Ox Labs Clinical Studies
Protodioscin and DHEA have been extensively studied to be effective, safe and have numerous health benefits. There are dozens of documented studies available. Here are a few:
DHEA
Improvement in mood and fatigue after dehydroepiandrosterone replacement in Addison's disease in a randomized, double blind trial.
Dehydroepiandrosterone (DHEA) and DHEA sulfate (DHEAS) are adrenal precursors of steroid biosynthesis
and centrally acting neurosteroids. Glucocorticoid and mineralocorticoid deficiencies in Addison's disease
require life-long hormone replacement, but the associated failure of DHEA synthesis is not corrected. We
conducted a randomized, double blind study in which 39 patients with Addison's disease received either 50
mg oral DHEA daily for 12 weeks, followed by a 4-week washout period, then 12 weeks of placebo, or vice
versa. After DHEA treatment, levels of DHEAS and Delta(4)-androstenedione rose from subnormal to within the
adult physiological range. Total testosterone increased from subnormal to low normal with a fall in serum
sex hormone-binding globulin in females, but with no change in either parameter in males. In both sexes,
psychological assessment showed significant enhancement of self-esteem with a tendency for improved overall
well-being. Mood and fatigue also improved significantly, with benefit being evident in the evenings. No
effects on cognitive or sexual function, body composition, lipids, or bone mineral density were observed.
Our results indicate that DHEA replacement corrects this steroid deficiency effectively and improves some
aspects of psychological function. Beneficial effects in males, independent of circulating testosterone
levels, suggest that it may act directly on the central nervous system rather than by augmenting peripheral
androgen biosynthesis. These positive effects, in the absence of significant adverse events, suggest a role
for DHEA replacement therapy in the treatment of Addison's disease.
Hunt PJ, Gurnell EM, Huppert FA, Richards C, Prevost AT, Wass JA, Herbert J, Chatterjee VK.
Effect of 1-year oral administration of dehydroepiandrosterone to 60- to 80-year-old individuals on muscle function and cross-sectional area: a double-blind placebo-controlled trial.
BACKGROUND: The age-related decline of dehydroepiandrosterone and its sulfate ester levels
is thought to be related to the development of age-associated usual modifications, such as neuromuscular
function impairments. It is often claimed that individuals can enhance their muscular capacity by boosting
dehydroepiandrosterone levels through oral supplementation. However, to our knowledge, there have been no
controlled studies on a significant number of individuals demonstrating positive effects on the neuromuscular
system. This study determines if 1-year administration of a replacement dose of dehydroepiandrosterone, 50
mg/d, orally administered, could have a beneficial influence on several determinants of the muscular function
altered during aging. METHODS: This work was completed within the frame of the DHEAge Study, which was
conducted in France from March 1, 1998, to October 31, 1999. It was performed on 280 healthy ambulatory and
independent men and women aged 60 to 80 years. The study design was a double-blind placebo-controlled trial.
Dehydroepiandrosterone sulfate serum concentration, handgrip strength, isometric and isokinetic knee muscle
strength, and thigh (fat and muscle) cross-sectional area were analyzed before and just after 12 months of
placebo or dehydroepiandrosterone treatment. RESULTS: The results give evidence that dehydroepiandrosterone
administration restores dehydroepiandrosterone sulfate serum concentrations to the normal range for young
adults (aged 20-50 years). However, no positive effect inherent to dehydroepiandrosterone treatment was
observed either on muscle strength or in muscle and fat cross-sectional areas. CONCLUSIONS: The compensation
of the deficit of dehydroepiandrosterone during aging using a 50-mg/d dose does not induce beneficial
effects on muscle state in healthy subjects. The conditions in which dehydroepiandrosterone could contribute
to preserve or improve muscle strength and morphological features still need to be determined.
Percheron G, Hogrel JY, Denot-Ledunois S, Fayet G, Forette F, Baulieu EE, Fardeau M, Marini JF; Double-blind
placebo-controlled trial.
Dehydroepiandrosterone replacement administration: pharmacokinetic and pharmacodynamic studies in healthy elderly subjects.
Dehydroepiandrosterone (DHEA; 50 and 25 mg) and placebo tablets were orally administered
daily to 24 healthy aging men and women (67.8 +/- 4.3 yr) for 8 days according to a balanced incomplete block
design. Nine blood tests on both the first and eighth days allowed the measurement of DHEA, its sulfate DHEAS,
and metabolites: testosterone, 5alpha-androstan-3alpha,17beta-diol glucuronide, estradiol, and estrone.
