(HealthDay News) -- Here are the latest clinical trials, courtesy of CenterWatch:
Heartburn
A clinical research study is under way for patients with heartburn.
If you take over-the-counter Prilosec, you may qualify to participate in a clinical research study to evaluate previous over-the-counter Prilosec users. Qualified participants will receive study-related medical evaluations at no cost.
More Information
Please see http://www.centerwatch.com/patient/studies/cat175.html.
-----
Amenorrhea
A clinical research trial is being conducted to compare an investigational medication and placebo to see if it induces menstrual periods.
This trial seeks females who are generally healthy, between 18 and 50 years of age, and not currently on any hormonal medication. Qualified participants will receive investigational medication, study-related medical and gynecology examinations, and study-related laboratory tests.
The research site is in San Diego.
More Information
Please see http://www.centerwatch.com/patient/studies/cat584.html.
-----
Study Reports GYNECARE THERMACHOICE III Helps Most Women With Heavy Periods Return To Normal Or Less Bleeding
Results from a multicenter, prospective clinical trial showed that nine out of 10 women undergoing treatment with GYNECARE THERMACHOICE III Uterine Balloon Therapy System to treat menorrhagia, or heavy menstrual periods, returned to a normal bleeding rate or less. The data were presented earlier this week at the American Association of Gynecologic Laparoscopists meeting in Las Vegas.
Women in the 250-patient trial were randomized to receive postablation curettage (PAC) or to no postablation curettage (NPAC) following treatment with GYNECARE THERMACHOICE III. The success rates in the two groups were comparable. At the 12-month follow up point, the intent-to-treat analysis showed that 37 percent of women experienced amenorrhea (or no menstrual bleeding). The study also compared this amenorrhea rate to that of historic patient-matched controls. Among the intent-to-treat matched patients, the amenorrhea rate was 32.6%, which is significantly greater than the 13.7% reported in the matched patients from the THERMACHOICE I study.
Additionally, more than 50 percent of women reported experiencing no premenstrual symptoms, including severe pain, fatigue and bloating following treatment. In fact, almost 90 percent of participants reported less pain associated with their periods (dysmenorrhea).
"These results show that GYNECARE THERMACHOICE III is a safe and effective choice for women who are candidates for endometrial ablation therapy," said Jose Garza Leal M.D., lead investigator of the study. "In addition, this treatment can actually help to 'normalize' a woman's menstrual flow so that it no longer interferes with her day-to-day activities, helping improve her quality of life."
Before receiving treatment, 80 percent of the women reported missing social activities due to their heavy periods. After treatment, more than 90 percent of women said they had not missed a social occasion or activity because of their period. Similarly, prior to treatment, more than half of women reported missing work because of their period. After 12 months, less than 3 percent reported absences.
Participants were premenopausal women, aged 30 years or older, who had completed childbearing, used contraception, and either failed or refused medical therapy.
The study was funded by ETHICON Women's Health & Urology.
About Menorrhagia
Menorrhagia, or heavy periods, wreaks havoc on the lives of approximately 10 million pre-menopausal women ages 30 to 55 in the United States each month. These women lose 10 to 25 times the normal amount of blood during their menstrual cycle and must often contend with iron deficiencies, pain, fatigue and inability to participate in normal daily activities.
About GYNECARE THERMACHOICE
The GYNECARE THERMACHOICE III Uterine Balloon Therapy System is a one-day treatment option designed to end heavy menstrual flows by removing the lining of the uterus. This medical device resolves heavy menstrual bleeding due to benign causes in premenopausal women who have completed childbearing. Unlike hysterectomy, which takes out the entire uterus, the device only treats the lining of the uterus with heat through a process called endometrial ablation.
GYNECARE THERMACHOICE is used in a minimally-invasive procedure that can be performed in a hospital, outpatient or office setting. Recovery is fast and most women can return to their normal activities by the next day. The treatment has been used to treat more than 500,000 women worldwide.
As with all endometrial ablation procedures, GYNECARE THERMACHOICE III should not be used in women who might want to become pregnant in the future. There is still a chance that pregnancy could occur, however, so it is very important that women use birth control correctly and consistently after any endometrial ablation procedure.
All surgical procedures present risks. Rare but possible safety risks include blood loss, heat burn of internal organs, electrical burn, perforation (hole) or rupture of the wall of the uterus, and leakage of heated fluid from the balloon or tissue into the cervix.
GYNECARE THERMACHOICE is from ETHICON Women's Health & Urology, a division of ETHICON, Inc., a Johnson & Johnson company. For more information, visit
http://www.endheavyperiods.com.
About ETHICON Women's Health & Urology
ETHICON Women's Health & Urology is dedicated to providing innovative, minimally invasive treatments for common urologic and women's health conditions. The division offers solutions for enlarged prostate (benign prostatic hyperplasia); female stress urinary incontinence; pelvic floor repair; post-surgical adhesions; heavy periods (menorrhagia); and benign uterine conditions, such as fibroids and polyps.
