A consultation training program for physicians for communication about complementary medicine with breast cancer patients: a prospective, multi-center, cluster-randomized, mixed-method pilot study.

BACKGROUND: The aim was to develop and evaluate a training program for physicians for communicating with breast cancer patients about complementary medicine (CM). METHODS: In a cluster-randomized pilot trial eight breast cancer centers (two physicians per center) were randomized to either a complementary communication training program (9 h e-learning + 20 h on-site skills training) or to a control group without training. Each physician was asked to consult ten patients for whom he or she is not the physician in charge. We used mixed methods: Quantitative outcomes included physicians' assessments (empathy, complexity of consultation, knowledge transfer) and patients' assessments (satisfaction, empathy, knowledge transfer). For qualitative analyses, 15 (eight in the training and seven in the control group) videotaped consultations were analyzed based on grounded theory, and separate focus groups with the physicians of both groups were conducted. RESULTS: A total of 137 patients were included. Although cluster-randomized, physicians in the two groups differed. Those in the training group were younger (33.4 ± 8.9 vs. 40.0 ± 8.5 years) and had less work experience (5.4 ± 8.9 vs. 11.1 ± 7.4 years). Patient satisfaction with the CM consultation was relatively high on a scale from 0 to 24 and was comparable in the two groups (training group: 19.4 ± 4.6; control group 20.5 ± 4.1). The qualitative findings showed that physicians structured majority of consultations as taught during the training. Comparing only the younger and less CM experienced physicians, those trained in CM communication felt more confident discussing CM-related topics than those without training. CONCLUSION: A CM communication-training program might be especially beneficial for physicians with less consulting experience when communicating about CM-related issues. A larger trial using more suitable quantitative outcomes needs to confirm this. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02223091 , date of registration: 7 February 2014.

Effectiveness of an additional individualized multi-component complementary medicine treatment on health-related quality of life in breast cancer patients: a pragmatic randomized trial.

The aim of this study was to evaluate the effectiveness of an additional, individualized, multi-component complementary medicine treatment offered to breast cancer patients at the Merano Hospital (South Tyrol) on health-related quality of life compared to patients receiving usual care only. A randomized pragmatic trial with two parallel arms was performed. Women with confirmed diagnoses of breast cancer were randomized (stratified by usual care treatment) to receive individualized complementary medicine (CM group) or usual care alone (usual care group). Both groups were allowed to use conventional treatment for breast cancer. Primary endpoint was the breast cancer-related quality of life FACT-B score at 6 months. For statistical analysis, we used analysis of covariance (with factors treatment, stratum, and baseline FACT-B score) and imputed missing FACT-B scores at 6 months with regression-based multiple imputation. A total of 275 patients were randomized between April 2011 and March 2012 to the CM group (n = 136, 56.3 ± 10.9 years of age) or the usual care group (n = 139, 56.0 ± 11.0). After 6 months from randomization, adjusted means for health-related quality of life were higher in the CM group (FACT-B score 107.9; 95 % CI 104.1-111.7) compared to the usual care group (102.2; 98.5-105.9) with an adjusted FACT-B score difference between groups of 5.7 (2.6-8.7, p < 0.001). Thus, an additional individualized and complex complementary medicine intervention improved quality of life of breast cancer patients compared to usual care alone. Further studies evaluating specific effects of treatment components should follow to optimize the treatment of breast cancer patients.

Internal health locus of control in users of complementary and alternative medicine: a cross-sectional survey.

BACKGROUND: Complementary and alternative medicine (CAM) is widely used in Germany, with some treatments eligible for health insurance reimbursements. CAM encourages patients to play an active role in their healing process. The belief that a person's own behavior influences health is assessed as the internal health locus of control (IHLOC). Studies on the association between IHLOC and CAM use yield inconsistent results. Using various indicators of CAM use, we evaluated whether there were differences in IHLOC between different groups of CAM users. METHODS: A cross-sectional online survey was conducted. IHLOC was compared between participants with high and low appraisal of CAM, between participants who used different types of medications (none, CAM, conventional, both), and who consulted with different health care professionals (none, CAM, conventional, both). Independent samples t-tests and ANOVAs were conducted for the total group and for subgroups of chronically ill and healthy participants. Post-hoc, we conducted a multivariate linear regression evaluating which indicators of CAM use or other characteristics showed the strongest association with IHLOC. RESULTS: A total of 1,054 undergraduate students completed the survey. Participants with high CAM appraisal showed higher IHLOC than those with low CAM appraisal, regardless of whether they were chronically ill (p < .001). Participants without chronic conditions showed higher IHLOC when only using CAM medications than when using either conventional medications alone or both conventional and CAM medications (p < .05). All participants showed higher IHLOC when visiting only CAM practitioners than when visiting either only conventional or both conventional and CAM practitioners (p < .05). CAM appraisal was associated the strongest with IHLOC in the linear regression model. CONCLUSIONS: Generally, participants using CAM more or exclusively, and participants with higher appraisal of CAM showed higher IHLOC than those with less CAM use or lower CAM appraisal. Because of the cross-sectional design, it is not possible to determine whether differences in IHLOC are reasons for or consequences of CAM use. Research using a longitudinal design is needed. The sample, though more representative than most student samples, might not represent the general population. Studies evaluating clinical populations might add to the findings.

