Increasing calcium intake ‘does not improve bone health of seniors’

Increasing calcium intake ‘does not improve bone health of seniors’
 Increasing calcium intake ‘does not improve bone health of seniors’

Mediterranean diet best for a healthy gut, study finds

Mediterranean diet best for a healthy gut, study finds
Based on the production of health-promoting short-chain fatty acids, a vegan, vegetarian or Mediterranean diet is best for health, according to the results of a new study published in the journal Gut.
[Mediterranean diet]
Those who follow a Mediterranean diet have higher levels of health-promoting short-chain fatty acids in their gut, new research finds.

Adding to the considerable volume of research that shows that eating a diet high in fiber is good for you, the new study shows a direct link between the amount of fiber-rich foods consumed and the production in the gut of important, health-promoting short-chain fatty acids (SCFAs).

The research authors conclude by saying why a Mediterranean diet is particularly good.

SCFAs are the connection, they say, to health benefits that include reducing the risk of inflammatory disease, diabetes and heart disease.

SCFAs are produced when fiber from dietary plant matter is fermented in the colon. SCFAs include acetate, propionate and butyrate. Butyrate, for example, is the primary energy source for colonic cells, making it vital to colon health. It has anticarcinogenic and anti-inflammatory properties.

The Mediterranean diet is high in fiber-rich fruits, vegetables and legumes, compared with an Anglo-Saxon diet that includes a lot of red meat and dairy products.

For their study, the researchers analyzed the diets of 153 adults from around Italy. Over a single week they noted everything the participants ate. They also analyzed stool and urine samples – a way of assessing participants’ gut bacteria and the “chemical fingerprints” of metabolites.

Of the 153 people taking part, 51 of them were omnivores, 51 were vegetarians and 51 were vegans. A Mediterranean diet made up 88% of what vegans ate, 65% of what vegetarians ate and 30% of what omnivores ate.

Microbial activity differed by diet

The researchers found that there were distinct patterns of microbial activity based on the eating patterns people had.

For example, it was found that those who ate a predominantly plant-based diet, particularly those who were vegan, had higher levels of Bacteroidetes in their gut, while those who ate a predominantly animal-based diet had higher levels of Firmicutes. Differing microbial species in these categories of organism – known as phyla – are better able to break down complex carbohydrates resulting in the all-important production of SCFAs.

Higher levels of SCFAs were found among vegans and vegetarians, as well as those who consistently consumed a Mediterranean diet.

It turns out that the quantity of fruit, vegetables, legumes and fiber consumed matters far more to the production of SCFAs than the type of dietary regime followed.

However, you can eat meat and benefit from the effects of SCFAs; the levels of a compound linked to cardiovascular disease – trimethylamine oxide (TMAO) – was far higher in the meat eaters than in the vegetarians and vegans. Sources of trimethylamine that the liver converts into TMAO include eggs, beef, pork and fish.

Commenting on their findings, the researchers say:

“We provide here tangible evidence of the impact of a healthy diet and a Mediterranean dietary pattern on gut microbiota and on the beneficial regulation of microbial metabolism toward health maintenance in the host.”

It appears that being a vegan most of the time, a vegetarian some of the time and an occasional meat eater would produce one of the healthiest diets – namely the Mediterranean diet.

Earlier this month, Medical News Today reported on a study that found a Mediterranean diet supplemented with olive oil may reduce the risk of breast cancer.

Aspirin may double survival for cancer patients

Aspirin may double survival for cancer patients
Aspirin may double the chances of survival for patients with gastrointestinal cancers, according to the results of a new study recently presented at the 2015 European Cancer Congress in Vienna, Austria.
[A bottle of aspirin
New research suggests aspirin could double the survival of patients with gastrointestinal cancers.

This research, led by Dr. Martine Frouws of Leiden University Medical Centre in the Netherlands, adds to growing evidence suggesting aspirin may be useful in the prevention and treatment of cancer.

Last month, Medical News Today reported on a study suggesting aspirin may reduce the risk of colorectal cancer, while a more recent study claims aspirin may help boost treatment response in patients with breast, skin and bowel cancers.

For their study, Dr. Frouws and colleagues set out to determine how aspirin impacts the survival of patients with tumors in the gastrointestinal (GI) tract – namely the rectum, colon and esophagus. This is the first time a study has simultaneously assessed survival data by different GI locations, according to the authors.

The study included 13,715 patients who received a GI cancer diagnosis between 1998 and 2011. They were followed up for a median of 48.6 months. Of these patients, 42.8% had colon cancer, 25.4% had rectal cancer and 10.2% had cancer of the esophagus.

