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Andreas Michalsen

Publications and source records attributed to Andreas Michalsen.

17 recordsLinked to original sources
PubMed2006

Checklist for the qualitative evaluation of clinical studies with particular focus on external validity and model validity.

BACKGROUND: It is often stated that external validity is not sufficiently considered in the assessment of clinical studies. Although tools for its evaluation have been established, there is a lack of awareness of their significance and application. In this article, a comprehensive checklist is presented addressing these relevant criteria. METHODS: The checklist was developed by listing the most commonly used assessment criteria for clinical studies. Additionally, specific lists for individual applications were included. The categories of biases of internal validity (selection, performance, attrition and detection bias) correspond to structural, treatment-related and observational differences between the test and control groups. Analogously, we have extended these categories to address external validity and model validity, regarding similarity between the study population/conditions and the general population/conditions related to structure, treatment and observation. RESULTS: A checklist is presented, in which the evaluation criteria concerning external validity and model validity are systemized and transformed into a questionnaire format. CONCLUSION: The checklist presented in this article can be applied to both planning and evaluating of clinical studies. We encourage the prospective user to modify the checklists according to the respective application and research question. The higher expenditure needed for the evaluation of clinical studies in systematic reviews is justified, particularly in the light of the influential nature of their conclusions on therapeutic decisions and the creation of clinical guidelines.

Bias↗
PubMed2006

[Complementary treatment of pneumonia with pleural effusion].

A 43-year-old male patient was diagnosed with acute sinistral pleuropneumonia and a pronounced thoracic pain syndrome. Despite of his painful ailments the patient refused antibiotic treatment. A complementary therapy comprising physiotherapy, hydrotherapy, herbal therapy and vitamin C, cupping and QiGong was initiated. A cantharidin blister was applied topically to the left thorax in order to treat the pain syndrome. The multimodal CAM treatment resulted in a rapid clinical and x-ray resolution of pneumonia, and cantharidin treatment effectively relieved pain. The case and the potential of topical cantharidin in pain syndromes are discussed.

Adult↗
PubMed2006

Effects of lifestyle modification on the progression of coronary atherosclerosis, autonomic function, and angina--the role of GNB3 C825T polymorphism.

BACKGROUND: Given the multimodal medical and interventional treatment options in coronary artery disease, the additional value of intensified lifestyle modification is unclear. We have therefore examined the effects of lifestyle modification on top of current treatment and also associated with the GNB3 C825T polymorphism, which has established association to sympathetic activation and the precipitation of angina. METHODS: One hundred one patients with established coronary artery disease were randomized to a 1-year lifestyle modification group (lifestyle group [LG]) or an advice group. Risk factors, coronary calcification (electron beam tomography), heart rate variability, baroreflex sensitivity, anginal symptoms, and quality of life (QOL) were assessed on entry and after 1 year. RESULTS: Patients in LG had excellent program adherence, but lifestyle modification had no impact on metabolic risk factors and coronary calcification. Changes in heart rate, heart rate variability, and blood pressure were only slightly favoring LG. Baroreflex sensitivity increased by 2 (0.79-3.13) ms/mm Hg in the LG but decreased by -0.10 (-1.11 to 0.92) in the advice group (P = .013). Lifestyle modification led to improved physical QOL, reductions of anginal attacks (-54% vs 11%, P = .01), and dose reductions in 30% of anti-ischemic medications (P = .004). *825T allele carriers had a more pronounced reduction of heart rate and improvement of angina and QOL. The beneficial effect on reduction of medication was seen in *825T allele carriers only. CONCLUSIONS: In the presence of modern treatments, comprehensive lifestyle modification provides no additional benefits on progression of atherosclerosis but improves autonomic function, angina, and QOL with concomitant reduced need of medication. These responses are more pronounced in GNB3*825T allele carriers.

Aged↗
PubMed2006

[Endocannabinoids as molecular instruments of health promotion].

