Christian Kessler

SAT0488 Comparative effectiveness of ayurveda and conventional care in knee osteoarthritis – a randomized controlled trial

Background Traditional Indian Medicine Ayurveda is used to treat knee osteoarthritis (OA) despite limited evidence. Objectives We aimed to evaluate the effectiveness of complex Ayurvedic treatment compared to complex conventional care in knee OA patients. Methods According to ACR criteria patients with knee OA were included in a multicenter randomized, controlled trial and treated in 2 hospital outpatient clinics and 2 private outpatient clinics in Germany with 5 physicians and 20 therapists participating. Patients received either Ayurvedic treatment (n=77) or conventional care (n=74) with 15 treatments over 12 weeks. Primary outcome was the change on the Western Ontario and McMaster University Osteoarthritis (WOMAC) Index after 12 weeks (validated German version). Secondary outcomes included the WOMAC subscales; a pain disability index, numeric rating scales for pain and sleep quality, a pain experience scale, a quality-of-life index, a profile of mood index, rescue medication use, and safety issues. Results A total of 151 patients (Ayurveda n=77, conventional care n=74) were included. Changes of the WOMAC Index from baseline to 12 weeks were more pronounced in the Ayurveda group (mean difference 61.0 [95% CI 52.4;69.6]) than in the conventional group (32.0 [95% CI 21.4;42.6]) resulting in a significant difference between groups (p<0.001) and a clinically relevant effect size (Cohens d 0.68 [95% CI 0.35;1.01]). Similar tendencies were observed for all secondary outcomes at week 12. Effects were sustainable at follow-ups after 6 and 12 months. Conclusions The results suggest that a complex Ayurvedic treatment might be clinically superior to a complex conventional intervention in the treatment of OA of the knee. Disclosure of Interest None declared

Yoga for Chronic Neck Pain: A Pilot Randomized Controlled Clinical Trial

UNLABELLED Yoga has been found effective in the treatment of chronic low back pain. We aimed to evaluate the effectiveness of Iyengar yoga in chronic neck pain by means of a randomized clinical trial. Seventy-seven patients (aged 47.9 ± 7.9, 67 female) with chronic neck pain who scored >40 mm on a 100-mm visual analog scale (VAS) were randomized to a 9-week Iyengar yoga program with weekly 90-minute classes (n = 38) or to a self-care/exercise program (n = 38). Patients were examined at baseline and after 4 and 10 weeks. The primary outcome measure was change of mean pain at rest (VAS) from baseline to week 10. Secondary outcomes included pain at motion, functional disability, quality of life (QOL), and psychological outcomes. Twelve patients in the yoga group and 11 patients in the self-care/exercise group were lost to follow-up, with higher study nonadherence in the self-care group (5 versus 10 patients). Mean pain at rest was reduced from 44.3 ± 20.1 to 13.0 ± 11.6 at week 10 by yoga and from 41.9 ± 21.9 to 34.4 ± 21.1 by self-care/exercise (group difference: -20.1, 95% confidence interval: -30.0, -10.1; P < .001). Pain at motion was reduced from 53.4 ± 18.5 to 22.4 ± 18.7 at week 10 by yoga and from 49.4 ± 22.8 to 39.9 ± 21.5 by self-care/exercise (group difference: -18.7, 95% confidence interval: -29.3, -8.1; P < .001). Significant treatment effects of yoga were also found for pain-related apprehension, disability, QOL, and psychological outcomes. Sensitivity analyses suggested minimal influence of dropout rates. Both programs were well tolerated. In this preliminary trial, yoga appears to be an effective treatment in chronic neck pain with possible additional effects on psychological well-being and QOL. The effectiveness of yoga in chronic neck pain should be further tested by comparative effectiveness studies with longer observation periods. PERSPECTIVE This article presents the results of a randomized controlled trial on the clinical effects of a 9-week yoga program or self-care exercise in patients with chronic neck pain. Yoga led to superior pain relief and functional improvements and might be a useful treatment option for chronic neck pain.