To determine how aspirin use after a GI cancer diagnosis impacted the overall survival of these patients, the researchers linked patient data with drug dispensing information from the PHARMO Institute in Utrecht, the Netherlands.

“In this study we analyzed each separate prescription per patient, and therefore we were able to achieve a more exact estimate of the effect of aspirin on cancer survival,” notes Dr. Frouws.

Post-diagnosis aspirin users twice as likely to survive GI cancer

Overall, around 30.5% of patients used aspirin prior to GI cancer diagnosis, 8.3% only used aspirin after their diagnosis, while 61.1% did not use aspirin.

Fast facts about aspirin

  • Aspirin is a widely used painkiller and anti-inflammatory drug, though it is increasingly used as an antiplatelet medication
  • The US Preventive Services Task Force recommend that people ages 50-59 take aspirin daily to lower their risk of heart attack and stroke
  • Side effects of aspirin use include nausea, stomach pain, vomiting, heartburn and, in more severe cases, intestinal bleeding.

Learn more about aspirin

Across all cancers, around 28% of patients survived for at least 5 years.

Compared with patients who used aspirin before their cancer diagnosis and those who did not use the medication, patients who used aspirin after their diagnosis were twice as likely to survive, according to the results.

This finding remained even after the team accounted for potential confounding factors, including age, sex, cancer stage, cancer treatment and the presence of other medical conditions.

While the exact mechanism underlying the anticancer effect of aspirin is unclear, the researchers suggest it could be down to its antiplatelet properties. They explain that circulating tumor cells (CTCs) are believed to use platelets – a component of blood – to shield themselves from the immune system. Because aspirin blocks the function of platelets, this may expose CTCs, leaving them open to attack.

Though the optimal dosage and duration of aspirin use and its effect on GI cancers need to be investigated in further research, the team believes they have uncovered a potential treatment option that could reach a wide number of patients.

“Given that aspirin is a cheap, off-patent drug with relatively few side effects, this will have a great impact on health care systems as well as patients,” says Dr. Frouws, adding:

“Medical research is focusing more and more on personalized medicine, but many personalized treatments are expensive and only useful in small populations.

We believe that our research shows quite the opposite – it demonstrates the considerable benefit of a cheap, well-established and easily obtainable drug in a larger group of patients, while still targeting the treatment to a specific individual.”

The team is now conducting a randomized, placebo-controlled trial investigating how an 80-milligram dose of aspirin affects elderly patients with colon cancer.

Earlier this year, MNT reported on a study published in JAMA suggesting that certain genetic variations may influence the effect of aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) on colorectal cancer.

Breast cancer: are men the forgotten victims?

Breast cancer: are men the forgotten victims?
In recognition of Breast Cancer Awareness Month this October, cancer charities and organizations around the globe will be “thinking pink.” On October 23rd, Breast Cancer Now will hold their annual “Wear it Pink” event, in which people all over the US will wear pink clothing to raise awareness of the disease that will be diagnosed in more than 230,000 women this year. But in this flurry of feminine pink, it can be easy to forget that men can get breast cancer, too.
Breast cancer campaign
Pink is the color for Breast Cancer Awareness Month this October. But is the femininity linked to breast cancer causing men with the disease to be forgotten?

In fact, it is estimated that 2,360 new cases of breast cancer will be diagnosed in men in the US this year, and around 430 men will die from the disease.

Admittedly, breast cancer in men is rare. A man’s lifetime risk of the disease is 1 in 1,000, while a woman’s is 1 in 8. But according to a 2012 study that assessed more than 13,000 male breast cancers from the US National Cancer Data Base, men with breast cancer are less likely to survive the disease than women.

The researchers found that at diagnosis, men were likely to have much larger breast tumors, and the cancer was more likely to have already spread to other areas of the body.

“This may be attributed to the fact that awareness of breast cancer is so much greater among women than men,” commented study leader Dr. Jon Greif. “Guidelines call for regular screening, both clinical and mammographic, in women, leading to earlier detection.”

And it seems Dr. Greif is not wrong. A 2010 study by Eileen Thomas, of the University of Colorado Denver, found that 80% of men surveyed were not aware that men could even develop breast cancer, and the majority could not identify any symptoms of male breast cancer other than a lump in the breast.

In this Spotlight feature, we look at the signs of male breast cancer, the diagnostic and treatment options for the disease, and why there is such lack of awareness of male breast cancer among the general public.

