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Most recent articles are listed first within a
Section (TMT reviews are included back to January, 2006 and
are available in archives for earlier years). The Sections below in order are:
Click on the
blue title above for any Section
to go to that Section. Clicking on the
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NOTE
September 1, 2007: Because of the great success of our
pain questionnaires (http://masterdocs.com/pain.htm
- over 3,500 responders to date) and the activity of our
collaborations with several academic units, we are
temporarily suspending regular postings on this medical news
web page,
Why we publish our
Medical News: We give you the
latest medical news without the hype. Our focus is "patient empowerment" -- free medical questionnaires for
common symptoms and medical conditions, and unbiased,
up-to-date medical news that can be understood by the public
as well as physicians. We flag three of the
commonest errors in interpreting clinical studies - not
prespecifying a primary study endpoint, overinterpreting
observational studies, and overinterpreting subgroup
analyses. We normally email the first author of an article
reviewed for comment and appropriate revision of our review.
Remember to check out
our free
Chronic Pain
Questionnaires and other
Medical Questionnaires.
Latest Entries (Sections in
parentheses):
July 26, 2007:
Adverse cardiovascular effects with rofecoxib (Vioxx) versus
placebo in patients with colorectal cancer (Heart Disease &
Stroke).
July 16, 2007: Older
oral hypoglycemic (metformin) gives equivalent blood sugar
control in Type II diabetes, lowers LDL cholesterol, and
does not increase weight (Other Chronic Disease).
July 12, 2007: As
implemented, Electronic Health Records were not associated
with better quality ambulatory care (Computers in Medicine).
June 29, 2007:
Second-hand smoke increases levels of tobacco-specific
carcinogens (Other Chronic Disease).
June 11, 2007:
Randomized study suggests weight loss is greater with a
reduced fat diet if more fruits and vegetables are eaten
(Diet & Exercise).
June 5, 2007:
Randomized acupuncture trial suggests blood pressure
reduction (Heart Disease & Stroke). Out of hospital cooling
of patients with cardiac arrest feasible and safe. Larger
studies should be done. (Heart Disease & Stroke).
May 21, 2007:
Meta-analysis suggests heart hazard with rosiglitazone
(Avandia) but manufacturer's data should be released (Heart
Disease & Stroke).
May 18, 2007: HPV
vaccine could prevent cancer of cervix, vulva, vagina, mouth
and throat (Cancer).
May 9, 2007: Senate
votes new powers to FDA on drug safety
(Administrative&Political).
May 2, 2007:
Depressed patients may need both antidepressants and
treatment for insomnia (Neurological/Psychological).
April 14, 2007:
Active, electronic post-marketing drug safety surveillance
system advocated by former FDA Commissioner (Computers in
Medicine).
April 4, 2007:
Combination of sumatriptan and naproxen useful for acute
treatment of migraine (Pain).
March 27, 2007:
Increasing HDL cholesterol with torcetrapib did not affect
the primary endpoint (percent atheroma volume) in the
ILLUSTRATE study (Heart Disease & Stroke).
March 17, 2007:
Cardiac-only resuscitation by bystanders may be best for
out-of-hospital cardiac arrest (Heart Disease & Stroke).
March 15, 2007:
Poor warfarin compliance associated with poor INR control,
and more stroke, heart attack, major bleeding, and
mortality. Many high risk patients are not prescribed
warfarin (Heart Disease & Stroke). Weekend hospital admission for heart attack associated with
higher mortality (Heart Disease & Stroke).
March 6, 2007:
Randomized study suggests slightly more weight loss with Atkins diet
(Diet & Exercise).
March 5, 2007:
Ibuprofen best pain killer for kids with acute traumatic
musculoskeletal injuries (Pain).
March 3, 2007: Happy
countries may have less high blood pressure (Neurological &
Psychological).
March 1, 2007: Pain
killers including acetaminophen and aspirin associated with
higher risk of high blood pressure (Heart Disease & Stroke).
Improvement in oral health may reduce cardiovascular risk
(Heart Disease & Stroke).
FEBRUARY 2007:
US
Government privacy standards for electronic health data in
"early stages". TMT privacy standards fully implemented.
(Computers in Medicine). Heart disease rate varies from state to state (Heart Disease
& Stroke). Controlled study shows low-dose morphine can improve
refractory cough (Other Chronic Disease). Weekly
motivational counseling improves mood after stroke (Heart
Disease & Stroke). Nasal spray better than flu shots for small children
(Miscellaneous). New method more accurate for identifying cardiovascular risk
in women (Heart Disease & Stroke). High dose atorvastatin (Lipitor) reduces heart failure
hospitalizations (Heart Disease & Stroke). Religious people with advanced cancer get inadequate
spiritual support and want aggressive measures to extend
life (Cancer). Randomized trial suggests that 3 months of psychoanalysis
helps patients with panic disorder (Neurological &
Psychological). In preliminary study, Down's Syndrome was identified by fetal DNA test on maternal
blood (Miscellaneous). Lessen burden of bereavement by spending more time with
family members and giving them a bereavement brochure
(Neurological & Psychological).
JANUARY 2007:
FDA announces new initiatives to assess
safety of marketed drugs (Administrative & Political). ABCD2 score predicts 2-day risk of
progression of TIA to stroke (Heart Disease & Stroke). Financial incentives improve hospital
performance (Administrative & Political). Observational study suggests that trans
fats may increase infertility but additional evaluation is
required (Diet & Exercise). In observational study, dense breast
tissue increased risk of breast cancer and increased
difficulty of diagnosis (Cancer). Cancer deaths are down. Cancer pain is
treatable. (Cancer). Arthritis and related conditions cost over
$500 per year per American adult (Pain). Black tea with no milk increases ability
of arteries to relax, but adding milk prevents this effect
(Diet & Exercise). Food industry-funded studies of soft
drinks, juice or milk tend to favor the commercial interests
of the funder (Diet & Exercise). Drug prices higher in
Medicare private plans than in VA system (Administrative &
Political). Starbucks removing trans fats from its
pastries (Diet & Exercise). Therapy with ACE inhibitors, angiotensin
receptor blockers or beta-blockers associated with better
outcome following hospital discharge for heart failure
(Heart Disease & Stroke). Pergolide (Permax) and
cabergoline (Dostinex) associated with heart valve
abnormalities in Parkinson's disease patients (Heart Disease
& Stroke).
DECEMBER 2006:
Evidence-based procedures reduce
catheter-related blood stream infections in ICUs
(Miscellaneous). Observational study suggests that proton
pump inhibitors increase hip fracture risk (Other Chronic
Diseases). Cognitive training helps mental function
in the elderly (Neurological & Psychological). Randomized study suggests reduced fat in
diet reduces breast cancer recurrence (Cancer). Breast cancer rate dropped 7% in 2003,
possibly because of less female hormone therapy (Cancer). Pain gene variants can increase or
eliminate pain (Pain). Observational study suggests that surgery
or radiation for localized prostate cancer improves survival
in elderly men (Cancer). More prolonged antiplatelet therapy
recommended by some experts for patients with drug-eluting
stents (Heart Disease & Stroke). More on torcetrapib: conflicting studies
of relationship between CETP levels and heart disease (Heart
Disease & Stroke). Physicians may defer to computer in
diagnosis (Computers in Medicine). Some more possible explanations for
torcetrapib safety problems (Heart Disease & Stroke). Possible explanations for torcetrapib
safety problems (Heart Disease & Stroke). FDA clarifies DSMB monitoring in Pfizer's
ILLUMINATE torcetrapib trial (Heart Disease & Stroke). Pfizer halts all torcetrapib trials
because of increase in mortality and cardiovascular events
(Heart Disease & Stroke).
NOVEMBER 2006:
Moderate alcohol consumption may reduce
risk of heart failure by reducing the risk of coronary
disease (Heart Disease & Stroke). Most back & sciatica patients who don't
require urgent surgery improve with either medical or
surgical therapy. You can always get surgery later. (Pain).
Identifying serious adverse drug effects: Drug companies,
Investigators, Advisory Committees, and the FDA (Administrative & Political). Naproxen increases risk of cardiovascular
events in Alzheimer's trial (Heart Disease & Stroke).
