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Archive for February, 2015

Primary Care Corner with Geoffrey Modest MD: Pharyngitis and fusobacterium

28 Feb, 15 | by EBM

By: Dr. Geoffrey Modest

throatA recent article in the Annals of Internal Medicine looked at the causes of pharyngitis at the University of Alabama at Birmingham student health center (see Ann Intern Med. 2015;162:241-247​).

Details:

–312 students aged 15-30 with acute pharyngitis were compared to 180 asymptomatic students (mean age 23, about 60% women, 74% white)

–PCR was done on the throat swabs to detect Fusobacterium necrophorum, Mycoplasma pneumoniae, and group A and  group C/G b-hemolytic streptococci. and the Centor score was calculated  (Centor, by the way, is the lead author of this study). The Centor score is 1 point for each of fever, lack of cough, tender anterior cervical nodes, and tonsillar exudates, with higher scores more likely to reflect group A strep infection.

Results:

–F necrophorum in 20.5% of those with pharyngitis and 9.4% of the asymptomatic

–group A strep in 10.3 vs 1.1%

–group C/G strep in 9.0 vs 3.9%

–M pneumoniae in 1.9 vs 0%

–many patients had multiple infections (eg, of the total of 35% of patients who had an identified infection, 28% had a single organism and 7% had multiple

–and, of course, “none” (ie, probably viral in those with pharyngitis) was found in 64.7 vs 86.1%.

–in looking at the Centor scores: the numbers of patients in the different cells were small, but 37% (n=7) of those with a Centor score of 4 had F necrophorum, vs 11- 16% of the others, with n=2-3. and 26% with “none” had a Centor score of 4.  For Centor scores of 2-3, about 30% had F necrophorum (n=31), 20% with group A strep (n=20), and about 15% with the others (with n= about 16), though “none” was found in close to 60% (n=88)

 –data from Europe have found that F necrophorum causes about 10% of cases of pharyngitis in those 15-30 yo

Concerns about this study:

–the presence of the organism does not necessarily mean that it is the cause of the infection. The asymptomatic carriage rate for F necrophorum is quite high, and often multiple organisms were found in those with pharyngitis (and, which, if any, was causing the symptoms???). The parallel with group A strep is that the asymptomatic carriage rate can be very high at certain times of the year, as detected by culture or PCR, but the accepted evidence of infection is by an increase in the blood ASO titer or by changes in acute vs convalescent serum antibody levels, reflecting the systemic effect of the infection.  So, even in those with pharyngitis and positive strep PCR in this study, some may have had a viral infection and were just carriers of strep.

–it is likely that these patterns of pharyngeal pathogen carriage are different in different areas and different times of the year

–it is likely not to be generalizable to the majority of people coming in with pharyngitis (little kids)

But this study does bring up several issues

–as with other studies, the Centor score reflects a trend/a continuum. more likely to be strep if high, but still large % with probably viral infection. In this study, 85% of those with Centor score 0 had “none” identified, decreasing to 73% in those with Centor score 1, to 58% in those with 2 or 3, to 26% in those with score of 4. So, “none” (ie probably mostly viral infections) was still found in a majority of those with Centor scores up to 4, and only 11% of those with the maximum Centor score actually had Group A strep (though n was only 2). It should be pointed out that in larger studies, those with a score of 4 had a 50% chance of having Group A strep (see  Arch Intern Med. 2012; 172:847-52.)

–it would be really useful to have region and age-specific data on the infection and carrier rates for the different organisms at different times of the year

–this study reinforces using penicillin as the antibiotic of choice. It should be so anyway, since its spectrum of activity is relatively narrow and it is therefore less likely to cause bacterial resistance. And, it turns out, F necrophorum is sensitive to penicillin (and first generation cephalosporins) and not to azithromycin. (And we mere mortals do not even have access to tests for F necrophorum anyway, so best to just use penicillin if you are going to give antibiotics….). It is worth keeping in mind: although only about 10% of adults with acute pharyingitis have strep, 60% receive antibiotics, and the rate of prescription for penicillin has decreased to about 10% — really good drug company marketing!!: strep is pretty universally sensitive to penicillin, which is now less-prescribed than azithromycin to which strep is occasionally resistant, or other “big guns” (penicillin-b-lactamase inhibitors, third-generation cephalosporins…) — see, for example, JAMA Intern Med. 2014; 174:138-40​.