Iyengar Yoga for Distressed Women: A 3-Armed Randomized Controlled Trial

Distress is an increasing public health problem. We aimed to investigate the effects of an Iyengar yoga program on perceived stress and psychological outcomes in distressed women and evaluated a potential dose-effect relationship. Seventy-two female distressed subjects were included into a 3-armed randomized controlled trial and allocated to yoga group 1 (n = 24) with twelve 90 min sessions over 3 months, yoga group 2 (n = 24) with 24 sessions over 3 months, or a waiting list control group (n = 24). The primary outcome was stress perception, measured by Cohen Stress Scale; secondary outcomes included state trait anxiety, depression, psychological and physical quality of life (QOL), profile of Mood States, well being, and bodily complaints. After three months, women in the yoga groups showed significant improvements in perceived stress (P = 0.003), state trait anxiety (P = 0.021 and P = 0.003), depression (P = 0.008), psychological QOL (P = 0.012), mood states being (P = 0.007), and bodily complaints well(P = 0.012) when compared to controls. Both yoga programs were similarly effective for these outcomes; however, compliance was better in the group with fewer sessions (yoga group 1). Dose effects were seen only in the analysis of group-independent effects for back pain, anxiety, and depression. These findings suggest that Iyengar yoga effectively reduces distress and improves related psychological and physical outcomes. Furthermore, attending twice-weekly yoga classes was not superior to once-weekly classes, as a result of limited compliance in the twice-weekly group.

Comparative effectiveness of a complex Ayurvedic treatment and conventional standard care in osteoarthritis of the knee – study protocol for a randomized controlled trial

BackgroundTraditional 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 designIn 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.DiscussionThis 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 registrationNCT01225133

Effects of different dietary approaches on inflammatory markers in patients with metabolic syndrome: A systematic review and meta-analysis

OBJECTIVE Chronic low-grade inflammation has been associated with insulin resistance, diabetes, atherosclerosis, obesity, and metabolic syndrome (MetS). A proinflammatory environment contributes to several metabolic disturbances and possibly the development of MetS. Dietary approaches have defined impact on immune function and putative antiinflammatory effects. The aim of this study was to assess the effects of different dietary approaches on markers of inflammation in patients with MetS. Further effects on weight loss and fasting insulin were analyzed. METHODS Medline/PubMed, Scopus, and the Cochrane Library were screened in September 2014 for randomized controlled trials (RCTs) on different dietary approaches for participants with MetS as defined by National Cholesterol Education Program Adult Treatment Panel III. Primary outcomes were markers of the immune system. Secondary outcome was body weight and fasting insulin. Standardized mean differences (SMD) and 95% confidence intervals (95% CIs) were calculated. RESULTS Thirteen randomized controlled trials with a total of 2017 patients were included. Low-fat diets (29 ± 2% energy from fats) decreased C-reactive protein compared with control diets (SMD: -0.98; 95% CI: -1.6 to -0.35; P = 0.002). Low-carbohydrate diets (23 ± 10% energy from carbohydrates; SMD: -0.33; 95% CI: -0.63 to -0.03; P = 0.004) and multimodal interventions (SMD: -1.02; 95% CI: -1.97 to -0.07; P = 0.04) were able to induce significant weight loss. Low-carbohydrate diets were able to decrease insulin (SMD: -0.33; 95% CI: -0.63 to -0.03; P = 0.03). CONCLUSIONS C-reactive protein; however, this effect is also dependent on weight loss. Furthermore, low-carbohydrate diets have beneficial effects on insulin and body weight. Dietary approaches should mainly be tried to reduce macronutrients and enrich functional food components such as vitamins, flavonoids, and unsaturated fatty acids. People with MetS will benefit most by combining weight loss and anti-inflammatory nutrients.

In-Patient Treatment of Fibromyalgia: A Controlled Nonrandomized Comparison of Conventional Medicine versus Integrative Medicine including Fasting Therapy

Fibromyalgia poses a challenge for therapy. Recent guidelines suggest that fibromyalgia should be treated within a multidisciplinary therapy approach. No data are available that evaluated multimodal treatment strategies of Integrative Medicine (IM). We conducted a controlled, nonrandomized pilot study that compared two inpatient treatment strategies, an IM approach that included fasting therapy and a conventional rheumatology (CM) approach. IM used fasting cure and Mind-Body-Medicine as specific methods. Of 48 included consecutive patients, 28 were treated with IM, 20 with CM. Primary outcome was change in the Fibromyalgia Impact Questionnaire (FIQ) score after the 2-week hospital stay. Secondary outcomes included scores of pain, depression, anxiety, and well being. Assessments were repeated after 12 weeks. At 2 weeks, there were significant improvements in the FIQ (P < 0.014) and for most of secondary outcomes for the IM group compared to the CM group. The beneficial effects for the IM approach were reduced after 12 weeks and no longer statistically significant with the exception of anxiety. Findings indicate that a multimodal IM treatment with fasting therapy might be superior to CM in the short term and not inferior in the mid term. Longer-term studies are warranted to assess the clinical impact of integrative multimodal treatment in fibromyalgia.

