Erectile Dysfunction: Traditional Chinese Medicine Formula (BetterMAN[R]) Shown Effective in Scientific Studies.

Townsend Letter for Doctors and Patients, Nov, 2001, by Peipei Wu Wishnow

As a third-generation Chinese medical professional, I firmly believe that Traditional Chinese Medicine (TCM) has much to offer Americans. After receiving a doctorate degree in biology in the United States, and spending most of my scientific career as a researcher at MIT, Caltech, and in the pharmaceutical industry, I founded Interceuticals, Inc. to apply Western scientific methods and quality control techniques to time-tested efficacious TCM formulas. In order to bridge the gap of understanding between a traditional herbal formula and the language of modern science, Interceuticals is committed to investing in on-going human and animal research, and to providing health professionals with factual and clinically-pertinent information. This article summarizes the currently available data for a TCM formula, BetterMAN[R], Interceuticals' flagship product. This is the first, but significant step. A Chinese proverb says: "A thousand-mile trip starts with the first step."

Background

Recent surveys estimate that some 30 million American men (representing 50% of men over age 40) report some form of erectile dysfunction (ED). Most men have additional issues concerning urinary control, especially frequent nighttime urination. Male sexual dysfunction is a complex problem in which behavior and psychological aspects must be addressed in addition to other causes such as injury, hormonal abnormality, medical diseases, surgical procedures, and the use of prescription drugs. The introduction of Viagra[R] made it more culturally acceptable to discuss ED and men's sexual issues. Even so, only 10% of men seek professional advice. A recent survey found that most men prefer a non-prescription approach to help them maintain and enhance their sexual and urinary wellness, supporting the American trend toward self-reliance in managing health care needs. Unfortunately, there is a paucity of factual and scientifically relevant information available on this category of products and their realistic health outc omes.

Introduced into the US market in 1998, BetterMAN[R], a proprietary Traditional Chinese Medicine (TCM) formula, was the first dietary supplement with scientific evidence to be touted in the media as a "natural herbal alternative" to Viagra[R]. In a landmark study published in the Journal of Urology, BetterMAN[R] was found to prevent ED in 100% of rats treated, and to exert dramatic beneficial physiological changes in penile tissue. In human studies involving American and Chinese men, BetterMAN[R] was found to be 70% effective in improving the following sexual and urinary functions:

* Obtaining and sustaining an erection

* Increasing libido and spontaneity

* Countering premature ejaculation

* Decreasing nighttime urinary frequency, and urinary urgency and hesitancy

* Enhancing prostate health

In the past 3 years, over 20,000 American men have used BetterMAN[R]. The following letter is typical of the issues and emotions facing men beginning to experience a change in their sexual health and their desire for some form of self-management:

"I am a CEO in my 50s. I am in tune with my body and have eaten healthy and exercised consistently for many years. So it was with some disappointment that I began to notice in my late 40s that my previously always-active libido seemed to be fading away, and I was beginning to have trouble sustaining erections through intercourse with my wife. This was a slow insidious change that I did not notice at first. In my younger days, I was able to sustain long erections and had never had anything like this problem. Perhaps of even more concern, I noticed that I was less interested, and even apathetic at times to the opposite sex. Didn't this happen to men in their 80's rather than 50's, especially if one maintained a healthy lifestyle? I was discouraged about this lack of interest and performance.

"I heard about BetterMAN[R] through a business acquaintance. At first, I was skeptical and a bit apprehensive, but I tried it. I did not notice any effect after the first bottle, and only a very slight effect after the second bottle. But during the third bottle it was apparent that something was happening! I began to get spontaneous erections in the middle of the day or while driving. I don't remember getting spontaneous erections since my teenage and 20's years. What an amazing result! I have stuck to the program, consistently taking the pills without side effects of any kind. While my performance is not quite that of a 20-year old, it has improved many times over from before I was taking BetterMAN[R]. Most important, my libido has returned to that of a younger man. Overall, this product has greatly improved my quality of life. Those ancient Chinese were much smarter than we are!"

