Clinical trial registration, and publication in acupuncture studies: A systematic review.

BACKGROUND: To research 1) how many acupuncture clinical trials are registered with the WHO International Clinical Trial Registry Platform (ICTRP) and what patterns they demonstrate, 2) publication of the articles of acupuncture clinical trials which were registered with ICTRP. METHODS: The search strategy using the ICTRP: Intervention: acupuncture; Recruitment status: All; Date of registration; from 1 Jan 1990 to 31 Dec 2018. We searched the indexed articles in PubMed using trial IDs on 25 Feb 2019. When the paper was published, we indicated the number of weeks from the date of registration with ICTRP to the date of publication in order to define time till the publication. We divided the whole period we analyzed into 6 periods of every 3 years and measured the proportion of publication and the time from the date of registration of each trial till its publication in each period by the Kaplan-Meier method. RESULTS: Forty-three countries/areas conducted at least one acupuncture clinical trial. The total number of registrations was 1758. China, the USA, and the Republic of Korea accounted for 61% of those registrations. The proportion of publication was 178/1758 10% for the fully published papers and 141/1758 8% for the protocol papers. CONCLUSIONS: The substantial increase of registrations by China, the Republic of Korea, Iran, Brazil, Japan was observed which may be attributed to improved awareness of the CONSORT statement. However, the fully published papers rate is low at 10%. The publication of results of acupuncture clinical trials should also be rigorously mandated.

Epidemiological characteristics of rheumatoid arthritis in Japan: Prevalence estimates using a nationwide population-based questionnaire survey.

Objectives: To elucidate the epidemiological characteristics of patients with rheumatoid arthritis (RA) in Japan using data from the Comprehensive Survey of Living Conditions, a nationwide questionnaire survey conducted in 2016.Methods: In total, 222,365 men and 245,251 women aged ≥16 years were included in the study. RA patients were defined as those who reported 'currently receiving treatment for RA at hospitals, clinics, or a facility for Japanese traditional massage, acupuncture, moxibustion, or judo-orthopedics.' The number of RA patients was estimated from the age-specific prevalence and total Japanese population in 2016. Further, the prevalence of individuals experiencing difficulties in activities of daily living due to health problems and those with mental distress as evaluated by K6 Scale was examined.Results: The estimated number and prevalence of RA in Japan with 95% confidence interval was 822 (768-880) thousand and 0.75% (0.70-0.80%). The population peaked in the late 60s, and the prevalence continued increasing until the early 80s, regardless of sex. Compared with non-RA participants, RA patients were more likely to experience difficulties in activities and to be distressed.Conclusion: High prevalence of RA in older age and mental and physical burden among RA patients were confirmed.

The utilization of complementary and alternative medicine in Taiwan: An internet survey using an adapted version of the international questionnaire (I-CAM-Q).

BACKGROUND: In Taiwan, numerous studies have been conducted to investigate the use of complementary and alternative medicine (CAM). However, most of them focused on specific diseases or the use of particular methods. Therefore, the results of those studies were quite different and difficult to compare with those of studies from other countries. The International CAM Questionnaire (I-CAM-Q), meanwhile, is a unified tool that can provide comparable results for studies conducted worldwide. Thus, the aim of this study was to discover the proportions of people in Taiwan receiving CAM treatments from different types of health care providers by using an adapted version of I-CAM-Q (I-CAM-QT). METHODS: I-CAM-QT was developed by translating the Korean version of I-CAM-Q (I-CAM-QK) into traditional Chinese language because of the similarity of CAM usage and doctor licensing system. This study had two stages: the first was a pretest survey used to adjust the questionnaire, while the second was an internet-based survey used to collect data from the community. RESULTS: Of the 1200 survey respondents, 37% and 37.7% were prescribed or advised to use Chinese herbal medicine (CHM) by Western medicine (WM) physicians and traditional Chinese medicine (TCM) doctors, respectively. Other than CHM, dietary supplements and massage were the forms of CAM most commonly prescribed or recommended by WM physicians or TCM doctors. Overall, walking and relaxation techniques were the most commonly used self-help practices (used by 61.9% and 40.4% of the respondents, respectively). Additionally, 70.3% of the respondents had used at least one kind of dietary supplement in the past 12 months. CONCLUSION: Regarding the utilization of CAM in Taiwan, this internet-based survey revealed that CHM, dietary supplements, and massage were the types of CAM most commonly prescribed or recommended by WM physicians or TCM doctors.

