14 Larry J Frieders RPh, on BioIdentical Hormones

Larry J Frieders RPh, on BioIdentical Hormones

by Jeffrey Dach MD

From Larry Frieders, August 2007

Good morning Dr. Dach;

I've been approached by some local doctors about getting involved with the
WILEY PROTOCOL for hormone replacement. I received a call yesterday from someone who works for Wiley and they've sent their contract materials. I am not completely familiar with the ins and outs, but I am aware that there is some controversy about her approach. There are fees involved, but they don't concern me as much as the protocol. My current information is mostly hearsay - and somewhat tainted.

However, upon review of the materials they sent I get an impression that perhaps Wiley is onto something - particularly as it relates to a method for standardizing hormone replacement. I've been involved with this type of therapy since 1998 and I become more and more dismayed at the wide range of methods and dosing I see. Some prescribers order large doses and others get along with what seems to be miniscule amounts. Some dose EVERY day and others tell me that the only legitimate way is to cycle the dosing - allowing time for receptors to clear.

Then, there's the variety of dosage forms, capsules, suppositories, troches, sublingual drops, transdermal creams, etc. Even when there seems to be some consistency in using a topical, the different bases used are enough to cause me to doubt the integrity of the whole idea of balancing hormones.

About 3 years ago a doctor I know very well threw up his hands in exasperation and stopped prescribing hormone replacement. He said that he was finished until "the" could give him better guidelines for evaluating and prescribing. I scurried to relocate his patients with other doctors. Perhaps Wiley is on the path to helping doctors like that.

You're a specialist in hormone replacement. What are your thoughts about Wiley's approach?

FYI...my next presentation on the HRT topic
http://carolinesutherland.com/images/FCKUploads/File/AntiAging-flyerSEP07B.pdf

Larry J Frieders, RPh, MMgt, MA
http://www.thecompounder.com/
340 Marshall Ave Unit 100 | Aurora, IL 60506
630 859 0333
_______________________________________________________________

----- Original Message -----
From: jeffrey dach
To: 'Larry Frieders, R.Ph.'
Cc: 'jeffrey dach'
Sent: Thursday, August 23, 2007 3:14 PM
Subject: FW: from jeffrey dach md

 Dear Larry,

I agree, the B HRT field is all over the place. I heard Wiley present at one of the ACAM meetings about 2 years ago, and the major criticism was that her dosing was too high and causes irregular bleeding. Besides, most patients prefer to avoid the inconvenience of cycling. We don’t use it.

Our (My ) approach to Bio Identical HRT is fairly simple.  We start at a low dose and gradually increase until symptoms of Hot flashes and night sweats are relieved.  Maintenance dose is the lowest with relief of symptoms and good quality of life.  Starting dosage for the average 50 year old is 1.25 mg/gram topical Bi-Est once a day, and for the average 70 year old is 0.625 Bi-Est once a day.  Dosage is increased gradually if needed for symptom relief.

Of course, we use an extensive baseline lab panel from Quest and recheck labs at 6 month intervals.  Although some authors like Vliet have given target areas for the labs published in her books, we don’t  dogmatically use those, since after trying that we found so much individual patient variation that Dr. Vliet’s hormone target ranges are only rough approximations, and in many cases too high.

There are the saliva testers (Eldred Taylor) and the blood testers (Reiss, Vliet, Cenegenics etc.).  We have tried both ways and have settled on blood testing.

We also tried using Dr. Uzi  Reiss’s dosages he lists in his book, and found them to be much too high for our population.

A common mistake is to omit giving thyroid which most B HRT patients need in spite of normal labs.  We  use the thyroflex (Konrad Kail Western Research) to measure reflex time which is a more accurate indicator of thyroid function than is the TSH. We use natural thyroid (western research naturethroid).  If thyroid is omitted, the patients gain weight and become discouraged with the program. 

Another common mistake is to omit or ignore Iodine supplementation.  We use Iodoral from Optimox (Guy Abraham, MD).

We also check serum vitamin B12 and Vitamin D levels.  Can’t get a good result unless these are optimized.  And you know b12 and D are cheap.  So is Iodine.  We have uncovered quite a few severe B12 deficient patients missed by conventional docs. This is rewarding because patients immediately improve with  nontoxic and inexpensive b12 shots or SL tabs.

Another pitfall is to ignore  adrenal fatigue which is ignored by conventional medicine.  We give adrenal supplements in selected cases.

Another stumbling block is progesterone excess from topical creams which can manifest in bizarre symptoms and can be difficult to recognize until the cream is stopped and symptoms go away.  This is bad because it usually discourages the patient who goes off the program and dumps the doctor.  Progesterone capsules or lozenges seem to avoid the excess problem.  On the other hand some women do better with the topical progesterone cream (Dr. Lee is a big advocate of the topical progesterone cream at dosage of about 20 mg per day.) .  If we use the topical progesterone, we dose 27 on and 3 days off to prevent excess build up in the Sub Q fat depo.

