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《内吸富含四氢大麻酚的大麻油治疗纤维肌痛:一项随机、双盲、安慰剂对照临床试验》。

Ingestion of a THC-Rich Cannabis Oil in People with Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

机构信息

Public Health School, Municipal Health Secretary, Florianopolis, Brazil.

Department of Internal Medicine, Federal University of Santa Catarina, Florianopolis, Brazil.

出版信息

Pain Med. 2020 Oct 1;21(10):2212-2218. doi: 10.1093/pm/pnaa303.

DOI:10.1093/pm/pnaa303
PMID:33118602
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7593796/
Abstract

OBJECTIVE

To determine the benefit of a tetrahydrocannabinol (THC)-rich cannabis oil on symptoms and quality of life of fibromyalgia patients.

METHODS

A double-blind, randomized, placebo-controlled clinical trial was conducted for eight weeks to determine the benefit of a THC-rich cannabis oil (24.44 mg/mL of THC and 0.51 mg/mL of cannabidiol [CBD]) on symptoms and quality of life of 17 women with fibromyalgia, residents of a neighborhood with a low socioeconomic profile and a high incidence of violence in the city of Florianopolis, Brazil. The initial dose was one drop (∼1.22 mg of THC and 0.02 mg of CBD) a day with subsequent increases according to symptoms. The Fibromyalgia Impact Questionnaire (FIQ) was applied at pre- and postintervention moments and in five visits over eight weeks.

RESULTS

There were no significant differences on baseline FIQ score between groups. However, after the intervention, the cannabis group presented a significant decrease in FIQ score in comparison with the placebo group (P = 0.005) and in comparison with cannabis group baseline score. (P < 0.001). Analyzing isolated items on the FIQ, the cannabis group presented significant improvement on the "feel good," "pain," "do work," and "fatigue" scores. The placebo group presented significant improvement on the "depression" score after intervention. There were no intolerable adverse effects.

CONCLUSIONS

Phytocannabinoids can be a low-cost and well-tolerated therapy to reduce symptoms and increase the quality of life of patients with fibromyalgia. Future studies are still needed to assess long-term benefits, and studies with different varieties of cannabinoids associated with a washout period must be done to enhance our knowledge of cannabis action in this health condition.

摘要

目的

评估富含四氢大麻酚(THC)的大麻油对纤维肌痛患者症状和生活质量的益处。

方法

开展了一项为期 8 周的双盲、随机、安慰剂对照临床试验,以确定富含 THC 的大麻油(THC 含量为 24.44mg/mL,大麻二酚 [CBD] 含量为 0.51mg/mL)对 17 名居住在巴西弗洛里亚诺波利斯市一个社会经济水平较低且暴力事件高发社区的纤维肌痛女性患者的症状和生活质量的影响。初始剂量为每天一滴(约 1.22mg THC 和 0.02mg CBD),随后根据症状增加剂量。在干预前后以及 8 周内的 5 次就诊时应用纤维肌痛影响问卷(FIQ)进行评估。

结果

两组患者在基线 FIQ 评分上无显著差异。然而,干预后,与安慰剂组相比,大麻组的 FIQ 评分显著降低(P=0.005),与大麻组基线评分相比也显著降低(P<0.001)。分析 FIQ 的孤立项目,大麻组在“感觉良好”、“疼痛”、“工作”和“疲劳”评分上均有显著改善。干预后,安慰剂组在“抑郁”评分上有显著改善。无不可耐受的不良反应。

结论

植物大麻素可能是一种低成本且耐受性良好的治疗方法,可减轻纤维肌痛患者的症状并提高其生活质量。未来仍需要研究来评估长期益处,并且必须进行不同种类的大麻素与洗脱期相结合的研究,以增进我们对大麻在这种健康状况下作用的了解。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f26c/7593796/9428aace2fca/pnaa303f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f26c/7593796/9428aace2fca/pnaa303f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f26c/7593796/9428aace2fca/pnaa303f1.jpg

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