Health Research Report

56th Issue Date 12 MAY 2009

Compiled By Ralph Turchiano

www.healthresearchreport.me www.vit.bz

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Editors Top Five:

1. Hopkins Children’s study: Folic acid may help treat allergies, asthma

2. Research finds Kava safe and effective

3. Stronger backbone: DHEA hormone replacement increases bone density in older women

4. Why Antidepressants Don’t Live Up to the Hype

5. Chinese workers urged to puff up economy by smoking

In this issue:

1. M. D. Anderson study predicts dramatic growth in cancer rates among US elderly, minorities

2. Half a glass of wine a day may boost life expectancy by 5 years

3. Hopkins Children’s study: Folic acid may help treat allergies, asthma

4. White tea — the solution to the obesity epidemic?

5. Drugs to combat anemia in cancer patients increase risk of death

6. Low vitamin D causes problems for acutely ill patients

7. Popular diabetes treatment could trigger pancreatitis, pancreatic cancer

8. Stinky” drywall imported from China raises health and safety concerns

9. Chinese workers urged to puff up economy by smoking

10. Research finds Kava safe and effective

11. Study reveals conflict between doctors, midwives over homebirth

12. Stronger backbone: DHEA hormone replacement increases bone density in older women

13. Probiotics may help ward off postpartum obesity

14. Why Antidepressants Don’t Live Up to the Hype

Public release date: 29-Apr-2009

M. D. Anderson study predicts dramatic growth in cancer rates among US elderly, minorities

Research underscores impact on health care system, importance of screenings, prevention strategies, inclusive clinical trials

HOUSTON – Over the next 20 years, the number of new cancer cases diagnosed annually in the United States will increase by 45 percent, from 1.6 million in 2010 to 2.3 million in 2030, with a dramatic spike in incidence predicted in the elderly and minority populations, according to research from The University of Texas M. D. Anderson Cancer Center.

The study, published online today in Journal of Clinical Oncology, is the first to determine such specific long-term cancer incidence projections. It predicts a 67 percent increase in the number of adults age-65-or-older diagnosed with cancer, from 1 million in 2010 to 1.6 million in 2030. In non-white individuals over the same 20-year span, the incidence is expected to increase by 100 percent, from 330,000 to 660,000.

According to Ben Smith, M.D., adjunct assistant professor in M. D. Anderson’s Department of Radiation Oncology, the study underscores cancer’s growing stress on the U.S. health care system.

“In 2030, 70 percent of all cancers will be diagnosed in the elderly and 28 percent in minorities, and the number of older adults diagnosed with cancer will be the same as the total number of Americans diagnosed with cancer in 2010,” said Smith, the study’s senior author. “Also alarming is that a number of the types of cancers that are expected to increase, such as liver, stomach and pancreas, still have tremendously high mortality rates.”

Unless specific prevention and/or treatment strategies are discovered, cancer death rates also will increase dramatically, said Smith, who is currently on active military duty and is stationed at Lackland Air Force Base.

To conduct their research, Smith and his team accessed the United States Census Bureau statistics, updated in 2008 to project population growth through 2050, and the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) registry, the premier population-based cancer registry representing 26 percent of the country’s population. Cancer incidence rates were calculated by multiplying the age, sex, race and origin-specific population projections by the age, sex, race and origin-specific cancer incidence rates.

The researchers found that from 2010 to 2030, the population is expected to grow by 19 percent (from 305 to 365 million). The total number of cancer cases will increase by 45 percent (from 1.6 to 2.3 million), with a 67 percent increase in cancer incidence in older Americans (1 to 1.6 million), compared to an 11 percent increase in those under the age of 65 (.63 to .67 million).

With respect to race, a 100 percent increase in cancer is expected for minorities (.33 to .66 million); in contrast, in white Americans, a 31 percent increase is anticipated (1.3 to 1.7 million). The rates of cancer in blacks, American Indian-Alaska Native, multi-racial, Asian-Pacific Islanders and Hispanics will increase by 64 percent, 76 percent, 101 percent, 132 percent and 142 percent, respectively.

Regarding disease-specific findings, Smith and his team found that the leading cancer sites are expected to remain constant – breast, prostate, colon and lung. However, cancer sites with the greatest increase in incidence expected are: stomach (67 percent); liver (59 percent); myeloma (57 percent); pancreas (55 percent); and bladder (54 percent).

Given these statistics, the role of screening and prevention strategies becomes all the more vital and should be strongly encouraged, said Smith. In the study, Smith and his team site: vaccinations for hepatitis B and HPV; the chemoprevention agents tamoxifen and raloxifene; interventions for tobacco and alcohol; and removal of pre-malignant lesions, such as colon polyps.

These findings also highlight two issues that must be addressed simultaneously: clinical trial participation and the increasing cost of cancer care. Historically, both older adults and minorities have been under-represented in such studies, and, therefore, vulnerable to sub-optimal cancer treatment. Simultaneously, over the past decade in particular, the cost of cancer care is growing at a rate that’s not sustainable.