I. UCSF Scientific Study: BetterMAN [R] TCM Formula Prevents Erectile Dysfunction in Rats -- Rules Out Placebo Effect

The first scientific evidence of the beneficial effects of BetterMAN[R] on penile tissue was published in the prestigious Journal of Urology (November 2000). The JU article reported on a study conducted by leading urologist, Tom Lue, MD at the University of California San Francisco, Department of Urology.

Dr. Lue, known throughout the world for his influential research in the field of impotency, wondered if any of the herbal dietary supplement formulas which claimed to improve ED actually worked. Dr. Lue was intrigued by the reported positive clinical outcomes of BetterMAN[R]. He and his colleagues set out to see if it indeed worked, and if there was a scientific basis for its purported benefits. According to Dr. Lue, "The effectiveness of a product for ED can be ascertained more accurately in animals than in humans due to the absence of the placebo effect, which can run as high as 40% in human studies."

With this in mind, Dr. Lue conducted his study with hypercholesterolemic rats. Hypercholesterolemia is a factor known to contribute to ED in men. Rats naturally develop ED around the age of 24 months, which is equivalent to 70 human years. Previous research found that rats consistently develop ED after being fed a 1% cholesterol diet for 4 months.

Accordingly, rats in this study were fed a 1% cholesterol diet for 4 months. During the last two-month period, two groups of rats were fed the BetterMAN[R] formula in their drinking water at two different dosages: 25 mg/kg per day and 50 mg/kg per day, while one group was fed water only. A separate control group of rats was fed a normal diet. At the end of the 4 months, 100% of the BetterMAN[R]-treated rats regained their erectile function as evidenced by the normal peak-sustained intracavernous pressure, while all the rats in the non-treated groups remained impotent.

The groups receiving the BetterMAN[R] formula showed no significant difference in cholesterol levels, systolic blood pressure, and neuronal and endothelial nitric oxide synthase (NOS) levels compared to the control groups. The most interesting results were the significant increases in membrane caveolae, caveolin-1, and basic fibroblastic growth factor (bFGF) protein levels in the penile tissue of the BetterMAN[R]-treated groups.

Caveolin-1 is the major component of caveolae, small bulb-shaped invaginations at or near the cell surface which act to sequester membrane-bound ligands away from extracellular space and facilitate their delivery to the cell cytoplasm. UCSF researchers suggest that the substantial increases of caveolin-1 and caveolae may compensate or overcome the harmful effects of hypercholesterolemia on the smooth muscle and endothelial cells, and thus, reverse erectile dysfunction in the treated groups.

Basic fibroblastic growth factor (bFGF) protein level was also significantly higher in the BetterMAN[R]-treated group as revealed by Western blot. This finding suggests that treatment with BetterMAN[R] results in up-regulation of bFGF, which may reverse the suppressive effect of hypercholesterolemia on the smooth muscle and endothelium.

The significance of this study is that it rules out the placebo effect. The study also indicates that the activities of BetterMAN[R] are very different from that of PDE-5 inhibitors, such as Viagra[R]. Dr. Lue and his colleagues concluded that it is likely that more factors may be involved in the formula's ability to treat ED, and that larger scale studies are needed to determine the mechanisms of action of the formula and its effect on other organ systems.

II. Clinical Studies

A. Ten-year Study of 5,000 Chinese Men Shows BetterMAN[R] 75% Effective in Improving Sexual and Urinary Functions

Researchers at two of the largest medical hospitals in China compiled data on 5,000 men who had taken the BetterMAN[R] formula between 1988 and 1997. Patients ranged in age from 35 to 65 and exhibited clinical symptoms of male sexual dysfunction: erectile dysfunction, premature ejaculation, low libido; as well as urinary problems. Physicians questioned patients regarding each symptom and recorded improvements (if any) based on each patient's self-assessment during office visits at the end of each cycle of treatment.

