As one of the most commonly used complementary and alternative medicine, acupuncture research has markedly grown. Consequently, summaries of acupuncture clinical research status have been reported (1-3), and several well-designed clinical trials that evaluated the effectiveness and safety of acupuncture for diseases such as migraine, constipation, incontinence, and polycystic ovary syndrome have been completed recently (4-7). According to the survey of Ma and colleagues, more than 7017 articles related to acupuncture clinical research including case reports, case series studies, non-randomized or randomized controlled trials have been published on academic journals from 1995 to 2014 (8). Despite ascending acupuncture-related research are arising, the bibliometric analysis for acupuncture clinical research protocol remain underexplored. Bibliometric analysis could be valuable to reveal historical development, existing research hot-point and predict the future of acupuncture clinical research as well. Hence, we conducted this study using Web of Science (WoS) database to summarize the productivity, performance, and structural trends of researchers, institutes, and research fields.
The WoS database was accessed through the Library of China Academy of Chinese Medical Sciences on 14th August, 2017. The search strategy comprises three steps. We used ‘acupunct*’ and ‘electroacupunct*’ as title words for the 1st step; ‘protocol’, ‘proposal’ and ‘design’ as titles words for the 2nd step; The 3rd step was the combination of step 1 and 2. All records of acupuncture related clinical research protocol were included. Excluded criteria were (I) original articles, (II) letter, (III) review, (IV) systematic review protocol, (V) abstract, and (VI) design of device. There were no publication year and language restrictions. All results were manually checked by two authors (Zongshi Qin and Jiani Wu) independently, and retrieval results were downloaded using export function of WoS website. Following aspects including publication trends, country/areas, authors (including all authors), journal name of published articles, organization which published articles, and main health conditions addressed were analyzed. To simplify analyses, only top-10 ranking results of each respect were listed.
A total of 295 records for acupuncture research were retrieved in the database. We excluded 90 records based on the titles and abstracts and 23 records were excluded after scanning full-text, of which 14 indicated the design of placebo needle or other devise, 9 were letters, 24 were original articles, 25 were reviews, 25 were systematic review protocols, and 18 were treatment protocol instead of the trial design. Finally, 182 records were included. All included protocols were journal articles, and were identified as type of randomized controlled trial.
In 1982, the first acupuncture clinical trial protocol, which reported acupuncture for primary headache was published (9), after that, no record arose until 1998 Margolin et al. described the rationale and design of acupuncture for cocaine alternative treatments study (10). The number of acupuncture protocols gradually increased to a peak of 30 from 2000 until the middle of 2017. Owing to the publication for 2017 was still in process, the final number was not yet available. During the last 5 years, the annual amount of protocols was higher than 20, and the average of annual publications equals to the total amount from 1982 to 2010. Figure 1 shows the growth in numbers of acupuncture clinical research protocols from 1982 to 2017.
Table 1 shows the research fields that last 3 years acupuncture clinical research protocols focused. Pain was the most commonly studied topic, accounting for 15% of identified protocols. Other research fields of focus included stroke (8.8%), arthritis (7.5%), insomnia (5%), depression (5%), polycystic ovary syndrome (5%), and post-chemotherapy symptoms such as nausea and vomiting (5%). Besides, less commonly studied health conditions included vertigo, urinary retention, hyperlipidemia, heart failure, sjogren syndrome, colic, cognitive impairment.
Table 2 illustrates the list of top ten areas of articles published related to acupuncture clinical research protocols. China (86, 47.2%) was the country responsible for the most published acupuncture protocols, and the amount of the acupuncture protocol came from China is higher than the total of South Korea (42, 23.1%), USA (23, 12.6%), and Germany (13, 7.1%). Following by South Korea, USA, and Germany.
Table 3 shows the list of top ten authors who published acupuncture clinical research protocols. Lee S from South Korea published the most acupuncture protocols (17, 9.3%), followed by Liu ZS (13, 7.1%), Choi SM (10, 5.5%), and Li Y (10, 5.5%).
