Monday, May 9, 2016

Shilajit: Ayurvedic Testosterone Booster that Works in Men, not Rats: ~20% Increase in Free T + Higher Total T & DHEA

"Get leaner, more muscular and hornier than ever before" - That's probably the promise on the T-booster someone will release after reading this SuppVersity article and sourcing an inferior Shilajit extract on Alibaba.
No, I hadn't heard of Purified Shilajit (PS), either, before I read about it in a very recent study in the peer-reviewed scientific journal Andrologia (Pandit. 2015). Actually, the study was first published in online (ahead or print), in late 2015. It took several months for it to be finally available in print and to appear on my "study radar", though.

Shilajit is traditionally used in Ayurveda, an indigenous system of Indian medicine, as a remedy for several diseases, particularly chronic diseases. It is a pale-brown to blackish-brown exudate that oozes from sedimentary rocks worldwide, largely in the Himalayas. The natives describe it as pahar-ki-pasina (sweat of mountains), paharki-khoon (mountain blood), shilaras (rock juice), asphalt, bitumen, etc.
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Shilajit is said to carry the healing power of these great mountains (Frawley. 1986) and is one of the "important drug[s] of the ancient Ayurvedic materia medica and [... ] to this day used extensively by Ayurvedic physicians for a variety of diseases (Pandit. 2015). As Pandit et al. point out, ...
"[e]arly Ayurvedic writings from the Charaka Samhita (Sharma, 1998) describe Shilajit as a cure for all diseases as well as a Rasayana (rejuvenator) that promises to increase longevity. It is composed of rock humus, rock minerals and organic substances that have been compressed by layers of rock mixed with marine organisms and microbial metabolites" (Pandit. 2015).
That this is probably not exactly accurate must not hide the fact that it has in fact been used successfully to treat diabetes and diseases of the urinary tract, oedema, tumours, muscle wasting, epilepsy and even insanity in practice and that clinical research confirms many of the properties for which Shilajit has been used (Talbert. 2004).
Figure 1: A study by Biswas 2009 in infertile men is the first to show the potent effects of Shilajt in a randomized controlled human trial involving a total of 60 (active treatment + placebo) oligospermic men (Biswas. 2009).
Needless to say that, in Ayurveda, Shilajit is also used for the management of male reproductive disorders, and in particular, under the parlance of Vrisya (an aphrodisiac with special reference to spermatogenesis). In that, it has been shown to pose no toxicity issues with several studies reporting an LD50 of  >2000 mg/kg, acutely (Acharya et al., 1988; Ghosal et al., 1989), and doses of 0.2–1.0 g per kg body weight when used chronically (Kelginbaev et al., 1973; Anisimov & Shakirzyanova, 1982; Fortan & Acharya, 1984; Al-Hamaidi & Umar, 2003).