UNLABELLED: Endocannabinoids may be a physiological model for our self-healin capacities, since they are part of a complex system of natural auto-regulatory processes. This system has been examined via neurobiology, where the experimental invertebrate model is useful. Endocannabinoids, as well as endogenous morphine, activate constitutive nitric oxide (NO) release, which exerts a variety of positive physiological effects. By doing so, we surmise endogenous stress reduction emerges. Therefore, in the context of endocannabinoid auto-regulation, it seems adequate to speak of "health promotion on a molecular level". The convergence of endogenous auto-regulation on NO pathways critically relies upon common or overlapping neurobiological molecular components, as they are represented by limbic reward and motivation mechanisms. To our knowledge, endogenous auto-regulation--involving deep limbic brain activities--plays a crucial role in successful modern strategies of applied and integrative health promotion. More research, however, is necessary before the different aspects of neurobiological science and clinical medicine in the field of prevention may be integrated extensively and with profound reason. CONCLUSIONS: Successful preventive programs, such as integrative medical stress management, include auto-regulative mechanisms on the physiological level. This leads to an interesting research potential, particularly when one considers the long-term effects of applied health promotion and its coupling to motivational neurobiological phenomena.

Amino Acid Sequence↗
PubMed2005

Mediterranean diet or extended fasting's influence on changing the intestinal microflora, immunoglobulin A secretion and clinical outcome in patients with rheumatoid arthritis and fibromyalgia: an observational study.

BACKGROUND: Alterations in the intestinal bacterial flora are believed to be contributing factors to many chronic inflammatory and degenerative diseases including rheumatic diseases. While microbiological fecal culture analysis is now increasingly used, little is known about the relationship of changes in intestinal flora, dietary patterns and clinical outcome in specific diseases. To clarify the role of microbiological culture analysis we aimed to evaluate whether in patients with rheumatoid arthritis (RA) or fibromyalgia (FM) a Mediterranean diet or an 8-day fasting period are associated with changes in fecal flora and whether changes in fecal flora are associated with clinical outcome. METHODS: During a two-months-period 51 consecutive patients from an Integrative Medicine hospital department with an established diagnosis of RA (n = 16) or FM (n = 35) were included in the study. According to predefined clinical criteria and the subjects' choice the patients received a mostly vegetarian Mediterranean diet (n = 21; mean age 50.9 +/-13.3 y) or participated in an intermittent modified 8-day fasting therapy (n = 30; mean age 53.7 +/- 9.4 y). Quantitative aerob and anaerob bacterial flora, stool pH and concentrations of secretory immunoglobulin A (sIgA) were analysed from stool samples at the beginning, at the end of the 2-week hospital stay and at a 3-months follow-up. Clinical outcome was assessed with the DAS 28 for RA patients and with a disease severity rating scale in FM patients. RESULTS: We found no significant changes in the fecal bacterial counts following the two dietary interventions within and between groups, nor were significant differences found in the analysis of sIgA and stool ph. Clinical improvement at the end of the hospital stay tended to be greater in fasting vs. non-fasting patients with RA (p = 0.09). Clinical outcome was not related to alterations in the intestinal flora. CONCLUSION: Neither Mediterranean diet nor fasting treatments affect the microbiologically assessed intestinal flora and sIgA levels in patients with RA and FM. The impact of dietary interventions on the human intestinal flora and the role of the fecal flora in rheumatic diseases have to be clarified with newer molecular analysis techniques. The potential benefit of fasting treatment in RA and FM should be further tested in randomised trials.

Arthritis, Rheumatoid↗
PubMed2005

Rapid stress reduction and anxiolysis among distressed women as a consequence of a three-month intensive yoga program.

BACKGROUND: Emotional distress is an increasing public health problem and Hatha yoga has been claimed to induce stress reduction and empowerment in practicing subjects. We aimed to evaluate potential effects of Iyengar Hatha yoga on perceived stress and associated psychological outcomes in mentally distressed women. MATERIAL/METHODS: A controlled prospective non-randomized study was conducted in 24 self-referred female subjects (mean age 37.9+/-7.3 years) who perceived themselves as emotionally distressed. Subjects were offered participation in one of two subsequential 3-months yoga programs. Group 1 (n=16) participated in the first class, group 2 (n=8) served as a waiting list control. During the yoga course, subjects attended two-weekly 90-min Iyengar yoga classes. Outcome was assessed on entry and after 3 months by Cohen Perceived Stress Scale, State-Trait Anxiety Inventory, Profile of Mood States, CESD-Depression Scale, Bf-S/Bf-S' Well-Being Scales, Freiburg Complaint List and ratings of physical well-being. Salivary cortisol levels were measured before and after an evening yoga class in a second sample. RESULTS: Compared to waiting-list, women who participated in the yoga-training demonstrated pronounced and significant improvements in perceived stress (P<0.02), State and Trait Anxiety (P<0.02 and P<0.01, respectively), well-being (P<0.01), vigor (P<0.02), fatigue (P<0.02) and depression (P<0.05). Physical well-being also increased (P<0.01), and those subjects suffering from headache or back pain reported marked pain relief. Salivary cortisol decreased significantly after participation in a yoga class (P<0.05). CONCLUSIONS: Women suffering from mental distress participating in a 3-month Iyengar yoga class show significant improvements on measures of stress and psychological outcomes. Further investigation of yoga with respect to prevention and treatment of stress-related disease and of underlying mechanism is warranted.

