Medical Reversal, Treatments that go from Boom to Bust

While writing an article on the various components of over-the-counter (OTC) cold medications, I learned that zinc, the active ingredient in a popular nasal spray marketed to shorten the duration of the common cold, had been removed from the product. This was requested by the Federal Drug Administration (FDA) because of numerous reports of loss of the ability to smell (anosmia) related to the zinc in this product. I found this interesting because not too long ago, zinc (given as an oral supplement), was considered to be an effective treatment for anosmia.

Those of us who have practiced medicine for longer than we care to mention have seen a fair number of treatments, which at one time were considered to be effective, end up either not working or in some cases, causing harm. The term “medical reversal” was coined to describe the process where evidence from newly conducted research contradicts existing practice standards. An analysis titled, “A Decade of Reversal: An Analysis of 146 Contradicted Medical Practices” published in the Mayo Clinic Proceedings reported on a number of these medical reversals.  Their study looked back at 10 years (2001-2010) of medical research that included 1344 studies involving various medical practices.  In their analysis, they found 146 examples of medical reversal, where a newer practice was found to be no better than an older practice.

Here are just a few examples of medical reversals, some of which you may have heard about already:

Coronary artery angioplasty - In the U.S., more than half a million Americans undergo a heart procedure known as angioplasty. During this procedure, a balloon is inflated at the site of a narrowed coronary artery in order to widen the vessel and restore blood flow.  Balloon dilation is usually accompanied by the placement of a stent, a small metal mesh tube used to prop the artery open. For someone who is experiencing a serious heart attack, this procedure can be life-saving.  It appears, however, that this procedure may be overused in many patients who have what is known as “stable” coronary artery disease. These people do have narrowing of a coronary artery, but they typically do not experience symptoms such as chest pain (angina) except during physical exertion. A major clinical trial known as COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) showed that in people with stable coronary artery disease, artery-opening angioplasty was no better than medications and lifestyle changes at preventing future heart attacks or strokes, nor did it extend life.

Taking vitamin E - As an antioxidant, it was thought that vitamin E could play an important role in preventing a number of diseases including certain types of cancer, Alzheimer’s, and heart disease. Recent research, however, has found no evidence that vitamin E is effective in preventing any of these illnesses and in fact, taking vitamin E at certain dosages could even be harmful.  One study found that taking vitamin E increased the risk of a having a type of stroke related to bleeding (hemorrhagic stroke) by 22 percent. Other researchers have reported that the use of high-dose vitamin E supplements, in excess of 400 IU (international units), is associated with a higher overall risk of dying.  Vitamin E supplements in this dosage continue to be one of the most popular available, in spite of the Recommended Dietary Allowances (RDAs) for Vitamin E for adults being 22.4 IU.

Vertebroplasty for spinal fractures - An estimated 750,000 vertebral compression fractures, primarily due to bone thinning (osteoporosis), occur each year in the United States.  A treatment for this that is still being used is called vertebroplasty.  In this procedure, bone cement is injected into the area of the fracture in order to help stabilize and support the fractured vertebra. Recent studies, however, have shown that the clinical outcome is virtually the same in patients with this type of fracture whether they have vertebroplasty or not. In 2010, the American Academy of Orthopaedic Surgeons issued a clinic practice guideline recommending against the use of vertebroplasty for patients with a vertebral compression fracture due to osteoporosis as long as there was no evidence of the unusual complication of nerves being compressed.

Tight control of Type 2 Diabetes - Conventional treatment of Type 2 diabetes has aimed for “tight” control of blood sugars, with levels approximating those of someone without diabetes.  This treatment includes measures such as weight loss, regular exercise, and a variety of glucose-lowering medications. Tight control, however, usually requires intensive treatment measures that can be difficult for patients to follow and runs the risk of causing severe low blood sugar (hypoglycemia).  Recently, the need for tight control of blood sugars in Type 2 diabetes has been brought into question. In an analysis of 13 separate studies, intensive control of blood sugars was not found to extend life expectancy. Moreover, intensive control of blood sugars appeared to double the risk of developing hypoglycemia.  A second study looking at intensive treatment in a group of Type 2 diabetics with existing heart disease found that tight control increased their risk of dying prematurely without significantly reducing heart attacks or strokes. While these studies may not yet warrant a “reversal” in standard treatment, they certainly bring into question whether tight control is appropriate for everyone with Type 2 diabetes.

It is entirely appropriate for medical science to question existing practices.  Medical replacement---when a new practice surpasses the standard of care---is a desirable outcome of ongoing research.  Medical reversal, on the other hand, is something that medical science tries its best to avoid. In some cases, reversals could be minimized by more careful attention to the design and analysis of studies as well as making sure that treatments are not rushed into use. Failure to do this not only runs the risk of harm to patients, it undermines faith in the medical system for patients as well as for physicians.

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Sound Levels and Hearing Loss

The World Health Organization (WHO) recently released a report on the effect of unsafe listening practices on hearing. They estimate that up to one billion young people worldwide could be at risk of hearing loss due to exposure to excessive sound levels.  According to WHO, teenagers and young adults in middle- and high-income countries are at particular risk due to: 

• Nearly half being exposed to unsafe levels of sound from the use of personal audio devices.
  
