SSRI Antidepressants for Menopausal Hot Flashes. Surely You Must Be Joking ?This article is part two of a series.
For part one, click here.
Instead of using hormone replacement as a treatment for menopausal hot flashes, mainstream medicine docs will sometimes prescribe SSRI antidepressants off-label.(22-26)
SSRI Antidepressant Drug Off-Label Use for Hot Flashes (24)
Chemical name Trade Name
fluoxetine Prozac
paroxetine Paxil
venlafaxine Effexor
escitalopram Lexapro
Off-label use means that the SSRI drug has not been FDA approved for treatment of menopausal symptoms.
Last week, for the first time in history, the FDA approved an SSRI antidepressant, Brisdelle, (Paxil paroxetine) for the treatment of menopausal hot flashes.(1)
The clinical trial which generated the data for FDA approval was funded by Noven Pharmaceuticals, and the lead author for the study is Dr James A Simon, a doctor who has disclosed a financial relationship with Noven as well as 30 or so additional pharmaceutical companies. (2-4)
FDA Advisory Committee Votes Against FDA Approval
The FDA approved the paroxetine drug against the opposition of an FDA advisory committee voting 10-4 against approval March 2013. (5-17) Click here for a transcript of the FDA meeting.:
Transcript_FDA_Advisory _MArch_2013.
Testimony of Dr. Mary Carol Jennings was presented to the Reproductive Health Drugs Advisory Committee of the FDA on Paroxetine MArch 2013. Dr Jennings advised against approval because the drugs adverse effects outweighs benefit.
No Meaningful Reduction in Hot Flashes Compared to Placebo
Women in the paroxetine clinical trial started
with about 10 hot flashes per day. After 12 weeks, those on paroxetine
had 4 hot flashes per day compared to 5-6 for the placebo group.
Members of the FDA advisory committee said such a marginal difference
between the drug and placebo would not be meaningful to women.(New York Times)(13) That is why they voted against approval.
Abuse and Mistreatment of Women
Not only is paroxetine, Paxil medically ineffective for treatment of menopausal symptoms (a hormone deficiency state), Paroxetine, Paxil is one of the most addictive of the SSRI drugs, and the FDA has warned that withdrawal from paroxetine can be severe. (BMJ). The drug has numerous adverse side effects including increased suicidal activity , loss of libido and sexual dysfunction.
The medical practice of prescribing SSRI antidepressant and other psychiatric drugs for treatment of menopausal symptoms in women borders on criminal behavior by the medical system. This is a medical practice that should be halted immediately.
The History of Medical Iatrogenesis in Women
Over-Diagnosis of “Hysteria” in Women.
Perhaps one of the early examples of medical iatrogenesis in women occurred in the 1800′s in Paris with the over-diagnosis of “Hysteria” by Dr Charcot (34) Dr. Martin Charcot of the Paris hospital La Salpetriere diagnosed, on the average, 10 hysterical women each day, The number of women diagnosed and hospitalized for “hysteria” increased from from one percent in 1841 to 17 percent in 1883.(34)
DES Diethyl-Stilbestrol
A more recent historical example of medical iatrogenesis in women is the story of DES (Diethylstilbestrol) the first synthetic hormone replacement drug. invented in 1938. This carcinogenic monster hormone was approved by the FDA and given to millions of women from 1940 until it was banned in 1975 when it was shown carcinogenic. The first report of cervical cancer in the daughters of DES treated women was published in April 1971 in the New England Journal of Medicine.(42-43)
Premarin
Our next example of medical iatrogenesis in women is Premarin, a horse estrogen isolated from the urine of pregnant horses. Available since FDA approval in 1942, Premarin has caused an estimated 15,000 cases of endometrial cancer, representing the largest epidemic of serious iatrogenic disease ever reported.(44-47) One might think this would be the end of any drug. However Premarin was promptly rehabilitated with the addition of another synthetic hormone, a progestin, to prevent endometrial cancer. Thus, in 1995, Prempro was born, a synthetic hormone pill containing both Premarin (the horse estrogen) and Provera (the progestin). Again, this was FDA approved, thought safe and handed out freely to millions of women.
Prempro
Our next example of medical iatrogeniesis in women is Prempro , the combination of Premarin with Provera (medroxyprogersterone) found to cause breast cancer and heart disease. Four large scale studies showed increased breast cancer and heart disease from this estrogen-progestin combination pill. The Breast Cancer Detection Demonstration Project, published in 2000, showed an eight fold increase in breast cancer for estrogen-progestin users.(48) The Swedish Record Review, published in 1996, had a fourfold increase in breast cancer with progestin use.(49) The Million Woman study, published in Lancet in 2003, had a fourfold increase in breast cancer for estrogen-progestin combination users compared to estrogen alone users.(50) Finally in 2002, JAMA published the Women’s Health Initiative (WHI), an NIH funded study terminated early because of increased breast cancer and heart disease in the estrogen-progestin users.(51) Incredibly, the medical system is still dispensing this discredited drug to women.
SSRI Antidepressants Shown to be No More Effective Than Placebo
The next example medial iatrogeneiss in women is SSRI antidepressant drugs that were shown to have little benefit for patients with mild to moderate depression. The benefits of SSRI drugs are equivalent to placebo pills.(52). In spite of these studies. discredited SSRI drugs are still being dispensed freely to millions of women.
Mistreatment of Women by the Medical System – Excessive Hysterectomies
The National Women’s Health Network has written extensively on the overuse of hysterectomies. Ernst Bartsich, M.D., a surgeon at Cornell in New York. says ” Of the 617,000 hysterectomies performed annually, “from 76 to 85 percent” may be unnecessary. “(CNN) Thus representing another example of mistreatment of women by the medical system.
More Discredited Treatments Used on Women:
Radical Mastectomy a disfiguring operation which provided no benefit compared to lesser procedures such as lumpectomy.
Bone Marrow Transplantation for Breast Cancer which was abandoned when studies showed it offered no benefit.(J Clin Oncology)
Kyphoplasty for Osteoporotic Fracture was discredited when studies found no benefit compared to a sham procedure
Arthroscopy for Osteoarthritis was abandoned after studies found no benefit compared to conservative treatment.