‘Most people don’t think of men as having breasts’

“Many people don’t know that men can get breast cancer because they don’t think of men as having breasts,” Jackie Harris, clinical nurse specialist at UK charity Breast Cancer Care, told Medical News Today. “In fact, both men and women have breast tissue, although men have much smaller amounts than women.”

Until puberty, both young girls and boys have small amounts of breast tissue consisting of lobules (glands than can produce milk), ducts (small tubes that carry milk from the lobules to the nipple) and stroma (fatty and connective tissue).

When girls reach puberty, high levels of the female hormone estrogen cause substantial growth in lobules, ducts and stroma, producing full breasts. Because boys and men have low levels of estrogen, they are very unlikely to form fully grown breasts.

However, what breast tissue a man has still contains ducts, and cells in these ducts – like all cells in the body – can become cancerous. The cancerous cells can then enter the lymphatic vessels of the breast and grow in the lymph nodes situated above and below the collarbone and under the breast bone. Once in the lymph nodes, it is likely the cancer cells have entered the bloodstream and spread to other areas of the body.

Although most male breast cancer cases begin in the ducts – known as ductal carcinoma – it can also develop in the breast lobules (lobular carcinoma), but this only accounts for around 2% of all male breast cancers.

The risk factors for male breast cancer

Exactly what causes breast cancer in men is unclear. But many of the factors that increase the risk of breast cancer among women are the same for men.

As men age, their risk of breast cancer increases, with the average age of diagnosis being 68 years. Men who have a family history of breast cancer are also at increased risk of developing the disease.

One of the most well-known risk factors for breast cancer among women is inherited BRCA1 and BRCA2 gene mutations. Men who inherit these mutations are also at much higher risk of breast cancer. Those who have a BRCA1 mutation have a 1 in 100 lifetime risk of the disease, while a BRCA1 mutation poses a 6 in 100 lifetime risk.

Past research has suggested that men with Klinefelter syndrome – a congenital condition in which an additional X chromosome is present – are also at higher risk of breast cancer.

Other factors that increase the risk of breast cancer in women, such as smoking, obesity, radiation exposure and high alcohol consumption, can also increase men’s breast cancer risk.

‘It is vital for everyone to be breast aware’

Women are encouraged to frequently check their breasts for any abnormalities, such as lumps, discharge from the nipple or changes in appearance or texture. And although many men may not be aware of it, they should do the same.

The most common signs of breast cancer in men are lumps or swelling in the breast or lymph node areas, dimpling or puckering of the skin, nipple retraction, nipple discharge and scaling or redness of the nipple or surrounding skin.

It is important to note that such signs do not always indicate breast cancer; they could be caused by a condition called gynecomastia – a benign enlargement of breast tissue. But Harris told MNT that if men spot any of these changes, they should visit their clinician immediately to determine the cause:

“We know that the sooner the diagnosis, the more effective treatment may be and the vast majority of breast cancers are found by men and women themselves. It’s vital for everyone to be breast aware.

Encouraging men to get used to looking at and feeling their chest and under their arms regularly will help them to feel more confident about noticing any unusual changes so they can go to their doctor promptly.”

Men embarrassed by breast cancer diagnosis

As with all cancers, early detection of breast cancer improves treatment outcomes. But as the study by Dr. Greif and his team found, the majority of male breast cancers are found in the later stages, which negatively impacts the chances of survival.

Man covering chest with hands
Because the majority of information and research on breast cancer focuses on women, men can feel ashamed if they are diagnosed with an illness that is seen as feminine.

One reason behind this is lack of awareness. Because male breast cancer is rare and many men do not realize it can affect them, they put signs of the disease down to another cause and delay visiting their doctor.

But with lack of awareness comes embarrassment. Because the majority of information and research on breast cancer focuses on women, men can feel ashamed if they are diagnosed with an illness that is seen as feminine.

The study by Eileen Thomas, for example, found that 43% of men said they would question their masculinity if they were diagnosed with breast cancer.

And it is not just the thought of having breast cancer itself that can deter men from seeing their doctor; the diagnosis and treatment procedures that go with it can be difficult for men to deal with.

Diagnosis of breast cancer is very similar for men and women. After a clinical examination to determine any abnormalities in the breast tissue or lymph nodes, a man may be required to undergo a mammogram if there is any suspicion of breast cancer.

“I think that many people are surprised to hear that men can have mammograms,” Susan Brown, director of health education at Susan G. Komen for the Cure – a nonprofit breast cancer organization – told The Huffington Post, noting that men are embarrassed by having to undergo a procedure that is usually used on women.