​–although this study does not prove F necrophorum is the cause of the pharyngitis cases, there is reasonable argument that it should be treated, since it does appear to be the most common cause of peritonsillar abscess in those 15-30 years old and the primary cause (on the order of 80%) of Lemierre’s syndrome (suppurative internal jugular thrombophlebitis with subsequent metastatic infections to the lung, brain, bone, often leading to ICU admission and significant morbidity/mortality — although, again, there are no data that treating early F necrophorum decreases the likelihood of Lemierre’s.

Primary Care Corner with Geoffrey Modest MD: Hepatitis A infections

27 Feb, 15 | by EBM

By: Dr. Geoffrey Modest 

A retrospective analysis from the CDC  was done of hospitalizations for hepatitis A, using the National Inpatient Sample — the largest population-based hospital inpatient database in the US, with annual data from about 1000 non-federal hospitals (see HEPATOLOGY 2015;61:481-485). They looked at data from 2002 to 2011.

Untitled

Results:

–Hospitalizations for hep A decreased from 0.72/100K to 0.29/100K (which has been attributed to universal vaccination of kids 12-23 months old)

–BUT there was

–an increase in the mean age of the hospitalized patient (37.6 to 45.5 years), with increases in those 40-64 and >64 yo groups but decreases in those <18 and 18-39 yo

–an increase in discharge comorbid medical conditions and other liver diseases

–an increase in % of hospitalizations for hep A covered by Medicare (12.4% to 22.7%) — reflecting the more advanced age of those hospitalized

–extrapolating from the NIS data, there were 641-935 hospitalizations for hep A in 2011 (and, keep in mind, only a minority of those infected are likely to be hospitalized)

 Hepatitis A is still a common cause of viral acute hepatitis in the US. This study highlights the continuing problem, and really supports universal hepatitis A immunization (which is already recommended in kids, but only in certain groups in adults). this is especially an issue, since

–hepatitis A is more severe in older people (increased hospitalizations both related to increased severity of the liver disease plus increase in comorbid conditions with aging)

–many people come from and travel to endemic areas. In my experience, with many  of my patients coming from endemic areas, I usually check hepatitis A serology (which is positive in probably 80+%), then immunize if negative (because these nonimmune patients are likely to visit their home countries at some point and may be exposed there).

–there is a strong recommendation from the CDC to make sure that people with any chronic liver disease are immunized against hepatitis A (this is one of their “high risk” groups).  I think this recommendation is based on patients with chronic hepatitis B and C infections, who, if then infected with hepatitis A, are more susceptible to developing fulminant hepatitis (the data seem most compelling for hepatitis C — see N Engl J Med 1998;338:286-90​).  However, the CDC guidelines are more general with “chronic liver disease” as an indication for vaccination, which I assume would apply to the burgeoning epidemic of non-alcoholic fatty liver disease, largely attributed to the huge numbers of people with obesity/insulin resistance, which also increases with age.

–those of us in high income, resource-rich countries are likely more susceptible to developing hepatitis A than we might expect, given that more foods are grown in resource-poor countries and imported (eg, the hepatitis A outbreak about a decade ago which was attributed to green onions imported from Mexico). Also, with the increasing industrialization/consolidation of farming and with, for example, cattle in extremely crowded conditions and vast quantities of their excrement filling the streams which provide water to plants, there may be more food contamination, as with the e. coli outbreak a few years ago. These conditions make it more likely that there could be spread of food-related infections.

So, bottom line: I think it makes sense to make sure everyone is either vaccinated or naturally immune to hepatitis A infection.

 

Primary Care Corner with Geoffrey Modest MD: Varenicline for almost-ready smoker cessation

26 Feb, 15 | by EBM

By: Dr. Geoffrey Modest 

JAMA presented a randomized controlled drug-company sponsored trial assessing the utility of varenicline for patients who are not quite ready to quit smoking (see JAMA. 2015;313(7):687-694). Details:

–760 patients from 61 centers in 10 countries were randomized to varenicline titrated to 1mg bid (vs 750 placed on placebo). All patients felt they were not ready to quit within the next month but were willing to reduce smoking and make a quit attempt within the next 3 months.

