Progesterone for smoking relapse prevention following delivery: A pilot, randomized, double-blind study.
Progesterone for smoking relapse prevention following delivery: A pilot, randomized, double-blind study.
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DOI：
10.1016/j.psyneuen.2017.09.012
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发表时间：
2017-12
影响因子：
3.7
通讯作者：
Yonkers KA
中科院分区：
文献类型：
--
作者：
Forray A;Gilstad-Hayden K;Suppies C;Bogen D;Sofuoglu M;Yonkers KA
简介近一半在怀孕前吸烟的女性在怀孕期间戒烟，此时内源性黄体酮水平很高。然而，至少有一半的人在分娩后的几周内恢复了孕前吸烟水平，当孕酮水平下降时。目前的试点研究测试的可行性和初步疗效的产后黄体酮替代预防复发的吸烟在产后妇女孕前smoking.MethodsThis的历史是一个为期8周，双盲，平行，随机，安慰剂对照的试点试验41名妇女孕前吸烟的历史谁达到禁欲32周的妊娠。分娩后立即将妇女随机分配到口服微粒化黄体酮（200毫克，每日两次）或安慰剂通过计算机化瓮随机化程序。主要的结果指标是研究可行性的描述：招募和保留。次要结果是7天点的禁欲率在第8周，复发时间和吸烟crawings.ResultsThe试验是可行的，充分的随机化，64%（41/64）的符合条件的妇女，和试验保留，78%（32/41）完成了试验。与安慰剂组相比，服用孕酮的女性在第8周期间禁欲的可能性是安慰剂组的1.8倍，复发时间更长（10周vs 4周），尽管这些差异没有达到统计学意义。调整年龄和戒烟前吸烟水平后，需要治疗的人数为7人。与安慰剂组相比，孕酮组的渴望等级每周下降10%（β =-0.10，95% CI：-0.15，-0.04，p < 0.01）。没有严重的不良事件发生在trial.ConclusionsThese初步研究结果支持孕激素治疗产后吸烟者的承诺，并可能构成一个治疗的突破，如果这些初步研究结果可以进行评估，并在一个更大的研究有足够的权力复制，这可能构成一个可接受的和安全的吸烟复发预防策略，用于哺乳期。
IntroductionClose to half of women who were smokers prior to conception quit smoking in pregnancy, when endogenous progesterone levels are high. However, at least half resume pre-pregnancy smoking levels within weeks after delivery and when progesterone levels drop. The current pilot study tested the feasibility and preliminary efficacy of postpartum progesterone replacement in preventing relapse to smoking in postpartum women with a history of pre-pregnancy smoking.MethodsThis was an 8-week, double-blind, parallel, randomized, placebo-controlled pilot trial of 41 women with a history of pre-pregnancy smoking who achieved abstinence by 32 weeks of gestation. Immediately following delivery women were randomized to oral micronized progesterone (200 mg twice daily) or placebo via computerized urn randomization program. The main outcome measures were descriptions of study feasibility: recruitment and retention. Secondary outcomes were 7-day point prevalence of abstinence at week 8, time to relapse and smoking cravings.ResultsThe trial was feasible with adequate randomization, 64% (41/64) of eligible women, and trial retention, 78% (32/41) completed the trial. Women taking progesterone were 1.8 times more likely to be abstinent during week 8 and took longer to relapse (10 vs. 4 weeks) compared to the placebo group, although these differences did not reach statistical significance. After adjusting for age and pre-quit smoking level, the number needed to treat was 7. There was a 10% greater decline per week in craving ratings in the progesterone group compared to placebo (β = −0.10, 95% CI: −0.15, −0.04, p < 0.01). No serious adverse events occurred during the trial.ConclusionsThese preliminary findings support the promise of progesterone treatment in postpartum smokers and could constitute a therapeutic breakthrough.If these preliminary findings can be evaluated and replicated in a larger study with sufficient power, this may constitute an acceptable and safe smoking relapse prevention strategy for use during lactation.
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