Nutritional supplements with phytohormone for the aging women (glimpses on menopause and andropause)
Adimoelja A
Hang Tuah University / Naval Teaching Hospital "Dr. Ramelan", Surabaya, Indonesia, 2003

INTRODUCTION

It is well known that dehydroepiandrosterone (DHEA) is very important for the development of the genital sex and reproductive organ system from birth to puberty. Up to the reproductive age, when the gonads are fully developed DHEA production declines remarkably. During reproductive age, while the DHEA production declines, ovaries and testis are those gonads that takeover the responsibility for the production of sex hormones for the maintanence and good development of genital sex organs and fertility.

After reaching the age of 50 years, sex hormone production declines and many of the phenomena associated with aging begins to develop. Estrogen production in women declines drastically, resulting in the well-known pre and menopause syndromes, and other aging phenomena in women, such as the negative bone-turn-over (BTO) process resulting in osteoporosis. Therefore sex hormone replacement therapy (HRT) is proposed to minimize the pre and menopause syndromes in women. HRT also has been suggested for aging men with partial androgen deficiency (PADAM) syndromes.

Current research on growth hormone (GH) and DHEA for the management of aging is, however, ongoing and intensive. This is mainly due to the many controversial results of sex HRT. Specicically this is related to the use of synthetic chemopharmaccutics and hormones and the belief that they possess many side effects and as well as a host of adverse reactions. This has therefore, caused the emergance of a “Back to Nature” movement. The hope is that nutritive supplementation with diversity of phytopharmaccutics, such as protodiscin, will prove to have both beneficial as well as satisfactory results for both men and women’s health. Especially for the management of ailments that both men and women experience as part of the aging phenomenon. It is noteworthy, that so far the uses of these phyto-chemicals do not show any noticeable harmful side effects. We hypothesize that the natural character of these phytochemicals being studies here will be shown to be as beneficial to humans as the effects consuming vegitable dishes during meals daily meals.

PROTODIOSCIN A NUTRITIONAL SUPPLEMENT FOR THE AGING MALE WITH DECREASE LIBIDO

Protodioscin is a phyto-chemical extract from Tribulus terrestris L plant that has been clinically tested to improve sexual desire and enhance erection in men via the conversion of protodioscin to DHEA. As has been reported in many trials, aging in men is associated with the decline of sexual mood and erection. These conditions are well proven with the decline of testosterone (T), GH, DHEA, IGF-1 (insuline-growth-factor-1) and others. Hence a nutritive supplementation with protodioscin may be beneficial, as it may increase the DHEA blood serum levels in the aging male. DHEA, as is known, can be converted whenever to T or further aromatized to estrogen. Within this line R. Huharam et all concluded that nutritive supplementation with protodioscin should also be beneficial for a positive response in the bone-turn-over (BTO) process, and thus in preventing osteoporosis in menopausal women. Where as the decrease blood serum levels of DHEA, GH, and IGF_1 and estrogen may trigger osteoporosis.

FOCUSING ON THE USE OF PROTODIOSCIN ON OSTEOPOROSIS PREVENTION & OBESITY

Materials and methods: A double blind placebo controlled study was therefore performed on 30 pre and menopausal women (ages 45 years and over). They were divided in two groups. Group I (n = 15) were consuming TTL extract 3 x 2 tabl. (250mg/tbl)/day for six weeks. Group II ( n = 15) were only given placebo. The BTO in the study were represented by the measurement of blood serum osteoclasin (OST) and alkaline phosphatase isonenzyme (ALP) before and after the nutritive supplementation with the protodioscin.

Ten other women of reproductive age participated in the study to get their normal routine blood examination. Estrogen, OST and APL blood serum measured for the base line control date.

Results: A significant decrease was observed in the mean ALP in group I from 81. 120(SD=29.649) to 73.267 (SD = 25.438); (p< 0.05). In group II, an increase of the mean ALP was observed from 86.533 (SD = 23.041), although it was not significant (p>.005) (see Fig. I and II).

Figure I. Bone Turnover Alkaline Phosphatase Isoenzyme
p < 0.05

Figure II. Bone Turnover Osteoblast activity
p < 0.05

In respect to the hormone profiles, protodioscin was reported to significantly increase DHEA, GH and SHBG and decrease prolactin, estradiol, and testosterone serum blood levels. Whereas in the placebo group, all hormone profiles were not significantly changed (p>0/05). Also, no changes of the liver and renal function tests were reported (p. 0.005) (see table A). Because of the very short period of this preliminary trial the BMD was not performed. A more extended trial should be conducted in the future so that the results of the BMD (before and after the trial) show convincingly the positive details of the BTO.

