对中医药领域开展循证医学研究的几点看法

近年来，随着循证医学在世界范围内的迅速发展，国内外学者对中医药学是否需要用循证医学的标准来评价，以及如何发展循证的中医药学进行了广泛而热烈地讨论。我们的观点是：中医药学需要循证医学；循证医学认可的证据并不仅仅是大样本的随机双盲对照试验和系统评价；中医药学的理论体系与临床诊疗有许多不同于现代医学的特点，需要针对这些特点进行方法学的创新性研究。本文根据作者近年来在中医药领域进行方法学培训与临床研究的经验，从完善临床试验流程、规范临床研究报告、系统评价当前的中医药临床研究、开展方法学研究、以及证据管理和资源优化整合等五个方面对如何在中医药领域进一步开展循证医学研究进行了讨论。     

中医药防治胆石症随机对照试验的质量评价

目的评价中医药防治胆石症随机对照试验的方法学和报告质量。方法计算机检索CNKI（1994～2007）、CBM（1978—2007）、CMCC（1994～2007）、VIP（1989～2007））、MEDLINE（1966～2007．4）、Cochrane图书馆（2006年第4期）。全面收集与中医药防治胆石症有关的临床试验，纳入凡文中有“随机”字样或“随机分组”、“随机对照”的以胆石症为目标疾病的研究，按照Cochrane协作网推荐的评价方法对纳入研究进行方法学质量评价，按照CONSORT for TCM清单项目进行研究报告质量评价。结果共纳入17篇文献，其中随机对照试验16个，半随机对照试验1个。评价结果显示，纳入文献方法学质量较低，均为C级；CONSORT for TCM评价最高18分。所有纳入研究的报告质量均低。结论以往的中医药防治胆石症的随机对照试验存在不同程度的方法学质量缺陷，使得其结论存在选择性偏倚、实施偏倚、测量偏倚以及减员偏倚的高度可能性。而较低的报告质量又会严重影响读者对研究结果真实性、重要性及实用性的正确理解和评价。因此期待设计严谨、实施科学、报告完整的大样本高质量的随机对照试验出现。     

Hospital doctors' self-rated skills in and use of evidence-based medicine - a questionnaire survey

RATIONALE, AIMS AND OBJECTIVES: Problems in understanding basic aspects of evidence-based medicine (EBM) may form barriers to its implementation into clinical practice. We examined hospital doctors' skills in EBM terms and related these skills to their use of information sources, critical appraisal, and implementation of EBM into clinical practice. METHODS: A self-administered questionnaire was sent to all hospital doctors (n = 376) at a university hospital in Denmark, including 12 questions on methodological terms frequently used in evidence-based literature plus one non-existing dummy term. Furthermore, participants were asked about their use of various information sources, self-rated skills of critical appraisal of standard scientific literature, and level of implementation of evidence-based principles in daily clinical settings. Based on the answers to the 12 evidence-based methodological terms, we calculated a familiarity score. RESULTS: Proportion of responding was 60% (n = 225), but representative for all hospital doctors regarding background data. Ten doctors (4.4%) could define and explain all 12 methodological terms. The majority of all doctors showed interest in knowing more about the terms. Fifty-six per cent knew the dummy term. Doctors mainly consulted traditional and possibly insufficient sources (textbooks, colleagues, scientific journals) when searching for clinical evidence. The Cochrane Library was the least consulted information source and had never been consulted by 49%. Only 18% always practised EBM. More reliance on PubMed and The Cochrane Library as information sources, more competence of critical appraisal, and more frequent practise of EBM were significantly (P < 0.001) associated with a higher familiarity score. Compared to seldom or never users of The Cochrane Library, frequent users had significantly higher academic degree (P = 0.01), familiarity score (P < 0.001), and use of PubMed (P = 0.0004). DISCUSSION AND CONCLUSIONS: Most hospital doctors seem to lack knowledge of key methodological evidence-based medicine terms. This may form a barrier when consulting EBM sources and to the implementation of EBM into clinical practice.     