“There’s the whole awkwardness of the procedure itself. And then there’s the idea that it’s difficult for many men to even imagine having a mammogram. It’s tough.”

Men may also be required to have a breast ultrasound or magnetic resonance imaging (MRI) of the breast, before having breast tissue samples taken to confirm if cancer is present.

Could routine breast cancer screening in men improve diagnosis?

For men at high risk of breast cancer, such as those with an inherited BRCA gene mutation, some organizations recommended regular screenings.

The National Comprehensive Cancer Network, for example, recommend that men at high risk of breast cancer have a clinical breast exam every 6-12 months from the age of 35, and should consider having a mammogram at the age of 40. However, there are no routine screening recommendations for the average man.

According to the American Cancer Society: “Because breast cancer is so uncommon in men, there is unlikely to be any benefit in screening men in the general population for breast cancer with mammograms or other tests.”

The organization admits, however, that routine screening for breast cancer in men has not been studied, therefore it is unclear as to whether it would be useful for early detection of male breast cancer or not.

It is important to note that there are still no routine screening programs for prostate cancer, which affects 1 in 7 men in the US. Past research into routine screening for prostate cancer has found that although it reduces deaths from the disease, it leads to overdiagnosis.

Given that the rate of male breast cancer is significantly lower, it is unlikely that routine screening for the disease will be considered anytime soon.

All treatments for male breast cancer based on data in women

Men with breast cancer have the same treatment options as women. The majority of male breast cancer patients have a mastectomy, which involves removal of all or some of the breast tissue and, in some cases, the removal of affected lymph nodes.

Chemotherapy drug
There have been very few in-depth studies looking at treatment for male breast cancer, meaning health care providers are using treatments that have only proven to be effective in women with the disease.

Male breast cancer patients may also need to have chemotherapy, radiation therapy, hormone therapy, targeted therapy or bone-directed therapy.

But some health care professionals have questioned the effectiveness of some of these treatments in men. To date, there have been very few in-depth studies looking at treatment for male breast cancer, meaning health care providers are using treatments that have only proven to be effective in women with the disease.

“We don’t know much about how to treat men specifically,” Dr. Kathryn Ruddy, of the Dana-Farber Cancer Institute in Boston, MA, told The Huffington Post. “Every treatment we do comes with the caveat that we’re extrapolating from data in women.”

Because of the rarity of male breast cancer, it can be challenging for scientists to receive the funding for research into the issue and to pull together enough participants to make the studies comprehensive.

But there has been some progress in the field. In 2007, Dr. Nick Orr and colleagues, of the Breakthrough Toby Robins Cancer Research Centre in the UK, launched the ongoing Male Breast Cancer Study, with the aim of identifying genetic, lifestyle and environmental factors that increase breast cancer risk in men.

The study, which now has more than 1,500 participants, has already led to the discovery of a gene – called RAD51B – that causes breast cancer in men. It is hoped the study will eventually lead to tailored treatments for men with breast cancer.

Is male breast cancer awareness increasing?

There is no denying that breast cancer affects the lives of women much more than men. This year, it is estimated that 231,840 women will be diagnosed with invasive breast cancer and 40,000 will die from the disease. With figures like these, it is no wonder that breast cancer information and campaigns are more tailored toward women than men.

But it seems such focus on breast cancer in women has left many people feeling that male breast cancer is overlooked.

In 2009, a number of male breast cancer advocacy groups – including Out of the Shadow of Pink – worked together to establish the third week of October as Male Breast Cancer Awareness Week.

Although this campaign has only officially been declared in the states of Pennsylvania, Florida, New Jersey and Massachusetts, it seems the myth that men are unable to get breast cancer is finally being dispelled, and awareness of male breast cancer is gradually increasing.

Osteopathic manipulative treatment for pneumonia

Osteopathic manipulative treatment for pneumonia

The pneumonias due to infection continue to be a meaningful threat to the health and viability of persons, particularly those in high risk groups: children, the aged and the debilitated. Noll and colleagues provide us with the results of a well-designed and well-executed multi-institutional controlled clinical trial to evaluate the efficacy of osteopathic manipulative treatment (OMT) in the treatment of pneumonia. The data obtained indicate that by intention-to-treat analysis, the addition of OMT to conventional care did not improve the designated outcomes when compared to conventional care only. A disappointing but important finding. However, by per-protocol analysis, the addition of OMT or of light touch decreased length of hospital stay, the duration of intravenous antibiotics and the incidence of respiratory failure and death relative to conventional care only. Further study is called for to explain these surprising results.

