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3.  Building a Strategic Framework for Comparative Effectiveness Research in Complementary and Integrative Medicine 
The increasing burden of chronic diseases presents not only challenges to the knowledge and expertise of the professional medical community, but also highlights the need to improve the quality and relevance of clinical research in this domain. Many patients now turn to complementary and integrative medicine (CIM) to treat their chronic illnesses; however, there is very little evidence to guide their decision-making in usual care. The following research recommendations were derived from a CIM Stakeholder Symposium on Comparative Effectiveness Research (CER): (1) CER studies should be made a priority in this field; (2) stakeholders should be engaged at every stage of the research; (3) CER study designs should highlight effectiveness over efficacy; (4) research questions should be well defined to enable the selection of an appropriate CER study design; (5) the CIM community should cultivate widely shared understandings, discourse, tools, and technologies to support the use and validity of CER methods; (6) Effectiveness Guidance Documents on methodological standards should be developed to shape future CER studies. CER is an emerging field and its development and impact must be reflected in future research strategies within CIM. This stakeholder symposium was a first step in providing systematic guidance for future CER in this field.
PMCID: PMC3544532  PMID: 23346206
4.  Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document 
Trials  2014;15:169.
There is a need for more Comparative Effectiveness Research (CER) on Chinese medicine (CM) to inform clinical and policy decision-making. This document aims to provide consensus advice for the design of CER trials on CM for researchers. It broadly aims to ensure more adequate design and optimal use of resources in generating evidence for CM to inform stakeholder decision-making.
The Effectiveness Guidance Document (EGD) development was based on multiple consensus procedures (survey, written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders, including patients, clinicians, researchers and payers were involved in creating this document.
Recommendations were developed for “using available data” and “future clinical studies”. The recommendations for future trials focus on randomized trials and cover the following areas: designing CER studies, treatments, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication.
The present EGD provides the first systematic methodological guidance for future CER trials on CM and can be applied to single or multi-component treatments. While CONSORT statements provide guidelines for reporting studies, EGDs provide recommendations for the design of future studies and can contribute to a more strategic use of limited research resources, as well as greater consistency in trial design.
PMCID: PMC4045891  PMID: 24885146
Comparative effectiveness research; Effectiveness guidance document; Chinese medicine research
5.  Physician Perspectives on Comparative Effectiveness Research: Implications for Practice-based Evidence 
Comparative effectiveness research (CER) is defined by the Institute of Medicine as “the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care.” The goal of CER is to provide timely, useful evidence to healthcare decision makers including physicians, patients, policymakers, and payers. A prime focus for the use of CER evidence is the interaction between physician and patient. Physicians in primary practice are critical to the success of the CER enterprise. A 2009 survey suggests, however, that physician attitudes toward CER may be mixed—somewhat positive toward the potential for patient care improvement, yet negative toward potential restriction on physician freedom of practice. CER methods and goals closely parallel those of practice-based research, an important movement in family medicine in the United States since the 1970s. This article addresses apparent physician ambivalence toward CER and makes a case for family medicine engagement in CER to produce useful practice-based evidence. Such an effort has potential to expand care options through personalized medicine, individualized guidelines, focus on patient preferences and patient-reported outcomes, and study of complex therapeutic interventions, such as integrative care. Academic medical researchers will need to collaborate with experienced family physicians to identify significant practice-based research questions and design meaningful studies. Such collaborations would shape CER to produce high-quality practice-based evidence to inform family and community medicine.
PMCID: PMC3833509  PMID: 24278829
Comparative effectiveness research; practice-based evidence; complementary and alternative medicine; patient-reported outcomes
6.  Perceived outcomes of music therapy with Body Tambura in end of life care – a qualitative pilot study 
BMC Palliative Care  2014;13:18.
In recent years, music therapy is increasingly used in palliative care. The aim of this pilot study was to record and describe the subjective experiences of patients and their relatives undergoing music therapy with a Body Tambura in a German hospice and to develop hypotheses for future studies.
In a qualitative interview pilot study, data collection and analyses were performed according to the methodological framework of grounded theory. We included German-speaking patients, or relatives of patients, receiving end of life care in an inpatient hospice setting.
11 persons consisting of 8 patients (age range 51–82 years, 4 male and 4 female) and 3 relatives were treated and interviewed. All patients suffered from cancer in an advanced stage. The most often described subjective experiences were a relaxing and calming effect, sensations that the body feels lighter, and the generation of relaxing images and visualizations. Family members enjoyed listening to the music and felt more connected with the sick family member.
Patient reported beneficial aspects. The small sample size could be seen as a limitation. Assessment instruments measuring relaxation, stress, quality of life and should be included in future quantitative studies.