With resveratrol, mice can run twice as long on a treadmill
(Diet & Exercise). Pain relief in fibromyalgia reported with
pregabelin (Lyrica) in 6-month double-blind study (Pain). Americans are living longer but have more
long-term pain (Pain). Medication blister packs and education
improve medication compliance in the elderly by 36%, with
lower BP & cholesterol (Miscellaneous). Stable patients
after acute phase of heart attack don't need angioplasty and
stent (Heart Disease & Stroke). Etoricoxib (Arcoxia) similar to
diclofenac in risk of heart attack, stroke & death but
causes more high blood pressure and heart failure (Heart
Disease & Stroke). Heart attack patients get angioplasty too
late (Heart Disease & Stroke). Diet with low carbohydrate and vegetable
sources of fat and protein may reduce coronary risk (Diet &
Exercise). Warts and all – trial of the tape
(Miscellaneous). Primary care in US lags other developed
countries in clinical information systems and quality and
efficiency incentives (Computers in Medicine). Poor people in wealthy neighborhoods have
higher death rate than poor people in poor neighborhoods
(Administrative & Political). Open study suggests that
one-year of therapy with a heart assist device combined with
drug therapy can reverse severe heart failure (Heart Disease
& Stroke). Restraining good hand improves movement of
affected arm after stroke (Heart Disease & Stroke). Chronic constipation associated with
higher mortality (Other Chronic Disease). Physically active
people have less macular degeneration (Other Chronic
Disease). Higher PSA velocity 10-15 years before prostate
cancer diagnosis may be associated with higher prostate
cancer mortality (Cancer). Study in mice shows that
resveratrol, found in red wine, offsets bad effects of high
calorie diet and extends lifespan (Diet & Exercise).
OCTOBER 2006:
Unblinded randomized study suggests
acupuncture is effective in patients with osteoarthritis
(Pain). Pneumococcal vaccine appears effective
with each of various vaccination schedules (Miscellaneous). 80% of
US Internet users have searched on-line for health
information (Computers in Medicine). Are flu shots as effective as claimed?
(Miscellaneous). CT screening detects early lung cancer
(Cancer). CDC recommends routine Zostavax shingles vaccine
for those 60 and over (Miscellaneous). Observational study associates higher
vegetable consumption with better cognitive function in
elderly (Neurological & Psychological). Observational
study in healthy men shows correlation between alcohol
consumption and reduced risk of heart attack (Diet &
Exercise). Less than 10% of US doctors use
full-fledged electronic health records for outpatients
(Computers in Medicine). NIH doctors criticize Eli Lilly's
promotion of sepsis drug (Administrative & Political).
Noise-cancelling headphones might prevent hearing loss in
noisy subway (Miscellaneous). Over 700,000 adverse drug events yearly
require treatment in US Emergency Rooms, with over 100,000
hospitalizations. Elderly at higher risk. (Administrative &
Political). Mortality in Medicare patients depends on
the hospital (Administrative & Political). FDA approves Aricept for severe
Alzheimer's Disease (Neurological & Psychological). Does daily weighing help maintain weight
loss? (Diet & Exercise). Symptoms suggesting stroke
occur in 18% of older people without a stroke diagnosis
(Heart Disease & Stroke). Industry-sponsored meta-analyses are of
poorer quality and conclusions are more favorable to the
experimental drug (Miscellaneous). Get
your 'flu shot - it could save your life (Miscellaneous).
NIH clinical trial will compare $20-100/month drug with
$2000/month drug in macular degeneration (Other Chronic Disease).Smarter breast-feeding mothers mean smarter breast-fed
children (Diet & Exercise).
SEPTEMBER 2006:
Bayer did not tell FDA about preliminary safety data from
Trasylol observational study (Heart Disease & Stroke). IOM report recommends more funding/staffing/enforcement
tools for FDA and more emphasis on safety of marketed drugs
(Administrative & Political). Test for H. Pylori before
starting NSAIDs in high GI risk patients (Pain). It's OK to
eat canned or frozen spinach (Diet & Exercise). Prescribing errors for seniors almost 7 times as likely as
with younger patients (Administrative & Political). Meta-analyses confirm Vioxx cardiovascular toxicity but
raise other questions (Heart Disease & Stroke). US divided into "Eight Americas" on basis of longevity
(Administrative & Political). Difficulty understanding
patient pamphlets and prescription labels is common and
associated with poor health (Administrative & Political).
Don't take ibuprofen less than 8 hours before or less than
30 minutes after aspirin taken for cardioprotection (Heart
Disease & Stroke). Report claims Norvasc reduces risk of diabetes (Other
Chronic Disease). High dose Lipitor reported to reduce heart
attack risk more than medium dose Zocor (Heart Disease &
Stroke). Subgroup analysis of TNT trial shows that high risk patients
with coronary disease and metabolic syndrome do well on high
dose (80mg) Lipitor (Heart Disease & Stroke).
AUGUST 2006:
APC and PreSAP double-blind trials show that celecoxib
(Celebrex) at dosage of 400 mg/day or greater reduces risk
of colorectal adenomas but increases cardiovascular risk
(Heart Disease & Stroke). Observational study suggests that NSAIDs may protect against
development of prostate cancer only in men with the gene
type associated with higher LTA levels (Cancer).
Observational study suggests that NSAIDs reduce BPH risk
(symptoms, prostate size, urinary flow & PSA) (Other Chronic
Disease). FDA Drug/Device Advisory Committees recommend
approval in 8 of 10 cases and FDA usually follows the
recommendation (Administrative & Political). Could stem cells be harvested from embryos without damaging
the developing embryo? (Miscellaneous). Being overweight at age 50 increases risk of death,
particularly in women. Waist/hip ratio may be a better
measure than BMI (Diet & Exercise). 'ReNu with
MoistureLoc" is 13 times as likely to cause fungus infection in
contact eye wearers (Miscellaneous).
Large observational study in 52 countries
shows heart attack risk with all forms of tobacco,
including second-hand smoke (Heart Disease & Stroke). Computerized feedback increases short-term
weight loss (Diet & Exercise). In randomized trials both
COX-2 inhibitors and traditional NSAIDs increase vascular
risk (Heart Disease & Stroke). Observational study suggests
that aspirin may mitigate the increased cardiovascular risk
with NSAIDs (Heart Disease & Stroke). High-dose Lipitor reduces risk of recurrent
stroke even in people without known coronary disease (Heart
Disease & Stroke). Observational study suggests all NSAIDs
(Cox-2-selective and non-Cox-2-selective) modestly increase heart attack risk (Heart Disease & Stroke).
JULY 2006:
Faster aging in poor people may be related to
shortened telomeres (Miscellaneous). Medication errors injure 1.5 million in US/year.
Patients can protect themselves. Electronic prescribing can
help. (Miscellaneous). FDA approves once-a-day 3-drug combination tablet
for HIV treatment (Miscellaneous). Increased energy expenditure associated with
reduced mortality in high-functioning older adults (Diet &
Exercise). Gene effects markedly different between males and
females (Miscellaneous). Most heart attacks might be prevented by a healthy
lifestyle (Heart Disease & Stroke).
JUNE 2006:
New England Journal of Medicine issues "correction" on Vioxx APPROVe trial (Heart Disease & Stroke). Observational study suggests mortality risk is
increased with short duration NSAID therapy in patients with
previous heart attack (Heart Disease & Stroke). Fibromyalgia symptoms respond to acupuncture in
controlled trial (Pain). Media stories on medical reports at scientific
meetings are misleading (Administrative & Political).
MAY 2006:
Dr. Scott Evans of the Harvard School of Public
Health, has provided us with a
Review
of the issue of changing clinical trial
endpoints after a trial has begun, an issue posted in our
Miscellaneous section on March 26, 2006 (Miscellaneous).
Please send any comments to
info@masterdocs.com
and we will forward them to Dr. Evans. Data from Merck report suggest fairly constant
cardiovascular risk (0.2% of patients/6 months) during most
of Vioxx therapy and in 1-year following therapy, with
higher risk in last 6 months of 3-year Vioxx period (Heart
Disease & Stroke). New analysis suggests greater, earlier and more
persistent increase in cardiovascular risk with rofecoxib
(Vioxx) (Heart Disease & Stroke). Node-positive breast cancer women who have more
HER2 receptor activity do better with epirubicin as part of
a triple therapy regimen (Cancer). Cardiovascular clinical trials report more
positive results if they are industry-funded
(Miscellaneous). 21% of office-based prescriptions are
off-label, usually without scientific support. Could
compromise patient safety and waste medications.
(Miscellaneous). Fusarium eye infections cause worldwide withdrawal
of MoistureLoc. Topping up storage case or leaving bottle
cap open could increase risk. (Miscellaneous). Academic researchers suggest Merck should continue
to follow APPROVe study patients for long-term heart damage
from Vioxx
(Heart Disease & Stroke). New Merck analysis suggests increased stroke risk
with rofecoxib (Vioxx); increased cardiovascular risk may
persist to some extent after stopping Vioxx
(Heart Disease & Stroke). New Analysis suggests that paroxetine (Paxil)
may increase risk of suicide attempts in young adults
(Neurological & Psychological). FDA approves varenicline (Chantix) for smoking
cessation (Miscellaneous). Despite higher healthcare spending, US lags in use
of health information technology (Computers in Medicine). Observational study of breast cancer in
post-hysterectomy women supports safety of estrogen therapy
for about 10-20 years, but breast cancer risk might increase
with longer duration of estrogen therapy (Cancer). Clinical trial design in the post-Vioxx world
(Administrative & Political). New prostate cancer gene may cause 8% of prostate
cancers in men of European stock and 16% of those in African
American men (Cancer). Update on fungus infections of eye in soft contact
lens wearers (Miscellaneous). New observational study suggests increased heart
attack risk during first 2 weeks of rofecoxib (Vioxx)
treatment (Heart Disease & Stroke). Naltrexone (Revia)
and combined behavioral intervention are effective in
alcohol dependence (Neurological & Psychological).