ETHICON Women's Health & Urology
http://www.endheavyperiods.com
Wyeth Presents Data On A Tissue Selective Estrogen Complex Class For Menopausal Therapy
Today, Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), presented Phase 2 clinical data at the American Society for Reproductive Medicine annual meeting in New Orleans related to the use of the bazedoxifene/conjugated estrogens complex in postmenopausal women. Bazedoxifene/conjugated estrogens could be the first in a new class of menopausal therapies called tissue selective estrogen complexes (TSECs). In Phase 2 clinical trials, several dose combinations of the TSEC containing bazedoxifene/conjugated estrogens were associated with a decrease in hot flashes compared to placebo, amenorrhea rates similar to placebo, and no increase in endometrial thickness compared to placebo.
"These clinical endpoints address considerations for physicians when evaluating menopausal therapies for their patients," says Gary Stiles, M.D., Executive Vice President and Chief Medical Officer of Wyeth Pharmaceuticals. "If confirmed in Phase 3 clinical trials, we believe the TSEC class may have the potential to change the way women and physicians approach menopausal therapy."
The presentation, "Bazedoxifene Combined with Conjugated Estrogens: A Novel Alternative to Traditional Hormone Therapies," highlighted Phase 2 clinical data regarding the effects of bazedoxifene/conjugated estrogens in healthy menopausal women. Results showed that conjugated estrogens alone increased endometrial thickness. Pairing bazedoxifene with conjugated estrogens resulted in a dose-related decrease in endometrial thickness and was similar to placebo at some dose combinations. Treatment with bazedoxifene paired with conjugated estrogens was associated with amenorrhea rates greater than 84 percent in all participants and was similar to placebo at the doses studied. In addition, there was a significant reduction of hot flashes in all treatment groups compared to placebo.
"Many women experience menopausal symptoms, yet remain untreated," says Vivian Lewis, M.D., University of Rochester. "I would expect physicians to be interested in this research on the TSEC class, as it could provide new options in menopausal therapy."
About TSEC
Preclinical data were presented at the North American Menopause Society (NAMS) on October 12, 2006, regarding the bazedoxifene/conjugated estrogens complex, which could be the first in a new drug class described as a tissue selective estrogen complex (TSEC). The TSEC class was developed to offer a menopausal therapeutic option that, for the first time, partners a selective estrogen receptor modulator (SERM) with estrogens. Phase 3 clinical trials are currently under way to evaluate the safety and efficacy of the bazedoxifene/conjugated estrogens complex.
About Menopause
According to the NAMS, there are approximately 40 million women in the United States of menopausal age. As many as 93 percent of women going through menopause experience vasomotor symptoms such as hot flashes, which can greatly impact a woman's life.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products, and nonprescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare, and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include risks associated with the inherent uncertainty of the timing and success of product research, development and commercialization (including with respect to our pipeline products), drug pricing and payment for our products by government and legal third-party payors, manufacturing, data generated on the safety and efficacy of our products, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade buying patterns, global business operations, product liability and other types of litigation, the impact of legislation and regulatory compliance, intellectual property rights, strategic relationships with third parties, environmental liabilities, and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, Risk Factors." We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Wyeth Pharmaceuticals
http://www.wyeth.com/
BIDMC Investigator Receives Novartis Award in Diabetes
Endocrinologist Christos S Mantzoros, MD, Director of the Human Nutrition Research Unit at Beth Israel Deaconess Medical Center (BIDMC), received the 2005 Novartis Award in Diabetes (Young Investigator) in a presentation held June 13, 2005, at the 65th Scientific Sessions of the American Diabetes Association in San Diego, California.
The annual Young Investigator award is sponsored by Novartis Pharmaceuticals to recognize a licensed physician under the age of 45 for innovative, patient-oriented research in the fields of physiology, pathophysiology or epidemiology of diabetes mellitus and its complications.
An Associate Professor of Medicine at Harvard Medical School, Mantzoros is a leader in the field of leptin research whose work has advanced the understanding of leptin as a hormonal mediator of the adaptation to starvation.
In clinical studies published in 2003, Mantzoros demonstrated that low leptin levels are responsible for key starvation-induced changes in neuroendocrine axes in humans, findings that have important implications for women with eating disorders and reproductive abnormalities. His subsequent research published in The New England Journal of Medicine provides valuable insights into the pathophysiology of hypothalamic amenorrhea, suggesting new therapeutic options for this prevalent condition.
"Chris's work is a perfect example of translational research," says BIDMC Chief Academic Officer Jeffrey S. Flier. "By applying the novel discoveries made in his lab to clinical studies of women suffering from amenorrhea, Chris has demonstrated that low leptin levels are indeed responsible for reproductive and neuroendocrine abnormalities. These findings are now leading to improved treatments for conditions affecting millions of women worldwide."
Mantzoros has additionally focused attention on the study of low-leptin states among HIV-positive patients, demonstrating that leptin replacement can ameliorate the metabolic abnormalities found in these individuals, who have experienced a generalized loss of adipose tissue. His other research interests extend to other molecules important in the regulation of energy homeostasis including resistin, ghrelin, and GLP-1.
A graduate of Athens (Greece) University Medical School with both M.D. and D.Sc. degrees, Mantzoros holds an M.Sc. degree in Public Health from the Harvard School of Public Health and an M.M.Sc. degree in Clinical Investigation from Harvard Medical School. After completing clinical and research fellowships in Endocrinology, Diabetes and Metabolism through the Longwood Medical Area/Harvard Medical School training program, Mantzoros joined the staff of BIDMC. He is an Overseer of Clinical Research in Endocrinology, Diabetes and Metabolism at BIDMC and Joslin Diabetes Center.
Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School, and ranks third in National Institutes of Health funding among independent hospitals nationwide. BIDMC is clinically affiliated with the Joslin Diabetes Cener and is a research partner of Dana-Farber/Harvard Cancer Center.
Contact: Bonnie Prescott
bprescot@bidmc.harvard.edu
617-667-7306
Beth Israel Deaconess Medical Center
http://www.bidmc.harvard.edu
Leptin May Treat Infertility and People with Eating Disorders
Leptin is an appetite suppressing hormone which, according to recent research, could also help treat infertility and eating disorders in women and. Leptin never lived up to being the answer to obesity, but it could become the answer to many women who are infertile, have low done density and/or have eating disorders.
Lead researcher, Dr. Jean Chan, said "This represents essentially a new era for leptin. Now that we understand so much more about what this hormone does, we can target it appropriately for the right condition."
The study was carried out at Beth Israel Deaconess Medical Center and Massachusetts General Hospital. You can read about it in the New England Journal of Medicine.
In this small study, researchers found that female athletes who had not had menstrual periods for 5 years got their periods back with Leptin.
When a woman stops having periods her bone density usually suffers. Researchers found that women on Leptin experienced improved bone density.
Female athletes and women with eating disorders have very low body fat, many stop having periods and develop hypothalamic amenorrhea.
Some say hypothalamic amenorrhea is caused by stress while others say it is caused by extreme diet and exercise.
In this study, 8 volunteers, all of them competitive female athletes, were given synthetic Leptin (made by Amgen). The administrated leptin raised the women's leptin to that of a woman of normal weight and fat content. The treatment carried on for three months, or until a woman's body responded if that happened before the three months. During that period one woman dropped out of the study.
Of the seven who completed the study, five had good results. Three ovulated and had menstrual bleeding. One of these women had not had a period for 14 years. The other two were about to ovulate.
The researchers said this could be the beginnings of some kind of treatment for very thin athletes and women recovering from anorexia as it can restore their bone density and bring their menstrual periods back.
Behavioural Therapy Can Restore Ovulation In Infertile Women
Fertility can be restored in some women by the use of behavioural therapy, thus avoiding recourse to expensive medicines and complex procedures, a scientist told the 22nd annual conference of the European Society of Human Reproduction and Embryology in Prague, Czech Republic on Tuesday 20 June 2006. Professor Sarah L. Berga, from the Department of Gynecology and Obstetrics, Emory University, Atlanta, Georgia, USA, said that her work was the first to show that reducing stress through psychological intervention could restore ovulation in women whose ovarian function had previously been impaired.
"Contrary to what had previously been believed", she said, "we found that multiple small stressors that seemingly would have minimal impact on reproductive competence can play a major role in causing anovulation. Up till now it was thought that failure to ovulate was usually caused by the energy deficits induced by excessive exercise and/or undernutrition, but we asked why women undertake such behaviours. Often dieting and exercise are a way of coping with psychosocial stress, and our previous work had shown that such stress is often increased in women who do not ovulate."
Professor Berga and her team set out to study the causes of functional hypothalamic amenorrhea (FHA) in women of normal weight who had not had a menstrual period for more than six months. FHA is caused by a prolonged reduction in gonadotropin-releasing hormone (GnRH), which signals the release into the bloodstream of hormones that simulate ovulation.
Analysis of the cerebrospinal fluid in women with FHA, as opposed to women who were ovulating normally, showed increased levels of cortisol, a hormone related to stress. Chronic elevation of cortisol levels heightens the risk for other health burdens, such as depression or osteoporosis, but chronic cortisol increases can often be reversed with behavioural therapy
In a pilot study, Professor Berga's team randomised 16 women with FHA into two groups. One group received cognitive behaviour therapy (CBT) for 20 weeks; members of the other group were observed. "A staggering 80% of the women who received CBT started to ovulate again, as opposed to only 25% of those randomised to observation", said Professor Berga. "Neither group gained weight nor showed significant changes in their levels of leptin, a hormone involved in regulating body weight and metabolism. This study underlines the important contribution that lifestyle factors play in determining overall health and reproductive health in particular. To reverse stress-induced ovulation, it is not enough simply to address metabolic sources of stress."
Professor Berga told the conference that the recovery of the stress and ovarian axes appears to occur independently of major metabolic changes such as an increase in leptin or thyroxine (a hormone that affects how cells use energetic compounds). Since CBT caused a drop in cortisol and a rise in TSH, it may be that the hypothalamic-pituitary-thyroid axis, involved in the regulation of metabolism, recovers, but only later.
The current practice in the treatment of anovulatory women is to offer hormonal treatments such as oral contraceptives, if immediate fertility is not desired, or ovulation induction if it is. "Aside from cost, these approaches mask ongoing endocrine disturbance", said Professor Berga. "Since these disturbances pose a risk to overall health, it is important to use a therapy that restores the endocrine system, including the reproductive system. Cognitive behaviour therapy offers a holistic treatment that is safe, cost effective, and easy to implement."
The team now intends to analyse further data from the pilot and to follow with a multi-centre trial involving a large number of women. "If the larger scale study confirms our earlier results," said Professor Berga, "we will have very strong evidence for offering stress reduction as an effective therapy for a significant group of infertile women."
