Primary Care Physician
Dr. Orrange received her BA in Biology at the University of California, San Diego, and a Masters Degree in Health Sciences at the Johns Hopkins University School of Public Health. She received her MD from the USC Keck School of…
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Bioidentical Hormone Replacement Therapy
Posted in Depression by Dr. Sharon Orrange on Jul 08, 2008

Many postmenopausal women are turning to "natural" or "bioidentical" hormone therapy after concerns about the conventional hormone preparations came to a head 2-3 years ago. Many are aware of the controversy surrounding Bioidentical Hormone Therapy which stems from the lack of evidence that these products are either safe or effective.



The terms "natural" or "bioidentical" hormone therapy are used to describe hormone treatment with individually compounded recipes of certain steroids in various dosage forms including testosterone, progesterone, estrone, estradiol, and estriol among others. These can be compounded as pills, gels, sublingual tablets, or suppositories. Based on the results of a person's salivary hormone levels, the final composition of the compounded dosage form is individualized to that specific person.


Supporters claim that bioidentical hormone therapy is better tolerated than manufactured products and possibly safer but that has not been shown to be true in the medical literature. A review of the medical literature was performed and published in the May-June 2004 Issue of Menopause 11(3):356-67 and little evidence was found to support individualized hormone dosing based upon saliva hormone concentrations. The conclusion of the authors was that evidence suggests that although individualized hormonal products may decrease some symptoms of menopause, it seems they have no proven advantage over conventional hormone therapies and their use is not supported by evidence regarding pharmacokinetics, safety, and efficacy.


What is a compounding pharmacy? The quality of compounded products may be substandard in some cases and that, among other things, is what worries the FDA and physicians. Compounding is the art of making custom made prescription medications specifically for an individual patient. There is an accreditation board and you should look for a compound pharmacy that carries the PCAB (Pharmacy Compounding Accreditation Board) approval. The U.S. Food and Drug Administration (FDA) has begun enforcement action against seven compounding pharmacies, stating that the claims made by these pharmacies about safety and efficacy of compounded "bioidentical hormones" are false and misleading, with no credible scientific evidence to support them.


What you need to know. While it appears that bioidentical hormone replacement therapy may decrease hot flashes there is no evidence that "bioidentical" hormones have any advantage over conventional hormone therapies. There are two factors to consider:


1. Their safety has not been established.


2. This approach is expensive and many providers perform frequent and unnecessary biochemical monitoring which you are paying "out of pocket" for in most cases. 


How do I feel about it? Many of my patients take bioidentical hormone therapy and I watch them closely and remind them of the hesitations I have listed in the discussion above. This is an individual decision and as long as the risks and benefits are discussed I will always support my patients who seek complementary and alternative therapies, and I see this as no different.


Dr O.

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20
Hi...
Nice post, I would like to request you to one more post about that **** careprost
Keep it up
Generic Cialis
By simonnicolos  Dec 22, 2010
19
Dear Dr. Orrange

Two weeks ago tomorrow I had received reclast for my osteo problem. All went well through the infusion, and then approximately 13 hours later woke up with a high fever, terrible bone pain close to kniving pain. In their information they talk of mild flu symptoms, these were not mild and after almost two weeks just a little bit better. I will tell you that I did take tylenol the day before and was very hydrated. My doc who is a wonderful person gave me torodol twice in the week and 1/2 and that seemed to help some. She considers that I had an adverse reaction to the Reclast. I dont want to scare anyone because I must mention that I am highly sensitive to drugs and have a hard time taking them. They say second time around reactions are less. Would like your feedback as to how long do u think these symptoms can stay??? I know by now Reclast is out of system and has just adhered to the bones, but pain is still there just a little lighter. Those who take it are kinda of stuck with reactions as there is no stopping it like a pill.
Reading on the internet some people of course had nothing some had up to 103 degree fever.