Meeting the need for randomized clinical trials of the role and efficacy of OMT is a responsibility of high priority for the osteopathic profession in this age of evidence-based medicine. The American Osteopathic Association (AOA) needs to consider reinstating a dues-generated financial set-aside both to increase its support of osteopathic research and to initiate a program of physician-investigator career development awards to recruit and help establish osteopathic clinical investigators in a career in translational and clinical research.
Introduction

The publication of the paper by Noll et al [1] on the efficacy of osteopathic manipulative treatment (OMT) in patients with acute infectious pneumonia in Osteopathic Medicine and Primary Care raises two important issues: the results of the research per se and meeting the need for implementing additional clinical studies of osteopathic principles and practices.
Results of a randomized controlled clinical trial

The pneumonias due to infection continue to be a meaningful threat to the health and viability of persons, particularly those in high risk groups: children, the aged and the debilitated. Osteopathic manipulative treatment has been used by osteopathic physicians in the past as a primary intervention and continues to be used at the present by them — usually as an adjunct to antibiotic therapy. What is the evidence supporting the use of OMT as an effective clinical intervention?

Pneumonia is a generic term identified with an inflammation of the lung parenchyma characterized by consolidation of the affected part, the alveolar air spaces being filled with exudates, inflammatory cells, and fibrin. Most cases are due to infection by bacteria (e.g. Streptococcus pneumoniae) or by viruses; a few are due to inhalation of chemicals (e.g. chlorine), trauma to the chest wall, and a small minority to rickettsias, fungi and yeasts. In addition there are a number of other events that come under the broad heading of pneumonia such as the aspiration pneumonias, post-embolic pulmonary infarction and eosinophilic pneumonia. Diagnosis is dependent on the history of events leading up to the illness, on other pathologies preceding or present at the time of occurrence and on characteristic findings which can include: systemic symptoms of acute infection, a cough, dyspnea, auscultatory evidence of airspace filling and/or lobar consolidation, hypoxemia, and presence of an infiltrate on imaging of the chest. Thus, pneumonia describes a syndrome of several potential etiologies and pathogeneses. Conventional therapy includes eliminating the etiologic agent (e.g. antibiotic therapy for the bacterial pneumonias); also, the judicious use of supportive therapy (e.g. oxygen inhalation; parenteral fluids). In addition, vaccines are available for prevention of infectious pneumonias in high-risk populations. Other classes of interventions used in conjunction with conventional therapy are usually included under the classification “complementary medicine”; at this time, OMT is included in this classification.

Prior to the development and availability of the sulfa drugs in the 1930-1940s and the antibiotics in the 1950s, the infectious pneumonias were treated symptomatically addressing primarily the respiratory distress, fever and malaise usually associated with them. Herbs, chest counter-irritants (e.g. mustard, cupping), and therapeutic baths were commonly used therapeutic modalities as were a broad spectrum of naturopathic and homeopathic modalities. Death was not uncommon, particularly in children and the aged. It was in this era that osteopathic treatment was reported to be of significance in preventing death and assisting in recovery. Utilizing osteopathic principles of mobilizing total body resources, particularly neurological and immune system mobilization, OMT was administered regularly to the patient, emphasizing spinal mobilization in the thoracic area and manipulative procedures directed at increasing lymphatic flow. Positive results following OMT were reported in observational studies, including case reports and on occasion, case series. During this period, the principles of the controlled clinical trial had not yet been fully developed as a basis for evidence-based medicine and thus results from observational studies were the source of most clinical therapies — including the use of osteopathic principles and OMT in the treatment of pneumonia.

The latter third of the 20th century and the early part of the 21st century are characterized in medicine by the application of the methodologies of the controlled clinical trial as the source of information for evidence-based medicine. During this period, the randomized, blinded, controlled clinical evaluation with sufficient power to meet statistical analysis needs has become the established standard for evaluation of a diagnostic, preventive or therapeutic modality. Variations from this standard were and are being developed to meet the needs of various situations in which the randomized controlled clinical trial would be difficult to utilize; examples are: rare diseases; disorders with a variety of characteristics as in some behavioral dysfunctions; diseases with a fixed end-point such as death or an anatomical structural defect. With full recognition of the valuable information accumulated over the years from observational studies, the randomized clinical trial has now become the standard for evidence-based medicine, including osteopathic clinical care. Both already established clinical interventions and newly developed potential interventions are now subject to evaluation by this research methodology.