Despite less healthcare expenditure, the English are
healthier than Americans (Miscellaneous). CCHIT Certification process issued for Electronic
Health Records (Computers in Medicine).
APRIL 2006:
JAMA article examines industry financial ties and voting
patterns at FDA Advisory Committee meetings (Administrative
& Political). A stroke in certain sections of the brain
can also damage the heart (Neurological & Psychological). Everyone agrees we need electronic medical records. So why
are we not doing it? (Computers in Medicine). Planning for pregnancy - CDC recommendations
(Miscellaneous). Treasury Secretary: “The typical
doctor’s office has less information technology in it than
the corner drug store” (Computers in Medicine). The Challenge of
Subgroup Analyses - Reporting without Distorting (Miscellaneous).
Compression stockings during air travel reduce leg
thrombosis, leg discomfort and swelling (Miscellaneous).
Review supports routine use of antibiotics in COPD
exacerbations (Other Chronic Disease). Observational study
suggests Mediterranean Diet
may reduce risk of Alzheimer's disease (Neurological &
Psychological). New observational
study suggests heart risk with COX-2 NSAIDs (Heart Disease &
Stroke). Trans fats
associated with coronary heart disease and sudden cardiac
death (Diet & Exercise). No increase in
breast cancer risk with estrogen alone (Cancer). Chemotherapy most useful in the 30% of women with
ER-negative breast cancers (Cancer). Coronary patients
should get ACE inhibitors (Heart Disease & Stroke). Brain Training
for the Aging Brain (Neurological/Psychological). 2) Prevent
Jet Lag using British Airways Jet Lag Advisor
(Miscellaneous). Observational study
suggests early removal of
ovaries may be associated with increased risk of Alzheimer's
(Neurological/Psychological). In a small controlled
trial, two longevity markers (insulin & temperature) fell with
6-months calorie restriction; larger, longer studies needed
to assess aging/longevity (Diet & Exercise). Study
shows donepezil (Aricept) improves cognition and activities
of daily living in severe Alzheimer's
(Neurological/Psychological). High dose Celebrex
reduces risk of new colon polyps but increases
cardiovascular risk in patients with previous colon polyps
(Cancer). Observational study finds less breast cancer
with use of COX-2 inhibitors (Cancer)
MARCH 2006:
Intercessory prayer
did not reduce cardiac complications after bypass surgery; patients who knew they were receiving intercessory prayer
had higher complication rate (Heart Disease & Stroke). Bird flu vaccine
may protect 55-60% of those people vaccinated. FDA approves flu drug that protects
against seasonal flu and bird flu (Miscellaneous). MRI
study shows that highly intelligent children have more
dynamically changing brains and reach peak thickness of the
cerebral cortex at a later age (Neurological/Psychological). Omega 3 fats (found
in fish oils and some plants) do not have a clear effect on
mortality, heart disease, or cancer (Diet/Exercise). Can clinical trial
endpoints be added after the clinical trial begins?
(Miscellaneous). Open-label
studies suggest that adding or switching antidepressants may
help citalopram (Celexa) non-responders
(Neurological/Psychological). Stimulants may cause
hallucinations in 2-5% of children taking these drugs
(Neurological/Psychological). Bird flu virus stays deep
in the lungs, preventing human transmission by coughing or
sneezing (Miscellaneous). Three full papers for studies
already reviewed by TMT (March 14 & 15, 2006) are now
available for download at no charge. These studies are: "Very High-Intensity Statin
Therapy and Regression of Coronary Atherosclerosis",
"Fondaparinux in Patients With Acute Myocardial Infarction"
and "Abciximab in Patients With Acute Coronary Syndromes
Undergoing PCI After Clopidogrel Pretreatment". Inaccuracies and
stigmatizing language are common in neurology coverage by US
newspapers (Neurological/Psychological). Seattle Heart
Failure model predicts life expectancy and effects of
different therapies (Heart Disease/Stroke). Breast
asymmetry may be associated with increased risk of breast
cancer (Cancer). Two separate H5N1 bird flu strains have
evolved, but not yet a strain allowing human-to-human
transmission (Miscellaneous). Study suggests
that donepezil (Aricept) could be associated with increased
death rate (Neurological/Psychological). Maintenance
therapy with antidepressant drug helps after drug-assisted
recovery from major depression in old age
(Neurological/Psychological). Only 55% of Americans
receive quality health care. Use of electronic medical
records could improve population-wide quality of care
(Administrative/Political). Developmental
drug torcetrapib raises HDL cholesterol but also raises
blood pressure (Heart Disease & Stroke). Drug-eluting stent better for coronary
restenosis of bare-metal stent than radiation (Heart Disease & Stroke). Fondaparinux (Arixtra) may reduce death and repeat heart
attack in STEMI heart attacks (Heart Disease & Stroke). Candesartan treatment of
pre-hypertension lowers blood pressure, but effect largely
disappears on stopping therapy (Heart Disease & Stroke). Adding abciximab to
clopidogrel reduces coronary events in acute coronary
syndrome (Heart Disease & Stroke). Surgical trial to
evaluate effect of closure of patent foramen ovale on
migraine headaches (Heart Disease & Stroke). High dose
Crestor may cause regression of coronary atherosclerosis
(Heart Disease & Stroke). High dosage or frequent use of
acetaminophen and non-selective NSAIDs may increase
cardiovascular risk (Heart Disease & Stroke). Salt & water
blood filter more effective than diuretics in severe heart
failure (Heart Disease & Stroke). High dose Lipitor may
improve kidney function in coronary disease patients (Other
Chronic Disease). No
cardiovascular benefit with Vitamin B (folic acid, B6, B12)
in two large trials (Heart Disease & Stroke). 2) Adding
Plavix to aspirin may increase risk in patients without
established heart disease (Heart
Disease & Stroke). Three of four
older Americans skip colon cancer screening (Cancer). Withdrawn MS drug might return to market
(Neurological/Psychological). "Caffeine Gene"
may (or may not) indicate increased risk of heart attack
(Heart Disease & Stroke). Restraining good
arm may give some recovery of affected arm after stroke
(Neurological/Psychological). Clinical trial
result causes emphysema patients to say "no" to lung surgery
(Other Chronic Disease). New publications
show multiple sclerosis drug previously withdrawn from
market is effective (Neurological/Psychological). New
analysis of Celebrex cardiovascular safety adds little
(Heart Disease & Stroke).
FEBRUARY 2006:
You're never too
old to exercise (Diet & Exercise). Before undergoing knee
cartilage surgery, make sure the symptoms come from the
cartilage damage (Pain). Optimistic people
have lower cardiovascular death rates
(Neurological/Psychological). Virus found in
prostate cancers (Cancer). The GAIT study
in osteoarthritis of the knee showed no clear benefit from glucosamine and chondroitin, but Celebrex was
effective
(Pain). The SUCCESS-I study showed less GI complications
with Celebrex than with non-COX-2-selective NSAIDs
(Pain). A study in rheumatoid arthritis reported that
chronic inflammation is "probably a driving force for
premature atherosclerosis" (Pain). Misdiagnosis occurs in
20% of fatal illnesses (Miscellaneous). Only 1/4 of US
hospitals have electronic medical records (Computers in
Medicine). AMA & Congress
agree on new standards of healthcare quality
(Administrative/Political). Lack of flu shots in
healthcare workers increases patient risk (Miscellaneous).
Poverty is associated with poor health & increased
mortality (Miscellaneous). In a British study,
women consulted their doctor for headache 2.6 times as often
as men (Pain). No clear
benefit of calcium+vitamin D on risk of fracture or colon
cancer in postmenopausal women, but dosage, duration and
concomitant therapy may have obscured benefit (Diet
& Exercise). FDA relabeling of whole grain foods
may encourage people to take recommended daily amounts of whole
grain foods ( 3 slices of bread, 3 cups of breakfast cereal,
or 1 1/2 cups of cooked rice or pasta) (Diet & Exercise).
For older couples, if one of the partners is hospitalized
for a debilitating illness, the non-hospitalized partner is
at increased risk for death (Miscellaneous). Over 80% accuracy of prognostic index for 4-year
mortality in older adults (Miscellaneous). Many heart
attacks go undetected (Heart Disease & Stroke).