Relatively low background levels of DHEA(S) were observed, and with the reestablishment of "young" levels, four
important results were obtained. 1) Blood DHEA had an apparent terminal half-life of more than 20 h, the same
order of magnitude as that of blood DHEAS, a result explainable by back-hydrolysis of the large amount of DHEAS
formed after oral administration of DHEA, a mechanism providing long-lived unconjugated DHEA and metabolites.
2) The metabolic conversion of DHEAS to DHEA was significantly greater in women than in men. 3) No accumulation
of steroids was observed. 4) No worrying transformation to androgen and estrogen was recorded; indeed, the
limited increased estradiol in aged women could be predicted to be beneficial. These results suggested that
daily oral administration of DHEA (25/50 mg) is safe in elderly subjects. The 50-mg dose was chosen for a 1 yr,
double blind, placebo-controlled trial of daily oral administration of DHEA in 60- to 80-yr-old individuals
(DHEAge).
Legrain S, Massien C, Lahlou N, Roger M, Debuire B, Diquet B, Chatellier G, Azizi M, Faucounau V,
Porchet H, Forette F, Baulieu EE.
Tribulus Terrestris (Protodioscin)
Effect of Tribulus terrestris treatment on impotence and libido disorders
To test the effectiveness of Tribulus terrestris in treating impotence and male libido disorders,
we enrolled 11 subjects, composed of 4 men diagnosed with lowered or nonexistent libido and 7 impotent men. To
these two groups, 3 x 1 Libilov tablets were administered per day for 2 weeks, without any additional vitamin
supplements or pharmaceutical therapeutics. 50% of the subjects with reduced libido reported increased sex drive
after Libilov treatment. Close to 60% of impotent subjects experienced improved erection, including prolonged
duration of erection after treatment. This trial suggested that even a short period of treatment with Libilov was
effective in treating these two conditions. Furthermore, as with previous trials, no adverse side-effects were
observed.
A.W. Nasution
Andalas University, School of Medicine, Padang, Indonesia (1993)
Tribulus terrestris (protodioscin) increases men's sex drive
Male erectile dysfunctions are composed of the dysfunctions of libido, erection, ejaculation and
orgasm. One medical approach to solve this problem is the use of natural medicine, i.e. the use of compounds derived
from natural sources rather than those of synthetic origins. Here, we conduct a clinical trial to test the efficacy
of Libilov's protodioscin, a natural compound derived from the extract of a medicinal plant Tribulus terrestris. In
this test, we study the sex drive, erection, ejaculation and orgasm of 53 married men diagnosed with sexual
dysfunctions. These men were given Libilov at 3 x 2 tablets per day for 3 months. We report that statistical analyses
suggest significant improvement in sex drive in the majority of our trial constituents, without any evidence of adverse
effects.
W. Pangkahila
Reproductive Medicine Faculty, University of Denpasar, Indonesia
Proceedings of the Xth National Congress on New Perspectives of Andrology on Human Reproduction
National Congress of Indonesian Association of Andrologs 10th Scientific Meeting in Denpasar(1993)
Pharmacological, pharmacokinetic, toxicological and clinical studies on protodioscin
Clinical investigations on a total of 212 males with disorders of sexual functions confirmed
experimental data pointing at a pronounced stimulating effect on these sexual functions by the new phytochemical
preparation of Tribulus terrestris extract. Administered in average daily doses of 1.5 g in the course of 30 to 40
days, it restores and improves libido sexualis in all forms of impotentia coeundi. Studies on the acute, subchronic and
chronic toxicities of protodioscin, the active ingredient of Tribulus terrestris extract, determined that the compound
is to be classified as practically non-toxic substances. The harmlessness of the preparation deserves particular
attention. No data about toxic manifestations were established under experimental conditions with acute, subchronic and
chronic toxicities (behavioral, hematological, biochemical, functional and morphological studies). No data were
established concerning carcinogenic and teratogenic effect. The combined action of the preparation (stimulation of the
sexual behavior and spermatogenesis) and the absence of adverse effects characterize the preparation as an original agent
for the treatment of males with disorders in the sexual functions.
I. Viktorov, E. Bozadjieva, M. Protich, et al.
Higher Medical Institute; Medical Academy Institute of Endocrinology, Gerontology and Geriatrics;
Medical Academy Institute
of Obstetrics and Gynecology, Bulgaria
IIMS Therapeutic Focus (1994)