Exercise Induced Muscle Soreness May Not Benefit from Regular Use of NSAID’s

The June 11, 2012 issue of MedPage carries coverage of the meeting of the European League Against Rheumatism where work by Matthias Rother, MD, PhD suggested that taking Ketoprofen or even Celecoxib (Celebrex) for exercise induced muscle soreness may not be a great idea.

The study looked at 64 healthy volunteers who were asked to walk down stairs totaling 400 vertical meters – similar to walking all the way down from the top of a 100-story building.  Forty of the volunteers were randomized to take 200 mg of Celebrex or a placebo twice a day. Twenty-four of the participants were randomized to take Ketoprofen or a placebo.

The patients in the Ketoprofen reported no improvement in pain.  In fact, their pain lasted longer (122 hours) than the placebo groups pain (105 hours).  Patients taking the Celecoxib had a mild pain improvement – so mild that it was not felt to be statistically significant.  This led the researchers to conclude that NSAID’s did not provide significant pain relief to justify their use in post-exercise muscle soreness. They went on to say that muscle inflammation and soreness are part of the inflammatory reaction following exercise that is “essential for recovery.”

This was a small study and it is hard to conclude anything. I will still recommend RICE therapy (Rest, Ice, Compression, Elevation) immediately following post injury or exercise.  Celecoxib (Celebrex) did reduce pain by 12- 13%, so, possibly the dosage and frequency of administration of the NSAID needs to be looked at as well. If my patients do not have a medical reason to avoid NSAIDs, they will still be advised to try them for work and exercise related aches and pains.

Prostate Cancer Risk Can Be Predicted With a Single PSA Test

The highly acclaimed Institute of Medicine and now the U.S. Preventive Task Force have recommended against routine screening of asymptomatic men for prostate cancer. Now, a study presented by Christopher Weight, MD from the Mayo Clinic Department of Urology adds more information and confusion to the fire. Dr. Weight presented his data at a recent meeting of the American Urologic Association.

The Mayo Clinic followed men younger than 50 years old for 16.8 years.  They concluded that men at age 40 with a PSA value of less than 1ng/ml had a less than 1% chance of having prostate cancer at age 55. They had less than a 3% chance of having prostate cancer at age 60.  They concluded that men with a baseline PSA < 1% in their 40s appear to be able to safely avoid annual screening until age 55.  “Men with a baseline PSA greater than or equal to 1 have a substantial risk of subsequent biopsy and cancer diagnosis and should be followed annually.”

This is one of the first research studies to quantify the actual relationship of screening young asymptomatic individuals and the subsequent risk of developing the disease.  It is the type of research needed to help guide us to make safe and sane recommendations about the type of screening for prostate cancer and frequency of screening using blood tests, ultrasound and of course digital rectal examination to palpate the prostate. All the patients in the Mayo study received a PSA assessment, digital rectal exam and transurethral ultrasound of the prostate at study entry and biennially thereafter.

This study affirms the recommendation for performing a screening digital rectal exam on all men at age forty and subsequently. It begins to answer the question of who needs follow-up PSA testing and when.  However, more research is clearly needed.

Statistics For Dummies: Primary Care Doctors’ Inability to Understand Statistical Concepts …

An article and editorial have appeared in the Annals of Internal Medicine demonstrating that primary care physicians do not understand simple statistical data presented to them regarding screening tests for cancer. The consequences, as outlined in an editorial written by a former chairperson of the much maligned Institute of Medicine, is that primary care doctors are over-using cancer screening tests because they do not understand the statistical ramifications and conclusions presented in the study. The editorialist recommends improving statistical courses at the medical school level and improving the editorial comments in journals when these studies appear.

As a primary care physician, out of medical school for 36 years, let me make a suggestion.  Keep It Simple Stupid.   Medical school was a four year program.  The statistics course was a brief three week interlude in the midst of a tsunami of new educational material presented in a new language (the language of “medicalese”) presented en masse in between students being used as cheap labor at all hours of the day to fill in drawing bloods, starting intravenous lines and running errands for the equally overworked interns and residents who were actually being paid to perform these tasks.

While internship and residency included a regular journal club, there was little attention paid to analyzing a paper critically from a statistical mathematical viewpoint.  I suggest applying the KISS principle to analyzing medical research papers. Make the language and definitions clear cut and understandable for the non math majors and non researchers.  We have eliminated the use of Latin, medical abbreviations and other time honored traditions of the profession in the name of clarity and safety.  It’s time to do the same with statistical analysis of research papers. Let authors and reviewers say what they mean at an understandable level. Practicing clinicians do not use this vocabulary regularly enough to master it.

