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- Ashwagandha (Withania somnifera, Solanaceae)
- Osteoarthritis
- Knee Pain
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Date:
12-15-2016 | HC# 111661-558
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Re: Clinical Efficacy of Ashwagandha for Knee Joint Pain
Ramakanth
GSH, Uday Kumar C, Kishan PV, Usharani P. A randomized, double blind placebo
controlled study of efficacy and tolerability of Withaina [sic] somnifera extracts in knee joint pain. J Ayurveda Integr Med. July-September
2016;7(3):151-157.
Osteoarthritis
(OA) is a common condition in the aging population. It is characterized by a
decrease in joint cartilage which leads to stiffness, pain, and disability.
Many patients use non-steroidal anti-inflammatory drugs and opioid drugs, but
these can cause adverse side effects. Ashwagandha (Withania somnifera, Solanaceae) is used to treat arthritis in
Ayurvedic medicine, and has been reported to alleviate pain in patients with OA.
Extracts of the root have been shown to have anti-inflammatory and analgesic
properties. This prospective, randomized, double-blind, placebo-controlled
study tested the efficacy of a water extract of ashwagandha roots and leaves (Sensoril®;
Natreon Inc.; New Brunswick, New Jersey) in patients with knee OA.
This
study took place at the Department of Clinical Pharmacology and Therapeutics,
Nizam's Institute of Medical Sciences, Hyderabad, India. Included patients were
between 40 and 70 years old, had experienced knee pain for at least 6 months with
a class I to III designation by the American Rheumatology Association (mild to
moderate physical limitations), and had a baseline pain score of 40 mm using a
visual analog scale (VAS). Patients were instructed to stop any pain medication
7-10 days before the study. The exclusion criteria were as follows: functional
class IV designation (severe physical limitations); using an "alternative
system of medicine"; psychiatric disorders; use of steroids within 12
weeks of the study; use of hyaluronic acid in the prior 9 months; needing joint
replacement; recent knee trauma; uncontrolled high blood pressure or diabetes; problems
with kidney or liver function; and pregnancy or lactation.
Included
patients were randomly assigned to receive either Sensoril, administered in 125-mg
or 250-mg capsules, or placebo capsules, also provided by Natreon Inc. The
Sensoril capsules were standardized to contain ≥ 10% withanolide glycosides, ≥
32% oligosaccharides, and ≤ 0.5% withaferin A. Patients took 2 capsules with
water daily after meals for 12 weeks. Rescue pain medication was acetaminophen
(650-mg tablets), and compliance was gauged by pill count. Screening for
adverse side effects also was conducted.
This
study's primary outcomes were any change in pain or stiffness measured using the
Modified Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
from baseline to endpoint. This system uses numerical assessments similar to a VAS,
where lower scores indicate better physical condition. Secondary outcomes were
any changes in the score after 4 and 8 weeks, changes in the Knee Swelling
Index (KSI, determined by knee circumference), and VAS of pain, disability, and
stiffness, after 4, 8, and 12 weeks of treatment or placebo. Also assessed were
the use of rescue medication and the Physician Global Assessment scale, which gauged
symptom relief.
In
total, 60 patients (43 men and 17 women; average age, 57.78 ± 4.49 years) were randomly
assigned equally into 3 groups. There were no dropouts in this study and no
significant differences among groups at baseline in demographic parameters or
WOMAC, KSI, or VAS scores. After 12 weeks of treatment, the WOMAC score
significantly decreased in both treatment groups, indicating improvement (250
mg ashwagandha, P<0.001; 125 mg ashwagandha, P<0.05). Also, the percent decrease
in WOMAC score from baseline to endpoint was significantly greater in those in
the 250-mg group as compared with both the 125-mg group (P<0.001) and the
placebo group (P<0.001). This also was significantly greater in those taking
125 mg of ashwagandha as compared with the placebo group (P<0.01).
The
KSI score significantly decreased from baseline to endpoint in those taking 250
mg of ashwagandha (P<0.001), as well as in those taking 125 mg (P<0.05).
The percent decrease was also significantly greater in those taking 250 mg as
compared with both 125 mg (P<0.001) and placebo (P<0.001). The VAS scores
for pain, stiffness, and disability were all significantly decreased in those
taking 250 mg (P<0.001 for all) and 125 mg (P<0.05 for all). The changes
in these scores were all significantly greater in those taking 250 mg as
compared with those taking 125 mg (P<0.001) and placebo (P<0.001). The
changes in scores were also significantly greater in those taking 125 mg as
compared with placebo (P<0.01).
Acetaminophen
use was an average of 10 tablets in the 250-mg group, 13 tablets in the 125-mg
group, and 17 tablets in the placebo group. According to the Physician Global
Assessment, 15 patients taking 250 mg thought the treatment was excellent, and
5 thought it was good. In those taking 125 mg, 17 thought it was good, and 3
thought it was fair; in those taking the placebo, 1 patient thought treatment
was fair, and 19 thought it was poor. After 4 weeks of treatment, only those in
the 250-mg group had significant reductions in WOMAC score, KSI, and VAS of pain,
stiffness, and disability (P<0.01 for all). After 8 weeks, this was still
observed in the 250-mg group, and those in 125-mg group had a significant
reduction in VAS of stiffness (P<0.05). It is mentioned that 4 patients
taking 250 mg of ashwagandha had nausea and 1 patient had gastritis; 2 patients
taking 125 mg had nausea and headaches. No adverse side effects were reported
in the placebo group.
This
study suggests the use of ashwagandha in treating mild and moderate knee OA.
The authors note that as withaferin A has been shown to modulate pain, this may
explain the significant reduction of pain in those taking ashwagandha. The
significant decrease in KSI scores also supports that ashwagandha may be
working as an anti-inflammatory agent. While further studies are needed to
understand its therapeutic efficacy, this botanical may be an effective
adjuvant treatment in those with OA.
—Amy C. Keller, PhD
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