BIRMINGHAM, England (EGMN) – The use of complementary or alterative medicines in rheumatoid arthritis, osteoarthritis, and fibromyalgia is not supported by credible evidence, according to an expert review of available data.
The review, commissioned by Arthritis Research UK for patients, shows that although there is some consistent suggestion of a benefit of fish body oil in RA and capsaicin gel in OA, there is no such support for the use of any oral or topical complementary or alterative medicines (CAMs) in fibromyalgia.
“Complementary medicines are popular, but considering particularly those taken orally or applied topically, we have relatively little information for most compounds on efficacy,” said Dr. Gary J. MacFarlane at the annual meeting of the British Society of Rheumatology.
“Both positive and negative conclusions are based upon relatively little amounts of evidence,” added Dr. MacFarlane, professor of epidemiology at the University of Aberdeen (Scotland) and head of the Arthritis Research UK working group on complementary and alternative medicines.
The working group consisted of eight expert advisors who looked at the available evidence on 41 CAMs for which there was some evidence from randomized controlled trials. There were a further 38 compounds commonly used by patients for which no suitable trial evidence could be found.
The aim of the review was to determine both the efficacy and safety of the compounds to give patients some idea of which CAMs worked and which probably did not, Dr. MacFarlane said. If a rigid Cochrane Review had been performed, he conceded, the majority of studies that were assessed would probably have been excluded.
“However, patients were saying to us, actually we want you to say something, not just that there is not enough evidence,” Dr. MacFarlane explained.
Efficacy was graded on a 1- to 5-level scale, with level 1 signifying that there is no overall evidence that the compound worked, and level 5 meaning that there was some consistent evidence across several studies.
The only compounds at level 5 were fish body oil for RA and capsaicin gel for OA.
Glucosamine sulfate for OA, was graded at level 3, meaning that there was some promising evidence, despite its not being recommended for the treatment of OA in the 2008 OA clinical guidelines of the U.K. National Institute for Health and Clinical Excellence.
Out of four CAMs used for fibromyalgia, none was graded higher than a level 2.
Dr. MacFarlane said that in his view, “fibromyalgia is a condition that really doesn’t have any very effective therapy.” Although there have been a small number of positive CAM studies in fibromyalgia, he added, their lack of replication means that further, higher-quality trials are necessary to determine whether these initial findings can be supported by a larger evidence base.
The working group’s findings on the use of CAM in fibromyalgia have recently been published (Rheumatology 2010;49:1063-8), and publications on the use of CAM in OA and RA will be forthcoming in the coming months.
“Most patients consider complementary medicines as safe,” Dr. MacFarlane observed, adding that there are important safety issues to consider, such as the quality of the preparation, contraindications, and interactions with conventionally prescribed medicines.
“A treatment should not be considered risk free unless the evidence suggests otherwise,” Dr. MacFarlane noted, stressing that the risks associated with CAM are often heightened by patients’ neglect to inform their doctors that they are using such therapies.
Dr. MacFarlane had no disclosures or conflicts of interest. The research was funded by Arthritis Research UK.
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英国伯明翰(EGMN)——一篇基于现有数据的专家述评显示,现有的可靠证据不支持补充或替代医学用于类风湿性关节炎(RA)、骨关节炎(OA)和纤维性肌痛的治疗。
这项评价是受英国关节炎研究组织的委托而开展的。结果显示,虽然有部分证据一致表明鱼体油和辣椒碱软膏分别对RA和OA患者有益,但却没有这样的证据支持任何口服或局部外用补充或替代医学(CAM)产品对纤维性肌痛患者有效。
在英国风湿病学会2010年年会上,Gary J. MacFarlane博士说:“现在补充医学很流行,但特别是对于那些口服或局部外用的产品,大部分化合物的疗效信息都相对很少。”
苏格兰阿伯丁大学的流行病学教授MacFarlane博士担任英国关节炎研究组织补充和替代医学工作组组长。MacFarlane博士补充道:“无论是阳性还是阴性结论,都是基于相对很少的证据。”
该工作组由8名专家顾问组成,他们对41种CAM化合物的现有证据进行了评价,其中部分证据来自于随机对照试验。还有另外38种化合物是患者常用的,但却找不到合适的试验证据。
MacFarlane博士说,这项评价的目的是确定这些化合物的疗效和安全性以便让患者了解哪些CAM产品有效,哪些很可能无效。MacFarlane博士总结道,如果采用的是标准更为严格的Cochrane系统评价,那么所评价的大部分试验很可能都会被排除在外。
MacFarlane博士解释道:“但患者对我们说,事实上我们希望你们这些专家说点什么,而不是只告诉我们没有足够的证据。”
采用1~5分级量表对疗效进行评估,1级表示无总体证据证明该化合物有效,5级表示来自于数项试验的部分证据一致提示该化合物有效。
达到5级的化合物只有2种:用于RA的鱼体油和用于OA的辣椒碱软膏。
用于OA的硫酸盐葡糖胺被评为3级,说明有部分肯定的证据,尽管英国国家卫生与临床优化研究所发布的2008年OA临床指南中并没有推荐该药用于OA的治疗。
在用于纤维性肌痛的4种CAM化合物中,没有一种的评级超过了2级。
MacFarlane博士说,“在我看来,对于纤维性肌痛这种疾病,事实上没有任何非常有效的治疗。” MacFarlane博士补充道,虽然有少数针对纤维性肌痛的CAM研究得出了阳性结果,但这些结果都缺乏可重复性,这说明还需要进一步开展更高质量的试验,以确定这些初始结果是否能被更多的证据所支持。
工作组最近已经发表了有关CAM治疗纤维性肌痛的评价结果(Rheumatology 2010;49:1063-8),有关CAM治疗OA和RA的评价结果将于未来数月内发表。
MacFarlane博士观察发现,“大部分患者都认为补充医学产品是很安全的。”他继续补充道,实际上这类产品也有许多重要的安全性问题值得我们重视,如制剂的质量、禁忌证及其与常规药物之间的相互作用。
MacFarlane博士指出:“除非有相关证据证实,否则不能轻易认为某种治疗是完全没有风险的。” MacFarlane博士还强调,患者往往没有告知医生他们正在使用CAM产品,这会导致与CAM产品相关的风险进一步增加。
MacFarlane博士声明无相关利益冲突。该研究由英国关节炎研究组织资助。
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