–mean age 45. 56% men, 62% white, 5% black, 23% asian. Average 20 cigarettes/d. 20% never attempted to quit before, 25% tried once, 16% twice and 40% at least 3 times

–patients had a reduction target of 50% or more by 4 weeks, 75% or more by 8 weeks, then a quit attempt by 12 weeks

–primary endpoint: carbon monoxide-confirmed self-reported abstinence during weeks 15-24. Secondary outcomes were carbon-monoxide-confirmed self-reported abstinence for weeks 21-24 and weeks 21-52.

Results:

–varenicline group had higher abstinence rates during weeks 15-24 (32.1%, vs 6.9% with placebo), risk difference of 25.2% and relative risk of 4.6 (3.5-6.1)

–varenicline group had higher abstinence rates during weeks 21-24 (37.8%, vs 12.5% with placebo), risk difference of 25.2% and relative risk of 3.0 (2.4-3.7)

–varenicline group had higher abstinence rates during weeks 21-52 (27.0%, vs 9.9% with placebo), risk difference of 17.1% and relative risk of 2.7 (2.1-3.5).

–the curves of varenicline vs placebo were flat from 28-52 weeks (ie, no evidence of deterioration with varenicline — see graph below)

–of those who were able to quit completely, those on varenicline quit a median of 50 days after starting the med; those on placebo quit after 85 days

–serious adverse events in 3.7% on varenicline and 2.2% on placebo. Significantly more adverse events with varenicline were: nausea (27.8%), abnormal dreams (11.5%), constipation (5.1%), weight increase (3.7%). The constipation and weight gain happen just with smoking cessation alone. No significant psych issues (those with baseline severe psych issues were excluded from the study).

Perspective: it is clear that many current smokers want to quit (44% in a telephone survey reported in 2007), but only about 8% feel that they are ready to quit in the next month. Practice guidelines (eg the US Public Health Service​) typically suggest that smokers quit abruptly, and it is commonly felt that aids are not useful unless the patient is really ready to quit. So, I think this is a pretty powerful study, which serves to reframe the approach to smoking cessation a bit. Lots of participants from many different countries. And in primary care, we all see many patients who want to cutback and quit soon but are unable to specify a quit date. The long term (1 year) abstinence rate of close to 30% is very impressive. This study is a further impetus to treat smokers and reach out to those who previously we might not have considered to be good candidates.

The graph below shows the 7-day point prevalence of smoking abstinence, without much of a falloff in efficacy after 28 weeks.

graph
(Ebbert et al., 2015)

 

 

Primary Care Corner with Geoffrey Modest MD: New nutrition draft guidelines

23 Feb, 15 | by EBM

By: Dr. Geoffrey Modest

There are new draft nutrition guidelines from the US Dept of Health and Human Services and the Dept of Agriculture (see here). No huge changes, other than the comment “cholesterol is not considered a nutrient of concern for overconsumption“. Other points:

fruit

–vitamin D, calcium, potassium and fiber are underconsumed across the entire US population

–iron is underconsumed for adolescent and premenopausal females

–sodium is overconsumed across the entire US population

–saturated fat is overconsumed and may pose the greatest risk to those > 50 years old

–caffeine intake does not exceed what are currently considered safe levels for any age group

–fruits, vegetables, whole grains, dairy foods are under recommended goals for vast majority of US population. Fruit intake is low but stable from 2001-2010, vegetables have declined.

–refined grains, solid fats, and added sugars are more consumed than recommended. added sugars have decreased a bit from 2001-2010

–young kids consume recommended amounts of fruit and dairy, but this drops off as kids reach school age

–rates of overweight and obesity are extremely high and have persisted for more than 25 years in children, adolescents and adults

–65% of adult females and 70% of adult males are overweight or obese
–rates of overweight and obese are highest in those >40yo, and vary by race/ethnicity
–same is true for abdominal obesity
–1 in 3 youth aged 2-19 is overweight or obese

–of note,from 2009-2012 the percent of males >20yo who are overweight, obese, and extremely obese has declined a tad. For women, these are still slowly increasing

Comments:

–cholesterol: it has long been known that the hypercholesterolemic effect (ie, increase in serum cholesterol) of eating cholesterol is about 1/3 that of eating saturated fats and about 1/9 of that of eating trans fats. Several very large observational studies have not found that eating foods high in cholesterol is much of a cardiovascular risk factor. Also, as a perspective, only a small minority of circulating cholesterol (about 20%) is from diet, most is from genes….
–saturated fats: there are some recent data that, in terms of cardiac outcomes, plant-derived saturated fats are much better than animal-derived ones
–trans fats: the worst. Finally, there are significant public health initiatives to decrease their use.
–sodium: for IOM (institute of medicine) report on sodium intake (which proposes a less-aggressive approach, but still targets much lower than current consumption), see blog 
–potassium: see appended blog below from 4/22/13. Seems like this is a really important clinical target for intervention.