Internet survey on the provision of complementary and alternative medicine in Japanese private clinics: a cross-sectional study.

OBJECTIVE: Although the use of complementary and alternative medicine (CAM) by the general population has been surveyed previously, the provision of CAM by Japanese physicians in private clinics has not been studied. Universal health insurance system was established in Japan in 1961, and most CAMs are not on the drug tariff. We aimed to clarify the current status of CAM provided by physicians at private clinics in Japan. METHODS: We conducted an internet survey on 400 directors/physicians of private clinics nationwide on the provision of CAM from February 6 to February 10, 2017. Survey items included attributes of subjects, presence/absence of sections or facilities for provision of CAM, proportions of health insurance coverage for medical practices, and source of information. Private clinic was defined as a clinic run by one physician, with less than 20 beds. RESULTS: Commonly provided CAMs were Kampo (traditional Japanese herbal) medicines (34.8%) and supplements/health foods (19.3%). CAMs on the drug tariff were provided in 46.5% of cases at the clinics, but only 16.5% of cases were provided CAMs which were not on the drug tariff, at different neighboring facilities. Among different specialties, Kampo medicines were prescribed at obstetrics/gynecology (54.0%), orthopedics (44.4%), and dermatology (43.0%). Clinics not providing any CAM accounted for 53.5%. With regard to health insurance coverage, 96.8% of the clinics provided only or mainly health services on the universal national health insurance tariff (29.8% and 67.0%, respectively). CONCLUSION: Kampo medicines represent the most commonly used CAM in private clinics in Japan, and universal national health insurance coverage is considered to be the reason for the high rate of their use.

Use of Complementary and Alternative Medicine in Japan: A Cross-sectional Internet Survey Using the Japanese Version of the International Complementary and Alternative Medicine Questionnaire.

INTRODUCTION: Although there have been several national survey studies on complementary and alternative medicine (CAM) use in Japan, previous studies have not been compared with investigations conducted in other countries. An international CAM questionnaire known as I-CAM-Q was developed through a two-day international workshop in 2006. The purpose of this study was to investigate the use of CAM by the general Japanese population using a modified version of the I-CAM-Q for the Japanese (I-CAM-QJ). METHODS: We developed the I-CAM-QJ to conduct an internet survey of 3,208 participants from the general population of Japan in February 2016. The respondents included 1,592 males (49.6%), 1,348 university graduates (38.8%), 1,105 individuals in good health (34.4%), and 1,028 individuals with long-term illness or disability (32.0%). RESULTS: Of the 3,208 respondents, 411 participants reported CAM use during the past 12 months (12.8%). The following therapies and products were used: Kampo medicines (over-the-counter Kampo medicines: 15.7%; prescribed Kampo medicines: 15.4%), dietary supplements 11.8%, massage services 3.9%, and physical therapy 3.5%. Regarding the use of self-care methods during the last 12 months, the following methods and products were used: bath salts 25.8% and walking 25.3%. CONCLUSIONS: An internet survey on CAM use by the general Japanese population with a modified I-CAM-Q (I-CAM-QJ) revealed that Kampo medicines and dietary supplements were the most commonly used CAMs in Japan.

An assessment of the use of complementary and alternative medicine by Korean people using an adapted version of the standardized international questionnaire (I-CAM-QK): a cross-sectional study of an internet survey.