PMCID: PMC3986446  PMID: 24708801
7.  A randomised multicentre trial of acupuncture in patients with seasonal allergic rhinitis – trial intervention including physician and treatment characteristics 
In a large randomised trial in patients with seasonal allergic rhinitis (SAR), acupuncture was superior compared to sham acupuncture and rescue medication. The aim of this paper is to describe the characteristics of the trial’s participating physicians and to describe the trial intervention in accordance with the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) guidelines, to make details of the trial intervention more transparent to researchers and physicians.
ACUSAR (ACUpuncture in Seasonal Allergic Rhinitis) was a three-armed, randomised, controlled multicentre trial. 422 SAR patients were randomised to semi-standardised acupuncture plus rescue medication (RM, cetirizine), sham acupuncture plus RM or RM alone. We sent a questionnaire to trial physicians in order to evaluate their characteristics regarding their education about and experience in providing acupuncture. During the trial, acupuncturists were asked to diagnose all of their patients according to Chinese Medicine (CM) as a basis for the semi-standardised, individualized intervention in the acupuncture group. Every acupuncture point used in this trial had to be documented after each session
Acupuncture was administered in outpatient clinics by 46 (mean age 47 ± 10 years; 24 female/ 22 male) conventionally-trained medical doctors (67% with postgraduate specialization such as internal or family medicine) with additional extensive acupuncture training (median 500 hours (1st quartile 350, 3rd quartile 1000 hours with 73% presenting a B-diploma in acupuncture training (350 hours)) and experience (mean 14 years in practice). The most reported traditional CM diagnosis was ‘wind-cold invading the lung’ (37%) and ‘wind-heat invading the lung’ (37%), followed by ‘lung and spleen qi deficiency’ (9%). The total number of needles used was higher in the acupuncture group compared to the sham acupuncture group (15.7 ± 2.5 vs. 10.0 ± 1.6).
The trial interventions were provided by well educated and experienced acupuncturists. The different number of needles in both intervention groups could be possibly a reason for the better clinical effect in SAR patients. For future trials it might be more appropriate to ensure that acupuncture and sham acupuncture groups should each be treated by a similar number of needles.
Trial registration NCT00610584.
PMCID: PMC3983860  PMID: 24708643
Acupuncture; Randomised controlled trial; Seasonal allergic rhinitis; Trial intervention; Sham acupuncture
8.  Influence of Control Group on Effect Size in Trials of Acupuncture for Chronic Pain: A Secondary Analysis of an Individual Patient Data Meta-Analysis 
PLoS ONE  2014;9(4):e93739.
In a recent individual patient data meta-analysis, acupuncture was found to be superior to both sham and non-sham controls in patients with chronic pain. In this paper we identify variations in types of sham and non-sham controls used and analyze their impact on the effect size of acupuncture.
Based on literature searches of acupuncture trials involving patients with headache and migraine, osteoarthritis, and back, neck and shoulder pain, 29 trials met inclusion criteria, 20 involving sham controls (n = 5,230) and 18 non-sham controls (n = 14,597). For sham controls, we analysed non-needle sham, penetrating sham needles and non-penetrating sham needles. For non-sham controls, we analysed non-specified routine care and protocol-guided care. Using meta-regression we explored impact of choice of control on effect of acupuncture.
Acupuncture was significantly superior to all categories of control group. For trials that used penetrating needles for sham control, acupuncture had smaller effect sizes than for trials with non-penetrating sham or sham control without needles. The difference in effect size was −0.45 (95% C.I. −0.78, −0.12; p = 0.007), or −0.19 (95% C.I. −0.39, 0.01; p = 0.058) after exclusion of outlying studies showing very large effects of acupuncture. In trials with non-sham controls, larger effect sizes associated with acupuncture vs. non-specified routine care than vs. protocol-guided care. Although the difference in effect size was large (0.26), it was not significant with a wide confidence interval (95% C.I. −0.05, 0.57, p = 0.1).
Acupuncture is significantly superior to control irrespective of the subtype of control. While the choice of control should be driven by the study question, our findings can help inform study design in acupuncture, particularly with respect to sample size. Penetrating needles appear to have important physiologic activity. We recommend that this type of sham be avoided.
PMCID: PMC3976298  PMID: 24705624
9.  Use of complementary and alternative medicine by older adults – a cross-sectional survey 
BMC Geriatrics  2014;14:38.
Very little is known about complementary and alternative medicine (CAM) use by older adults in Germany. The aim of this study was to investigate the use of CAM and other health promoting substances (e.g., herbal teas) by older adults of at least 70 years of age.
A cross-sectional questionnaire study was conducted among persons of ≥70 years from metropolitan Berlin and rural parts of Brandenburg, Germany. Recorded were: demographics, current use of CAM, medical diagnoses, users’ opinions and preferences.