Screening mammograms for under 50 age women offers more harm than benefit.
Hot Flashes Are Caused By Hormone Deficiency of Menopause
Menopausal symptoms are not caused by a SSRI antidepressant deficiency. They are caused by hormone deficiency. SSRI drugs are addictive psychiatric drugs that do not address the hormone deficiency of menopause. To suggest them as a treatment for hormone deficiency is ludicrous, and creates a new population of women as medical victims.
Safe and Effective Treatment : BioIdentical Hormones
The safest and most effective treatment for menopausal symptoms of hot flashes a biodentical hormone program. Progestins and other synthetic hormones are associated with increased risk of cancer and heart disease. On the other hand, Bioidentical Hormones are safe, effective and are not associated with increased risk of cancer or heart disease. That is why bioidentical hormones are the preferred treatment .
Don’t Be a Victim of SSRI Antidepressants for Menopausal Hot Flashes
Don’t be a medical victim. Avoid the SSRI for menopause trap.
This article is part two of a series. For part one, click here.
Articles with related interest
Lexepro for Hot Flashes , a Joke?
The Safety of Bio-Identical Hormones
The Importance of BioIdentical Hormones
Bioidentical Hormones Prevent Arthritis
Bioidentical Hormone Estrogen Prevents Heart Disease
Morning Rounds With Steven Economou MD
Don’t Monkey With My Hormones
Waking Up from the Synthetic Hormone Nightmare
HRT Does Not Cause Breast Cancer
author : Jeffrey Dach MD
1) http://www.prnewswire.com/
NOVEN ANNOUNCES POSITIVE PHASE 3 DATA RESULTS FOR INVESTIGATIONAL LOW-DOSE NONHORMONAL THERAPY FOR THE TREATMENT OF VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
Data from 12- and 24-Week Pivotal Studies Selected to Be Presented at The North American Menopause Society Annual Meeting
MIAMI, FL, NEW YORK, NY and ORLANDO, FL, Oct. 3, 2012 /PRNewswire/ — Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced positive results from two multicenter, double-blind, randomized, placebo-controlled Phase 3 clinical studies evaluating low-dose mesylate salt of paroxetine (LDMP; 7.5 mg/day) for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Menopausal VMS, which comprise hot flashes and night sweats, affect up to 80 percent of women experiencing menopause, and many women report them as the most bothersome symptoms related to the condition. The co-primary endpoints of the studies evaluated weekly reductions in the frequency and severity of VMS associated with menopause in patients taking LDMP versus placebo at Week 4 and Week 12. The 24-week study achieved statistical significance in all co-primary endpoints. The 12-week study also achieved statistical significance for all co-primary endpoints, except for severity of VMS symptoms at Week 12. “If a patient is unable or unwilling to take hormone therapy, which is currently the only FDA-approved treatment option for menopausal hot flashes and night sweats, these symptoms often go untreated,” said James A. Simon, MD, CCD, NCMP, FACOG, clinical professor of obstetrics and gynecology at the George Washington University School of Medicine, Washington, D.C. and study investigator. “The approval of a nonhormonal therapy would be an important milestone to expand available options for women seeking treatment for VMS associated with menopause.”
2) http://www.endocrinetoday.com/
Low-dose mesylate salt of paroxetine effective in treating vasomotor symptoms
Posted on October 12, 2012 n/a Simon JA. S-2. Presented at: the North American Menopause Society 23rd Annual Meeting; Oct. 3-6, 2012; Orlando, Fla.
Disclosure: Simon is on the advisory board/review panel, has received grant or research support from, and/or has been on the speakers’ bureau for various entities, including:
Abbott Laboratories, Agile Therapeutics, Amgen, Ascend Therapeutics, Azur Pharma, Bayer, BioSante Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals,
Depomed, Endoceutics, Fabre-Kramer Pharmaceuticals, Laboratoire HRA Pharma, Meditrina Pharmaceuticals, Merck, Merrion Pharmaceuticals,
NDA Partners LLC, Novartis Pharmaceuticals Corp., Novo Nordisk, Novogyne, Palatin Technologies, Pfizer, Shionogi, Slate Pharmaceuticals,
Sprout Pharmaceuticals, Teva Women’s Health, Trovis Pharmaceuticals LLC, Warner Chilcott and Watson Pharmaceuticals.
3) http://www.medscape.org/
James A Simon, MD, CCD, FACOG
Clinical Professor, Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, George Washington University, Washington, DC; Medical Director, Women’s Health & Research Consultants, Washington, DC; President, James A. Simon, MD, PC, Washington, DC
Disclosure: James A. Simon, MD, CCD, FACOG, has disclosed that he has served as a consultant or on the advisory boards of Allergan, Alliance for Better Bone Health, Ascend, Barr, Bayer, BioSante, Concert Pharmaceuticals, Corcept Therapeutics, Inc., Depomed, Inc., GlaxoSmithKline, KV, Meditrina, Merck, Merrion, Nanma/Tripharma/Trinity, Novo Nordisk, Novogyne, Pear Tree, QuatRx, Roche, Sciele, Solvay, Ther-Rx, Warner Chilcott, and Wyeth. Dr. Simon has also disclosed that he has received grant/research support from BioSante, Boehringer Ingelheim, FemmePharma, GlaxoSmithKline, Nanma/Tripharma/Trinity, Novartis, and Procter & Gamble.
Dr. Simon has also disclosed that he has served on the speaker’s bureau for Ascend, Barr, Bayer, GlaxoSmithKline, KV, Merck, Novartis, Novogyne, Sciele, Ther-Rx, Warner Chilcott, and Wyeth.