BACKGROUND: In Korea, there are two types of medical doctors: one practises conventional medicine (hereafter called a physician), and the other practises traditional medicine (hereafter called a Korean medical doctor). This study aimed to compare the provision of complementary and alternative medicine (CAM) by these providers to CAM use per self-judgement in Korea. METHODS: We analysed 1668 Korean people via an internet survey with the Korean adopted version of the I-CAM-Q, namely, the International Questionnaire to measure use of CAM, to understand whether respondents used CAM based either on a prescription or advice from a physician or a Korean medical doctor or on self-judgement. RESULTS: In the previous 12 months, the proportions of respondents who were treated by a physician, who were treated by a Korean medical doctor and who were not treated by anyone were 67.9, 20.7 and 14.2%, respectively. Among the respondents who received CAM based on a prescription or advice from a physician, traditional Korean medicine practices and dietary supplements were commonly used; only a small percentage used other CAM therapies. Respondents who received CAM based on a prescription or advice from a Korean medical doctor showed similar results. Acupuncture and moxibustion, traditional Korean medicines (decoction), or cupping were more commonly used. Korean traditional medicines as over-the-counter (OTC) drugs were more commonly used by respondents who received CAM therapy based on a prescription or advice from a physician than by those who received CAM therapy based on a prescription or advice from a Korean medical doctor. A total of 74% of the responders used any CAM by self-judgement in the previous 12 months. CONCLUSIONS: For the use of CAM in Korea, in addition to the Korean traditional medical care provided by Korean medical doctors, general physicians advised people regarding Korean traditional medical care and dietary supplements.

Standards of Reporting Kampo Products (STORK) in research articles.

There had been no standardized rules for citing ethical Kampo products used in clinical trials in journal articles. Although the name of a Kampo manufacturer was described in 77.9% of research articles, the name and ratios of crude drug components of Kampo formulas were not described in 77.5% of these papers. Considering the importance of proper characterization of interventions in the Consolidated Standards of Reporting Trials (CONSORT) checklist, we hereby propose the use of the Standards of Reporting Kampo Products (STORK) website, http://mpdb.nibiohn.go.jp/stork, as a reference for Kampo products. This will provide an official source on the internet for verified information on individual Kampo formulations for citation purposes in clinical research articles.

Effectiveness of Pilates exercise: A quality evaluation and summary of systematic reviews based on randomized controlled trials.

OBJECTIVE: The objective of this review were to summarize evidence for the effectiveness of Pilates exercise (PE) and to assess the quality of systematic review (SRs) based on randomized controlled trials (RCTs). STUDY DESIGN: A systematic review of SRs based on RCTs. METHODS: Studies were eligible if they were RCTs. Studies included those with one treatment group in which PE was applied. We searched the following databases from 1995 up to August 20, 2014: MEDLINE via PubMed, CINAHL, Web of Science, Global Health Library, and Ichushi-Web. We also searched All Cochrane Database and Campbell Systematic Reviews up to August 20, 2014. Based on the International Classification of Diseases-10 (ICD-10), we identified a disease targeted for each article. RESULTS: Nine studies met all inclusion criteria. As a whole, the quality of the articles was good. Seven studies were about "Musculoskeletal system and connective tissue (M5456)". There were two studies in "Factors influencing health status and contact with health services (Z723)". The traits of participants were for females and the comparatively young- and middle-aged. Five SRs for chronic low back pain (CLBP) concluded that there was pain-relief and functional improvement of the intervention in the short term, but two SRs were inconclusive about the effectiveness of PE. There were no adverse events described in any of the studies. CONCLUSION: Although no SR reported any adverse effect or harm by PE, there was pain-relief and functional improvement attributed to PE in the short term in participants with CLBP. There was also evidence of improved flexibility and dynamic balance, and of enhanced muscular endurance in healthy people in the short term. In addition, there may have been an effect on body composition in the short term.

