Author Archives: Menon Medical Center

Do Women Over The Age of 65 Need Pap Smears?

Analysis that corrects for hysterectomy rates indicates risk in women 
older than 65 is higher than previously thought.

Hysterectomy is common in the U.S., and the vast majority of these 
surgeries involve removal of the cervix as well as the uterus. Because 
total hysterectomy protects women from future invasive cervical cancer 
(ICC), hysterectomy rates affect estimates of ICC incidence.

In contrast to the relative decline in uncorrected ICC rates with age, 
rates corrected for hysterectomy continued to rise after age 39, 
peaking among women aged 65 to 69. In addition, correction revealed 
greater disparity in ICC incidence between white women and black 
women, with the latter group having higher incidence than previously 
thought.

Comment

Current guidance (NEJM JW Womens Health Apr 12 2012) states that, in 
women older than 65 with adequate recent screening, further screening 
can be discontinued (because of low rates of invasive cervical cancer 
as well as high false-positive rates for cytologic changes reflecting 
atrophy of the lower genital tract in this population). Given that 
hysterectomy-corrected ICC rates in older women are substantially 
higher than the uncorrected rates underlying these recommendations, I 
agree with the authors of this analysis that the existing guidelines 
should be reviewed.

Rositch AF et al., Cancer 2014 May 12

FDA Approves New Omega-3 Supplement

The FDA has approved a new omega-3 supplement (brand name, Epanova) to 
treat adults with severe hypertriglyceridemia, defined as triglyceride 
levels 500 mg/dL or higher.

In its announcement, the manufacturer said that Epanova is the first 
omega-3 formulation approved by the FDA in free fatty acid form. It 
will be available in 1-g capsules and has been approved for 2-g and 4-
g dosages, which can be taken with or without food.

There are currently two other prescription formulations of omega-3 
supplements on the market: Lovaza and Vascepa. All three are approved 
only for the treatment of severe hypertriglyceridemia, though studies 
of expanded indications are underway.

By Larry Husten

Triple Therapy For Ulcerative Colitis

Response rates continue to be promising for amoxicillin, tetracycline, 
and metronidazole.

Bacteria are widely suspected to be one of the inciting antigens in 
ulcerative colitis (UC). As such, antibiotics, probiotics, and fecal 
microbiota transplantation have all been established or proposed as 
treatments for UC.

In the current open-label, multicenter trial, researchers assessed the 
efficacy of a combination of amoxicillin (500 mg), tetracycline (500 
mg), and metronidazole (250 mg) 3 times daily for 2 weeks to induce 
and maintain remission in patients refractory to or dependent on 
steroids. The same researchers had previously designed this regimen to 
treat elevated levels of Fusobacterium varium observed in inflamed 
colonic mucosa of patients with ulcerative colitis and serum 
antibodies to F. varium. The regimen was effective for short-term 
control of UC in a randomized, double-blind, placebo-controlled study 
(NEJM JW Gastroenterol Aug 27 2010).

Kato K et al. Aliment Pharmacol Ther 2014 May

Syphilis on the Rise, Especially in Men Who Have Sex with Men

Syphilis rates have nearly doubled in the past decade, with the 
steepest rise among men who have sex with men (MSM), according to an 
analysis of national data in MMWR.

From 2005 to 2013, annual rates of primary and secondary syphilis 
increased from 2.9 to 5.3 cases per 100,000 population. Increases were 
greatest among men, who accounted for 91% of cases in 2013, and were 
seen in men of all ages, races/ethnicities, and geographic regions. 
The rise was especially pronounced among MSM, who accounted for about 
80% of cases in men. Among women, rates increased from 2005 to 2008 
and dropped thereafter.

Notably, syphilis was at record low levels in 2000.

Calling the syphilis increase in MSM “a major public health concern,” 
the researchers recommend promoting prevention measures, including 
safer sex practices, syphilis screening, and partner notification.

MMWR article

Vitamin D2 or D3 as a supplement?

Vitamin D3 seems like the better choice for supplementation.

Despite considerable research, the health benefits of vitamin D 
supplementation in the general population remain controversial. In 
this systematic review and meta-analysis, investigators determined 
whether blood vitamin D levels and vitamin D supplementation were 
associated with risk for death.

One analysis involved 73 observational studies (mean follow-up, 0.3–
29 years) that involved 850,000 participants (median age, 63; median 
baseline blood 25-hydroxyvitamin D [25(OH)D] level, 20.7 ng/mL). 
Overall, compared with participants whose blood 25(OH)D levels were in 
the top third, those whose levels were in the bottom third had 
significantly greater risks for cardiovascular (CV)-related death 
(adjusted relative risk, 1.4), cancer-related death (ARR, 1.1), and 
all-cause death (ARR, 1.4). For each 10 ng/mL lower increment of 25(OH)
D, risk for all-cause death increased by 16%.

Another analysis involved 22 randomized, placebo-controlled trials 
(31,000 older participants; mean follow-up, 0.4–6.8 years) with data 
on the effect of vitamin D supplementation on all-cause mortality; 8 
trials provided vitamin D2 (dose range, 208–4500 IU/day), and 14 
trials provided vitamin D3 (dose range, 10–6000 IU/day). Vitamin D3 
supplementation significantly lowered mortality risk (relative risk, 
0.9), but vitamin D2 supplementation did not.

