4 replies to this topic

[fishinghat]

https://www.ncbi.nlm...pubmed/31728244

Cureus. 2019 Sep 28;11(9):e5797. doi: 10.7759/cureus.5797.

Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract in Insomnia and Anxiety: A Double-blind, Randomized, Placebo-controlled Study.

Abstract
Introduction Insomnia is a prevalent sleep disorder that can profoundly impact a person's physical health and mental wellbeing. Most of the currently available drugs for insomnia exert adverse effects. Hence, alternative herbal therapies could be effective in treating insomnia. Ashwagandha, a proven "Rasayana" from ancient Ayurveda is having the required potential to treat insomnia. Objective To determine the efficacy and safety of Ashwagandha root extract in patients with insomnia and anxiety. Methods This was a randomized, double-blind, placebo-controlled study conducted at Prakruti Hospital, Kalwa, Maharashtra, India. A total of 60 patients were randomly divided into two groups: test (n = 40) and placebo (n = 20) in a randomization ratio of 2:1. Test product was a capsule containing highest concentration full-spectrum Ashwagandha root extract 300 mg, and the placebo was an identical capsule containing starch. Both treatments were given twice daily with milk or water for 10 weeks. Sleep actigraphy (Respironics Philips) was used for assessment of sleep onset latency (SOL), total sleep time (TST), sleep efficiency (SE) and wake after sleep onset (WASO). Other assessments were total time in bed (sleep log), mental alertness on rising, sleep quality, Pittsburgh Sleep Quality Index (PSQI), and Hamilton Anxiety Rating Scale (HAM-A) scales. Results Two patients, one from each group, did not complete study and the per-protocol dataset (n = 58) included 29 and 19 patients from test and placebo, respectively. The baseline parameters were similar in the two groups at baseline. The sleep onset latency was improved in both test and placebo at five and 10 weeks. However, the SOL was significantly shorter (p, 0.019) after 10 weeks with test [29.00 (7.14)] compared to placebo [33.94 (7.65)]. Also, significant improvement in SE scores was observed with Ashwagandha which was 75.63 (2.70) for test at the baseline and increased to 83.48 (2.83) after 10 weeks, whereas for placebo the SE scores changed from 75.14 (3.73) at baseline to 79.68 (3.59) after 10 weeks. Similarly, significant improvement in sleep quality was observed with test compared to placebo (p, 0.002). Significant improvement was observed in all other sleep parameters, i.e., SOL, SE, PSQI and anxiety (HAM-A scores) with Ashwagandha root extract treatment for 10 weeks. Conclusion Ashwagandha root extract is a natural compound with sleep-inducing potential, well tolerated and improves sleep quality and sleep onset latency in patients with insomnia at a dose of 300 mg extract twice daily. It could be of potential use to improve sleep parameters in patients with insomnia and anxiety, but need further large-scale studies.

 

Note - These results may be statistically significant but I am not impressed. The improvement on sleep averages around 5% more than placebo and this is in healthy individuals not someone going through withdrawal. Also, like many have noted on this site, the effects tend to wear off after a few weeks.

[fishinghat]

https://www.ncbi.nlm...les/PMC6750292/

An investigation into the stress-relieving and pharmacological actions of an ashwagandha (Withania somnifera) extract

A randomized, double-blind, placebo-controlled study

Abstract

Background:
Ashwagandha (Withania somnifera (L.) Dunal) is a herb traditionally used to reduce stress and enhance wellbeing. The aim of this study was to investigate its anxiolytic effects on adults with self-reported high stress and to examine potential mechanisms associated with its therapeutic effects.

 

Methods:
In this 60-day, randomized, double-blind, placebo-controlled study the stress-relieving and pharmacological activity of an ashwagandha extract was investigated in stressed, healthy adults. Sixty adults were randomly allocated to take either a placebo or 240 mg of a standardized ashwagandha extract (Shoden) once daily. Outcomes were measured using the Hamilton Anxiety Rating Scale (HAM-A), Depression, Anxiety, and Stress Scale -21 (DASS-21), and hormonal changes in cortisol, dehydroepiandrosterone-sulphate (DHEA-S), and testosterone.

 

Results:
All participants completed the trial with no adverse events reported. In comparison with the placebo, ashwagandha supplementation was associated with a statistically significant reduction in the HAM-A (P = .040) and a near-significant reduction in the DASS-21 (P = .096). Ashwagandha intake was also associated with greater reductions in morning cortisol (P < .001), and DHEA-S (P = .004) compared with the placebo. Testosterone levels increased in males (P = .038) but not females (P = .989) over time, although this change was not statistically significant compared with the placebo (P = .158).

 

Conclusions:
These findings suggest that ashwagandha's stress-relieving effects may occur via its moderating effect on the hypothalamus-pituitary-adrenal axis. However, further investigation utilizing larger sample sizes, diverse clinical and cultural populations, and varying treatment dosages are needed to substantiate these findings.

[invalidusername]

Just had a quick browse of the first paper and I personally find it quite difficult to read. I am suspicious of course because Ashwagnadha is becoming a very high commodity for Indian export... and the test was undertaken where... an Indian hospital! I know I might be way off, but you just don't know!!

 

I agree with you that there are a lot of people reporting effects wearing off which is not indicated anywhere in the data, not even a plateau in the results. I find this very difficult to believe.

 

But overall, given the apparent benefit to the quality and onset times, it does show to be up there with some of the other meds in terms if efficacy in so much that many of our members have reported waking up soon after doses of various meds. I still say it is a contender, but I would like to see more studies like this showing similar data. This one doesn't stand well on its own in my opinion.

[fishinghat]

I fully agree. I had the same thoughts. There is a certain lack of credulity for med studies from India. They have a certain lack of resonsibility for stating conflict of interest on their medical studies.

"The sleep onset latency was improved in both test and placebo at five and 10 weeks. However, the SOL was significantly shorter (p, 0.019) after 10 weeks with test [29.00 (7.14)] compared to placebo [33.94 (7.65)]."

So it does drop off in efficiency by the 20 week mark. I think even this is optimistic from what we have seen here.

[invalidusername]

I'd never heard of the journal myself, so I did a quick bit of digging to find an interview with the founder;

 

https://scopeblog.st...e-21st-century/

 

Still not entirely convinced by the credibility of it,,, but when a publication started by an Emeritus Professor of Stanford has to start digging the drenches of studies conducted in remote Indian hospitals, things don't tend to add up!