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耳针治疗药物依赖:一项关于临床疗效、健康相关生活质量和患者可接受性的开放标签随机研究。

Auricular acupuncture for drug dependence: an open-label randomized investigation on clinical outcomes, health-related quality of life, and patient acceptability.

作者信息

Lua Pei Lin, Talib Nor Samira

机构信息

Center for Clinical and Quality of Life Studies, Faculty of Medicine and Health Sciences, Universiti Sultan Zainal Abidini, Kota Campus, Kuala Terengganu, Malaysia.

出版信息

Altern Ther Health Med. 2013 Jul-Aug;19(4):28-42.

Abstract

CONTEXT

Substance abuse has been prevalent in Malaysia for many years and currently represents one of the main concerns to its society. The limitations of conventional therapies have resulted in efforts to explore the potentia of complementary therapies in the management of drug addiction. The evidence for auricular acupuncture (AA) as a potential complementary therapy for drug addiction is still limited and inconclusive.

OBJECTIVE

The study intended (1) to compare the clinical outcomes of methadone maintenance treatment (MMT) alone and MMT plus AA (MMT+AA) with regard to the daily methadone dose, number of cigarettes smoked/wk, relapse rates, and withdrawal symptoms; (2) to evaluate health-related quality of life (HR QoL) pre- and postintervention; and (3) to determine participants' acceptance of AA therapy.

DESIGN

The research team designed this study to be prospective, longitudinal, open-labeled, and randomized, with one intervention group (AA group) and one control group.

SETTING

The settings were three MMT centers in Terengganu, Malaysia: (1) the Methadone Maintenance Treatment (MMT) Center, Hospital Sultanah Nur Zahirah; (2) the MMT Center, Marang Health Clinic; and (3) the MMT Center, Seberang Takir Health Clinic.

PARTICIPANTS

Participants were individuals who were enrolled in the three MMT programs.

INTERVENTION

After randomization, the intervention group received MMT+AA while the control group received MMT only. Participants in the AA group underwent concurrent AA sessions for 8 wk.

OUTCOME MEASURES

All outcomes were evaluated using questionnaires that the research team developed and WHOQOL-BREF. Data were analysed employing descriptive and nonparametric statistics (SPSS v16).

RESULTS

A total of 97, eligible, male patients consented to participation (MMT = 42; MMT+AA = 55; median age = 36.0 y; Malay ethnicity = 97.9%). After screening for dropouts, the data from only 69 participants were considered for postintervention analysis (MMT = 40; MMT+AA = 29). At preintervention, participants differed significantly by HR QoL profile and the frequency of withdrawal symptoms (better for MMT participants). Postintervention, all groups reported significantly reduced numbers of cigarettes smoked and a reduced methadone dose (P < .05), whereas no significant difference was detected for other parameters. No difference for relapse rate was detected between the groups. On separate group analysis, only the number of cigarettes was significantly lower for MMT+AA participants, whereas apart from methadone dose, all other parameters had significantly improved over time in the MMT+AA cohort. The additional AA therapy also demonstrated favorable acceptance and tolerable side effects.

CONCLUSION

Findings implied that AA could be beneficial as an adjunct to MMT in managing addiction, but the effectiveness of AA still requires further extensive investigation.

摘要

背景

药物滥用在马来西亚已盛行多年,目前是该国社会主要关注的问题之一。传统疗法的局限性促使人们努力探索辅助疗法在药物成瘾管理中的潜力。耳针疗法(AA)作为一种潜在的药物成瘾辅助疗法,其证据仍然有限且尚无定论。

目的

本研究旨在(1)比较单独美沙酮维持治疗(MMT)与MMT加AA(MMT+AA)在每日美沙酮剂量、每周吸烟量、复发率和戒断症状方面的临床结果;(2)评估干预前后与健康相关的生活质量(HR QoL);(3)确定参与者对AA疗法的接受程度。

设计

研究团队将本研究设计为前瞻性、纵向、开放标签和随机对照试验,设有一个干预组(AA组)和一个对照组。

地点

研究地点为马来西亚丁加奴州的三个MMT中心:(1)苏丹娜努尔扎希拉医院美沙酮维持治疗(MMT)中心;(2)马朗健康诊所MMT中心;(3)塞贝朗塔基尔健康诊所MMT中心。

参与者

参与者为参加这三个MMT项目的个体。

干预措施

随机分组后,干预组接受MMT+AA,而对照组仅接受MMT。AA组的参与者同时进行为期8周的AA治疗。

结果测量

所有结果均使用研究团队编制的问卷和世界卫生组织生活质量简表(WHOQOL-BREF)进行评估。采用描述性和非参数统计方法(SPSS v16)对数据进行分析。

结果

共有97名符合条件的男性患者同意参与研究(MMT组 = 42人;MMT+AA组 = 55人;中位年龄 = 36.0岁;马来族裔 = 97.9%)。在筛查退出者后,仅69名参与者的数据被纳入干预后分析(MMT组 = 40人;MMT+AA组 = 29人)。干预前,参与者在HR QoL概况和戒断症状频率方面存在显著差异(MMT参与者情况较好)。干预后,所有组报告的吸烟量和美沙酮剂量均显著减少(P < 0.05),而其他参数未检测到显著差异。两组之间未检测到复发率的差异。在单独的组分析中,MMT+AA参与者的吸烟量显著较低,而在MMT+AA队列中,除美沙酮剂量外,所有其他参数随时间均有显著改善。额外添加的AA疗法也显示出良好的接受度和可耐受的副作用。

结论

研究结果表明,AA作为MMT的辅助手段在管理成瘾方面可能有益,但AA的有效性仍需进一步广泛研究。

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