Medical Research Studies & “Spin”

May 30, 2010 by  
Filed under Weekly Health Update

 

Welcome to Weekly Health Update



“A critical weekly review of important new research findings for health-conscious readers” 



 

I would like to take the occasion of this Memorial Day weekend to sincerely thank the millions of active duty service members, veterans, and families of The Fallen, for their selfless and courageous service to our nation, and for their many sacrifices.

 

Robert A. Wascher, MD, FACS

Colonel, US Army, Retired 

 

MEDICAL RESEARCH STUDIES & “SPIN”

2010 marks the fourth year that I have been writing this column, and despite the diverse range of health-related topics that I’ve reviewed over the years, each weekly column has been written with the same basic goal in mind: to bring cutting-edge health research findings to the public in as objective and honest a manner as possible. 

We would all like to believe that research studies that have been successfully published in highly regarded medical and scientific journals have been so thoroughly vetted prior to publication, that we can readily accept their findings and conclusions.  However, as with any other endeavor that is undertaken by humans, flaws in research hypotheses or methodologies, errors in the actual conduct of research, and erroneous conclusions drawn from the resulting research data can all lead research scientists and clinicians astray.  It is because of these inherent weaknesses associated with research that standardized checks and balances are supposed to be observed in the conduct of all research studies, in an effort to reduce the risk of bias and error in the conduct of research, and in the analysis of the data that they generate.

Despite all of the safeguards that are supposed to be observed while conducting research, and with research studies involving human subjects in particular, bias and error cannot be completely eliminated in every case, and this reality must be accepted.  However, a more worrisome cause of erroneous conclusions in health-related research has been of growing concern to medical journal editors and medical ethicists, lately.  While many clinical research studies produce important new findings that improve our understanding of the diagnosis and treatment of human disease, many other studies result in non-significant findings that do not really advance our understanding in any meaningful way.  In view of the enormous pressure upon research scientists and clinicians to publish clinically meaningful and statistically significant research findings, it is probably not too surprising to learn that some researchers can succumb to the pressure of “fudging” their conclusions when their research data fails to yield any clinically (or statistically) significant findings.  Although the overly optimistic interpretation of research results by researchers is a well-known phenomenon, the extent to which this routinely occurs has been unclear.  Now, a newly published study in the Journal of the American Medical Association reveals the apparent extent to which this disturbing trend contaminates the published findings of clinical research studies.

In this study of “researcher spin,” the authors analyzed 72 prospective randomized clinical research trials, out of a total of 616 randomized controlled research study papers published in peer-reviewed medical journals in December of 2006.  These 72 studies were selected because their treatment findings failed to reach scientifically accepted levels of statistical significance (which is usually defined as a less than 5 percent probability of the observed outcome occurring by chance). 

 

The results of this analytic study are disturbing, to say the least:

 

  In 18 percent of cases, the authors of these “negative” studies chose a title for their study that clearly implied statistically or clinically significant results, despite the lack of significant primary research findings.

 

  Within the abstract section (a brief summary of the entire study), 38 percent of the authors either exaggerated or minimized their results in such a way as to imply that their results were actually significant.  An incredible 58 percent of authors also “spun” the conclusions in their abstracts to suggest clinically meaningful outcomes that were not supported by their own published research data.

 

  Within the main body of these 72 research papers, additional “spin” was identified in 29 percent of the Results sections, 43 percent of the Discussion sections, and 50 percent of the Conclusions sections!

 

  Among these 72 research papers, more than 40 percent of the authors engaged in “spin” in at least 2 sections of the main body of their research papers.

 



The findings of this study, that research authors are routinely exaggerating or otherwise embellishing their research outcomes, are not surprising to me, as a former cancer research scientist, nor would they be surprising to most other research scientists.  However, the sheer scale of “spin” on the part of research scientists, as revealed by this study, is a real eye-opener.  Despite all of the safeguards that have been enacted, over the past 30 to 40 years, to promote objective and honest research, to think that at least half of all authors are routinely engaging in “spinning” their nonsignificant research results, in an intentional effort to imply that their findings are significant, is disturbing (to say the least).

These highly disappointing findings also further validate the primary purpose of this global health research update column:  to objectively and critically present cutting edge clinical and laboratory health-research findings to the hundreds of thousands of my regular readers around the world.  While this method of health journalism may not be as sensational or as sexy as that presented by the non-physician and non-scientist columnists in the mainstream media, it is, nonetheless, a more honest and informative approach than that used by traditional media companies seeking to lure new readers with their hyperbole and their breathless (but superficial) reporting.