4) http://www.medscape.org/
James A. Simon, MD, CCD, FACOG
Clinical Professor, Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, George Washington University, Washington, DC; Medical Director, Women’s Health & Research Consultants, Washington, DC; President, James A. Simon, MD, PC, Washington, DC
James A. Simon, MD, CCD, FACOG
Clinical Professor, Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, George Washington University, Washington, DC; Medical Director, Women’s Health & Research Consultants, Washington, DC; President, James A. Simon, MD, PC, Washington, DC
Disclosure: James A. Simon,
MD, CCD, FACOG, has disclosed that he has served as a consultant and/or
on the advisory boards of Allergan, Inc.; Alliance for Better Bone
Health; Ascend; Barr Laboratories, Inc.; Bayer HealthCare
Pharmaceuticals; BioSante Pharmaceuticals, Inc.; Concert
Pharmaceuticals, Inc.; Corcept Therapeutics Inc.; Depomed, Inc.;
GlaxoSmithKline; KV Pharmaceutical Company; Meditrina Pharmaceuticals,
Inc.; Merck & Co., Inc.; Merrion Pharmaceuticals, Ltd.;
Nanma/Tripharma/Trinity; Novo Nordisk; Novogyne Pharmaceuticals; Pear
Tree Pharmaceuticals, Inc.; QuatRx Pharmaceuticals Company; Roche
Laboratories Inc.; Sciele Pharma, Inc.; Solvay Pharmaceuticals, Inc.;
Ther-Rx Corporation; Warner Chilcott; and Wyeth Pharmaceuticals Inc. Dr.
Simon has also disclosed that he has received grants and/or research
support from BioSante Pharmaceuticals, Inc.; Boehringer Ingelheim
Pharmaceuticals, Inc.; FemmePharma Global Healthcare, Inc.;
GlaxoSmithKline; Nanma/Tripharma/Trinity; Novartis Pharmaceuticals
Corporation; and Procter & Gamble.
Dr. Simon has also disclosed that he has served on the speaker’s bureau of Ascend; Barr Laboratories, Inc.; Bayer HealthCare Pharmaceuticals; GlaxoSmithKline; KV Pharmaceutical Company; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Novogyne Pharmaceuticals; Sciele Pharma, Inc.; Ther-Rx Corporation; Warner Chilcott; and Wyeth Pharmaceuticals Inc.
Dr. Simon has also disclosed that he has served on the speaker’s bureau of Ascend; Barr Laboratories, Inc.; Bayer HealthCare Pharmaceuticals; GlaxoSmithKline; KV Pharmaceutical Company; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Novogyne Pharmaceuticals; Sciele Pharma, Inc.; Ther-Rx Corporation; Warner Chilcott; and Wyeth Pharmaceuticals Inc.
5) http://www.fda.gov/newsevents/
FDA NEWS RELEASE June 28, 2013
FDA approves the first non-hormonal treatment for hot flashes associated with menopause. The U.S. Food and Drug Administration today approved Brisdelle (paroxetine)to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause. Brisdelle, which contains the selective serotonin reuptake inhibitor paroxetine mesylate, is currently the only non-hormonal treatment for hot flashes approved by the FDA.
There are a variety of FDA-approved treatments for hot flashes, but all contain either estrogen alone or estrogen plus a progestin.
FDA NEWS RELEASE June 28, 2013
FDA approves the first non-hormonal treatment for hot flashes associated with menopause. The U.S. Food and Drug Administration today approved Brisdelle (paroxetine)to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause. Brisdelle, which contains the selective serotonin reuptake inhibitor paroxetine mesylate, is currently the only non-hormonal treatment for hot flashes approved by the FDA.
There are a variety of FDA-approved treatments for hot flashes, but all contain either estrogen alone or estrogen plus a progestin.
6) http://abclocal.go.com/kabc/
Denise Dador LOS ANGELES (KABC) — The Food and Drug Administration just approved the first non-hormonal drug to treat hot flashes. “Noven Therapeutics Brisdelle is actually the same ingredient that’s in the FDA-approved medication Paxil, which is an antidepressant,” said gynecologist Dr. Steven Rabin.
Denise Dador LOS ANGELES (KABC) — The Food and Drug Administration just approved the first non-hormonal drug to treat hot flashes. “Noven Therapeutics Brisdelle is actually the same ingredient that’s in the FDA-approved medication Paxil, which is an antidepressant,” said gynecologist Dr. Steven Rabin.
7) http://www.huffingtonpost.com/
FDA Approves First Non-Hormonal Treatment For Menopausal Hot Flashes Reuters 07/01/2013
FDA Approves First Non-Hormonal Treatment For Menopausal Hot Flashes Reuters 07/01/2013
8) http://www.miamiherald.com/
Noven wins FDA approval for first non-hormonal drug to treat menopausal symptoms
By Joseph A. Mann Jr.The U.S. Food and Drug Administration has approved a new, non-hormonal medication for treating hot flashes and night sweats in women that was developed by Miami-based Noven Pharmaceuticals.
The medication, called Brisdelle, is the first non-hormonal treatment option for hot flashes and night sweats associated with menopause, the company said
Noven wins FDA approval for first non-hormonal drug to treat menopausal symptoms
By Joseph A. Mann Jr.The U.S. Food and Drug Administration has approved a new, non-hormonal medication for treating hot flashes and night sweats in women that was developed by Miami-based Noven Pharmaceuticals.
The medication, called Brisdelle, is the first non-hormonal treatment option for hot flashes and night sweats associated with menopause, the company said
.9) http://www.nydailynews.com/
First nonhormonal treatment for hot flashes, Brisdelle, approved by FDA
The drug, which contains the antidepressant peroxetine, has been prescribed off-label by doctors for years as a treatment for menopausal symptoms. Many women prefer not to take hormonal therapy because some scientific evidence shows an association with increased cancer risk. By Tracy Miller / NEW YORK DAILY NEWS
First nonhormonal treatment for hot flashes, Brisdelle, approved by FDA
The drug, which contains the antidepressant peroxetine, has been prescribed off-label by doctors for years as a treatment for menopausal symptoms. Many women prefer not to take hormonal therapy because some scientific evidence shows an association with increased cancer risk. By Tracy Miller / NEW YORK DAILY NEWS
10) http://www.ibtimes.com/fda-
FDA Approves First Nonhormonal Hot Flash Treatment, Despite Advisory Panel Recommendation By Roxanne Palmeron June 28 2013 4:55 PM
FDA Approves First Nonhormonal Hot Flash Treatment, Despite Advisory Panel Recommendation By Roxanne Palmeron June 28 2013 4:55 PM
11) http://www.healthline.com/
Antidepressant Brisdelle Approved by FDA for Hot Flashes in Women By Magnolia Miller | Published Jul 2, 2013
12) http://www.medscape.com/Antidepressant Brisdelle Approved by FDA for Hot Flashes in Women By Magnolia Miller | Published Jul 2, 2013
Brisdelle Okayed as First Nonhormonal Rx for Hot Flashes Robert LowesJun 28, 2013
13) http://www.nytimes.com/2013/
F.D.A. Approves a Drug for Hot Flashes By ANDREW POLLACK June 28, 2013
14) http://www.dranitapetruzzelli.
