Namphong Hospital, Namphong District, Khon Kaen, 40140, Thailand.
Department of Social Medicine, Khon Kaen Hospital, Muang District, Khon Kaen, 40000, Thailand.
Asian Pac J Cancer Prev. 2023 Jan 1;24(1):101-109. doi: 10.31557/APJCP.2023.24.1.101.
This study aimed to compare the efficacy and safety of Vernonia cinerea (VC) and nortriptyline for smoking cessation. A randomized, active-comparator, open-label trial was conducted in 2019. A total of 84 patients participated in the study, and equally randomized with 42 participants in each group. Overall, there was no statistically significant difference of continuous abstinence rate (CAR) between VC and nortriptyline group (Odd ratio 0.68, 95%CI 0.25-1.85, P=0.451). After week 12, the end of treatment, CAR between both groups was not different (44.44% vs 45.95%, Odd ratio 0.77, 95%CI 0.23-2.54, P>0.999). After follow up by the end of research at week 24, the CAR in both groups was not different (41.67% vs 43.24%, Odd ratio 0.76, 95%CI 0.23-2.55, P>0.999). After week 24, relapse rate between VC and nortriptyline group was not different (13.89% vs 10.81%, P=0.923). In addition, both groups were effective in reducing the number of cigarettes per day compared to baseline. However, there was no difference between the groups. Overall, the VC group had an 8% smoking rate less than nortriptyline group, but not statistically significant (IRR 0.92, 95%CI 0.59-1.43, P=0.702). They also resulted in reducing the exhaled CO level at treatment period and wash out period (at week 12; 7(-17-20) vs 7(-12-16), mean difference 0.78, 95%CI -3.07-4.63, P>0.999, at week 24; 8(-5-22) vs 8.5(-5-17), mean difference 0.39, 95%CI -3.46-4.24, P>0.999). Overall, there was no difference between either group (mean difference -0.31, 95%CI -3.10-2.47). For safety data, adverse events including tongue bitter taste or numbness were found in VC group to be greater than in nortriptyline group (61.9% vs 30.95%, P=0.004), whereas dry mouth and drowsiness were greater found in nortriptyline group (35.71% vs 90.48%, P<0.001 and 16.67% vs 90.48%, P<0.001, respectively). Serious adverse events were not found. In smoking cessation, efficacy and safety of either VC or nortriptyline showed no difference.
本研究旨在比较苍耳（VC）和去甲替林戒烟的疗效和安全性。这是一项 2019 年进行的随机、阳性对照、开放标签试验。共有 84 名患者参与了这项研究，平均分为 VC 组和去甲替林组各 42 名患者。总体而言，VC 组和去甲替林组的持续戒烟率（CAR）无统计学差异（优势比 0.68，95%CI 0.25-1.85，P=0.451）。治疗结束时（第 12 周），两组之间的 CAR 没有差异（44.44% vs 45.95%，优势比 0.77，95%CI 0.23-2.54，P>0.999）。在第 24 周的研究结束时进行随访后，两组之间的 CAR 也没有差异（41.67% vs 43.24%，优势比 0.76，95%CI 0.23-2.55，P>0.999）。第 24 周后，VC 组和去甲替林组的复发率无差异（13.89% vs 10.81%，P=0.923）。此外，两组均能有效减少每日吸烟量，与基线相比。然而，两组之间没有差异。总体而言，VC 组的吸烟率比去甲替林组低 8%，但无统计学意义（IRR 0.92，95%CI 0.59-1.43，P=0.702）。两组在治疗期和洗脱期都能降低呼气 CO 水平（第 12 周：7（-17-20）vs 7（-12-16），平均差值 0.78，95%CI -3.07-4.63，P>0.999，第 24 周：8（-5-22）vs 8.5（-5-17），平均差值 0.39，95%CI -3.46-4.24，P>0.999）。总体而言，两组之间没有差异（平均差值-0.31，95%CI -3.10-2.47）。安全性数据显示，VC 组出现的不良反应（包括舌苦或麻木）比去甲替林组更常见（61.9% vs 30.95%，P=0.004），而口干和嗜睡在去甲替林组更为常见（35.71% vs 90.48%，P<0.001和 16.67% vs 90.48%，P<0.001）。未发现严重不良事件。在戒烟方面，VC 或去甲替林的疗效和安全性无差异。