 

For other columns related to this topic, please see:

 

Publication & Citation Bias in Favor of Industry-Funded Research?

Drug Company Marketing & Physician Prescribing Bias

Obesity & Risk of Cancer; Testosterone Level & Risk of Death; Drug Company Funding of Research & Results; Smoking & the Risk of Colon & Rectal Cancer 

 

 

 

To read more objective, in-depth, and factual research-based information related to cancer prevention, look for the publication of my new landmark book, “A Cancer Prevention Guide for the Human Race,” in the summer of this year.


Disclaimer: As always, my advice to readers is to seek the advice of your physician before making any significant changes in medications, diet, or level of physical activity 


Dr. Wascher is an oncologic surgeon, a professor of surgery, a cancer researcher, an oncology consultant, and a widely published author



For a different perspective on Dr. Wascher, please click on the following YouTube link: 

http://www.youtube.com/watch?v=7-Tdv7XW0qg



I and the staff of Weekly Health Update would like to take this opportunity to thank the nearly 120,000 new and returning readers who visited our premier global health information website last month.  As always, we enjoy receiving your stimulating feedback and questions, and I will continue to try and personally answer as many of your inquiries as I possibly can. 





 

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Soy & Curcumin Reduce Prostate-Specific Antigen (PSA)

May 23, 2010 by  
Filed under Weekly Health Update

 

Welcome to Weekly Health Update



“A critical weekly review of important new research findings for health-conscious readers” 

SOY & CURCUMIN REDUCE PROSTATE-SPECIFIC ANTIGEN (PSA)

Regular readers of this column are already aware that the regular consumption of foods containing soy isoflavones may be associated with a reduced risk of developing prostate cancer, and other types of cancer as well.  Curcumin, as curry lovers know, is contained within the spice known as turmeric.  Curcumin has been extensively studied, and it too may possess anti-cancer properties as well.  Both of these dietary compounds are thought to have potent anti-inflammatory effects on the prostate gland, and on other organs of the body.  Additionally, soy isoflavones also act weak estrogens (“phytoestrogens”), and may suppress prostate gland activity on this basis too.

Prostate cancers, as well as the normal prostate gland cells that give rise to prostate cancer, produce PSA (prostate-specific antigen), which allows doctors to detect new or recurrent prostate cancers by measuring the level of PSA in the blood.  A newly published research study, which appears in the current issue of the journal The Prostate, adds further evidence that soy isoflavones and curcumin may have an important role to play in prostate cancer prevention and, possibly, prostate cancer treatment.

This study consisted of both a laboratory experiment and a small clinical research trial with human volunteers.  In the laboratory portion of this study, human prostate cancer cells were treated with soy isoflavones and curcumin.  When these prostate cancer cells were treated with soy isoflavones and curcumin, the production of PSA by these cells was dramatically decreased.  Moreover, a receptor for male sex hormones, which prostate cancers use to fuel their growth, was significantly suppressed following treatment of these cells with soy isoflavones and curcumin.

In the clinical portion of this research study, men who had undergone prostate gland biopsies due to an elevated PSA blood level, but who were subsequently found not to have prostate cancer, were also evaluated.  In this prospective, randomized, placebo-controlled trial, 85 men without prostate cancer, but with elevated blood PSA levels, were divided into two groups.  The “experimental group” of men received curcumin and soy isoflavones once per day.  The “control group” of men received a placebo (“sugar pill”) once per day.  Neither group of male volunteers, nor the research assistants who dispensed these pills, knew which men received the placebo pills and which received the soy isoflavone and curcumin pills.

PSA levels were tested in all of these male volunteers at the beginning of the study, and 6 months later.  Among the men randomized to receive daily supplements of soy isoflavones and curcumin, the level of PSA in their blood dramatically declined following 6 months of supplementation with soy isoflavones and curcumin. 

While the results of this small and elegant research study do not prove that soy isoflavones and curcumin can actually prevent prostate cancer in humans, these results do suggest, at least, a biological mechanism whereby these dietary compounds might reduce the risk of developing prostate cancer, and might also have anti-cancer effects in patients with prostate cancer.  However, only large-sale prospective, randomized, blinded, placebo-controlled human clinical trials will be able to prove that these dietary compounds can actually prevent or effectively treat prostate cancer.

At this time, there are multiple ongoing and recently completed prostate cancer prevention and treatment clinical research trials using soy isoflavone supplements.  The results of several of these studies will, hopefully, become available within the next 3 to 5 years. 

While there are multiple cancer prevention and cancer treatment research trials underway that are evaluating curcumin, none of these ongoing curcumin clinical trials are focused on prostate cancer, unfortunately. 