“The fact that these two groups have been under-represented in clinical research participation, yet their incidence of cancer is growing so rapidly, reflects the need for therapeutic trials to be more inclusive and address issues that are particularly relevant to both populations,” said Smith. “In addition, as we design clinical trials, we need to seek not only the treatment that will prolong survival, but prolong survival at a reasonable cost to patients. These are two issues that oncologists need to be much more concerned about and attuned to.”

Another issue that needs to be addressed is the shortage of health care professionals predicted. For example, according to a workforce assessment by American Society for Clinical Oncology (ASCO), the shortage of medical oncologists will impact the health care system by 2020. Smith said ASCO and other professional medical organizations beyond oncology are aware of the problem, and are actively engaged in efforts to try and grow the number of physicians, as well as encourage the careers of nurse practitioners and physician assistants who are part of the continuum of care, to best accommodate the increase in demand forecasted.

“There’s no doubt the increasing incidence of cancer is a very important societal issue. There will not be one solution to this problem, but many different issues that need to be addressed to prepare for these changes,” said Smith. “I’m afraid if we don’t come to grips with this as a society, health care may be the next bubble to burst.”

Public release date: 29-Apr-2009

Half a glass of wine a day may boost life expectancy by 5 years

Long-term wine consumption is related to cardiovascular mortality and life expectancy independently of moderate alcohol intake

Drinking up to half a glass of wine a day may boost life expectancy by five years—at least in men—suggests research published ahead of print in the Journal of Epidemiology and Community Health.

The Dutch authors base their findings on a total of 1,373 randomly selected men whose cardiovascular health and life expectancy at age 50 were repeatedly monitored between 1960 and 2000.

The researchers looked into how much alcohol the men drank, what type it was, and over what period, in a bid to assess whether this had any impact on the risks of their dying from cardiovascular disease, cerebrovascular disease, and from all causes.

They also tracked weight and diet, whether the men smoked, and for how long, and checked for the presence of serious illness.

During the 40 years of monitoring, 1,130 of the men died. Over half the deaths were caused by cardiovascular disease.

The proportion of men who drank alcohol almost doubled from 45% in 1960 to 86% in 2000, with the proportion of those drinking wine soaring from 2% to 44% during that period.

The researchers found that light long term alcohol consumption of all types—up to 20 g a day— extended life by around two extra years compared with no alcohol at all. Extended life expectancy was slightly less for those who drank more than 20 g.

And men who drank only wine, and less than half a glass of it a day, lived around 2.5 years longer than those who drank beer and spirits, and almost five years longer than those who drank no alcohol at all.

Drinking wine was strongly associated with a lower risk of dying from coronary heart disease, cerebrovascular disease, and death from all causes.

These results held true, irrespective of socioeconomic status, dietary and other lifestyle habits, factors long thought to influence the association between wine drinking and better health.

Public release date: 30-Apr-2009

Hopkins Children’s study: Folic acid may help treat allergies, asthma

Folic acid, or vitamin B9, essential for red blood cell health and long known to reduce the risk of spinal birth defects, may also suppress allergic reactions and lessen the severity of allergy and asthma symptoms, according to new research from the Johns Hopkins Children’s Center.

In what is believed to be the first study in humans examining the link between blood levels of folate – the naturally occurring form of folic acid — and allergies, the Hopkins scientists say results add to mounting evidence that folate can help regulate inflammation. Recent studies, including research from Hopkins, have found a link between folate levels and inflammation-mediated diseases, including heart disease. A report on the Hopkins Children’s findings appears online ahead of print in the Journal of Allergy & Clinical Immunology.

Cautioning that it’s far too soon to recommend folic acid supplements to prevent or treat people with asthma and allergies, the researchers emphasize that more research needs to be done to confirm their results, and to establish safe doses and risks.

Reviewing the medical records of more than 8,000 people ages 2 to 85 the investigators tracked the effect of folate levels on respiratory and allergic symptoms and on levels of IgE antibodies, immune system markers that rise in response to an allergen. People with higher blood levels of folate had fewer IgE antibodies, fewer reported allergies, less wheezing and lower likelihood of asthma, researchers report.

“Our findings are a clear indication that folic acid may indeed help regulate immune response to allergens, and may reduce allergy and asthma symptoms,” says lead investigator Elizabeth Matsui, M.D. M.H.S., pediatric allergist at Hopkins Children’s. “But we still need to figure out the exact mechanism behind it, and to do so we need studies that follow people receiving treatment with folic acid, before we even consider supplementation with folic acid to treat or prevent allergies and asthma.”

The current recommendation for daily dietary intake of folic acid is 400 micrograms for healthy men and non-pregnant women. Many cereals and grain products are already fortified with folate, and folate is found naturally in green, leafy vegetables, beans and nuts.

Other findings of the study:

People with the lowest folate levels (below 8 nanograms per milliliter) had 40 percent higher risk of wheezing than people with the highest folate levels (above 18 ng/ml).

People with the lowest folate levels had a 30 percent higher risk than those with the highest folate levels of having elevated IgE antibodies, markers of allergy predisposition.

Those with the lowest folate levels had 31 percent higher risk of atopy (allergic symptoms) than people with the highest folate levels.

Those with lowest folate levels had 16 percent higher risk of having asthma than people with the highest folate levels.