A total of 400 older adults, living as ‘self-reliant’ (n = 154), ‘home care service user’ (n = 97), or ‘in nursing home’ (n = 149), and with the legal status ‘without guardian’ (n = 355) or ‘with guardian’ (n = 45) were included (mean age 81.8 ± 7.4 years, 78.5% female). Any type of CAM used 61.3% of respondents (dietary supplements 35.5%, herbal medicines 33.3%, and external preparations 26.8%); 3.0% used drug-interaction causing preparations. Usage was based on recommendations (total 30.3%; in 20.0% by friends or family and 10.4% by pharmacists), own initiative (27.3%), and doctors’ prescription (25.8%). Participants with legal guardian took almost solely prescribed dietary supplements. Of the others, only half (58.7%) informed their general practitioner (GP) of their CAM use. Participants expected significant (44.9%) or moderate (37.1%) improvement; half of them perceived a good effect (58.7%) and two-thirds (64.9%) generally preferred a combination of CAM and conventional medicine. More than half (57.9%) stated that they could neither assess whether their CAM preparations have side effects, nor assess what the side effects might be. Strongest predictors for CAM use were two treatment preferences (vs. ‘conventional only’: ‘CAM only’, OR = 3.98, p = 0.0042 and ‘CAM + conventional’, 3.02, 0.0028) and the type of health insurance (‘statutory’ vs. ‘private’, 3.57, 0.0356); against CAM use two subjective assessments predicted (vs. ‘CAM causes no harm’: ‘CAM causes harmful drug interactions’, 0.25, 0.0536 and ‘I cannot assess side effects’, 0.28, 0.0010).
Older German adults frequently use CAM. They perceived it as an effective complement to conventional medicine, but are not sufficiently informed about risks and benefits.
PMCID: PMC3974184  PMID: 24669824
Older adults; CAM; Dietary supplements; Nursing home; Residential care; Legal guardian
10.  Clinical trial participants’ experiences of completing questionnaires: a qualitative study 
BMJ Open  2014;4(3):e004363.
To improve clinical study developments for elderly populations, we aim to understand how they transfer their experiences into validated, standardised self-completed study measurement instruments. We analysed how women (mean 78±8 years of age) participating in a randomised controlled trial (RCT) cognised study instruments used to evaluate outcomes of the intervention.
The interview study was nested in an RCT on chronic neck pain using common measurement instruments situated in an elderly community in Berlin, Germany, which comprised of units for independent and assisted-living options.
The sample (n=20 women) was selected from the RCT sample (n=117, 95% women, mean age 76 (SD±8) years). Interview participants were selected using a purposive sampling list based on the RCT outcomes.
We asked participants about their experiences completing the RCT questionnaires. Interviews were analysed thematically, then compared with the questionnaires.
Interviewees had difficulties in translating complex experiences into a single value on a scale and understanding the relationship of the questionnaires to study aims. Interviewees considered important for the trial that their actual experiences were understood by trial organisers. This information was not transferrable by means of the questionnaires. To rectify these difficulties, interviewees used strategies such as adding notes, adding response categories or skipping an item.
Elderly interview participants understood the importance of completing questionnaires for trial success. This led to strategies of completing the questionnaires that resulted in ‘missing’ or ambiguous data. To improve data collection in elderly populations, educational materials addressing the differential logics should be developed and tested. Pilot testing validated instruments using cognitive interviews may be particularly important in such populations. Finally, when the target of an intervention is a subjective experience, it seems important to create a method by which participants can convey their personal experiences. These could be nested qualitative studies.
Trial registration number
PMCID: PMC3975744  PMID: 24662446
11.  Corporate Culture Assessments in Integrative Oncology: A Qualitative Case Study of Two Integrative Oncology Centers 
The offer of “integrative oncology” is one option for clinics to provide safe and evidence-based complementary medicine treatments to cancer patients. As known from merger theories, corporate culture and integration models have a strong influence on the success of such integration. To identify relevant corporate culture aspects that might influence the success in two highly visible integrative oncology clinics, we interviewed physicians, nurses, practitioners, and managers. All interviews (11 in a German breast cancer clinic and 9 in an integrative medicine cancer service in the USA) were audio-recorded, transcribed and analyzed with content analysis. According to the theoretical framework of mergers, each clinic selected a different integration type (“best of both worlds” and “linking”). Nonetheless, each developed a similar corporate culture that has a strong focus on research and safe and evidence-based treatments, and fosters a holistic and patient-centered approach. Structured communication within the team and with other departments had high relevance. Research was highlighted as a way to open doors and to facilitate a more general acceptance within the hospital. Conventional physicians felt unburdened by the provision of integrative medicine service but also saw problems in the time required for scheduled treatments, which often resulted in long waiting lists.
