Ayurveda in Knee Osteoarthritis—Secondary Analyses of a Randomized Controlled Trial

Background: Ayurveda is widely practiced in South Asia in the treatment of osteoarthritis (OA). The aim of these secondary data analyses were to identify the most relevant variables for treatment response and group differences between Ayurvedic therapy compared to conventional therapy in knee OA patients. Methods: A total of 151 patients (Ayurveda n = 77, conventional care n = 74) were analyzed according to the intention-to-treat principle in a randomized controlled trial. Different statistical approaches including generalized linear models, a radial basis function (RBF) network, exhausted CHAID, classification and regression trees (CART), and C5.0 with adaptive boosting were applied. Results: The RBF network implicated that the therapy arm and the baseline values of the WOMAC Index subscales might be the most important variables for the significant between-group differences of the WOMAC Index from baseline to 12 weeks in favor of Ayurveda. The intake of nutritional supplements in the Ayurveda group did not seem to be a significant factor in changes in the WOMAC Index. Ayurveda patients with functional limitations > 60 points and pain > 25 points at baseline showed the greatest improvements in the WOMAC Index from baseline to 12 weeks (mean value 107.8 +/- 27.4). A C5.0 model with nine predictors had a predictive accuracy of 89.4% for a change in the WOMAC Index after 12 weeks > 10. With adaptive boosting, the accuracy rose to 98%. Conclusions: These secondary analyses suggested that therapeutic effects cannot be explained by the therapies themselves alone, although they were the most important factors in the applied models

Vergleichende Wirksamkeit von Ayurveda und konventioneller Behandlung bei Kniegelenksarthrose - eine randomisierte, kontrollierte Studie

Osteoarthritis (OA) is of global relevance with up to 250 million people affected by knee OA [Michaud 2006; OARSI 2016; Bitton 2009; Abramson 2009]. Despite progress in conventional care, patients continue to be affected by disability, and there is a need for further treatment approaches [McAlindon 2014; Hochberg 2012; Griffin 1991]. In South Asia, Ayurveda is commonly used as a treatment approach in knee OA. Ayurveda uses individualized treatments with a multi-modal concept utilizing manual and nutritional therapy, herbal therapy, lifestyle counseling and yoga [Tuffs 2002]. No clinical trial evaluated Ayurveda treatment with such an approach for knee OA prior to this study [Lauche 2016]. The goal was to analyze clinical effectiveness of an Ayurvedic method by example of treatments on patients with knee OA. In this case, a comparison was made of the treatment methods Ayurveda and conventional therapy of knee OA. For this purpose, patients diagnosed with knee OA according to ACR (American College of Rheuma-tology) criteria were included in a "multicenter, randomized, control¬led clinical trial". Of 151 enrolled patients, 77 received Ayurveda therapy and the remaining 74 were treated by conventional therapy. Every participant received 15 treatments during a period of 12 weeks. The primary outcome was the change on the Western Ontario and McMaster University Osteoarthritis (WOMAC) Index according to the validated German version after 12 weeks. Parameters for the secondary outcome consisted of WOMAC subscales (pain, stiffness, function); validated questionnaires for pain, pain experience, quality of life and mood; numeric rating scales for pain and sleep quality; rescue medication use and safety issues. [Kessler 2018] In summary, the improvements shown in the WOMAC Index from baseline to 12 weeks were greater 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])”. Moreover, this result was under-lined with a significant between-group “difference (p<0.001) and a clinically relevant effect size (Cohen’s d 0.68 [95 % CI:0.35;1.01])”. After 12 weeks of treatment, com-parable effects in favor of Ayurveda were detected for a number of secondary outcomes. Furthermore, even 3 and 9 months after the last treatments therapy effects persisted. These findings imply that the treatment of knee OA with a complex Ayurvedic therapy might be superior to a complex conventional OA therapy. However, additional studies are required to examine the extent of the effectiveness and to illuminate further the influence of diverse treatment factors and "non-specific effects". [Kessler 2018]Arthrose ist eine Erkrankung von globaler Relevanz. Weltweit leiden über 250 Mio. Menschen an Gonarthrose [Michaud 2006; OARSI 2016; Bitton 2009; Abramson 2009]. Trotz Fortschritten in der konservativen Gonarthroseversorgung gibt es Patienten, die im Anschluss der Therapie weiterhin mit Einschränkungen leben müssen. Daraus resultiert ein Bedarf an wirkungsvollen, zusätzlichen Behandlungsmethoden [McAlindon 2014; Hochberg 2012; Griffin 1991]. In Südasien ist die traditionelle ayurvedische Medizin eine weitverbreitete Behandlungsform bei Gonarthrose. Im Ayurveda kommen individualisierte Behandlungen mit multimodalem Konzept unter Miteinbeziehung von Manual- und Ernährungstherapie, Phytotherapie, Lebensstil-Beratung sowie Yoga-Übungen zum Einsatz [Tuffs 2002]. Jedoch liegen bislang noch keine klinischen Studien zur Behandlung von Gonarthrose mit Ayurveda durch einen solchen Ansatz vor [Hegana 2016]. Ziel dieser Arbeit war es, die klinische Wirksamkeit eines ayurvedischen Therapie-verfahrens am Beispiel der Gonarthrose zu überprüfen. Hierbei wurde ein Vergleich der beiden Behandlungsmethoden Ayurveda und konventionelle Therapie bei Gonarthrose vorgenommen. Hierzu wurden Probanden mit diagnostizierter Gonarthrose gemäß der ACR-Kriterien (American College of Rheumatology) in eine "multizentrische, rando-misierte, kontrollierte klinische Studie eingeschlossen." Von 151 Patienten erhielten 77 ausschließlich eine Ayurveda-Behandlung und 74 eine konventionelle Behandlung. Dabei erhielten die Patienten über einen Behandlungszeitraum von 12 Wochen jeweils 15 Therapiesitzungen. Der Primärzielparameter stellte der Western Ontario und McMaster University Osteoarthritis Index (WOMAC Index) in der validierten deutschen Version dar. Die Änderungen des WOMAC Index wurden über einen Zeitraum von 12 Wochen beobachtet. Zu den sekundären Zielparametern gehörten die WOMAC-Subskalen (Schmerz, Steifigkeit, Funktion); validierte Fragebögen für Schmerz, Schmerzerfahrung, Lebensqualität und Stimmung; numerische Ratingskalen für Schmerz und Schlafqualität sowie Bedarfsmedikationsgebrauch und Sicherheitsaspekte. [Kessler 2018] Zusammenfassend lässt sich feststellen, dass die Änderungen im WOMAC Index zwischen Ausgangswerten und dem Ergebnis nach 12 Wochen in der Ayurveda Gruppe signifikant stärker ausgeprägt waren (Mittelwertdifferenz 61,0 [95 % CI 52,4; 69,6]) als in der konventionellen Gruppe (32,0 [95 % CI 21,4;42,6]). Des Weiteren ließen sich signifikante Unterschiede zwischen den beiden Gruppen (p < 0,001) und der klinisch relevanten Effektgröße (Cohens d 0,68 [95 % CI 0,35; 1,01]) feststellen. Auch für viele sekundäre Zielparameter konnten ähnliche Tendenzen zu Gunsten des Ayurveda beobachtet werden. Darüber hinaus waren Effekte noch 3 und 9 Monaten nach der letzten Behandlung nachweisbar. Die Ergebnisse deuten darauf hin, dass die Behand-lung der Gonarthrose mittels einer komplexen Ayurveda-Therapie im Vergleich zur komplexen konventionellen Therapie womöglich überlegen sein könnte. Jedoch sind zunächst weiterführende Studien erforderlich, um die Wirksamkeit zu belegen und um die Einflüsse der verschiedenen Behandlungskomponenten sowie die Einflüsse der nicht-spezifische Effekte weiter zu klären. [Kessler 2018