Blacks and Hispanics had lower blood folate levels — 12 and 12.5 nanograms per milliliter, respectively — than whites (15 ng/ml), but the differences were not due to income and socio-economic status.

The Hopkins team is planning a study comparing the effects of folic acid and placebo in people with allergies and asthma.

Public release date: 30-Apr-2009

White tea — the solution to the obesity epidemic?

Possible anti-obesity effects of white tea have been demonstrated in a series of experiments on human fat cells (adipocytes). Researchers writing in BioMed Central’s open access journal Nutrition and Metabolism have shown that an extract of the herbal brew effectively inhibits the generation of new adipocytes and stimulates fat mobilization from mature fat cells.

Marc Winnefeld led a team of researchers from Beiersdorf AG, Germany, who studied the biological effects of an extract of white tea – the least processed version of the tea plant Camellia sinensis. He said, “In the industrialized countries, the rising incidence of obesity-associated disorders including cardiovascular diseases and diabetes constitutes a growing problem. We’ve shown that white tea may be an ideal natural source of slimming substances”.

After treating lab-cultured human pre-adipocytes with the tea extract, the authors found that fat incorporation during the genesis of new adipocytes was reduced. According to Winnefeld, “The extract solution induced a decrease in the expression of genes associated with the growth of new fat cells, while also prompting existing adipocytes to break down the fat they contain”.

White tea is made from the buds and first leaves of the plant used to make green tea and the black tea most commonly drunk in Western countries. It is less processed than the other teas and contains more of the ingredients thought to be active on human cells, such as methylxanthines (like caffeine) and epigallocatechin-3-gallate (EGCG) – which the authors believe to be responsible for many of the anti-adipogenic effects demonstrated in their study.

Public release date: 30-Apr-2009

Drugs to combat anemia in cancer patients increase risk of death

Erythropoiesis-stimulating agents not recommended as routine therapy

OTTAWA, ONTARIO, CANADA – The use of drugs to encourage red blood cell formation (erythropoiesis-stimulating agents) in cancer patients with anemia increases the risk of death and serious adverse events such as blood clots, found a new study in CMAJ.

While the relative increased risk of death was only 15-16%, because of the high mortality rates in cancer patients this increase might translate into significant numbers of people.

“These findings suggest that erythropoiesis-stimulating agents should not be routinely used as an alternative to blood transfusion in patients with chemotherapy-induced anemia unless future studies document safety and clinical benefits in this population,” write Dr. Marcello Tonelli from the University of Alberta and coauthors.

Anemia in cancer patients can develop because of the cancer itself or because of treatments such as chemotherapy. Treatment with agents to stimulate red blood cell formation has been widely used to improve quality of life for many patients and as an alternative to blood transfusions. However, these agents are expensive and reimbursement policies in Canada vary across provinces and territories.

The study, a meta-analysis of 52 clinical trials with 12,006 participants, was based on work done for the Canadian Agency for Drugs and Technologies in Health (CADTH) to summarize the benefits and harms of these agents in adults with cancer-related anemia.

The findings, which are consistent with studies from the United States and the United Kingdom, provide important information for clinicians treating cancer patients and for Canadian policy makers regarding drug reimbursement plans.

“Our findings suggest that existing practice guidelines should be revised to recommend against the routine use of erythropoiesis-stimulating agents as an alternative to blood transfusion in patients with cancer,” conclude the authors. The authors add that erythropoiesis-stimulating agents may be warranted in situations where blood transfusions are not possible or practical.

Public release date: 30-Apr-2009

Low vitamin D causes problems for acutely ill patients

A group of endocrinologists in Sydney have observed that very sick patients tend to have very low levels of Vitamin D. The sicker they are, the lower the levels.

Dr Paul Lee, Professor John Eisman and Associate Professor Jackie Center, researchers at Sydney’s Garvan Institute of Medical Research, examined a cohort of 42 Intensive Care Unit (ICU) patients. Forty-five percent turned out to be Vitamin D deficient.

These findings will be published as a letter in the April 30, 2009 issue of the New England Journal of Medicine.

“Until now, the medical community has thought of Vitamin D deficiency as a chronic condition,” said Dr Lee. “Little is known about its acute complications.”

“Last year, we published several cases showing that Vitamin D deficiency can cause acute complications in the intensive care unit.”

“Recently, Vitamin D has been recognised for its many roles beyond the musculoskeletal system. It has been implicated in diabetes, in the immune system, in cancers, in heart disease and in metabolic syndrome.”

“Vitamin D appears to have roles in controlling sugar, calcium, heart function, gut integrity, immunity and defence against infection. Patients in ICU suffer from different degrees of inflammation, infection, heart dysfunction, diarrhoea and metabolic dysregulation – so vitamin D deficiency may play a role in each of these common ICU conditions.”

“So we did a preliminary study and found that 45% of people in our ICU were Vitamin D deficient. There may be a bias, in that all patients were referred to endocrinology, so the numbers may not reflect the prevalence in a standard ICU cohort. However 45% is still a significant proportion.