New Menopause Drug Comes with Side Effects
The FDA has approved a new drug to treat hot flashes in menopausal women called Brisdelle. It is a form of Paxil, an antidepressant.
Antidepressants are not a new treatment for menopausal symptoms. Medications such as Effexor, Paxil, and Prozac can decrease hot flashes and night sweats. They are not as effective as hormone therapy and side effects can include nausea, dizziness, weight gain, and sexual dysfunction. They can also be difficult to stop.
Neurontin, a seizure medication and Clonidine, a blood pressure medication can also help menopausal symptoms such as hot flashes and night sweats. These two can also cause side effects similar to those of antidepressants.
However, these medications may be a safe option for someone who is not a candidate for hormone therapy, such as breast cancer patients.
FDA’s advisory panel voted against approval of Brisdelle for treatment of hot flashes and for the very reason you described.
!!!!!!!!!!!!!!!!!!!!!!!!
leave reply here :
15) http://www.hormonesmatter.com/
Advisory Panel Votes No, But FDA Approves Antidepressant for Hot Flashes Anyway
Tuesday, July 2nd, 2013 / Robin Karr
Brisdelle Background
Noven Pharmaceuticals makes Brisdelle and funded the studies on the use of Brisdelle to treat hot flashes.
Dr. James A. Simon, Clinical Professor of Obstetrics and Gynecology at the George Washington University School of Medicine in Washington DC,
led the study. Dr. Simon openly reports having a financial relationship with Noven. The fact that Noven supported the study and provided the drug for the study, along with the fact that the lead doctor overseeing the study has financial ties with Noven, is troubling in my opinion, but standard fair in pharmaceutical research.
16) http://www.cjr.org/the_second_
Flash: this new drug is not so new Disappointing coverage of Brisdelle, the hot flash drug, misses a chance to expose one of Big Pharma’s oldest tricks
By Sibyl Shalo Wilmont
17) http://online.wsj.com/article/
FDA Approves Drug for Hot Flashes
Non-Hormonal Medication Aimed at Treating Main Symptom of Menopause
18) http://www.peoplespharmacy.
New FDA Drug Approval: Blessing or Boondoggle? July 1, 2013 in Drug Library, People’s Pharmacy Alerts
19) http://
Low dose paxil now for hot flashes Started by Karma , Jun 30 2013 03:27 PM
Saw this on the news tonight and looked up an article on it. On Friday the FDA approved Brisdelle for moderate to severe hot flashes. Brisdelle is low dose paroxetine or Paxil.
The committee that studied it recommended against approving it … but the FDA thought it was a good idea. This is marketed to women who are afraid of cancer due to hormone replacement therapy – I wonder if they bother to tell the patients that there is a risk of withdrawal syndrome when they no longer have hot flashes.
I think this is a really BAD idea. I predict that over some time we will see more visitors to our site looking for help getting off of Brisdelle … very sad. Karma
20 ) http://www.paxilprogress.org/
Are you f’ing kidding me?Read this
21) http://www.scienceworldreport.
I saw the teaser on the news about a “new hot flash treatment”..yup, as expected, low dose paxil. They tried this with effexor too and it created more hot flashes. These people are disgusting.
__________________
22) http://www.medscape.com/
Pharmacotherapy - Use of Antidepressants for Management of Hot Flashes
Dana G. Carroll, Pharm.D., Kristi W. Kelley, Pharm.D.
Disclosures Pharmacotherapy. 2009;29(11):1357-1374.
23) http://www.aafp.org/afp/2006/
Nonhormonal Therapies for Hot Flashes in Menopause
DANA G. CARROLL, PHARM.D., B.C.P.S., University of Oklahoma–Tulsa College of Medicine, Tulsa, Oklahoma
Am Fam Physician. 2006 Feb 1;73(3):457-464.
24) http://www.webmd.com/
Antidepressants for Hot Flashes
Examples -
Generic Name Brand Name
fluoxetine Prozac
paroxetine Paxil
venlafaxine Effexor
escitalopram Lexapro
——————————
25) http://www.ncbi.nlm.nih.gov/
J Clin Oncol. 2005 Oct 1;23(28):6919-30.
Paroxetine is an effective treatment for hot flashes: results from a prospective randomized clinical trial. Stearns V, Slack R, Greep N, Henry-Tilman R, Osborne M, Bunnell C, Ullmer L, Gallagher A, Cullen J, Gehan E, Hayes DF, Isaacs C. Source Lombardi Comprehensive Cancer Center at Georgetown University, Washington, DC, USA.
In an open-label trial we have previously demonstrated that paroxetine reduces hot flashes. We initiated a stratified, randomized, double-blind, cross-over, placebo-controlled trial to investigate the efficacy of paroxetine 10 mg and 20 mg compared to placebo in reducing hot flash frequency and composite score. A secondary objective was to evaluate quality of life (QOL) parameters.
PATIENTS AND METHODS:Women who suffered at least two hot flashes a day for 1 month or longer were eligible. Women were randomly assigned to 4 weeks of paroxetine 10 mg or 20 mg followed by placebo for 4 weeks, or placebo for 4 weeks followed by paroxetine 10 mg or 20 mg for 4 weeks. Participants completed baseline daily hot flash diaries for one week prior to the start of the study and throughout the study, and QOL questionnaires at baseline, week 5 and week 9.