Table 4 lists the top ten journals which published acupuncture clinical research protocols. It shows that Trials (102, 56%) published the most acupuncture clinical research protocol, followed by BMC Complementary and Alternative Medicine (24, 13.2%), BMJ Open (13, 7.1%), Evidence-based Complementary and Alternative Medicine (8, 4.4%), Journal of Alternative and Complementary Medicine (5, 2.7%), and Contemporary Clinical Trials (3, 1.6%).
Table 5 demonstrates the list of top ten institutes where published acupuncture clinical research protocols. Kyung Hee University published the most acupuncture protocols (25, 13.7%), followed by Korea Institute of Oriental Medicine (18, 10%), the China Academy of Chinese Medical Sciences (16, 8.8%), Capital Medical University (14, 7.7%), and Chengdu University of Chinese Medicine (13, 7.1%).
In the early of 2017, Kung et al. published an article and summarized acupuncture publication trends from 1988 to 2015 based on searching WoS database (11). It is valuable to objectively characterize acupuncture publication trends, which listed the ranking of prolific country/areas, authors, organizations, research fields, and related journals. China, USA, and South Korea were the countries responsible for the most published acupuncture article according to Kung’s study. This result was generally consistent with our findings, in which the South Korea was ranked first, followed by China and USA. This result may be linked to an increased demand of academic papers from institutes and universities, on the other hand, increasing open access academic journals give positions for publishing research protocols. Because of acupuncture analgesia, acupuncture was firstly recognized by the worldwide. Until now, regarding to research fields, pain was consistently the most common focus of acupuncture research. However, we found that with the exception of pain and pain related symptoms such as osteoarthritis and inflammation, other less commonly research fields but effect health significantly such as urinary retention, hyperlipidemia, heart failure, sjogren syndrome, colic, cognitive impairment has been studied in last 3 years.
Our results showed that all included protocols were identified as type of RCT, indicating that other types of clinical research such as cohort study has not been reported yet. However, in addition to RCTs, observational research also plays important roles in clinical research, which could be a supplementary for RCTs, especially for generating the hypothesis (12-14). In recent years, the development of guidelines such as the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and the Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) helped to develop standards for protocol writing in acupuncture clinical research (15,16). In turn, the methodology and quality of acupuncture clinical research has been improved significantly.
Among 182 records, multi-center randomized controlled trials account for a small part of available randomized controlled trial protocols. Most included clinical protocols calculated small sample size with single center design. As the golden standard evidence in clinical research, the results that RCTs generated were considered to be the most valued data in evidence-based medicine. However, several limitations of acupuncture RCTs should be mentioned. First, conducting small sample size RCT to explore the effectiveness and safety of acupuncture might fail to minimize bias because of the insufficient power. Otherwise, it is hard to conduct blinding to acupuncturist during the acupuncture treatment, considering the characteristics of acupuncture, which also have influence on the precision of research results. Third, different from medicine RCTs that comparing western drugs with placebo, sham acupuncture used in acupuncture RCTs is still controversial (17). Depending on the variety of depth, location, and whether electricity stimulation will be used, there are 17 kinds of sham control groups in acupuncture RCTs could be utilized (18). In addition, it is inefficiency and lavish to explore the effectiveness and safety of acupuncture for diseases through conducting small sample size RCTs.
Observational research could be used to generate hypotheses to be answered in front of large-scale RCTs and replace the exploration role of RCTs with small sample size. The selection of optimal acupuncture point protocol is complex and tough to acupuncturists, and large-scale cohort study or registry study might be able to solve this problem according to big data collected from hospital information system. The relationship between internal validity and external validity of acupuncture related RCTs should also be valued by clinical researchers. Although acupuncture related RCTs are able to provide high-level clinical evidence, considering the tough inclusion/exclusion criteria and standard intervention protocols, the external validity might be limited. To achieving acupuncture clinical research evidence, observational research such as cohort study and registry study based on large sample size and multi-center are needed in the future. To avoid selected reporting of partial results between exposure (acupuncture) and outcomes, protocols of these studies should be recommended to report on the platforms or peer-review journal.
The limitations of this study should be noted. First, we only searched WoS database, making it impossible to trace all sources that might be included by other databases. Another limitation is that we did not assess the quality of included protocols or designs, such as whether the included protocols or designs has followed SPIRIT or STRICTA statements, and whether they appropriately described the details of trials such as randomization, concealment, blinding, and statistics.