Comment

In this analysis, the observational data showed an inverse association 
between blood 25-hydroxyvitamin D levels and death, but reverse 
causality is possible (i.e., ill people having low vitamin D levels 
rather than low vitamin D levels causing illness). In randomized 
trials, vitamin D3 supplementation modestly lowered all-cause 
mortality risk; however, the optimal dose and duration of vitamin D3 
supplementation are unknown. Thus, widespread vitamin D 
supplementation should not be recommended.

Chowdhury R et al., BMJ 2014 
Apr 1; 348:g1903

Aspirin Not Approved for Primary Prevention of Heart Attacks or Strokes

Aspirin shouldn’t be marketed for primary prevention of heart attack 
or stroke, the FDA has announced. The statement follows the agency’s 
rejection on Friday of Bayer Healthcare’s decade-old petition 
requesting approval of a primary prevention indication.

Aspirin is still widely used for primary prevention. The American 
Heart Association currently supports its use for primary prevention 
when recommended by a physician in high-risk patients. (There is 
widespread agreement that for secondary prevention, aspirin’s benefits 
outweigh the risks, and it should be used to prevent a second heart 
attack or stroke after an earlier cardiovascular event.)

In its statement, the FDA said it had “reviewed the available data and 
does not believe the evidence supports the general use of aspirin for 
primary prevention of a heart attack or stroke. In fact, there are 
serious risks associated with the use of aspirin, including increased 
risk of bleeding in the stomach and brain.”

FDA consumer information

FDA Approves Implantable Device for Sleep Apnea

The FDA has approved a new treatment — Inspire Upper Airway 
Stimulation therapy — for patients with moderate-to-severe 
obstructive sleep apnea who cannot use a continuous positive airway 
pressure machine.

The device is implanted in the upper chest, senses breathing patterns, 
and mildly stimulates the airway muscles, keeping the airway open. The 
device is turned on and off using a handheld remote.

In a study published in the New England Journal of Medicine, some 125 
patients (83% men, mean age: 55 years) had the device implanted. At 12 
months, the number of apnea events per hour decreased by 68% and 
oxygen desaturation events decreased by 70%.

The procedure to implant the device has a shorter recovery time than 
surgery to alter airway or facial anatomy, according to the 
manufacturer. It is expected to be available to patients by the end of 
2014.

Global Threat of Antibiotic Resistance

Global Threat of Antibiotic Resistance – The UN World Health 
Organization has published a report which “… makes a clear case that 
resistance to common bacteria has reached alarming levels in many 
parts of the world and that in some settings, few, if any, of the 
available treatments options remain effective for common 
infections …” – The report focuses on “… antibiotic resistance in 
seven different bacteria responsible for common, serious diseases such 
as bloodstream infections (sepsis), diarrhoea, pneumonia, urinary 
tract infections and gonorrhoea. The results are cause for high 
concern, documenting resistance to antibiotics, especially ‘last 
resort’ antibiotics, in all regions of the world … The report 
reveals that key tools to tackle antibiotic resistance – such as 
basic systems to track and monitor the problem – show gaps or do not 
exist in many countries … Other important actions include preventing 
infections from happening in the first place – through better 
hygiene, access to clean water, infection control in health-care 
facilities, and vaccination – to reduce the need for antibiotics. WHO 
is also calling attention to the need to develop new diagnostics, 
antibiotics and other tools to allow healthcare professionals to stay 
ahead of emerging resistance …”

For Adult Cancer Survivors

The American Society of Clinical Oncology has released three 
guidelines on treating problems commonly encountered by adult cancer 
survivors: chemotherapy-induced peripheral neuropathy, anxiety and 
depression, and fatigue. The guidelines are published in the Journal 
of Clinical Oncology.

To treat chemotherapy-induced peripheral neuropathy, clinicians may 
offer patients duloxetine. The group declined to make official 
recommendations on tricyclic antidepressants, gabapentin, and a 
topical gel (comprising baclofen, amitriptyline, and ketamine), but 
said they may be reasonable options in certain patients.

Patients should be periodically evaluated for depression and anxiety, 
and compliance with treatments should be assessed regularly. After 8 
weeks, if symptoms have not improved, clinicians should try a new 
approach.

Patients should be screened for fatigue at the time of cancer 
diagnosis and routinely thereafter, at least annually. They should be 
educated about ways to manage fatigue, such as through physical 
activity (150 minutes of moderate aerobic weekly plus two to three 
strength training sessions), cognitive behavioral therapy, and 
mindfulness-based approaches like yoga and acupuncture.

Dietary Fiber After Heart Attack Linked to Improved Survival

Consuming more dietary fiber after myocardial infarction is associated 
with a reduced risk for death, a BMJ study finds.

Researchers analyzed long-term data about diet and other risk factors 
from more than 4000 healthcare professionals who had an MI. Nine years 
after the MI, people who were in the highest quintile of fiber 
consumption had a 25% lower risk for death from any cause. Overall, 
there was a 15% reduction in mortality risk associated with every 10-g/
day increase in fiber intake.

The strongest association was observed for fiber derived from cereals 
and grains. A strong benefit was also found for people with the 
largest increases in fiber consumption after their MI. The findings 
remained significant after adjustment for other factors known to 
influence survival after MI. However, the authors acknowledge that 
they were unable to “fully adjust for all known or unknown healthy 
lifestyle changes.”

The authors note that less than 5% of people in the U.S. consume the 
minimum recommended amount of fiber (25 g/day for women and 38 g/day 
for men).

BMJ article