–caffeine: good news that we don’t have to cut back….

blog from 4/22/13:

BMJ did a systematic review of studies on potassium intake and blood pressure response/clinical outcomes (see BMJ 2013;346:f1378). looked at 22 RCTs (1600 people) and 11 cohort studies (127K people). assessed relation between potassium intake and blood pressure, lipids, catecholamines and renal function in the RCTs and all cause mortality, cardiovascular dz, stroke or CAD in the cohort studies. Results:

–BP is lowered by potassium intake, but only in hypertensive patients

–in those taking 90-120 mmol/d of potassium, the blood pressure decreased 7.2/4.0 mmHg

–no significant further decrease of BP if potassium intake >120 mmol/d

–all pts with hypertension benefitted by potassium supplementation (does not seem to matter if by food or supplements, whether on BP meds or not), though those with high Na intake (>4gm/d, which is pretty normal in our society), benefitted the most

–in kids, cohort data found that high K intake associated with less increase in BP over time (1mm Hg systolic BP difference/yr)

–for stroke, 24% decrease in those with higher potassium intake overall, 30% decrease in those with potassium intake in the 90-120 mmol/d range. No diff in cardiovasc events

–no change in renal function, serum lipids, or catecholamine levels

Background: Overall, potassium intake is much lower than it used to be (was over 200 mmol/d in remote ancestors, decreased in modern society dramatically to 70-80 mmol/L range in many countries, likely attributed to eating fewer unprocessed foods now and esp decreased fruits/veges/legumes. Recommended daily intake of potassium in US is 120 mmol/d. Older epidemiologic studies found relationship between low potassium and high BP and stroke. Intervention data have been mixed. So, present study initiated by WHO to evaluate.

The 2011 NICE guidelines on hypertension, which I personally think are the best/most complete/most up-to-date around, evaluated the data and were pretty restrictive in what they included. They noted that there were inconsistencies in the results of high potassium intake on blood pressure, concluding that there were insufficient data to recommend a higher potassium intake as part of therapy.

So…. as with many of these non-pharmacological interventions, it makes sense to encourage patients strongly to eat non-processed foods, and esp to eat fresh fruits and vegetables/legumes. Helps the blood pressure and probably everything else. I would be a bit reluctant to simply give potassium supplements, though would recommend the fruits/veges (perhaps one of the reasons the DASH diet works is that it is relatively high in potassium). And, one other, tangential and unproved (i.e., personal) feeling is that diuretics may not be the best first-line med (supported by recommendations by NICE), that this may be especially true in those with low K intake, and when diuretics seem indicated in pts wtih low K intake, consider the combo K-sparing (and Mg-sparing, by the way) meds, such as triamterene-HCTZ.

 

by the way, i know that many of us see pts with very high blood pressures, but it is important to remember that the vast majority of hypertensive patients have only small BP elevations.  the data in the UK is that lowering blood pressure 5mmHg would decrease hypertension by 50%.  lowering BP by 2mmHg in the US would decrease cardiac events by 67K and stroke by 35K. so, the level of decrease by raising K intake as above would have really profound effects.​

Primary Care Corner with Geoffrey Modest MD: Length of menopausal symptoms

21 Feb, 15 | by EBM

By: Dr. Geoffrey Modest

A subgroup assessment of the Study of Women’s Health Across the Nation (SWAN), a multiracial/multiethnic observational study from 7 US communities,  assessed the duration of frequent menopausal vasomotor symptoms (VMS), defined as occurring at least 6 days over prior 2 weeks, and the duration of frequent VMS after the final menstrual period (see doi:10.1001/jamainternmed.2014.8063).