1. DIET & EXERCISE
Randomized study suggests weight loss is greater with a
reduced fat diet if more fruits and vegetables are eaten
June
11, 2007: A 1-year randomized study in 97 obese women
found that counseling subjects to reduce fat intake and
also increase intake of foods low in energy density was
associated with more weight loss (17 lb vs. 14 lb) than
just counseling to reduce fat intake. Low energy density
foods (e.g., fruits and vegetables) usually have high
water content.
Randomized study suggests slightly more weight loss with
Atkins diet
March 6, 2007:
A randomized 1-year trial in 311 overweight or obese women
(average weight 189 pounds) showed
only slight weight loss with any diet but weight loss
was somewhat larger (10.3 lbs) with the
low-carbohydrate, high-protein, high fat Atkins diet than with the
low fat, high carbohydrate LEARN diet (5.7 lbs), the
very low fat Ornish diet (4.8 lbs), or the moderately
low carbohydrate Zone diet (3.5 lbs). However, results were only statistically
significant for the Atkins-Zone comparison. Secondary
measures (lipid profile, % body fat, waist-hip ratio,
insulin & glucose levels, blood pressure) showed little
difference between the diets. Adherence to the diets was
limited. It is not known if
effects are similar over periods longer than one year or
in populations other than overweight/obese women.
Observational study suggests that trans fats may increase
infertility but additional evaluation is required
January 20, 2007:
A Harvard observational
study using a complex statistical analysis suggests that
increased intake of trans fats may increase infertility.
However, this preliminary finding needs to be confirmed
in additional studies. Infertility affects 10-15% of
couples. Fertility in part depends on the PPAR-gamma
receptor, activation of which can be affected by fat
intake. The
study was designed to "test the hypotheses that trans
unsaturated fatty acids (TFAs) increase the risk of
ovulatory infertility whereas polyunsaturated fatty
acids (PUFAs) reduce this risk" and was based on
analysis of almost 27,000 married women from the Nurses'
Health Study II who provided dietary histories. For the
initial analysis, "dietary fat was modeled by
quintiles of intake" but this analysis showed no
significant effects on fertility of TFAs or of other
fats. The authors performed an additional analysis using
derived measures of fat intake as continuous variables
and showed that "When the intakes of protein and all
major types of fat were simultaneously included in the
models (to estimate the effect of the isocaloric
substitution of fat for carbohydrates), intake of TFAs
was positively associated with risk of ovulatory
infertility". "Each 2% increase in the intake of
energy from trans unsaturated fats, as opposed to that
from carbohydrates," [a measure that is not defined
in greater detail in the paper] was associated with a
73% greater adjusted risk of ovulatory infertility. It
appears that the authors performed many different
analyses of various indices of fat consumption. Results
were adjusted for potential confounders but not,
apparently, for multiple testing. Observational studies
cannot establish causality but can suggest the need for
additional study.
Black tea with no milk increases ability of arteries to
relax, but adding milk prevents this effect
January 10, 2007: A study in 16 volunteers found that
the ability of the arteries to relax (flow-mediated
dilatation) was increased with freshly brewed black tea
but not when skimmed milk was added to the tea or with
boiled water alone. Similar effects were seen in rat
aorta and adding tea also prevented increased activity
of nitric oxide synthase in endothelial cells
(endothelial cells line the inside of arteries). The
results suggest that casein proteins in milk form
complexes with tea catechins and thus negate the
favorable effects of tea on arterial relaxation.
Food industry-funded studies of soft drinks, juice or milk
tend to favor the commercial interests of the funder
January 10, 2007: A PLoS Medicine review of published
studies of soft drinks, juice or milk showed that
studies funded by the food industry tend are almost 8
times as likely to have results favorable to the funder
than studies not funded by industry. Possible reasons
suggested by the author include 1) studies unlikely to
be favorable may not be funded, 2) study hypotheses,
design and analysis may favor the funder, 3) industry
may delay or prevent publication of studies with
unfavorable results, 4) the authors of scientific
reviews may focus on favorable studies. TMT comment:
Food manufacturers know the strengths and weaknesses of
their products and can focus on studies that (correctly)
identify the strengths of a product, while not closely
examining the weaknesses.
Starbucks removing trans fats from its pastries
January 4, 2007: Starbucks is eliminating trans fat from
pastries in one-third of its stores, with a plan to
eventually do the same nationwide. As
of Wednesday, there will no longer be trans fat in
pastries in half the Starbucks stores in the US and
Canada (Seattle, San Francisco, Chicago, Los Angeles,
San Diego, Boston, New York, Philadelphia, Washington,
and Portland, Ore.). The rest of the company-owned US
and Canada stores will phase out trans fat by the end of
the year. Starbucks will encourage a zero trans fat
policy in about 3,200 other North American
establishments that license the Starbucks name. There
are 6 g of trans fats in a chocolate croissant sold at a
typical Starbucks in New York, 5 g in a chocolate
doughnut swirl, 3.5 g in a coffee almost bar, 2.5 g in a
glazed doughnut, and 2 g in a vanilla or chocolate
cupcake. There is 1 g in every gingerbread scone,
crumble coffee cake, and white cheddar brioche.
With resveratrol, mice can run twice as long on a treadmill
November 17, 2006: A recent study (see TMT review of
November 1 below) reported that resveratrol (RSV) prolonged
life span in mice. Now a new study has reported that RSV
treated mice can run twice as long on a treadmill, and were
protected against diet-induced-obesity and insulin
resistance. These effects "were associated with an induction
of genes for oxidative phosphorylation and mitochondrial
biogenesis and were largely explained by an RSV-mediated
decrease in PGC-1α
acetylation and an increase in PGC-1α
activity. this mechanism is consistent with RSV being a
known activator of the protein deacetylase, SIRT1...".
Diet with low carbohydrate and vegetable sources of fat and
protein may reduce coronary risk
November 8, 2006: A 20-year observational study in over
80,000 women in the Nurses' Health Study suggests that a low
carbohydrate diet in which fat and protein come from
vegetables is associated with a 30% reduction in adjusted
risk of coronary heart disease. Observational studies cannot
establish causality but can suggest the need for further
study.
Study in mice shows that resveratrol, found in red wine,
offsets bad effects of high calorie diet and extends
lifespan
November 1, 2006: Resveratrol, a natural, small-molecule
substance found in red wine, is known to extend lifespan in
several non-mammalian species. A new study published in
Nature confirms this finding in middle-aged mammals (mice)
exposed to a high-calorie diet. Compared with a control
group, mice receiving resveratrol lived longer and offset
the adverse effects on blood glucose, insulin and the liver
that occurred in the mice not receiving resveratrol. The National Institute of Aging's Dr.
Richard Hodes advised people to wait for the results of
safety testing of the high doses of resveratrol used in the
mouse study. Dr. Ronald Kahn, president of the Joslin
Diabetes Center in Boston, advised "Have another glass of
pinot noir — that's as far as I'd take it right now."
Observational study in healthy men shows correlation between
alcohol consumption and reduced risk of heart attack
October 24, 2006: In an observational study, a cohort of
almost 9,000 men free of major illness and with favorable
lifestyles for cardiovascular health were followed for 16
years. Compared with men who abstained from alcohol, a lower
risk of heart attack was seen in those who took alcohol: 2%,
41%, 62% and 14% with alcohol consumption of 0.1 to 4.9 g/d,
5.0 to 14.9 g/d, 15.0 to 29.9 g/d (about 2 drinks a day), and 30.0 g/d or more,
respectively. The authors conclude "Even in men already at
low risk on the basis of body mass index, physical activity,
smoking, and diet, moderate alcohol intake is associated
with lower risk" for heart attack.
Observational studies cannot establish causality but can
suggest the need for further study.
Does daily weighing help maintain weight loss?
October 12, 2006: A paper in the New England Journal of
Medicine examined various ways of maintaining weight loss in
a group of people who had lost at least 10% of body weight
through dieting. Participants were randomly assigned to a
control group (105 people who received quarterly
newsletters), face-to-face intervention (105 who regularly
met with study staff and received a scale for daily weight
measurement) and Internet-based intervention (104 who
received a laptop computer and a scale for daily weight
measurement). The face-to-face group did significantly
(p=0.05) better in maintaining weight loss than the control
group, whereas the Internet group was similar to controls.
The authors performed a subgroup analysis comparing those
with and without daily self-weighing; daily self-weighing
was associated with significantly less risk of regaining 2.3
kg or more. The abstract concluded that "a self-regulation
program based on daily weighing improved maintenance of
weight loss". However, in the body of the text, the authors
commented that "frequent self-weighing could be either a
cause or a consequence of weight-loss maintenance". In
addition, and perhaps more importantly, since patients were
not randomized to daily weighing or no daily weighing, and
baseline variables were not examined to show comparability
of the daily weighing and no-daily weighing groups, it
cannot be concluded from these data that daily weighing
helps to maintain weight loss. However, daily weighing is
intuitively appealing and may be worth evaluating in a
properly controlled study.