When the team correlated the Vitamin D levels with a disease severity score, there was a direct correspondence between sickness and Vitamin D deficiency. In other words, the sicker someone was, the lower the levels of Vitamin D. Out of the 42 patients studied, there were 3 deaths. The 3 patients who died all had the lowest level of Vitamin D in the cohort.

“Perhaps when we are well, we have ways to compensate for organ dysfunction if we run low on Vitamin D,” said Lee.

“But when we are very sick, the “sick organs” draw upon any vitamin D available to function properly, therefore we may need extra Vitamin D to maintain organ function during critical illness. However, at this stage, we don’t know whether Vitamin D deficiency is just a marker of ill health, or whether it contributes to disease severity.”

Lee believes that the study, while preliminary, is important because it highlights the fact that Vitamin D deficiency is common in intensive care units and is associated with disease severity.

The next step will be a randomised control study to investigate whether Vitamin D has benefits in critically ill patients. In simple terms, two groups of patients (who are evenly matched) will be treated, with Vitamin D added to the treatment of one group, but not the other. The outcomes will then be compared.

So should doctors be trying to raise the Vitamin D levels of their patients in the meantime?

Dr Lee hopes the randomised study may provide a more definitive answer to the question. “However, Vitamin D is very safe. It’s inexpensive and has a very large safety window, making toxicity unlikely, unless there are underlying diseases causing high calcium. Giving vitamin D to severely deficient patients is very unlikely to cause harm. In addition, ICU patients are lying in bed for a long time, and are at risk of bone loss and osteoporosis. So if nothing else, Vitamin D will help protect their bones.”

Public release date: 30-Apr-2009

Popular diabetes treatment could trigger pancreatitis, pancreatic cancer

Drug’s adverse effects negated when combined with older diabetes drug

A drug widely used to treat Type 2 diabetes may have unintended effects on the pancreas that could lead to a form of low-grade pancreatitis in some patients and a greater risk of pancreatic cancer in long-term users, UCLA researchers have found.

In a study published in the online edition of the journal Diabetes, researchers from the Larry L. Hillblom Islet Research Center at UCLA found that sitagliptin, sold in pill form as Januvia, caused abnormalities in the pancreas that are recognized as risk factors for pancreatitis and, with time, pancreatic cancer in humans. Januvia is marketed by Merck & Co. Inc. Sitagliptin is a member of a new class of drugs that enhance the actions of the gut hormone known as glucagon-like peptide 1 (GLP-1), which has been shown to be effective in lowering blood sugar in people with Type 2 diabetes. The study is available at http://diabetes.diabetesjournals.org/cgi/content/abstract/db09-0058v1.

“Type 2 diabetes is a lifelong disease — people often take the same drugs for many years, so any adverse effect that could over time increase the risk for pancreatic cancer would be a concern,” said Dr. Peter Butler, director of the Hillblom Center and the study’s lead investigator. “A concern here is that the unwanted effects of this drug on the pancreas would likely not be detected in humans unless the pancreas was removed and examined.”

An observed connection between Byetta, a drug used to treat Type 2 diabetes that is related to Januvia in its intended actions, and pancreatitis has already been reported, prompting a Food and Drug Administration warning. Amylin Corp., which markets Byetta, has suggested that since there is no known mechanism linking the cases of pancreatitis with Byetta, the association might be chance. The UCLA study suggests that there may indeed be a link between drugs that enhance the actions of GLP-1 and pancreatitis — by increasing the rate of formation of cells that line the pancreatic ducts.

In the study, researchers used human IAPP transgenic (HIP) rats to test both sitagliptin and metformin; metformin, a member of an older, different class of diabetes drugs in use since the 1950s, has recently been found to have anti-tumor properties. The researchers sought to determine how the drugs, both singly and in combination, affected islet disease progression in the pancreas — particularly how they affected beta cells in the pancreas’s Islets of Langerhans. Beta cells are responsible for releasing insulin in people with normal metabolism, but they don’t produce insulin in sufficient amounts in diabetes patients. HIP rats approximate both the islets and metabolism of people with Type 2 diabetes. The drugs were tested in 40 rats for 12 weeks.

The researchers found that the two drugs in combination had a synergistic effect that helped preserve beta cells, improved their function and enhanced insulin sensitivity in the test rats. With the sitagliptin alone, however, the rats had abnormally high rates of cell production in their pancreatic ducts; a few developed an abnormality known as ductal metaplasia, and one developed pancreatitis.

But the metformin, trade name Glucophage, seems to counteract sitagliptin’s adverse effect.

“The apparent protection against the unwanted actions of sitagliptin in the exocrine pancreas are intriguing and may offer a potential way of using the GLP-1 class of drugs safely,” Butler said. “The protective effect may have been either by the actions of metformin to decrease blood glucose values or its recently appreciated properties as a tumor suppressive agent.”

Butler noted that the present study was undertaken in rats and that it is possible the adverse effects observed would not occur in humans.

“Given these findings, it is probably sensible to use the GLP-1 class of drugs only with metformin until other data is forthcoming,” he said.

