姜黄素及其与乳香酸联合应用于骨关节炎的疗效与安全性：一项对比、随机、双盲、安慰剂对照研究。

Efficacy and safety of curcumin and its combination with boswellic acid in osteoarthritis: a comparative, randomized, double-blind, placebo-controlled study.

作者信息

Haroyan Armine, Mukuchyan Vahan, Mkrtchyan Nana, Minasyan Naira, Gasparyan Srbuhi, Sargsyan Aida, Narimanyan Mikael, Hovhannisyan Areg

机构信息

"Erebuni" Medical Center, 14 Titogradian Street, 0087, Yerevan, Armenia.

Yerevan State Medical University of Armenia, Koryun 2, 0025, Yerevan, Armenia.

出版信息

BMC Complement Altern Med. 2018 Jan 9;18(1):7. doi: 10.1186/s12906-017-2062-z.

BACKGROUND

The aim of this clinical trial was to assess the efficacy and safety of curcuminoid complex extract from turmeric rhizome with turmeric volatile oil (CuraMed®) and its combination with boswellic acid extract from Indian frankincense root (Curamin®) vs placebo for the treatment of 40- to 70-year-old patients with osteoarthritis (OA).

METHODS

The effects of CuraMed® 500-mg capsules (333 mg curcuminoids) and Curamin® 500-mg capsules (350 mg curcuminoids and 150 mg boswellic acid) taken orally three times a day for 12 weeks in 201 patients was investigated in a three-arm, parallel-group, randomized, double-blinded, placebo-controlled trial. Primary outcome efficacy measures included OA physical function performance-based tests, the WOMAC recommended index of joint pain, morning stiffness, limitations of physical function, and the patients' global assessment of disease severity.

RESULTS

Favorable effects of both preparations compared to placebo were observed after only 3 months of continuous treatment. A significant effect of Curamin® compared to placebo was observed both in physical performance tests and the WOMAC joint pain index, while superior efficacy of CuraMed vs placebo was observed only in physical performance tests. The effect size compared to placebo was comparable for both treatment groups but was superior in the Curamin® group. The treatments were well tolerated.

CONCLUSIONS

Twelve-week use of curcumin complex or its combination with boswellic acid reduces pain-related symptoms in patients with OA. Curcumin in combination with boswellic acid is more effective. Combining Curcuma longa and Boswellia serrata extracts in Curamin® increases the efficacy of OA treatment presumably due to synergistic effects of curcumin and boswellic acid.

TRIAL REGISTRATION

This trial is registered at the database www.clinicaltrials.gov . https://clinicaltrials.gov/ct2/show/NCT02390349?term=EuroPharma&rank=1 . Study registration number: NCT02390349 .

背景

本临床试验的目的是评估姜黄根茎类姜黄素复合物与姜黄挥发油（CuraMed®）及其与印度乳香根中提取的乳香酸提取物（Curamin®）联合使用相对于安慰剂治疗40至70岁骨关节炎（OA）患者的疗效和安全性。

方法

在一项三臂、平行组、随机、双盲、安慰剂对照试验中，对201例患者口服CuraMed® 500毫克胶囊（333毫克类姜黄素）和Curamin® 500毫克胶囊（350毫克类姜黄素和150毫克乳香酸），每日三次，持续12周的效果进行了研究。主要结局疗效指标包括基于OA身体功能表现的测试、WOMAC推荐的关节疼痛指数、晨僵、身体功能受限以及患者对疾病严重程度的整体评估。