Over the past two decades, a limited number of controlled clinical trials of manipulative treatment — osteopathic, chiropractic and allopathic — have been completed. Most trials addressed the issue of pain: headache, cervical pain, lower back pain; a few addressed systemic disease. However, despite this effort many suffered from a scarcity of the resources essential to the organization and conduct of controlled clinical trials: research design expertise; a sufficient number of patients; operational experience; statistical support; adequate funding. To meet these needs, the osteopathic profession has developed several national centers which can assist in mobilizing the resources necessary for the conduct of well-designed clinical trials to evaluate the efficacy of osteopathic diagnostic and therapeutic methodologies. The A.T. Still Research Institute at the Kirksville College of Osteopathic Medicine and The Osteopathic Research Center at the University of North Texas Health Science Center are examples of these. Both provide investigators with the technical assistance and support necessary to develop and conduct institutional and multi-institutional controlled clinical trials of osteopathic clinical care.

With participation of the A.T. Still Research Institute and assistance from The Osteopathic Research Center, a multi-institutional, blinded controlled clinical trial has been reported in 2010 to evaluate the efficacy of OMT in the treatment of pneumonia: “Efficacy of osteopathic manipulation as an adjunctive treatment for hospitalized patients with pneumonia: a randomized controlled trial.” The participants were Donald R Noll, Brian F Degenhardt, Thomas F Morley, Francis X Blais, Kari A Hortos, Kendi Hensel, Jane C Johnson, David J Pasta and Scott T Stoll. The study included over 400 patients; 50 years of age or older; randomized to three intervention protocols: conventional care only (CCO), CCO plus OMT; and CCO plus light touch (LT). The data obtained indicate that by intention-to-treat (ITT) analysis, the addition of OMT to conventional care did not improve the designated outcomes when compared to conventional care only. By per- protocol (PP) analysis, the addition of OMT decreased length of hospital stay, duration of intravenous antibiotics and the incidence of respiratory failure and death relative to conventional care only. Thus, if a subject received the OMT plus conventional care protocol as prescribed without missing any treatment sessions, there was significant benefit; however, the same positive result was found with light touch. Why no difference in outcome between OMT and light touch, that remains to be studied. Was it because there are no differences, or because it is a result of research design? These are questions that now require a response.
Evidence-based medicine: the evaluation of osteopathic principles and practice

The authors are to be congratulated for mastering the technology and the art of the randomized controlled trial (RCT) and for utilizing it for the evaluation of OMT in the treatment of a life-threatening acute illness. Modern medicine now requires that OMT’s present and future clinical application be evaluated utilizing methodologies that are reliable and reproducible. The RCT is a critical methodology for meeting that objective. It is a methodology that the osteopathic profession must foster so that its identifying characteristics of patient care become part of conventional medicine rather than continuing to be considered complementary medicine.

The basic principles of the RCT are well established, although its application to a specific question requires a variety of specific expertise. However, the conduct of a RCT is an art form requiring the continuing interaction of a variety of committees to monitor the conduct of the protocol and to address the several operational problems that will undoubtedly arise during the conduct of the trial. The RCT is also usually very expensive and often dependent upon government funding. In order to be successful in its design, operation and funding, funds in support of a pilot study become an essential requirement. Once the proposed study — its concept, objectives and potential have been tested, the probability of receiving adequate funding for the full study becomes more realistic. Meeting the need for pilot studies of RCT of OMT is a responsibility of the osteopathic profession — including national, state and local osteopathic associations and the several private foundations associated with the profession.

The American Osteopathic Association (AOA) and its affiliates continue to provide funds for this purpose. However, the funds available are in short supply. In years past, the AOA established a special financial set-aside for osteopathic research by initiating a modest assessment attached to AOA dues. This assessment was time limited and has been discontinued. Should this mechanism for enlarging the resources available be reinstated by the AOA in order to stimulate additional osteopathic research? Should these funds be used also to establish a program of career development awards to prepare a cadre of osteopathic physician-investigators for future leadership in OMT research? I suggest it should. How else can the osteopathic profession meet its responsibilities to be active participants in what is rapidly becoming the basis for modern clinical care — evidence-based medicine. The osteopathic profession through its national organization, the AOA, needs to move ahead aggressively to provide the resources necessary — people and money — for accelerating osteopathic participation in modern medical research, specifically the role and efficacy of OMT in the promotion of health and the treatment of illness.