Public Release: 5-May-2009

Stinky” drywall imported from China raises health and safety concerns

Chemical & Engineering News

Homeowners throughout the nation are complaining of stinky odors, copper pipe and wire corrosion, and respiratory problems in an ongoing crisis that officials say is linked to drywall imported from China. An article on this topic is scheduled for the May 4 issue of Chemical & Engineering News, ACS’ weekly newsmagazine.

C&EN associate editor Bethany Halford explains in the article that drywall — also known as wallboard, plasterboard, and gypsum board — is composed of a gypsum, a chalk-like material. Spurred by complaints from homeowners that their homes smell like rotten eggs, investigators have traced the problem to drywall imported from China starting in 2004. But officials do not know the exact chemicals that are causing the problem and how they got into the drywall.

Researchers suspect that the odors are caused by certain sulfur-containing substances in the drywall. Released as gases, these substances can corrode copper pipes, wiring, and air conditioning coils, the article notes. Although officials believe that the gases do not pose a serious health threat, many homeowners with the drywall have reported nosebleeds, sinus problems, and respiratory infections. Several government agencies are now investigating the exact health effects caused by exposure to these gases as well as the electrical safety issues related to corrosion of copper wiring.

Public Release: 5-May-2009

Chinese workers urged to puff up economy by smoking

CLIFFORD COONAN in Beijing

CHINESE STATE employees are being asked to do their patriotic duty to support the local economy – by lighting up a cigarette. And no butts.

In Gongan county in Hubei province, the order has come down from above that employees of all local government departments, organisations, service centres and corporations must consume at least 23,000 cartons of cigarettes this year.

This translates into 400 cartons for most departments and state companies, and 140 cartons for each school.

In a law which gives a whole new meaning to the phrase “the state picks up the tab”, cadres are required to smoke local brands, and anyone smoking other brands can be fined. The smoking allowance aims to boost the regional economy by encouraging more consumption of local cigarettes.

Each work unit in the local government has to produce a monthly work plan, which outlines rates of consumption by employees.

This plan will be closely monitored, and if the bureaucrats and civil servants fail to smoke the required amount, their department risks losing out on its full share of the full smoking allowance of four million yuan (€440,000).

During one school inspection at Zhangtiansi Middle School in April, officials going through waste paper baskets in the staff room found three butts from cigarettes made in other provinces, and the school was strongly criticised.

A fine of 1,000 yuan (€110) can be imposed, although in this particular instance the transgression is being used as a test case to show the way to observe the new ruling.

The local government hopes to retrieve losses from cigarette income tax with the decree, said Chen Nianzu, a member of Gongan’s cigarette leadership group.

“We’re guiding people to help contribute to the local economy,” said Mr Chen, according to the Hubei Daily newspaper.

This patriotic smoking drive follows pressure earlier this year on cadres in Hefei province and other citizens to buy apartments as part of their national duty to keep the real estate market afloat.

China has more smokers than any other country, with 350 million puffing away regularly. A million die of smoking-related diseases every year.

The government has introduced more anti-smoking measures recently to try and encourage people to stop, such as introducing no-smoking areas and trying to educate children not to smoke.

Internet commentators were outraged at the move. “Why should we use public money to pay for government officials to smoke?

“If they want a fag, they should buy their own, and put the money into social welfare, healthcare and stopping people from smoking,” wrote one blogger.

© 2009 The Irish Times

Public release date: 11-May-2009

Research finds Kava safe and effective

Extract of Kava useful in treating anxiety and improving mood

Researchers at the University of Queensland in Australia have found a traditional extract of Kava, a medicinal plant from the South Pacific, to be safe and effective in reducing anxiety.

To be published online this week in the Springer journal Psychopharmacology, the results of a world-first clinical trial which found that a water-soluble extract of Kava was effective in treating anxiety and improving mood. The Kava was prescribed in the form of tablets.

Lead researcher Jerome Sarris, a PhD candidate from UQ’s School of Medicine, said the placebo-controlled study found Kava to be an effective and safe treatment option for people with chronic anxiety and varying levels of depression.

“We’ve been able to show that Kava offers a natural alternative for the treatment of anxiety, and unlike some pharmaceutical options, has less risk of dependency and less potential of side effects,” Mr. Sarris said.

Each week participants were given a clinical assessment as well as a self-rating questionnaire to measure their anxiety and depression levels. The researchers found anxiety levels decreased dramatically for participants taking five tablets of Kava per day as opposed to the placebo group which took dummy pills.

“We also found that Kava had a positive impact on reducing depression levels, something which had not been tested before,” Mr. Sarris said. In 2002 Kava was banned in Europe, UK and Canada due to concerns over liver toxicity.

While the three-week trial raised no major health concerns regarding the Kava extract used, the researchers said larger studies were required to confirm the drug’s safety.

“When extracted in the appropriate way, Kava may pose less or no potential liver problems. I hope the results will encourage governments to reconsider the ban,” Mr. Sarris said.

“Ethanol and acetone extracts, which sometimes use the incorrect parts of the Kava, were being sold in Europe. That is not the traditional way of prescribing Kava in the Pacific Islands. Our study used a water-soluble extract from the peeled rootstock of a medicinal cultivar of the plant, which is approved by the Therapeutic Goods Administration of Australia and is currently legal in Australia for medicinal use.”