###
Contact: Mary Rice
European Society for Human Reproduction and Embryology
Benefits Of Mother's Milk For Premature Babies - Your Breast Feeding Questions Answered
Breastfeeding has a special benefit for premature infants. Premature babies are those who are delivered before 37 weeks of gestation. The mother's milk, under such circumstances, helps in supplying important nutrients to the premature infant. These nutrients help the premature infant to not only survive but also develop a strong immunity against possible infections. Such infants develop the immunity to protect themselves from a bowel inflammation disease (Necrotizing Enterocolitis).
Babies with medical problems since their birth, such as congenital heart disease, Down's syndrome, and many similar disorders develop immunity for such diseases by breastfeeding. Oral suckling of breast milk by the baby contributes to their optimal oral development and there is less risk of malocclusion. There is a higher risk of baby bottle tooth decay in other babies who are bottle-fed.
Health Benefits for Nursing Moms
Breast milk is not only beneficial for babies but is beneficial to mother as well. It is understood that mothers who breastfeed their babies have many direct health benefits. There is a high risk of hemorrhage in women within 24-48 hours of childbirth. However, for women who breastfeed their infants during this period, this risk is reduced or removed to a higher extent. The uterus of such breastfeeding mothers contracts due the repeated burst of oxytocin, released in response to the baby suckling the milk. This is a great protection mechanism against hemorrhage.
Women performing continued exclusive nursing without giving any supplemental food to their children have a tendency of delayed periods. This is called Lactational Amenorrhea Method (LAM). LAM serves as a natural contraceptive for such women and helps in maintaining proper age gap between two children. Not only this, there is decreased iron loss in such women. It results in the decreased risk of anemia that is likely to happen in women.
There is rapid weight loss in women while breastfeeding their children. Almost 200-500 calories are used for milk production every day. To burn off these many calories, a rigorous exercise regimen is required on a regular basis. However, feeding mothers can stick to the same diet routine and still lose weight without any extra efforts.
Other diseases in women that breastfeeding can keep at bay: diabetes, breast cancer, uterine cancer, and osteoporosis, are some of the diseases that you can avoid by breastfeeding your baby.
Breastfeeding is undoubtedly more than a lifestyle choice. After becoming aware of all its benefits, it is clear that no woman would deliberately want to substitute her child's food with an inferior artificial substance that does not have any disease-protection mechanism.
By Michelle O'Connor
Early Pregnancy SymptomsEarly Pregnancy Symptoms
Breast Feeding Supply
Health experts define menstrual cycle as critical indicator of women's overall health
Leading women's health advocates met today at a scientific forum titled, "The Menstrual Cycle is a Vital Sign," held at the New York Academy of Sciences. Co-sponsored by Rachel's Well, Inc. and the Society for Menstrual Cycle Research, the discussion was designed to raise awareness about the role of menstruation as a unique indicator of a woman's overall physical health.
At the center of the discussion was the importance of identifying health issues linked to the menstrual cycle, as well as clarifying any misconceptions. "The menstrual cycle is a window into the general health and well-being of women, and not just a reproductive event," said Paula Hillard, M.D., professor of obstetrics & gynecology and pediatrics at the University of Cincinnati College of Medicine. "It can indicate the status of bone health, heart disease, and ovarian failure, as well as long-term fertility. Therefore, if a woman is not having her period, it is the first sign that something else could be going on."
Doctors and scientists also discussed the long- and short-term effects of irregular or interrupted periods (amenorrhea) brought on by over-training of female athletes and excessive dieting and exercise, as well as oral contraceptives designed to suppress the monthly cycle. The experts called for more research to determine the impact of menstrual suppression and its potential side effects on future fertility and long-range health.
"The most important thing to emphasize about menstrual suppression is that the long-term effects are simply unknown," said Jerilynn Prior, M.D., professor of endocrinology and metabolism at the University of British Columbia in Vancouver, and board member for the Society for Menstrual Cycle Research. "Whether a woman is electing to do so with new birth control products, or it results from excessive dieting or exercise, we as a society are allowing the one vital sign unique to women to go unmonitored, which could ultimately lead to an enormous uncontrolled experiment with a woman's health."
The clear message of today's forum was the importance of the relationship between women and their menstrual cycles. "Regular and effective health screenings and an open dialogue between women and their health care providers are critical to their overall health," said Lawrence Nelson, M.D., M.B.A. president of Rachel's Well, Inc.
The "Menstrual Cycle is a Vital Sign" scientific forum, supported by an unrestricted educational grant from Procter & Gamble, consisted of the following nationally recognized physicians and researchers:
-- Sarah L. Berga, M.D., professor and chair, Department of Gynecology and Obstetrics, Emory University School of Medicine.
-- Siob�n Harlow, Ph.D., associate director of the International Institute, professor of epidemiology, University of Michigan
-- Paula Hillard, M.D., professor, Department of Obstetrics and Gynecology and the Department of Pediatrics, University of Cincinnati, College of Medicine
-- Julie Isphording, former Olympic runner and patient representative
-- Elizabeth A. Kissling, Ph.D., professor of communication studies and women's studies, Eastern Washington University, board member, Society for Menstrual Cycle Research
-- Jerilynn C. Prior B.A., M.D., FRCPC, ABIM, ABEM, professor of endocrinology and metabolism, University of British Columbia, Vancouver
-- Evelyn O. Talbott, M.P.H., Dr.P.H., professor, Department of Epidemiology, University of Pittsburgh
-- Michelle Warren, M.D., professor, Department of Medicine and Obstetrics and Gynecology, Columbia University, medical director, Center for Menopause, Hormonal Disorders and Women's Health
About Rachel's Well, Inc.
