[Study on establishing a methodology of comprehensive clinical evaluation for Chinese patent medicine based on health technology assessment].

At present, most of Chinese patent medicines have problems, such as weak scientific basis, unclear clinical value evaluation, etc., which lead to the lack of sufficient evidence for the entry into the essential medicine list, medical insurance catalog and other important health resource allocation tools. This has a negative impact on the development of traditional Chinese medicine. It is urgent to establish a comprehensive evaluation methodology system of Chinese patent medicine in China. There are at least three reasons including producing evidence for clinical rational use scientifically, developing an objective and transparent selecting strategy, eventuating and highlighting its clinical value. The process and method of health technology assessment(HTA) can provide reference for the establishment of comprehensive evaluation method of Chinese patent medicine. However, HTA is rarely carried out in the field of traditional Chinese medicine. The latest domestic and international research showed that HTA combined with multi-criteria decision analysis(MCDA) can increase the transparency of decision-making and improve the quality of decision-making. The combined two formed the EVIDEM framework, which is conducive to drug selection and its clinical use. In this paper, the EVIDEM framework was introduced to establish the methodology framework of the comprehensive clinical evaluation system of Chinese patent medicine. A preliminary research idea has been put forward. In the future, we can establish a set of comprehensive clinical evaluation methods for Chinese patent medicine in cooperation with relevant national drug decision-making departments and management departments. It is believed that such cooperation could promote the full implementation of the re-evaluation for Chinese patent medicine.

Helical tomotherapy for cancer treatment: a rapid health technology assessment.

OBJECTIVES: Helical tomotherapy (HT) can be applied to treat complex malignant cancer with high-precise radiotherapy, and it can reduce the damage to normal tissues and improve treatment effects. But the procurement of HT must be approved by relevant departments of administration affairs. This study, appointed by the National Health and Family Planning Commission of China and undertook by the National Health Development Research Center and the Chinese Evidence-Based Medicine Centre, was aimed to rapidly assess the effectiveness, safety, costs, and applicability of HT, so as to provide currently available best evidence for decision-makers of health policies. METHODS: We electronically searched databases including PubMed, EMbase, The Cochrane Library, CNKI, WanFang Data, VIP, CBM, and other professional websites. Two reviewer independently screened literature according to the inclusion and exclusion criteria, extracted data, assessed quality, and then performed descriptive analysis. RESULTS: (i) We finally included 150 studies, encompassing 5 HTAs, 18 CCTs, and 127 observational studies. (ii) The included HTAs were published during 2006-2009, providing fairly less evidence of low quality and the results of 145 primary studies showed that: HT had been used mainly in the treatments of 14 kinds of cancer, with low total toxicity and high survival rates. Although the quality of the included studies was poor, there was much evidence about prostate cancer, head and neck cancer, nasopharynx cancer, cervical cancer, lung cancer and liver cancer, with enough sample and fairly reliable results in HT efficacy and safety. And (iii) a total of 56 clinical trials were registered in Clinicaltrials.gov, most of which were registered by the occident. Among them, 9 were completed but the results had not been published yet. CONCLUSIONS: The evidence of this study showed that, HT is safe and effective in clinic. But the abovementioned conclusion needs to be verified by conducting more high-quality studies with long-term follow-up. The costs of HT in procurement, maintenance, and application are high; and the skills, training, and qualification of operators are required. We suggest that the procurement of HT should be reduced; it should be allocated rationally and effectively used after comprehensive assessment in China's cancer epidemiology characteristics, health resource allocation, disease burden, medical service level, etc.; and also high-quality studies with long-term follow-up should be financially supported on the basis of establishing projects, so as to provide local evidence and consistently guide and improve scientific decision-making.