Reference

1.  Sarris J et al. (2009). The Kava Anxiety Depression Spectrum Study (KADSS): a randomized, placebo-controlled crossover trial using an aqueous extract of Piper methysticum. Psychopharmacology. DOI 10.1007/s00213-009-1549-9

Public release date: 11-May-2009

Study reveals conflict between doctors, midwives over homebirth

CORVALLIS, Ore. – Two Oregon State University researchers have uncovered a pattern of distrust – and sometimes outright antagonism – among physicians at hospitals and midwives who are transporting their home-birth clients to the hospital because of complications.

Oregon State University assistant professor Melissa Cheyney and doctoral student Courtney Everson said their work revealed an ongoing conflict between physicians and midwives that is reflective of discord across the country.

The pair recently examined birth records in Oregon’s Jackson County from 1998 through 2003, a period when that county saw higher-than-expected rates of prematurity and low birth weight in some populations. The researchers wanted to assess whether those rates were linked to midwife-attended homebirths.

The findings revealed that assisted homebirths did not appear to be contributing to the lower-than-average health outcomes and, in fact, that the homebirths documented all had successful outcomes. But even more importantly to Cheyney, discussions with doctors and midwives uncovered a deep gulf between the two groups of birthing providers, with doctors expressing the firm belief that only hospital births are safe, while midwives felt marginalized, mocked and put on the defensive when in contact with physicians.

“We’ve been getting insight into their world view, and it’s been quite illuminating,” Cheyney said.

Cheyney, who is a practicing midwife in addition to being an assistant professor of medical anthropology and reproductive biology, said she was surprised that physicians, when presented with scientifically conducted research that indicates homebirths do not increase infant mortality rates, still refuse to believe that births outside of the hospital are safe.

“Medicine is a social construct, and it’s heavily politicized,” she said.

Last year the American Medical Association passed Resolution 205, which states: “the safest setting for labor, delivery and the immediate post-partum period is in the hospital, or a birthing center within a hospital complex…” The resolution was passed in direct response to media attention on home births, the AMA stated.

What is interesting, Cheyney points out, is that 99 percent of American births occur in the hospital, but the United States has one of the highest infant mortality rates of any developed country, with 6.3 deaths per 1,000 babies born. Meanwhile, the Netherlands, where a third of deliveries occur in the home with the assistance of midwives, has a lower rate of 4.73 deaths per 1,000.

One of the biggest problems Cheyney sees is that physicians only come into contact with midwives when something has gone wrong with the homebirth, and the patient has been transported to the hospital for care. There are a number of reasons why this interaction often is tension-filled and unpleasant for both sides, she says.

First is the assumption that homebirth must be dangerous, because the patient they’re seeing has had to be transported to the hospital. Secondly, the physician is now taking on the risk of caring for a patient who is unknown to them, and who has a medical chart provided by a midwife which may not include the kind of information the physician is used to receiving.

And because the midwife is often feeling defensive and upset, Cheyney said, the contact between her and the physician can often be tense and unproductive. Meanwhile, the patient, whose intention was not to have a hospital birth, is already feeling upset at the change in birth plan, and is now watching her care provider come into conflict with the stranger who is about to deliver her baby.

“It’s an extremely tension-fraught encounter,” Cheyney said, “and something needs to be done to address it.” As homebirths increase in popularity, she added, these encounters are bound to increase and a plan needs to be in place so that doctors and midwives know what protocol to follow.

She is working with Lane County obstetrician Dr. Paul Qualtere-Burcher to draft guidelines that would help midwives and their clients decide when they need to seek medical help, based in large part on Cheyney’s research, and another that would ask physicians to recognize midwives as legitimate caregivers.

Qualtere-Burcher said creating an open channel of communication isn’t easy.

“I do get some pushback from physician friends who say that I’m too open and too supportive,” he said. “My answer, to quote (President) Obama, is that dialogue is always a good idea.”

Qualtere-Burcher said he believes that if midwives felt more comfortable contacting physicians with medical questions or concerns, there would be a greater chance that women would get medical help when they needed it.

“Treat (midwives) with respect, as colleagues, and they’ll not be afraid to call,” he said.

Qualtere-Burcher doesn’t expect immediate buy-in, but hopes that if a small group on each side agrees to the plan, it will provide more evidence that a stronger relationship between physicians and midwives will lead to better outcomes for mothers and infants.

“We’re having a meeting in early May to propose a draft for a model of collaborative care that might be the first of its kind in the United States,” Cheyney said.

Cheyney is also pushing to get hospitals and the state records division to better track homebirths. The department of vital records had no way to indicate whether a birth occurred at home until 2008, and without being able to pull data, Cheyney said it’s hard to explore the nature of home birth in Oregon.

She’s also working on education programs for midwives in rural areas, including a cultural competency piece as demographics in Oregon continue to change.

Public release date: 11-May-2009

Stronger backbone: DHEA hormone replacement increases bone density in older women

Drug combination could lower risk of fracture by 30 to 50 percent in women, according to Saint Louis University research

ST. LOUIS – Taking a DHEA supplement combined with vitamin D and calcium can significantly improve spinal bone density in older women, according to a new study from a Saint Louis University scientist and his colleagues at Washington University.