Conflicts of Interest: The authors have no conflicts of interest to declare.
- Goh YL, Ho CE, Zhao B. Acupuncture and depth: future direction for acupuncture research. Evid Based Complement Alternat Med 2014;2014:871217. [PubMed]
- More AO, Tesser CD, da Silva JB, et al. Status and Impact of Acupuncture Research: A Bibliometric Analysis of Global and Brazilian Scientific Output from 2000 to 2014. J Altern Complement Med 2016;22:429-36. [Crossref] [PubMed]
- Fu JY, Zhang X, Zhao YH, et al. Bibliometric Analysis of Acupuncture Research Fronts and Their Worldwide Distribution over Three Decades. Afr J Tradit Complement Altern Med 2017;14:257-73. [Crossref] [PubMed]
- Liu Z, Yan S, Wu J, et al. Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial. Ann Intern Med 2016;165:761-9. [PubMed]
- Liu Z, Liu Y, Xu H, et al. Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial. JAMA 2017;317:2493-501. [Crossref] [PubMed]
- Wu XK, Stener-Victorin E, Kuang HY, et al. Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary Syndrome: A Randomized Clinical Trial. JAMA 2017;317:2502-14. [Crossref] [PubMed]
- Zhao L, Chen J, Li Y, et al. The Long-term Effect of Acupuncture for Migraine Prophylaxis: A Randomized Clinical Trial. JAMA Intern Med 2017;177:508-15. [Crossref] [PubMed]
- Ma Y, Dong M, Zhou K, et al. Publication Trends in Acupuncture Research: A 20-Year Bibliometric Analysis Based on PubMed. PLoS One 2016;11:e0168123. [Crossref] [PubMed]
- Ceccherelli F, Ambrosio F, Vettorazzi M, et al. Treatment of primary headache by means of somatic acupuncture - a proposal for an experimental protocol. Minerva Medica 1982;73:731-53. [PubMed]
- Margolin A, Avants SK, Kleber HD. Rationale and design of the Cocaine Alternative Treatments Study (CATS): A randomized, controlled trial of acupuncture. J Altern Complement Med 1998;4:405-18. [Crossref] [PubMed]
- Kung YY, Hwang SJ, Li TF, et al. Trends in global acupuncture publications: An analysis of the Web of Science database from 1988 to 2015. J Chin Med Assoc 2017;80:521-5. [Crossref] [PubMed]
- Johnson ES, Dickerson JF, Vollmer WM, et al. The feasibility of matching on a propensity score for acupuncture in a prospective cohort study of patients with chronic pain. BMC Med Res Methodol 2017;17:42. [Crossref] [PubMed]
- Shih CC, Yeh CC, Hu CJ, et al. Risk of dementia in patients with non-haemorrhagic stroke receiving acupuncture treatment: a nationwide matched cohort study from Taiwan's National Health Insurance Research Database. BMJ Open 2017;7:e013638. [Crossref] [PubMed]
- Wu MY, Huang MC, Chiang JH, et al. Acupuncture decreased the risk of coronary heart disease in patients with fibromyalgia in Taiwan: a nationwide matched cohort study. Arthritis Res Ther 2017;19:37. [Crossref] [PubMed]
- Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200-7. [Crossref] [PubMed]
- Clark MT, Clark RJ, Toohey S, et al. Suggestions regarding adaptation of the STRICTA guidelines for reporting acupuncture practice and research. Acupunct Med 2017;35:75-7. [Crossref] [PubMed]
- Yang Y, Que Q, Ye X, et al. Verum versus sham manual acupuncture for migraine: a systematic review of randomised controlled trials. Acupunct Med 2016;34:76-83. [Crossref] [PubMed]
- Chen ZX, Li Y, Zhang XG, et al. Sham Electroacupuncture Methods in Randomized Controlled Trials. Sci Rep 2017;7:40837. [Crossref] [PubMed]
Cite this article as: Qin Z, Tian J, Wu J. Bibliometric analysis of publication trends in global acupuncture clinical research protocol. AME Med J 2017;2:151.