PMCID: PMC3683441  PMID: 23818923
12.  The perspectives of older women with chronic neck pain on perceived effects of qigong and exercise therapy on aging: a qualitative interview study 
Chronic pain is prevalent in elderly populations. The goals of this study were 1) to understand the results of a randomized clinical trial – Qigong and Exercise Therapy for Elderly Patients with Chronic Neck Pain (QIBANE) – that showed no difference between qigong, exercise therapy, and no-treatment on quality of life, and 2) to understand how elderly individuals with chronic pain experience interventions of qigong and exercise therapy. A qualitative interview study was conducted with 20 QIBANE participants. Interviews asked about motivation for and expectations of trial participation, experiences with the exercise classes (qigong or exercise therapy), and changes in pain experience. Interviews were transcribed, entered into the software program ATLAS.ti, and coded thematically by two coders. Content analysis was performed. All interviewees reflected positively on their QIBANE experience and described their participation in QIBANE as helpful. However, what was discussed in both groups when they talked about “positive experiences” in the study differed between the two groups. For example, themes that emerged in the exercise-therapy group related to difficulties associated with aging and staying physically active. In the interviews with qigong group members, emergent themes related to qigong as a method that improved bodily experiences and influenced daily activities. The effects that exercise therapy and qigong have on an elderly population cannot be captured by health-related quality-of-life measurements, such as the Short Form (36) Health Survey. Broader concepts of quality of life that include the concepts of self-efficacy and positive affect may be more appropriate. The results presented in this study suggest that for this population group, the approach of patient-centered outcomes is especially pertinent in order to design meaningful intervention studies in the elderly. This means that research questions, interventions, and outcome measurements need to take into account the special situation of elderly people.
PMCID: PMC3948360  PMID: 24627629
qigong; exercise therapy; neck pain; back pain; women
13.  Responses to the Acupuncture Trialists' Collaboration individual patient data meta-analysis 
In September 2012, the Acupuncture Trialists' Collaboration published the results of an individual patient data meta-analysis of close to 18,000 patients in high quality-randomized trials. The results favored acupuncture. Although there was little argument about the findings in the scientific press, a controversy played out in blog posts and the lay press. This controversy was characterized by ad hominem remarks, anonymous criticism, phony expertise, and the use of opinion to contradict data, predominately by self-proclaimed skeptics. There was a near complete absence of substantive scientific critque. The lack of any reasoned debate about the main findings of the Acupuncture Trialists' Collaboration paper underlines that mainstream science has moved on from the intellectual sterility and ad hominem attacks that characterize the skeptics’ movement.
PMCID: PMC3658608  PMID: 23449559
Pain; Skepticism; Headache; Acupuncture; Statistics and Research Design
14.  High prevalence but limited evidence in complementary and alternative medicine: guidelines for future research 
The use of complementary and alternative Medicine (CAM) has increased over the past two decades in Europe. Nonetheless, research investigating the evidence to support its use remains limited. The CAMbrella project funded by the European Commission aimed to develop a strategic research agenda starting by systematically evaluating the state of CAM in the EU. CAMbrella involved 9 work packages covering issues such as the definition of CAM; its legal status, provision and use in the EU; and a synthesis of international research perspectives. Based on the work package reports, we developed a strategic and methodologically robust research roadmap based on expert workshops, a systematic Delphi-based process and a final consensus conference. The CAMbrella project suggests six core areas for research to examine the potential contribution of CAM to the health care challenges faced by the EU. These areas include evaluating the prevalence of CAM use in Europe; the EU cititzens’ needs and attitudes regarding CAM; the safety of CAM; the comparative effectiveness of CAM; the effects of meaning and context on CAM outcomes; and different models for integrating CAM into existing health care systems. CAM research should use methods generally accepted in the evaluation of health services, including comparative effectiveness studies and mixed-methods designs. A research strategy is urgently needed, ideally led by a European CAM coordinating research office dedicated to fostering systematic communication between EU governments, the public, charitable and industry funders, researchers and other stakeholders. A European Centre for CAM should also be established to monitor and further a coordinated research strategy with sufficient funds to commission and promote high quality, independent research focusing on the public’s health needs and pan-European collaboration. There is a disparity between highly prevalent use of CAM in Europe and solid knowledge about it. A strategic approach on CAM research should be established to investigate the identified gaps of knowledge and to address upcoming health care challenges.
