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Ayurvedic Treatment with Ashwagandha followed by Processed Gold, Sulfur, and Mercury May Provide Benefits to Patients with Rheumatoid Arthritis in India
Date 05-29-2015
HC# 051561-521
Ashwagandha (Withania somnifera, Solanaceae)
Sidh Makardhwaj
Rheumatoid Arthritis

Kumar G, Srivastava A, Sharma SK, Rao TD, Gupta YK. Efficacy & safety evaluation of Ayurvedic treatment (ashwagandha powder & Sidh Makardhwaj) in rheumatoid arthritis patients: a pilot prospective study. Indian J Med Res. January 2015;141(1):100-106.

Rheumatoid arthritis (RA, an autoimmune disease) is characterized by inflamed joints and leads to loss of joint function, chronic pain, and resultant decreased quality of life. Current treatments target symptoms such as pain and swelling and aim to attenuate the progress of disease; however, many of these therapies cause adverse side effects. Ashwagandha (Withania somnifera, Solanaceae) is a botanical used to treat RA in Ayurvedic medicine, a traditional medicinal system common to India, and has been shown to have anti-inflammatory, antioxidant, and immunomodulatory bioactivity. Sidh Makardhwaj, an Ayurvedic mixture of mercury, sulfur, and gold, is also used in RA treatment. It is mentioned that the safety and efficacy of these treatments in RA have not been established. This prospective, open-label, non-randomized trial investigated the impact of these treatments in patients with RA.

This study took place at the All India Institute of Medical Sciences in New Delhi, India, from October 2009 to December 2010. Ashwagandha (plant parts and source not specified), Sidh Makardhwaj (procured from Maharshi Ayurveda Pharmaceutical Pvt. Ltd.; India), and honey (from Dabur India Ltd.; Ghaziabad, Uttar Pradesh, India) were used. RA was diagnosed according to the standards of the American College of Rheumatology (ACR), and patients between 18 and 60 years of age were enrolled. Those with "unstable" angina, myocardial infarction, heart failure, or stroke in the 3 months prior to the study were excluded. Other exclusion criteria included hypertension with diastolic blood pressure > 100 mm Hg, diabetes, liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > twice the upper limit for healthy subjects, kidney problems, pregnancy or lactation, and consumption of other Ayurvedic preparations within 15 days of beginning the study.

From a total of 125 patients with joint pain screened, 86 were enrolled in the study. Patients took 5 g of ashwagandha powder mixed with water or milk twice daily for 3 weeks. Following this treatment, 100 mg per day of Sidh Makardhwaj mixed with honey was given to patients for another 4 weeks; this included 3545.4 µg mercury and 2.91 mg gold ingested daily. Patients kept their regular routines but were not allowed pain medication unless it was a rescue situation; in this case, the patient was then excluded from the study. An improvement of RA by 20% in 5 areas, including tender joint counts and swollen joint counts, along with other symptoms such as pain, was the primary outcome. Changes in specific ACR criteria, Disease Activity Score in 28 joints (DAS28, a score largely based on joint pain), and other assessments were secondary endpoints. To measure safety, liver enzymes and kidney function were assessed.

In total, 78 patients finished the protocol. Eight patients dropped out of the study due to the perception of failed efficacy; 4 of these patients took other medication, 2 used allopathic therapies during the study, and 2 stopped treatment for unknown reasons. There were 45 female and 33 male patients in the study with average ages of 45.7 ± 8.6 years (females) and 49.8 ± 7.9 years (males). Rheumatoid factor (RF), an autoantibody protein marker of RA, was present in a majority of patients and significantly decreased at the end of the study (P<0.01). The erythrocyte sedimentation rate (a marker of inflammation) was also significantly less for both male and female patients after the study (P<0.01).

In both male and female patients, tender and swollen joint counts, both physician and patient global assessment scores, pain assessment scores, and patient self-assessed disability index scores were significantly reduced at the end of the study as compared to baseline values (P<0.01 for all). Also, an ACR improvement of 20% was reported in 16 (48.5%) male and 28 (62.2%) female patients. The DAS28 of both male and female patients significantly decreased after the study as compared to baseline scores (P<0.01), indicative of RA improvement. The average final DAS28 for both genders was within the range of moderate improvement in 39.7% of patients. There were no significant differences in any of the safety markers at the end of the study; however, mercury concentrations in urine increased from 6.9 ± 1.3 to 32.5 ± 2.4 µg/l in men and from 8.2 ± 1.6 to 41.7 ± 3.1 µg/l in women.

In summary, ashwagandha and Sidh Makardhwaj showed efficacy in treating RA in both men and women. This study does address a primary concern of potential toxicity with mercury use, particularly as urine concentrations measurably increased with Sidh Makardhwaj use. It is mentioned that the daily mercury dose with this treatment (over 3.5 mg/day) is much higher than that recommended by the United States Environmental Protection Agency (0.1 µg/kg body weight/day). Outside of India, this likely renders Sidh Makardhwaj impractical as a therapy, regardless of efficacy. Also, separate measurements addressing both treatments would have been welcome, as it is not possible to determine the effects of each treatment from results following the 2 treatments in sequence. Ashwagandha may be useful in RA therapy and will ideally be adequately characterized and more rigorously studied in the future.

Amy C. Keller, PhD