Ayurveda: between religion, spirituality, and medicine.

Ayurveda is playing a growing part in Europe. Questions regarding the role of religion and spirituality within Ayurveda are discussed widely. Yet, there is little data on the influence of religious and spiritual aspects on its European diffusion. Methods. A survey was conducted with a new questionnaire. It was analysed by calculating frequency variables and testing differences in distributions with the χ 2-Test. Principal Component Analyses with Varimax Rotation were performed. Results. 140 questionnaires were analysed. Researchers found that individual religious and spiritual backgrounds influence attitudes and expectations towards Ayurveda. Statistical relationships were found between religious/spiritual backgrounds and decisions to offer/access Ayurveda. Accessing Ayurveda did not exclude the simultaneous use of modern medicine and CAM. From the majoritys perspective Ayurveda is simultaneously a science, medicine, and a spiritual approach. Conclusion. Ayurveda seems to be able to satisfy the individual needs of therapists and patients, despite worldview differences. Ayurvedic concepts are based on anthropologic assumptions including different levels of existence in healing approaches. Thereby, Ayurveda can be seen in accordance with the prerequisites for a Whole Medical System. As a result of this, intimate and individual therapist-patient relationships can emerge. Larger surveys involving bigger participant numbers with fully validated questionnaires are warranted to support these results.

Personality Profiles, Values and Empathy: Differences between Lacto-Ovo-Vegetarians and Vegans

Background: Vegetarian nutrition is gaining increasing public attention worldwide. While some studies have examined differences in motivations and personality traits between vegetarians and omnivores, only few studies have considered differences in motivations and personality traits between the 2 largest vegetarian subgroups: lacto-ovo-vegetarians and vegans. Objectives: To examine differences between lacto-ovo-vegetarians and vegans in the distribution patterns of motives, values, empathy, and personality profiles. Methods: An anonymous online survey was performed in January 2014. Group differences between vegetarians and vegans in their initial motives for the choice of nutritional approaches, health-related quality of life (World Health Organization Quality of Life-BREF (WHOQOL-BREF)), personality traits (Big Five Inventory-SOEP (BFI-S)), values (Portraits Value Questionnaire (PVQ)), and empathy (Empathizing Scale) were analyzed by univariate analyses of covariance; P values were adjusted for multiple testing. Results: 10,184 individuals completed the survey; 4,427 (43.5%) were vegetarians and 4,822 (47.3%) were vegans. Regarding the initial motives for the choice of nutritional approaches, vegans rated food taste, love of animals, and global/humanitarian reasons as more important, and the influence of their social environment as less important than did vegetarians. Compared to vegetarians, vegans had higher values on physical, psychological, and social quality of life on the WHOQOL-BREF, and scored lower on neuroticism and higher on openness on the BFI-S. In the PVQ, vegans scored lower than vegetarians on power/might, achievement, safety, conformity, and tradition and higher on self-determination and universalism. Vegans had higher empathy than vegetarians (all p < 0.001). Discussion: This survey suggests that vegans have more open and compatible personality traits, are more universalistic, empathic, and ethically oriented, and have a slightly higher quality of life when compared to vegetarians. Given the small absolute size of these differences, further research is needed to evaluate whether these group differences are relevant in everyday life and can be confirmed in other populations.