Adult↗
PubMed2005

Incorporation of fasting therapy in an integrative medicine ward: evaluation of outcome, safety, and effects on lifestyle adherence in a large prospective cohort study.

OBJECTIVES: The aim of this study was to implement fasting therapy in an inpatient integrative medicine ward and to evaluate safety, acceptance, and effects on health-related outcomes and lifestyle adherence. DESIGN: This was a prospective observational study with consecutive inpatients over 3 [corrected] years. Inclusion and exclusion criteria for fasting therapy were checked by treating physicians and recommendations given. After receiving full information patients decided whether they would participate in fasting. Outcomes were assessed on admission, at discharge, and 3 and 6 months after discharge. SETTING: The study took place in an integrative medicine department of an academic teaching hospital. SUBJECTS: Subjects were newly admitted inpatients with chronic internal diseases and chronic pain syndromes, with lengths of hospital stay of >3 days. INTERVENTIONS: All patients received intensive integrative treatments including Mind/Body Medicine, acupuncture, nutritional/lifestyle education, and hydrotherapy. Fasting patients participated in a 7-day juice fast (intake <350 kcal/day) with accompanying bowel cleansing, 2 prefasting relief days, and 3 days with stepwise reintroduction of food. OUTCOME MEASURES: Outcomes were assessed based on rate of participation in fasting, severity of main complaint, quality of life (QOL, MOS 36-Item Short-Form Health Survey), safety, lifestyle adherence to recommendations given (relaxation, diet, exercise). RESULTS: Of 2121 patients with complete discharge questionnaires, 952 patients participated in fasting, 873 had a normocaloric vegetarian diet, and 296 patients had other diets and were excluded. Response rates were 71% and 56% at 3- and 6-month follow-up. The main disease-related complaint at discharge was significantly greater improved in fasters versus nonfasters (p < 0.01). Patient QOL increased significantly and comparably from baseline to discharge in both groups. Fasting was well tolerated and no serious fasting-related adverse effects were reported. In all, 743 (78%) of fasting patients reported improvement of their health through fasting. Descriptors of lifestyle adherence showed higher levels of related activities in the 3 and 6 months of follow-up. CONCLUSIONS: Fasting can safely and successfully be implemented in an inpatient integrative medicine concept and is perceived as a health-promoting method by the majority of patients. Potential effects on disease-related complaints and lifestyle adherence should be further evaluated in randomized trials.

Adolescent↗
PubMed2005

Amount of systemic steroid medication is a strong predictor for the use of complementary and alternative medicine in patients with inflammatory bowel disease: results from a German national survey.

OBJECTIVES: Previous studies have suggested that inflammatory bowel disease (IBD) patients rank high among users of complementary and alternative medicine (CAM). To further elucidate this phenomenon, we sent questionnaires to a large sample of IBD patients in Germany to determine the patterns and predictors of their CAM use. METHODS: Pretested 73-item questionnaires were mailed to a randomly selected representative sample of 1000 IBD patients from the approximately 16,000 members and associates of the German Crohn's and Colitis Association. Predictors of CAM use were evaluated by logistic regression models. RESULTS: Completed questionnaires were returned by 684 patients (female patients, 61.4%; Crohn's disease patients, 58.3%; ulcerative colitis patients, 38.2%). Of the 671 adult respondents, 344 (51.3%) had experience with CAM, and significantly more of the ulcerative colitis patients (59.8%) than the Crohn's disease patients (48.3%) had experience with CAM. There was no difference by gender. Homeopathy (52.9%) and herbal medicine (43.6%) were the most commonly used types of CAM. The most frequent personal reasons for CAM use were the search for an "optimum treatment" (78.9%) and the wish to stop taking steroids (63.8%). Using logistic regression, we found that total cortisone intake (P = 0.0077), but not duration of disease, was a strong predictor of CAM use. Other predictors were experience with psychosomatic and psychotherapeutic support (P = 0.0029), relaxation techniques (P = 0.0284), an academic education (P = 0.0173), a diet utilizing whole grains (P = 0.0123), and a normal body weight (P = 0.0215). Although 80% of patients indicated that they were interested in using CAM in the future, only 24.7% felt sufficiently informed about it. CONCLUSIONS: More than 50% of a large group of German IBD patients had used CAM. Prolonged or intensive steroid treatment, an academic education, active ways of coping, and a health-conscious life-style are associated with CAM use. Given the potential side effects and interactions, the treating physician should focus on thorough information about the benefits and limitations of conventional and complementary treatment options, especially for IBD patients who have received prolonged or intensive steroid treatment.