2006～2011年我国中医药护理临床试验的方法学质量评价

目的评价近6年来我国中医药护理临床试验的方法学质量。方法计算机检索CNKI、VIP、WanFang Data和CBM disc数据库中发表的中医药护理的临床试验文献,检索时限为2006年1月～2011年9月。同时手检2010年1月至2011年9月国内主要护理期刊,采用Cochrane偏倚风险评估表进行临床试验文献质量评估。结果共纳入临床对照试验854篇,其中随机对照试验706篇(82.7%),半随机对照试验108篇(12.6%),非随机对照试验40篇(4.7%)。方法学质量分析显示:91.8%的纳入研究(784篇)均描述了组间基线资料可比性,并有明确的诊断标准(498篇,58.3%)和排除标准(178篇,20.8%);97.3%的纳入研究(831篇)统计方法运用正确。但只有55篇(6.4%)报告了随机序列的产生方法;10篇(1.2%)阐述随机序列隐匿方法;22篇(2.6%)采用了盲法;98篇(11.5%)报告进行了随访,93篇(10.9%)报告了安全性,20篇(2.3%)报告了失访及退出情况,2篇进行了意向性分析;所有研究均未报告研究方案,无法判断是否存在选择性报告偏倚,但21篇(2.5%)试验结果中的结局指标明显少于方法中的结局指标数,可判断为存在偏倚。符合Cochrane低风险标准2条及以上的研究共81篇,其中2009年10篇(12.3%)、2010年26篇(32.1%)、2011年前9个月27篇(33.3%),呈上升趋势。结论按Cochrane偏倚风险评估标准,近6年来,中医药护理临床试验研究总体质量不高,均存在不同程度的缺陷,但研究质量有逐年增高的趋势。     

Chinese herbal medicine for severe acute respiratory syndrome: a systematic review and meta-analysis

OBJECTIVES: To review randomized controlled trials (RCTs) evaluating the effects of Chinese herbal medicine for treating severe acute respiratory syndrome (SARS) systematically. DESIGN: Electronic and manual searches identified RCTs comparing Chinese medicine integrated to conventional medicine versus conventional medicine alone. Methodological quality of trials was assessed by generation of allocation sequence, allocation concealment, blinding, and intention-to-treat. RESULTS: Eight RCTs (488 patients with SARS) were included. The methodological quality was generally low. The combined therapy showed significant reduction of mortality (relative risk 0.32 [95% confidence interval {CI} 0.12 to 0.91]), shortened duration of fever, symptom relief, reductions in chest radiograph abnormalities, and reductions in secondary fungal infections among patients receiving glucocorticoids. There were no significant effects on quality of life or glucocorticoid dosage. CONCLUSION: Chinese herbal medicine combined with conventional medicine may have beneficial effects in patients with SARS. The evidence is insufficient because of the low methodological quality of the included trials.     

Bibliometric analysis of randomized trials in complementary medicine

Objective:

To determine the following features of randomized trials in complementary medicine: the extent to which they are indexed on Medline, the journals in which they are published, dates of publication, the therapies and conditions most commonly the focus of study.

Design:

Bibliometric analysis of the registry of randomized trials of the Cochrane Collaboration field in Complementary Medicine. Outcome measures: The number of trials in each category.

Results:

There were 3774 randomized trials on the registry of which 3072 (81%) were indexed on Medline. However, only about a third of these references could be easily found with a Medline search. Trials were published in a total of 965 different journals. Most trials (84%) were published in a conventional medical journal. The number of trials is increasing rapidly, having approximately doubled every 5 year period since 1965. There was a large variation in the number of trials for different complementary therapies. There were a high number of trials in acupuncture (554), herbal medicine (804) and meditation and relaxation techniques (643) but few trials in aromatherapy (47) and osteopathy (18). There were many trials in cardiovascular disease (501), musculoskeletal disorders (386) and surgery-related symptoms (293), but few in fatigue disorders (11).

Conclusion:

Medline is an incomplete source of randomized trials in complementary medicine. Searching of Medline could be significantly enhanced by changes to keywords and improved data on type of publication. The conditions and therapies subject to trials in complementary medicine do not provide an accurate reflection of clinical practice.     

