Monday, November 30, 2009

Tylenol and Iburpofen to treat fever in children???

First, it must be made clear that any child with a fever should be evaluated by a physician to determine if antibiotics or a higher level of care is required, especially during H1N1 season.

That being said, you have a child who doesn't have any other source of infection other than a viral illness and now what do you do. There are a lot of theories as to whether you should treat it or not with medications like tylenol and ibuprofen. I will leave that up to parents to decide. My opinion is that when you treat a fever, the child feels better, sleeps better and is able to return to normal activities. Typically children greater than 1 year can have either tylenol or ibuprofen. Some viral illnesses will have a high fever and many parents will call when they can't give another dose based on the bottle instruction and child's fever, breaks through. When that happens, I recommend alternating doses of tylenol and iburpofen every 4 hours so their is at least 8 hours between doses of the same medications. I will even recommend mom set an alarm and wake the child up in the middle of the night to give them some medicine and some fluids and have them go back to bed. Attached is an article about using both medications is better. Read for yourself.

Bryan Glick, DO

Journal of Family Practice
December 2008 (Vol. 57, No. 12)
Patient Oriented Evidence that Matters

Do combination antipyretics work faster than ibuprofen alone in children?

Hay AD, Costelloe C, Redmond NM, et al. Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): randomised controlled trial. BMJ. 2008;337:a1302.

No. Adding acetaminophen (paracetamol) to ibuprofen does not reduce fever faster than ibuprofen alone in children. Over 24 hours, however, children receiving the combination spent 2.5 to 4.4 more hours without fever than children who took either drug alone.
Individual randomized controlled trials (with narrow confidence interval)
These investigators enrolled 156 children ages 6 months to 6 years at 35 primary care sites. The children were un-well and had a fever of at least 37.8°C, but no more than 41.0°C, and could be cared for at home. Children with dehydration were excluded.
The children were randomly assigned (concealed allocation) to receive ibuprofen 10 mg/kg per dose every 8 hours, acetaminophen 15 mg/kg per dose every 6 hours, or the combination, for the first 24 hours and then in response to symptoms for another 24 hours. The first doses were given in the office upon enrollment. Matching placebo of the alternate drug was given to the children in the single-drug groups. Analysis was by intent-to-treat, ie, the children were analyzed in the group to which they were assigned regardless of whether they followed the advice for therapy. Over the first 24 hours, full dosing of acetaminophen occurred in 42% to 65% of children and full dosing of ibuprofen occurred in 71% to 73% of children.

Combination antipyretics don’t work faster than ibuprofen, but they are longer acting
Ibuprofen lengthens time without fever during first 4 hours
Ibuprofen, either alone or with acetaminophen, produced more time without fever in the first 4 hours—an additional 55 minutes with the combination and an extra 39 minutes with ibuprofen alone—as compared with acetaminophen alone. This difference resulted from a 23- to 26-minute faster onset of fever reduction when ibuprofen was used either in combination with acetaminophen or alone.
Combination therapy has benefits during the 24-hour window
Over the first 24 hours, children spent more time afebrile with the combination of drugs as compared with either drug alone: 20.3 hours as compared with 15.7 hours with acetaminophen alone and 17.6 hours with ibuprofen alone.

Wednesday, November 25, 2009

What do these Breast Cancer guidlines mean?

Breast Cancer Screening Information for Patients

EBSCO Publishing's Consumer Health editors have created a 3-page handout to explain current breast cancer screening evidence and guidelines to patients.

See Breast Cancer Screening: Research and Guidelines.

DynaMed's Systematic Literature Surveillance is used to update Nursing Reference Center (NRC), Rehabilitation Reference Center (RRC), and Patient Education Reference Center (PERC), supporting EBSCO Publishing in providing current evidence-based references across the continuum of clinical care.

New Breast Cancer Screening Guidelines

Mammography Screening May Reduce Breast Cancer Mortality

The United States Preventive Services Task Force (USPSTF) recently updated their recommendations for breast cancer screening. These recommendations were based in part on a systematic review that included 8 randomized trials evaluating mammography screening for women ≥ 39 years old. Follow-up ranged from 11-20 years. Most trials were designed to compare the effects of inviting women for screening vs. no invitation rather than to directly compare screening vs. no screening. Invitation to mammography screening was associated with decreased risk of breast cancer mortality in all age strata for women aged 39-69 years (level 2 [mid-level] evidence).