There are some such as Dr. Rami, the hormone specialist at Diagnos-Techs (the saliva lab) who have totally given up on using topical progesterone (Caps or SL troches ar OK) because they have run into progesterone excess too many times in their patients (mood disturbance such as depression seems to be the major symptom)  I spoke to Rami about this and he said he had a consultation with  Dr. Lee (before he passed away) who came to their facility and worked with them on this issue.  In spite of the Lee visit, Rami still doesn’t advise using topical progesterone.  He prefers the caps or lozenges.  Rami is very knowledgable and a great intellectual asset, and I am glad he is available for consultation and advice on difficult cases.
 
For the first few months, we may change the route of administration and tweak dosages, so we usually call the patient every 2 week for the first few months just to check in on them.  This can be time consuming and labor intensive, but needs to be done.  Not only do we follow serial labs, we also do a baseline pelvic sonogram and follow endometrial thickness, and keep track of the usual routine annual exams and send out reminders if that stuff needs to get done.

I think after two years and three hundred patients, I am ahead of most docs when it comes to B HRT, but I realize there is still much to learn.  I didn’t feel comfortable with radiology interpretation until after 10 years in practice.  B HRT may take as long.

The major points are (1) start low and gradually increase over time to relieve symptoms.( 2) Hormones are just part of an overall evaluation and other issues such as B12, vit D, thyroid, iodine, adrenal are all part of the picture and need to be addressed to get good results.

Please let me know your thoughts on the above and what changes or additions you would make, as I value your opinion.

BTW, Channell 7 Fox news was at the office yesterday doing  a news segment on us.  Will come out on Sept 15 on TV at 5 PM and I will send you the internet video link when available since you don’t get Florida in Chicago.  The media is starting to pick up the rising tide of bioidentical hormone usage by the consumer population.

Your newsletter is the greatest, and thanks for thinking of me.

Warmest Regards from,

Jeffrey Dach, M.D.
4700 Sheridan, Suite T
Hollywood, Florida 33021
www.jeffreydach.com
www.drdach.com
www.naturalmedicine101.com
www.truemedmd.com
_____________________________________________________________

From: Larry Frieders, R.Ph.
Sent: Monday, August 27, 2007 4:13 PM
To: jeffrey dach

Dear Dr. Dach;

We first got involved with the HRT stuff about 10 years ago and we've been doing our best to let people know about the advantages of using human (bioidentical) hormones instead of the commercial types (the alien substances). 

We have devoted most of our attention to saliva testing and helping women who are predominantly plagued by estrogen dominance. This is clearly a widespread problem that is made worse by the chemicals in our environment. The majority of the people we consult with are clearly deficient in progesterone. They benefit dramatically from a small non-prescription dose of progesterone cream. We always recommend using it according to a schedule. Younger women apply 20mg daily from days 13 through 26. Those with more symptoms or nearer to menopause are instructed to apply 20mg once daily from day 1 to 12, then twice daily from 13 to 26, then stopping until day one. If they are not having periods the days are marked with a calendar.
For the first few years we suggested retesting (saliva) in 9 to 12 months. But, as many have seen, saliva testing after using a supplement returns some wild numbers. We concluded that follow-up testing by saliva is a waste of resources.

As I said, most women do well with progesterone - and lifestyle adjustments. Women who have a history of birth control pill use, or who have had a hysterectomy usually need something more than just progesterone. These are a problem for us because we cannot prescribe estrogens or testosterone. Problems? There aren't many doctors around our office who are comfortable prescribing B HRT.  I also think that these patients require more time and attention than most "employed" doctors are able to devote.

Back to testing. I think that an initial saliva test is useful. Yet, I am seeing more people going to blood/serum, especially for testosterone levels. I also think that blood/serum tests have a long history and they add a solid degree of comfort for the prescribers.

Almost all of our estrogen doses are les than 1mg. People who have had prescriptions for larger doses don't seem to have them refilled as regularly as those who are using the lower amounts.

Your observations about thyroid are vital. Too many doctors, though, seem to shy away from those systems. We regularly talk to people who have every hypothyroid symptom in the book, but they have a "normal" TSH. I'd say that most prescribers are uncomfortable ordering thyroid supplements for someone who has a "normal" TSH.

We've been dispensing a thyroid challenge test hat consists of 5 strengths of T3 (slow release) and a chart to report temperatures and symptoms. Patients take the doses every 12 hours - increasing and then decreasing strengths according to a schedule. There is usually a place in the doses where the person reports feeling better (or has a higher temp). The doctors use that dose as a starting place for further supplementing.

We have stocked Iodoral since it first became available and it is fairly popular. I remember when almost all table salt was "iodized". Recently I've noticed that it doesn't seem to be the case these days.

FYI... some of my compounding colleagues are starting to use hormones mixed in oil (almond, grape seed, etc) and the doses are in the drop range. They use a calibrated dropper and apply the dose to the wrist - and then rub the wrists together. The claim is that patients appreciate the convenience. Also, some people are reporting that they can adjust their doses by their need. Women seem to be particularly good at knowing when they need a little boost of testosterone or estrogen. I'm hoping that one or two of our local doctors might be interested in trying this approach. Do you have any experience with hormones in topical oils?