Adaptation, Psychological↗
PubMed2005

Comparison of 4 neutrophil-derived proteins in feces as indicators of disease activity in ulcerative colitis.

BACKGROUND: To evaluate the diagnostic use of fecal concentrations of lactoferrin (Lf), calprotectin (Cal), polymorphonuclear neutrophil-elastase (PMN-e), and lysozyme (Lys) as indicators of disease activity in patients with active and inactive ulcerative colitis (UC). METHODS: A total of 76 fecal specimens were collected from 31 patients with UC in times of active and inactive status of disease. Disease activity was determined with the colitis activity index (CAI; Rachmilewitz index), which includes a combination of laboratory parameters and clinical symptoms, with a score of at least 6 indicating active disease. Fecal Lf, Cal, PMN-e, and Lys were measured and reported as micrograms per milliliter feces. Levels of more than 7.25, more than 6.00, at least 0.062, and at least 0.6 for Lf, Cal, PMN-e, and Lys, respectively, were considered elevated as specified by the manufacturers. RESULTS: Based on the CAI classification, 25 of the samples were from patients with active disease status and 51 were from patients with inactive status. Lf, PMN-e, and Cal but not Lys showed increased levels in samples from patients in active disease compared with those in remission (median for Lf: 28.12 +/- 110.86 versus 179.54 +/- 334.09, P < 0.001; median for Cal: 15.13 +/- 30.27 versus 116.23 +/- 182.29, P < 0.001; median for PMN-e: 0.21 +/- 0.44 versus 1.02 +/- 0.89, P < 0.001; median for Lys: 1.54 +/- 2.39 versus 3.75 +/- 5.39, P > 0.05). All 4 parameters correlated with the CAI (Lf: r = 0.441, P < 0.001; Cal: r = 0.505, P < 0.001; PMN-e: r = 0.604, P < 0.001; Lys: r = 0.295, P < 0.05). Introducing a composite index based on Lf, Cal, and PMN-e, the specificity was 72.5% and the sensitivity 88% compared with the CAI. CONCLUSIONS: Among the neutrophil-derived proteins in feces, PMN-e, Cal, and Lf represent useful markers of disease activity in patients with UC. Using all 3 markers in a composite index may be an additional noninvasive tool for the management of ambulant patients with UC.

Adult↗
PubMed2005

Effects of mind-body therapy on quality of life and neuroendocrine and cellular immune functions in patients with ulcerative colitis.

BACKGROUND: The aim of this study was to investigate the effects of mind-body therapy on neuroendocrine and cellular immune measures, health-related quality of life and disease activity in patients with ulcerative colitis (UC) in remission. METHODS: Thirty UC patients in remission or with low disease activity were randomly assigned to an intervention group (n = 15) or a usual-care waiting control group (n = 15). Intervention consisted of a structured 60-hour training program over 10 weeks which included stress management training, moderate exercise, Mediterranean diet, behavioral techniques and self-care strategies. Quality of life, perceived stress and disease activity were assessed with standardized questionnaires (IBDQ, SF-36, PSS, CAI). In addition, the distribution of circulating lymphocytes and lymphocyte subsets as well as the beta-adrenergic modulation of TNF-alpha production in vitro were analyzed. Urine catecholamines and plasma cortisol, prolactin and growth hormone were measured pre- and postinterventionally, and were compared with a healthy control group (n = 10). RESULTS: In response to therapy, patients in the intervention group showed significantly greater improvement in the SF-36 scale Mental Health and the Psychological Health Sum score compared with changes observed in the usual-care waiting control group. Patients in the intervention group showed significantly greater improvement on the IBDQ scale Bowel Symptoms compared with the control group. However, no significant group differences in circulating lymphocyte subsets or endocrine parameters were observed in response to therapy. In addition, no significant effects of intervention on either the basal levels of TNF-alpha or the suppressive action of the beta-adrenergic agonist isoproterenol on TNF-alpha production were observed. CONCLUSION: Mind-body therapy may improve quality of life in patients with UC in remission, while no effects of therapy on clinical or physiological parameters were found, which may at least in part be related to selective patient recruitment.