Factors influencing further acupuncture usage and a more positive outcome in patients with osteoarthritis of the knee and the hip: a 3-year follow-up of a randomized pragmatic trial.

OBJECTIVE: Considering the chronicity of osteoarthritis-associated pain, we aimed to evaluate long-term outcome differences between patients who received immediate or delayed acupuncture in addition to usual care, and to identify predictors for further acupuncture usage and a better long-term outcome. MATERIALS AND METHODS: The Acupuncture in Routine Care study was an open-label randomized pragmatic trial. As adjunct to usual care patients (>40 y, clinical and radiologic diagnosis of primary osteoarthritis of the knee or hip, pain duration >6 mo) received either immediate acupuncture in the first 3 months or delayed acupuncture in the subsequent 3 months. After 36 months 613 of 632 patients were available and asked to complete follow-up questionnaires. Primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). RESULTS: A total of 500 (82%) of the contacted patients completed questionnaires. After 36 months the WOMAC Index did not differ significantly between groups (immediate acupuncture 36.53±26.19 vs. delayed acupuncture 38.24±25.54; P=0.420). Further acupuncture treatment during the follow-up period was reported by 202 patients and predicted by previous successful acupuncture treatment at baseline (odds ratio=2.5; 95% confidence interval, 1.6-3.9). Less osteoarthritis symptoms (WOMAC Index) after 36 months were predicted by being an acupuncture responder at 6 months (P<0.001), having higher school education (P=0.005), not wanting to use medications (P=0.016), and using additional therapies (P≤0.001 to P=0.025). DISCUSSION: No long-term outcome differences were found between patients who received immediate versus those who received delayed acupuncture treatment. Education level and additional therapies were identified as predictors for a better long-term outcome.

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.

Homeopathy for depression: a randomized, partially double-blind, placebo-controlled, four-armed study (DEP-HOM).

BACKGROUND: The specific clinical benefit of the homeopathic consultation and of homeopathic remedies in patients with depression has not yet been investigated. AIMS: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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: clinicaltrials.gov identifier NCT01178255. Protocol publication: http://www.trialsjournal.com/content/12/1/43.

Effectiveness of additional self-care acupressure for women with menstrual pain compared to usual care alone: using stakeholder engagement to design a pragmatic randomized trial and study protocol.

BACKGROUND: Self-care acupressure might be successful in treating menstrual pain, which is common among young women. There is a need for comparative effectiveness research with stakeholder engagement in all phases seeking to address the needs of decision-makers. Our aim was to design a study on the effectiveness of additional self-care acupressure for menstrual pain comparing usual care alone using different methods of stakeholder engagement. METHODS: The study was designed using multiple mixed methods for stakeholder engagement. Based on the results of a survey and focus group discussion, a stakeholder advisory group developed the study design. RESULTS: Stakeholder engagement resulted in a two-arm pragmatic randomized trial. Two hundred and twenty women aged 18 to 25 years with menstrual pain will be included in the study. Outcome measurement will be done using electronic questionnaires provided by a study specific mobile application (App). Primary outcome will be the mean pain intensity at the days of pain during the third menstruation after therapy start. CONCLUSION: Stakeholder engagement helped to develop a study design that better serves the needs of decision makers, including an App as a modern tool for both intervention and data collection in a young target group. TRIAL REGISTRATION: Clinicaltrials.gov identifier http://NCT01582724.

The illness/injury sensitivity index: validation of a German version of the ISI-R.

