (95% confidence interval (CI) = –1.4 to 10.4%, odds ratio (OR) = 1.38)]. The Bayes factor for superiority of the ACE condition was 1.24. Conclusion There was no clear evidence of a difference in the efficacies of the Allen Carr's Easyway (ACE) and specialist smoking cessation support involving behavioural support and pharmacotherapy.

中文翻译：

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Allen Carr 的 Easyway 计划与专业的行为和药物戒烟支持服务的比较：一项随机对照试验

摘要 背景和目的 行为和药物支持的组合被认为是协助戒烟的最佳方法。Allen Carr's Easyway (ACE) 是一项单次无药物治疗计划，已在国际上运作 38 年。我们将 ACE 的有效性与按照英国国家标准提供的专家行为和药理学支持进行了比较。设计一项双臂、平行组、单盲、随机对照试验。设置地点为 2017 年 2 月至 2018 年 5 月期间的英国伦敦。 参与者 共有 620 名参与者（310 名在 ACE 中，310 名在行为和药物支持条件下）被纳入分析。想要戒烟的成年（≥ 18 岁）吸烟者以 1:1 的比例随机分组。总样本的平均年龄为 40.8 岁，其中 53 岁。4% 是男性。参与者的基线特征（种族、教育水平、既往戒烟尝试次数、尼古丁依赖）在治疗组之间均衡。干预和对照 干预是戒烟的 ACE 方法。这以 4.5-6 小时的小组支持会议为中心，以及随后的短信和必要的充值会议。它旨在通过说服吸烟者吸烟对他们没有任何好处来使戒烟变得容易。比较对象是根据国家标准提供行为和药物支持的专家戒烟服务 (SSS)。测量 主要结果是自我报告的自戒烟/戒烟重置日期起 26 周内连续戒烟，通过呼出气一氧化碳测量值 < 百万分之 10 (ppm) 进行验证。主要分析是按意向治疗。次要结果是：药物治疗的使用、不良事件和长达 4 周和 12 周的持续禁欲。结果 共有 468 名参与者参加了治疗（255 名 ACE 对 213 名 SSS，P < 0.05）。在参加治疗的患者中，100 人完成了 6 个月的测量（23.7% ACE 对 20.7% SSS）。连续戒断 26 周在 ACE 干预中为 19.4%（310 个中的 60 个），在 SSS 干预中为 14.8%（310 个中的 46 个）[ACE 与 SSS 的风险差异为 4.5%（95% 置信区间 (CI) = –1.4 至10.4%，优势比 (OR) = 1.38)]。ACE 条件优越性的贝叶斯因子为 1.24。结论 没有明确的证据表明 Allen Carr's Easyway (ACE) 和包括行为支持和药物治疗在内的专家戒烟支持的效果存在差异。