中药治疗慢性阻塞性肺疾病稳定期随机对照试验的系统评价

目的评价中药治疗慢性阻塞性肺疾病（COPD）稳定期的临床疗效和安全性。方法计算机检索MEDLINE（1950～2008）、PubMed（1996～2008）、VIP（1989～2008）、万方数据库（1998～2008）、CNKI（1979～2008）、CBM（1978～2008）,收集中药治疗慢性阻塞性肺疾病稳定期的随机对照试验（RCT）。按纳入排除标准筛选试验、评价研究质量、提取有效数据,并采用RevMan4．2．7进行统计分析。结果共纳入30个RCT,均以中文发表。结果显示：（1）单纯中药治疗组与空白或安慰剂组比较：①显效率：共纳入3个RCT。有1个RCT结果显示中药治疗组显效率优于空白或安慰剂组。②肺功能：共纳入5个RCT,有2个RCT治疗后两组FEV1％预计值中药治疗组优于空白或安慰剂组。③生存质量：共纳入4个RCT,3个RCT结果显示治疗后中药治疗组生活质量改善优于空白组。（2）单纯中药治疗组与单纯西医治疗组比较：共纳入2个RCT,结果显示两组显效率差异无统计学意义,但文献数量少,尚须进一步评价。（3）中西医结合治疗与单纯西医治疗相比较：①显效率：共纳入11个RCT,3个RCT显示中西结合治疗组显效率高于单纯西医组。②肺功能：共纳入8个RCT,2个RCT结果显示治疗后FEV1％预计值中西医结合治疗组优于单纯西医组。③6min步行距离：共纳入3个RCT,结果均显示中西医结合治疗组优于单纯西医组。④生存质量：共纳入4个RCT,结果显示治疗后中西医结合治疗组均较单纯西医组质量改善。所纳文献均未报道与中药相关的严重不良反应。结论在COPD稳定期治疗中,中药可改善临床症状、提高生活质量,且未见明显不良反应。由于纳入试验方法学质量普遍较低,缺乏一些重要的中间指标和终点指标,尚需进一步开展设计科学、指标合理的随机对照试验。     

急性药物性肝损伤64例临床分析

目的探讨64例急性药物性肝损伤（drug-induced liver injury,DILI）患者的临床特征。方法采用回顾性分析法对64例急性DILI住院患者的用药史、临床表现及治疗转归进行分析。结果多种药物均可引起急性DILI,以抗结核药物为主,占23.4%,其次为中药23.4%,抗菌药11.0%;临床类型为肝细胞型多见,占84.4%,胆汁淤积型占11.0%,混合型占4.7%;主要临床表现有纳差、乏力、黄疸、恶心、呕吐等;绝大多数患者治疗后预后较好,但重症患者仍可危及生命。结论多种药物均可引起急性DILI,以抗结核药和中药为主;急性DILI以肝细胞损伤型最为常见;大多患者预后良好,但重症患者仍可危及生命。     

442例中药汤剂降压效应的Meta分析

目的系统评价中药与单一西药相比的降压效应。方法以中药、高血压、中医疗法、降压、中药汤剂为检索词检索中国生物医学文献数据库、中文期刊全文数据库、中国科技文献数据库、中国知网、Cochrane协作网等数据库,纳入所有中药汤剂和单一西药控制血压的随机对照试验。用Meta分析方法对资料进行定量综合。结果最终纳入7个研究、808例患者,其中中药组442例,西药组366例,中药组相比西药组血压控制总有效率OR值[95%CI]为2.65[1.77,3.95],P<0.00001,两组控制血压的显效Meta分析结果:OR值[95%CI]为1.74[1.28,2.36],P=0.00004。结论中药汤剂控制血压的总有效率和显效率均不及单一西药组。     

Knee orthosis. Evaluation of clinical efficiency with a review of the literature]

INTRODUCTION: The aim of this work was to collect literature data to assess the knee orthosis use with controlled clinical trials. METHOD: The international literature relating to the years 1980-2000 was carried out with the Medline data bank. RESULTS: Five hundred and twelve articles were collected and 35 were retained, 32 related to clinical studies and three related to toxicity. The evaluations were performed with either functional tests or clinical studies. The open-non controlled clinical trials are far higher than prospective comparative clinical trials that were developed only during last years. Main criteria of judgement are articular stability, functional pain and clinical index. Most of studies focused the anterior cruciate ligament lesions, patellar pains and osteoarthritis. DISCUSSION: This review of the literature may help to determine the interest and the limits of orthosis use as well as side effect occurrence. Both these clinical and experimental data point out the methodological difficulties facing the investigatory clinician in knee orthosis evaluation.CONCLUSION: Many studies contributed to the clinical evaluation of the knee orthosis. This work highlights various clinical indications for the same orthosis and variable results for the same indication. These methodological difficulties may not prevent a further evaluation of these devices to improve their use in current practice.     