After taking the BetterMAN[R] formula for 3x20-day cycles, 95% of patients reported various degrees of improvement in sexual performance and urinary control. Seventy-five percent reported a high degree of satisfaction. In most case reports, patients only noticed small improvements after the first cycle with major symptoms subsiding after completing 3x20-day cycles of the formula.

Fifty patients who used the formula continuously for 3 years reported experiencing an improvement in overall well-being, greater energy levels, and an ability to maintain their desired level of sexual performance and urinary control.

The compiled data showed BetterMAN[R] to be a well-balanced formula providing the following benefits:

* Promotes both yin and yang functions of the kidney

* Enhances ability to attain and maintain an erection

* Improves sexual drive and libido

* Counters premature ejaculation

* Decreases nighttime urinary frequency, and urinary urgency and hesitancy

* Supports prostate health

* No side effects; safe to use

This data provides evidence that the BetterMAN[R] formula is effective for Chinese men. However, an herbal formula proven effective with one ethnic group may not be equally effective for another due to a wide variety of factors, e.g., diet and metabolic differences. Prior to its introduction into the US market a study was designed to determine if BetterMAN[R] would have a similar success rate with American men.

B. Short-term Study with American Men: BetterMAN[R] Found to be 70% Effective for Improving Sexual Functions and/or Urinary Control

Results from a 1997-98 independent study of American men indicate that even taken short-term, BetterMAN[R] is 70% effective at enhancing sexual functions and promoting urinary control. In the study, 45 men between the ages of 41 and 71 were recruited to take BetterMAN[R] at the suggested 3x20day cycle (2 capsules daily after meals with a 3-day break between each bottle). The study was modeled after the A Brief Male Sexual Function Iventory developed at Harvard University to quantitatively measure the effects of BetterMAN[R] pre-post three cycles of use.

The following results were tabulated by a third party:

* 70%: Improved either sexual or urinary functions

* 60%: Improved sexual functions

* 68%: Improved urinary functions

Percentage of participants noticing improvements versus length of treatment:

25% after 1st cycle (bottle)

55% after 2nd cycle

70% after 3rd cycle

Increases in the following measures were noted (% increase of pre-post means):

* 58% Erection lasting as long as wished

* 54% Overall satisfaction with sex life

* 48% Partial or full sexual erections when sexually stimulated

* 41% Ejaculations occurring at the time hoped

* 32% Erections firm enough for sexual intercourse

* 31% Level of sexual drive

* 26% Felt sexual drive

There were no side effects or adverse reactions, and after the study, 90% of participants elected to continue taking BetterMAN[R].

C. 2001 Survey of American Users Confirms Claimed BetterMAN[R] Sexual and Urinary Health Benefits

Two-hundred and thirty BetterMAN[R] users participated in a recent survey conducted between April 24 and May 8 2001. Participants were asked to complete an on-line questionnaire to assess whether BetterMAN[R] had helped their sexual and/or urinary issues. A third party tabulated the results.

Of the 230 respondents, one-third had taken less than the recommended 3 bottles of BetterMAN[R], one-third had taken 3 bottles, and one-third had taken more than 3 bottles. Seventy percent were between 45 and 64 years old, 67% were married, and 96% described their current health status as either excellent (49%) or good (47%).

Even though 76 (33%) of the respondents had not finished taking the recommended 3-bottle cycle, the effectiveness rate of the BetterMAN[R] formula with these respondents supports previous clinical results. Of those taking BetterMAN[R] for the purpose of improving or enhancing a specific sexual and/or urinary health function, the following percentage noted an improvement:

* Decrease nighttime bathroom trips (91%)

* Improve urinary control (91%)

* Improve spontaneity of erections (84%)

* Improve sexual desire (78%)

* Improve erections (76%)

* Improve prostate health (76%)

* Delay ejaculation (64%)

More than half of the respondents (53%) claimed to have used Viagra[R], and 29% of those continued to use Viagra[R] concurrently with BetterMAN[R] in order to "get the best of both products." Of those who had stopped using Viagra[R], the main reasons for no longer using it were:

* Immediate side effects (40%)

* Prefer a natural alternative (37%)

* Not as effective as expected (38%)

Of those men who had never used Viagra[R], 54% cited a preference for natural approach. Overall, men in the survey expressed a desire for a product offering a broad spectrum of benefits for their sexual health, rather than focusing on erection only.