Effectiveness of horticultural therapy: a systematic review of randomized controlled trials.

AIM: To summarize the evidence from randomized controlled trials (RCTs) on the effects of horticultural therapy (HT). METHODS: Studies were eligible if they were RCTs. Studies included one treatment group in which HT was applied. We searched the following databases from 1990 up to August 20, 2013: MEDLINE via PubMed, CINAHL, Web of Science, Ichushi-Web, GHL, WPRIM, and PsyclNFO. We also searched all Cochrane Database and Campbell Systematic Reviews up to September 20, 2013. RESULTS: Four studies met all inclusion criteria. The language of all eligible publications was English and Korean. Target diseases and/or symptoms were dementia, severe mental illness such as schizophrenia, bipolar disorder, and major depression, frail elderly in nursing home, and hemiplegic patients after stroke. These studies showed significant effectiveness in one or more outcomes for mental health and behavior. However, our review especially detected omissions of the following descriptions: method used to generate randomization, concealment, blinding, and intention-to-treat analysis. In addition, the results of this study suggested that the RCTs conducted have been of relatively low quality. CONCLUSION: Although there was insufficient evidence in the studies of HT due to poor methodological and reporting quality and heterogeneity, HT may be an effective treatment for mental and behavioral disorders such as dementia, schizophrenia, depression, and terminal-care for cancer.

Assessing the quality of study reports on spa therapy based on randomized controlled trials by the spa therapy checklist (SPAC).

The purpose of this study was to assess the quality of study reports on spa therapy based on randomized controlled trials by the spa therapy and balneotherapy checklist (SPAC), and to show the relationship between SPAC score and the characteristics of publication. We searched the following databases from 1990 up to September 30, 2013: MEDLINE via PubMed, CINAHL, Web of Science, Ichushi Web, Global Health Library, the Western Pacific Region Index Medicus, PsycINFO, and the Cochrane Database of Systematic Reviews. We used the SPAC to assess the quality of reports on spa therapy and balneotherapy trials (SPAC) that was developed using the Delphi consensus method. Fifty-one studies met all inclusion criteria. Forty studies (78%) were about "Diseases of the musculoskeletal system and connective)". The total SPAC score (full-mark; 19 pts) was 10.8 ± 2.3 pts (mean ± SD). The items for which a description was lacking (very poor; <50%) in many studies were as follows: "locations of spa facility where the data were collected"; "pH"; "scale of bathtub"; "presence of other facility and exposure than bathing (sauna, steam bath, etc.)"; "qualification and experience of care provider"; "Instructions about daily life" and "adherence". We clarified that there was no relationship between the publish period, languages, and the impact factor (IF) for the SPAC score. In order to prevent flawed description, SPAC could provide indispensable information for researchers who are going to design a research protocol according to each disease.

Use of Kampo diagnosis in randomized controlled trials of Kampo products in Japan: a systematic review.

BACKGROUND: The Committee for Evidence-based Medicine (EBM) of the Japan Society for Oriental Medicine started compiling Evidence Reports of Kampo Treatment (EKAT) in 2007. EKAT is a compilation of structured abstracts of randomized controlled trials (RCTs), along with comments by a third party reviewer. As of 31 December, 2012, there were 378 RCTs of Kampo medicines in Japan. The primary research question of this study is "How frequently is Kampo diagnosis used in RCTs of Kampo medicines?" The secondary research question is "When is Kampo diagnosis used in RCTs?" MATERIALS AND METHODS: The structured abstract (SA) of each RCT article was reviewed to examine how Kampo diagnosis was used in RCTs, especially how Kampo diagnosis was used in the randomization process. RESULTS: Kampo diagnosis was used before randomization in 27 RCTs (7.1%), after randomization in 31 RCTs (8.2%), and not used in 320 RCTs (84.7%). Before randomization, Kampo diagnosis was used as a criterion for inclusion in 10 RCTs, criterion for exclusion in 9 RCTs, and criteria for both inclusion and exclusion in 2 RCTs. Kampo formulas were determined according to Kampo diagnosis in 7 RCTs. After randomization, subgroup analyses according to Kampo diagnosis were done in 27 RCTs, and grade of disease severity at Kampo diagnosis was used for analysis as an endpoint in 4 RCTs. CONCLUSIONS: Kampo diagnosis was used before randomization only in approximately 15% of RCTs, and the number of RCT articles using Kampo diagnosis after randomization was almost the same as that before randomization. Further studies to determine the good RCTs conforming to CONSORT requirements and good systematic reviews conforming to PRISMA requirements are needed to clarify the significance of Kampo diagnosis.