Details:

–analysis of 1449 women with frequent VMS, from Feb 1996 through Apr 2013. all with natural menopause. an array of psychosocial variables were recorded, including attitudes toward menopause, symptom sensitivity (assessment of heightened attention to bodily sensations), anxiety, perceived stress, depressive symptoms, and social support

–mean age at first VMS report was 50. only about 35% had symptoms starting post-menopause, 10% premenopausal and rest were perimenopausal. BMI <25 in 35%, BMI 25-30 in 27% , BMI >30 in 37% .

–median total VMS duration was 7.4 years

–of the 881 women with known final menstrual period (FMP), the median persistence of frequent VMS was 4.5 years after FMP

–those women who were premenopausal or early perimenopausal with frequent VMS had the longest duration of frequent VMS (11.8 years) and those with known FMP had the longest persistence of frequent VMS (9.4 years)

–women who were post-menopausal at onset of frequent VMS had the shortest VMS duration (median 3.4 years)

–African-American women reported the longest total VMS duration (10.1 years). Japanese/Chinese with shortest (4.8/5.4 yrs). nonHispanic White=6.5 yrs. Hispanic=8.9 yrs

–also, those who were younger at onset of frequent VMS, had lower educational level, greater perceived stress and symptom sensitivity, and higher depressive symptoms and anxiety at start of VMS had longer duration VMS

–overall, the strongest relationships with VMS duration and with persistence of symptoms in those with known FMP were: whether they were premenopausal or menopausal at onset of VMS and their age at onset of VMS (the hazard ratio being >10.9 if symptoms began age 42-45).

Menopausal vasomotor symptoms (e.g. hot flashes, night sweats) are really common, about 80% of women have them and most rate them as moderate to severe and affect their quality of life. Although the ACOG bulletin (Am College of Ob and Gyn) has until recently maintained that hot flashes lasted from 6 months to 2 years, this is the second report I’ve seen in the past couple of years which seriously challenge this (the Penn Ovarian Aging Study, found a median of 10.2 years of moderate-to-severe hot flashes postmenopausally. see Freeman E. Obstetrics & Gynecology. 2011; 117:1095-1104​). Overall in the current study, the symptoms on average lasted 7.4 years, but even in the lowest-risk groups, 20% had symptoms at 13 years out. So, as those of us in primary care have known for decades, VMS frequently lasts much much longer than ACOG has historically noted, and that this has profound implications in terms of what what we as clinicians should consider within normal limits (i.e. when we should be concerned about underlying pathology), what women should expect, and, if medical treatment is needed, how long that treatment might last (i.e., it seems that short-term estrogen replacement has minimal adverse events, especially if administered by transdermal route which bypasses first-pass hepatic metabolism and thereby does not induce high levels of clotting factors. but now we are acknowledging that treatment may actually be required for far longer, raising big questions about development of breast cancer, for example, if estrogens, the most potent medication, is used).

Primary Care Corner with Geoffrey Modest MD: Moderate alcohol and cardioprotection????

20 Feb, 15 | by EBM

By: Dr. Geoffrey Modest

alcoholI have been one of those occasionally advocating small amounts of alcohol to some of my patients (ie, those with no personal or family history of addictions  and who were resistant to taking statins despite their increased cardiovascular risk) for several reasons. There have been large meta-analyses (for example, see Ronksley P E et al. BMJ 2011;342:bmj.d671  — meta-analysis of 84 studies with 11 years followup) finding 25% decrease in CAD incidence and mortality and 13% decrease in total mortality in moderate alcohol consumers. And, there was reasonable biological plausibility (reviewed by Brien, et al BMJ 2011) finding increased HDL, slightly decreased LDL, increased apolipoprotein A1, decreased fibrinogen, and increased adiponectin (which is decreased in the setting of insulin resistance/diabetes and negatively correlates with insulin resistance) — all of which should decrease CAD.  There are many clinicians strongly against our promoting a glass of wine with meals, partly because of the overall devastating effects of excessive alcohol intake (and that we as providers should not suggest a toxic chemical) and partly because of very likely biases in the retrospective and uncontrolled studies on moderate alcohol consumption. Some of these biases, for example, include the fact that “non-drinkers” in many of the studies included former drinkers (who from several other studies have more depression and increased mortality than “never drinkers”); in addition, those who drink small amounts of wine with dinner might well take care of themselves better (healthier diet, more exercise, other factors??) than those who either drink much more or do not drink at all. In this light, a new BMJ article found minimal benefit of alcohol (see BMJ 2015;350:h384).