thank you
lauraden123
By lauraden123  Sep 21, 2008
18
Please disregard that post # 17 I found that article on the cholesterol and will look into the red yeast. thanks
By asilinc298  Sep 03, 2008
17
In reponse to the blog, what is the www page adress so I can find it and read about lowering the cholesterol naturally. thanks :)
YOu said to go to your home page and click read all articles by Dr Orrange. I need that home page address
By asilinc298  Sep 03, 2008
16
Hey Asilinc298
I actually wrote a blog on "Lowering Cholesterol Natures Way"
so you can check it out...on my home page you can click on
"read all articles by Dr Orrange" and look for that one...
Dr O.
By DrOrrange  Aug 11, 2008
15
I have been on bioidentical hormone therapy for several years and I have found more of a balance and tolerance than standard therapies.I had a surgically enduced menopause in my forties and did not tolerate pills and the patch. I was constantly having to change and wear combinations and it was either too much or not enough. The pharmacy I use is great and my insurance pays most of the cost.
By DorothyAnn  Aug 09, 2008
14
have been taking hrt for menopause symptoms.

For the most part the hrt make me feel better.

One thing that I have noticed on my blood work since
starting the estradiol is that my bad cholesterol level
went up to about 241. I have never had a problem with
cholesterol prior to taking estrogen.

What is the safest non statin way to lower that cholesterol?

I have fibromyalgia, and statins generally tend to cause more pain as a side effect. I don't need any drug induced pain.

Thanks in advance for your input on this matter.
By asilinc298  Aug 07, 2008
13
I am on this therapy now, and it has made a positve difference in my life. It has calmed the hot flashes and other symptoms. I use low dose bio identicles. Estrodiol progesterone cream, testosterone capsules. This is a wonderful thing.
By asilinc298  Aug 07, 2008
12
To cb72:
Of course these substances are no different and will have the same potential adverse effects that conventional hormone replacement therapy have
These are simply the same variations of hormones (estrone, estradiol, etc) done by a compound pharmacy so yes...no reason to believe they will behave any differently. I thought that point was conveyed but I guess not.

Another thing many of you have asked: whats the difference in the preparations of estrogen...nothing really and here are some useful equivalents to know:
1) 0.625 mg esterified estrogen or estrone sulfate is EQUIVALENT to
1 mg micronized 17-?-estradiol which is EQUIVALENT to 1.25 mg piperazine estrone sulfate which is EQUIVALENT to 5 to 10 ?g ethinyl estradiol