痛灵止胶囊治疗癌性疼痛临床观察

目的:观察验证痛灵止胶囊对癌性疼痛缓解的临床有效性及安全性。方法:采用随机、平行对照实验方法,将癌性疼痛(气滞血瘀型)患者200例随机分为两组,每组100例。结果:中医证候疗效分析,实验组愈显率为76.00%,对照组愈显率为54.00%,两组比较有统计学意义(P<0.05)。实验组改善疼痛症状明显优于对照组(P<0.05),改善善太息、脉络瘀血、癥积等症状、体征两组无明显差异(P>0.05)。两组中医证候积分治疗后组内、组间比较均有统计学意义(P<0.05)。结论:痛灵止胶囊治疗癌性疼痛(气滞血瘀型)疗效确切,疗效优于天蟾胶囊,安全性较好,无明显不良反应。     

Evidence Base of Clinical Studies on Qi Gong: A Bibliometric Analysis

ObjectiveThis bibliometric study aimed to systematically and comprehensively summarize the volume, breadth and evidence for clinical research on Qigong. And this bibliometric analysis also can provide the evidence of this field.DesignBibliometric analysis.MethodsAll types of primary and secondary studies on humans were included: systematic reviews, randomized clinical trials, non-randomized controlled clinical studies, case series and case reports. Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Chinese Scientific Journal Database, Chinese Academic Conference Papers Database and Chinese Dissertation Database, PubMed and the Cochrane Library were searched from the date of inception to December 10, 2018. Bibliometric information, such as publication information, disease/condition, Qigong intervention and research results were extracted and analyzed.ResultsA total of 886 clinical studies were identified: including 47 systematic reviews, 705 randomized clinical trials, 116 non-randomized controlled clinical studies, 12 case series and 6 case reports. The studies were conducted in 14 countries. The top 15 diseases/conditions studied were: diabetes, chronic obstructive pulmonary disease, hypertension, stroke, cervical spondylosis, lumbar disc herniation, insomnia, knee osteoarthritis, low back pain, and osteoporosis, Coronary heart disease, breast cancer, periarthritis of shoulder, depression, metabolic syndrome. Of the various Qigong exercises reported in these 886 clinical studies, Ba Duan Jin was the most frequently researched in 492 (55.5%) studies, followed by Health Qigong 107 (12.1%), Dao Yin Shu 85 (9.6%), Wu Qin Xi 67 (7.6%) and Yi Jin Jing 66 (7.4%). The most frequently used comparisons in randomized trials were maintaining normal way of life unchanged 149 (18.1%), the remaining controls included conventional treatment, mainly western medicine, Chinese herbal medicine, acupuncture, health education, psychological therapy, Yoga, Tai Chi and other non-drug therapy. The most frequently reported outcomes were physical function, quality of life, symptoms, pain and mental health indicators. Beneficial results from practicing Qigong were reported in 97% of studies.ConclusionsQigong research publications have been increasing gradually. Reports on study types, participants, Qigong Intervention, and outcomes are diverse and inconsistent. There is an urgent need to develop a set of reporting standards for various interventions of Qigong. Further trials of high methodological quality with sufficient sample size and real world studies are needed to verify the effects of Qigong in health and disease management.     

Acupuncture for the relief of cancer-related pain--a systematic review.

AIMS: This systematic review summarises the existing evidence on acupuncture for cancer-related pain. METHODS: Literature searches were conducted in seven databases. All clinical studies of acupuncture, electroacupuncture and ear acupuncture in cancer patients with the main outcome measure of pain were included. Data were extracted according to pre-defined criteria by two independent reviewers and methodological quality was assessed using the Jadad scale. RESULTS: Of the seven studies included, one high quality randomised clinical trial of ear acupuncture showed statistically significant pain relief in comparison with placebo ear acupuncture. All the other studies were either non-blinded (n=2) or uncontrolled clinical trials (n=4). Most investigations suffered from methodological flaws such as inadequate study design, poor reporting of results, small sample size and overestimation of the results. CONCLUSIONS: The notion that acupuncture may be an effective analgesic adjunctive method for cancer patients is not supported by the data currently available from the majority of rigorous clinical trials. Because of its widespread acceptance, appropriately powered RCTs are needed.     