Rachel's Well, Inc. is a non-profit 501c3 organization that aims to improve access to health services for uninsured women and develop a model of healthcare delivery that will improve women's health overall. The organization was founded by Dr. Lawrence Nelson, research gynecologist, and a dedicated group of professionals, who feel that there is a need for increased capacity to provide preventative healthcare services for women. Rachel's Well, Inc. initiated the development of "The Menstrual Cycle is a Vital Sign" to establish an educational platform through which the role of menstruation as a unique indicator of a woman's overall physical health can be communicated. "The Menstrual Cycle is a Vital Sign" is a registered trademark of Rachel's Well, Inc. Through a panel of nationally-recognized healthcare experts, Rachel's Well, Inc. is building relationships on a greater scale to improve communication about significant women's health issues. Rachel's Well, Inc. seeks to become a respected source of accurate information about women's reproductive health and a credible authority on these issues for mainstream America. The organization hopes to create a model of healthcare delivery that could have a significant impact on policy-making decisions and improve the health of women. For more information about Rachel's Well, Inc., visit
http://www.rachelswell.org.
About the Society for Menstrual Cycle Research
The Society for Menstrual Cycle Research is a nonprofit organization founded by a multidisciplinary group of women who were pioneers in understanding the centrality of menstrual cycle research to women's health. The organization consist of researchers, health care providers, policy makers, and students who share an interest in women's lives and health needs as they are related to the menstrual cycle. Their mission is to be the source of guidance, expertise, and ethical considerations for researchers, practitioners, policy makers and funding resources interested in the menstrual cycle. They do this by offering a network of communication and support that spans discipline, professional responsibilities, and geography to provide woman-centered perspectives on menstrual experiences. For more information about the Society for Menstrual Cycle Research, visit
http://www.pop.psu.edu/smcr.
Please call 212-598-4400 for details on a webcast of this event.
Contacts: Ann Blumenstock
ablumenstock@lippetaylor.com
212-598-0336 x115
Lippe Taylor
Traci Tournoux
mailto:ttournoux@lippetaylor.com
212-598-0336 x 160
Lippe Taylor
Chronic Obstructive Lung Disease
A research study is being held to evaluate the effects of a new treatment on patients suffering from Chronic Obstructive Pulmonary Disease (COPD).
You may qualify for this study if you have a clinical diagnosis of COPD, are at least 40 years of age or older, and have no history of asthma.
The research sites located in various cities throughout the United States.
More Information
Please see http://www.centerwatch.com/patient/studies/cat710.html.
-----
Readmission of patients with chronic obstructive pulmonary disease (COPD) is a major problem within health systems. Each admission for exacerbation worsens the patient's quality of life and, at the same time, presents an economic challenge for the hospital centre. A study published in the European Respiratory Journal describes the usefulness of an integrated and coordinated intervention of primary health care and hospital health care. This work, which demonstrates the benefits of cooperation among several health care levels, has been led by Dr. Josep Roca and Mrs. Carme Hernandez, members of the IDIBAPS Physiopathological Mechanisms of the Respiratory Disease Group and of the Pneumology Unit of Hospital Clínic.
This study includes 150 patients, 65 of which receive integrated health care. Results show that more than a half of these patients do not need readmission, whereas 67% of patients receiving conventional health care are readmitted in hospital. Previous studies assessing home health care did not obtain conclusive results. The main limitations were the lack of standardisation of the interventions and the lack of homogeneity of patients. In this new work, highly precise criteria for the inclusion of patients have been defined, and intervention protocols have been highly detailed. Protocols were not identical in both countries participating in the study, what reinforces the positive results obtained. Differences among both countries have permitted to conclude that a higher number of home health care appointments does not imply better results on the health of patients. The Belgian system implied more home care assistance than the Catalan system, but no differences were observed in the results. This works is presented as a conclusion of the European project CHRONIC, a pioneer European telemedicine research project started on January 2000 that closes with this publication.
The design of integrated health care of these initiatives makes health specialists much more accessible to patients, primarily thanks to an only telephonic switchboard for these patients. Furthermore, COPD patients receive an informative course on their disease, which gives them more autonomy. Results of this study are along the same line of those obtained with the Home Care Programme promoted by Hospital Clinic during the first trimester of 2006 aimed to patients with COPD and cardiac insufficiency. Patients included in this programme evolved from a 9-day admission to a 2-day admission. This programme, which emphasizes specialised nursing and medical cooperation, was initially supported by CATSalut, but now and until 31 December the project will be supported by Hospital Clinic. Home care health reflects the fructuous relationship between hospital care and research in Hospital Clinic, and could be a major tool of health management in several chronic diseases in the future. 60% of patients admitted in emergencies have a chronic pathology; therefore, the fact of giving assistance to these patients at the correct health care levels can be a decisive factor in third level hospitals, such as Hospital Clinic, in order not to collapse the centre.
UK researchers think they are close to finding the first effective treatment to fight one of the biggest killer diseases in the UK - Chronic Obstructive Pulmonary Disease (COPD). Professor Peter Barnes will present the work at the British Endocrine Societies 2005 meeting in Harrogate.
