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------------------------------------------------------------------------- PD AND HORMONES PART FOUR OF FIVE ------------------------------------------------------------------------- -----17------------------------------------------------------------------ Date: Mon, 4 Dec 1995 17:36:08 -0600 From: John Cottingham <[log in to unmask]> Subject: NINDS Studying Postmenopausal Estrogen Replacement in PD Women ------------------------------------------------------------------------- Postmenopausal females with Parkinson's Disease, stages I-IV are needed for a study of the effect of ESTROGEN on parkinsonian symptoms and levodopa response. This study requires two brief hospitalizations as well as outpatient visits over a one month period while receiving estrogen. Otherwise healthy, nonsmoking women with no personal or strong family history of breast or uterine cancer are sought for this study. Individuals desiring further information about this study or wishing to be considered as participants are invited to call the Experimental Therapeutics Branch at the NIH Clinical Center at 301-496-4604. Alternatively, letters from patients or their referring physicians may be addressed to Dr. Thomas N. Chase, NIH/NINDS, Building 10 / Room SC103, 10 Center Drive, MSC 1406, Bethesda, Maryland 20892-1406. Editors note: Some studies at NIH/ETB/NINDS have travel expenses available for those not living in the Washington, DC area. To determine if this one has travel expenses available, call Marge Gillespie, R.N. or Susan Kastris, R.N. at 1-800-362-3479. STUDY TITLE: Estrogen Replacement Therapy in Parkinson's Disease INTRODUCTION We invite you (or your child) to take part in a research study at the National Institutes of Health. It is important that you read and understand several general principles that apply to all who take part in our studies: (a) taking part in the study is entirely voluntary; (b) personal benefit may not result from taking part in the study, but knowledge may be gained that will benefit others; (c) you may withdraw from the study at any time without penalty or loss of any benefits to which you are otherwise entitled. The nature of the study, the risks, inconveniences, discomforts, and other pertinent information about the study are discussed below. If you have personal, religious or ethical beliefs which you think might limit the types of medical treatment (for example, blood transfusions) that you would agree to receive (or would want your child to receive), you should discuss them fully with your NIH physicians (or appropriate members of the research team) before entering this study, You are urged to discuss any questions you have about this study with the staff members who explain it to you. Purpose of the study This study is designed to evaluate the clinical and biochemical effects of estradiol, a potent and major estrogen hormone normally secreted by the body, in the treatment of postmenopausal female patients with Parkinson's Disease. This study will evaluate the ability of this hormone to modify symptoms of Parkinson's Disease and/or its treatment complications like dyskinesia. Study plan This study will take place over a six-week period during which time you will be an inpatient at the NIH Clinical Center for up to five days at four week intervals (maximum of 10 days). You will not be able to participate in the study if you have not received a mandatory complete gynecologic evaluation including a pelvic and breast examination, Pap smear and a mammogram within nine months prior to beginning the study. The results should be transmitted to us before your inclusion in the study and should be satisfactory. Prior to receiving the hormonal drug, you will also receive a medical history and general physical examination, including a neurologic evaluation, routine blood studies and EKG. A chest X-ray will be done if you have not had one in the previous year. Brain CT or MRI will be done if deemed necessary by the physician. The physical examination given as part of this protocol is for the purposes of the protocol and should not be construed as a complete assessment of your health. In addition, motor function tests will be pertormed before and during the drug study. You will also be asked to keep a diary of your parkinsonian symptoms for 12 hours on two days prior to entry into the study and during the study. Following the above baseline work, you will begin receiving a hormonal drug treatment made of estradiol. You will receive the drug (for 2 weeks) and placebo (for 4 weeks) in a random order through a maximum of four skin patches dally. for a total of 6 weeks. The number of patches may be varied in order to reach a desired blood level. You will wear these patches constantly and change them twice weekly. The placement of the patches will be moved each time so as to prevent the development of an allergic reaction to the adhesive. The hormonal dose administered is approximately 4 times higher than what is normally recommended for standard hormonal