Dr. Hale's Medical Blog

*Graduated from Anderson University, Anderson, Indiana in 1968. *Graduated from Kirksville College of Osteopathic Medicine in 1974. *Completed a rotating internship in Erie, PA at the Doctors Hospital in 1975. *Family practitioner in West Virginia for two years. *Moved to Tennessee in 1977. After a short time in Emergency Medicine began his own family practice in Mooristown, Tennessee. *Certified in Family practice in 1988. *In 2001 began hair transplantation and was certified by the International Academy of Hair Restoration Surgery in 2005. *Was certified in LipoDissolve by Network-Lipolysis of WorldHealth Network in 2006. *Was certified in Age Management by Cenegenics in 2007.

Recent Pellet Hormone Replacement Therapy document

WHAT ARE NATURAL BIO-EQUIVALENT HORMONES?

Bio-equivalent hormones are chemically structured to be equivalent to the hormones that your body produces naturally. By contrast, synthetic hormones are patentable hormones such as Premarin, Prempro, Provera.

Most physicians prescribe synthetic hormones to treat menopausal symptoms. However, synthetic hormones do not correct the hormonal imbalance that causes so many health problems.

WHAT HORMONES SHOULD I TAKE?

Women naturally produce estrogen, progesterone, and testosterone while men produce mostly testosterone. They will replace these hormones with natural bio-equivalent pellets to achieve balance again.

HOW ARE MY HORMONE LEVELS DETERMINED?

The patient will provide a detailed personal and familial medical history. A simple exam of the patient is given and lab work will be drawn. From the lab results, a doctor will determine the dosage needed to rebalance the hormones. Patients will be seen in 2 or 3 days to discuss their personal treatment plan.

HOW ARE THE HORMONES ADMINISTERED?

Hormones come in a pellet form similar to a grain of rice. A small area of the lateral buttocks is anesthetized, a tiny incision is made, and the pellets are inserted into the subcutaneous fat. The area is covered with a small dressing and the patient will be released and be able to go back to normal daily activities. Lab work will be repeated in 3 weeks for women and 6 weeks for men to evaluate their response to the treatment.

*Recent post*

Written by: Dr. Dan E. Hale

Medical Director of HRC Medical

Sexual stimulating hormones, estrogen, progesterone and testosterone, begin to diminish as we age. There is a wide range of hormonal changes within age groups. A 22-year-old female may have lower testosterone than a 42-year-old female. A 62-year-old male may have 4 times the testosterone as a 30-year-old young man. Usually one can sense that "things are just not right". The most frequent complaints are tiredness, less energy, and poor sleep. However, there are a whole host of other symptoms: decreased sex drive, hot flashes, night swears, vaginal dryness, dry skin, anxiety, mood swings, headaches, weight gain, restless leg syndrome, depression, memory loss, painful intercourse, palpitations, irregular menstruation, hair loss, food cravings, irritability, painful joints, loss of muscle mass, loss of pubic hair, osteoporosis, overly emotional and, lack of self-esteem. Virtually every overweight patient is low in testosterone. Burris et al. found hypogonadal men to have statistically significant reductions in the incidence of nocturnal erections, the degree of rigidity during erection, and the frequency of sexual thoughts, feelings of desire, and sexual fantasies.(1) An article in Metabolism 1990 noted alterations in body composition, including increases in percent body fat, changes in adipose tissue distribution, and reduction in muscle mass, are frequently seen in hypogonadal men."(2)

These symptoms may be caused by lack of one or more of the sex hormones. For example, foggy thinking may result from low estrogen and/or progesterone and/or testosterone. When these hormones are in balance we function better as when we were much younger.

Subcutaneous pellet hormone replacement therapy is preformed with the insertion of bio-equivalent 17-beta-estradiol and testosterone and oral micronized bio-equivalent progesterone. The results of pellet hormone replacement therapy are measurable. Relief of symptoms is not just antidotal. The hormone levels are checked before pellet insertion and again after. The levels always return to normal.