Effectiveness of music therapy: a summary of systematic reviews based on randomized controlled trials of music interventions.

OBJECTIVE: The objective of this review was to summarize evidence for the effectiveness of music therapy (MT) and to assess the quality of systematic reviews (SRs) based on randomized controlled trials (RCTs). STUDY DESIGN: An SR of SRs based on RCTs. METHODS: Studies were eligible if they were RCTs. Studies included were those with at least one treatment group in which MT was applied. We searched the following databases from 1995 to October 1, 2012: MEDLINE via PubMed, CINAHL (Cumulative Index of Nursing and Allied Health Literature), Web of Science, Global Health Library, and Ichushi-Web. We also searched all Cochrane Database and Campbell Systematic Reviews up to October 1, 2012. Based on the International Classification of Diseases, 10th revision, we identified a disease targeted for each article. RESULTS: Twenty-one studies met all inclusion criteria. This study included 16 Cochrane reviews. As a whole, the quality of the articles was very good. Eight studies were about "Mental and behavioural disorders (F00-99)"; there were two studies on "Diseases of the nervous system (G00-99)" and "Diseases of the respiratory system (J00-99)"; and there was one study each for "Endocrine, nutritional and metabolic diseases (E00-90)", "Diseases of the circulatory system (I00-99)", and "Pregnancy, childbirth and the puerperium (O60)". MT treatment improved the following: global and social functioning in schizophrenia and/or serious mental disorders, gait and related activities in Parkinson's disease, depressive symptoms, and sleep quality. CONCLUSION: THIS COMPREHENSIVE SUMMARY OF SRS DEMONSTRATED THAT MT TREATMENT IMPROVED THE FOLLOWING: global and social functioning in schizophrenia and/or serious mental disorders, gait and related activities in Parkinson's disease, depressive symptoms, and sleep quality. MT may have the potential for improving other diseases, but there is not enough evidence at present. Most importantly, no specific adverse effect or harmful phenomenon occurred in any of the studies, and MT was well tolerated by almost all patients.

Effectiveness of animal-assisted therapy: A systematic review of randomized controlled trials.

The objectives of this review were to summarize the evidence from randomized controlled trials (RCTs) on the effects of animal-assisted therapy (AAT). Studies were eligible if they were RCTs. Studies included one treatment group in which AAT was applied. We searched the following databases from 1990 up to October 31, 2012: MEDLINE via PubMed, CINAHL, Web of Science, Ichushi Web, GHL, WPRIM, and PsycINFO. We also searched all Cochrane Database up to October 31, 2012. Eleven RCTs were identified, and seven studies were about "Mental and behavioral disorders". Types of animal intervention were dog, cat, dolphin, bird, cow, rabbit, ferret, and guinea pig. The RCTs conducted have been of relatively low quality. We could not perform meta-analysis because of heterogeneity. In a study environment limited to the people who like animals, AAT may be an effective treatment for mental and behavioral disorders such as depression, schizophrenia, and alcohol/drug addictions, and is based on a holistic approach through interaction with animals in nature. To most effectively assess the potential benefits for AAT, it will be important for further research to utilize and describe (1) RCT methodology when appropriate, (2) reasons for non-participation, (3) intervention dose, (4) adverse effects and withdrawals, and (5) cost.