Efficacy of therapeutic fasting and plant-based diet in patients with rheumatoid arthritis (NutriFast): study protocol for a randomised controlled clinical trial

Background: Previous studies have shown beneficial effects of therapeutic fasting and plant-based dietary interventions on disease activity in patients with rheumatoid arthritis (RA) for a duration of up to 1 year. To date, the effects of such interventions on the gut microbiome and on modern diagnostic markers in patients with RA have not been studied. This trial aims to investigate the clinical effects of therapeutic fasting and a plant-based diet in patients with RA, additionally considering current immunological diagnostic tools and microbiome analyses. Methods/design: This trial is an open-label, single-centre, randomised, controlled, parallel-group clinical trial. We will randomly assign 84 patients with RA under a stable standard therapy to either (1) therapeutic fasting followed by a plant-based dietary intervention or (2) to a conventional nutritional counselling focusing on an anti-inflammatory dietary pattern according to the recommendations of the Deutsche Gesellschaft für Ernährung (German society for nutrition). Primary outcome parameter is the group difference from baseline to 12 weeks on the Health Assessment Questionnaire (HAQ). Other secondary outcomes include established clinical criteria for disease activity and treatment response in RA (Disease Activity Score 28, Simple Disease Activity Index, ACR-Response Criteria), changes in self-reported health and physical functional ability, mood, stress, quality of life, dietary behaviour via 3-day food records and a modified Food Frequency Questionnaire, body composition, changes in the gut microbiome, metabolomics and cytometric parameters. Outcomes will be assessed at baseline and day 7, after 6 weeks, 12 weeks and after 6 months. Ethics and dissemination: Ethical approval to process and analyse data, and to publish the results was obtained through the institutional review board of Charite-Universitätsmedizin Berlin. Results of this trial will be disseminated through peer-reviewed publications and scientific presentations

Ayurveda in Knee Osteoarthritis—Secondary Analyses of a Randomized Controlled Trial

Background: Ayurveda is widely practiced in South Asia in the treatment of osteoarthritis (OA). The aim of these secondary data analyses were to identify the most relevant variables for treatment response and group differences between Ayurvedic therapy compared to conventional therapy in knee OA patients. Methods: A total of 151 patients (Ayurveda n = 77, conventional care n = 74) were analyzed according to the intention-to-treat principle in a randomized controlled trial. Different statistical approaches including generalized linear models, a radial basis function (RBF) network, exhausted CHAID, classification and regression trees (CART), and C5.0 with adaptive boosting were applied. Results: The RBF network implicated that the therapy arm and the baseline values of the WOMAC Index subscales might be the most important variables for the significant between-group differences of the WOMAC Index from baseline to 12 weeks in favor of Ayurveda. The intake of nutritional supplements in the Ayurveda group did not seem to be a significant factor in changes in the WOMAC Index. Ayurveda patients with functional limitations > 60 points and pain > 25 points at baseline showed the greatest improvements in the WOMAC Index from baseline to 12 weeks (mean value 107.8 ± 27.4). A C5.0 model with nine predictors had a predictive accuracy of 89.4% for a change in the WOMAC Index after 12 weeks > 10. With adaptive boosting, the accuracy rose to 98%. Conclusions: These secondary analyses suggested that therapeutic effects cannot be explained by the therapies themselves alone, although they were the most important factors in the applied models. Keywords: Ayurveda; traditional Indian medicine; knee osteoarthritis; complementary medicine; integrative medicin