For women aged 39-49 years, the pooled risk ratio (RR) for breast cancer mortality in screening groups was 0.85 (95% CI 0.75-0.96) in 8 trials with 348,219 women. The authors estimate that 1 breast cancer death would be prevented for every 1,904 women in this age group in a screening program for 10 years. Mammography was also associated with reduced breast cancer mortality in women aged 50-59 years (RR 0.86, 95% CI 0.75-0.99 in 6 trials), with 1 breast cancer death prevented for every 1,339 women recommended for screening, and in women aged 60-69 years (RR 0.65, 95% CI 0.54-0.87 in 2 trials), with 1 breast cancer death prevented for every 377 women. There was no significant difference in breast cancer mortality in women aged 70-74 years in the only trial that included this age group.

The review also examined outcomes per screening round in a cohort of 600,830 women ≥ 40 years old who had mammograms between 2000-2005. Rates of false positive mammograms per 1,000 women screened were 97.8 for ages 40-49 years, 86.6 for 50-59 years and 79 for 60-69 years. In addition, for women aged 40-49 years, 5 biopsies were performed for each cancer detected compared with 3 biopsies per cancer detected for women aged 50-59 years and 2 biopsies per cancer detected in women aged 60-69 years.

The most serious potential harm from screening is "overdiagnosis," meaning detection of cancers that would never have been symptomatic during the life of the woman. This can lead to unnecessary treatment with surgery, chemotherapy, or radiation. The overdiagnosis rate was estimated to be 1%-10% based on increased rates of cancer detected in screening groups compared to control groups (Ann Intern Med 2009 Nov 17;151(10):727). However, there are many factors in addition to overdiagnosis that may increase the rate of cancers detected through screening (Breast Cancer Res 2005;7(6):266).

The USPSTF now recommends against routine screening for women aged 40-49 years, suggesting the decision to begin screening should be individualized based on each patient's context and values (grade C recommendation). They recommend screening for women aged 50-74 years (grade B recommendation) and find insufficient data to make recommendations for women aged 75 years or older (grade I recommendation). USPSTF also recommends against clinicians teaching breast self-examination (grade D recommendation) and makes no recommendation about clinical breast exams (grade I recommendation). When mammography screening is done, USPSTF suggests every 2 years instead of annually (Ann Intern Med 2009 Nov 17;151(10):716). It should also be noted that the USPSTF recommendations do not apply to women who may be at increased risk for breast cancer due to factors such as genetics.

The benefits of breast cancer screening were also examined in a recent Cochrane review of 11 randomized trials (including the 8 above) with 616,327 women. There was no reduction in overall mortality associated with mammography (RR 0.99, 95% CI 0.97-1.01 in analysis of 8 trials), but there was a reduction in breast cancer mortality (RR 0.81, 95% CI 0.74-0.87 in analysis of 9 trials) (level 2 [mid-level] evidence). This reduction, however, was not statistically significant in an analysis restricted to 4 higher quality trials (RR 0.9, 95% CI 0.79-1.02). Attendance rates for scheduled mammography ranged from 60%-100% for the first mammogram and 40%-89% on subsequent screenings (Cochrane Database Syst Rev 2009 Oct 7;(4):CD001877).

For more information, see the Mammography for breast cancer screening topic in DynaMed.

Wednesday, November 4, 2009

Elderberry Extract May Reduce Influenza Symptoms

One of my evidence-based medicine resources just sent out a weekly update discussing Elderberry extract as a natural remedy for influenza symptoms. You can google Elderberry extract but the two commonly marketed forms are Sambucol and ViraBloc are avialable locally. You can find ViraBloc at GNC, online. I searched at Wal-mart and Walgreens and neither sell it online. The Sambucol can be found online at Walgreens and CVS. CVS online reports that it's in stock at CVS on Daisey Mountain.
Again, during influenza season, it's most important to be seen in a timely manner, especially with H1N1 or if you have any chronic medical problems. Elderberry extract is something that may help improve symptoms after having influenza. I wouldn't use this as an exclusive therapy for influenza.
Pilot Clinical Study on a Proprietary Elderberry Extract: Efficacy in Addressing Influenza Symptoms. Fan-kun Kong, PhD.

Free Influenza information

Bryan Glick, DO

Sunday, November 1, 2009

What's the purpose of those package inserts that come attached to your medications?

Medication package inserts, or as I like to call them, 1001 reasons to not take this medicine, are informational documents included with all medications, prescription and OTC (over-the-counter) medications.