Based upon the findings of this small and innovative research study of soy isoflavones and curcumin, the next logical step would be a large prospective, randomized, placebo-controlled, blinded study that randomizes patient volunteers to placebo, versus soy isoflavones only, versus curcumin only, versus a combination of soy isoflavones and curcumin.  A cancer prevention study could look at prostate cancer incidence in men who are already at high risk of developing this common form of cancer.  A prostate cancer treatment study, using the same methods, could assess the clinical impact of soy isoflavones and curcumin on the progression or recurrence of prostate cancer in men who have already been diagnosed with this form of cancer.

 

To learn more about the role of soy isoflavones and curcumin as potential cancer prevention nutrients, look for the publication of my new landmark evidence-based book, “A Cancer Prevention Guide for the Human Race,” in the summer of this year.



Disclaimer: As always, my advice to readers is to seek the advice of your physician before making any significant changes in medications, diet, or level of physical activity


Dr. Wascher is an oncologic surgeon, a professor of surgery, a cancer researcher, an oncology consultant, and a widely published author



For a different perspective on Dr. Wascher, please click on the following YouTube link: 

http://www.youtube.com/watch?v=7-Tdv7XW0qg



I and the staff of Weekly Health Update would like to take this opportunity to thank the nearly 120,000 new and returning readers who visited our premier global health information website last month.  As always, we enjoy receiving your stimulating feedback and questions, and I will continue to try and personally answer as many of your inquiries as I possibly can. 


 

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Coffee & the Risk of Death from Heart Disease & Cancer

May 15, 2010 by  
Filed under Weekly Health Update

 

Welcome to Weekly Health Update



“A critical weekly review of important new research findings for health-conscious readers” 

COFFEE & THE RISK OF DEATH FROM HEART DISEASE & CANCER

Last month, I reviewed research showing that increased coffee consumption was associated with a decrease in inflammation and an increase in HDL cholesterol (the “good cholesterol”).  However, as I noted in that column, this small study did not address any long-term health outcomes of frequent coffee consumption (Coffee Improves HDL Cholesterol Levels).  Now, a newly published prospective public health study, from Japan, suggests that regular coffee consumption may, indeed, have long-term health benefits (at least for half of the population…).  (I should also note that, as a disclaimer, I am not a coffee drinker, despite reviewing two coffee-related health research studies in as many months!)

The results of this large Japanese research study appear in the current issue of the Journal of Nutrition.  In this prospective epidemiological study, 18,287 men and 19,455 women (between the ages of 40 and 64 years) were prospectively included in the Miyagi Cohort Study, which began in 1990.  All of these study volunteers were without any clinical history of cancer, heart disease, or stroke when they entered into the Study.  After an average of more than 10 years of follow-up, 2,454 of the volunteers died from various causes, including 426 cases of fatal cardiovascular disease and 724 fatal cases of cancer. 

These volunteers were categorized and analyzed according to their self-reported daily consumption of coffee: “never-drinkers,” “occasional-drinkers,” 1 to 2 cups per day, and 3 or more cups per day.  Other known risk factors for cardiovascular disease (including heart disease and stroke) and cancer were also factored into the analysis of the risk of death associated with coffee consumption for each volunteer.

Among the women in this study, increasing levels of daily coffee consumption were associated a decreasing risk of death, due to any cause.  (This “dose-dependent” relationship between daily coffee consumption and risk of death strongly suggests a direct clinical relationship between increased coffee consumption and a decreased risk of death.)  When compared to the women who did not drink coffee at all, the women who drank 3 or more cups of java per day were 25 percent less likely to die, from any cause, during this decade-long public health study.  The coffee-associated reduction in the risk of death from cardiovascular disease was even more powerful (and also appeared to be “dose-dependent”), as the women who downed 3 or more cups of coffee per day experienced a whopping 55 percent decrease in the risk of death due to cardiovascular causes!  Finally, there was an apparent modest decrease in the risk of dying from colorectal cancer among the female coffee drinkers, but no other reduction in the risk of dying from cancer was observed in association with regular coffee consumption among these women volunteers.

Well, I have just shared with you the good news regarding reduced death rates associated with regular coffee consumption from this large, prospective, long-term public health study; and many of you will notice that I have not yet mentioned the health impact of coffee on men!   This is because, unfortunately, this study did not identify any apparent beneficial health effects of regular coffee consumption in men.  The reason, or reasons, for this gender-related disparity is not clear, although it is well known that there are major differences in both the incidence of cardiovascular disease between men and women, and differences in the way that cardiovascular diseases (and heart disease, in particular) manifest themselves in women versus men.  It is, therefore, possible, that cardiovascular disease factors that are more unique to women are directly impacted upon by regular coffee consumption.  (At least no adverse effects of regular coffee consumption on male mortality were observed in this large public health study!)