Details:

–analyses were done of 10 waves of the Health Survey for England from 1998-2008, in adults >50 yo​.

–the Health Survey is an annual cross sectional survey of the non-institutionalized general English population, which included questions about self-reported average weekly alcohol consumption and consumption on the heaviest day in the past week. the survey assessed “former drinkers” as well as “never drinkers”

–all-cause mortality was based on recorded deaths, with prior consent by the patient to link to the Health Survey database (n=18,368)

Results:

–controlling for age (their Model 1), weekly use and use on heaviest day were protective at all levels of consumption and in all age groups except women 50-64 yo (where consumption of >20 units/week was insignificant)

–controlling for age, BMI, economic activity, education, ethnicity, country region, marital status, smoking status, and social class (their Model 2), and not including “former drinkers”, the only groups with protection from alcohol were women >65 yo consuming <=10 units/week or up to 3 units on their heaviest consumption day as well as those who consumed at a frequency of <=2 drinking occasions/month, and men 50-64 yo consuming 15-20 units/week or drinking up to 1.5 units on their heaviest consumption day (though the magnitude of protection in men was “minimal”).

So, this study adds to others which have found that when “former drinkers” are removed from the non-drinker category, the protective effect of alcohol is either attenuated or nullified.

__

Tim Naimi published an editorial in the journal Addiction, which argues strongly that moderate alcohol consumption should not be considered cardioprotective at this point and that we should not be recommending that patients drink (see doi:10.1111/add.12828). He (and coauthors) cite impressive data from several Mandelian randomization studies (which decreases the likelihood of confounding) which seem to contradict a direct role of alcohol in decreasing both CAD biomarkers as well as several of the attributed “health-promoting” effects of moderate alcohol (cardiac, but also cognitive function, blood pressure, and prenatal exposure with both balance and academic achievement in kids).

 

Primary Care Corner with Geoffrey Modest MD: OTC supplements — not what they say they are…

19 Feb, 15 | by EBM

By: Dr. Geoffrey Modest 

The New York Times had a rather remarkable article on Feb 3rd noting that in a NY attorney general’s investigation, approx 80% of herbal supplements from 4 retailers “contained none of the herbs listed on their labels”, but included “cheap fillers like rice and house plants, or substances that could be hazardous to people with food allergies”. Specifically, they analyzed products from GNC, Target, Walmart, and Walgreens (see here). This raises several issues.

–there is a total lack of oversight/regulation for these “dietary supplements”: ie, no FDA or other agency assuring the quantity or quality. I have previously sent out an article on vitamin D supplementation of milk (see N Engl J Med 1992; 326: 1178), finding that only 29% of 42 samples of 13 brands of milk had the amount of vitamin D advertised on their label (within 20%), 62% had < 80% of what was advertised, and 3 of 14 samples of skim milk had NO vitamin D!! So, people relying on any of the “dietary supplements” are at risk of getting none of what they want.

–there is clearly a potential health risk if one has an allergy to an added (but not listed) ingredient to the supplements

–and, unfortunately, I do find that even in the relatively poor urban community where I work, many patients are buying these overpriced supplements (which it turns out are often fraudulently labeled).

 

Will append the list from the article below (O’Connor, 2015):

gncFrom GNC, Herbal Plus brand- 

Gingko Biloba:

  • No gingko biloba found
  • Did detect allium (garlic), rice, spruce and asparagus

St. John’s Wort

  • No St. John’s Wort found
  • Did detect allium (garlic), rice and dracaena (a tropical houseplant)

Ginseng

  • No ginseng found
  • Did detect rice, dracaena, pine, wheat/grass and citrus

Garlic

  • Contained garlic

Echinacea

  • No echinacea found
  • Did detect rice in some samples

Saw Palmetto

  • One sample contained the clear presence of palmetto
  • Other samples contained a variety of ingredients, including asparagus, rice and primrose

From Target, Up & Up brand-

Gingko Biloba

  • No gingko biloba found
  • Found garlic, rice and mung/French bean

St. John’s Wort

  • No St. John’s Wort found
  • Found garlic, rice and dracaena (houseplant)