How current Clinical Practice Guidelines for low back pain reflect Traditional Medicine in East Asian Countries: a systematic review of Clinical Practice Guidelines and systematic reviews.

OBJECTIVES: The aims of this study were to investigate whether there is a gap between evidence of traditional medicine (TM) interventions in East-Asian countries from the current Clinical Practice Guidelines (CPGs) and evidence from current systematic reviews and meta-analyses (SR-MAs) and to analyze the impact of this gap on present CPGs. METHODS: We examined 5 representative TM interventions in the health care systems of East-Asian countries. We searched seven relevant databases for CPGs to identify whether core CPGs included evidence of TM interventions, and we searched 11 databases for SR-MAs to re-evaluate current evidence on TM interventions. We then compared the gap between the evidence from CPGs and SR-MAs. RESULTS: Thirteen CPGs and 22 SR-MAs met our inclusion criteria. Of the 13 CPGs, 7 CPGs (54%) mentioned TM interventions, and all were for acupuncture (only one was for both acupuncture and acupressure). However, the CPGs did not recommend acupuncture (or acupressure). Of 22 SR-MAs, 16 were for acupuncture, 5 for manual therapy, 1 for cupping, and none for moxibustion and herbal medicine. Comparing the evidence from CPGs and SR-MAs, an underestimation or omission of evidence for acupuncture, cupping, and manual therapy in current CPGs was detected. Thus, applying the results from the SR-MAs, we moderately recommend acupuncture for chronic LBP, but we inconclusively recommend acupuncture for (sub)acute LBP due to the limited current evidence. Furthermore, we weakly recommend cupping and manual therapy for both (sub)acute and chronic LBP. We cannot provide recommendations for moxibustion and herbal medicine due to a lack of evidence. CONCLUSIONS: The current CPGs did not fully reflect the evidence for TM interventions. As relevant studies such as SR-MAs are conducted and evidence increases, the current evidence on acupuncture, cupping, and manual therapy should be rigorously considered in the process of developing or updating the CPG system.

A checklist to assess the quality of reports on spa therapy and balneotherapy trials was developed using the Delphi consensus method: the SPAC checklist.

OBJECTIVE: The purpose of this study was to develop a checklist of items that describes and measures the quality of reports of interventional trials assessing spa therapy. METHODS: The Delphi consensus method was used to select the number of items in the checklist. A total of eight individuals participated, including an epidemiologist, a clinical research methodologist, clinical researchers, a medical journalist, and a health fitness programmer. Participants ranked on a 9-point Likert scale whether an item should be included in the checklist. RESULTS: Three rounds of the Delphi method were conducted to achieve consensus. The final checklist contained 19 items, with items related to title, place of implementation (specificity of spa), care provider influence, and additional measures to minimize the potential bias from withdrawals, loss to follow-up, and low treatment adherence. CONCLUSION: This checklist is simple and quick to complete, and should help clinicians and researchers critically appraise the medical and healthcare literature, reviewers assess the quality of reports included in systematic reviews, and researchers plan interventional trials of spa therapy.

Bibliometric and content analysis of the Cochrane Complementary Medicine Field specialized register of controlled trials.