“The results of our study are very promising. Similar studies have demonstrated much smaller benefits for bone than we found. However, calcium and vitamin D deficiencies, which are present in half of older adults, may have prevented DHEA from improving bone density in the earlier studies,” said Edward Weiss, Ph.D., associate professor of nutrition and dietetics at Saint Louis University’s Doisy College of Health Sciences and lead author of the study.

“In our study, we supplemented all participants with calcium and vitamin D to ensure that deficiencies were not present. This may explain why our study showed more favorable effects on bone density.”

DHEA (dehydroepiandrosterone), a naturally occurring steroid hormone produced in the adrenal gland, gonads and brain, decreases with age. According to Weiss, low DHEA concentration has been associated with low bone density, which lead researchers to question whether restoring DHEA levels could improve or preserve bone health.

The two-year study divided men and women, ages 65 to 75 years old, into two groups. The first group received the DHEA supplement, vitamin D and calcium for two years. The control group received a placebo, vitamin D and calcium for the first year and then received the DHEA supplement the second year in place of the placebo.

The effects of the treatment differed for men and women. After the first year, women in the test group experienced an approximate 2 percent increase in bone density, while women in the control group did not see an increase. After the second year when both groups took the DHEA supplement, women in the test group experienced an additional 2 percent increase for a total of approximately 4 percent, while women who switched from placebo to DHEA also experienced an approximate 2 percent increase.

The same treatment, however, did not offer similar benefits for older men. Instead, men in both the test and control groups experienced a 1 to 2 percent increase in spinal bone density. According to researchers, the results suggest that vitamin D and calcium supplements, which were give to both groups, could be responsible for the increase in bone density.

The results of the study are promising for older women. According to Weiss, patients who achieve similar increases of 2 to 4 percent in spinal bone density with the help of medication experience a 30 to 50 percent reduction in risk of spine fractures.

Further, researchers say that the increase in spinal bone density experienced by women in the test group who took DHEA for two years, is at least as effective as other current therapies including estrogen and bisphosphonates, a class of prescription drugs that increases bone density.

However, like other therapies, the benefits of DHEA supplements were limited to spinal bone density. Neither men nor women experienced an improvement in hip bone density. Weiss says the hip may respond more slowly to bone-enhancing therapies than the spine, thus requiring more time to see a beneficial effect. More research is needed though.

“In addition to its beneficial effects on bone, DHEA replacement may have other benefits including improvements in risk factors for diabetes and heart disease, improvements in immune function, and improvements in psychological health,” Weiss said.

While the research findings are promising, Weiss says that people should consult with their doctor before taking DHEA, which is an over-the-counter dietary supplement.

“Although DHEA is generally considered safe for consumption at 50 mg per day, it increases estrogen and testosterone levels which in turn could increase cancer risk,” Weiss explained. “Therefore, DHEA supplementation should be avoided in men and women who have had cancer or who have a strong family history of cancer until further research can establish whether or not it is safe for these individuals.”

Public release date: 11-May-2009

Probiotics may help ward off postpartum obesity

NEW YORK (Reuters Health) – Pregnant women who take probiotic supplements starting in the first trimester are less likely to develop central obesity after they’ve given birth, according to a new study.

Central obesity was defined as a body mass index of 30 or higher or a waist circumference greater than 80 centimeters, about 31-1/2 inches.

At 1 year after giving birth, 25 percent of women given probiotics along with dietary counseling had central obesity based on that definition, compared with 43 percent of women given diet advice alone.

The findings were reported Thursday at the European Congress on Obesity being held in Amsterdam, the Netherlands.

“This is the first study showing that probiotics-supplemented diet during pregnancy and breastfeeding influences the adiposity of women over the 12-month postpartum period,” Kirsi Laitinen, from the University of Turku, Finland, told Reuters Health.

The results stem from a study of 256 pregnant women who were given either probiotic capsules plus dietary advice, or placebo capsules plus dietary advice, or placebo capsules and no dietary advice. The probiotic capsules, which contained Lactobacillus and Bifidobacterium, were continued for up to 6 months after delivery until the women had stopped exclusive breastfeeding.

The percentages of women with central obesity at 1 year were 25 percent, 43 percent, and 40 percent in the probiotic, dietary advice-only, and no-probiotic/advice groups, respectively. The corresponding average body fat percentages were 28 percent, 29 percent, and 30 percent.

Laitinen noted that one limitation of the study was “the lack of baseline measurement of waist circumference, which was not possible to conduct in pregnant women.”

Modification of normal bacterial in the intestines probiotics “together with a balanced diet may offer a reasonably economic, practical, safe and potentially successful method to be used with other lifestyle-related factors in controlling obesity,” the researcher said — while acknowledging that further studies are needed to verify these findings.

Public release date: 11-May-2009

Why Antidepressants Don’t Live Up to the Hype

In the ’90s, Americans grew fond of the idea that you can fix depression simply by taking a pill – most famously fluoxetine (better known as Prozac), though fluoxetine is just one of at least seven selective serotonin reuptake inhibitors (SSRIs) that have been prescribed to treat hundreds of millions of people around the world.

