The information in this column is intended for informational purposes only, and does not constitute medical advice or recommendations by the author.  Please consult with your physician before making any lifestyle or medication changes, or if you have any other concerns regarding your health.

 HAPPY FATHERS DAY!

PREVENTABLE DEATHS AFTER CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY

A great deal of attention is being directed at reducing preventable complications and deaths following surgery.  Because so much clinical data is available for coronary artery bypass graft (CABG) surgery, it has long been used a model for studying risk reduction following surgery. 

As an important aside, increasing pressure is being exerted upon surgeons and hospitals to achieve high levels of compliance with specific “quality of care” parameters that have been put into place by Medicare and other large healthcare insurers.  Although these criteria have already become etched in stone, many of them of have been implemented despite a lack of any high level research evidence showing a direct correlation between these benchmarks and clinical outcomes.  There are already some very strong feelings among many physicians and hospital administrators regarding the imposition of these new “quality improvement” guidelines in the absence of compelling research data to support them.  A new research paper in the journal Circulation adds more fuel to the fires burning over this very controversial topic.

For CABG operations, and for several other complex, high-risk operations, cumulative death rates following surgery have long been used as a surrogate measure of overall quality of care.  Indeed, mortality rates for CABG surgery at individual hospitals can, increasingly, be found published on websites sponsored by the healthcare insurance industry and other groups.

In this study from Ontario, Canada, a retrospective analysis of 347 randomly selected in-hospital deaths following CABG surgery at 9 Canadian hospitals was performed.  Two expert consultant heart surgeons reviewed summaries of the charts from these patients while being blinded to patient identification as well as both the operating surgeons and the hospitals involved in the care of these patients.  In those cases where the 2 expert reviewers were not in complete agreement, a third cardiac surgery consultant was also brought in.

Among all 9 hospitals, the overall risk of death associated with CABG surgery was a very impressive 1.3 to 3.1%.  However, when the cardiac surgeon consultants completed their analysis of these 347 perioperative deaths, they determined that 111 of them, or 32%, were preventable (in 86% of these deaths, problems in the operating room were found to have contributed to the death of patients, while 61% of the deaths appeared to have also involved problems in the intensive care unit following surgery).  Both primary reviewers jointly agreed that 32% of the patient deaths appeared to involved deviations in established perioperative care guidelines, while 42% of the deaths were considered by at least 1 reviewer to have involved significant deviations from established care guidelines.

I find the results of this study to be simultaneously stunning and confirmatory to what I—and many other surgeons—intuitively believe.  While all of us strongly desire to drive complication and death rates after surgery to the lowest possible achievable numbers, many of the current indicators of “quality of care” that have been implemented thus far are probably not valid tools for monitoring the very events that they were designed to detect.  Regarding preventable perioperative deaths following CABG surgery, specifically, this provocative study found absolutely no correlation between the overall mortality statistics at 9 different hospitals and the presence of a large percentage of apparently preventable deaths, and despite the current and routine use of overall mortality rates as the primary benchmark of “quality of care.”

The findings of this study are important, and suggest that we need to find better indicators of preventable complications and deaths other than the currently standard of overall mortality.  With the enormous pressures facing all aspects of healthcare in the United States today, we simply cannot afford to base critically important healthcare quality- and performance-improvement decisions upon faulty and inaccurate statistical benchmarks.  The results of this study should serve as a wake-up call to both the healthcare insurance industry administrators who have imposed these faulty standards upon all of us; as well as physicians and administrators, the vast majority of whom genuinely desire to deliver the highest possible quality of care to their patients.

GREEN TEA & COLORECTAL CANCER

Much has been written about the potential anti-cancer effects of green tea, including the many research studies that I have reviewed in this column (please see my archives, below).  A new research study, just published in the journal Gastroenterology, adds additional important information to our understanding about the effects of green tea, and its active ingredients, on the development and progression of cancer.

Researchers from the University of Tennessee performed several interesting experiments using epigallocatechin-3-gallate, the predominant active compound in green tea.  This extract of green tea was first applied to human colorectal cancer cells growing in a culture dish.  A series of complex laboratory tests determined that the green tea extract significantly reduced the presence of the protein basic fibroblast growth factor, which has been implicated, along with several other proteins, in tumor cell growth and spread (metastasis). 