Finally, I'm pretty certain that we are not going to get involved with Wiley - the high doses make me nervous - and I agree that most women are not eager to continue having periods into their 60s and beyond. There is one doctor locally who has asked me to get involved. Wiley asks for about $6,000 to get started - and then requires that the pharmacy purchase devices only from her. There is a statement in her patient guide that specifically tells the users to NOT take any medical advice from the pharmacist. She wants me to play along with her protocol but not offer any advice. I think I'd have a difficult time staying silent when someone asks for my input.

I really appreciate your comments about our newsletter.

Regards,

Larry J Frieders, RPh, MMgt, MA
http://www.thecompounder.com/
340 Marshall Ave Unit 100 | Aurora, IL 60506
630 859 0333
___________________________________________________

From: jeffrey dach md
To: 'Larry Frieders, R.Ph.'
Cc: Jeffrey Dach
Sent: Tuesday, August 28, 2007 11:20 AM

Dear Larry,

Regarding the estrogen doses all less than 1 mg, is this Bi-Est cream?  Or oral capsules, or SL troches? What form is it?

So far, we haven’t used the Oil based drops for hormone administration.  I am willing to try it, though, if it offers a benefit.  Keep me updated on it. 

Also, so far, we haven’t used a thyroid T3 schedule to determine dosage.

We usually start with ½ grain Naturethroid and gradually increase by ½ grain increments every 2 to three weeks until there is relief of symptoms or symptoms of thyroid excess become apparent at which point we reduce dosage.

We also monitor reflex time on the thyroflex, and thyroid labs every 12 weeks.  The free T3 level is useful.  TSH usually drops below 1 with adequate treatment.

So far we have been having good results with the NatureThroid from Western Research, so I have no plans to use the compounded T3/ T4 combinations available. 

Another issue is safety, I feel that the Naturethroid is safer, since the effects dissipate after 6 hours.  Not sure about the extended release T3, though, and I am hesitant to use it for safety reasons. 

Also, with your permission, I would like to post our latest email exchange about bio-identical hormones on my blog www.jeffreydach.com,  and eventually I plan to write a book which will include a chapter on Bio-Identical Hormones- How I Do IT, and I would like to include the your experience with saliva testing and natural progesterone which you have mentioned.  Would you be interested in contributing to that chapter?

Warmest Regards from,
Jeffrey Dach, M.D.
www.jeffreydach.com
www.drdach.com
www.naturalmedicine101.com
www.truemedmd.com
_____________________________________________________________________________

Dr. Dach;

Dosage forms - almost exclusively topical/transdermal. There are a few doctors who still order oral estrogens in spite of the slight increased risks.  I think the research says one thing about risk, but something else happens in practice. Biest seems to be the leader - Triest is practically off the screen. I don't know many prescribers who are still ordering estrone (E1). The ratios range from 50/50 to 90/10. Probably greater than half of our Biest are the 80/20. The 90/10 ratio is out of fashion and 50/50 is running a distant second.

Progesterone capsules are still popular, particularly for younger women who may be having difficulties with PMS. It seems that the metabolites from oral doses are active - actually calming. Some ladies insist on oral progesterone because it helps them relax and sleep. The oral preparations we make are in a slow release formulation - much different from the commercial capsules that are made with peanut oil (Prometrium).

I've not had much luck with any kid of troche - or sublingual drops for that matter. First, hormones are terrible tasting and it is difficult to find a flavor/sweetener that is satisfactory. Second, I find that a LOT of a sublingual dose is actually swallowed. In effect, then, it's an oral dose - or at least a lot of it is an oral dose.

I'm not particular about the version of thyroid. Naturthroid is an excellent commercial product and probably meets most needs. We're ready when someone wants something a little different. The slow release ingredient is methocel and it somewhat retards the dissolution in the gut. It makes some medicines a little easier on the GI lining - probably not a big issue with T3 and T4.

Our most popular T3 preparation is the challenge kit. It consists of 5 different strengths of T3 (from 7.5mcg to 37.5mcg. The patient starts low and takes 1 capsule every 12 hours, changing doses every 2 days on the way up and every 3 days on the way down. The dose at which there's an improvement or a temperature increase is an indication of a place to start dosing.  Some people find this useful when they exhibit hypothyroid symptoms without a definitive lab report.

It's a rare doctor who aggressively treat hypothyroid symptoms in the absence of clear TSH values. We think the challenge helps identify low thyroid and points to a starting supplement dose.

If you'd like to use any of my writings, feel free. I haven't written anything that I wouldn't want to see in print elsewhere. Use whatever you think best suits your needs.

I'd be delighted to contribute to a book. Just let me know when and point me in the right direction.  Will your audience be other practitioners or patients?

Larry

Larry J Frieders, RPh, MMgt, MA
http://www.thecompounder.com/
340 Marshall Ave Unit 100 | Aurora, IL 60506
630 859 0333



For more information on Bio-Identical Hormones, see my new book:  http://www.bioidenticalhormones101.com