Clinical studies in rehabilitation research--problems and solutions from biometrical perspective

Methodology of clinical studies is highly sophisticated in drug research. But clinical trials are also necessary to demonstrate efficacy and safety of rehabilitation treatment. The call for evidence based medicine has also reached rehabilitation. However, in rehabilitation medicine it is much more difficult to design and conduct clinical trials with a high methodological standard. Among the reasons are: A comparable control group is necessary because spontaneous healing and unspecific measures contribute to therapeutic success, too. But what could "placebo rehabilitation" look like? The masking of therapies (blinded studies) will hardly ever be possible. Therefore, it is more difficult to achieve the same treatment and observation for the treatment and control group. Treatments in rehabilitation take longer to become effective than a drug and maybe the success will disappear after some time. Therefore, long-term trials and follow-ups are necessary. Such studies are expensive, need a strong organisation, and drop-outs are unavoidable. An appropriate outcome variable does not always exist. "Return to work" is an important, reliable and valid variable, but it delivers only one bit of information per patient. As a consequence, smaller progress in rehabilitation can only be demonstrated with large sample sizes. Outcome variables based on time enable studies with reasonable sample sizes. Sometimes it is more difficult to obtain acceptance of randomisation in rehabilitation patients than in acute patients. Some rehabilitation hospitals have only recently begun to take an interest in controlled clinical trials, hence are not so experienced. Nevertheless, controlled clinical trials delivering convincing results are possible in rehabilitation medicine as well. But biometrical consultation is necessary e.g. for study design, study conduction and evaluation. Most important points are the methodology of the study design and its practicability. Especially in these topics rehabilitation physicians and biometrician have to cooperate.     

Healing as a therapy for human disease: a systematic review

OBJECTIVE: To assess, from published clinical trials, the evidence for the use of healing as a complementary medical intervention in human disease. DESIGN: Limited to studies involving random assignment to a treatment group consisting of "healing," broadly defined, or to a concurrent control group. All randomized trials published up to the year 2000, were identified from MEDLINE, CINAHL, BIDS-EMBASE, the CISCOM complementary medicine databases and from bibliographic references of published articles. Copies of all published studies were obtained, data were extracted, and methodological quality (Jadad) scores were derived where possible. RESULTS: Fifty-nine randomized clinical trials (RCTs) were found comparing healing with a control intervention on human participants. In 37 of these, healing was used for existing diseases or symptoms (22 existed as fully accessible published reports, 10 as dissertation abstracts only, and 5 as "preliminary" investigations with limited evidential value). The 22 full trials (10 reporting a "significant" effect of healing compared with control) constitute an extremely heterogeneous group, varying greatly in the method and duration of healing; the medical condition treated; the outcome measure employed; and the control intervention used. Many trials had a number of methodological shortcomings, including small sample sizes, and were inadequately reported. Only 8 studies (5 with a significant outcome for healing) had a maximum methodological quality score of 5, and in 10 studies this score was 3 or less. Two trials-both large scale and methodologically sound-were replicates, and each found a significant beneficial effect of intercessory prayer on the clinical progress of cardiac patients. Eleven of the 15 dissertation abstracts and pilot studies reported nonsignificant results for healing compared with control, a finding that probably reflects the relatively small sample sizes and the likelihood of type II errors. The significant heterogeneity found in this group of trials makes categorization problematic and inhibits the pooling of results by meta-analysis or similar techniques to obtain a global estimate of the "treatment effect" of healing. CONCLUSIONS: No firm conclusions about the efficacy or inefficacy of healing can be drawn from this diverse group of RCTs. Given the current emphasis on evidence-based medicine, future investigations should be adequately powered, appropriately controlled, and properly described. These future investigations would most usefully consist of: (1) pragmatic trials of healing for undifferentiated conditions on patients based in general practice and (2) larger RCTs of distant healing on large numbers of patients with well-defined measurable illness.     

Devil's Claw (Harpagophytum procumbens) as a treatment for osteoarthritis: a review of efficacy and safety