Hope that helps
Dr O.
By DrOrrange  Jul 31, 2008
11
Hm - this was really not helpful. You're treating "bioidentical" hormones like an exotic herbal supplement (it's not proved that it's safe). That is not the point. It is not proved that it is DIFFERENT. If a "bio-identical" estrogen binds to estrogen receptors, it will have the same side-effects as the "regular" estrogen. You can call it what you want, but I have not seen yet any reason to think "bioidentical" acts differently in the body then "regular". I was hoping this would be discussed in this article. Please, give us more substance.
By cb72  Jul 24, 2008
10
Hey enya4me
Your comments are so much appreciated.
No there are no other published studies in the peer reviewed medical literature on bioidentical hormone replacement therapy...that 2004 meta-analysis is the most recent. Sad isnt it
By DrOrrange  Jul 13, 2008
9
I went to ITC pharmacy web site and was going to order perscription refills. I found a news release I thought was worth posting.
http://www.itcpharmacy.com/june2008...
FOR IMMEDIATE RELEASE MEDIA CONTACT
June 9, 2008
Allan Jolly , R. Ph
(303) 663-4224 Ext. 503
ajolly@itcpharmacy.com
Local Pharmacist Lobbies Congress
to Protect Access to Bioidentical Hormones
Castle Rock, CO – Compounding pharmacists from across the nation stormed Capitol Hill this
month to lobby members of Congress to protect access to commonly compounded bioidentical
hormones. Allan Jolly, of ITC Compounding & Natural Wellness Pharmacy in Castle Rock, CO,
made the trip to Washington, D.C. While meeting with various elected officials and their staff,
Mr. Jolly discussed the value of pharmacy compounding and bioidentical hormone replacement
therapy (BHRT). Earlier this year, the Food and Drug Administration (FDA) asserted a new
policy to deny women’s access to bioidentical hormones.
Wyeth Pharmaceuticals, the number one manufacturer of synthetic hormone products, petitioned
the FDA to restrict the compounding of medications containing estriol, an estrogen produced by
the human body. Like many commonly prescribed drugs, estriol has a monograph from the U.S.
Pharmacopeia (USP), but is not a component of an FDA-approved drug. When it passed the
FDA Modernization Act in 1997, Congress clearly indicated that drugs with a USP monograph
could be compounded.
“This trip gave us a chance to have our voices heard by members of Congress,” said Mr. Jolly.
“With help from thousands of patients and prescribers who called and wrote their members of
Congress, our voices were heard loud and clear on Capitol Hill.”
The trip to Washington, D.C., dubbed Compounders on Capitol Hill, was the 14th annual trip
coordinated by the International Academy of Compounding Pharmacists (IACP). It was Mr.
Jolly’s 1st time joining the group.
ITC Pharmacy’s visit to Congress came at a particularly critical time for their pharmacy and
similar compounding pharmacies across the country. Last month several key representatives
introduced H. Con. Res. 342. The bipartisan resolution states that “the Food and Drug
Administration's (FDA) new policy restricting women’s access to medications containing estriol
does not serve the public interest” and called on the FDA to “reverse its policy.” Pharmacists
were greeted with an overwhelming sense of support from their members of Congress regarding
H. Con. Res. 342.
“This is an important step for compounding pharmacies like ours. We fill an important void for
hundreds of thousands of women whose needs can’t be met by manufactured medicines. They
rely on us and I simply don’t know where they would get the medicines they need if we couldn’t
compound with bioidentical hormones anymore” said, Allan Jolly, R. Ph, at ITC Pharmacy.
Pharmacy compounding is a pharmacy practice that enables doctors to prescribe customized
pharmaceutical treatments for patients when one-size-fits-all manufactured products are
inappropriate. While pharmacy compounding is regulated by state boards of pharmacy,
pharmaceutical manufacturers are pushing for onerous, federal restrictions that would restrict
patients’ access to needed medications.
About ITC Compounding & Natural Wellness Pharmacy
ITC Compounding & Natural Wellness Pharmacy was established in 1994 and provides
customers with numerous natural and holistic options to medicinal needs. With the latest
laboratory equipment and highest grade of ingredients, our Pharmacists can formulate
customized medications specific to your needs. By customizing each formula, ITC is able to
create precise dosages and ideal preparations that will best be absorbed and tolerated specifically
for you while ensuring optimal results. The staff and pharmacists at ITC Pharmacy care about
your overall wellness and will work with you to achieve the results you are looking for.
###

Bioidentical Hormone Therapy isn't only for women and menopause, but several medical conditions, for men as well.
http://www.itcpharmacy.com/aboutus.htm

I would like to also share with everyone an audio seminar that has started, but you could possibly still participate.

Bio-Identical Hormone Audio Seminar Features Top Experts
Are you interested in hearing top medical experts speak on Bio-identical hormone therapy? If so, the BHRT World Summit conference is coming to you on May 14th-May 29th in the comfort of your own home. Listen to top practitioners and experts reveal their approach to treating a variety of topics including menopause to prostates, migraines to depression, cancer prevention to thyroid health and many more hormone related conditions.