Traditionally hormones have been prescribed as pills, creams, injections or patches. There are many problems with all these routs of administration. An important problem is the variability of hormone concentrations from one hour to the next; in other words, the half-life is too short. With each dose the hormone concentration elevates quickly but in a short time the concentration is so low as to be essentially ineffective. Oral conjugated estrogen, as we all know, is made from horse urine, from a pregnant mare. This hormone causes an abnormal elevation in estrone which causes constant stimulation of the breasts.

It is also difficult, if not impossible, to elevate the concentrations of these hormones sufficiently high to be of practical benefit to relieve the symptoms and to return the body to the levels needed to maintain optimal health. As one physician noted recently, "You would have to take a bath in the ointment to get the levels high enough to do any good." Again, these levels are easily measured before and after treatment; but, equally important is to listen to the patient when they celebrate the return to a normal healthy life. After implantation of bio-equivalent hormone pellets we frequently hear, "This has changed my life. I sleep all night now with no night sweats. I have more energy and I feel like exercising. And my husband is so glad I am back to the way I used to be."

Compliance is a major problem when the patient has to take a pill every day. To rub on a cream once or twice a day and getting the exact correct dosage each time is probably not going to happen. For a patient to give himself/herself an injection of testosterone once or twice a week is problematic. Patches frequently come unattached and are not going to give therapeutic blood levels for hormone replacement. Compliance with the use of implanted hormones is excellent. The patient is seen usually every 4 to 6 months for a re-implantation.

Menopause is much more than just not having a period. Menopause begins when the level of follicular stimulating hormone (FSH), a pituitary hormone, goes up to 23 whether she is menstruation or not. This can be a scary time. Women may have significant hot flushes and increased sexual dysfunction, as well as depressive symptoms which can cause psychosocial impairment. Women worry about what life will be like after menopause. Will my mood change? Will I be able to enjoy life? The answer is to maintain the natural hormones you had when you were 20 years old.

The commonly used synthetic conjugated estrogen for menopausal symptoms has inherent problems, namely an increased incidence of breast and cervical cancer, blood clots and heart disease as noted by the Women’s Health Initiative. This study enrolled over 16,000 women who were taking synthetic conjugated estrogens. The study was designed for 7 years but was stopped after 2 years for ethical reasons. The erroneous assumptions of this study implied that ALL estrogens given with progestin or progesterone produce an increase in breast cancer. Oral hormone replacement therapy cannot produce normal, steady physiologic levels of estrogen and maintain the physiologic ratio of estradiol to estrone 2:1.(3) Since most women in the USA now know of the health risks associated with synthetic hormones many are looking for a safe natural alternative.

Bio-equivalent hormone replacement is safe. There have never been any of the above noted health risks. As a matter of fact, replacing the natural hormones we once had when we were 20 can be protective. Dr. Gino Tutera performed a study of 976 women over a period of 10 years (1992 through 2002) who all had the bio-equivalent pellet hormone insertions of estradiol and/or testosterone. After 10 years there was only 1 lady who had breast cancer. There were no cases of ovarian cancer, and only one case of endometrial cancer. The endometrial cancer was found after the patient’s first six months in therapy. The patient had Stage 3 Grade 1, well differentiated tumor who has remained disease free three years after therapy.(4)

There are several points to ponder about the lady with breast cancer. First, the cancer was discovered less than 1 year after the insertion. As we know, frequently breast cancer cannot be detected for 4 to 5 years by mammography. Most likely she already she had a microscopic cancer before the implants. Second, Dr. Tutera included all patients having inserts; he did not exclude anyone in the study who had breast cancer in the family or even if the patient had a history of breast cancer. These were patients in the years of a woman’s life where she would most likely find breast cancer. Third, with the law of averages (1 in 9 will develop breast cancer) one would expect to find 60 or 70 or even 80 women from a study group like this to develop breast cancer over a 10 year period.

From the above discussion one could surmise that subcutaneous bio-equivalent hormone replacement therapy with estradiol and testosterone with progesterone usage, imparts a protective physiologic environment that markedly reduces breast, endometrial and ovarian cancer. We know that breast cancer is extremely rare in an 18-year-old. An 18-year-old has normal levels of sex hormones to protect her. Subcutaneous pellet therapy causes the release of minute amounts of estradiol steadily over a 24-hour period for up to 4 to 6 months giving a protective physiologic ratio of estradiol to estrone at 2:1.

