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| Date: 05-29-2015 | HC# 051561-521 |
Re: Ayurvedic Treatment with Ashwagandha followed by Processed Gold,
Sulfur, and Mercury May Provide Benefits to Patients with Rheumatoid
Arthritis in India
Wednesday, 3 June 2015
Re: Ayurvedic Treatment with Ashwagandha followed by Processed Gold, Sulfur, and Mercury May Provide Benefits to Patients with Rheumatoid Arthritis in India
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