Garlic

  • Contained garlic
  • One test identified no DNA

Echinacea

  • Most but not all tests detected Echinacea
  • One test identified rice

Saw Palmetto

  • Most tests detected saw palmetto
  • Some tests found no plant DNA

Valerian Root

  • No valerian root found
  • Found allium, bean, asparagus, pea family, rice, wild carrot and saw palmetto

From Walgreens, Finest Nutrition brand-

Gingko Biloba

  • No gingko biloba found
  • Did detect rice

St. John’s Wort

  • No St. John’s Wort found
  • Detected garlic, rice and dracaena

Ginseng

  • No ginseng found
  • Detected garlic and rice

Garlic

  • No garlic found
  • Detected palm, dracaena, wheat and rice

Echinacea

  • No echinacea found
  • Identified garlic, rice and daisy

Saw Palmetto

  • Contained saw palmetto

From Walmart, Spring Valley brand-

Gingko Biloba

  • No gingko biloba found
  • Found rice, dracaena, mustard, wheat and radish

St. John’s Wort

  • No St. John’s Wort found
  • Detected garlic, rice and cassava

Ginseng

  • No ginseng found
  • Found rice, dracaena, pine, wheat/grass and citrus

Garlic

  • One sample showed small amounts of garlic
  • Found rice, pine, palm, dracaena and wheat

Echinacea

  • No echinacea or plant material found

Saw Palmetto

  • Some samples contained small amounts of saw palmetto
  • Also found garlic and rice​

Primary Care Corner with Geoffrey Modest MD: Hydroxyzine and prolonged QTc

18 Feb, 15 | by EBM

By: Dr. Geoffrey Modest

The Pharmacovigilence Risk Assessment Committee (PRAC) of the  European Medicines Agency just issues a warning about hydroxyzine being associated with increased QTc intervals and torsade de pointes (see here). Hydroxyzine is a first-generation antihistamine, commonly used for pruritus, anxiety disorders, sleep disorders and as a premedication before surgery, as well as off-label as an anti-emetic.  They felt it was okay to continue using hydoxyzine since the cardiac arrhythmias were most likely to occur in those with risk factors, but they do suggest:

–maximum dose of 100mg/d or 2 mg/kg for kids up to 40 kg. Use lowest effective dose and for shortest time possible

–avoid using in those “at risk of heart rhythm problems” or in those taking other medications that prolong the QTc

–try to avoid using in those taking medications that lower the potassium or slow the heart rate, since these may predispose to arrhythmias.

–try to avoid use in the elderly, but if necessary, only up to 50mg/d

–there was no comment in the warning about the frequency of prolonged QTc, the length of the prolongation, or the frequency of torsades or ventricular tachycardia/fibrillation

So, quite unfortunate. hydroxyzine has been my go-to med for persistent pruritus.​ However, I will now try to avoid it especially in those on other meds which prolong the QTc, especially azithro/clarithromycin, tricyclics, citalopram, as well as in patients predisposed to arrhythmias. And decreasing the maximum dose in elderly seems appropriate.

Primary Care Corner with Geoffrey Modest MD: Medicare and lung CT screening of smokers

18 Feb, 15 | by EBM

By: Dr. Geoffrey Modest 

Medicare just came out with their formal decision on low dose CT scans (LDCT) for lung cancer screening in smokers (see here)​. These are somewhat between the USPSTF recommendations, recommending screening 55-80 year olds annually, and the actual criteria for the National Lung Screening Trial (NSLT) which was only 3 annual screens for the age range of 55-74 (and was the study upon which USPSTF based their recommendations).

lung

For Medicare, eligibility criteria are:

