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对在ClinicalTrials.gov数据库中注册的补充和替代医学试验的评估。

Evaluation of complementary and alternative medicine trials registered in clinicaltrials.gov database.

作者信息

Dizdar Omer, Bilgin Emre, Akin Serkan, Kilickap Saadettin, Hayran Mutlu

机构信息

Hacettepe University Cancer Institute, Department of Preventive Oncology, Ankara, Turkey.

出版信息

J BUON. 2017 Mar-Apr;22(2):530-534.

PMID:28534381
Abstract

PURPOSE

Complementary and alternative medicine (CAM) products are increasingly used because they are perceived as natural, relatively low-cost and probably effective therapies for various diseases including cancer. We aimed to determine the quantity and major characteristics of recent herbal/alternative medicine trials registered in clinicaltrials. gov in patients with cancer.

METHODS

"Cancer AND (herbal OR complementary OR alternative)" key words were used to query clinicaltrials. gov (access date 17 April 2015). From the results, 163 trials which have been conducted in patients with the diagnosis of cancer were identified and included in this analysis.

RESULTS

At the date of access, 72 trials were completed, 37 trials were still recruiting patients and 10 trials had been withdrawn. Most common cancer type was breast cancer. Eighty-eight percent of trials were interventional and 60% of trials were randomized. The rate of new trial submission were similar for 5-year periods after 2000. The majority of the trials were conducted in United States of America (55%) and People's Republic of China (11%). Nine and 4 of 37 recruiting trials were recorded as phase II and phase III, respectively. When browsing was restricted to "recruiting" and "interventional" studies, the ratio of herbal/complementary treatment trials to all chemotherapy trials was 1.8 %.

CONCLUSION

CAM research in patients with cancer is currently limited, both in terms of quantity and quality. Until high quality scientific and clinical research establishes safety and efficacy of CAM practices, physicians should rigorously inform patients and the public on potential risks and caveats associated with CAM practices.

摘要

目的

补充和替代医学(CAM)产品的使用日益增加,因为它们被视为对包括癌症在内的各种疾病的天然、相对低成本且可能有效的疗法。我们旨在确定近期在clinicaltrials.gov上注册的针对癌症患者的草药/替代医学试验的数量和主要特征。

方法

使用“癌症 AND(草药 OR 补充 OR 替代)”关键词查询clinicaltrials.gov(访问日期为2015年4月17日)。从结果中,识别出163项已在确诊癌症患者中进行的试验并纳入本分析。

结果

在访问之日,72项试验已完成,37项试验仍在招募患者,10项试验已撤回。最常见的癌症类型是乳腺癌。88%的试验为干预性试验,60%的试验为随机试验。2000年后的5年期间,新试验提交率相似。大多数试验在美国(55%)和中华人民共和国(11%)进行。在37项招募试验中,分别有9项和4项被记录为II期和III期试验。当浏览仅限于“招募中”和“干预性”研究时,草药/补充治疗试验与所有化疗试验的比例为1.8%。

结论

目前,针对癌症患者的补充和替代医学研究在数量和质量方面都很有限。在高质量的科学和临床研究确定补充和替代医学实践的安全性和有效性之前,医生应严格告知患者和公众与补充和替代医学实践相关的潜在风险和注意事项。

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