And the data from Biswas 2009 study (Figure 1) demonstrates that Shilajit is not just safe (no alterations in serum urea, uric acid, serum bilirubin, total protein, serum globulin, SGPT, SGOT and alkaline phosphatase were observed), but also effective in improving the total sperm count (+61.4%), motility (12.4–17.4% after different time intervals), normal sperm count (+18.9%) and total testosterone (+23.5%) levels with concomitant decrease in 28 patients with oligospermia and infertility when it was administered at a dosage of only 100 mg twice daily for 90 days.
Sponsored study warning: The study used a product that goes by the name PrimaVie™. It is a a patented (US 6,440,436, 6,969,612, 6,558,712, EP 1 387 614) standardized extract of native Shilajit from Natreon, Inc. of which the scientists confirmed in HPLC analysis that it contains >60% w/w of total bioactives, which include not less than 50% w/w of fulvic acids (FAs), not less than 0.3% w/w of dibenzo α-pyrones (DBPs) and not less than 10% w/w of dibenzo-α-pyrone chromoproteins (DCPs). Unfortunately, the producers didn't just sponsor the product but also supported the study. This does not mean that the results are not reliable, but we must still treat the scientists conclusions more carefully than those of independent researchers. Furthermore, the scientists recorded 21 dropouts (total from both groups) who were not included in the calculations of testosterone and co.
According to Pandit et al. the data from Biswas study is supported by their own unpublished human safety study of purified Shilajit from Natreon, Inc., New Brunswick, NJ, USA, and an unpublished animal study in rats with 100 mg/kg b.w. (equivalent to human dose of 850 mg) by Natreon showed a significant increase in testosterone levels. Based on the three studies, Pandit et al. chose a dose of 250 mg twice daily for their study.
Figure 2: Schematics of study design (Pandit. 2015).
"A schematic of the study design is shown in Fig. 2. Healthy volunteers aged between 45 and 55 years, irrelevant of religion, income status and occupation, were selected for the present purpose, and the distribution of patients was done by the method of double-blind randomised techniques. Initially, 145 volunteers were selected on the basis of primary assessment eligibility and 49 among them were excluded for various reasons (Fig. 2). A total of 96 volunteers were enrolled in the present trial and randomly divided into two equal groups as PS treated and placebo treated, each with 48 subjects. In the course of the study, 21 subjects discontinued for various reasons and 38 subjects in PS-treated group and 37 subjects in the placebo group completed the study (Fig. 2). Mean age of the volunteers was 49.44 years in the test drug group and 48.89 years in the placebo group, and thus, there is no bias due to the difference in mean ages" (Pandit. 2015).
Subjects in both groups received respective drugs in the dose of 250 mg/capsule orally, twice daily after major meals, for a total duration of 90 days. In that...
  • Group – I received the active treatment PS 250 mg BID (38 subjects), while 
  • Group – II was supplied w/ a Placebo 250 mg (microcrystalline cellulose 124 mg + lactose 124 mg + magnesium stearate 2 mg) BID (37 subjects)
Both the PS and placebo capsules were white opaque, Size 1, and looked identical. The same cannot be said of the study results in Figure 3.
Figure 3: Effect of PS on testosterone & its mediators w/ respect to placebo control; rel. changes over bars (Pandit. 2015).
More specifically, Pandit et al. observed that in the "PS-treated group, there was an increase in testosterone levels (ng/ml) on days 30 (6.82%), 60 (3.09%) and 90 (20.45%) with respect to day ‘0’" (Pandit. 2015). Furthermore, ...
  • testosterone levels on day ‘90’ rose significantly (P < 0.05) vs. baseline in PS,
  • testosterone levels decreased sign. (P < 0.05) vs. baseline in placebo,
  • testosterone in PS-treated group on day 90 was sign. higher (P < 0.05) than placebo, 
  • free testosterone in PS-treated group on day 90 increased sign. (19.14%), and 
  • free testosterone level of PS-treated group on day 90 was also sign. higher than placebo.
In addition, the researchers recorded no difference in LH levels (which is good, because this means the testes worked more efficient, not overtime) and a significantly increased FSH level (P < 0.004) in the PS-treated group on days 30, 60 and 90 with respect to baseline. Thus, the result of FSH was significantly better in PS-treated group than placebo group on day 90.

The same goes for DHEAs, the adrenal hormone and potential (!) precursor of testosterone, which showed "interesting results" (Pandit. 2015) with PS, where the level of DHEAs gradually increased on day 30 (9.14%), 60 (9.59%) and 90 (31.35%) with respect to values on day ‘0’. The change of DHEAs in placebo group, on the other hand was "irregular" (Pandit. 2015). Eventually, the level of increase in DHEA in PS-treated group on day 90 was found to be significantly higher (P < 0.05) than baseline value of PS-treated group and 90-day value of placebo.
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Bottom line: So what's going on, here? 20% increase in testosterone? That's huge! No? Well, it is a significant difference, but the 20% decrease in testosterone 'due to' a placebo, of which the researchers say that it "has neither stimulation nor inhibiting role on testosterone secretion or synthesis" (Pundit. 2015), should be evidence enough that a 20% change in testosterone levels can occur "randomly".

Against that background and in view of the fact that the scientists don't discuss the regular circadian variety in testosterone levels, I have to repeat my "watch out: sponsored research!"-warning | Comment on Facebook!
  • Biswas, Tuhin Kanti, et al. "Clinical evaluation of spermatogenic activity of processed Shilajit in oligospermia." Andrologia 42.1 (2010): 48-56.
  • Frawley, David, and Vasant Lad. "The yoga of herbs." Santa Fe (NM): Lotus (1986).
  • Pandit, S., et al. "Clinical evaluation of purified Shilajit on testosterone levels in healthy volunteers." Andrologia (2015).
  • Talbert, Robert. "Shilajit: a materia medica monograph." California College of Ayurveda A 1117 (2004).