PMCID: PMC3931324  PMID: 24499316
Complementary and alternative medicine; Research strategy; Randomized clinical trials; Safety; Qualitative studies; Comparative effectiveness research
15.  Integrative Oncology: Best of Both Worlds—Theoretical, Practical, and Research Issues 
More and more cancer patients use complementary therapies. As the majority of patients do not disclose their use of complementary therapies to their oncologists, they expose themselves to possible detrimental effects from the therapies due to drug interactions. To meet the needs of patients and health care professionals on valid information on complementary therapies, the collaborative research project “Competence Network Complementary Medicine in Oncology—KOKON”, an interdisciplinary network for complementary medicine research in oncology, was established. Moreover, Integrative Oncology, a combination of conventional and evidenced-based complementary therapies delivered using a comprehensive approach, is now increasingly used in the United States and Europe. A variety of different Integrative Oncology models have been established worldwide including an expert-based model at the Kliniken Essen-Mitte, Essen, Germany and a patient-centered, evidenced-based approach at The University of Texas MD Anderson Cancer Center. Both models are briefly reviewed. More research is needed and Comparative Effectiveness Research that places strong emphasis on the comparison of different treatment options in usual care settings by including more heterogeneous patients, using less standardized treatment protocols, and measuring patient-centered outcomes would provide useful information for decision-making. To improve the quality of care and research in Integrative Oncology, sustainable financial models for Integrative Oncology and more funding for research are needed.
PMCID: PMC3863498  PMID: 24371456
16.  Body-Efficacy Expectation: Assessment of Beliefs concerning Bodily Coping Capabilities with a Five-Item Scale 
Background. Expectancies regarding a treatment play an important role in recovery as has been shown in placebo research. The role of expectations regarding the bodily capability to overcome illness is less investigated although in complementary and alternative medicine (CAM) such capability is the target of interventions. We introduced a new construct, body-efficacy expectation, defined as the conviction that one's body is able to deal with health-threatening factors by itself, and developed and validated a scale for its measurement. Methods. The scale was developed following expert recommendations. Using online survey data from 1054 participants an exploratory factor analysis was conducted and psychometric properties of the scale were examined (item characteristics, reliability, and validity). Results. The exploratory factor analysis yielded a one-factor solution explaining 51.96% of total variance (Cronbach's α = 0.77). One of the originally six items was removed due to poor item characteristics. Correlations with several validation measures were in line with the theoretical background of the construct. Most importantly, participants with better general health showed higher body-efficacy expectation than participants with poorer health status. Conclusions. Further studies confirming the factor structure and using clinical samples are recommended. Also, the relations with the appraisal of CAM and CAM use warrant further research.
PMCID: PMC3838828  PMID: 24312132
17.  Standardized versus Individualized Acupuncture for Chronic Low Back Pain: A Randomized Controlled Trial 
We aimed to compare the effectiveness of standardized and individualized acupuncture treatment in patients with chronic low back pain. A single-center randomized controlled single-blind trial was performed in a general medical practice in Germany run by a Chinese-born medical doctor trained in western and Chinese medicine. One hundred and fifty outpatients with chronic low back pain were randomly allocated to two groups (78 standardized and 72 individualized acupuncture). Patients received either standardized acupuncture or individualized acupuncture. Treatment encompassed between 10 and 15 treatments based on individual symptoms with two treatments per week. The main outcome measure was the area under the curve (AUC) summarizing eight weeks of daily rated pain severity measured with a visual analogue scale (0 mm = no pain, 100 mm = worst imaginable pain). No significant differences between groups were observed for the AUC (individualized acupuncture mean: 1768.7 (95% CI, 1460.4; 2077.1); standardized acupuncture 1482.9 (1177.2; 1788.7); group difference, 285.8 (−33.9; 605.5) P = 0.080). In this single-center trial, individualized acupuncture was not superior to standardized acupuncture for patients suffering from chronic pain. As a next step, a multicenter noninferiority study should be performed to investigate whether standardised acupuncture treatment for chronic low back pain might be applicable in a broader usual care setting. This trial is registered with NCT00758017.
PMCID: PMC3830844  PMID: 24288556
18.  Acupuncture for chronic pain: individual patient data meta-analysis 
Archives of internal medicine  2012;172(19):1444-1453.
Although acupuncture is widely used for chronic pain, there remains considerable controversy as to its value. We aimed to determine the effect size of acupuncture for four chronic pain conditions: back and neck pain, osteoarthritis, chronic headache, and shoulder pain.
We conducted a systematic review to identify randomized trials of acupuncture for chronic pain where allocation concealment was determined unambiguously to be adequate. Individual patient data meta-analyses were conducted using data from 29 of 31 eligible trials, with a total of 17,922 patients analyzed.