Smarter breast-feeding mothers mean smarter breast-fed
children
October 4, 2006: Scottish researchers analyzed a US
observational study and concluded that, after adjusting for
confounding factors, increased intelligence in breast-fed
children may be largely related to increased intelligence in
the breast-feeding mothers. The authors conclude “Breast
feeding has little or no effect on intelligence in children.
While breast feeding has many advantages for the child and
mother, enhancement of the child's intelligence is unlikely
to be among them.” The three authors were male and did not
mention the potential impact of the intelligence of the
fathers. Observational studies cannot establish causal
relationships, although they can suggest the need for
further study.
It's OK to eat canned or frozen spinach
September 25, 2006: As of September 24, 173
cases of people with E. Coli infection from spinach have
been reported to FDA. Infected spinach has come from three
coastal California counties (Monterey, San Benito, Santa
Clara). FDA says that fresh spinach known to be grown
outside the implicated counties, as well as canned and
frozen spinach, is safe to eat. E. coli O157:H7 causes
diarrhea, often with bloody stools. Although most healthy
adults can recover completely within a week, some people can
develop a form of kidney failure called HUS (hemolytic
uremic syndrome). HUS is most likely to occur in young
children and the elderly. The condition can lead to serious
kidney damage and even death. [Added Note: October 8 - FDA
has now cleared the eating of fresh spinach.]
Being overweight at age 50 increases risk of death,
particularly in women. Waist/hip ratio may be a better
measure than BMI.
August 23, 2006: Over half a million US
adults 50-71 years old were enrolled in a prospective study
to evaluate self-reported Body Mass Index (BMI). In healthy
people who had never smoked moderate increase in BMI
(25.0-29.9 - “overweight”) was associated with an increase
in the risk of death during up to 10 years follow-up,
particularly if present at age 50 (20-40% increase in death
risk). However, risk increased in women at the lower levels
in the “overweight” range whereas increase in risk in men
occurred at higher levels in the “overweight” range. In a
second study published in the same issue of the New England
Journal of Medicine (Korean
BMI Study), the association
between BMI and risk of death was examined in a 12-year
prospective study of over 1 million Koreans aged 30-95. Risk
of death and risk of atherosclerotic death was increased
with higher BMI. Risk of respiratory death was higher with
lower BMI. The impact of BMI on risk was less with higher
age. However a recent study (Weight,
shape, and mortality risk in older persons: elevated
waist-hip ratio, not high body mass index, is associated
with a greater risk of death), as well as a number of
previous studies, has shown that the waist/hip ratio may be more useful
than BMI in predicting increased mortality; in this study in
elderly patients (>75 years) increase in waist/hip ratio but
not increase in BMI or waist size was associated with
increased total and cardiovascular mortality.
Computerized feedback increases short-term weight loss
August 15, 2006: A randomized study compared
weight loss using three Internet treatments in 182
overweight adults (mean BMI 32.7). All subjects had one
weight loss group session, coupons for meal replacements and
access to an interactive website. The human e-mail
counseling and computer-automated feedback groups also had
access to an electronic diary and message board. The human
e-mail counseling group received weekly email feedback from
a counselor, and the computer-automated feedback group
received automated, tailored messages. At 3 months, weight
loss with computer-automated feedback (-5.3 kg) and human
email counseling (-6.1 kg) was comparable and significantly
greater than with no counseling (-2.8 kg). However, at 6
months weight loss was significantly greater with human
email counseling (-7.3 kg) than with computer-automated
feedback (-4.9 kg) or no counseling (-2.6 kg). The authors
state "Further research is needed to improve the efficacy of
automated computer-tailored feedback as a population-based
weight loss approach."
Increased energy expenditure associated with reduced
mortality in high-functioning older adults
July 12, 2006: In an observational study in
302 high-functioning, community-dwelling older adults (70-82
years) followed for 6 years, objectively measured
free-living activity energy expenditure was strongly
associated with lower risk of mortality. After adjusting for
various confounders, the "hazard ratio" for mortality was
0.31 for the most active third versus the least active third
(12% vs. 25% mortality). According to self-reports, more
active subjects were more likely to work for pay (P = .004)
and climb stairs (P = .01) but self-reported high-intensity
exercise, walking for exercise, walking other than for
exercise, volunteering, and caregiving did not differ
significantly. A major strength of this study was
recruitment of high-functioning, community-dwelling
individuals and the objective measurement of total energy
expenditure, but a weakness is the lack of objective
measurement of the relationship of peak intensity of
exercise to mortality. Observational studies cannot
establish causal relationships, but can suggest the need for
further study.
Trans fats associated with coronary heart disease and sudden
cardiac death
April 14, 2006: A New England Journal of Medicine review and
meta-analysis of four prospective cohort studies with nearly
140,000 subjects showed that trans fats were associated with
an increased risk of coronary heart disease (CHD; 23%), and
sudden cardiac death (47%). The authors believe that
long-term controlled trans fat trials would be unethical and
that a "reasonable approach" is to combine short-term
controlled studies of intermediate endpoints with "carefully
performed observational studies". The authors write “Trans
fats, unsaturated fatty acids with at least one double bond
in the trans configuration, are formed during the partial
hydrogenation of vegetable oils, a process that converts
vegetable oils into semisolid fats .... From the perspective
of the food industry, partially hydrogenated vegetable oils
are attractive because of their long shelf life, their
stability during deep-frying, and their semisolidity, which
can be customized to enhance the palatability of baked goods
and sweets…. Major sources of trans fats are deep-fried fast
foods, bakery products, packaged snack foods, margarines,
and crackers”. The authors conclude “Thus, given the 1.2
million annual myocardial infarctions and deaths from CHD in
the United States, near-elimination of industrially produced
trans fats might avert between 72,000 (6 percent) and
228,000 (19 percent) CHD events each year.”
In a small controlled trial, 2 longevity markers (insulin &
temperature) fell with 6-months calorie restriction; larger,
longer studies needed to assess aging/longevity
April 5, 2006: Prolonged calorie restriction increases life
span in rodents and in previous uncontrolled studies in
humans has been associated with significant decreases in
cardiovascular risk factors, blood pressure, inflammatory
markers, and fasting insulin and glucose levels. The CALEIRE
6-month randomized controlled trial in 48 healthy,
sedentary, "overweight" (but not "obese") adults compared 4
groups: 1) control (weight maintenance diet); 2) calorie
restriction (25% calorie restriction of baseline energy
requirements); 3) calorie restriction with exercise (12.5%
calorie restriction plus 12.5% increase in energy
expenditure by structured exercise); 4) very low-calorie
diet (890 kcal/d until 15% weight reduction, followed by a
weight maintenance diet). Weight loss from baseline was 1%,
10%, 10% and 14% for groups 1, 2, 3 & 4 respectively.
Compared with baseline, fasting insulin levels and
DNA damage fell in the intervention groups 2, 3 & 4, but DNA
damage was not significantly reduced compared with
controls (group 1). Compared with baseline, core body
temperature was reduced in groups 2 & 3 but not in groups 1
& 4. Compared with controls, metabolic adaptation (decrease
in energy expenditure more than predicted by loss of
metabolic mass) was significantly more common (p<0.05) in
the intervention groups. The other primary outcome measures
(DHEAS, glucose, protein carbonyls) showed no significant
changes, perhaps because the study was of only 6 months
duration. The authors conclude that calorie restriction
reduces metabolic rate more than would be expected from the
"reduced metabolic body mass" but that studies "of longer
duration are required to determine if calorie restriction
attenuates the aging process in humans".
Omega 3 fats (found in fish oils and some plants) do not
have a clear effect on mortality, heart disease, or cancer
March 27, 2006: A review of 48 controlled
clinical trials (37,000 participants) and 41 cohort
observational studies showed no clear reduction in
total mortality, combined cardiovascular events, or cancer
from consumption of long chain and shorter chain omega 3
fats [found in fish oils (especially mackerel, lake
trout, herring, sardines, albacore tuna and salmon), and
some plants (such as soybeans, canola and flaxseed)]. There
was a slight beneficial trend for overall
mortality (13% reduction - relative risk 0.87,
95% confidence interval 0.73 to 1.03), with evidence
of benefit being stronger in people with established heart
disease. To determine effects in people without established heart disease,
larger primary prevention studies would be needed.
You're never too old to exercise
February 28, 2006: A study in the February issue of The
Journal of Aging and Health says that people are never too
old to gain health benefits from exercise. An elderly group
of 64 volunteers were divided into three groups: 1) exercise
by walking twice a week. 2) resistance training twice a week.