RESULTS:279 women were screened, and 151 were randomly assigned.
Paroxetine 10 mg reduced hot flash frequency and composite score by 40.6% and 45.6%, respectively, compared to 13.7% and 13.7% for placebo (P = .0006 and P = .0008, respectively).
Paroxetine 20 mg reduced hot flash frequency and composite score by 51.7% and 56.1%, respectively, compared with 26.6% and 28.8% for placebo (P = .002 and P = .004, respectively). Efficacy was similar between the two doses, but women were less likely to discontinue low-dose paroxetine. Paroxetine 10 mg was associated with a significant improvement in sleep compared with placebo (P = .01).
CONCLUSION:Paroxetine is an effective treatment for hot flashes in women with or without a prior breast cancer.
26) http://www.ncbi.nlm.nih.gov/
Ann Oncol. 2000 Jan;11(1):17-22.
A pilot trial assessing the efficacy of paroxetine hydrochloride (Paxil) in controlling hot flashes in breast cancer survivors. Stearns V, Isaacs C, Rowland J, Crawford J, Ellis MJ, Kramer R, Lawrence W, Hanfelt JJ, Hayes DF. Source Breast Cancer Program, Lombardi Cancer Center, Georgetown University School of Medicine, Washington, DC, USA.
BACKGROUND: Many breast cancer survivors suffer debilitating hot flashes. Estrogen, the drug of choice in perimenopausal women, is generally not recommenced to breast cancer survivors. Nonhormonal treatments are mostly disappointing. Anecdotal reports in our institution suggested that the selective serotonin-reuptake inhibitor, paroxetine hydrochloride, might be efficacious in alleviating hot flashes.
PATIENTS AND METHODS: Thirty women with prior breast cancer who were suffering at least two hot flashes a day entered a single institution pilot trial to evaluate paroxetine’s efficacy in reducing the frequency and severity of hot flashes. After completing daily diaries for one week on no therapy, the women received open-label paroxetine, 10 mg daily for one week, followed by four weeks of paroxetine, 20 mg daily. The women completed hot-flash daily diaries throughout the study period, and a health-related symptom-assessment questionnaire and a quality-of-life rating scale in the first and sixth week of the study.
RESULTS: Twenty-seven women completed the six-week study period.
The mean reduction of hot flash frequency was 67% (95% confidence interval (95% CI): 56%-79%). The mean reduction in hot flash severity score was 75% (95% CI: 66%-85%). There was a statistically significant improvement in depression, sleep, anxiety, and quality of life scores. Furthermore, 25 (83%) of the study participants chose to continue paroxetine therapy at the end of study. The most common adverse effect was somnolence, resulting in drug discontinuation in two women, and dose reduction in two women. One woman discontinued drug due to anxiety.
CONCLUSIONS: Paroxetine hydrochloride is a promising new treatment for hot flashes in breast cancer survivors, and warrants further evaluation in a double-blind randomized placebo-controlled trial.
27) http://www.ncbi.nlm.nih.gov/
JAMA. 2003 Jun 4;289(21):2827-34.
Paroxetine controlled release in the treatment of menopausal hot flashes: a randomized controlled trial. Stearns V, Beebe KL, Iyengar M, Dube E.
Breast Oncology Program, University of Michigan Comprehensive Cancer Center, Ann Arbor, USA. Standard therapy for hot flashes has been hormone replacement with estradiol or progestational agents, but recent data suggest that antidepressants inhibiting serotonin reuptake may also be effective. To evaluate a selective serotonin reuptake inhibitor (paroxetine controlled release [CR]) in treating the vasomotor symptoms displayed by a general cross-section of menopausal women. Randomized, double-blind, placebo-controlled, parallel group study conducted across 17 US sites, including urban, suburban, and rural clinics. A total of 165 menopausal women aged 18 years or older experiencing at least 2 to 3 daily hot flashes and must have discontinued any hormone replacement therapy for at least 6 weeks. Women were excluded if they had any signs of active cancer or were undergoing chemotherapy or radiation therapy.
After a 1-week placebo run-in phase, study participants were randomized to receive placebo or receive 12.5 mg/d or 25.0 mg/d of paroxetine CR (in a 1:1:1 ratio) for 6 weeks.
Fifty-six participants were randomly assigned to receive placebo and 51 to receive 12.5 mg/d and 58 to receive 25.0 mg/d of paroxetine CR. The mean reductions in the hot flash frequency composite score from baseline to week 6 were statistically significantly greater for those receiving paroxetine CR than for those receiving placebo.
By week 6, the mean daily hot flash frequency went from 7.1 to 3.8 (mean reduction, 3.3) for those in the 12.5-mg/d and from 6.4 to 3.2 (mean reduction, 3.2) for those in the 25-mg/d paroxetine CR groups and from 6.6 to 4.8 (mean reduction, 1.8) for those in the placebo group. Mean placebo-adjusted reduction in hot flash composite scores were -4.7 (95% confidence interval, – 8.1 to -1.3; P =.007) comparing 12.5-mg/d paroxetine CR with placebo; and -3.6 (95% confidence interval, -6.8 to -0.4; P =.03) comparing 25.0-mg/d paroxetine CR with placebo. This corresponded to median reductions of 62.2% for those in the 12.5-mg/d and 64.6% for those in the 25.0-mg/d paroxetine CR groups compared with 37.8% for those in the placebo group.
CONCLUSION:Paroxetine CR may be an effective and acceptable alternative to hormone replacement and other therapies in treating menopausal hot flash symptoms.
28) http://www.ncbi.nlm.nih.gov/
J Clin Oncol. 2009 June 10; 27(17): 2831–2837.
