Authors:
Prof. Andreas Michalsen, PD Dr. Oliver Sander (University Hospital Düsseldorf), Dr. Inna Frohne (University Hospital Düsseldorf), Dr. Mandy Gläß (Vogelsang-Gommern Rheumatology Clinic), Adjunct Prof. Gernot Keyßer (University Hospital Halle - Saale), Assistant Professor Alexander Pfeil (University Hospital Jena), Prof. Monika Reuß-Borst (Rheumatology Practice, Bad Bocklet), Dr. Olaf Schultz (Baden-Baden Rheumatology Clinic), Prof. Olga Seifert (Commission for Complementary Therapies and Nutrition)
The origins of Ayurveda are traced to the period between 1500 and 800 B.C. The central concepts of traditional Indian medicine are based on its own internal paradigms, with numerous connections to the natural philosophical and epistemological systems of South Asia. Vegetative/physical and mental functions are interconnected, similar to the Western concept of psychosomatics.
Body and mind are the two complementary components of life; individual homeostasis is responsible for health, and its imbalance for the onset of disease. Ayurveda seeks to maintain a balance between these forces and is therefore primarily designed as a form of health care and prevention in addition to disease treatment [1].
Since 2015, India has had its own federal Ministry of Traditional Medicine Systems (AYUSH), as well as numerous academic institutions and dedicated degree programs in Ayurveda, offering the Bachelor of Ayurveda Medicine and Surgery (B.A.M.S.), Doctor of Medicine in Ayurveda (M.D. (Ayu)), and Bachelor’s and Master’s of Pharmacy in Ayurveda (B.Pharm (Ayu)). According to AYUSH, there are currently over 400,000 licensed Ayurvedic physicians in India.
In Ayurveda, diagnosis and treatment are preceded by a comprehensive clinical examination and a highly individualized medical history. The patient is examined not only as a sick person but also as an individual with the attributes listed below, including their constitution, lifestyle, and specific life circumstances, as well as possible external influencing factors.
The following are assessed individually: psychosomatic constitution; susceptibility to disease; tissue quality; physique; anthropometry; adaptability; mental health; nutrition and digestion; endurance/fitness level; age. The examination of the patient includes, among other things: pulse, tongue, voice and speech, skin; eyes, overall appearance, as well as inspection of urine and stool.
As a fundamental conceptual model, Ayurveda uses the concept of the three property-based functional principles: Vata (kinetic-catabolic principle), Pitta (metabolic-thermal principle), and Kapha (anabolic principle), whose dynamic interaction within the organism defines biological life. This concept also serves to describe health disorders. The therapeutic goal is to restore, or come as close as possible to, the individual homeostasis of Vata, Pitta, and Kapha.
The therapies are primarily used in primary health care and comprise several components:
Examples include:
Rasayana (tonic and fortifying therapy) serves to maintain and promote health. Rasayana therapies are intended to promote longevity and delay the aging process, as well as to enhance immunity and resilience.
Another treatment modality is Panchakarma (inpatient cleansing therapy). It is intended to remove toxins, waste products, and deposits from the body, as well as to prevent disease and promote health. Panchakarma procedures are used in Ayurveda to address numerous chronic internal and neurological conditions.
In February 2022, the WHO published new benchmarks for education and practice in the field of Ayurveda, in which phytotherapy plays an important role1 . For the treatment of “arthritis,” combination preparations based on, for example, myrrh (Commiphora mukul) and frankincense (Boswellia serrata), or individual plants such as ashwagandha (Withania somnifera), turmeric (Curcuma longa), and ginger (Zingiber officinale) are frequently used as part of multimodal treatment approaches [2–4].
1 WHO. WHO benchmarks for the practice of Ayurveda. 2022 Feb. 28, 2022]; Available from: https://www.who.int/publications/i/item/9789240042674
The scientific evidence supporting the efficacy of Ayurveda is weak. There are no long-term, controlled scientific data on the preventive effects of Ayurveda. The complex, individualized, and multimodal treatment is difficult to replicate in (placebo-controlled) prospective studies. To date, its effects have been substantiated primarily by documented individual cases of successful treatment and a continuous medical tradition in South Asia spanning over 2,000 years. For individual substances such as turmeric or frankincense, there is evidence from experimental studies regarding the inhibition of lipoxygenase [5–8]. There is also a growing body of clinical evidence for turmeric (review in [9]).
Osteoarthritis
In a recent meta-analysis on the use of frankincense preparations for osteoarthritis, only seven out of 513 eligible publications could be included, involving 545 patients. A significant improvement in WOMAC pain, stiffness, and function compared to placebo was reported. The time to improvement was at least four weeks [10].
For turmeric as a single extract, evidence is available from a high-quality randomized trial involving 70 patients with symptomatic knee osteoarthritis, demonstrating a beneficial effect on knee pain and joint function [11].
Another methodologically sound study conducts a randomized, controlled comparison of a multimodal Ayurvedic treatment approach with a conventional approach based on standard care, using the symptomatic treatment of knee osteoarthritis as an example. This study demonstrated significant superiority for the patient-centered endpoint WOMAC during treatment, as well as a benefit of Ayurveda that persisted for up to one year [12].