But in the past few years, researchers have challenged the effectiveness of Prozac and other SSRIs in several studies. For instance, a review published in the Journal of Affective Disorders in February attributed 68% of the benefit from antidepressants to the placebo effect. Likewise, a paper published in PLoS Medicine a year earlier suggested that widely used SSRIs, including Prozac, Effexor and Paxil, offer no clinically significant benefit over placebos for patients with moderate or severe depression. Meanwhile, pharmaceutical companies maintain that their research shows that SSRIs are powerful weapons against depression. (Here’s a helpful blog post that summarizes the debate.)

Now a major new study suggests that both critics and proponents might be right about SSRIs: the drugs can work, but they appear to work best for only a subset of depressed patients – those with a limited range of psychological problems. People whose depression is compounded with, say, substance abuse or a personality disorder may not get much help from SSRIs – which is unfortunate for the 45% to 60% of patients in the U.S. who have been diagnosed with a common mental disorder like depression and also meet the criteria for at least one other disorder, like substance abuse. (Multiple diagnoses are known in medical parlance as comorbidities.)

The new study, published online in April by the American Journal of Psychiatry, was conducted using data from a large, government-funded trial called Sequenced Treatment Alternatives to Relieve Depression, which usually goes by the moniker STAR*D. The STAR*D project, which collected data from 2001 to 2004 at 41 U.S. psychiatric facilities, was one of the most ambitious efforts ever to understand how best to treat people with major depression. STAR*D participants comprise a powerful research sample because they are highly representative of all depressed Americans. Very few depressed people were excluded from STAR*D; only women who were pregnant, those with seizure disorders and a few others with acute conditions were kept out. All other psychiatric and medical comorbidities were allowed.

The authors of the new paper, a team of 11 researchers led by University of Pittsburgh professor of epidemiology Stephen Wisniewski, were curious how the STAR*D group would compare with a typical group of patients selected for a run-of-the-mill drug-company trial for a new antidepressant – the very trials on which the Food and Drug Administration bases its decisions regarding new drug approval. Drawing on their own experiences in helping to conduct such trials, which have far more stringent inclusion criteria than the STAR*D group, Wisniewski and his team divided the STAR*D patients into two groups – an “efficacy” sample of patients who would normally be included in a typical Phase III clinical trial for a new antidepressant and a “nonefficacy” sample of patients who would normally be rejected.

Depressed STAR*D patients who were classified for inclusion had no more than one general medical condition (like, say, heart disease) and no more than one additional primary psychiatric disorder besides depression. All patients with multiple comorbidities – along with anyone whose depression had lasted more than two years – were excluded. Once the authors crunched all the numbers, they found that only 22% of STAR*D patients met entry criteria for a conventional antidepressant trial.

All the STAR*D patients were taking citalopram, an SSRI marketed in North America as Celexa. Not surprisingly, those who met standard inclusion criteria for a clinical trial had significantly better outcomes on the drug. In the efficacy group, 52% responded to Celexa vs. 40% of the nonefficacy group. Patients in the latter group also took longer to respond and had to be readmitted to psychiatric settings more often. “Thus,” the authors conclude, “current efficacy trials suggest a more optimistic outcome than is likely in practice, and the duration of adequate treatment suggested by data from efficacy trials may be too short.”

To bolster their findings, the authors cite a smaller 2002 study that arrived at similar results: in that paper, published in the American Journal of Psychiatry, Dr. Mark Zimmerman of Brown University and his colleagues found that of 315 patients with major depressive disorder who sought care, only 29, or 9.2%, met typical criteria for an efficacy trial. Similarly, psychologist Ronald Kessler of Harvard co-authored a 2003 paper in the Journal of the American Medical Association that concluded that most “real world” patients with major depression would be excluded from clinical trials because of comorbidities.

Such findings help explain why antidepressants haven’t quite lived up to their promise. But the University of Pittsburgh’s Wisniewski, the lead author of the new study, cautions against interpreting the results as an indictment against greedy drug companies eager to exclude difficult patients in order to show better results. “If the population in a [clinical] trial were more representative, that would come at a cost,” he says. Researchers expect a certain number of bad reactions during clinical trials; some of these reactions can cause serious medical problems. If patients enter a trial with multiple complications – if they are, say, not only depressed, but also cocaine-addicted, hypertensive and diabetic – you dramatically increase the chances of adverse side effects. “That’s why trials to determine efficacy are done on a relatively homogeneous population,” Wisniewski says.

That’s understandable, but the new study does shed light on the limitations of antidepressants. Conducting clinical trials with representative samples would undoubtedly be more complex – and expensive – since patients with multiple risk factors would have to be monitored more carefully. But for a future generation of antidepressants to be truly effective for most patients, more-inclusive trials may be the best answer.

Ralph’s Note: Good Job, Time

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These reports are done with the appreciation of all the Doctors, Scientist, and other

Medical Researchers who sacrificed their time and effort. In order to give people the

ability to empower themselves. Without the base aspirations for fame, or fortune.

Just honorable people, doing honorable things.