III. Case Studies/Clinical Feedback

Health professionals and consumers have provided Interceuticals with first-hand feedback on their results with BetterMAN[R]. For privacy reasons, the persons quoted herein remain anonymous. However, if you are interested in using BetterMAN[R] in your practice and would like to speak with a colleague, please call Interceuticals for names and contact information.

Doctor of Osteopathy, Medical Center, Missouri: "We have treated over 300 patients with BetterMAN[R] in an attempt to restore optimum prostate health and reverse impotency. Eighty percent of men with nocturia noticed marked improvement in symptoms. We have used many products over the last 30 years, and have found BetterMAN[R] to be the most beneficial product for treating chronic prostate conditions, including inflammation and enlargement. BetterMAN[R] quickly relieves the discomfort associated with urination along with urgency, frequency and hesitancy. BetterMAN[R] is a tremendous treatment for impotency. Men state that they have harder, firmer, much longer lasting erections, and much better sex. BetterMAN[R] is nontoxic, safe, all natural, and works to revitalize prostate and sexual health. I unreservedly recommend BetterMAN[R] as the best product currently on the market."

Customer, late 60s, Massachusetts: "I went to my doctor about urination and sexual problems and was diagnosed via cystoscopic exam with an enlarged prostate. My symptoms included excessive trips to the bathroom at night, severe water relief urgency problem, and terminal dripping. I also noticed a decrease in sexual performance. My doctor provided me with samples of Viagra[R] on more than one visit. I was not happy with the results even with two 50 mg pills. To resolve the urination problem, the doctor prescribed Cardura[R] (4 mg), which I took for approximately 2 months, but the side effects were too great (constipation, fatigue, rapid heartbeat). I started to research and try dietary supplements, which my doctor said was OK to do. When I heard about BetterMAN[R] through an advertisement, I started taking the recommended 3 bottles. My urination problems have improved 10,000 percent, to a point now where I do not have a noticeable problem. I have also had a wonderful increase in sexual performance (eleven time s in 23 days) and continuing."

Medical Doctor, Private Practice, Missouri: "Seventy-seven year old, white male with history of atherosclerosis, hypertension, muscular weakness, depression, sleeping excessively, diabetes, severe bladder problems with urination 8 times after bedtime, thus insomnia. Patient had a TUR in 1992. Patient was put on Detrol[R] by MD for 3 months, prior to BetterMAN(r); helped minimally or not at all. Patient started on BetterMAN[R] in August 2000. At his last visit in October 2000 he has had no difficulty with excessive frequency of urination after bedtime. He has also improved in other areas with treatment of other diseases.

Pharmacist, Drug Store, Boston,Massachusetts: "We have more than 1,000 men currently using BetterMAN[R]. Many of the men report a decrease in urinary urgency and frequency of nighttime urination. Most customers have noticed major improvements in being able to achieve and maintain an erection, and have found an overall greater sexual satisfaction. We have been recommending BetterMAN[R] for over 3 years now, and have found it to be a safe product, without side effects or contraindications with prescription medications commonly used by hypertensive and diabetic patients."

IV.Product Information

BetterMAN[R] is manufactured in the US under current Good Manufacturing practices (GMPs), and all ingredients are screened for heavy metal contamination. Each 900 mg capsule contains the following herbs (the botanical name is followed by a more common name and its key function in TOM terms):

* Radix ginseng (Ginseng root): improves whole body vital energy (Qi) and sexual functions.

* Rhizoma dioscoreae (Yam rhizomes): improves the yang function of kidney.

* Radix paeoniae alba (White peony root): improves immune functions; acts as a vasodilator.

* Herba epimedii (Aerial parts of Epimedium): improves muscle and sexual functions.

* Cornu cervi pantotrichum (Deer antler): improves overall metabolism and sexual functions.

