Michael Teut

Pulsatile dry cupping in patients with osteoarthritis of the knee - a randomized controlled exploratory trial

IntroductionCupping is used in various traditional medicine forms to relieve pain in musculoskeletal diseases. The aim of this study was to investigate the effectiveness of cupping in relieving the symptoms of knee osteoarthritis (OA).MethodsIn a two-group, randomized controlled exploratory pilot study patients with a clinically and radiological confirmed knee OA (Kellgren-Lawrence Grading Scale: 2-4) and a pain intensityu2009>u200940u2009mm on a 100u2009mm visual analogue scale (VAS) were included. 40 Patients were randomized to either 8 sessions of pulsatile dry cupping within 4u2009weeks or no intervention (control). Paracetamol was allowed on demand for both groups. Outcomes were the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) score, the pain intensity on a VAS (0u2009mmu2009=u2009no pain to 100u2009mmu2009=u2009maximum intensity) and Quality of Life (SF-36) 4 and 12u2009weeks after randomization. Use of Paracetamol was documented within the 4-week treatment period. Analyses were performed by analysis of covariance adjusting for the baseline value for each outcome.Results21 patients were allocated to the cupping group (5 male; mean age 68u2009±u2009SD 7.2) and 19 to the control group (8 male; 69u2009±u20096.8). After 4u2009weeks the WOMAC global score improved significantly more in the cupping group with a mean of 27.7 (95% confidence interval 22.1; 33.3) compared to 42.2 (36.3; 48.1) in the control group (pu2009=u20090.001). After 12u2009weeks the WOMAC global score were still significantly different in favor for cupping (31.0 (24.9; 37.2) vs. 40.8 (34.4; 47.3) pu2009=u20090.032), however the WOMAC subscores for pain and stiffness were not significant anymore. Significantly better outcomes in the cupping group were also observed for pain intensity on VAS and for the SF-36 Physical Component Scale compared to the control group after 4 and 12u2009weeks. No significant difference was observed for the SF-36 Mental Component Scale and the total number of consumed Paracetamol tablets between both groups (mean 9.1, SD ± 20.0 vs. 11.5 ± 15.9).ConclusionIn this exploratory study dry cupping with a pulsatile cupping device relieved symptoms of knee OA compared to no intervention. Further studies comparing cupping with active treatments are needed.Trial registrationClinicaltrials.gov Identifier: NCT01057043

Use of complementary and alternative medicine by older adults – a cross-sectional survey

BackgroundVery 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.MethodsA 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.ResultsA 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).ConclusionOlder German adults frequently use CAM. They perceived it as an effective complement to conventional medicine, but are not sufficiently informed about risks and benefits.

Perceived outcomes of music therapy with Body Tambura in end of life care - a qualitative pilot study.

BackgroundIn 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.MethodsIn 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.Results11 persons consisting of 8 patients (age range 51–82xa0years, 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.ConclusionPatient 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.

Mindful Walking in Psychologically Distressed Individuals: A Randomized Controlled Trial

Background. The aim of this randomized, controlled study was to investigate the effectiveness of a mindful walking program in patients with high levels of perceived psychological distress. Methods. Participants aged between 18 and 65 years with moderate to high levels of perceived psychological distress were randomized to 8 sessions of mindful walking in 4 weeks (each 40 minutes walking, 10 minutes mindful walking, 10 minutes discussion) or to no study intervention (waiting group). Primary outcome parameter was the difference to baseline on Cohens Perceived Stress Scale (CPSS) after 4 weeks between intervention and control. Results. Seventy-four participants were randomized in the study; 36 (32 female, 52.3 ± 8.6 years) were allocated to the intervention and 38 (35 female, 49.5 ± 8.8 years) to the control group. Adjusted CPSS differences after 4 weeks were −8.8 [95% CI: −10.8; −6.8] (mean 24.2 [22.2; 26.2]) in the intervention group and −1.0 [−2.9; 0.9] (mean 32.0 [30.1; 33.9]) in the control group, resulting in a highly significant group difference (P < 0.001). Conclusion. Patients participating in a mindful walking program showed reduced psychological stress symptoms and improved quality of life compared to no study intervention. Further studies should include an active treatment group and a long-term follow-up.