So, ladies, keep the favorable results of this clinical research study in mind whenever you order that next cuppa Joe!

 

To learn more about the role of coffee, and other sources of dietary tannins, as potential cancer prevention nutrients, look for the publication of my new landmark evidence-based book, “A Cancer Prevention Guide for the Human Race,” in the summer of this year.



Disclaimer: As always, my advice to readers is to seek the advice of your physician before making any significant changes in medications, diet, or level of physical activity


Dr. Wascher is an oncologic surgeon, a professor of surgery, a cancer researcher, an oncology consultant, and a widely published author



For a different perspective on Dr. Wascher, please click on the following YouTube link: 

http://www.youtube.com/watch?v=7-Tdv7XW0qg



I and the staff of Weekly Health Update would like to take this opportunity to thank the nearly 120,000 new and returning readers who visited our premier global health information website last month.  As always, we enjoy receiving your stimulating feedback and questions, and I will continue to try and personally answer as many of your inquiries as I possibly can. 


 

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Soy Foods & Stomach Cancer Risk

May 9, 2010 by  
Filed under Weekly Health Update

 

Welcome to Weekly Health Update



“A critical weekly review of important new research findings for health-conscious readers” 

SOY FOODS & STOMACH CANCER RISK

There is a great deal of interest regarding the potential effects of soy-based foods (like tofu and soy beverages) on cancer risk.  As discussed in my forthcoming book (“A Cancer Prevention Guide for the Human Race”), there is a growing body of laboratory and human research data suggesting that dietary soy isoflavones might be able to reduce the risk of prostate and breast cancer.

Now, a newly published clinical research study from Korea suggests that high levels of soy isoflavones in the blood may also be linked to a reduced risk of stomach cancer, as well.  (Korea has one of the highest incidences of stomach cancer in the world.)  This study appears in the current issue of the journal Cancer Epidemiology, Biomarkers & Prevention.

As most of the published research in the area of cancer prevention is based upon the subjective recall of patient volunteers regarding their diet (and other habits), the authors of this study chose, instead, to directly measure the levels of soy isoflavones in the blood of patient volunteers.  This study included 131 patients with recently diagnosed stomach cancer, and 393 “control” patients who did not have stomach (gastric) cancer.  Blood levels of the two major dietary soy isoflavones (genistein and daidzein) were directly measured in all 524 of these research volunteers, and these results were compared between the patients with stomach cancer and the “control” patients without gastric cancer.

Study volunteers with the highest levels of genistein in their blood, when compared with those with the lowest levels, were found to be 46 percent less likely to be diagnosed with stomach cancer.  Even more impressive was the finding that study volunteers with the highest daidzein blood levels were 79 percent less likely to be diagnosed with stomach cancer when compared to the volunteers with the lowest levels of daidzen in their blood

While there may be other health-related factors at work among the study volunteers with high levels of soy isoflavones in their blood that could explain the much lower stomach cancer risk observed in these same patients, this study’s results are nonetheless intriguing enough to justify a large scale, prospective, randomized, placebo-controlled soy isoflavone clinical research study to confirm the findings of this relatively small Korean public health study.

 

To learn more about the role of soy isoflavones as potential cancer prevention nutrients, look for the publication of my new landmark evidence-based book, “A Cancer Prevention Guide for the Human Race,” in the summer of this year.





Disclaimer: As always, my advice to readers is to seek the advice of your physician before making any significant changes in medications, diet, or level of physical activity


Dr. Wascher is an oncologic surgeon, a professor of surgery, a cancer researcher, an oncology consultant, and a widely published author



For a different perspective on Dr. Wascher, please click on the following YouTube link: 

http://www.youtube.com/watch?v=7-Tdv7XW0qg



I and the staff of Weekly Health Update would like to take this opportunity to thank the nearly 120,000 new and returning readers who visited our premier global health information website last month.  As always, we enjoy receiving your stimulating feedback and questions, and I will continue to try and personally answer as many of your inquiries as I possibly can. 