Newer Antidepressants and Gabapentin for Hot Flashes: An Individual Patient Pooled Analysis . Charles L. Loprinzi, Jeff Sloan, Vered Stearns, Rebecca Slack, Malini Iyengar, Brent Diekmann, Gretchen Kimmick, James Lovato, Paul Gordon, Kishan Pandya, Thomas Guttuso, Jr, Debra Barton, and Paul Novotny
Homeopathic Medicine for Hot Flashes
29) http://www.ncbi.nlm.nih.gov/
Drugs R D. 2012 September; 12(3): 107–119.
Published online 2012 December 18. doi: 10.2165/11640240-000000000-
PMCID: PMC3585763
Efficacy of a Non-Hormonal Treatment, BRN-01, on Menopausal Hot Flashes
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Jean-Claude Colau, Stéphane Vincent, PharmD,corresponding author Philippe Marijnen, and François-André Allaert
Treatment was either BRN-01 tablets, a registered homeopathic medicine containing Actaea racemosa (4 centesimal dilutions [4CH]), Arnica montana (4CH), Glonoinum (4CH), Lachesis mutus (5CH), and Sanguinaria canadensis (4CH), or identical placebo tablets, prepared by Laboratoires Boiron according to European Pharmacopoeia standards. Oral treatment (2 to 4 tablets per day) was started on day 3 after study enrollment and was continued for 12 weeks.
BRN-01 seemed to have a significant effect on the HFS, compared with placebo. According to the results of this clinical trial, BRN-01 may be considered a new therapeutic option with a safe profile for hot flashes in menopausal women who do not want or are not able to take hormone replacement therapy or other recognized treatments for this indication.
—————————————————————————————————-
Financial Disclosures Charles L. Loprinzi, MD,
Professor of Oncology, Mayo Clinic College of Medicine, Rochester, Minnesota . Interviewee Disclosure: Charles L. Loprinzi, MD, has disclosed that he has served as a consultant for Concert Pharmaceuticals. Grant/Research/Clinical Trial Support: Pfizer Dr. Loprinzi had disclosed that he has received research funding from the North Central Cancer Treatment Group.
2011 ASCO Annual Meeting ‐ Committee Disclosures
Reserach funding from: Abbott Laboratories Amgen Bristol-Myers Squibb Eisai Novartis Ortho Biotech Roche sanofi-aventis
30) http://www.
Dr. Loprinzi disclosed receiving research funding from Abbott, Amgen, Bristol-Myers Squibb, Eisai, Novartis, Ortho Biotech, Pfizer, Roche, and Sanofi.
Vered Stearns Financial Disclosures
31) http://www.zoominfo.com/p/
Financial Disclosure: Dr. Stearns has received investigator-initiated grants from
Abraxis, Merck, Novartis, and Pfizer, and has received honoraria from AstraZeneca.
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32) http://www.washingtonpost.com/
Unequal Treatment Reviewed by Alondra Nelson Sunday, January 7, 2007
MEDICAL APARTHEID- The Dark History of Medical Experimentation on Black Americans From Colonial Times to the Present By Harriet A. Washington
33) http://www.ncbi.nlm.nih.gov/
Med Hist. 2010 April; 54(2): 171–194. “Divine Stramonium”: The Rise and Fall of Smoking for Asthma MARK JACKSON*
34) http://books.google.com/books?
http://www.healthe-livingnews.
WOMEN’S EXPERIENCE IN MEDICINE
Briefly, we will look at the medical iatrogenesis of women in particular. Dr. Martin Charcot (1825-1893) was world-renowned, the most celebrated doctor of his time. He practiced in the Paris hospital La Salpetriere. He became an expert in hysteria diagnosing an average of 10 hysterical women each day, transforming them into … “iatrogenic monsters,” turning simple ‘neurosis’ into hysteria.96 The number of women diagnosed with hysteria and hospitalized rose from one percent in 1841 to 17 percent in 1883.
Hysteria is derived from the Latin “hystera,” meaning uterus.
Dr. Adriane Fugh-Berman stated very clearly in her paper that there is a tradition in U.S. medicine of excessive medical and surgical interventions on women. Only 100 years ago male doctors decided that female psychological imbalance originated in the uterus. When surgery to remove the uterus was perfected it became the “cure” for mental instability, effecting a physical and psychological castration.
Dr. Fugh-Berman noted that U.S. doctors eventually disabused themselves of that notion but have continued to treat women very differently than they treat men.97 She cites the following:
Thousands of prophylactic mastectomies are performed annually.
One-third of U.S. women have had a hysterectomy before menopause.
Women are prescribed drugs more frequently than are men.
Women are given potent drugs for disease prevention, which results in disease substitution due to side effects.
Fetal monitoring is unsupported by studies and not recommended by the CDC.98 It confines women to a hospital bed and may result in higher incidence of cesarean section.99
Normal processes such as menopause and childbirth have been heavily medicalized.
Synthetic hormone replacement therapy (HRT) does not prevent heart disease or dementia. It does increase the risk of breast cancer, heart disease, stroke, and gall bladder attack.100
We would add that as many as one-third of postmenopausal women use HRT.101,102 These numbers are important in light of the much-publicized Women’s Health Initiative Study, which was forced to stop before its completion because of a higher death rate in the synthetic estrogen-progestin (HRT) group.103
Cesarean Section
In 1983, 809,000 cesarean sections (21 percent of live births) were performed, making it the most common obstetric and gynecologic (OB/GYN) surgical procedure.
The second most common OB/GYN operation was hysterectomy (673,000), and diagnostic dilation and curettage of the uterus (632,000) was third. In 1983, OB/GYN operations represented 23 percent of all surgery completed in this country.104
In 2001, Cesarean section is still the most common OB/GYN surgical procedure. Approximately 4 million births occur annually, with a 24 percent C-Section rate, i.e., 960,000 operations. In the Netherlands only eight percent of babies are delivered by Cesarean section. Assuming human babies are similar in the United States and in the Netherlands, we are performing 640,000 unnecessary C-Sections in the United States with its three to four times higher mortality and 20 times greater morbidity than vaginal delivery.105
The cesarean section rate was only 4.5 percent in the United States in 1965. By 1986 it had climbed to 24.1 percent. The author states that obviously an “uncontrolled pandemic of medically unnecessary cesarean births is occurring.”106 VanHam reported a cesarean section postpartum hemorrhage rate of seven percent, a hematoma formation rate of 3.5 percent, a urinary tract infection rate of three percent, and a combined postoperative morbidity rate of 35.7 percent in a high-risk population undergoing cesarean section.107
35) http://www.ncbi.nlm.nih.gov/
Yale J Biol Med. 2011 December; 84(4): 471–478.