It’s time for creating a “Khan Kollege” You-Tube video on statistical analysis and medical paper review that clinicians can refer to routinely to buff up their understanding of medical research papers.  If the American College of Physicians or American Academy of Family Practitioners already have such programs on their websites I apologize for not knowing where to find it.

Each year the economic advisors who freely give advice to us PCP providers have asked me to add three patients per day per year to my schedule to economically be able to stay in the same place.  Amidst that high volume and need to stay current and need to have some balance in my life I admit my statistical analysis skills have grown rusty.  I believe many of my colleagues have suffered the same fate. When the Medical Knowledge Self Assessment syllabus arrives every other year, the statistics booklet is probably one of the last we look at because not only does it involve re-learning material but you must first re–learn a vocabulary you do not use day to day or week to week.

I will make my effort to re-learn statistics to better understand the literature. It is my professional responsibility to do so. I ask my colleagues in academia to do a better job, however, of explaining and teaching the concepts so the data and the logical conclusions are understandable.

Computerized Prescribing and Pain Medications

As part of the government initiative to modernize health information recording and exchange , doctors and health care providers are encouraged (with financial incentives) to prescribe medications using the computer.  This “e-RX” system allows you to send prescriptions to the patients’ designated pharmacy right from your computer screen with a few clicks and turns of your computer mouse controls. The only medications you are not permitted to prescribe are narcotics, controlled substances and pain medications with narcotic contents.

At the same time this initiative is occurring, there is a massive crackdown in the State of Florida on prescribing medications for pain. Sloppy legislation in Tallahassee by the State Legislature led to the opening and growth of “pill mills.”   Drug addicts and suppliers from all over the country routinely travelled to Florida to obtain massive quantities of prescription medications from these fraudulent facilities staffed by criminal physicians. The medications ended up on the streets causing numerous drug and alcohol related deaths around the country.

The “sloppy” Florida State Legislature then attempted to rectify the problem by passing new rules and regulations that closed the “pill mills” with the help of the police and drug enforcement authorities but has frightened the legitimate physician population into not being willing to prescribe for legitimate chronic pain. Their actions included updating physicians’ online profile with the state licensing agency to declare whether you write narcotic scripts for chronic pain or not.  If you reply “yes” you are apparently placed on a list of “chronic pain” prescribing doctors that the public can access as well as the criminal elements looking for doctors to write scripts for cash.

At the same time legislation now requires doctors to take specific courses to prescribe some of the newer pain delivery products necessitating the physician to leave their practice to train on the use of the new medications. The result is that legitimate neurologists and anesthesiologists are shying away from seeing chronic pain patients less than 65 years of age even if they have been referred and have legitimate needs for pain medications.

This brings me back to computerized prescription ordering. If you are trying to track narcotic prescriptions, why prevent the doctors from using the computer to prescribe controlled substances?   What is easier to track and trace, a computerized order or a hand written prescription?   It would seem that computerized record keeping through electronic order entry would be the preferred method of tracking narcotic prescriptions.

Metal Joint Replacement – Should Allergy Testing Be Done First?

As our physically active baby boomers age, more and more of them are facing the need for joint replacement. We run, golf, bike and attend exercise class all in the name of fitness and cardiovascular health.  As a result, many of us have bodies that are becoming beat up and worn.

There have been numerous articles discussing the large increase in knee and hip replacements in active 50 year olds who wish to continue to be as active as they were prior to joint replacement surgery.  An article appeared in this week’s MedPage online journal about a small Italian study conducted regarding chronic pain in “successful “metal joint replacements in the lower extremity. Most of us know someone who had a perfectly unremarkable uncomplicated knee or hip replacement who is now suffering from unexplained pain at the surgically repaired joint site.  X Rays show perfect alignment. CT Scans and MRI scans show perfect surgical alignment. The patient remains in pain.

The study released by Italian researchers’ discusses allergic contact allergy being the cause of the continued pain. The individuals evaluated are allergic to the metals in the artificial joint. In the study subjects were patch tested in advance of joint replacement. Those showing allergic sensitivity to metals contained in the prosthesis received a hypoallergenic product instead. They did not develop the unexplained pain and discomfort and had a great outcome. While the study was small and the results preliminary, it raises the question of whether allergy patch testing prior to elective joint replacement should, and will, become the norm in the future.