Equally, ovarian cancer shows marked reduction in those on oral contraceptive therapy as noted in the National Nurses Study. The reasoning is that OC therapy produces suppression of serum FSH thereby halting follicular development. Dr. Tutera’s study showed a complete absence of ovarian cancer for the same reason, suppression of FSH over 4 to 6 months. This produces a dormant state in the ovaries therefore a lower risk of ovarian cancer.

The round cylindrical pellets are manufactured from soy to be bio-equivalent to our own natural hormones of either estradiol or testosterone. If the patient is allergic to soy, yams can be used to compound the pellets. In general, the estradiol pellet is much smaller than the testosterone pellet. The dosages of the estradiol vary from 6mg to 25mg. Testosterone comes in a large variety of pellet sizes from 25mg to 200mg. Most women will receive 12.5mg to 25mg of estradiol and 100mg to 137.5mg of testosterone. Many men will receive 2000mg of testosterone. These dosages vary greatly according to the weight of the patient and symptoms of the patient and the blood levels measured. Natural compounded progesterone is given to women 21 days of each month who are still menstruating. In postmenopausal women who do not want to have a period progesterone is given every evening as progesterone may cause some drossiness. The dosage varies from 50mg to 300mg at bedtime with the higher doses occasionally necessary to prevent bleeding in postmenopausal women. If there is spotting the estradiol can be reduced with the next insertion.

The typical procedure is to see the patient on consult for complaints of menopause or andropause. "I have no energy. I am tired all the time. I am dragging by 3 in the afternoon." are almost universal comments of those who have hormonal deficiencies. On further questioning most will confess that they have no sex drive. Most note that they began to gain weight after the last baby or when they reached 40. A majority of women complain of not sleeping well. Many of these women also have restless leg syndrome. Often patients, especially women, are on antidepressants and sleeping pills for the above symptoms. When a patient presents with the symptoms of not resting well, tired all the time, no sex drive, not able to manage stress well, and being moody frequently their physician will diagnose depression. Many patients report that they are not depressed but know something is not right. Perhaps a diagnosis of low hormones should be considered before prescribing antidepressants.

When a diagnosis of lack of hormones is made by history blood is drawn for further confirmation. Generally a panel is ordered for FSH, TSH, progesterone, testosterone, estradiol, PSA for men, perhaps B12 and a CBC. A bone density study is also good to have. A return appointment is made for 4 days to review the results.

The physician determines the deficiencies and makes a recommendation based on the history the patient gives, the physical exam and the results of the blood tests. For women the FSH is often elevated and the estradiol is low. The testosterone is low and maybe the B12. Very often the progesterone will be low. Men often will have low testosterone. If the TSH is abnormal further studies are needed to determine an exact diagnosis and a treatment plan.

The lab studies are presented to the patient with a thorough discussion as to the pertinence of this information to their symptoms. It is not sufficient to have as a goal the often stated, "Your hormones are good. You are within normal limits for your age." Every question is answered and the possible side effects are discussed. Women are told they may develop acne usually very mild if at all. They may have spotting if they are menopausal. This is why progesterone is given daily to prevent bleeding. Female patients are told they could develop more facial hair than usual. Again, this is very unusual. Most of these side effects do not occur with proper dosing and all these problems can easily be corrected by adjusting the dosages.

Men receive only testosterone pellets and there are virtually no side effects with proper dosing. Men who achieved supraphysiologic levels of serum testosterone have no significant changes in PSA levels.(4) Equally, hypogonadal men with normal pretreatment digital rectal exams and serum PSA levels who were treated with parenteral testosterone replacement showed no abnormal alterations in PSA or PSA velocity.(5) The estradiol level is checked with each blood draw. It is important to maintain estradiol below 30. Testosterone can convert to estradiol when testosterone is administered. To lower the estradiol back below 30 an aromatase inhibitor, such as Femara 2.5mg can be given one every other month.

