Department of Iranian Traditional Medicine, Faculty of Medicine, Shahed University, Tehran, Iran.
Psychiatry Department and National Center for Addiction Studies, Tehran University of Medical Sciences, Tehran, Iran.
J Altern Complement Med. 2020 May;26(5):376-383. doi: 10.1089/acm.2019.0390. Epub 2020 Feb 28.
The major problem in maintenance treatment of opioid use disorder is craving and relapse. The utilization of herbal compounds and complementary therapy for treatment of disease and addiction has been widely expanding. Considering the significant effect of Hab-o Shefa in detoxification phase, this clinical trial has explored the influence of this compound on maintenance treatment of opioid-dependent patients. This product is made of four herbs, including L., L., Roscoe, and L. The authors conducted a two-group parallel randomized double-blind clinical trial on 81 opioid-dependent patients within 12 weeks. After medically assisted detoxification, participants were assigned randomly to Hab-o Shefa ( = 41) and placebo ( = 40). Outcome measures included craving assessed by craving beliefs questionnaire, self-reported opioid use, and lapse (any opioid-positive urine test) according to urinalysis and addiction severity index-lite questionnaire, retention in treatment, and depression and anxiety scores on the Hamilton's anxiety and depression scales. Forty-one participants completed the study for 12 weeks, 21 subjects in the drug group and 20 subjects in the placebo group. The rates of opioid-positive urine tests and self-reported opioid use were significantly lower in Hab-o Shefa group ( = 8.41, = 0.001). Hab-o Shefa also indicated a significant superiority over placebo in the effect of treatment by time interaction for craving ( = 5.91, = 0.001), depression ( = 3.40, = 0.01), and anxiety ( = 2.58, = 0.035). The retention time was 66.6 days for drug group and 59.6 days for placebo one. Although the causes for dropping out in two groups were different, there was no significant difference ( = 0.623). The side effects of the two groups were not significantly different. Results indicated that Hab-o Shefa could be useful for opioid maintenance treatment, and it can also be considered as a new promising drug for prevention of craving and relapse.
阿片类物质使用障碍维持治疗的主要问题是渴望和复发。草药化合物和补充疗法在治疗疾病和成瘾方面的应用已经广泛扩展。考虑到 Hab-o Shefa 在戒毒阶段的显著效果，本临床试验探索了该化合物对阿片类药物依赖患者维持治疗的影响。该产品由四种草药组成，包括 L.、 L.、 Roscoe 和 L. 。作者在 12 周内对 81 名阿片类药物依赖患者进行了两组平行随机双盲临床试验。在医学辅助戒毒后，参与者被随机分配到 Hab-o Shefa（n=41）和安慰剂组（n=40）。主要观察终点包括渴望信念问卷评估的渴望、自我报告的阿片类药物使用以及尿分析和成瘾严重程度指数简化问卷评估的 lapse（任何阿片类药物阳性尿液检测）、治疗保留率以及汉密尔顿焦虑和抑郁量表评估的抑郁和焦虑评分。41 名参与者完成了 12 周的研究，药物组 21 名，安慰剂组 20 名。Hab-o Shefa 组阿片类药物阳性尿液检测和自我报告的阿片类药物使用率显著低于安慰剂组（分别为 8.41，p=0.001）。Hab-o Shefa 在治疗时间交互作用对渴望（p=5.91，p=0.001）、抑郁（p=3.40，p=0.01）和焦虑（p=2.58，p=0.035）的治疗效果方面也明显优于安慰剂。药物组的保留时间为 66.6 天，安慰剂组为 59.6 天。虽然两组脱落的原因不同，但无统计学差异（p=0.623）。两组的副作用无显著差异。结果表明，Hab-o Shefa 可用于阿片类药物维持治疗，也可作为预防渴望和复发的一种新的有前途的药物。