In the primary analysis including all eligible trials, acupuncture was superior to both sham and no acupuncture control for each pain condition (all p<0.001). After exclusion of an outlying set of trials that strongly favored acupuncture, the effect sizes were similar across pain conditions. Patients receiving acupuncture had less pain, with scores 0.23 (95% C.I. 0.13, 0.33), 0.16 (95% C.I. 0.07, 0.25) and 0.15 (95% C.I. 0.07, 0.24) standard deviations lower than sham controls for back and neck pain, osteoarthritis, and chronic headache respectively; the effect sizes in comparison to no acupuncture controls were 0.55 (95% C.I. 0.51, 0.58), 0.57 (95% C.I. 0.50, 0.64) and 0.42 (95% C.I. 0.37, 0.46). These results were robust to a variety of sensitivity analyses, including those related to publication bias.
Acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture.
PMCID: PMC3658605  PMID: 22965186
19.  Homeopathy for Depression: A Randomized, Partially Double-Blind, Placebo-Controlled, Four-Armed Study (DEP-HOM) 
PLoS ONE  2013;8(9):e74537.
The specific clinical benefit of the homeopathic consultation and of homeopathic remedies in patients with depression has not yet been investigated.
To investigate the 1) specific effect of individualized homeopathic Q-potencies compared to placebo and 2) the effect of an extensive homeopathic case taking (case history I) compared to a shorter, rather conventional one (case history II) in the treatment of acute major depression (moderate episode) after six weeks.
A randomized, partially double-blind, placebo-controlled, four-armed trial using a 2×2 factorial design with a six-week study duration per patient was performed.
A total of 44 from 228 planned patients were randomized (2∶1∶2∶1 randomization: 16 homeopathic Q-potencies/case history I, 7 placebo/case history I, 14 homeopathic Q-potencies/case history II, 7 placebo/case history II). Because of recruitment problems, the study was terminated prior to full recruitment, and was underpowered for the preplanned confirmatory hypothesis testing. Exploratory data analyses showed heterogeneous and inconclusive results with large variance in the sample. The mean difference for the Hamilton-D after 6 weeks was 2.0 (95%CI −1.2;5.2) for Q-potencies vs. placebo and −3.1 (−5.9;−0.2) for case history I vs. case history II. Overall, no consistent or clinically relevant results across all outcomes between homeopathic Q-potencies versus placebo and homeopathic versus conventional case taking were observed. The frequency of adverse events was comparable for all groups.
Although our results are inconclusive, given that recruitment into this trial was very difficult and we had to terminate early, we cannot recommend undertaking a further trial addressing this question in a similar setting.
Prof. Dr. Claudia Witt had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Trial registration identifier NCT01178255.
Protocol publication:
PMCID: PMC3781106  PMID: 24086352
20.  Traditional Japanese Kampo Medicine: Clinical Research between Modernity and Traditional Medicine—The State of Research and Methodological Suggestions for the Future 
The Japanese traditional herbal medicine, Kampo, has gradually reemerged and 148 different formulations (mainly herbal extracts) can be prescribed within the national health insurance system. The objective of this article is to introduce Kampo and to present information from previous clinical studies that tested Kampo formulae. In addition, suggestions on the design of future research will be stated. The literature search was based on a summary, up until January 2009, by the Japanese Society of Oriental Medicine and included only those trials which were also available in either Pubmed or ICHUSHI (Japan Medical Abstracts Society). We included 135 studies, half of these studies (n = 68) used a standard control and 28 a placebo control. Thirty-seven trials were published in English [all randomized controlled trials (RCTs)] and the remaining articles were in Japanese only. The sample size for most studies was small (two-third of the studies included less than 100 patients) and the overall methodological quality appeared to be low. None of the studies used Kampo diagnosis as the basis for the treatment. In order to evaluate Kampo as a whole treatment system, certain aspects should be taken into account while designing studies. RCTs are the appropriate study design to test efficacy or effectiveness; however, within the trial the treatment could be individualized according to the Kampo diagnosis. Kampo is a complex and individualized treatment with a long tradition, and it would be appropriate for further research on Kampo medicine to take this into account.
PMCID: PMC3114407  PMID: 21687585
21.  Effects and feasibility of an Integrative Medicine program for geriatric patients–a cluster-randomized pilot study 
Older adults often use complementary medicine; however, very few interventional studies have focused on them. The aim of this study was to evaluate the feasibility and to obtain preliminary data on effectiveness of an Integrative Medicine (IM) program compared to usual medical care.
The study consisted of older adults living in shared apartment communities including caregiving. The shared apartments were cluster-randomized to the IM program or Usual Care (UC). IM consisted of additional lifestyle modification (exercise and diet), external naturopathic applications, homeopathic treatment, and modification of conventional drug therapy for 12 months. The UC group received conventional care alone. The following outcomes were used: Nurses Observation Scale for Geriatric Patients (NOSGER); Assessment of Motor and Process Skills; Barthel Index; Qualidem; Profile of Wellbeing; and Mini-mental State Examination. Exploratory effect sizes (Cohen’s d, means adjusted for differences of baseline values) were calculated to analyze group differences.