Medical Reversal: Why We Must Raise the Bar Before Adopting New Technologies
Vinay Prasad, MDa and Adam Cifu, MDb,*
36) http://jama.jamanetwork.com/
Reversals of Established Medical Practices Evidence to Abandon Ship
Vinay Prasad, MD; Adam Cifu, MD; John P. A. Ioannidis, MD, DSc
JAMA. 2012;307(1):37-38. doi:10.1001/jama.2011.1960.
Ideally, good medical practices are replaced by better ones, based on robust comparative trials in which new interventions outperform older ones and establish new standards of care. Often, however, established standards must be abandoned not because a better replacement has been identified but simply because what was thought to be beneficial was not. In these cases, it becomes apparent that clinicians, encouraged by professional societies and guidelines, have been using medications, procedures, or preventive measures in vain. For example, percutaneous coronary intervention performed for stable coronary artery disease and hormone therapy prescribed for postmenopausal women cost billions of dollars and supported the existence of entire specialties for many years. Stable coronary artery disease accounted for 85% of all stenting in the United States at the time of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial.1 Large, well-designed randomized trials that tested whether these practices improved major patient outcomes revealed that patients were not being helped. Defenders of these therapies and interventions wrote rebuttals and editorials and fought for their specialties, but the reality was that the best that could be done was to abandon ship.
37) http://www.ncbi.nlm.nih.gov/
PLoS Med. 2005 Aug;2(8):e124. Epub 2005 Aug 30.
Why most published research findings are false. Ioannidis JP. Source Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece.
There is increasing concern that most current published research findings are false. The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. In this framework, a research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser preselection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical modes; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance. Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias. In this essay, I discuss the implications of these problems for the conduct and interpretation of research.
38) http://www.ncbi.nlm.nih.gov/
BMJ. 2002 Aug 3;325(7358):249.
Association between competing interests and authors’ conclusions: epidemiological study of randomised clinical trials published in the BMJ. Kjaergard LL, Als-Nielsen B.
Cochrane Hepatobiliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Department 7102, H:S Rigshospitalet, DK-2100 Copenhagen, Denmark.
To assess the association between competing interests and authors’ conclusions in randomised clinical trials.
DESIGN:Epidemiological study of randomised clinical trials published in the BMJ from January 1997 to June 2001. Financial competing interests were defined as funding by for profit organisations and other competing interests as personal, academic, or political. Studies: 159 trials from 12 medical specialties.
MAIN OUTCOME MEASURES:Authors’ conclusions defined as interpretation of extent to which overall results favoured experimental intervention. Conclusions appraised on 6 point scale; higher scores favour experimental intervention.
RESULTS:Authors’ conclusions were significantly more positive towards the experimental intervention in trials funded by for profit organisations alone compared with trials without competing interests (mean difference 0.48 (SE 0.13), P=0.014), trials funded by both for profit and non-profit organisations (0.30 (SE 0.10), P=0.003), and trials with other competing interests (0.45 (SE 0.13), P=0.006). Other competing interests and funding from both for profit and non-profit organisations were not significantly associated with authors’ conclusions. The association between financial competing interests and authors’ conclusions was not explained by methodological quality, statistical power, type of experimental intervention (pharmacological or non-pharmacological), type of control intervention (for example, placebo or active drug), or medical specialty.
CONCLUSIONS: Authors’ conclusions in randomised clinical trials significantly favoured experimental interventions if financial competing interests were declared. Other competing interests were not significantly associated with authors’ conclusions.
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42) (3) http://www.nejm.org/doi/pdf/10.1056/NEJM197104222841604 Adenocarcinoma of the Vagina — Association of Maternal Stilbestrol Therapy with Tumor Appearance in Young Women. Arthur L. Herbst, M.D., Howard Ulfelder, M.D., and David C. Poskanzer, M.D. N Engl J Med 1971; 284:878-881April 22, 1971
43) (4) http://www.jstor.org/pss/2683841 Epidemiologic Evidence for Adverse Effects of DES Exposure during Pregnancy Theodore Colton and E. Robert Greenberg The American Statistician Vol. 36, No. 3, Part 2: Proceedings of the Sixth Symposium on Statistics and the Environment (Aug., 1982), pp. 268-272
44) (5) http://ajph.aphapublications.org/cgi/reprint/70/3/264.pdf The Epidemic of Endometrial Cancer:A Commentary Hershel Jick et al.Am J Public Health 70:264-267, 1980.
45) (6) http://www.nejm.org/doi/full/10.1056/NEJM197512042932303 Increased Risk of Endometrial Carcinoma among Users of Conjugated Estrogens. Harry K. Ziel, M.D., and William D. Finkle, Ph.D. N Engl J Med 1975; 293:1167-1170 December 4, 1975
46) (7) http://www.ncbi.nlm.nih.gov/pubmed/213722 N Engl J Med. 1979 Jan 4;300(1):9-13. Endometrial cancer and estrogen use. Report of a large case-control study. Antunes CM, Strolley PD, Rosenshein NB, Davies JL, Tonascia JA, Brown C, Burnett L, Rutledge A, Pokempner M, Garcia R.
47) (8) http://www.ncbi.nlm.nih.gov/pubmed/3358913
The dose-effect relationship between ‘unopposed’ oestrogens and endometrial mitotic rate: its central role in explaining and predicting endometrial cancer risk.Key TJ, Pike MC.
Br J Cancer. 1988 Feb;57(2):205-12.