Homeopathic treatment of elderly patients - a prospective observational study with follow-up over a two year period

BackgroundVery little is known about the range of diagnoses, course of treatment and long-term outcome in elderly patients who choose to receive homeopathic medical treatment. We investigated homeopathic practice in an industrialised country under everyday conditions.The aim of the study was to determine the spectrum of diagnoses and treatments, as well as to describe the course of illness over time among older patients who chose to receive homeopathic treatment.MethodsIn this subgroup analysis of a prospective, multicentre cohort study totally including 3981 patients treated by homeopathic physicians in primary care practices in Germany and Switzerland, data was analysed from all patients > 70 years consulting the physician for the first time. The main outcome measures were: assessment by patient of the severity of complaints (numeric rating scales) and quality of life (SF-36) and by the physician of the severity of diagnoses (numeric rating scales) at baseline, and after 3, 12, and 24 months.ResultsA total of 83 patients were included in the subgroup analysis (41% men, mean age 73.2 ± (SD) 3.1 years; 59% women, 74.3 ± 3.8 years).98.6 percent of all diagnoses were chronic with an average duration of 11.5 ± 11.5 years. 82 percent of the patients were taking medication at baseline.The most frequent diagnoses were hypertension (20.5%, 11.1 ± 7.5 years) and sleep disturbances (15.7%, 22.1 ± 25.8 years).The severity of complaints decreased significantly between baseline and 24 months in both patients (from 6.3 (95%CI: 5.7-6.8) to 4.6 (4.0-5.1), p < 0.001) and physicians assessments (from 6.6 (6.0-7.1) to 3.7 (3.2-4.3), p < 0.001); quality of life (SF 36) and the number of medicines taken did not significantly change.ConclusionThe severity of disease showed marked and sustained improvements under homeopathic treatment, but this did not lead to an improvement of quality of life. Our findings might indicate that homeopathic medical therapy may play a beneficial role in the long-term care of older adults with chronic diseases and studies on comparative effectiveness are needed to evaluate this hypothesis.

Perceived outcomes of spiritual healing and explanations - a qualitative study on the perspectives of German healers and their clients

BackgroundLimited research has been conducted on contemporary spiritual healing in European countries. The aim of this article is to report how German healers and their clients experienced and perceived the outcomes of spiritual healing and which explanations they use to describe the perceived effects.MethodsSemistructured interviews and participatory observation was used to collect data from spiritual healers and their clients. Analyses were based on the methodological concept of directed qualitative content analysis. Data was analyzed using MAXQDA software, discussed and reviewed by a multidisciplinary research team consisting of medical anthropologists, medical doctors and a religious studies scholar.ResultsIn total 15 healers and 16 clients participated in this study, 24 interviews with healers, 20 interviews with clients and 8 participatory observations were analyzed. Healers and clients reported outcomes as positively perceived body sensations, increased well-being, positive emotions and symptomatic relief of medical complaints. Clients often described changes in their self-concepts and adapted life values. Explanations for perceived effects included connecting with transcendent sources, construction of meaning, as a result of the client-healer relationship, and as empowerment to make changes. Because the interviewed clients were recruited by the healers, a selection bias towards positive healing experiences is possible.ConclusionWe hypothesize that concepts of meaning construction, resource activation and the utilization of the clients’ expectations help to explain the data. Grounded in the emic perspective, we propose to use the following outcomes for further prospective studies: positive body sensations, changes of self-concepts and values, changes of medical symptoms and complaints. From the etic perspective, physical, emotional, social and spiritual wellbeing, sense of coherence, meaningfulness of life, empowerment, resource activation, change and symptom control should be further explored as potential outcomes.

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

BackgroundHomeopathy 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/DesignA randomized, partially double-blind, placebo-controlled, four-armed trial using a 2 × 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.DiscussionFor 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 homeopathyTrial registrationClinicalTrials.gov: NCT01178255

Blutegel, Phytotherapie und Physiotherapie bei Gonarthrose – eine geriatrische Fallstudie