replacement therapy. You will also receive intravenous doses of L-Dopa infused in your bloodstream over 10 minutes, for a maximum of 3 doses on a single day and a maximum of $ days throughout the whole protocol. Your standard Sinemet therapy will be withheld on those days only and resumed as soon as the effects from the last infusion of the day have vanished. Before each intravenous infusion, you will receive an oral drug called carbidopa that you are used to taking as part of your Sinemet tablets, to prevent nausea and vomiting. Participation in this study requires that you temporarily discontinue drugs like Eldepryl and your current hormonal replacement therapy for at least 2 months prior to inclusion, and temporarily stop antiparkinsonian medications like Permax or Parlodel for at least 2 weeks prior to inclusion. If these drug changes lead to discomfort, you have the right to resume your original medication schedule and withdraw from the study. You may temporarily feel worse because of the new treatment. During the study, motor function will be evaluated for a few hours after each intravenous dose of L-Dopa, administered while you are wearing your daily skin patches. Periodic videotaping may be done under a separate written consent. Blood chemistry, hormone levels and lipid levels will be obtained at baseline and then twice during the study. Vital signs (blood pressure and pulse) will also be monitored before and during each intravenous dose of L-Dopa. In addition. 2 lumbar punctures (spinal taps) may be performed during the study and cerebrospinal fluid collected for biochemical assays (see below). Risks The beneficial and adverse effects of estradiol in postmenopausal women at standard doses are well known. Although the dose you will receive is substantially higher than the standard hormonal treatment normally administered to postmenopausal women, all side effects should be reduced by the short duration of estradiol exposure in this study (2 weeks). The most important and publicized adverse effect of hormones relates to a higher risk of developing cancer of the breast and uterus. The risk is clearly dependent upon the duration of the exposure and starts to rise only after 2 years of estradiol therapy. If your uterus has not been surgically removed, there is also a possibility that you may experience vaginal bleeding once the study is over due to the sudden withdrawal of hormonal replacement. Certain preexisting gynecologic conditions may predispose some women to this complication. You will be referred back to your regular doctor or gynecologist for a repeat examination should such a breakthrough bleeding be abundant or prolonged. One other risk relates to an elevation in triglyceride levels. Your lipid profile will be monitored every two weeks during the protocol. The known relationship between hormones and venous thrombosis (susceptible to produce blood clots flowing to the lungs) is mainly based on the experience of women on birth control pills. The skin patches you will wear are different from birth control pills and the duration of exposure to the patches is such that the risk of thrombosis is minimized. -----18----------------------------------------------------------------------- Date: Sun, 10 Dec 1995 22:07:40 -0500 From: Patricia Yothers <[log in to unmask]> Subject: Not even 60 yet ------------------------------------------------------------------------------ Dear Under 60's, ...... I'm trying to make some sense out of all this but guess nobody knows where PD comes from, how fast it progresses and what medicine is best for it. I've been reading the PD on line list and it is informative but I'm too young to have this already. Anyone else feel the same? I take Sinemet (1 & a half tablets, HRT, and Zoloft) Patricia of DPYOTHERS -----19----------------------------------------------------------------------- Date: Sun, 10 Dec 1995 23:19:27 -0500 From: Barbara Patterson <[log in to unmask]> Subject: Re: Not even 60 yet ------------------------------------------------------------------------------ Hi, Patricia. I was diagnosed at 49 and am now 52. We have many members of our list who are a lot younger than you and I, and I think we all agree with you... we're TOO YOUNG for this. You mentioned HRT in your message. Some of our members have found that HRT interferes with the effect of Sinemet. Perhaps you could discuss this with your family doctor (or neurologist or gynecologist). Many of us (including me) are still working full-time; some of us are considering early retirement/ltd, etc. In other words, Patricia, you have joined the right group. Whatever stage we are in, others have been in, so we have the benefit of their experience and advice and support. Hang in there....we're all in this together. Barb -----20----------------------------------------------------------------------- Date: Mon, 11 Dec 1995 08:54:27 EST From: MS D J KIPP <[log in to unmask]> Subject: Hormone Replacement Therapy ------------------------------------------------------------------------------ Confused about HRT