BACKGROUND: Osteoarthritis (OA) is a highly prevalent musculoskeletal disorder. Conventional treatment (i.e., the use of nonsteroidal anti-inflammatory drugs-NSAIDs) is associated with well-documented adverse effects. Devil's Claw (Harpagophytum procumbens) a traditional South African herbal remedy used for rheumatic conditions, may be a safer treatment option. To date, 14 clinical trials have assessed its efficacy/ effectiveness in OA. AIM: To address the two main questions of importance to clinicians: (1) Does Devil's Claw work for the treatment of OA, and (2) Is it safe? METHODS: A review of the literature on Devil's Claw and OA from 1966 to 2006 was performed using multiple search databases, monographs, and citation tracking. Relevant trials in all languages were identified and included. Both internal validity (i.e., adequacy of the dosage and period of treatment for this condition, reporting of randomization, rates of dropout, blinding, and statistical analysis) and external validity (i.e., inclusion/ exclusion criteria, baseline characteristics of the study populations, trial setting, and the appropriateness of the outcome measures of the trials) were assessed. RESULTS: Fourteen studies were identified: eight observational studies; 2 comparator trials (1 open, the other randomized to assess clinical effectiveness); and 4 double-blinded, placebo-controlled, randomized controlled trials to assess efficacy. Many of the published trials lacked certain important methodological quality criteria. However, the data from the higher quality studies suggest that Devil's Claw appeared effective in the reduction of the main clinical symptom of pain. The assessment of safety is limited by the small populations generally evaluated in the clinical studies. From the current data, Devil's Claw appears to be associated with minor risk (relative to NSAIDs), but further long-term assessment is required. CONCLUSIONS: The methodological quality of the existing clinical trials is generally poor, and although they provide some support, there are a considerable number of methodologic caveats that make further clinical investigations warranted. The clinical evidence to date cannot provide a definitive answer to the two questions posed: (1) Does it work? And (2) is it safe? A definitive high-quality trial that addresses the necessary methodologic improvements noted is needed to answer these important clinical questions.     

Randomized, controlled clinical trials in sepsis: has methodological quality improved over time?

OBJECTIVE: To systematically evaluate the methodological quality of randomized clinical trials and to determine whether randomized clinical trials of sepsis improved in methodological quality over time. DATA SOURCES: Computerized MEDLINE search of articles published in any language from 1966 to 1998 combined with a manual search of bibliographies of published articles and communication with known experts in the field. STUDY SELECTION: All randomized clinical trials of sepsis, severe sepsis, and septic shock performed in adults and published as full articles. DATA EXTRACTION: Abstracts of all retrieved records were reviewed and the inclusion criteria were applied. All selected articles were classified into (a) trials designed to detect differences in mortality as the primary end point, or (b) trials focusing on surrogate outcome measures (i.e., physiological or biochemical parameters). All retrieved trials were then graded for methodological quality using an objective grading scheme developed specifically for this study. The data selection and extraction process was carried out independently by two of the authors; any disagreement was resolved by discussion. DATA SYNTHESIS: Seventy-four randomized clinical trials involving septic patients qualified for inclusion in this study (40 reporting mortality outcomes, 34 reporting other surrogate outcomes). Trials reporting mortality as the primary outcome had significantly higher quality scores compared with trials reporting surrogate outcome measures (29.6 +/- 1.0 vs. 24.3 +/- 0.8, p =.0006). From 1976 to 1998, trial methodology improved significantly over time (an average of 0.36 points per year, p =.021). Mortality outcome trials improved an average of 0.58 points per year (p =.0011) whereas surrogate outcome trials did not demonstrate an improvement in methodological quality over time (p =.249). CONCLUSION: The methodological limitations identified in this article can help to target further improvement in trial design to enhance the validity of findings from future randomized clinical trials of sepsis.     

Is tai chi an effective adjunct in cancer care? A systematic review of controlled clinical trials

Background Tai chi is a form of complementary and alternative medicine with similarities to aerobic exercises, which has been recommended for relieving cancer-related symptoms. The aim of this systematic review is to summarize and critically evaluate the evidence available from controlled clinical trials of tai chi as a supportive therapy for cancer patients. Methods We have searched the literature using 19 databases from their respective inceptions through October 2006, without language restrictions. Methodological quality was assessed using Jadad score. Results The searches identified 27 potentially relevant studies. Three randomised clinical trials (RCTs) and one non-randomised controlled trial (CCT) met our inclusion criteria. All of these trials assessed patients with breast cancer. Two RCTs reported significant differences in psychological and physiological symptoms compared to psychosocial support control. Most trials suffered from methodological flaws such as small sample size, inadequate study design and poor reporting. Conclusion The evidence is not convincing enough to suggest that tai chi is an effective supportive treatment for cancer. Further research should attempt to answer the many open questions related to the usefulness of tai chi for supportive cancer care.     

Evidence-Based Research in Complementary and Alternative Medicine III: Treatment of Patients with Alzheimer's Disease

This paper presents the novel domain of evidence-based research (EBR) in the treatment of patients with Alzheimer's disease (AD) from the perspective of traditional medicine and of complementary and alternative medicine. In earlier lectures we have described the process of evidence-based medicine as a methodological approach to clinical practice that is directed to aid clinical decision-making. Here, we present a practical example of this approach with respect to traditional pharmacological interventions and to complementary and alternative treatments for patients with AD.