Withania - Australia's most popular herb

Ashwagandha (Withania somnifera) is used in Ayurvedic medicine to promote youthful vigour, enhance muscle strength and endurance, and improve overall health.

Introduced to Australian practitioners of Western Herbal Medicine in the mid-90s, withania rapidly became a much-loved herb and is now one of the top selling herb in Australia and even in the UK.

Ashwagandha's popularity is no doubt related to its use as a relaxing or non-stimulating adaptogen and tonic and because it is considered safe for use in children.

A recent 16-week, randomized, double-blind, placebo-controlled, crossover study (n=50) found that a withania extract known as Shoden beads for 8 weeks was associated with an 18% greater increase in DHEA-S (p = 0.005) and 14.7% greater increase in testosterone ( p = 0.010) compared to the placebo in overweight men (40-70 years) with symptoms of mild fatigue. The study found no significant improvement in cortisol, oestradiol, fatigue, vigor, or sexual well-being.[1]

Shoden beads is manufactured by Arjuna Natural in Kerala, India from the roots and leaves of withania.

Shoden beads contain an extract standardised to eight withanolide glycosides with a reported high level of withanoside X (number 10). The total withanolide concentration 35% with each bead containing extract equivalent 10.5 mg withanolides. The dose was two tablets twice daily thus providing a total of 21 mg withanolides daily.

MediHerb's Withania 2:1 root extract is standardised to contain not-less-than 4.0 mg/mL of withanolides, so to reach an equivalent dose based on total withanolides. 4.0 mg/mL is a concentration of withanolides of 4% compared to the 35% extract used in the clinical trial. You could certainly argue that 35% is quite a concentrated extract, 2/3 are withanolide, the last 1/3 everything else. You would need to dose at 5.25 ml daily or 37 ml per week to provide the same level of withanolide. This is a very achievable dose.

In another study by the same group, 240 mg daily of the Shoden extract was shown to reduce symptoms of anxiety as measured by the Hamilton Anxiety Rating Scale (HAM-A) in a 60 day RCT of adults with self-reported high stress levels.[2] Now that would be equivalent to 84 mg withanolides daily, a much greater dose than the previous study (four-fold higher). Interestingly, they also measured the response with another scale, the Stress Scale -21 (DASS-21), but the improvement was not statistically significant.

There are 28 clinical trials with withania published on PubMed examining various conditions including osteoarrhitis, hyperglycaemia, dislipidaemia, sleep, anxiety, stress, degenerative disease, semen quality, infertility, immune modulation, ADHD in children, schizophrenia, cognitive dysfunction in bipolar disorder, memory and cognition, OCD, maintenance of body weight during stress, hypothyroidism, strength training, depression in schizophrenia. These are single, generally small studies and while some may have suffered bias and poor methodology, several used standardised extracts and seems of good quality. Together, the studies provide an indication for how you may use withania in clinical practice.

A few of the studies used a standardised extract. Two, as mentioned, used the Shoden extract. Another study used the Sensoril extract. Sensoril is an aqueous extract standardised to contain 8% withanolides comprising of 2% withaferin A; and 32% oligosaccharides. The dose was 250 mg extract daily, which is equivalent to 20 mg withanolides. The study examined the effects of cognitive function in people with bipolar disorder.[3] A second study based on Sensoril examined the effects on stress in people with schizophrenia.{Chengappa, 2018 #144}. A third study examined adaptation and recovery associated with strength training.{Ziegenfuss, 2018 #136}

Another study used 300 mg of a standardized (containing 5% withanolides) Ashwagandha root extract KSM-66 Ashwagandha from Indian company, Ixoreal Biomed. This is of course equivalent to 15 mg total withanolides. This RCT examined the anxiolytic effects of withania.[4] KSM-66 is based on the root only (as it should be). Some of the other extracts are based on root and leaves. The primary use of leaves traditionally was for topical treatments on the skin for conditions like burns or carbuncles, not internal consumption.

KSM-66 was recently found to normalise thyroid hormone levels in an RCT of people with subclinical hypothyroidism.{Sharma, 2018 #163} The authors suggest caution in the use of withania in hyperthyroidism. This is speculative although there has been one published case report with a possibility of thyrotoxicosis induced by withania.{van der Hooft, 2005 #164} The case report is in Dutch and I have not read it, but I know from the examination of many other such case reports that a causal connection is rarely shown.

A second case report of potential thyrotoxicosis was recently published: A 62-year-old female, in otherwise good health, was diagnosed with thyrotoxicosis after self-medication with Withania somnifera (Ashwagandha). She began supplementing with Ashwagandha root extract for stress and anxiety relief. After about two months of consistent daily dosing at 1950 mg, she experienced worsened anxiety, hysteric behaviors, extreme physical fatigue, unintentional weight loss, lack of concentration, poor memory, and increased resting heart rate. A physical examination determined her thyroid was uniformly enlarged, with tenderness to palpation and odynophagia. Laboratory results revealed low thyroid-stimulating hormone and elevated thyroxine, confirming hyperthyroidism, and borderline anaemia evidenced by low haematocrit and red blood cell distribution width. After discontinuation of Ashwagandha, the patient's symptoms resolved, weight normalized, and subsequent laboratory values displayed normal thyroid functioning.{Curry, 2019 #170}

Summary

• Two studies used the Shoden extract which is highly concentrated at 34% withanolides. The other studies were based on extracts containing 5% withanolides (KSM-66, Ixoreal Biomed) or 8% withanolides (Sensoril).
• KSM-66 is used in Adrenoplex and Astragard from Bioceuticals.
• Sensoril is used in Nature's Own EQ Control.
• Neither of these two case reports provide evidence of a causal relationship between withania and the development of thyrotoxicosis. That withania was shown to normalise thyroid hormone levels in patients with subclinical hypothyroidism in the clinical trial does not mean that withania can cause thyrotoxicosis or that it is necessarily contraindicated in hypertheroidism. Nevertheless, we should use withania with caution in patients with Graves' disease.

References

1.Lopresti, A.L., P.D. Drummond, and S.J. Smith, A Randomized, Double-Blind, Placebo-Controlled, Crossover Study Examining the Hormonal and Vitality Effects of Ashwagandha ( Withania somnifera) in Aging, Overweight Males. Am J Mens Health, 2019. 13(2): p. 1557988319835985.

2.Lopresti, A.L., et al., An investigation into the stress-relieving and pharmacological actions of an ashwagandha (Withania somnifera) extract: A randomized, double-blind, placebo-controlled study. Medicine (Baltimore), 2019. 98(37): p. e17186.

3.Chengappa, K.N., et al., Randomized placebo-controlled adjunctive study of an extract of withania somnifera for cognitive dysfunction in bipolar disorder. J Clin Psychiatry, 2013. 74(11): p. 1076-83.

4.Choudhary, D., S. Bhattacharyya, and K. Joshi, Body Weight Management in Adults Under Chronic Stress Through Treatment With Ashwagandha Root Extract: A Double-Blind, Randomized, Placebo-Controlled Trial. J Evid Based Complementary Altern Med, 2017. 22(1): p. 96-106.