The objective of this 8 week double-blind, randomized, placebo-controlled trial was to evaluate the safety and efficacy of a standardized extract of Ashwagandha for controlling weight and improving general well-being in adults with chronic stress.
Individuals were selected from several outpatient clinics in Pune, India, for the purpose of addressing stress and being overweight. Inclusion criteria included: chronic/routine work stress; a Perceived Stress Scale (PSS) of 20 or more; between the ages of 18-60 years; and a body mass index between 25 and 39.9 kg/m2. All individuals had chronic stress symptoms and the majority were troubled with difficulties in concentration and insomnia. About 44% Ashwagandha group and 52% placebo group had problems with anxiety and restlessness. Other significant symptoms included physical exhaustion, mental fatigue and headaches. A total of 38 men and 14 women were enrolled in the study and randomized to either group.
Individuals were given either a standardized extract of Ashwagandha root extract (containing 5% withanolides) 300 mg twice per day or placebo for 8 weeks.
The primary outcome measures were the PSS, and the Food Cravings Questionnaire-Trait (FCQ-T). Secondary outcome measures included the Oxford Happiness Questionnaire (OHQ), the Three-Factor Eating Questionnaire (TFEQ), serum cortisol levels, initial and final body weight, and body mass index. The PSS is a measure of psychological stress and is a 14-item scale that determines general stress that is experienced in the previous month with scores ranging from 0 to 56 and higher scores representing higher stress. The PSS evaluates physical and mental symptoms of depression, the requirement for health services, social anxiety and life event scores that correlate. The FCQ-T is a 39 item, self-reported questionnaire and is used to measure food cravings in 9 domains. The OHQ consists of 29 questions and is a tool to measure happiness, well-being, and optimism. Serum cortisol levels are an indicator of stress and are associated with appetite. In this study, cortisol represents a measurement of the anti-stress effect of Ashwagandha in those individuals under chronic stress and the impact on weight gain. The TFEQ questionnaire is used to determine eating behavior and contains 18 items and scales to assess cognitive restraint, uncontrolled eating and emotional eating.
Of the 52 originally enrolled, 1 each in the placebo and Ashwagandha group were not compliant with the protocol and data was analyzed for the 50 remaining individuals. The mean PSS score decreased in both groups but there was a significantly greater reduction in the treatment group decrease compared to placebo at week 4 and even more so at week 8 with a 22.1% reduction at week four and 32.7% reduction at week 8 in the Ashwagandha group. The mean FCQ-T “planning score” was lower in both groups but was significantly lower in the treatment group than the placebo group at the end of week 4 and 8. The FCQ-T “positive reinforcement” score at week 8 was significantly lower in the treatment group than that of the placebo group. The mean FCQ-T “negative reinforcement” scores of the treatment group did not show any significant difference compared to placebo at week 4 or 8. Lastly, the mean FCQ-T sores showed a significant reduction from baseline and compared to placebo for lack of control, emotion and environment although the thoughts about food, physiological and guilt components did not show any significant differences compared to placebo.
Of the secondary outcomes, I will just report on serum cortisol and weight loss here because I find it interesting and clinically useful. By the end of week 8, mean serum cortisol levels of the treatment group were significantly lower compared to the placebo group, after being the same at baseline. After week 4, there was a 16.05% reduction from baseline and after week 8, a 22.2% reduction in the Ashwagandha group. A reduction in 2.14% body weight was seen in the Ashwagandha group vs 1.09% in the placebo group at week 4, which was not statistically significant. However, after 8 weeks of treatment, the reduction in body weight for the treatment group was 3.03% and 1.46% for the placebo which was a significant difference in mean reduction of body weight, for both groups, although greater for Ashwagandha.
Commentary: As a quick summary, after 8 weeks, Ashwagandha was more effective than placebo in reducing PSS, several aspects of food cravings (although not thoughts about food or guilt about food), uncontrolled and emotional eating (but not cognitive restraint). A reduction in body weight, body mass index and serum cortisol were also observed in these stressed individuals who took Ashwagandha standardized to 5% withanolides and 300 mg bid for 8 weeks. Previous research, and decades if not generations of observations from users and prescribers of Ashwagandha, strongly support its anti-stress and anti-anxiety therapeutic influence. The results of the current study punctuate these reports and observations and take the evaluation several steps further, with the added feature of weight loss in those living with chronic stress. From this study, we can add to our body of previous knowledge about Ashwagandha and confirm its ability to reduce psychological and physiological markers of stress, improve well-being, reduce serum cortisol, reduce food cravings, improve eating behaviors and promote weight management in those men and women under chronic stress. Longer term studies would provide further insight and perhaps especially in the problematic area of weight gain caused by long term chronic stress.
Reference
Choudhary D, Bhattacharyya S, Pharm M, Joshi K. Body weight management in adults under chronic stress through treatment with Ashwagandha root extract: a double-blind, randomized, placebo-controlled design. J Evidence-Based Complementary and Alternative Medicine. Published in cam.sagepub.com August 10, 2016.