BACKGROUND: The identification of eligible controlled trials for systematic reviews of complementary and alternative medicine (CAM) interventions can be difficult. To increase access to these difficult to locate trials, the Cochrane Collaboration Complementary Medicine Field (CAM Field) has established a specialized register of citations of CAM controlled trials. The objective of this study is to describe the sources and characteristics of citations included in the CAM Field specialized register. METHODS: Between 2006 and 2011, regular searches for citations of CAM trials in MEDLINE and the Cochrane Central Register of Controlled Trials (CENTRAL) were supplemented with contributions of controlled trial citations from international collaborators. The specialized register was 'frozen' for analysis in 2011, and frequencies were calculated for publication date, language, journal, presence in MEDLINE, type of intervention, and type of medical condition. RESULTS: The CAM Field specialized register increased in size from under 5,000 controlled trial citations in 2006 to 44,840 citations in 2011. Most citations (60%) were from 2000 or later, and the majority (71%) were reported in English; the next most common language was Chinese (23%). The journals with the greatest number of citations were CAM journals published in Chinese and non-CAM nutrition journals published in English. More than one-third of register citations (36%) were not indexed in MEDLINE. The most common CAM intervention type in the register was non-vitamin, non-mineral dietary supplements (e.g., glucosamine, fish oil) (34%), followed by Chinese herbal medicines (e.g., Astragalus membranaceus, Schisandra chinensis) (27%). CONCLUSIONS: The availability of the CAM Field specialized register presents both opportunities and challenges for CAM systematic reviewers. While the register provides access to thousands of difficult to locate trial citations, many of these trials are of low quality and may overestimate treatment effects. When including these trials in systematic reviews, adequate analysis of their risk of bias is of utmost importance.

Review of Cochrane reviews on acupuncture: how Chinese resources contribute to Cochrane reviews.

BACKGROUND: Cochrane Systematic Reviews (CSRs) are frequently referenced by acupuncture efficacy studies currently. In this study, the CSRs on acupuncture are reviewed, and the disease fields they covered and the conclusions they reached are analyzed. In order to explore the potential contribution to CSRs by Chinese resources, the authors analyzed whether the participation of Chinese reviewers, the utilization of Chinese databases, and the inclusion of Chinese clinical trials would affect the positive conclusion ratios of the CSRs. METHODS: Acupuncture-related CSRs in the Cochrane Library were searched and classified based on the International Classification of Diseases-10 (ICD-10). The CSRs were further designated as positive or negative according to the conclusion statements. CSRs with the participation of Chinese reviewers, the utilization of Chinese databases, or the inclusion of Chinese clinical trials were extracted, and the positive ratios of conclusions were compared separately with corresponding CSRs without those three Chinese resources. RESULTS: Thirty-two (32) CSRs were identified, 9 (28.1%) of which reached positive conclusions. The CSRs with positive conclusions were mainly about multifarious pains, nausea and vomiting, and functional disorders. Seventeen (17; 53.1%) included the participation of Chinese reviewers, 18 (56.3%) involved the utilization of Chinese databases, and 20 (62.5%) included Chinese clinical trials. No differences on the positive conclusion ratios were observed between CSRs with reviewers from Chinese institutions and those that did not (odds ratio [OR]: 0.32, 95% confidence interval [CI]: 0.06, 1.62), the utilization of Chinese databases and those that did not (OR: 0.51, 95% CI: 0.11, 2.44), or the inclusion of Chinese clinical trials and those that did not (OR: 1.29, 95% CI: 0.26, 6.49). CONCLUSIONS: Most CSRs on acupuncture are inconclusive. No significant differences regarding the positive conclusion ratios were found between the CSRs with or without the utilization of Chinese resources.

Analysis of direct medical and nonmedical costs for care of rheumatoid arthritis patients using the large cohort database, IORRA.

