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

Abstract

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

The Effect of a Complex Multi-modality Ayurvedic Treatment in a Case of Unknown Female Infertility

“…In summary, the current data for the effectiveness of Ayurvedic interventions is based primarily on rather small and mostly preliminary clinical trials from South Asia [19]. However, Ayurvedic medicine as a WMS has been practiced in South Asia for more than 2000 years, and as such this long history of practice should be considered when evaluating its potential effects, as in this case report.…”

“…WMSs like Ayurveda do not represent a mere collection of single and autonomous treatment items but a complex combination of treatments whose functioning can only be understood if viewed as an integrated whole [42,43]. An important aspect of the holistic and milieu-oriented Ayurvedic strategy is the therapeutic integration of the somatic, psycho-mental, and spiritual realm [19. ]…”

“…Ayurveda is originated in South Asia, has been practiced for thousands of years, and is one of the oldest whole medical systems (WMS) [19,20,21,22] It is recognized by the WHO as a medical science, analogous to traditional Chinese medicine (TCM), and embodies a wealth of empirical healing knowledge. In India and some neighboring countries, Ayurvedic medicine is officially recognized and legally on a par with conventional medicine, serving more than 1.4 billion people [23,24] The importance of Ayurveda in the modern South Asian health care framework is reflected in the following figures: in India alone, there are more than 400,000 registered physicians practicing Ayurveda [25] and more than 250 universities and colleges teaching Ayurvedic medicine systematically within 4- to 6-year university degree programs [26.…”

Additive Complex Ayurvedic Treatment in Patients with Fibromyalgia Syndrome Compared to Conventional Standard Care Alone: A Nonrandomized Controlled Clinical Pilot Study (KAFA Trial)

“…The traditional Indian WMS Ayurveda has been experiencing a resurgence in popularity in its native countries (in particular in India and Sri Lanka) and abroad (in particular in Europe and North America) as it has become more accessible and more in demand [17]. Ayurveda is the most prominent traditional medical (TM) system in South Asia [18].…”

Clinical trials of homoeopathy in osteoarthritis: A systematic review

“…Rheumatologic problems are among the most common disease conditions encountered by CAM practitioners 7,8 . Many patients use CAM therapies including homoeopathy to prevent, control and manage the pain of rheumatologic conditions 9,10 . However, scientific research has so far not provided evidences solid enough to support the effectiveness of CAM as treatment options for rheumatologic conditions including OA and has remained ambiguous 11 .…”