BACKGROUNDnChronic pain is a serious problem for geriatric patients. Conventional pharmacotherapy with nonsteroidal anti-inflammatory drugs or opiates is often accompanied by serious side effects.nnnOBJECTIVESnAn 87-year-old woman with severe joint pain due to osteoarthritis of the knee presented with side effects from fentanyl therapy. She was subsequently treated in an inpatient setting with leeches, phytotherapy, physiotherapy and three single doses of metamizol.nnnDESIGNnProspective single-case study.nnnOUTCOME MEASURESnPain reduction was assessed with a numeric rating scale (0-10; 0 = minimum; 10 = maximum), mobility by walking distance, and activities of daily living by Barthel index. The association between complementary therapy and the changes observed in the patient under treatment were evaluated using cognition-based medicine.nnnRESULTSnUnder complementary therapy, the patient experienced a clear reduction in pain (from 8 to 3 points on the numeric rating scale); regained the ability to walk (increase in walking distance from 0 to 70 m); and showed improvements in activities of daily living (increase in Barthel index from 45 to 65). An association between pain reduction and the complementary treatment setting seems likely.nnnCONCLUSIONnThe role of complementary pain therapy in geriatric patients should be evaluated systematically.Hintergrund: Chronische Schmerzerkrankungen stellen ein groβes Problem im Alter dar. Die konventionelle Therapie mit nichtsteroidalen Antirheumatika (NSAR) oder Opiaten geht häufig mit unerwünschten Arzneiwirkungen einher. Fragestellung: Bei einer 87-jährigen Patientin mit ausgeprägten Gonarthroseschmerzen und Nebenwirkungen unter einer Fentanyl-Therapie wurde eine stationäre komplementäre Behandlung mit Blutegeln, Phytotherapie, Physiotherapie und drei Einzeldosen Metamizol durchgeführt. Design: Prospektive Einzelfallstudie. Outcome-Maße: Die Schmerzen wurden anhand einer numerischen Ratingskala beurteilt (0–10; 0 = minimal, 10 = maximal), die Mobilität durch die Gehstrecke und die Aktivitäten des täglichen Lebens durch den Barthel-Index. Der therapeutische Zusammenhang zwischen komplementärer Therapie und den klinischen Veränderungen wurde anhand der Kriterien der Cognition Based Medicine beurteilt. Ergebnis: Unter der komplementären Therapie erfuhr die Patientin eine deutliche Schmerzlinderung (Reduktion der Schmerzintensität auf der numerischen Ratingskala von 8 auf 3), gewann ihre Gehfähigkeit wieder (Steigerung der Wegstrecke von 0 auf 70 m) und verbesserte sich bezüglich ihrer Aktivitäten des täglichen Lebens (Steigerung des Barthel-Index von 45 auf 65). Eine therapeutische Kausalität zwischen Schmerzlinderung und dem komplementären therapeutischen Setting scheint wahrscheinlich. Schlussfolgerung: Die Anwendung komplementärer Schmerztherapien in der Geriatrie sollte systematisch untersucht werden.

Scientific case research in complementary and alternative medicine-a review.

The description of individual cases is probably the most important didactic tool for teaching in medicine, especially in complementary and alternative medicine (CAM). However, only very rarely is the information provided in traditional single case reports sufficient to answer scientific questions. These reports typically are demonstrations of the solution to a clinical problem. To contribute to scientific discussion single-case research must ask critical questions whose answers are open. Two fundamental questions are: (1) Is my observation reliable? (2) Which factors, other than my treatment, may explain the observed outcome? In this review we will give an introduction to single-case research, as well as present and explain single-case designs as a tool for research and discuss their relevance and applicability for clinical practice in CAM. This review deals exclusively with single-case research on treatment effects and covers observational single-case studies, progressive and repetitive experimental single case designs, n-of-1-RCT, multiple baseline design, best case series and meta-analysis of single-case studies.

Protocol for a phase 1 homeopathic drug proving trial

BackgroundThis study protocol adapts the traditional homeopathic drug proving methodology to a modern clinical trial design.MethodMulti-centre, randomised, double-blind, placebo-controlled phase 1 trial with 30 healthy volunteers. The study consists of a seven day run-in period, a five day intervention period and a 16 day post-intervention observation period. Subjects, investigators and the statisticians are blinded from the allocation to the study arm and from the identity of the homeopathic drug. The intervention is a highly diluted homeopathic drug (potency C12 = 1024), Dose: 5 globules taken 5 times per day over a maximum period of 5 days. The placebo consists of an optically identical carrier substance (sucrose globules). Subjects document the symptoms they experience in a semi-structured online diary. The primary outcome parameter is the number of specific symptoms that characterise the intervention compared to the placebo after a period of three weeks. Secondary outcome parameters are qualitative differences in profiles of characteristic and proving symptoms and the total number of all proving symptoms. The number of symptoms will be quantitatively analysed on an intention-to-treat basis using ANCOVA with the subjects expectation and baseline values as covariates. Content analysis according to Mayring is adapted to suit the homeopathic qualitative analysis procedure.DiscussionHomeopathic drug proving trials using the terminology of clinical trials according GCP and fulfilling current requirements for research under the current drug regulations is feasible. However, within the current regulations, homeopathic drug proving trials are classified as phase 1 trials, although their aim is not to explore the safety and pharmacological dynamics of the drug, but rather to find clinical indications according to the theory of homeopathy. To avoid bias, it is necessary that neither the subjects nor the investigators know the identity of the drug. This requires a modification to the informed consent process and blinded study materials. Because it is impossible to distinguish between adverse events and proving symptoms, both must be documented together.Trial registrationClinicalTrials.gov identifier: NCT01061229.