Efficacy and Safety of Ashwagandha Root Extract in Subclinical Hypothyroid Patients: A Double-Blind, Randomized Placebo-Controlled Trial
Publication: The Journal of Alternative and Complementary Medicine
Volume 24, Issue Number 3
Abstract
Background: Subclinical hypothyroidism, a thyroid disorder without obvious symptoms of thyroid deficiency, occurs in 3%–8% of the global population. Ashwagandha [Withania somnifera (L.) Dunal], a traditional medicine in Ayurveda, is often prescribed for thyroid dysfunctions.
Objective: This pilot study was designed to evaluate the efficacy and safety of ashwagandha root extract in subclinical hypothyroid patients.
Design, Setting, and Participants: A prospective, randomized, double-blind, single-center placebo-controlled study was performed at Sudbhawana Hospital, Varanasi, India between May 2016 and September 2016. Fifty subjects with elevated serum thyroid stimulating hormone (TSH) levels (4.5–10 μIU/L) aged between 18 and 50 were randomized in either treatment (n = 25) or placebo (n = 25) groups for an 8-week treatment period.
Interventions: Ashwagandha root extract (600 mg daily) or starch as placebo.
Efficacy Variables: Serum TSH, serum triiodothyronine (T3), and thyroxine (T4) levels.
Results: A total of four subjects (two from each group) withdrew their consent before the second visit. Eight weeks of treatment with ashwagandha improved serum TSH (p < 0.001), T3 (p = 0.0031), and T4 (p = 0.0096) levels significantly compared to placebo. Ashwagandha treatment effectively normalized the serum thyroid indices during the 8-week treatment period in a significant manner (time-effects: TSH [p < 0.001], T3 [p < 0.001], and T4 [p < 0.001]). Four subjects (8%) (ashwagandha: 1[4%]; Placebo: 3[12%]) out of 50 reported few mild and temporary adverse effects during this study.
Conclusion: Treatment with ashwagandha may be beneficial for normalizing thyroid indices in subclinical hypothyroid patients.
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References
1.
Fatourechi V. Subclinical hypothyroidism: An update for primary care physicians. Mayo Clin Proc 2009;84:65–71.
2.
Hollowell JG, Staehling NW, Flanders WD, et al. Serum TSH, T4, and thyroid antibodies in the United States population (1988 to 1994): National Health and Nutrition Examination Survey (NHANES III). J Clin Endocrinol Metab 2002;87:489–499.
3.
Canaris GJ, Manowitz NR, Mayor G, et al. The colorado thyroid disease prevalence study. Arch Intern Med 2000;160:526–534.
4.
Dayan CM, Daniels GH. Chronic autoimmune thyroiditis. N Engl J Med 1996;335:99–107.
5.
Vanderpump MPJ, Tunbridge WMG, French Jm, et al. The incidence of thyroid disorders in the community: A twenty-year follow-up of the Whickham Survey. Clin Endocrinol (Oxf) 1995;43:55–68.
6.
Chu JW, Crapo LM. The treatment of subclinical hypothyroidism is seldom necessary. J Clin Endocrinol Metab 2001;86:4591–4599.
7.
McDermott MT, Ridgway EC. Subclinical hypothyroidism is mild thyroid failure and should be treated. J Clin Endocrinol Metab 2001;86:4585–4590.
8.
Javed Z, Sathyapalan T. Levothyroxine treatment of mild subclinical hypothyroidism: A review of potential risks and benefits. Ther Adv Endocrinol Metab 2016;7:12–23.
9.
Villar HCCE, Saconato H, Valente O, et al. Thyroid hormone replacement for subclinical hypothyroidism. Cochrane Database Syst Rev 2007;CD003419.
10.
Chandrasekhar K, Kapoor J, Anishetty S. A prospective, randomized double-blind, placebo-controlled study of safety and efficacy of a high-concentration full-spectrum extract of ashwagandha root in reducing stress and anxiety in adults. Indian J Psychol Med 2012;34:255–262.
11.
Panda S, Kar A. Withania somnifera and Bauhinia purpurea in the regulation of circulating thyroid hormone concentrations in female mice. J Ethnopharmacol 1999;67:233–239.
12.
Panda S, Kar A. Changes in thyroid hormone concentrations after administration of ashwagandha root extract to adult male mice. J Pharm Pharmacol 1998;50:1065–1068.
13.
Gannon JM, Forrest PE, Chengappa KNR. Subtle changes in thyroid indices during a placebo-controlled study of an extract of Withania somnifera in persons with bipolar disorder. J Ayurveda Integr Med 2014;5:241.
14.
Olff M, Güzelcan Y, de Vries GJ, et al. HPA- and HPT-axis alterations in chronic posttraumatic stress disorder. Psychoneuroendocrinology 2006;31:1220–1230.
15.
Turnbull AV, Rivier C. Regulation of the HPA Axis by Cytokines. Brain Behav Immun 1995;9:253–275.
16.
Dunn AJ. Cytokine activation of the HPA axis. Ann N Y Acad Sci 2000;917:608–617.
17.
Singh D, Aggarwal A, Maurya R, et al. Withania somnifera inhibits NF-kappaB and AP-1 transcription factors in human peripheral blood and synovial fluid mononuclear cells. Phytother Res 2007;21:905–913.
18.
Kour K, Pandey A, Suri KA, et al. Restoration of stress-induced altered T cell function and corresponding cytokines patterns by Withanolide A. Int Immunopharmacol 2009;9:1137–1144.
19.
Van Der Hooft CS, Hoekstra A, Winter A, et al. Thyrotoxicosis following the use of ashwagandha. Ned Tijdschr Geneeskd 2005;149:2637–2638.
Information & Authors
Information
Published In
The Journal of Alternative and Complementary Medicine
Volume 24 • Issue Number 3 • March 2018
Pages: 243 - 248
PubMed: 28829155
Copyright
Copyright 2018, Mary Ann Liebert, Inc.
History
Published in print: March 2018
Published online: 1 March 2018
Published ahead of print: 22 August 2017
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No competing financial interests exist.
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