3) control group who did no exercise. The age range
was 66-96 years (average age 84) and three-quarters were
women. All volunteers could take care of daily tasks on
their own. Some of the exercisers used canes or walkers
during their exercise sessions. After 16 weeks, the exercise
groups had lower systolic blood pressure, improved upper and
lower body strength, improved hip and shoulder flexibility
and improvements in tests of agility, balance and
coordination when compared with the no-exercise group.
Beneficial effects were similar in the walking and
resistance exercise groups.
FDA will require better labeling of whole grains
February 16, 2006: FDA says that anything labeled as
containing whole grains must contain a comparable amount of
the fibrous, protein-dense and nutrient-rich portions of
grains — the endosperm, germ and bran — in the same
proportion normally present in the intact grain. Whole
grains include barley, buckwheat, bulgur, corn, millet,
rice, rye, oats, sorghum, wheat and wild rice. The FDA
suggests that people eat at least 3 ounces of whole-grain
cereals, breads, crackers, rice or pasta every day. One
ounce is about a slice of bread, a cup of breakfast cereal,
or a half cup of cooked rice or pasta.
Calcium/Vitamin D Supplement does not reduce Risk of Hip
Fracture or Colon Cancer in Postmenopausal Women
February 16, 2006: As part of the WHI study, over 36,000
postmenopausal women were randomized to placebo or daily
calcium + vitamin D supplementation for an average of 7
years. There was no significant difference between the
randomized groups in the frequency of hip fracture or
colorectal cancer, but there was a significantly increased
risk of kidney stone in the calcium+vitamin D group.
However, subjects in both groups were allowed to use
additional calcium, vitamin D, bisphosphonates, calcitonin
and hormone therapy - which may have obscured any potential
benefit. Overall, the yearly rate of hip fracture was 0.14%
in the active treatment group versus 0.16% in the placebo
group (a 12% reduction that was not statistically
significant). However, subset analyses (which should be
interpreted cautiously) showed that women who
consistently took the full supplement dose had a
29% reduction in hip fracture, and
in women 60 years or older there was a 21% decrease in hip
fracture risk. There was also a very small (but
statistically significant) overall increase in hip bone
density. There was no reduction in colorectal cancer
although the calcium/vitamin D dosage and 7-year duration of
the study may have been insufficient to detect a benefit.
Study Finds Low-Fat Diet Won't Stop Cancer or Heart Disease
February 7, 2006: A low-fat diet did not prevent cancer or
heart disease in a $415 million NIH WHI study of nearly 49,000
women aged 50 to 79 randomly assigned to a low-fat or normal
diet and followed for eight years. The results were reported
in the Feb. 8 issue of JAMA and showed that the women
assigned to the low-fat diet did eat significantly less fat
(about 25% versus about 35% of calories as fat), but they
had no statistically significant differences in rates of
breast cancer, colon cancer, heart disease or diabetes, and
showed little or no effect on body weight, insulin or
glucose blood levels. For heart disease risk factors, only
LDL cholesterol was lower with the low-fat diet but this
effect was small. The breast cancer data showed a 9%
non-statistically-significant reduction in risk with the low
fat diet and the study women will continue to be followed,
and the possibility of beneficial effects in certain
subgroups will be examined. This study was designed 2
decades ago and does not reflect current thinking on the
possible benefits of the Mediterranean diet or exercise -
life style modifications that have not yet been tested in a
large randomized clinical trial. These disappointing results
are similar to those shown with dietary fiber, vitamin
therapy and hormone replacement therapy in which
non-randomized observational studies suggested benefit, but
in which subsequent randomized studies showed no benefit.
Fruits & Vegetables May Reduce Stroke Risk
January 27, 2006: Five or more daily servings of fruits and
vegetables were associated with a 26% reduction in
stroke risk compared with less than 3 servings daily in a
meta-analysis of 8 observational studies including over
250,000 adults with average follow-up of 13 years. The risk
reduction applied to both hemorrhagic and ischemic strokes.
Although the results of observational studies should be
regarded with some caution, these latest results certainly
support many other studies (as well as your mother's
admonitions to eat your vegetables).
2. PAIN
Combination of sumatriptan and naproxen useful for acute
treatment of migraine
April 4, 2007: A fixed dose tablet containing sumatriptan
(85mg) and naproxen (500mg) was more effective than placebo
and than either agent alone for acute treatment of a
moderate or severe migraine attack.
Ibuprofen best pain killer for kids with acute traumatic
musculoskeletal injuries
March 5, 2007: In a double blind study in 336 children 6-17
years old with musculoskeletal injury (to extremities, neck,
and back) in the last 48 hours, ibuprofen (10 mg/kg) was
better than acetaminophen (15 mg/kg) and codeine (1 mg/kg)
in pain relief.
Arthritis and related conditions cost over $500 per year per
American adult
January 11, 2007: The US Government Center for Disease
Control and Prevention (CDC) says that arthritis and other
rheumatic conditions (46 million people) cost $128 billion
in 2003, i.e., $538 per American 15 years or older. Direct
costs were $81 billion, with $47 billion for indirect costs
such as lost wages. The 2003 figure is an increase of almost
60% in six years and is attributed by CDC to more Americans
being overweight and to the aging of the population. The
government recommends lowering costs with self-management
programs to teach patients how to manage their pain and
continue working despite the pain. Note: Over 2,000
people with chronic pain have used TMT's chronic pain
questionnaires to help them understand their pain (http://masterdocs.com/pain.htm).
Pain gene variants can increase or eliminate pain
December 14, 2006: Variants of the SCN9A gene can cause pain
hypersensitivity or total elimination of the sensation of
pain. Pain signals are carried to the brain through nerve
impulses generated by a SCN9A-coded voltage-gated sodium
channel. Because all pain fibers depend on the SCN9A gene’s
protein for amplification, all signals of pain are assumed
to be muted when the gene is inactive. This finding may
provide a new therapeutic target for drug development.
Most back & sciatica patients who don't require urgent
surgery improve with either medical or surgical therapy. You
can always get surgery later.
November 22, 2006: JAMA today published the two SPORT trials
(randomized and observational) and two editorials comparing
surgical (open diskectomy) and non-surgical (standard
medical care) treatment of patients with a herniated
intervertebral disk and sciatica for at least 6 weeks but
without evidence of an urgent need for surgery such as loss
of bowel or bladder control. Medical and surgical patients
improved at about the same rate with a slight but
unconvincing trend in favor of surgery. There was no
evidence that delaying surgery increased the risk of serious
complications. Neither trial gave adequate reason for saying
either that the treatments were equivalent in effectiveness
or for saying that one or other was better. One trial was
randomized but 30% of medical patients actually received
surgery in the first 3 months of the study. The
non-randomized study (patients from the same clinics who
declined randomization) showed an advantage for surgery by
patient self-assessment of outcome but observational studies
such as this cannot establish causality and require
confirmation in a randomized trial of adequate size, design
and execution. It is reasonable for patients with a
herniated disk with sciatica but without urgent indications
for surgery to select medical or surgical therapy on the
basis of personal preference and level of pain; they can
always decide to have surgery later if they don’t improve. A
TMT associate has suggested that any superiority of surgery
might not be because of the surgery itself but because it is
socially and medically acceptable to have a period of bed
rest and enforced inactivity following such surgery.
Pain relief in fibromyalgia reported with pregabelin
(Lyrica) in 6-month double-blind study
November 17, 2006: Previous short-term studies with
pregabelin (Lyrica) have reported pain relief in patients
with fibromyalgia, a poorly understood condition that
affects 2-4% of the population. In a new 6-month
double-blind trial, Lyrica relieved fibromyalgia pain
significantly more than placebo. This trial used a
placebo-withdrawal design in which responders (at least 50%
improvement in pain score) after 6 weeks of open-label
Lyrica treatment (663 of 1051 patients, 63%) were assigned
to continue Lyrica or to be switched to placebo. By the end
of the 6-month trial, 68% of Lyrica patients had maintained
their pain response versus only 39% of placebo patients.
Although these findings are encouraging, a definitive
assessment of this study must await full publication of the
results.
Americans are living longer but have more long-term pain
November 15, 2006: The annual report for the US Government
Centers for Disease Control and Prevention (CDC) says that
chronic pain is common in US adults: 1) One in 10 have pain
that lasts a year or more, 2) One quarter had a day-long
bout of pain in the past month, 3) More than a quarter had
low back pain in the past three months. 4) Fifteen per cent
had migraines or severe headaches in the past three months,
and 5) Almost one in twenty used a narcotic drug in the past
month for pain relief. Americans are living longer, with
life span at a record average of almost 80 years. At birth,
life expectancy for females is just over 80 years and nearly
75 for males. The gap in life expectancy between white and
black Americans also has narrowed from seven years in 1990
to five years in 2004.