Don’t miss the chance to participate in this unique audio opportunity that is usually only available to physicians attending medical conventions. The BHRT World Summit invites you to listen and learn. For more information on the doctors, topics of discussion, and to register for this event, visit http://www.BHRT1.com/default.asp?id...
Hope this gives some more helpful information to pass along.
By enya4me  Jul 13, 2008
8
Bioidentical Hormone Therapy is supposed to be individualized to that specific person, but note is needed here. Bioidentical Hormone Therapy is medicine that is more naturally close to what your body produces and is better tolerated than manufactured products. I agree. As stated above "is the art of making custom made prescription medications specifically for an individual patient," but more specifically stated, Bioidentical Hormone Therapy is closer to the natural production of what our body produces.
Also stated above, “A review of the medical literature was performed and published in the May-June 2004 Issue of Menopause 11(3):356-67 and little evidence was found to support individualized hormone dosing. The conclusion of the authors was that evidence suggests that although individualized hormonal products may decrease some symptoms of menopause, it seems they have no proven advantage over conventional hormone therapies and their use is not supported by evidence regarding pharmacokinetics, safety, and efficacy”. This is an older article from 2004, so is there any articles more recent? With no credible scientific evidence to support Bioidentical Hormone Therapy compared to the conventional hormone therapy of manufactured products since 2004, I can understand both the consumer wanting something different to help them, and a business wanting in on the action to sell what will produce them profits.
To know about the pharmacy providing your medicine is a must! There are several internet based businesses with claims on Bioidentical Hormones so don't be sucked in. The accreditation board PCAB (Pharmacy Compounding Accreditation Board) is needed. Mentioned above, the FDA is taking action on seven compounding pharmacies for there false claims. These compounding pharmacies only spoil what may be a good thing to legitimately approved pharmacies, and to the consumer. This, in actuality, is the American way.
To me “manufactured products” make a one pill “fits all” that just doesn't work for all people. Bioidentical Hormone Therapy is compounding medicines to what our body produces naturally. This isn’t only for menopausal women.
My first prescription of a Bioidentical Hormone Therapy was a sinus spray. I have chronic sinus problems and use to use Flonase nasal spray daily with not much success. I now use a sinusitis spray made from ITC compounding pharmacy that is just absolutely wonderful and would never go back to Flonase.
I am a woman who is 44 years old. I started menopause around 32 years old and was completely done at 42 years old. I have Reynaud’s; I have a problem with the cold, and assume this is why I never had hot flashes only night sweats. With my own ignorance guided by my primary care doctors, I didn’t realize I was in menopause until I was right in the middle to ending of it. This was confirmed by blood work and a bone density scan. Since I was so young, my doctor and I made the decision to do HRT. On my days I took Prometrium I would still have light menstrual periods that were sporadic in existence. Now still on HRT, I haven’t had any cycle for over a year.
In March I started doctoring (along with my primary care doctor) out of state at the Fibromylagia and Fatigue Centers. My second prescription of a Bioidentical Hormone was for my thyroid. My T3 & T4 levels are off according to the Fibro and Fatigue Center and I was also put on Cortisol. Both of these were compounded by ITC pharmacy. My primary care doctor of 22 years didn’t say much about the thyroid medicine, but didn’t like Cortisol. The research I have done is that Cortisol is a stress hormone that women loose. Between the two of these medicines, within 2 (two) months time my body had a period, not just a spotty cycle, and I wasn’t on Prometrium those days. I feel my body is getting back into hormonal balance.
It is a matter how you feel, but years of doctors telling you what you feel or not feel I have learned to ignore “how I feel”. Learning to listen to my body again ……….
By enya4me  Jul 13, 2008
7
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By rwaller  Jul 12, 2008
6
Hi Repangel~~
Sounds like a good question. I dont know, but I would guess there IS something like that. It might take a little looking...What I *would* probably do... is call a compounding Pharmacy first... (that is IF your Doc doesnt have a suggestion about it, they just might if you ask) and ask if they have something like that. Then... you can bring it up to your doc for feedback and see what happens. That way you already know it exists before you ask.
I wish you luck in this and hope it works out for you!
LFH
By lladyfairhair  Jul 10, 2008
5
To all- I found this to be very interesting...seems like a long history / safety profile here.

The History of pharmacy is the history of compounding. Compounding occurs when a pharmacist prepares a medication by combining, mixing, or altering two or more ingredients for a patient based on the receipt of a valid prescription. For compounding to occur a valid relationship must exist between the pharmacist-physician-patient. This is known as the compounding “triad”.

Compounding dates back to biblical times. Ointments, balms, perfumes and oils are examples of compounding often referred to in the bible. The process of compounding was used to prepare these biblical preparations. In the Catholic bible the book of Sirach, referring to plants states “By them the physician heals and takes away pain; the pharmacist makes a mixture from them.” Compounding was used extensively in ancient times. Plants were the main ingredients in pharmaceutical mixtures even in modern times. A compounding pharmacist would take the medicinal plants and make concoctions, decoctions and extracts.

Compounding is also referred to in the story of the birth of Jesus. One of the wise men brought the gift of aromatic myrrh to the baby Jesus as a gift made by a compounding pharmacist. Myrrh is still is used today in compounding, often to treat inflammation and ulceration of the mouth and throat and pharynx and in spongy and bleeding gums. Internally, myrrh has been used in chronic cough, catarrh, and as an expectorant.

There existed a close relationship between compounding and religion up until the end of the period of alchemy during the medieval times. The birth of modern chemistry and pharmacy occurred when philosophy gave rise to the scientific method. The use of science to seperate fact from myth caused a rapid expansion of the numbers of plants used for medicinal purposes.