Table A

Results
HORMONAL PROFILES

A significant increase of OST in group I (Fig. II) was reported 11.3900 (SD = 5.9668) to 14.5560 (SD = 8.7275); (p<0.05). A significant decrease of ALP from 81.12 (SD = 73.27 (SD = 25.438) was reported (Fig. I).
In group II a non-significant increase (p>0.05) of mean OST was reported from 13.5740 (SD +5.5323) to 14.1135 (SD + 52.953) was also reported (Fig. I)/
Although the BMI after consuming protodioscin was not decreasing significantly, the lost visceral fat or decrease of the whip-hip-ratio (WHR) from 0.82 ± 0.007 to 0.80 ± 0.006 was very promising (significant by p<0.05) Tab. B)

Table B

Obesity

Conclusion and remarks: Daily nutritional supplementation with protodioscon may exert positive effect on the BTO in pre and menopausal women. Obesity or weight gain - which can also significantly affect the quality of a woman’s life - was reduced within 6 weeks of consuming the Tribulus terrestris extract (Tab. B). No other side effects or adverse reaction were resported in this preliminary study (Tab C). Regular nutrive supplementation with the extract of Tribulus terrestris is therefore recommended for the pre and menopausal women.

Table C

Liver and renal function

PROTODIOSCIN FOR THE AGING MALE WITH DECREASED LIBIDO

Androgens for HRT in the males experiencing the symptoms of aging, such as decreased libido and erectile dysfunction (ED) have been proposed. In some cases, current studies have shown the benefits of HRT especially in men with PADAM or ADAM (androgen defieincy in aging male). However, there is a growing controversy over the application of HRT with testosterone. This is especially true for cases where the individual subjects that have prostate hypertrophy (BPH) or cancer, as is frequently found in aging men.

New research on the bodies production of DHEA and its precursors is quite promising as an alternative method of therapy. Protodioscin is a natural plant product that has been proven to be a precursor of DHEA. This phytochemical product’s effectiveness has already been greatly evaluated in the aging male with a decreased libido (sexual fatigue).

Materials and methods: A double blind cross-over placebo controlled study of 60 aging males (ages 50 y.o. and over) were divided into 2 groups of 30 males. Group A (n = 30) was treated with the active drug containing protodioscin 250 mg/ tablet 3x 2 tablets for 3 weeks. Group B (n = 30) was treated with placebo’s only within the same period. After one-weeks ‘wash-out’ period Group A in turn received placebo’s only and Group B active supplements. DHEA serum blood levels were measured before and after each experiment for both groups.

Results: In both groups ( A and B) who had both been receiving active supplements showed a significant (p<0.005) increase of DHEA serum blood levels (Tab. 1 and 2):
Group A (in first round experiment) before levels (Tab. 1 and 2):
Group B ( in second round treatment, after wash-out period); before =1.164) and after = 1.989 (see table 2). No change (p>0.005) in DHEA blood serum levels were observed in both groups (A and B) receiving placebo’s. The testosterone blood serum levels remain unchanged as shown on table 1, 2 and 3. Group B(in first round experiment before the washout period) The DHEA serum blood levels before = 1.163 and after = 1.167 (Tab. 1).
Group A ( in the second round experiment, after washout period) DHEA serum blood levels before = 1.973 and after = 1.970. (Tab. 2) During the washout periods the DHEA serum blood levels remained unchanged (p>0.05) in both (A and B) groups (Tab. 3).
And improvements (47% = 28 from 60) of their sexual performances were also reported when active drugs were given.

Conclusions and overall remarks: Protodioscin has been extensively shown to improve sexual performance in aging males and now current studies suggest that it also has positive bone-turn-over effects in pre and menopausal women.

Aging and the accompanying phenomena, or the physio-pathological processes, associated with aging brings with it a diversity health related problems that have the ability to greatly decrease the quality of life in both genders.

During a persons younger years DHEA is likely very important for the proper development of the genital, sexual and reproductive organ systems. Therefore, as DHEA blood serum levels start to drop with age there is an apparent increase in the pathological aging phenomena in both men and women. HRT with DHEA is likely, therefore, a means of ‘slowing-down’ the pathological aging process. Menopause and other aging phenomena in women (including obesity and osteoporosis) are still being regarded as being related to a decline in the production of sex hormones. Furthermore, until recently no normal sex hormone parameters of older aged subjects were known. Treatments therefore had been developed to adjust the subjects sex hormone levels to what was believed to be the optimal level, a level that was actually the optimal level for subjects of a younger or reproductive age.

As was mentioned earlier in this report this report, chemical products and hormones are believed to have many negative side effects and adverse reactions. Therefore, nutritive supplementation therapy with pre-phyto-hormones may much safer and efficient means of treatment.

Protodioscin, a natural extract from Tribulus terrestris L plant, is a pre-phyto-hormone which has been shown to be a precursor of DHEA. The pharmaco-dynamic action of this purified plant extract interacts holistically and integrates within the physiologic metabolic pathway in the human body when consumed. The consuming of certain phyto-pharmaccutics can be considered as holistic and safe as the daily consumption of vegtable dishes, which has been historically proven for their usefulness to maintain health. While mild and no harmful side effects can be reported from the consumption of vegetables we hope this will also hold true for the consuming of medicinal plant extracts when properly used.

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Presented at the PERMI-APMF National Sympsium, Jakarta, 2003