  • Age 55 – 77 years;
  • Asymptomatic (no signs or symptoms of lung cancer);
  • Tobacco smoking history of at least 30 pack-years (one pack-year = smoking one pack per day for one year; 1 pack = 20 cigarettes);
  • Current smoker or one who has quit smoking within the last 15 years; and
  • Receives a written order for LDCT lung cancer screening that meets the following criteria:
    • For the initial LDCT lung cancer screening service:  a beneficiary must receive a written order for LDCT lung cancer screening during a lung cancer screening counseling and shared decision making visit, furnished by a physician or qualified non-physician practitioner (physician assistant, nurse practitioner, or clinical nurse specialist).  A lung cancer screening counseling and shared decision making visit includes the following elements (and is appropriately documented in the beneficiary’s medical records):
      • Determination of beneficiary eligibility including age, absence of signs or symptoms of lung cancer, a specific calculation of cigarette smoking pack-years; and if a former smoker, the number of years since quitting;
      • Shared decision making, including the use of one or more decision aids, to include benefits and harms of screening, follow-up diagnostic testing, over-diagnosis, false positive rate, and total radiation exposure;
      • Counseling on the importance of adherence to annual lung cancer LDCT screening, impact of comorbidities and ability or willingness to undergo diagnosis and treatment;
      • Counseling on the importance of maintaining cigarette smoking abstinence if former smoker; or the importance of smoking cessation if current smoker and, if appropriate, furnishing of information about tobacco cessation interventions; and
      • If appropriate, the furnishing of a written order for lung cancer screening with LDCT.
    • For subsequent LDCT lung cancer screenings:  the beneficiary must receive a written order for LDCT lung cancer screening, which may be furnished during any appropriate visit with a physician or qualified non-physician practitioner. If a physician or qualified non-physician practitioner elects to provide a lung cancer screening counseling and shared decision making visit for subsequent lung cancer screenings with LDCT, the visit must meet the criteria described above for a counseling and shared decision making visit.
    • Written orders for both initial and subsequent LDCT lung cancer screenings must contain the following information, which must also be appropriately documented in the beneficiary’s medical records:
      • Beneficiary date of birth;
      • Actual pack – year smoking history (number);
      • Current smoking status, and for former smokers, the number of years since quitting smoking;
      • Statement that the beneficiary is asymptomatic (no signs or symptoms of lung cancer); and
      • National Provider Identifier (NPI) of the ordering practitioner.

So, the decision has arrived. As noted in my prior blogs, there are several very important issues. The extent of radiation exposure by doing the LDCT scans is perhaps the most important, and there are a few salient points with the Medicare recommendation:

​–patients could get up to 22 annual LDCTs done, if they continue to smoke or stop after age 62.

–in NSLT, the average individual’s radiation exposure was essentially the same as with the regular (high-dose) CT, when one adds in the additional radiation from follow-up studies from positive LDCTs (the vast majority of which were false positives)

the NSLT was mathematically projected to create one cancer death per 2500 screened in just 3 years!!  Medicare only noted that there is a radiation risk but felt that we needed to study/quantify the effects of the radiation exposure.

See my prior blog for more detailed critique.

Primary Care Corner with Geoffrey Modest MD: Meningococcal B vaccine

17 Feb, 15 | by EBM

By: Dr. Geoffrey Modest

The FDA has recently approved the use of serogroup B meningocococcal vaccines

Untitled

In brief:

–current meningococcal vaccines do not include serogroup B because the capsule is not immunogenic, though serogroup B is a very common cause of meningococcal disease: of the 500 cases of meningococcal disease in the US in 2012, 160 were caused by serogroup B.  The current vaccines only includes serogroups A, C, Y, and W-135.

–the new vaccines target outer membrane proteins with some success, though there are many different outer membrane proteins and they are not consistently present in different serogroup B strains.

–the FDA has now approved 2 different vaccines (Trumenba and now Bexsero), for those aged 10-25 yo. ACIP (The Advisory Committee of Immunization Practices) has not yet published a recommendation for these vaccines, though in Europe Bexsero is given for those >2 months old as a series of 3 intramuscular doses and can be given concomitantly with the other vaccines.   At age 10, the recommendation is 2 doses more than 1 month apart.

–for Boxsero, there have been 3 studies of 2600 adolescents finding 62-88% had antibodies that killed 3 different outer capsule strains of serotype B.  These 3 strains are representative of strains that cause most serogroup B infections in the US

–adverse effects in 5000 participants were mostly pain/swelling at injection site, headache, diarrhea, myalgia, arthralgia, fatigue and chills. Additionally, the vaccine was given to 15,000 students at 2 universities where there were outbreaks of serogroup B meningococcal infections, without evident problems.

So, given that these are the only vaccines covering serogroup B infections, the FDA has given them “accelerated approval” to get them to market sooner. But there have not been studies showing clinical efficacy, just that they seem to promote killer antibodies in the lab.  We will see what ACIP recommends, but these vaccines may be really important in preventing a potentially very serious disease.

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