not as much as I. I have decided to try it again after the holidays after much consideration. I recently read the there appears that HRT helps to slow down the progression of Alzhiemers. The scientists feel that estrogen may afford a level of protection. After doing a mother -in-law survey and observing that younger women with PD seem to do better then younger men with PD. I called my neuro and asked him his opinion and agreed that women do seem to do better then men and cautiously agreed that it is possible that Estrogen may be a factor. I realize that this is a long shot and that I will have to increase my Sinemet dosage upward but have decided to do it. ...... Donna -----21----------------------------------------------------------------------- Date: Fri, 12 Jan 1996 21:36:31 LCL From: Don Voegeli <[log in to unmask]> Subject: Sleep & sugar ------------------------------------------------------------------------------ Hi all; FWIW, this a rare post from a lurking listener who has learnde a lot from this list. I noticed during my annual Holiday-Cookie-Eating Marathon (still going on) that I seem to be sleeping better and longer than usual. Then I found an answer that I'll gladly accept in a newspaper piece that looks like it's written by the Sugar Cane Grower s Association. MYTH #3: Sweets give you a sugar buzz. "We've done studies evaluating this idea that sugar produces a high, the so-called sugar buzz," said Bonnie Spring, a psychology professor at the Univ. of Health Sciences at the Chicago Medical School. For most people "the most common reaction is to get sleepy." She explained it this way: When you eat carbohydrates, the amount of glucose in your blood rises. That rise triggers an outpouring of insulin. a pancreatic hormone that lowers the blood glucose level by sending glucose to the muscles for energy or to the liver for storage. But insulin also removes many other compounds called amino acids from the blood. The exception is the amino acid tryptophan. Without the "competition" of the other amino acids, more tryptophan enters the brain, where its effect is to increase a key nerve chemical, serotonin. This tends to produce drowsiness, even while blood glucose levels are still elevated. At the same time, in those who have a deficient supply of serotonin, sugar can have the opposite effect. A low level of serotonin is linked to seasonal affective disorder (winter depression), nicotine withdrawal, premenstrual syndrome and carbohydrate food craving, Spring said. "With people who show signs of a serotonin deficiency, [sugar] actually gives them energy," she explained. Very "medical" information from a psychology professor. This is an excerpt. E-mail me for the whole thing. Authoritative debunking welcome. -----22----------------------------------------------------------------------- Date: Mon, 29 Jan 1996 14:14:52 EST From: "Patrick J. Martin" <[log in to unmask]> Subject: Digestion & Drug Digest ------------------------------------------------------------------------------ BROMOCRIPTINE (PARLODEL) - This worked for a couple years after amantadine lost its impact, but led to a continuing low back pain (What is retroperitoneal fibrosis?). Since bromocriptine's other use is to stop lactation in postpartum patients and it hits the hormonal balances, its effects during menstruation and menopause may be important to female Parkies. Comments?? -----23----------------------------------------------------------------------- Date: Wed, 6 Mar 1996 12:36:46 EST From: MR ROBERT A MARTONE <[log in to unmask]> Subject: Pallidotomy 8mos later, Carpel tunell discovery ------------------------------------------------------------------------------ Nancy, age 50, PD 20yrs. Pallidotomies May & July 1995 Since her Pallidotomies last year, May & July, Nancy has progressed on many fronts. Parkinson's meds Sinemet 25/100 - 1/2 every 3 hours, Sinemet cr 25/100 every 3 hours, and Permax 1 mg.- 1/2 every 3 hours are all doing their job now. Occasional use of Ativan for anxiety works well. Replacement of Prozac with Serzone 1 per day is in progress. Hope is to improve sexual function (still to soon to tell). Prozac worked well but with some sexual dysfunction. Menopause/menstrual cycle creates havoc with the Meds. Usually the weeks before menstruation Bob & Nancy Martone [log in to unmask] -----24----------------------------------------------------------------------- Date: Thu, 28 Mar 1996 09:59:16 -0500 From: Marlene Pelton <[log in to unmask]> Subject: Estrogen Replacement Therapy and PD ------------------------------------------------------------------------------ There is not a whole lot out there in the medical literature about women with PD - menopause, and estrogen replacement therapy. I am in need of some real life experiences. If anyone would like to share - please reply directly to me. Thank you. Marlene Pelton Medical Library St. Luke's Hospital 232 S. Woods Mill Rd. Chesterfield, MO 63017 [log in to unmask] ------------------------------------------------------------------------------ [log in to unmask]