Pradaxa: More Concerns. More Myocardial Infarctions?

Pradaxa is part of a new group of anticoagulants (thrombin X inhibitors) that eventually will allow anticoagulation by the pill route without requiring patients to alter their food and medication intake and avoid foods and medications that interfere with the anticoagulant as patients must do with Warfarin. Pradaxa additionally eliminates the need to take blood tests (INR/ PT) to monitor the dosage as one has to do with Warfarin (Coumadin).

There is a large commercial advertising campaign underway on TV and print media to encourage patients with atrial fibrillation to ask their doctors to switch them from Coumadin to Pradaxa (Dabigatrin).  The campaign bases its claims on the RE-LY trial of 18,000 patients at 80 medical centers throughout the world who took the 150 mg dosage and had significantly fewer strokes than patients taking Warfarin.  The original study was criticized because many of the patients in the Warfarin (Coumadin) group were not on enough Warfarin or at a therapeutic PT/INR to prevent embolic strokes so the comparison with Pradaxa may not be valid. Another criticism involved the fact that Pradaxa can cause major bleeding and there is no antidote to stop the bleeding. Patients on Pradaxa who are bleeding are advised to undergo hemodialysis to remove the drug from their system because there are no medications or treatments available to stop Pradaxa related bleeding.

One wonders how the Food and Drug Administration approved this product for general use under these circumstances without conducting further testing?  The issue becomes even more confusing with the addition of data presented by Ken Uchino, MD, and Adrian Hernandez MD, PhD of the Cleveland Clinic in the online version of the Archives of Internal Medicine. They claim that by reviewing the RE-LY data there is a 38% relative increase in the risk of a myocardial infarction (MI) or heart attack in the Pradaxa group. In an accompanying editorial in the same journal, clinicians at the Hadassah- Hebrew University Medical Center in Jerusalem wrote, “The robust finding that Dabigatran is associated with increased rates of MI (heart attack) is alarming and emphasizes the need for continued critical appraisal of new drugs after phase III trials.”

In my practice I generally will not switch to a new or controversial medication until it has been on the US market for at least one year. I make exceptions for orphan drugs, products to treat incurable diseases with no other choices available. The 12 months gives the medical and scientific community a chance to see how the medication performs and what unexpected adverse effects may be associated with it.

Thrombin X inhibitors are the wave of the future. With no way to stop the bleeding, and data on their safety and efficacy still accumulating, they are just not ready for prime time yet.

Deep Vein Thrombosis Prophylaxis, Safety and the Joint Commission on Accreditation of Hospitals

Over the last few years, great emphasis has been placed on preventing blood clots from forming in the legs and pelvis of all hospitalized patients. These blood clots can break off and travel to the lungs causing life-threatening breathing problems and fatal heart arrhythmias and sudden death. Preventing these “venous thromboembolic events” has been a priority of quality organizations like the Joint Commission on Accreditation of Hospitals which inspect hospitals and offer certification if the hospital meets their criteria.

The movement to prevent these clots and sudden death has become so strong that you cannot admit a patient to the hospital without addressing these issues. Physicians must either choose to give injections below the skin with the blood thinner heparin three times a day or the low molecular weight heparin twice a day. You are additionally asked to prescribe mechanical compression stockings to the legs to further reduce the risk.

If you choose not to institute these orders you must clearly write out and outline your objections and reasons for not taking these measures. Even if you document your reasons for not instituting these measures you’re assured of receiving a call from your hospital’s quality care organization.

This all becomes newsworthy because two recent studies called into question the practices. One study concluded that mechanical compression stockings added nothing to the use of blood thinners in preventing deep vein clots. The other study cited that for every 1000 patients treated with blood thinners to prevent pulmonary emboli; you prevented three non-fatal pulmonary emboli at the expense of causing nine bleeding events – four of which are major.  I suspect this data will be discussed in our medical journals and at scholarly meetings and a consensus opinion will be reached on how to proceed. Letters will be written to journals criticizing the methods of these studies and other letters will be written defending them and, ultimately, a common sense approach will be reached.

In the meantime, it would be far more interesting to look at the Joint Commission on Accreditation of Hospitals and determine how they got so powerful that they can mandate procedures which may not have any value and may do harm?  Who are they?  How do they generate income and how much goes to who and why?