Three fundamental fears-anxiety sensitivity, fear of negative evaluation, and illness/injury sensitivity-are considered integral components of anxiety-related psychopathology and also bear connections with chronic pain. Scales measuring the first two fears, the Anxiety Sensitivity Index and the Fear of Negative Evaluation Scale, have been translated into German; however, the nine-item Illness/Injury Sensitivity Index-Revised (ISI-R) that measures fears of injury and illness has not been available in German language yet. The aim of this study therefore was a translation of the ISI-R into German language and an initial validation of the translated scale in two different samples. The German ISI-R was translated by both professionals and laypersons, and a final version was decided on by consensus. In Study 1, participants included 96 undergraduate students (85% women) who completed the German version of the ISI as part of a larger study. An exploratory factor analysis with oblique rotation was conducted and suggested a two-factor-solution with one factor representing fears of illness and the other fears of injury. This factor structure was confirmed via a confirmatory factor analysis (CFA) in Study 2. Participants included 117 community members (79% women). Convergent validity was supported using a visual analogue scale for fear of illness in both samples and the German translation of the Whiteley Index in Study. Overall, the results supported the German translation of the ISI-R. Comprehensive results, limitations, and directions for future research are discussed.

Homeopathy for depression--DEP-HOM: study protocol for a randomized, partially double-blind, placebo controlled, four armed study.

BACKGROUND: Homeopathy is often sought by patients with depression. In classical homeopathy, the treatment consists of two main elements: the case history and the prescription of an individually selected homeopathic remedy. Previous data suggest that individualized homeopathic Q-potencies were not inferior to the antidepressant fluoxetine in a sample of patients with moderate to severe depression. However, the question remains whether individualized homeopathic Q-potencies and/or the type of the homeopathic case history have a specific therapeutical effect in acute depression as this has not yet been investigated. The study aims to assess the two components of individualized homeopathic treatment for acute depression, i.e., to investigate the specific effect of individualized Q-potencies versus placebo and to investigate the effect of different approaches to the homeopathic case history. METHODS/DESIGN: A randomized, partially double-blind, placebo-controlled, four-armed trial using a 2 x 2 factorial design with a six-week study duration per patient will be performed. 228 patients diagnosed with major depression (moderate episode) by a psychiatrist will be included. The primary endpoint is the total score on the 17-item Hamilton Depression Rating Scale after six weeks. Secondary end points are: Hamilton Depression Rating Scale total score after two and four weeks; response and remission rates, Beck Depression inventory total score, quality of life and safety at two, four and six weeks. Statistical analyses will be by intention-to-treat. The main endpoint will be analysed by a two-factorial analysis of covariance. Within this model generalized estimation equations will be used to estimate differences between verum and placebo, and between both types of case history. DISCUSSION: For the first time this study evaluates both the specific effect of homeopathic medicines and of a homeopathic case taking in patients with depression. It is an attempt to deal with the challenges of homeopathic research and the results might be useful information in the current discussion about the evidence on homeopathy TRIAL REGISTRATION: ClinicalTrials.gov: NCT01178255.

Patient characteristics and variation in treatment outcomes: which patients benefit most from acupuncture for chronic pain?

OBJECTIVES: The aim of this study was to identify patients' characteristics that increase or decrease their benefit from acupuncture treatment of chronic pain. METHODS: Patients with chronic low back pain, headache, neck pain, or pain due to osteoarthritis of the knee or hip, were included in 4 multicenter, randomized, controlled studies, all conducted in Germany. All patients received routine care; the patients randomized to the acupuncture group received additional acupuncture treatment. Data were pooled, and the main outcome was defined as the 3-month change from baseline of the SF-36 bodily pain subscale. To identify predictors for treatment effects and effect modifiers (ie, variables that interact with the form of treatment), patients' characteristics and their interaction with treatment were included in a mixed linear model to predict treatment outcome. RESULTS: A total of 9,990 patients who were treated by 2,781 physicians were analyzed. The outcome was markedly improved in the acupuncture group (P < 0.001). Age, education, duration of illness, baseline pain, and some concomitant diseases predicted treatment outcome in both groups. Patients' characteristics that enlarged the acupuncture effect (ie, acted as effect modifiers) were being female (P = 0.028), living in a multi-person household (P = 0.002), failure of other therapies before the study (P = 0.049), and former positive acupuncture experience (P = 0.005). DISCUSSION: Future research to clarify the modifying effects with special focus on patients' expectations and other psychological variables is needed.