One of the most interesting developments in the history of compounding occurred with the use of coal tar for medicinal purposes. Coal tar contains hundreds of various chemicals. When applied topically coal tar often cures or treats many skin conditions like dandruff. German chemists began to isolate the different constituents of coal tar and developed synthetic dyes from them. One of these synthetic dyes was the first sulfa drug which gave rise to modern antibiotic therapy.

Compounding pharmacists used their intuition and scientific method to develop various medications. Petroleum jelly was discovered to contain healing properties. Fly larva was discovered to produce a substance, allantoin, which rejuvenated damaged skin. Quinine alkaloids from the bark of the South American Cinchona tree was discovered to treat malaria and leg cramps. Witch hazel, digitalis and opium are other examples of the plants and natural substances compounding pharmacists used to prepare medications for their patients.

As time went on, some chemists specialized exclusively in the compounding of medications. Thus the term “chemist” is still used to refer to a pharmacist in England. These chemists became known as pharmacists or druggists in the United States. By the 1800’s compounding became the exclusive domain of the specialized chemist. Compounding was needed because most of the medications required preparation to be usable. It was the practice of compounding that developed laudanum, one of the first pain medications. Laudanum is a combination of opium extract in the extraction vehicle, alcohol.

By the 1800’s most towns and cities in the United States had a drugstore staffed by a compounding pharmacist. Education requirements were established and societies of apothecaries began. One group of compounding professionals started the National Formulary and another started the United States Pharmacopoeia in 1820.

In 1877, compounding pharmacist, Dr. Squib, the drug company founder reinvigorated the United States Pharmacopoeia. Eventually the National Formulary and the United States Pharmacopoeia combined their efforts and set medicinal standards for the American public. Other noteworthy compounding publications were The Dispensatory of the United States of America, Remingtons and Martindales. All of these books contained information about the proper compounding practices as well as formulation standards.

As compounding continued to grow, compounding pharmacists needed to develop good tasting vehicles to dispense bad tasting drugs to their patients. These innovative compounding pharmacists developed various syrup extracts for this purpose. Compounding pharmacists learned that soda water when combined with syrup made drugs even more palatable. It was soon discovered that these syrups and soda water tasted great when combined so the soda fountain was born.

Charles Hires was a Philadelphia compounding pharmacist who according to his biography discovered a recipe for a delicious herbal tea while on his honeymoon. These compounders marketed sodas like Coke and Pepsi and thus the great soft drink industry was started. In May, 1886, Coca Cola was invented by John Pemberton a compounding pharmacist from Atlanta, Georgia. The term soft drink was not always applicable to these sodas. Sodas like Coke contained caffeine from the Kava plant and cocaine from the cocoa leaf. Coka-Cola took off when it was marketed as a headache remedy. It really did work but the risk of addiction outweighed the benefit.

Compounding pharmacists started the pharmaceutical industry with well-known companies like Eli Lilly, Merck, Squib, Upjohn and Sandoz to name a few. Merck eventually sold pure compounding chemicals to compounding pharmacists.

Allopathic Medicine the branch of medicine practiced by medical doctors owes the basis of their medical practice in large part upon compounding. The allopathic school uses drugs extensively to treat and cure diseases. This would have been impossible without compounding pharmacists to develop and make the drugs they prescribe. Other medical practitioners such as osteopathic doctors, naturopaths and homeopathic doctors all have the compounding pharmacist to thank for the success of their branches of medicine.

During the industrial revolution major drug manufacturing came into existence. Based upon compounding principles these compounding pharmacists increased their production capacity and began mass-producing medications. The mass produced drugs were enticing to compounding pharmacists because they made their life easier. No longer would a compounding pharmacist have to toil to prepare a compound while their patient waited. The compounding pharmacist could simply count out some manufactured pills and dispense them. This began the demise of the compounding pharmacist.

During the early 1900’s just about every prescription dispensed was compounded. By the 1960’s compounding was less than 5 percent of all prescriptions dispensed. The compounding pharmacist became a dispenser of medications rather than a compounder. In the 1950’s pharmacists were still trained extensively in compounding. Classes on compounding were an essential part of the pharmacy education. By the 1980’s compounding classes had become relegated to basically an after thought by most colleges of pharmacy.