In the second part of this study, mice with a genetic defect that results in a 100% risk of colorectal cancer had their diet supplemented with the green tea extract (while a control group of similar mice did not receive this supplement).  Once again, the researchers found that the mice treated with the green tea extract had decreased levels of basic fibroblast growth factor in their colorectal tumor cells.  Moreover, supplementation with green tea extract resulted in considerably fewer colorectal tumors when compared with the mice that did not receive the extract. 

The results of this study provide intriguing insight into the potential caner prevention effects of green tea, and at the molecular level.  Several human clinical trials are already underway, looking at the effects of green tea on cancer prevention and cancer treatment.  As we have seen with other areas of clinical research, what works in Petri dishes and laboratory mice doesn’t always translate well to humans.  It will be interesting to see what the long-term results of ongoing human green tea clinical trials will tell us about the potential disease prevention and therapeutic effects of green tea.     

ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD) & ST. JOHN’S WORT

Parents of children with ADHD are, understandably, reluctant to see their children take the powerful stimulant drugs that are most commonly prescribed for this condition.  As with many other illnesses, people often turn to herbal supplements and other “natural remedies” as an alternative to prescription medicines.  St. John’s Wort, also known by its scientific name, Hypericum perforatum, is a plant with worldwide distribution, and has been touted as a remedy for a variety of ailments, including ADHD.

A new prospective, randomized, double-blinded study, just published in the Journal of the American Medical Association, reports on the effects of St. John’s Wort supplements on children and adolescents with ADHD.  The design of this research study conformed to the highest achievable level of clinical research in that neither the patients nor the researchers knew who was receiving St. John’s Wort and who was receiving a placebo (sugar) pill of identical appearance until after the study was over.  Researchers from the following institutions participated in this study: the School of Naturopathic Medicine at Bastyr University in Washington, the University of Washington, the Massachusetts General Hospital, and Harvard University.

In this study, 54 children and adolescents with ADHD were randomly assigned to receive either St. John’s Wort or a placebo pill 3 times per day, for 8 weeks.  No other ADHD medications were permitted during the course of this clinical research study.  At the end of the study, all patients underwent reevaluation of their ADHD.  One of the patients withdrew from the study due to side effects from the pills, leaving 53 patients who completed the entire study.

Unfortunately, there was no discernible difference between the two groups of children in terms of inattentiveness and hyperactivity.  In fact, there was no significant difference in overall ADHD scoring between the group of children who received St. John’s Wort and those who received the inactive placebo pills. 

The findings of this study are, unfortunately, consistent with an increasing number of other recent high-quality clinical research trials that have looked at St. John’s Wort, and other herbal or “natural” remedies, for the prevention or treatment of various diseases.  Before these kinds of clinical research trials were performed, the largely unregulated sales and promotion of dietary supplements allowed manufacturers to make almost any health claims they wanted, as long as they included the necessary disclaimer indicating that the FDA had not assessed the validity of any such claims.  Even today, the multi-billion dollar supplements industry remains almost completely unregulated, except with regards to industrial hygiene at their manufacturing plants.  Fortunately, the scientific world is taking a greater interest in evaluating many of these supplements.  Hopefully, this kind of research will not only debunk the often absurd claims made for the beneficial effects of dietary supplements by their manufacturers but, perhaps, will also validate the potential health benefits of at least some of the hundreds of different supplements currently being produced and sold. 

Unfortunately, this particular study, although rather small, was well-designed and conducted, and it did not find any apparent benefit associated with St. John’s Wort in children and teenagers with ADHD.  

Dr. Wascher is an oncologic surgeon, professor of surgery, a widely published author, and the Director of the Division of Surgical Oncology at Newark Beth Israel Medical Center:

http://www.sbhcs.com/hospitals/newark_beth_israel/mservices/oncology/surgical.html

Send your feedback to Dr. Wascher at:  rwascher@doctorwascher.net
 

http://www.doctorwascher.com

Copyright 2008.  Robert A. Wascher, MD, FACS.  

All rights reserved.

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