* Radix astragali (Astragalus root): improves immune system, whole body stamina and sexual functions via the central nervous system.

* Poria cocos (Poria fungus): provides tranquilizing effects, strengthens yang functions.

* Radix morindae officinalis (Morinda root): strengthens muscle and bone functions, enhances endocrine system functions.

* Fructus corni (Cornus fruit): improves yang function of kidney.

* Cortex eucommiac (Wood cotton bark): strengthens muscle and bone functions; low dose dilates peripheral blood vessels; high dose causes vasoconstriction.

* Radix angelicae sinensis (Dong quai root): improves blood circulation.

* Fructus lycii (Wolfberry fruit): improves immune system function and the yin function of kidney.

* Radix rehmanniae (Rehmannia root): improves immune system function and the yin function of kidney.

* Rhizoma chuanxiong (Szechuan Lovage root): improves blood circulation and dilates peripheral blood vessels.

* Fructus schisandrae (Schisandra fruit): improves yang function of kidney.

* Acanthopanax senticosus (Siberian ginseng): tranquilizing effect, improves sexual functions.

* Cynomorium songaricum rupr (fleshy stem of Cynomorium): improves immune system and endocrine system.

* Cortex cinnamomi (Cinnamon bark): improves yang function of kidney. Dosage and Directions for Use:

Dosage and Directions for Use: Take two capsules daily, one after breakfast, and one after dinner, for 20 days to finish one cycle (bottle). Take a 3-day break between each bottle. For best results, take a minimum of 3 bottles consecutively. For men over 70 and those with other medical conditions, the minimum effective dose is 4 to 6 cycles (bottles). Continued usage will provide ongoing improvement. BetterMAN[R] is safe for long-term use. Note: The 3-day break between each bottle is a "wash out" period recommended based on TOM theory to prevent potential resistance to the formula as a result of long term usage.

Contraindications: Since its introduction into the US market in April 1998, BetterMAN[R] has had no reported contraindications. In a survey of 5,000 men at 2 major hospitals in China over a 10-year period, there were no reports of drug interactions among those taking prescribed medications of Chinese origin.

Safety Data: There have been no reported side effects or adverse events associated with the use of BetterMAN[R] at the recommended dose. BetterMAN[R] contains no stimulants.

Acute Toxicity Data: In mice fed the BetterMAN[R] formula at 333 times the human dose, there was no incidence of death or abnormalities.

Warnings and Precautions: Men over the age of 50 should have their prostate checked regularly, particularly if they experience difficulties with urination. Men taking prescription medications, prone to allergic reactions or about to undergo any medical procedure or operation, should notify their physician or health care practitioner before taking any dietary supplement.

Frequently Asked Questions

Q: How can the placebo effect be ruled out for BetterMAN[R]?

A: The UCSF scientific study with rats (see section I) clearly demonstrated that the BetterMAN[R] formula was not only highly effective in treating ED in rats, but also caused specific physiological changes in penile tissues -- both of which rule out the placebo effect. In addition, in human clinical studies, the success rate of BetterMAN[R] has been shown to be proportional to the length of usage: 25% success rate after first bottle, 55% after 2nd and 70% after 3rd bottle. This trend is the opposite of the placebo effect, which has an immediate onset, but is not sustainable over time.

Q: Can the data from a rat model be extrapolated to humans?

A: The efficacy of BetterMAN[R] in humans is supported by over 50 years of use in China, open-label studies with US men, and health professional and consumer feedback. The rat model study was conducted as a "reverse" scientific study: studying a known phenomenon to find out why the phenomenon occurs. This type of research provides scientific insights that would be impossible to obtain in human studies.

