Status quo, issues, and challenges for acupuncture research evidence: an overview of clinical and fundamental studies

To systematically review the status quo, issues, and challenges from home and abroad for acupuncture research evidence, in order to identify global acupuncture research datum lines and policy-making evidence for future research direction.

To carry out computed searching through the Cochrane Library, MEDLINE, CNKI, SCI, WHO-ICTRP, and Chinese Clinical Trials Registry (ChiCTR) (up to January, 2010) for acupuncture-related secondary studies (systematic reviews and meta-analysis), animal randomized controlled trials (RCTs), published human RCTs (fundamental research with the human body or human body specimens as subjects), and registered on-going clinical trials (regardless of subject recruiting), and to analyze yearly publishing trends and research hotspots on subject headings for secondary studies and published and registered RCTs.

(1) 63.7% of acupuncture clinical RCTs were published in the Cochrane Central Register of Controlled Trials (CENTRAL), while RCTs published in MEDLINE, SCI, and CNKI each accounted for a third of all acupuncture fundamental RCTs. Publishing trends of acupuncture clinical RCTs indicated three periods - a period of slow growth before 1998, a period of gradual growth between 1999 and 2005, and a period of rapid growth after 2005. While few fundamental acupuncture RCTs were published before 2004, the period after 2005 demonstrated an increasing trend, but did not exhibit the same rapid growth as with clinical RCTs. Publication of Cochrane systematic reviews (CSRs) exhibited a time-dependent effect with acupuncture clinical RCTs, a trend that became more pronounced as time passed, while time intervals between CSR and acupuncture clinical RCT publications decreased. (2) Nine SRs were published in China, accounting for 30% of the global total of 29, while China's 68 RCTs accounted for 21% of global RCTs. Among five CSRs affirming the effects of acupuncture, only one contained four RCTs from China, which accounted for 10% of all RCTs included in that CSR. All information provided above demonstrates a deficiency of high-quality evidence from China affirming the efficiency of acupuncture. (3) Nine CSRs published by Chinese researchers included 38 RCTs (44%) from China, as well as 48 foreign RCTs; four of these CSRs included RCTs from China only. (4) Over 70% of acupuncture fundamental RCTs were carried out by China alone while only 11% of acupuncture clinical RCTs included in SCI were from China, both of which suggest the methodology quality of acupuncture clinical RCTs in China should be raised to meet international standards. (5) Clinical research was the primary focus of acupuncture studies in Europe and the US. (6) Acupuncture studies were divided into nine research areas according to the top 50 disease-related high-frequency words in acupuncture RCTs. The first three disease categories, comprehensively ranked using published clinical RCTs, were pain and analgesia, cardio-cerebrovascular diseases, and the neuropsychological system. The top three disease categories of both on-going clinical RCTs and acupuncture fundamental RCTs, respectively, were in accordance with those of published clinical RCTs.

(1) CL CTRD is the key database in searching for published acupuncture clinical RCTs, and thus should be used first. Databases such as MEDLINE, SCI, and CNKI are all indispensable in retrieving acupuncture fundamental RCTs. (2) China leads the world in terms of both clinical and acupuncture fundamental RCTs, but while publication occurs rapidly, there is a lack of high-quality RCTs, suggesting future acupuncture clinical RCTs in China should place a higher emphasis on quality. Further development of acupuncture fundamental studies with little clinical research is a coming challenge for China. The US provides many of the RCTs published in SCI and on-going RCTs registered in WHO-ICTRP. Its small but high-quality publication will increasingly strengthen its impact on acupuncture research. (3) The fact that the top three disease categories of on-going clinical RCTs and of acupuncture fundamental RCTs, respectively, were in accordance with published clinical RCTs indicate that pain, cardio-cerebrovascular diseases, and neuropsychological diseases are major treatment disease categories for acupuncture and also primary development directions for the future. (4) CSRs will achieve synchronized updates with acupuncture clinical RCTs and its influence in guiding acupuncture clinical RCTs will grow clearer day by day. (5) Though registration of on-going RCTs is still in its initial stage and the number of RCTs registered is still relatively small, that the continued operation of the WHO-ICTRP will boost both the number of acupuncture RCTs registered and their quality. Innovation and time in acupuncture methodology will definitely advance the development of acupuncture research, while national and international cooperative programs in acupuncture research need evidence to support their claims throughout the course of project approval to implementation to inspection and acceptance to transformation to follow-up appraisal, in order to supply scientific and transparent research, thus improving credibility and practicality of the results.