 

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Chemotherapy for Breast Cancer & Memory Loss

 

Welcome to Weekly Health Update



“A critical weekly review of important new research findings for health-conscious readers” 

CHEMOTHERAPY FOR BREAST CANCER & MEMORY LOSS

“Chemo Brain” is a term often used by breast cancer patients to describe the decreased memory, and other cognitive dysfunctions, associated with chemotherapy for this common form of cancer.  However, there has been very little prospective, objective clinical research into this phenomenon.  Furthermore, what little research that has been done in this area, to date, has primarily focused upon subjective self-assessments, by breast cancer patients, of their own level of cognitive function following chemotherapy.  Moreover, until recently, the complaints of breast cancer patients regarding their self-perceived memory loss following chemotherapy were often dismissed by many physicians. 

Now, a newly published prospective clinical research study from the M.D. Anderson Cancer Center suggests that physicians may have vastly underestimated the frequency, severity, and duration of cognitive dysfunction following standard breast cancer chemotherapy.  This clinical study, which appears in the current issue of the journal Cancer, prospectively enrolled 42 women with newly diagnosed breast cancer.  All of these women then underwent standardized neuropsychological evaluation before, during, and after chemotherapy.  Importantly, this study not only tested these breast cancer patients in the early period after they completed their chemotherapy, but also one year after their chemotherapy had ended.  The findings from this small study strikingly illustrate just how common, and how enduring, memory loss and other forms of cognitive dysfunction are following chemotherapy for breast cancer.

Prior to beginning chemotherapy, 21 percent of these patients had some detectable degree of cognitive dysfunction.  By the end of their chemotherapy treatments, a whopping 65 percent of these 42 patients displayed measurable declines in memory function, organizational ability, and cognitive processing speed.  One year later, 61 percent of these women continued to display measurable declines in cognitive function.  Worse yet, among this group of women with persistent cognitive dysfunction one year after completion of their chemotherapy, 71 percent continued to display progressively worsening of cognitive function when compared to their level of function immediately after finishing chemotherapy.  Finally, the remaining 29 percent of this group of women with long-term evidence of cognitive dysfunction actually displayed a delayed-onset of cognitive decline when they were tested one year after chemotherapy (i.e., when compared to the results of their neuropsychological testing immediately after chemotherapy).

Although this clinical research study enrolled a small cohort of patients, its prospective nature, and its use of validated neuropsychological tests, make it a powerful research study for its size.  The findings of this study also fit well with previous laboratory research studies that have shown both acute and delayed changes in the actual structure of the brains of animals treated, proportionately, with the same chemotherapy drugs commonly used to treat breast cancer in humans.  Whether or not the significant declines in cognitive function that were observed, one year after chemotherapy in the 61 percent of women who participated in this study, will eventually stabilize, improve or worsen is unknown at this time.  Longer follow-up of these 42 breast cancer patients will have to be performed to answer this important question.  However, this small prospective study clearly indicates that the majority of women who undergo standard chemotherapy for breast cancer appear to experience significant and prolonged declines in their level of cognitive function, including memory loss, decreased organizational skills, and a general slowing of their cognitive processing speed, and that these adverse changes persist for at least a year after completion of chemotherapy.

The findings of this study should spur additional research into the precise cause(s) of this chemotherapy-associated impairment in cognitive function, as well as strategies to reduce the severity and duration of these adverse health effects following chemotherapy for breast cancer.  Meanwhile, it is important for me to stress that chemotherapy unquestionably extends survival, and saves lives, among women who are appropriately advised to undergo such treatment for breast cancer.  In my opinion, no patient should read this column, and then go on to refuse chemotherapy that has been appropriately recommended because of the findings of this clinical research study.  

 

To learn more about the prevention, screening, diagnosis and treatment of breast cancer, look for the publication of my new landmark evidence-based book, “A Cancer Prevention Guide for the Human Race,” in the summer of this year.



Disclaimer: As always, my advice to readers is to seek the advice of your physician before making any significant changes in medications, diet, or level of physical activity


Dr. Wascher is an oncologic surgeon, a professor of surgery, a cancer researcher, an oncology consultant, and a widely published author



For a different perspective on Dr. Wascher, please click on the following YouTube link: 

http://www.youtube.com/watch?v=7-Tdv7XW0qg



I and the staff of Weekly Health Update would like to take this opportunity to thank the nearly 120,000 new and returning readers who visited our premier global health information website last month.  As always, we enjoy receiving your stimulating feedback and questions, and I will continue to try and personally answer as many of your inquiries as I possibly can. 


In view of the extreme devastation and human misery brought about in Haiti and Chile by the recent earthquakes, Weekly Health Update asks our tens of thousands of caring readers to give generously to established charities that are currently working in those countries to assist the injured, the ill, and the homeless.  There are many such legitimate charities, including the following two:

http://www.redcross.org/

http://www.imcworldwide.org/haiti 


 

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