The package insert follows a standard outline of information provided: pharmacology, indications, off-label uses, contraindications, warnings, precautions, adverse reactions, abuse and dependence, over dosage, dose and administration, manufactured forms and recommended storage.

Typically a patient will present to the office with a myriad of complaints, for example, a patient with anxiety and panic attack. These patients will have a plethora of complaints and serious concern that "something bad is going to happen." Complaints commonly made by anxious patients include but are not limited to the following: impending doom, chest pain, shortness of breath, numbness in the fingers, dizziness, fatigue, poor sleep, thoughts racing, rapid heart rate, irregular heart rate, upset stomach, memory problems, etc. Many anxious patients will present with this many complaints and additional ones that they fixate on and really want to know what is causing of all of this. That being said, the patient and I have a meaningful conversation about what is most concerning to the patient and what treatment strategy they interested in pursuing.

I feel that stuffing an evidenced-based treatment regime down the throat of a patient who is not ready for that therapy is only delaying treatment and ultimately destroying credibility between myself and the patient. Some patients are very motivated and want some reassurance and then would like to make an effort to fix the problem with little or no medications. Other patients are wholly in the grip of anxieties hand. For these patients, very good medications with rather minimal side effects and very good evidence-based efficacy exist. With either patient, the question is, do the benefits of the therapy out weight the risks?

The office visit is concluded and those patients who chose a medication, take their prescription to their local pharmacy to be filled. Upon pick-up and purchase of the medicine, attached is the package insert to which I refer.

Many patients, especially those with anxiety, are by far the biggest population of people who read these documents. To be honest, I don't think I have every read one.

Now here's where the problem exists for me as a physician. The patient and I have discussed the symptoms, the diagnosis, the medications and the risks and benefits and in one fell swoop many of these anxious patients will actually pay for the medicine but will decide to not take the medicine.

I see the patient at a follow-up visit with many of the same complaints and I ask, "How is the medication we started last time working?" and the patient says, "I didn't take it."
From a physician perspective, this is very frustrating. I have learned to anticipate this scenario and play devils advocate in an attempt to prepare the patient for the package insert.

I have patients call me days later and ask, "Is this new medication going to interact with the other medications that I'm taking?" To ease the mind of my patients and the population as a whole, I have an electronic medical record (EMR) which will not let me prescribe two medications that interact, in some way, without a warning and having to manually override the system. Do all doctors have EMRs? The answer is no, but the federal government is mandating that all medical records be paperless by 2012.

These package inserts have generated a lot of calls to my office regarding certain risks of taking this medication. I have to remind the patient of the original symptom complex they presented with and asking for a solution. Medications are relatively safe and do a good job at improving quality of life for the most part. While some people may have an opinion about the FDA, the bottom line is, they do a reasonable job and provide over site for an industry that is constantly inventing new products. The vitamin industry, by comparison, doesn't have any oversight, nor do they provide package inserts. Vitamins can be just as risky if not more risky than traditional medicines because of their lack of regulation.

As it relates to anxiety, I recently was directed to a website by a patient for a new anxiety medication. Touts itself as relieving your stress, no prescription required, asserts you can be stress free if you take these pills. The website was very well done, soothing colors, beautiful imagery and then at the bottom of the site was the price, $24.99 for 1 month. That's where I about lost it. $24.99, are you kidding me? This company is probably making money hand over fist with absolutely zero regulations on the claims that it makes. By the way, the bottle was filled with a mix of B vitamins. My medication, on the other hand, has many double-blinded randomized controlled trials showing almost proven efficacy and costs only $4 for 1 month at Wal-mart.

The bottom line is that these package inserts are medical-legal documents that absolve any and all persons associated with this medication, except the prescriber, from legal responsibility.

I wish the package inserts would have at the top of the sheet in bold letters "NOT TAKING THIS MEDICINE WILL ALMOST GUARANTEE YOUR SYMPTOMS TO CONTINUE TO WORSEN." Maybe that's too harsh, but the sentiment is real. A patient had a complaint bad enough or persisted long enough that they presented to a doctors office for a solution. A solution was given and at just that critical point before the patient administered the medication, the package insert reared its ugly head in an effort to terminate or delay therapy.

My advice is, take the package insert with a grain of salt, along with your pill as prescribed by your doctor. Remember, this perspective isn't about getting patients to take pills but rather trying to improve treatment outcomes in those patients who asked for a pill to fix their problem.

Info about package inserts.

Bryan Glick, DO