Scientists from Imperial College, London have found out why 'smokers lung' - one of the most common fatal diseases in the UK - is resistant to steroid treatment. They have gone on to discover how to combat this resistance, and have begun clinical trials of a potential therapy.
Chronic Obstructive Pulmonary Disease (COPD) - chronic bronchitis and emphysema, or 'smoker's lung' - currently affects 6% of the population. It is already the fourth most common cause of death in the UK and its prevalence keeps on rising*.
Steroids would normally be effective at treating inflammatory diseases such as COPD. However, COPD patients do not respond to steroid therapy. This is a major clinical problem due to the prevalence of the disease and the fact that it gets progressively worse.
Inflammation is caused by cells producing certain chemical signals. They do this by 'switching on' specific genes. Switching these genes off - and stopping inflammation - requires an enzyme called Histone Deacetylase 2 (HDAC2)**.
Professor Peter Barnes and his colleagues discovered that steroids act as a 'molecular bridge' to recruit HDAC2 to the appropriate genes where it can act to switch them off.
The London researchers found that in COPD, levels of HDAC2 are very low compared to normal cells, so that the steroids have no effect in switching off the activated inflammatory genes.
They then found that in lung cells in vitro, and in rats, low doses of a cheap and widely available drug raised the levels of HDAC2 and broke the steroid resistance.
The first stages of clinical trials to test low doses of this drug, theophylline, in COPD patients are now underway. If successful, this may lead to a change in the treatment of COPD and other severe inflammatory diseases that do not respond well to steroid therapy.
Professor Peter Barnes commented, 'COPD kills tens of thousands of people in the UK every year and currently we can only treat the symptoms, not the underlying problem of inflammation of the lungs. Our work has finally provided an explanation for steroid resistance in COPD, and has allowed us to identify ways to combat this.
We hope that the clinical trials of theophylline will be successful so that we can finally offer an effective therapy to COPD sufferers - a staggering 6% of the population.'
*Last year the European Respiratory Society reported that COPD kills over 30,000 people each year in the UK and that by 2020 it is likely to account for over 6 million deaths worldwide - making it the third leading cause of death.
**HDAC2 is an enzyme that helps to 'switch off' or deactivate genes. It does this by altering proteins that package genetic material within the nucleus of a cell. HDAC2 acts on proteins called histones, altering their structure to stimulate their association with genetic material, twisting and coiling it into tight packages. When genes are tightly packed they become inaccessible and the information they contain cannot be translated into chemical signals - they are 'switched off'.
Professor Barnes will be presenting this work on Wednesday 6 April 2005 at the British Endocrine Societies meeting in Harrogate, UK.
The British Endocrine Societies are made up of 17 constituent bodies that represent UK scientists and health professionals in the various specialities of hormone research and clinical practice. The 2005 annual meeting is taking place on 4-6 April in Harrogate, UK.
The work relating to this press release, and being presented at the BES2005 meeting is:
S30 - Glucocorticoid action in asthma and COPD. Barnes PJ. National heart and lung institute, Imperial College, London, UK
endocrine-abstracts.org/ea/0009/ea0009s30.htm
For more information please contact Tom Parkhill, on 07971 691774.
Reference URL
endocrine-abstracts.org/ea/0009/ea0009s30.htm
SOURCE: http://www.alphagalileo.org
A new National Service Framework (NSF) will be developed to improve standards of care and increase choice for patients with Chronic Obstructive Pulmonary Disease (COPD) announced the Secretary of State for Health Patricia Hewitt today.
The proposed NSF for COPD patients, those suffering from diseases like emphysema and chronic bronchitis, would seek to:
Provide more choice in treatment for patients Reduce inequalities in treatment, which can vary across the country, and Improve standards of care for patients.
Speaking about plans for the new NSF, Patricia Hewitt said:
"The development of a new National Service Framework is an important step which will support the NHS in managing and delivering COPD services more effectively, in a way that supports patient choice. It will support improvements in standards, tackle the current inequalities in COPD care and ensure that patients are able to access the services they need, where and when they want them."
Launching the plans at a British Thoracic Society event in the House of Commons, Health Services minister Rosie Winterton said: "There are currently around three million people suffering from COPD in this country and 30,000 people each year die because of this disease. Whilst there are many examples of new and innovative approaches in COPD care in some areas, best practice is not always followed and there is considerable variation in COPD services across the country. It is clear that more needs to be done to ensure that all patients suffering from this debilitating disease are given the standards of care they deserve."
Dame Helena Shovelton, Chief Executive of the British Lung Foundation, welcomed the announcement. She said: "This is a huge step forward for the millions of people with COPD in England. Our hope is that everyone with COPD will benefit from the disease being made a priority for the NHS and from the improvements in diagnosis, treatment and care that should follow. Better management of the disease will also address ways of reducing the significant burden of COPD on the NHS."
To ensure that the NSF meets the needs of COPD patients and their carers an External Reference Group will be established, bringing together health professionals, service users and carers and health service managers, to advise on the development of the framework. It will be jointly chaired by Professor Peter Calverley (President of the British Thoracic Society), and Professor Sue Hill (Chief Scientific Officer at the Department of Health).
