Ayurvedic medicines: efficacy doubtful with considerable risks

One alternative therapy that I have so far almost entirely neglected is Ayurveda. It is said to be one of the fastest growing system within this sector. Ayurvedic healing includes herbs, nutrition, panchakarma cleansing, acupressure massage, Yoga, Sanskrit, and Jyotish (Vedic astrology). The website of the ‘Choppra Center’ explains: Recognizing that human beings are part of nature, Ayurveda describes three fundamental energies that govern our inner and outer environments: movement, transformation, and structure. Known in Sanskrit as Vata (Wind), Pitta (Fire), and Kapha (Earth), these primary forces are responsible for the characteristics of our mind and body. Each of us has a unique proportion of these three forces that shapes our nature. If Vata is dominant in our system, we tend to be thin, light, enthusiastic, energetic, and changeable. If Pitta predominates in our nature, we tend to be intense, intelligent, and goal-oriented and we have a strong appetite for life. When Kapha prevails, we tend to be easy-going, methodical, and nurturing. Although each of us has all three forces, most people have one or two elements that predominate.

However, the evidence for its effectiveness is not overwhelming. In 2007, we published a systematic review of Ayurvedic treatments for rheumatoid arthritis (RA). Seven studies met our inclusion criteria. Trials tested either Ayurvedic medicine against placebo or other Ayurvedic medicines. Of 3 placebo-controlled RCTs, one high-quality trial did not show benefit of the active treatment against placebo, while another incompletely reported study indicated beneficial effects of an Ayurvedic medicine. A further incompletely reported study showed no significant difference. The remaining 4 trials were difficult to interpret because they tested an Ayurvedic medicine against other Ayurvedic medicines whose effects were not proven. We concluded that there is a paucity of RCTs of Ayurvedic medicines for RA. The existing RCTs fail to show convincingly that such treatments are effective therapeutic options for RA.

Because of this paucity of reliable evidence, any new assessments are welcome.

The aim of this article was to review and meta-analyze the effectiveness and safety of different Ayurvedic interventions in patients with osteoarthritis (OA). 138 electronic databases were searched through August 2013. Randomized controlled trials, randomized crossover studies, cluster-randomized trials, and non-randomized controlled clinical trials were eligible. Adults with pre-diagnosed OA were included as participants.

Interventions were included as Ayurvedic, if they were explicitly labeled as such. The main outcome measures were pain, physical function, and global improvement. Risk of bias was assessed using the Cochrane risk of bias tool.

19 randomized and 14 non-randomized controlled trials on 12 different drugs and 3 non-pharmaceutical interventions with a total of 2,952 patients were included. For the compound preparation, Rumalaya, large and apparently unbiased effects beyond placebo were found for pain (standardized mean difference [SMD] -3.73; 95 % confidence interval [CI] -4.97, -2.50; P < 0.01) and global improvement (risk ratio 12.20; 95 % CI 5.83, 25.54; P < 0.01).

There was also some evidence that effects of the herbal compound preparation Shunti-Guduchi are comparable to those of glucosamine for pain (SMD 0.08; 95 % CI -0.20, 0.36; P = 0.56) and function (SMD 0.15; 95 % CI -0.12, 0.36; P = 0.41).

Based on single trials, positive effects were found for the compound preparations RA-11, Reosto, and Siriraj Wattana. For Boswellia serrata, Lepidium Sativum, a Boswellia serrata containing multicomponent formulation and the compounds Nirgundi Taila, Panchatikta Ghrita Guggulu, and Rhumayog, and for non-pharmacological interventions like Ayurvedic massage, steam therapy, and enema, no evidence for significant effects against potential methodological bias was found.

No severe adverse events were observed in any of the trials.

The authors concluded that the drugs Rumalaya and Shunti-Guduchi seem to be safe and effective drugs for treatment of OA-patients, based on these data. However, several limitations relate to clinical research on Ayurveda. Well-planned, well-conducted and well-published trials are warranted to improve the evidence for Ayurvedic interventions.

I am, of course, pleased that other too have noticed the paucity of good evidence and recommend more and better research into this area. There are, however, several things that worry me about this systematic review:

• How can there be a total absence of adverse effects? Even placebos would generate some.
• The conclusion that Rumalaya and Shunti-Guduchi are safe does not seem justified on the basis of just a few trials.
• My own review found quite encouraging effects for Boswellia serrate.
• 138 electronic databases? I did not even know that so many existed!
• I am also concerned by the way the treatments found to be ‘safe and effective’ are being promoted on the internet:

Rumalaya is a phytopharmaceutical formulation that relieves joint and bone ache associated with various orthopedic ailments. Its natural ingredients possess potent anti-inflammatory properties that alleviate pain. As an immunomodulator, Rumalaya modulates both the humoral and cell-mediated immune response to aches and pain. The medicine has strong anti-arthritic properties that work to combat arthritis.

Indications:

• Rheumatic arthritis
• Rheumatoid arthritis
• Cervical and lumbar spondylosis
• Osteoarthritis
• Arthralgia
• Gout
• Frozen shoulder
• Traumatic inflammatory conditions like fibrositis, bursitis, synovitis, capsulitis, tenosynovitis, myositis and sciatica.

I fail to see good evidence to support most of these claims.

Lastly, I find that the authors fail to warn the public in sufficiently strong terms of some of the drawbacks of Ayurvedic medicines. Many of them seem not to be safe. One of several problems is that they have been shown to be often contaminated/adulterated with toxic substances such as heavy metals.

My conclusion about the value of Ayurvedic medicines is therefore not so optimistic: EFFICACY IS USUALLY MORE THAN DOUBTFUL, WHILE RISKS ARE WELL-DOCUMENTED.