The Role of Whole Medical Systems in Global Medicine

‘The whole is more than the sum of its parts’ [1]. This quote by Aristotle, one of the most influential instigators in occidental philosophy, science and taxonomy, is timeless. Yet at the same time this very idea also points towards an unheralded treasure in the development of a globalized 21st century medicine: the active rediscovery of an enormous hibernating potential for meta-integration of medical knowledge worldwide. Essentially it has always been there, dormant to a greater or lesser extent, especially when we look at prominent evergreens of present-day healthcare debates like disease prevention and health promotion. In this context it is not at all surprising that the WHO’s still non-amended definition of health from 1948 [2] was already more or less articulated about 1,700 years ago in the Ayurvedic classical text Sushruta Samhita [3]. There, health is comprehensively defined as a complex physiological balance added to psycho-sensual happiness and contentment of the soul. For the purpose of realization and implementation of this Aristotelian completeness axiom, and similar concepts from most other cultures around the globe, in medicine, we are now being invited to move on beyond the traditional realms of discussion, particularly in the context of Complementary and Integrative Medicine. Issues about demarcation from modern evidence-based medicine and/or a rigorous orientation to holism in charged atmospheres might innervate our egos. However, it will only delay processes of integrating global healthcare. Therefore, the step ahead for genuine Integrative Medicine seems to be neither towards a reductionistic analytical view on single components nor towards a pure synthetic holistic view being reductionistic on the other side of the river. The solution lies in ‘synthesis additionally to analysis.’[4] This is where systems thinking [5] and whole medical systems thinking [6] come into play and might lead us to a way of bridging and transcending reductionism in medicine in all areas. Whole medical systems are eo ipso complete and coherent systems of medical theory and practice that have evolved, and continue evolving, in different regions, cultures and time periods around the globe, independently from modern western medicine, e.g. Traditional European, Indian, Chinese, Tibetan, Arabian systems of medicine, Kampo, Anthroposophy, Homeopathy, etc. It is interesting to reflect on the fact that, alongside the continuing renaissance of our own flourishing European heritage in this field [7], some whole medical systems of Asian origin are not only thriving as officially acknowledged healthcare systems, but have a continuous mainstream medical tradition since more than 2,000 years on a continent currently bearing more than 60% of the world’s population. Here, the most well-known traditional Indian system of medicine, Ayurveda, can spearhead as pars pro toto for all others for a particular reason: on top of its inbound coherence it possesses an inherent outbound quality of openness to its surrounding realities. In South Asia, Ayurveda is recognized by the state and is viewed on equal terms with conventional medicine. Within India, Sri Lanka and Nepal, it is applied in a living environment of approximately 1.4 billion people alongside other systems of care. Ayurvedic medicine is in much the same way as Traditional Chinese Medicine fully recognized as a medical science by the WHO. According to the Association of Ayurvedic Physicians of India, there are currently approximately 450,000 Ayurvedic physicians and more than 250 universityaffiliated colleges and Ayurveda universities in India alone [8]. In addition to its key role in a number of Asian healthcare systems, it is playing a growing role in international Integrative Medicine contexts, especially in Europe and North America. Ayurvedic medicine is characterized by a complex and multidimensional approach focusing on the delivery of treatments individualized to the person and disease [9] including: modification of lifestyle, dietary treatments, relaxation and meditation techniques, physical therapies, yoga, herbal medicine, as well as a broad range of highly specialized manual techniques and cleansing procedures. Furthermore, Ayurveda’s and most other whole medical systems’ therapeutic concepts are focusing on the fundamental

Effectiveness of focused meditation for patients with chronic low back pain—A randomized controlled clinical trial ☆

OBJECTIVES We aimed to evaluate the effectiveness of an 8-week meditation program (focused meditation) in patients with chronic low-back pain. DESIGN A randomized clinical trial was conducted on 68 patients (55 years;75% female) with chronic low-back pain who scored >40mm on a 100mm Visual-Analogue-Scale. Subjects were allocated to an 8-week meditation program (focused meditation) with weekly 75min classes or to a self-care exercise program with a wait-list offer for meditation. Both groups were instructed to practice at home. Outcomes were assessed baseline and after 4 and 8 weeks. The primary outcome measure was the change in mean back pain at rest after 8 weeks. Secondary outcomes included function, pain-related bothersomeness, perceived stress, quality-of-life (QOL), and psychological outcomes. RESULTS Twelve (meditation) and 4 (exercise) patients were lost to follow-up. The primary outcome, pain at rest after 8 weeks, was reduced from 59.3±13.9mm to 40.8±21.8mm with meditation vs. 52.9±11.8mm to 37.3±18.2mm with exercise (adjusted group difference: -1.4 (95%CI:11.6;8.8;p=n.s.) Perceived stress was significantly more reduced with meditation (p=0.011). No significant treatment effects were found for other secondary outcomes as pain-related bothersomeness, function, quality-of-life and psychological scores, although the meditation group consistently showed non-significant better improvements compared to the exercise group. CONCLUSIONS Focused meditation and self-care exercise lead to comparable, symptomatic improvements in patients with chronic low back pain. Future studies should include longer-term follow-ups and develop guided meditation programs to support compliance.