OBJECTIVES: Our goal was to determine the annual direct medical and nonmedical costs for the care of patients with rheumatoid arthritis (RA) using data from a large cohort database in Japan. METHODS: Direct medical costs [out of pocket to hospitals and pharmacies and for complementary and alternative medicine (CAM)] and nonmedical costs (caregiving, transportation, self-help devices, house modifications) were determined for RA patients who were participants in the Institute of Rheumatology, Rheumatoid Arthritis (IORRA) studies conducted in October 2007 and April 2008. Correlations between these costs and RA disease activity, disability level, and quality of life (QOL) were assessed. RESULTS: Data were analyzed from 5,204 and 5,265 RA patients in October 2007 and April 2008, respectively. The annual direct medical costs were JPY132,000 [out of pocket to hospital (US$1 = JPY90 in 2007)], JPY84,000 (out of pocket to pharmacy), and JPY146,000 (CAM). Annual direct nonmedical costs were JPY105,000 (caregiving), JPY22,000 (transportation), JPY30,000 (self-help devices), and JPY188,000 (house modifications). Based on the utilization rate for each cost component, the annual medical and nonmedical costs for each RA patient were JPY262,136 and JPY61,441, respectively. Costs increased with increasing RA disease activity and disability level or worsening quality of life (QOL). CONCLUSIONS: Based on the IORRA database, patients with RA bear heavy economic burdens that increase as the disease is exacerbated. The results also suggest that the increase in medical and nonmedical costs may be ameliorated by the proactive control of disease activity.

Review of the use of defined daily dose concept in drug utilisation research in China.

PURPOSE: This study aimed to understand the characteristics of drug utilisation researches (DURs) using concepts of defined daily dose in China and to provide further suggestion for future DURs in China. METHODS: DURs using concepts of defined daily dose published in China were identified from China Journal Full-text Database, and in-depth data analysis was conducted for DURs published in every even-numbered year. RESULTS: In total, 2,911 DURs published between 1989 and 2009 were identified, of which 1,268 were included for further data analysis. All studies were hospital-based. Types of drugs commonly assessed in DURs were Anti-infectives for systemic use (34.1%), drugs for Nervous system (25.5%) and drugs for Alimentary tract and metabolism (14.3%). In addition, 63 DURs published in even-numbered year focusing on Chinese Herbal Medicine (CHM) were identified. Commonly used sources of defined dose were Xin Bian Yao Wu Xue/New Materia Medica (83.9%), drug information leaflets (66.8%) and Chinese Pharmacopoeia (52.0%). Common indicators used in DURs include defined daily doses (DDDs), drug utilisation index (DUI) and daily dose cost (DDC). CONCLUSION: DUR is a popular method to explore the use of both pharmaceutical drugs and CHM in China. The definition of defined daily dose and its related indicators presented in the DURs were highly varied. From this, it follows that DURs with more consistent methodology are highly needed for a thorough understanding of drug utilisation in China. Apart from DURs focusing on the hospital setting, more DURs from other health settings are needed.

Duplicate publication cases in the field of Kampo (Japanese herbal medicine) in Japan.

OBJECTIVE: Duplicate publication has a negative influence on science and publishing communities. We found duplicate publication cases in the field of Kampo (traditional Japanese herbal medicine) while compiling the Evidence Reports of Kampo Treatment (EKAT) 2009 published by the Special Committee for Evidence-based Medicine (EBM), the Japan Society for Oriental Medicine (JSOM). Therefore, we checked the articles that appeared in the EKAT 2009 and analyzed how duplicate publication occurred. METHODS: The EKAT 2009 contains structured abstracts of 320 randomized controlled trial studies. We checked 384 articles referred to by the structured abstracts to identify duplicate publications according to the following criteria: hypothesis and results are the same; the authors are in common; no description as to a secondary publication is offered; no cross-references to related papers. RESULTS: Eleven articles that appeared in the EKAT 2009 were identified as duplicate publications. These articles showed four duplicate patterns: reproducing an already published article with the same sample data and results (n=3); adding new sample data with the same results (n=1); reporting part of the preliminary sample with the same results (n=1); translating an original article into another language (n=6). CONCLUSION: Among the 11 duplicate publications in the EKAT 2009, we discovered 4 duplicate patterns. These patterns reflect Japanese researchers' behavior that leads to the production of duplicate publications: the authors complete a previous article and submit it to a more prestigious journal; translate an original English article for Japanese physicians without referring to the original paper. To raise the awareness of duplicate publication among researchers, the understanding of publication ethics is essential.