Professor Peter Calverley said:
"The new COPD NSF gives us a great opportunity to improve the lot of people with this disabling condition and to take a lead internationally in the implementation of effective COPD care."
Professor Sue Hill said of her role in the Group:
"Answers to the problems faced by patients with COPD and the healthcare professionals who have a vital role in their care can not be found overnight. It is vital that we take time to seek the views of the whole COPD community on how the NSF should tackle these challenging issues.
"The announcement of the NSF is very timely, and a chance to ensure COPD services fit with recent reforms to the whole health and social care system."
1) National Service Frameworks were established to improve services through setting national quality requirements (QRs) and markers of good practice to improve services and tackle existing variations in care.
2) Chronic Obstructive Pulmonary Disease (COPD) is an umbrella term covering a range of conditions including chronic bronchitis and emphysema. It is a long term condition that leads to damaged airways, causing them to become narrow, making it harder for air to get in and out of the lungs. There is no cure for COPD, but it can be managed through drug therapy.
3) Professor Calverley is Professor of Respiratory Medicine at the University of Liverpool and an Honorary Consultant Physician at University Hospital Aintree. He is currently the President of the British Thoracic Society. He has published extensively on COPD, sleep and breathing disorders and is a key figure in the international respiratory community.
4) Professor Hill was appointed as the Department of Health Chief Scientific Officer in 2002. She is now also the national clinical lead for physiological measurement within the 18 week delivery programme. She was previously a consultant clinical scientist and clinical lead for respiratory medicine at University Hospital Birmingham and held an honorary position at the University of Birmingham in the Department of Medicine. She has published widely on the pathophysiology of COPD, bringing together basic and applied clinical science.
5) Announcements regarding the full membership of the External Reference Group will be made in due course.
http://www.dh.gov.uk
Incremental exercise tests show that the peak work rate in patients who suffer from chronic obstructive pulmonary disease (COPD) and who have participated in a pulmonary rehabilitation program increases an average of 18 percent, according to a "State of the Art" article on COPD pulmonary rehabilitation in the first issue for July 2005 of the American Thoracic Society's peer-reviewed American Journal of Respiratory and Critical Care Medicine.
According to the expert article, the goals of pulmonary rehabilitation programs for COPD patients are to reduce symptoms, improve activity and daily function, and restore the highest level of independent function in patients with respiratory disease.
COPD involves persistent obstruction of the airways caused by severe emphysema and chronic bronchitis. Severe emphysema causes enlargement of the tiny air sacs of the lung (alveoli) and the destruction of their walls. In chronic bronchitis, bronchial glands are enlarged, causing excess secretion of mucus. Frequently, the small airways of the lung become inflamed and blocked. Also, bronchitis victims suffer from a persistent cough that produces sputum. Long-term smoking is the root cause of each of the two illnesses involved. In 2002, 11.2 million U.S. adults were estimated to have COPD.
One of the benefits of pulmonary rehabilitation is improved function capacity, as measured by the 6-minute walk test. Patients who underwent rehabilitation, including exercise training, improved their results by a distance of 54 meters (about 48.6 yards).
Also, the authors point out that improved health-related quality of life is also observed even in the absence of clinically significant improvements in exercise capacity.
Although exercise reconditioning is the key to a successful rehabilitation program, exercise training programs need to be adapted to the individual limitations of the COPD patient, taking into consideration cardiovascular, pulmonary, and skeletal muscle limitations.
They note that exercises should be performed 3 to 5 days per week at an intensity above 40 to 85 percent of the oxygen uptake reserve (the difference between resting and peak oxygen intake) for more than 20 minutes per session.
American Thoracic Society Journal news tips for July 2005 (first issue)
Cathy Carlomagno
ccarlomagno@thoracic.org
212-315-6442
American Thoracic Society
http://www.thoracic.org
For the complete text of these articles, please see the American Thoracic Society Online Web Site at atsjournals.org. For either contact information or to request a complimentary journalist subscription to ATS journals online, or if you would like to add your name to the Society's twice monthly journal news e-mail list, contact Cathy Carlomago at 212-315-6442, or by e-mail at ccarlomagno@thoracic.org
Women in developing countries who cook over a wood stove for years and inhale the smoke can develop chronic obstructive pulmonary disease (COPD) and experience the same clinical characteristics, diminished quality of life and increased mortality rates as tobacco smokers.
These findings from a Mexican study appear in the second issue for February 2006 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.
Over a seven-year period, Alejandra Ram�rez-Venegas, M.D., and six associates from the COPD Clinic at the National Institutes of Respiratory Diseases in Mexico City, followed up on clinical, functional, health-related quality of life and survival characteristics of 481 COPD patients. Of this group, 345 persons (76 percent of whom were male) had COPD associated with tobacco smoke and 186 individuals (86 percent female) developed the disease as a result of inhaling wood smoke.
Although cigarette smoking is a greater risk factor for COPD in developed countries, indoor air pollution from solid fuel use is responsible for more than 1.6 million annual deaths and 2.7 percent of the global burden of COPD in developing countries, according to the World Health Organization.
COPD results from persistent obstruction of the airways associated with either severe emphysema or chronic bronchitis. In emphysema, the tiny air sacs of the lung (alveoli) become enlarged and their walls are destroyed. In chronic bronchitis, the bronchial glands enlarge, causing a chronic cough and excess mucus. Ten to 15 percent of all smokers develop COPD as a result of irritants in tobacco that cause inflammation of the alveoli.