It is a fact that in the state of Florida, private insurers like Blue Cross Blue Shield, Aetna, Humana, will not contract with a hospital or institution unless it receives certification from this organization.  A study should be done to see if these JCAHO inspections costing $7-8 million dollars every other year resulted in any reduction of in-hospital errors, iatrogenic illnesses, death rates and serious illness?

Insurers and employers who pick up the “lion’s share” of our health care costs are always asking for accountability and efficiency and want to pay for what works. It would be nice to know if their relationship with JCAHO has made the patient safer or healthier over the last 15 years.

Lancet Study Emphasizes Long Term Benefit and Safety of Statin Use

Richard Bulbulia, MD, of the Heart Protection Study Group reported in the Lancet that statin medications are safe and effective over long periods of time.  They looked at 20,536 patients at high risk for vascular events. They studied patients who were between 40 and 80 years old. These patients were randomized to one group receiving Simvastatin (Zocor) daily at the 40 mg dose or placebo for 5.3 years. They were then followed for another six years during which both groups received the statin.

Researchers found that during the initial 5.3 years of the study there was a 23% decrease in major vascular events and an 18% reduction in vascular mortality in the Simvastatin treated group.

They also looked at complications of therapy over the eleven year period and concluded, “Reassuringly, there was no evidence that any adverse effect on particular causes of non–vascular mortality or major morbidity, including site-specific cancer, was emerging during this prolonged follow-up period.”  In an editorial in the same edition, Payal Kohli, MD and Christopher Cannon, MD of the Brigham and Women’s Hospital in Boston said the results “provide contemporary and confirmatory evidence that extended use of statins is safe with respect to possible risk of cancer and non-vascular mortality.”

It is noted that the dosages used are higher than what the FDA currently recommends for Simvastatin due to the risk of muscle injury at higher doses. Despite that, the Lancet editorialists concluded that “concerns should be put to rest and doctors should feel reassured about the long-term safety of this life saving treatment for patients at increased cardiovascular risk.”

Low Dose Zolpidem (Ambien) for Middle of the Night Awakening

Staying asleep and getting back to sleep after awakening are major issues for seniors.   In the past, physicians were counseled not to use drugs like Zolpidem (Ambien) unless a user had a good 7- 8 hours after taking the drug to remain in bed and rest while the product is metabolized and leaves their body.  The drug is relatively long acting and has been associated with sleep walking, day time sleepiness, falling and motor vehicle accidents especially when the user takes them in the middle of the night and awakens early for activities. Seniors are particularly prone to night time awakening for toileting activities, aches and pains and other issues.

The FDA has just approved a low dose version of Zolpidem for those patients who awaken in the middle of the night and cannot get back to sleep.  It is manufactured under the brand name Intermezzo in doses of 1.75 mg for women and 3.5 mg for men. The difference in dosing is based on the difference in the speed at which men and women metabolize the drug.

I am advising my patients to please be patient and allow us to evaluate how this product performs in large numbers of human subjects. The original studies were performed on 375 patients. It will be interesting to see if this product will be appropriate for overnight airplane travelers on four and five hour plane flights as well.

Higher Death Risk with Dietary Supplements

The vitamin, mineral and herbal supplement industry in the United States has been so effective in marketing that currently 50% of adults regularly consume their products.  Traditional health care advocates have believed that a well balanced varied diet rich in fresh fruits and vegetables, appropriately prepared, will provide all the nutrients, Co-enzymes and anti-oxidants that you need.

A recent article in Medpage Today cited the long-term study of Jaakko Mursu, PhD, of the University of Eastern Finland which states that dietary supplements are linked to a higher death risk. The use of multivitamins and vitamin B6, folic acid, iron, magnesium, zinc and copper supplements was associated with a greater “all cause mortality” during the 19 years the study was in progress.

Mursu evaluated the use of vitamin and mineral supplements among 38,772 post-menopausal women participating in the Iowa Women’s Health Study. Initiated in 1986, the average age of the participants in the study was 61.6 years.

“Based on existing evidence, we see little justification for the general and widespread use of dietary supplements.” stated Mursu.  “Calcium supplementation, on the other hand, was associated with a lower risk of death.”

The Food and Drug Administration does not require manufacturers of these products to reveal their efficacy or safety.  At this point I will continue to recommend a balanced, healthy and well prepared diet to my patients with avoidance of supplements unless we can demonstrate safety and efficacy.