A total of eight shared apartment communities were included; four were allocated to IM (29 patients, median seven patients; [mean ± standard deviation] 82.7 ± 8.6 years) and four to UC (29 patients, median eight patients; 76.0 ± 12.8 years of age). After 12 months, effect sizes ≥0.3 were observed for activities of daily living on the NOSGER-Activities of Daily Living subscale (0.53), Barthel Index (0.30), Qualidem total sum score (0.39), Profile of Wellbeing (0.36), NOSGER-Impaired Social Behavior (0.47), and NOSGER-Depressed Mood subscales (0.40). Smaller or no effects were observed for all other outcomes. The intervention itself was found to be feasible, but elaborate and time consuming.
This exploratory pilot study showed that for a full-scale trial, the outcomes of Activities of Daily Living and Quality of Life seem to be the most promising. The results have to be interpreted with care; larger confirmatory trials are necessary to validate the effects.
PMCID: PMC3724560  PMID: 23901266
Activities of Daily Living; complementary and alternative medicine strategies; NOSGER; older adults; caregiving; apartment-sharing communities; homeopathy
22.  Prospective registration, bias risk and outcome-reporting bias in randomised clinical trials of traditional Chinese medicine: an empirical methodological study 
BMJ Open  2013;3(7):e002968.
Clinical trials on Traditional Chinese Medicine (TCM) should be registered in a publicly accessible international trial register and report on all outcomes. We systematically assessed and evaluated TCM trials in registries with their subsequent publications.
To describe the characteristics of TCM trials, estimate bias risk and outcome-reporting bias in clinical trials.
Data sources and study selection
Fifteen trial registries were searched from their inception to July 2012 to identify randomised trials on TCM including Chinese herbs, acupuncture and/or moxibustion, cupping, tuina, qigong, etc.
Data extraction
We extracted data including TCM specialty and treated disease/conditions from the registries and searched for subsequent publications in PubMed and Chinese databases. We compared information in the registries of completed trials with any publications focusing on study design, sample size, randomisation, bias risk including reporting bias from the register protocol.
1096 registered randomised trials were identified evaluating TCM, of which 505 were completed studies (46.1%). The most frequent conditions were pain (13.3%), musculoskeletal (11.7%), nervous (8.7%), digestive (7.1%), circulatory (6.5%), respiratory (6.3%), mental and behavioural disorders (6.2%) and cancer (6.0%). The trial register data identified parallel, phase II/III randomised trials with sample size estimations and blinding, but limited information about randomisation (sequence generation and allocation concealment). Comparing trial registration data of 115 completed trials (22.8%) with their subsequent 136 publications, inconsistencies were identified in one or more of the following: sample size (11%), outcome assessor blinding (37.5%), primary outcomes (29%) and safety (28%) reporting.
Increasing numbers of clinical trials investigating a variety of TCM interventions have been registered in international trial registries. The study design of registered TCM trials has improved in estimating sample size, use of blinding and placebos. However, selective outcome reporting is widespread and similar to conventional medicine and therefore study conclusions should be interpreted with caution.
PMCID: PMC3717464  PMID: 23864210
23.  The quest for modernisation of traditional Chinese medicine 
Traditional Chinese medicine (TCM) is an integral part of mainstream medicine in China. Due to its worldwide use, potential impact on healthcare and opportunities for new drug development, TCM is also of great international interest. Recently, a new era for modernisation of TCM was launched with the successful completion of the Good Practice in Traditional Chinese Medicine Research in the Post-genomic Era (GP-TCM) project, the European Union’s Seventh Framework Programme (FP7) coordination action on TCM research. This 3.5-year project that involved inputs from over 200 scientists resulted in the production of 20 editorials and in-depth reviews on different aspects of TCM that were published in a special issue of Journal of Ethnopharmacology (2012; volume 140, issue 3). In this narrative review, we aim to summarise the findings of the FP7 GP-TCM project and highlight the relevance of TCM to modern medicine within a historical and international context. Advances in TCM research since the 1950s can be characterised into three phases: Phase I (1950s-1970s) was fundamental for developing TCM higher education, research and hospital networks in China; Phase II (1980s-2000s) was critical for developing legal, economic and scientific foundations and international networks for TCM; and Phase III (2011 onwards) is concentrating on consolidating the scientific basis and clinical practice of TCM through interdisciplinary, interregional and intersectoral collaborations. Taking into account the quality and safety requirements newly imposed by a globalised market, we especially highlight the scientific evidence behind TCM, update the most important milestones and pitfalls, and propose integrity, integration and innovation as key principles for further modernisation of TCM. These principles will serve as foundations for further research and development of TCM, and for its future integration into tomorrow’s medicine.