During this time some pharmacists looked at each other and wondered what had happened to their profession. With good intentions and profit motive the government and major drug companies had slowly eroded the practice of compounding. Some of these pharmacists began the journey back to their compounding roots.

Today compounding has become a normal part of the pharmacy profession again thanks to the efforts of pharmacists in the 1980’s. Additionally bulk drug distributors like PCCA, Medisca, Hawkins Chemical, Apothecary Products and Paddock all have substantially contributed to compounding. The International Journal of Pharmaceutical Compounding (IJPC) is a scientific journal emphasizing quality pharmaceutical compounding.

Compounding continues to expand and plays an important role in the healthcare of millions of people. Compounding pharmacists have developed many innovative new compounds. Many disease states have been cured or effectively treated thanks to compounding.



Some examples of how compounding is used today:
Compounding natural hormone replacement therapy
Compounding pain medications
Compounding combination therapies like blood-pressure medications
Compounding beauty products
Compounding surgical medications
Compounding food supplements
Compounding male health medications
Compounding women’s health medications
Compounding impotence medications
Compounding herbal remedies
Compounding moisturizing lotions
Compounding deodorants
Compounding preservative free medications
Compounding dye free medications
Compounding lactose free medications
The compounding list is endless…


~Courtesy of "Soderlund Village Drug"
By lladyfairhair  Jul 10, 2008
4
Kweebs, I am so happy that you found what works FOR YOU. You know your body better than anyone. Compounding Pharmacies are very useful. They can compound almost ANY RX that you may need.
By lladyfairhair  Jul 10, 2008
3
Well the advantage to me with BHRT was that I have another illness to contend with, and BHRT could be made to a very low dose for me as I don't react to any drug the way I should. There is no way to lower the Big Pharm doses. Add to that a family history of cancer, and I was nervous about the pills.

My BHRT was a topical cream and it literally saved my life. My journals begin October 2007 of what I went through, a sudden and very severe onset of symptoms.

I know BHRT doesn't work for everyone, but it worked for me, and our insurance DID cover it. And it turned out that I was sensitive to one of the ingredients and had to go still lower with the dosage, which I could not have done with traditional HRT.

And I am thankful to have many accredited compounding pharmacies in my area. The one I use, I have nothing but praise for, she is thorough, is a licensed pharmacist, plus has studied Indian and Chinese alternative medicines for years. She is a true chemist. She got rid of two of my other discomforts from my other illness that traditional medicine simply masked with drugs.

I seem to be over the major menopause symptom hump, and am not using anything now for almost a year. I have had no surgeries so I'm hoping I will be able to stay this course too and my bones won't become an issue. But if they do, straight to my Compounding pharmacist I go.
By KweebsLS  Jul 09, 2008
2
I just want to know if there is anything you can take to replace hormones if you've had a total hysterectomy...no ovaries left? If you have history of pulmonary embolis. I need HELP!!!!!!!!!!!!!!!!!
By repangel911  Jul 09, 2008
1
"Conventional" ways were threatened to the point where they were trying to "shut down" the compounding pharmacies and STOP all use of "Bioidentical hormones" - they are now getting a little TOO much "business" and so "Bigpharma" is miffed ... ALOT of people are sending their money there and NOT to them (waaa) so the FDA now "decides" isnt not safe? BS. This has effected me, and I was so afraid that they were going to take this away- something that helps. AlOT. They dont give a RIP whether or not its "SAFE" yeah right... look what they have "approved" to put into peoples bodies. Studies?? Not enough studies? Well studies are about as useful as a hole in the head. As we ALL know... WHO is doing the study...how BIASED is it?? Who will it benefit. Most of the time its NOT the patient/ consumer. Studies say this studies say that. if you really think about how many "stuides says this, get EVERYONE and their dog on the "bandwagon" and 5 years later... "oh NO, thats NOT good to do... you NEED to do this!" YEAAH. The only way to know is to wait- see what happens- sad to say- get a Dr. that you respect and have the same outlook on your care. You both can decide what is right for you. I listen to studies as much as Charlie Browns teacher. "wa wa wa"
By lladyfairhair  Jul 08, 2008
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