"Biomass (wood) smoke is composed of a relatively equal mixture of coarse and ultrafine particles and can penetrate deeply into the lung, producing a variety of morphologic and biochemical changes," said Dr. Ram�rez-Venegas.
According to the authors, the patients in the wood smoke group were older, shorter and had a greater body mass than those in the tobacco smoke group.
The cumulative exposure for the wood smoke COPD patients was expressed in hour-years, the number of hours of cooking with wood stoves multiplied by the average number of hours spent daily in the kitchen. The average cumulative exposure was 214 hour-years for the wood smoke group and 56 pack years for the tobacco smokers.
"In our study, the degree of airflow limitation was worse in tobacco smokers than in subjects exposed to wood smoke," said Dr. Ram�rez-Venegas. "Whether biomass exposure affects lung growth and, consequently, function in adulthood and elderly life is unclear. However, biomass smoke exposure starts early in life because women cook using wood stoves in the same room where children sleep, play and eat, increasing the risk of respiratory infections and possible reduction in lung growth. Likewise, because the girls spend more time with their mothers and help with the domestic work at a very early age, these girls as women may be more susceptible to pulmonary infection, because they may have a very long time response to biomass, lasting at least 40 to 50 years. Women stop the exposure when they leave the rural community and move to live in urban areas, such as Mexico City."
During a follow-up period of almost 7 years, 124 (26 percent) of the total patient group died. Twenty-five patients (20 percent) died as a result of biomass smoke exposure and 99 suffered from fatal COPD associated with tobacco smoke. Sixty percent of the deaths in the tobacco smoke cohort came from respiratory failure, while 48 percent of the wood smoke patients died from the same problem.
###
Contact:
Alejandra Ram�rez Venegas, M.D., Instituto Nacional de Enfermedades Respiratorias, Calzada de Tialpan No. 4502, C.P. 14080, Mexico, Mexico
E-mail: aleramirezv@prodigy.net.mx
Contact: Suzy Martin
smartin@thoracic.org
American Thoracic Society
To contribute to the improvement of COPD (Chronic Obstructive Pulmonary Disease) prevention, by identifying groups at risk for COPD, reseachers carried out a detailed analysis of the determinants of COPD using the Stepwise Target Group-Oriented Prevention (STOP) model.
Results had shown that, apart from smoking, other environmental determinants and host factors contribute to further lung function's rapid decline.
Target groups for early disease detection and appropriate interventions can be identified by the presence of one or more known risk factors and by identification of high-risk groups.
It was concluded that the STOP strategy is a step toward improvement in COPD prevention, by shifting the focus from symptomatic smokers aged 45+ years to much earlier and preventable stages of the disease, that is, from disease treatment to risk management.
M. H. Ghambarian et al., Preventive Medicine, Vol. 39 (2) 337-43, August 2004
http://www.sciencedirect.comhttp://www.sciencedirect.com
The combination of two existing clinical treatments, salmeterol and fluticasone propionate, can significantly reduce inflammatory cells in the airways of current and former smokers being treated for moderate to severe chronic obstructive pulmonary disease (COPD).
These findings appear in the first issue for April 2006 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.
Neil Barnes, M.D., Professor of Respiratory Medicine at London Chest Hospital in United Kingdom, and nine colleagues, performed a randomized, double-blind, placebo-controlled, parallel-group, multi-center study on 140 COPD patients. Of this total, 67 patients (average age 65) were treated with salmeterol/fluticasone propionate, while 73 individuals received a placebo medication. Both treatment groups were matched for demographics, smoking history, and baseline lung function.
"This is the first demonstration that a currently available treatment can reduce the exaggerated bronchial inflammation in COPD," said Dr. Barnes. He adds that this therapy decreased inflammation by 36 percent.
After conducting a biopsy examination, the researchers conclude that the combination therapy significantly reduced the absolute numbers of certain inflammatory cells, including leukocytes, CD8+ cells and CD4+ cells, and caused a reduction in cells expressing genes for certain pro-inflammatory mediators in the lung.
"Inflammation in COPD is distinct from that in asthma and is characterized by a predominance of CD8+ cells at all airway levels, including the functional part of the lung, or parenchyma," explained Dr. Barnes.
According to the authors, this broad spectrum of anti-inflammatory effects was also accompanied by a significant improvement in lung function.
"The magnitude of the improvement in the standard lung function test was similar to or greater than that seen in other studies of anti-inflammatory treatments used in COPD," said Dr. Barnes.
Using a bronchoscope, the investigators examined each participant's lung passages one week before the study began and after 12 weeks of treatment. Only four patients experienced adverse reactions to the bronchoscopy, such as nose bleed, cough, sore throat, etc.
The researchers gave six patients in the treatment group and eight in the control cohort an antibiotic to reduce worsening COPD symptoms. One patient from the treatment group also was hospitalized to treat worsening symptoms.
"As designed, our research represents the largest biopsy study ever to be completed in COPD," said Dr. Barnes.
He noted that these findings support the premise that the combination treatment could be applied earlier than currently proposed in existing COPD guidelines.
Contact: Professor Neil Barnes, M.D., Prof of Respiratory Medicine London Chest Hospital, Barts and the London Trust and Medical