Adult↗
PubMed2005

Psychological and quality-of-life outcomes from a comprehensive stress reduction and lifestyle program in patients with coronary artery disease: results of a randomized trial.

BACKGROUND: Stress reduction and comprehensive lifestyle modification programs have improved atherosclerosis and cardiac risk factors in earlier trials. Little is known about the impact of such programs on quality-of-life (QoL) and psychological outcomes. Given recent significant improvements in cardiac care, we evaluated the current benefit of stress reduction/lifestyle modification on QoL and emotional distress in patients with coronary artery disease (CAD). METHODS: 101 patients (59.4 +/- 8.6 years, 23 female) with CAD were randomized to a 1-year lifestyle/stress management program (n = 48) or written advice (n = 53). QoL and psychological outcomes were assessed with the SF-36, Beck Depression, Spielberger State/Trait Anxiety, Spielberger State/Trait Anger and Perceived Stress Inventories. Group repeated-measures analyses of variance were performed for all measures. RESULTS: Adherence to the program was excellent (daily relaxation practice 39 +/- 5 vs. 5 +/- 8 min, respectively; p < 0.001). Both groups improved comparably in most dimensions of QoL, and significantly greater improvements for the lifestyle group were found for physical function and physical sum score (p = 0.046 and p = 0.045). Depression, anxiety, anger and perceived stress were reduced similarly in both groups. However, intervention x gender interaction effects revealed greater benefits among women in the lifestyle intervention vs. advice group for depression and anger (p = 0.025 and p = 0.040), but no effects for men. CONCLUSIONS: A comprehensive lifestyle modification and stress management program did not improve psychological outcomes in medically stable CAD patients. The program did appear to confer psychological benefits for women but not men. Further trials should investigate gender-related differences in coronary patient responses to behavioral interventions.

Aged↗
PubMed2003

Effectiveness of leech therapy in osteoarthritis of the knee: a randomized, controlled trial.

BACKGROUND: Leech therapy was commonly used in traditional medicine for treating localized pain. Clinically significant pain relief after leech therapy for osteoarthritis of the knee has been demonstrated by preliminary data. OBJECTIVE: To evaluate the effectiveness of leech therapy for symptomatic relief of osteoarthritis of the knee. DESIGN: Randomized, controlled trial. SETTING: Outpatient department for integrative medicine of an academic teaching hospital. PATIENTS: 51 patients with osteoarthritis of the knee (leech therapy: 24 patients, mean age [+/-SD], 62.5 +/- 10.2 years; topical diclofenac therapy: 27 patients, mean age [+/-SD], 65.5 +/- 6.7 years). INTERVENTION: A single treatment with 4 to 6 locally applied leeches (leech therapy group) or a 28-day topical diclofenac regimen (control group). MEASUREMENTS: Mean of the pain, function, and stiffness subscores of the Western Ontario and McMaster Universities Osteoarthritis Index and physical sum score of the Medical Outcomes Study 36-Item Short-Form Health Survey with group comparisons at days 3, 7, 28, and 91. RESULTS: The primary end point, pain at day 7, was reduced from a mean (+/-SD) of 53.5 +/- 13.7 to 19.3 +/- 12.2 after leech therapy compared with 51.5 +/- 16.8 to 42.4 +/- 19.7 with topical diclofenac (estimated group difference, -23.9 [95% CI, -32.8 to -15.1]; P < 0.001). Although the difference between group pain scores was no longer significant after day 7, differences for function, stiffness, and total symptoms remained significant in favor of leech therapy until the end of study and for quality of life until day 28. Results were not affected by outcome expectation. CONCLUSIONS: Leech therapy helps relieve symptoms in patients with osteoarthritis of the knee. The potential of leech therapy for treating osteoarthritis and the pharmacologic properties of leech saliva remain to be clarified.