The current S2k guideline on knee osteoarthritis mentions phytotherapeutics used in Ayurvedic medicine1 . These include frankincense preparations, which are not recommended. Based on the available evidence, no conclusion can be drawn regarding ginger and turmeric extracts.
However, this recommendation does not yet reflect the complexity of the multimodal Ayurvedic treatments used in the aforementioned study [12]. For the evaluation of turmeric, the study by Henrotin et al. [11]was not yet available.
Rheumatoid Arthritis (RA)
The AWMF guideline on the management of early rheumatoid arthritis [13], published in 2020, cannot make a recommendation regarding the use of specific complementary therapies (… “Indian medicine” …) due to a lack of evidence. It finds insufficient evidence from controlled studies on various formulations of verifiable, higher quality from the field of Ayurveda.
Only one systematic review on Ayurvedic treatment for RA, which is already 18 years old, is cited in this regard. This review finds insufficient evidence to demonstrate a benefit [14].
The individualized and constitution-based management of RA in Ayurveda has so far been investigated in only one double-blind randomized trial. In this randomized pilot study, three arms compared MTX plus an Ayurvedic placebo (n = 14), Ayurveda plus an MTX placebo (n = 12), and Ayurveda plus MTX (n = 17). The main finding was that the three interventions were largely equivalent in terms of DAS28 and ACR response at 24 and 36 months; a significant difference was documented only for MTX at 24 weeks with regard to the ACR 70 response. Ayurveda therapy was generally better tolerated. However, limitations include the very small cohorts, which are insufficient to demonstrate equivalence, and the high proportion of randomized but not evaluated patients (n = 18). Treatment in the Ayurveda arm was tailored individually; thus, this arm does not reflect the pharmacological effect of a standardized substance but rather the effect of multi-component mixtures as well as the therapists’ individual assessment of the patient’s condition. This design does not allow for conclusions regarding the general effects of individual substances [15]. A similar, larger, and longer-term study with a confirmatory design is currently being conducted by the same research group; results are expected in 2023.
RA-1, an Ayurveda-inspired blend of four substances—ashwagandha (Ashwagandha) (Withania somnifera), frankincense (Boswellia serrata), ginger (Zingiber officinale), and turmeric e (Curcuma longa)—failed to demonstrate a significant effect in a 16-week double-blind, randomized study [16].
In the subsequent long-term study of RA-1 involving 182 enrolled patients, 122 patients were followed for three years. Approximately half of the patients took RA-1 without additional DMARDs. The outcome was comparable to that of patients taking DMARDs; however, the latter group showed higher initial disease activity when given free choice of therapy. Patients on DMARDs experienced more side effects [17].
In a 90-day, three-arm study, turmeric (CuroWhite) was administered in doses of 250 and 500 mg or as a placebo to patients with RA. The authors describe significant and marked improvements in DAS28 (by 50–64%), ESR (by 88–89%), CRP (by 31–45%), and rheumatoid factor (by 80–84%). Only eight patients were included in each arm, and only half of them were female. The study is implausible in terms of statistics, methodology, and results, and contains serious methodological flaws [18].
In Germany, two randomized, double-blind, placebo-controlled trials were conducted with the frankincense preparation H15 in outpatients with long-standing RA, and a significantly superior effect of the test substance compared to placebo was published as an abstract without study details or calculation methods [19]. A recalculation of the raw data failed to demonstrate a benefit of frankincense over placebo in add-on therapy for RA [20].
1 AWMF Guidelines of the German Society for Orthopedics and Orthopedic Surgery (DGOOC) www.awmf.org/uploads/tx_szleitlinien/033-004l_S2k_Gonarthrose_2018-01_1-verlaengert_01.pdf
Based on the above discussion, the data for therapy with individual Ayurvedic phytotherapeutic substances in rheumatoid arthritis do not show a sufficient effect on the established surrogate markers for disease control. For individualized therapy with multi-component mixtures and multimodal treatments, the results of ongoing studies must be awaited.
For the treatment of osteoarthritis, there is preliminary positive evidence supporting Ayurvedic multimodal therapy as well as the use of turmeric or curcumin extracts as single substances. The insufficient data on other rheumatic diseases does not allow for an assessment.
Phytotherapies can have various side effects and interactions. Potential risks could include toxins and heavy metals in herbal extracts of unknown origin, especially when untested preparations are obtained from unreliable sources. There is a fundamental risk that the necessary DMARD therapy may be delayed due to the use of Ayurvedic medicine.
The current body of evidence is insufficient to revise the recommendation in the guideline on the management of rheumatoid arthritis regarding Ayurveda, which does not recommend this method for RA.
The practice of Ayurveda beyond the use of individual substances requires specialized training, which in Germany is certified by the German Medical Society for Ayurvedic Medicine (DÄGAM)1 . If this qualification is met, Ayurvedic medicine may be used as part of a comprehensive treatment regimen for degenerative joint diseases.
Further studies and research designs to evaluate the additional benefits of the complementary use of Ayurveda are encouraged.
1https://daegam.de/.cm4all/iproc.php/Qualit%C3%A4tskriterien%20f%C3%BCr%20das%20D%C3%84GAM-Zertifikat.pdf?cdp=a&cm_odfile
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Last updated: April 18, 2023