Unblinded randomized study suggests acupuncture is effective
in patients with osteoarthritis
October 31, 2006: In a study in over 700 patients with
osteoarthritis, patients were randomly assigned to
acupuncture or to a control group. Over a 6-month period,
acupuncture patients improved significantly more than
control patients. Neither patients nor physicians were
blinded to treatment group allocation, so that bias may
explain the differences between treatment groups. However,
previous evaluation using sham acupuncture has supported the
efficacy of acupuncture for the treatment of arthritis (see
the June 19, 2006 TMT review below).
Test for H. Pylori Before Starting NSAIDs in High GI Risk
Patients
September 25, 2006: The American Gastroenterology
Association recommends evaluation of both gastrointestinal
and cardiovascular risks when considering NSAID therapy.
This should include a routine test for Helicobacter pylori
(H. Pylori) infection for all such patients at high risk of
GI complications. Short-term studies have shown that
eradicating H. Pylori infection before starting an NSAID
reduces the risk of peptic ulcers from the NSAID.
Fibromyalgia symptoms respond to acupuncture in controlled
trial
June 19, 2006: A 50-patient clinical trial from the Mayo
Clinic suggests that acupuncture may ease pain, fatigue and
anxiety in patient with fibromyalgia. Patients were randomly
assigned to acupuncture or (in a technically interesting
approach) to simulated acupuncture in which subjects were
unaware whether the needle merely pricked the skin or was
inserted into the muscle beneath the skin. The acupuncture
group improved significantly compared to the simulated
acupuncture group, as determined by serial measurements of
the Fibromyalgia Impact Questionnaire (FIQ) and the
Multidimensional Pain Inventory (MPI). Effects were maximal
at 1 month and were somewhat attenuated by 7 months. The
level of clinical benefit seen was similar to that seen with
drug interventions.
Before undergoing knee cartilage surgery, make sure the
symptoms come from the cartilage damage
February 28, 2006: According to
the Boston Osteoarthritis Knee Study, patients with
osteoarthritis of the knee commonly have damaged cartilage
(medial meniscus in 86% and lateral meniscus in 63%).
However, the lead author of the study stated that while
meniscectomies are often performed to relieve pain, "all
efforts should be made not to go in and remove the menisci
unless they are likely to be the cause of arthritis
symptoms." A previous study found that tears of the menisci,
common in osteoarthritis of the knee, are often incidental
findings that don’t cause symptoms. Non-surgical methods to
manage osteoarthritis pain include exercise and weight loss,
knee braces, motion control shoes, and analgesics and
anti-inflammatory drugs. (Hunter DJ et al., Arthritis &
Rheumatism. 2006; 54(3):795-801).
Celebrex effective in knee osteoarthritis. Glucosamine &
chondroitin did not show clear improvement.
February 23, 2006: The GAIT study
was a 1583-patient, 24-week, double-blind study in patients
with painful osteoarthritis of the knee and compared 1)
glucosamine (1500 mg/day), 2) chondroitin (1200 mg/day), 3)
glucosamine + chondroitin, 4) celecoxib (200 mg/day), and 5)
placebo. The results for the primary efficacy measure (20
percent decrease in knee pain from baseline to week 24)
showed no significant improvement versus placebo for
glucosamine or chondroitin (alone or in combination),
although an exploratory analysis of patients with more
severe pain suggested some improvement. In the celecoxib (Celebrex)
patient group, there was a statistically significant
(P=0.008) increase in the primary efficacy measure (70.1%
response versus 60.1% for placebo). The study was not large
enough or long enough for definitive evaluation of
cardiovascular safety. There were three serious adverse
events judged by the investigator to be related to study
treatment - one patient on combined glucosamine and
chondroitin had congestive heart failure; one patient on
glucosamine had chest pain; and one patient on celecoxib had
a stroke. A review of all adverse events requested by the
data and safety monitoring board did not suggest that
celecoxib increased ischemic cardiovascular events. Most adverse events were mild, infrequent, and evenly
distributed among the groups.
Fewer upper gastrointestinal complications with Celebrex
than NSAIDs
February 23, 2006: The SUCCESS-I
osteoarthritis trial (March 2006 issue of American Journal of Medicine) was
a 13,274 patient, double-blind, 12-week comparison of twice
daily dosing with celecoxib
(Celebrex 200 mg or 400 mg/day), and non-COX-2-selective NSAIDs (diclofenac
100 mg/day or naproxen 1,000 mg/day). The treatments
were equally effective in treating osteoarthritis. Celebrex was
associated with significantly fewer serious upper
gastrointestinal events than NSAIDs. The study was not
designed to look at cardiovascular safety, was not large
enough to answer this question definitively, and did not
provide clear definitions of cardiovascular endpoints (e.g.,
heart attack). Although heart failure was 4.5 times as
common in the non-selective NSAID group (P=.01), this
finding should be interpreted cautiously and would need to
be confirmed in a further prospective clinical trial.
Additional analysis comparing the effects of the high (400
mg/day) and moderate (200 mg/day) doses of Celebrex would be
useful.
Inflammation may be "driving force" for atherosclerosis
February 23, 2006: Rheumatoid
arthritis (RA) patients had a threefold increase in
preclinical carotid atherosclerotic plaque, independent of
traditional risk factors, according to a matched
cross-sectional study. The researchers recommend rigorous
control of rheumatoid disease activity because chronic
inflammation is "probably a driving force for premature
atherosclerosis." This report supports previous work showing
that chronic pain conditions associated with inflammation
are associated with increased cardiovascular risk and
increased mortality. This work does not establish that the
inflammation causes cardiovascular disease. Additional
research is required to determine if effective drug
treatment of inflammation associated with chronic pain might
reduce cardiac risk and mortality.
Headache more common in women
February 18, 2006: In a British
general practice study, women consulted their doctor for
headache 2.6 times as often as men. Consultation rates were
highest in the 15 to 24 year age group and declined with
age. In one third of the consultations, drug treatment for
migraine was prescribed.
Heat Therapy Proves Effective for Acute Lower Back Pain
January 27, 2006: A Johns Hopkins
study suggests that continuous low-level heat wrap therapy
is an effective adjunct or alternative to painkillers in
treatment of acute lower back pain (Journal of Occupational
and Environmental Medicine, December 2005). In a randomized
study of 43 patients, those wearing the wrap (worn under the
clothes and uses a chemical reaction to deliver low-level
topical heat) improved by nearly two points from baseline on
a 10-point pain-intensity scale, compared with less than one
point of improvement in the standard care group
(P=0.0029).The heat-therapy group also rated their pain
relief as "more than half better" on average at day one,
compared with an average assessment of "less than half
better" for the standard care group (P=0.0027). The benefits
of heat therapy were maintained through two weeks of
follow-up. The heat-therapy group also had significantly
greater improvements in mobility. The ThermaCare HeatWrap,
manufactured by Proctor & Gamble, is an FDA-approved class I
medical device and can be purchased without a prescription.
3. CANCER
HPV vaccine could prevent cancer of cervix, vulva, vagina,
mouth and throat.
May 18,
2007: The vaccine against the human papillomavirus (HPV) is
believed to reduce the risk of cancer of the cervix
(http://content.nejm.org/cgi/content/abstract/356/19/1915).
Mandatory HPV vaccination of girls has been suggested but is
controversial
(http://content.nejm.org/cgi/content/full/356/19/1905).
Recent controlled trials indicate that the HPV virus may
also be implicated in oropharyngeal cancer (cancer of
the mouth and throat in which HPV virus may be transmitted
by oral sex; http://content.nejm.org/cgi/content/abstract/356/19/1944)
and in cancer of the vulva and vagina (http://www.thelancet.com/journals/lancet/article/PIIS0140673607607776/abstract).
Religious people with advanced cancer get inadequate
spiritual support and want aggressive measures to extend
life
February
9, 2007: The “Coping with Cancer” federally-funded study
examined religiousness among cancer patients and its
associations with end-of-life treatment preferences and
quality of life. The authors stated: “Most (88%) of the
study population (N = 230) considered religion to be at
least somewhat important. Nearly half (47%) reported that
their spiritual needs were minimally or not at all supported
by a religious community, and 72% reported that their
spiritual needs were supported minimally or not at all by
the medical system. Spiritual support by religious
communities or the medical system was significantly
associated with patient QOL (P = .0003). Religiousness was
significantly associated with wanting all measures to extend
life (odds ratio, 1.96; 95% CI, 1.08 to 3.57).” They
concluded that “Many advanced cancer patients’ spiritual
needs are not supported by religious communities or the
medical system, and spiritual support is associated with
better QOL. Religious individuals more frequently want
aggressive measures to extend life.”