If the patient elects to proceed with the insertion he/she is laid on the side. The fleshiest part of the upper outer quadrant of the buttocks is located and cleansed. This is usually midway between the iliac crest and the greater trocanter. A 10cc syringe of Lidocaine is used with 2cc of N/S using a 1½ inch 25 gauge needle to infiltrate an area parallel to the table. A very small shallow incision is made at the point of infiltration. A female 3.5cm trochar or male 4.5cm trochar is inserted through the puncture site and quickly angled parallel to the table anteriorly along the path of the local anesthesia to the hub of the trochar. The stylus is removed and the appropriate size pellets are placed in the trochar and inserted with the plunger. Because men receive more pellets and larger pellets than females it is customary to make 2 paths with the Lidocaine at 90 degree angles followed by the trochar. Half of the pellets are placed in one direction and the other half in the other. The trochar is then removed. Benozin is applied around the incision site followed by Steri-Strips to close the incision. A 2X2 is applied directly over the Steri-Strips and large 3" elastic tape placed over the 2X2. The patient is instructed to avoid hot tubs, whirlpools and swimming for 5 days. Females return in 3 weeks for blood work and men in 6 weeks. Most women will have very minimal discomfort. Men will be some sore for 2 to 4 days but have little limitation in exercising. There is less discomfort when there is more available fat at the insertion site.

Women will have another blood test done in 3 weeks post-implant and men in 6 weeks to validate their response. This is also a good opportunity to talk to the patient about the changes they have seen in their life. Within this time period most will begin seeing marked improvement in their energy and sense of well-being. It is very unusual for a patient to not achieve within 3 and 6 weeks the levels of hormones needed for optimal health. If not, they may need another pellet or two. It is good to reach for the upper limits of these hormone levels. When we were younger our hormones were surging. Why not now?

Some physicians give progesterone to all women and even all men. Females who have had a hysterectomy may not need progesterone. All women with a uterus who are given estradiol pellets will need progesterone at bedtime either cyclically for those having periods or continuously for menopausal patients.

It is so emotionally rewarding to the physician to hear "My energy is so much better. I can sleep 8 hours a night without my legs twitching. I never have night sweats any more. My palpitations are gone. And my husband loves me being like I was when we were first married." Most patients on antidepressants are able to discontinue their medications. Many type 2 diabetics are able to decrease or discontinue their medicines and control their blood sugars with diet and exercise alone. No one on oral conjugated estrogen or testosterone injections or using the cream will have to continue this type of treatment. At times blood pressure drops sufficiently to reduce their medicines. Bone density increases much more than could be expected from the mainstream therapies of calcitonin, bisphosphonates and selective estrogen receptor modulators with all their long list of inherent side effects. Frequently cholesterol is reduced. It could be argued that these changes are because the patients lose weight as they feel like exercising more.

In conclusion, pellet insertion hormone replacement therapy is safe, effective and cost efficient with very minimal side effects. Virtually anyone over 40 years old should be tested for possible hormone deficiency. It is not extreme to consider the possible diagnosis of hormone deficiency in anyone younger than 20 who is symptomatic.

Burris, A.S., Banks, S.M., Carter, C.S., Davidson, J.M. and Sherins, R.J.: A long-term, prospective study of the physiologic and behavioral effects of hormone replacement in untreated hypogonadal men. J Androl, 13(4):297, 1992.

Seidell, J.C., Bjorntorp, P., Sjostrom, L., Kvist, H. and Sannerstedt, R. : Visceral fat accumulation in men is positively associated with insulin, glucose, and C-peptide levels, but negatively with testosterone levels. Metabolism, 39:897, 1990.

Thom, M.H.; Studd, J.W.W., Estrogen and Testosterone Implant Therapy. Whitehead, M., Campbell , Estrogen and the Menopause. Queensboorough, Kent; Abbott Laboratories, Ltd., 1978: 85-88.

Tutera, G. Subcutaneous hormone therapy reduces breast cancer incidence. Rediscover You. Scottsdale, AZ.

Ebling, D.W., Ruffer J., Whittington R., Vanarsdalen K., Broderick G.A., Malkowicz S.B., Wein A.J.,: Development of prostate cancer after pituitary dysfunction: A report of 8 patients. Urology 1997;49:564-568.