Q. How do the ingredients in the BetterMAN[R] formula work to produce the desired sexual and urinary health benefits?

A. Based on TCM theory, BetterMAN[R] improves both the yinand yangof kidney function. It also improves blood circulation and modulates muscle, neuromuscular and central nervous system functions. It does not contain any stimulants. Very little is known about how the formula works at the molecular level. The UCSF study (see section I) provided the first scientific insight using the hypercholesterolemic rat model. The BetterMAN(r)-treated rats were able to reverse erectile dysfunction and restore lost potency through the formula's protective effects on penile tissue against the harmful effects of cholesterol. These protective effects may be a result of the significant increases in caveolin-1 and caveolae, and up-regulation of bFGF. Due to the complexity of the BetterMAN[R] formula, more studies are required to decipher the exact mechanisms of action involved.

Q: Has BetterMAN[R] an effect on nitric oxide synthase (NOS) levels?

A: No, BetterMAN[R] does not have an effect at the enzyme expression level. Based on the findings of UCSF study (see section I), the mechanism of action of the BetterMAN[R] formula appears to be very different from the PDE-5 inhibitors, such as Viagra[R].

BetterMAN[R] produces spontaneous erections after 3x20-day cycles of use rather than a pill-induced temporary erection within hours of the prescribed dose. In addition to improving erection, BetterMAN[R] also increases sexual desire, libido and supports prostate and urinary functions.

Q: Can I take BetterMAN[R] even if I don't currently have any issues with my sexual health or urinary control?

A: Yes. BetterMAN[R] may be taken as part of a preventative dietary regimen in men 18 years or older. Research has found that one-third of men over 18 experience erectile difficulties of some form. After age 40, about 50% of men experience issues with their sexual and/or urinary health.

Q: Is the BetterMAN[R] formula able to reduce the size of an enlarged prostate?

A: Although BetterMAN[R] has been shown to dramatically improve urinary hesitancy, frequency, and urgency issues - symptoms associated with enlarged prostate - the reports of reduced prostate size have been anecdotal. Further clinical data needs to be collected to understand the formula's impact on the prostate.

Q: How does the BetterMAN[R] TCM formula differ from other TCM formulas for sexual health?

A: Generally, a TCM formula would have no application to a large population since Chinese physicians trained in TCM treat each patient individually and specifically. In contrast, the proprietary BetterMAN[R] TCM formula was shown to be more than 70% effective across a large population of both Chinese and American men - without side effects.

Q: How can I measure my pre-and post-sexual performance levels (even if I don't have a partner)?

A: Answer the simple, 11-questions in the A Brief Male Sexual Function Inventory questionnaire developed by Harvard Medical School and available at www.BetterMANnow.com. Score your current sexual performance level based on the questionnaire. Take the recommended 3-bottle cycle of BetterMAN[R]. Then, answer the questions again. Compare your pre-and post-BetterMAN[R] scores. If preferred, the effectiveness of BetterMAN[R] may also be measured by using the International Index of Erectile Function (IIEF) questionnaire.

Q: Do I have to take BetterMAN[R] continuously to retain the sexual and urinary health benefits it provides?

A: No. However, continued usage of BetterMAN[R] has been shown to provide on-going improvements in sexual and urinary health. Long-term users have also noted an improvement in overall well-being and increased energy levels. BetterMAN[R] is safe for long term use when taken as directed.

References

Bakircioglu, M.E., Hsu, K., El-Sakka, A., Sievert, K.-D., Lin, C.S., Lue, T.F.: Effect of a Chinese herbal medicine mixture on a rat model of hypercholesterolemic erectile dysfunction. Journal of Urology, 164: 1798, 2000.

Kee, C.H.: The Pharmacology of Chinese Herbs, CRC Press, 1993.

Laumann, E.O., Paik, A., Rosen, R.C.: Sexual dysfunction in the United States. Prevalence and predictors. Journal of the American Medical Association, 281: 537,1999.

O'Leary, M.P., Fowler, F.J., Lenderking, W.R. et al.: A brief male sexual function inventory for urology. Urology 45(5): 697, 1995.

Wei, M., Macera, C.A., Davis, D.R. et al.: Total cholesterol and high density lipoprotein cholesterol as important predictors of erectile dysfunction. American Journal of Epidemiology, 140: 930, 1994.

COPYRIGHT 2001 The Townsend Letter Group COPYRIGHT 2001 Gale Group