48) (9) http://jama.ama-assn.org/content/283/4/485.abstract Menopausal Estrogen and Estrogen-Progestin Replacement Therapy and Breast Cancer Risk. Catherine Schairer, PhD et al. JAMA. 2000;283(4):485-491.
49) (10) http://onlinelibrary.wiley.com/doi/10.1002/(SICI)1097-0215(19960729)67:3%3C327::AID-IJC4%3E3.0.CO;2-T/pdf
see also http://www.ncbi.nlm.nih.gov/pubmed/8707404
Cancer incidence and mortality in women receiving estrogen and estrogen-progestin replacement therapy—long-term follow-up of a Swedish cohort. Ingemar Persson et al. International Journal of Cancer Volume 67, Issue 3, pages 327–332, 29 July 1996
50) (11) http://www.ncbi.nlm.nih.gov/pubmed/12927427 Lancet. 2003 Aug 9;362(9382):419-27. Breast cancer and hormone-replacement therapy in the Million Women Study. Beral V; Million Women Study Collaborators.
51) 12) http://jama.ama-assn.org/cgi/content/abstract/288/3/321
Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women
Principal Results From the Women’s Health Initiative Randomized Controlled Trial
Writing Group for the Women’s Health Initiative Investigators JAMA. 2002;288:321-333.
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52) http://jama.ama-assn.org/cgi/content/abstract/303/1/47
Fournier JC, DeRubeis RJ, Hollon SD; et al. Antidepressant drug effects and depression severity: a patient-level meta-analysis. JAMA. 2010;303(1):47-53
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rerferences from http://truthaboutpaxil.com/
PAxil Withdrawal Symptoms
[1] International Journal of Neuorpsychopharmacology, Fava GA, et al., “Effects of gradual discontinuation of selective serotonin reuptake inhibitors in panic disorder with agoraphobia” (16 January 2007) , http://www.ncbi.nlm.nih.gov/
[2] USA Today, AP, “Judge: Paxil ads can’t say it isn’t habit-forming,” (20 August 2002), http://usatoday30.usatoday.
BMJ., Tonks A., “Withdrawal from paroxetine can be severe, warns FDA” (2 February 2002), http://www.ncbi.nlm.nih.gov/
[3] Ann Med Interne (Paris), Belloef L. at al., “Paroxetine withdrawal syndrome” (April 2000), http://www.ncbi.nlm.nih.gov/
[4] Drug Saf., Haddad PM., “Antidepressant discontinuation syndromes” (2001), http://www.ncbi.nlm.nih.gov/
[5] Arch Dis Child Fetal Neonatal Ed., Stiskal N. et al., “Neonatal paroxetine withdrawal syndrome” (March 2001), http://www.ncbi.nlm.nih.gov/
Paxil not effective in Depression
[1] crazymeds.us, Patient forums (retrieved 8 December 2012), http://www.crazymeds.us/
[2] NEJM, Turner EH et al.,”Selective publication of antidepressant trials and its influence on apparent efficacy,” (17 January 2008), http://www.ncbi.nlm.nih.gov/
A 2008 review of clinical trials reported to the FDA found that studies used to get FDA approval of SSRI anti-depressants were not published accurately, that unfavorable results were not published and in some cases published in a way that made them falsely appear to be favorable.[2]
[3] Ibid.
[4] New York Times, “MEDICINE’S DATA GAP: Selective Disclosure; Two Studies, Two Results, And a Debate Over a Drug” (3 June 2004), http://www.nytimes.com/2004/
[5] healthyskepticism.org, Jureidini J., “Paxil Study 329: Paroxetine vs Imipramine vs Placebo in Adolescents” (January 2010), http://www.healthyskepticism.
Adverse side effects
The FDA reports side effects of Paxil include the risk of suicide and suicidal thoughts or actions, serotonin syndrome or neuroleptic malignant syndrome-like reactions, severe allergic reactions (trouble breathing, swelling of face, tongue, eyes or mouth, rash), abnormal bleeding, seizures or convulsions, manic episodes, changes in appetite or weight, low salt levels in blood.[2]
Common paxil side effects include nausea, sleepiness, weakness, dizziness, feeling anxious or trouble sleeping, asexual problems, sweating, shaking, not feeling hungry, dry mount, constipation, infection and yawning.[3]
[1] Food and Drug Administration, “Class Suicidality Labeling Language for Antidepressants” (2005), http://www.accessdata.fda.gov/
[2] Food and Drug Administration, Paxil Medication Guide (July 2011), http://www.fda.gov/downloads/
Withdrawal Syndrome
[1] International Journal of Neuorpsychopharmacology, Fava GA, et al., “Effects of gradual discontinuation of selective serotonin reuptake inhibitors in panic disorder with agoraphobia” (16 January 2007) , http://www.ncbi.nlm.nih.gov/
[2] USA Today, AP, “Judge: Paxil ads can’t say it isn’t habit-forming,” (20 August 2002), http://usatoday30.usatoday.
BMJ., Tonks A., “Withdrawal from paroxetine can be severe, warns FDA” (2 February 2002), http://www.ncbi.nlm.nih.gov/
In a class-action suit against Paxil’s manufacturer, a federal judge ruled that GlaxoSmithKline (GSK) had falsely advertised that Paxil wasn’t habit forming and couldn’t make that claim in advertising. Thirty-five patients in this action had reported that they had experienced withdrawal symptoms including nausea, fever and “electric zaps” in their bodies.[2]
[3] Ann Med Interne (Paris), Belloef L. at al., “Paroxetine withdrawal syndrome” (April 2000), http://www.ncbi.nlm.nih.gov/
[4] Drug Saf., Haddad PM., “Antidepressant discontinuation syndromes” (2001), http://www.ncbi.nlm.nih.gov/
[5] Arch Dis Child Fetal Neonatal Ed., Stiskal N. et al., “Neonatal paroxetine withdrawal syndrome” (March 2001), http://www.ncbi.nlm.nih.gov/
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http://www.drugwatch.com/
Paxil – Antidepressant Drug with Dangerous Side Effects
http://breggin.com/index.php?
Paxil Withdrawal Case Settled in California
Jeffrey Dach MD
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