PMCID: PMC3689083  PMID: 23763836
Evidence-based medicine; Chinese herbal medicine; Acupuncture; History; Science; Efficacy; Safety; Integrity; Integration; Innovation
24.  Comparative effectiveness of a complex Ayurvedic treatment and conventional standard care in osteoarthritis of the knee – study protocol for a randomized controlled trial 
Trials  2013;14:149.
Traditional Indian Ayurvedic medicine uses complex treatment approaches, including manual therapies, lifestyle and nutritional advice, dietary supplements, medication, yoga, and purification techniques. Ayurvedic strategies are often used to treat osteoarthritis (OA) of the knee; however, no systematic data are available on their effectiveness in comparison with standard care. The aim of this study is to evaluate the effectiveness of complex Ayurvedic treatment in comparison with conventional methods of treating OA symptoms in patients with knee osteoarthritis.
Methods and design
In a prospective, multicenter, randomized controlled trial, 150 patients between 40 and 70 years, diagnosed with osteoarthritis of the knee, following American College of Rheumatology criteria and an average pain intensity of ≥40 mm on a 100 mm visual analog scale in the affected knee at baseline will be randomized into two groups. In the Ayurveda group, treatment will include tailored combinations of manual treatments, massages, dietary and lifestyle advice, consideration of selected foods, nutritional supplements, yoga posture advice, and knee massage. Patients in the conventional group will receive self-care advice, pain medication, weight-loss advice (if overweight), and physiotherapy following current international guidelines. Both groups will receive 15 treatment sessions over 12 weeks. Outcomes will be evaluated after 6 and 12 weeks and 6 and 12 months. The primary endpoint is a change in the score on the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) after 12 weeks. Secondary outcome measurements will use WOMAC subscales, a pain disability index, a visual analog scale for pain and sleep quality, a pain experience scale, a quality-of-life index, a profile of mood states, and Likert scales for patient satisfaction, patient diaries, and safety. Using an adapted PRECIS scale, the trial was identified as lying mainly in the middle of the efficacy-effectiveness continuum.
This trial is the first to compare the effectiveness of a complex Ayurvedic intervention with a complex conventional intervention in a Western medical setting in patients with knee osteoarthritis. During the trial design, aspects of efficacy and effectiveness were discussed. The resulting design is a compromise between rigor and pragmatism.
Trial registration
PMCID: PMC3664613  PMID: 23701973
Ayurveda; Ayurvedic; Comparative-effectiveness research; Whole medical system; Osteoarthritis of the knee; Randomized trial; Traditional Indian medicine
25.  Opinions on Kampo and reasons for using it – results from a cross-sectional survey in three Japanese clinics 
Traditional Japanese Medicine (Kampo) is often used in Japan, but very little data on its users are available. We investigated who uses Kampo, the reasons and opinions for its use.
Questionnaire survey in three Japanese outpatient clinics offering Kampo in different settings: Kampo only, Kampo and traditional Chinese medicine, Kampo and Western medicine. Before seeing the doctor, patients were asked about socio-demographic data, medical history, experience with Kampo, general health-related opinions and behaviours, opinions about Western medicine and Kampo, and reasons for Kampo utilization. Descriptive statistics and predictors for Kampo use were calculated.
A total of 354 questionnaires were completed. Participants were 50.97 ± 15.60 (mean ± SD) years of age, 68% were female. Of all patients, 73% (n = 202) were using Kampo currently and 84% (297) had taken Kampo before. Questions on general health-related opinions and behaviour revealed a strong environmental awareness. The most frequent indications for earlier Kampo use were: common cold (36%), gastrointestinal complaints (30%), oversensitivity to cold (“Hi’e-sho”; 29%), stress/anxiety (21%), and shoulder stiffness (20%). Kampo users suffered more often from chronic illnesses (OR 2.88 [1.48-5.58]). Beliefs in underlying philosophy (Wu Xing (adjusted OR 3.08, [1.11-8.55]), Ying and Yang (OR 2.57 [1.15-5.73], a holistic way of seeing the patient (OR 2.17 [1.53-3.08]), and in Kampo efficacy (OR 2.62 [1.66-4.13]) were positively associated with Kampo use. So was, interestingly, conviction of the efficacy of Western medicine (OR 1.87 [1.28-2.74]). Half of the patients had a general preference for a combination of Kampo and Western treatment.
Most patients visiting a clinic that also provided Kampo had previous experience with Kampo. Usage was associated with beliefs in philosophical Kampo concepts and its efficacy.
PMCID: PMC3669030  PMID: 23680097
Kampo; Survey; Patient opinions

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