Administration, Topical↗
PubMed2003

Thermal hydrotherapy improves quality of life and hemodynamic function in patients with chronic heart failure.

BACKGROUND: Chronic heart failure is characterized by increased peripheral vascular resistance and reduced peripheral perfusion due to adrenergic and renin angiotensin activation and impaired endothelial function. Recent studies have shown that nonpharmacological peripheral vasodilation with thermal therapy by means of warm-water baths and sauna has beneficial effects in chronic heart failure. European hydrotherapy (according to Kneipp) additionally uses short cold water stimuli, which lead to prolonged vasodilation and adaptive responses. Studies on the efficacy of hydrotherapy in chronic heart failure are lacking. METHODS: We studied 15 patients (5 men, 10 women, mean (+/- SD) age 64.3 +/- 1.8 years) with mild chronic heart failure (NYHA functional class II to III, ejection fraction 30%-40%). Patients were randomly assigned to 6 weeks of intensive home-based hydrotherapy or 6 weeks restriction in a crossover intervention trial. Quality of life and heart-failure--related symptoms were assessed by means of a validated questionnaire (PLC). Graded bicycle exercise test with incremental workloads (0, 50, 75, 100 watts) was performed at the end of each treatment period. The hydrotherapeutic program consisted of a structured combination of daily home-based external warm- and cold-water applications. RESULTS: Baseline characteristics were balanced between the groups. With hydrotherapy, a significant (P < or =.05) improvement in 3 of 6 dimensions of quality of life (mood, physical capacity, enjoyment) and a significant reduction in heart-failure-related symptoms was found. Heart rates at rest and at 50-Watt workload were significantly reduced by hydrotherapy; blood pressure decreased nonsignificantly at rest and during exercise. The hydrotherapeutic treatment was well accepted and no relevant adverse effects were observed. CONCLUSIONS: A home-based hydrotherapeutic thermal treatment program improves quality of life, heart-failure-related symptoms and heart rate response to exercise in patients with mild chronic heart failure. The results of this investigation suggest a beneficial adaptive response to repeated brief cold stimuli in addition to enhanced peripheral perfusion due to thermal hydrotherapy in patients with chronic heart failure.

Aged↗
PubMedDate not supplied

Leech therapy for symptomatic treatment of knee osteoarthritis: results and implications of a pilot study.

CONTEXT: Leech therapy was a mainstay in conventional treatment for pain from antiquity until the mid-19th century. Its use is still widespread in traditional healing procedures in Asia, Africa, and Arabic countries. There is renewed interest in leech therapy in the field of complementary medicine and empirical evidence for specific benefit in knee osteoarthritis. OBJECTIVES: To determine the effect of leech therapy as an adjunctive treatment in painful knee osteoarthritis, to investigate the onset of action, to evaluate patients' acceptance of this treatment, and to investigate the side effects of the procedure. DESIGN: Observational, controlled, nonrandomized pilot-study. SETTING: Subjects were inpatients of an academic teaching hospital of the University of Essen, Department of Internal and Integrative Medicine, Essen, Germany. PATIENTS: 16 inpatients (mean age 69 +/- 9 years) with a confirmed diagnosis of osteoarthritis of the knee joint; 10 patients were treated with leeches and 6 served as controls. INTERVENTION: A single trial of 4 leeches (Hirudo medicinalis) applied topically at painful periarticular sites of the knee joint in the experimental group (n = 10). Both groups received conventional treatment for pain with the exclusion of nonsteroidal anti-inflammatory drugs. MAIN OUTCOME MEASURES: Self-reported general knee pain, assessed by visual analog scale for 10 days daily and in a follow-up after 28 days. Frequency of adverse effects also was recorded. RESULTS: Periarticular application of 4 leeches led to rapid relief of pain with sustained improvement after 4 weeks in the absence of major complications. CONCLUSION: Leech therapy may be an effective treatment for rapid reduction of pain associated with osteoarthritis of the knee. Its efficacy should be tested in larger randomized controlled trials with assessment of expectation bias.

Aged↗