In observational study, dense breast tissue increased risk
of breast cancer and increased difficulty of diagnosis
January
18, 2007:
In an observational study,
women with breasts with higher "mammographic density" (more
epithelium/stroma and less fat) had a higher rate of breast
cancer. As compared with women with
density in less than 10% of the mammogram, women with
density in 75% or more had an almost 5 times increase in risk. Fat is radiographically lucent and
appears dark on a mammogram. In contrast, breast epithelium (layers
of cells derived from membranous
tissue covering internal surfaces) and
stroma (connective tissue providing a support framework) are
radiographically dense and look light, an appearance
referred to as "mammographic density". Cancer in
breasts with higher mammographic density was also more
difficult to detect. The authors conclude
"Extensive mammographic density is strongly associated
with the risk of breast cancer detected by screening or
between screening tests. A substantial fraction of breast
cancers can be attributed to this risk factor".
Observational studies cannot establish causality but can
suggest the need for additional study.
Cancer deaths are down. Cancer pain is treatable.
January
17, 2007: Fewer people died of cancer in 2004 than in 2003,
the second consecutive year cancer deaths declined in the
United States. Rates declined for most major cancers. Breast
cancer death rates have been dropping steadily since 1990,
attributed by the American Cancer Society (ACS) to earlier
detection and better treatments. Both incidence and death
rates have dropped for colorectal cancer in recent years.
Lung cancer remains the top cancer killer among both men and
women; rates among women have flattened in recent years, but
fewer men are getting lung cancer or dying from it.
African-Americans are still much more likely than any other
group to develop cancer and die from it. Hispanics, Asian
Americans, and Pacific Islanders have lower rates of most
cancers than whites, but tend to have higher rates of
cancers that may be linked to infections, such as cervical
cancer and liver cancer. About 30% of cancer deaths in the
US are caused by smoking. Another third are linked to
nutrition and physical activity. ACS recommends keeping
weight in a healthy range, getting plenty of exercise, and
eating a healthy diet with lots of fruits and vegetables to
reduce cancer risk. The ACS has a special section in this
year's Facts & Figures focusing on cancer pain and how to
treat it; cancer survivors and doctors should discuss pain
at every visit, and treat it promptly. [Note: TMT has an
ongoing collaboration with the MD Anderson Cancer Center
evaluating bone pain in patients with bony metastases.]
Randomized study suggests reduced fat in diet reduces breast
cancer recurrence
December
18, 2006: An interim analysis of data from the 2,437
subjects in the Women's Intervention Nutrition Study (WINS)
found that after 5 years women with previous breast cancer
who were randomized to a low fat diet (compared with those
randomized to a normal diet) consumed about 20 grams less
fat, weighed about 6 pounds less, and had a 24% lower risk
of recurrence (9.8% versus 12.4%). A reduced fat diet is
known to reduce estrogen levels and the reduction in
relative risk was greater for estrogen-negative cancer (42%)
than for estrogen-positive cancer (15%). Although there were
possible imbalances in treatment between the two groups,
randomized studies like WINS provide more persuasive
evidence than can be obtained from an observational study.
Breast cancer rate dropped 7% in 2003, possibly because of
less female hormone therapy
December
14, 2006: In 2003, the US breast cancer rate dropped 7%, the
largest-ever recorded yearly drop. Rates have risen most
years since 1945. The drop could be related to slowing,
stopping or reversal of the growth of small cancers because
of sudden discontinuation of female hormone therapy (~50%
drop in the number of hormone users in 1 year) by millions
of women following the July 2002 publication of the 26%
increase in risk of breast cancer associated with hormone
therapy in the WHI trial. In California, where hormone
therapy had been highest, the drop was larger than in other
states. The drop in estrogen-positive breast cancers (the
70% of breast cancers that are fueled by female hormones)
dropped twice as much as estrogen-negative breast cancer.
Women 50-69 years old (those most likely to take hormones)
had a drop 3 times greater than other age groups. Yearly
breast cancer rates dropped 2.5% from 2001 to 2002 and
dropped 7% from 2002 to 2003 (6% in the first half of 2003
and 9% in the second half). Until 2002 about one third of
American women over 50 took hormones. Other explanations for
the drop are possible. Observational studies cannot
establish causality but can suggest the need for further
study.
Observational study suggests that surgery or radiation for
localized prostate cancer improves survival in elderly men
December
12, 2006: Over 44,000 men 65-80 years old with localized and
well/moderately well differentiated prostate cancer who had
survived for 1 year after diagnosis were followed for up to
12 years. Mortality was 37% in the observational group and
24% in the treatment group (those who received radical
prostatectomy or radiation); adjusted analysis showed a
statistically significant advantage for the treatment group.
Observational studies cannot establish causality but can
suggest the need for further study. The authors state that
“these results must be validated in randomized controlled
trials of alternative management strategies in elderly men
with localized prostate cancer”.
Higher PSA velocity 10-15 years before prostate cancer
diagnosis may be associated with higher prostate cancer
mortality
October
26, 2006: An observational study in the Journal of the
National Cancer Institute suggests that the rate at which
serum PSA levels change (PSA velocity) may be an indicator
of the risk of prostate cancer death 25 years later.
However, an accompanying
Editorial suggests that definite conclusions on this
issue should await completion of large randomized trials
that are ongoing. Observational studies cannot establish
causality but can suggest the need for further study.
CT screening detects early lung cancer
October
26, 2006: Lung cancer was detected in 1.5% of over 30,000
people at risk of lung cancer who were screened by CT. The
cancer was judged to be early (Stage I) in 1.3%. The authors
"estimated" 10-year survival rates at 88% for all Stage I
cancer patients, and 92% for the 73% of Stage I cancer
patients who had surgical resection of the cancer within one
month of diagnosis. Although these results are encouraging,
without a control group it is not possible to determine if
survival in the screening group was improved by the early
detection of the lung cancer.
Observational study suggests that NSAIDs may protect against
development of prostate cancer only in men with the gene
type associated with higher LTA levels
August 30, 2006: An
observational (case-control) study suggests that a
protective effect of NSAIDs against the development of
prostate cancer may be confined to those with a particular
inflammatory response gene type (the LTA +80CC genotype).
Aspirin or ibuprofen reduced risk of prostate cancer by 33%
overall. However, this beneficial effect appeared to be
confined to men with the LTA + 80CC genotype (which is
associated with increased production of lymphotoxin alpha)
in whom a significant 57% reduction was seen (compared to
men without this genetic variant in whom no significant
reduction in risk was seen with NSAIDs). Observational
studies cannot establish causality but can suggest the need
for further study.
Node-positive breast cancer women who have
more HER2 receptor activity do better with epirubicin as
part of a triple therapy regimen
May 18, 2006: An article
in the New England Journal of Medicine describes a
prespecified subgroup multivariate analysis of the Mammary.5
controlled trial in women with node-positive breast cancer
and concludes “Amplification of HER2 in breast-cancer cells
is associated with clinical responsiveness to
anthracycline-containing chemotherapy.” Amplification of the
human epidermal growth factor receptor type 2 (HER2) means
an increased response of breast cancer cells to this growth
factor. The 710 women in the trial were followed for an
average of 10 years; 363 had a recurrence and 284 died.
Women who had HER2 amplification (about one-quarter of the
women) had a greater risk of relapse and death respectively
of 24% and 53% compared to non-HER2 amplification women.
However, if the Pfizer drug epirubicin [Ellence] rather than
methotrexate was given as part of a triple drug therapy
regimen to the HER2 amplification women, prognosis was
improved: 48% (p=0.003) better for relapse-free survival,
and 35% (p=0.06) better for overall survival; the adjusted
hazard ratio for the “interaction between treatment and
amplification status” was 1.96 (p=0.01) for relapse-free
survival and 2.04 (P=0.02) for overall survival. No clear
advantage was seen for epirubicin in the non-HER2
amplification group. The authors conclude that the increase
in benefit attributable to the triple therapy regimen with
epirubicin "is confined almost completely to women whose
tumors exhibit amplification or overexpression of HER2” and
they recommend that women with non-HER2 amplified breast
cancer should receive the “less toxic regimen” containing
methotrexate. An accompanying
Editorial expresses a few caveats about this study
(women were premenopausal, topoisomerase IIa may be a better molecular predictor
than HER2, trastuzumab [Herceptin] may prove superior to
chemotherapy) but concludes “The time has come to divide
breast cancer into clinically relevant molecular subgroups,
to prioritize the clinical questions applicable to each
subgroup, and to strengthen collaboration between clinicians
and laboratory scientists in identifying molecular
signatures that can predict the success or failure of
treatment.”
Observational study of breast cancer in post-hysterectomy
women supports safety of estrogen therapy for up to 15
years, but breast cancer risk might increase with longer
duration of estrogen therapy
May
9, 2006: In an observational study, post-hysterectomy
women in the Nurses Health Study were divided into six
pre-specified 5-year groups
depending on t |