• Around 40% being exposed to potentially damaging sound levels at clubs, discotheques and bars.

An estimated 5.2 million children and adolescents aged 6–19 years have suffered permanent damage to their hearing from unsafe levels of sound.  The fact that people are losing their hearing at much younger ages than they did just 30 years ago, along with the surge in sales of personal listening devices, suggests that loud music may be playing a role.
 
How does loud music affect the ears? Exposure to loud music, whether live or recorded, can damage sensitive structures in the inner ear, resulting in noise-induced hearing loss (NIHL).  Once damaged, the sensitive structures, called hair cells, cannot repair themselves. NIHL is related both to the decibel level of a sound and how long someone is exposed to it.  Additionally, the risk of developing NIHL from exposure to loud sounds is cumulative, adding up over a lifetime of exposure.

At what sound level can damage to the ears occur? Sound level (or more correctly sound pressure) is measured in decibels (dB).  The lower limit of hearing is defined as 0 dB and a normal conservational level is around 60 dB.  Sound reaching 85 dB or stronger, particularly if the exposure is prolonged, can result in permanent hearing damage. Many personal listening devices generate sound levels as high as 105 dB at maximum level, more than enough to cause permanent hearing loss.

 What about the effects of prolonged listening?  As mentioned, it’s not just the sound level that is a concern regarding potential hearing damage. The length of exposure is also a critical issue. Hearing damage can occur with as little of 15 minutes of exposure to music at 100 decibels. With newer digital music players being capable of storing several hours of music, prolonged listening times increase listener’s risk of cumulative damage to their ears.

What can be done to minimize the risk of hearing loss?  Fortunately, NIHL related to listening to loud music, whether live or recorded, is almost completely preventable. Here are some tips for minimizing the risk of developing NIHL from loud music:

1. Follow the 60 percent/60 minute rule.  Researchers have determined that listening to music, a movie, or a video game a portable music player at 60 percent of its potential volume for one hour a day is relatively safe. This 60 percent for 60 minutes rule is a good guideline for everyone to follow.
    
2. If noise levels reach the point that you have to raise your voice to be heard more than an arms length away, remove yourself from the situation or wear earplugs.
    
3. In situations in which live music is consistently louder than 85 dB, consider the use of sound attenuating ear plugs. If inserted properly, earplugs can reduce the exposure by 5 to 45 dB, depending on the type of earplugs. The ones used by professional musicians can be quite expensive, however, “consumer” models are available for as little as $12 (e.g.  ETY•Plugs® High Fidelity Earplugs).
    
4. Certain newer listening devices (e.g. iPod Shuffle) allow the listener to limit the maximum volume of the device.
    
5. Consider using noise-canceling earphone or ear buds.  These allow the listener to reduce the volume of the music by blocking the majority of external sounds.
    
6. Take listening breaks.  When going to nightclubs, sporting events or other noisy places, move to a quieter spot intermittently to help reduce the overall duration of noise exposure.

You know that you have abused your ears if you have ringing in the ears, a feeling of fullness in the ears, or if speech sounds muffled.  Avoid loud noises long enough to allow your hearing to return to normal. After that, avoid repeating the exposure to excessive loud sound.  If features suggestive of damage to the ears persist, have your hearing checked by a medical professional.
 
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Navigating through the Cold Medication Jungle

A trip to the pharmacy or grocery store to pick up an over-the-counter medicine to help with cold symptoms can be a confusing affair.  A host of manufacturers, each vying for your business, claim to be better than the others.  The use of different letters behind the name of the  same medication---AC, DM, LR, XP, NX, PD, and so on---just confuse things even further.

In reality, most cold medicines are made from just a few types of drugs.  These drugs fall into just a few categories, designated by the symptoms that they treat.  By learning these categories and a few names of the drugs in these categories can help direct you toward the most appropriate medications for your cold symptoms.
 
Oral Decongestants are some of the most commonly used medications for cold symptoms. They help to open congested nasal passages and improve air flow through the nose. Decongestants work by shrinking blood vessels in the nasal region which reduces the leakage of fluid into the tissues. Two of the most common decongestants are pseudoephedrine (e.g. Sudafed) and phenylephrine (e.g. Sudafed PE).  Cold medications containing phenylephrine are available over-the-counter. Pseudoephedrine-containing cold medicines can be obtained without a prescription but have to be signed for at the Pharmacist’s counter.

Intranasal decongestants work in a similar manner as oral decongestants but are delivered to the nasal tissue via drops or sprays.  Examples include oxymetazolin (Afrin, Nasin, and others) and phenylephrine (Neo-Synephrine). In general, one or the other type of decongestant (oral or intranasal) should be used at a time.  A major concern with the nasal decongestants is using them for too long a period of time which can result in “rebound” congestion.

Antihistamines help primarily with allergy-related symptoms. In general, they are not as helpful as decongestants for stuffy nose associated with a cold. Histamine is a chemical released by the immune system when the body is challenged by infection or allergens.  Histamine causes small blood vessels to expand resulting in typical allergy symptoms such as runny nose, watery eyes, and itching.   Antihistamines work by blocking histamine receptors on the cells to prevent histamine from being released.  There are a number of antihistamines on the market, including diphenhydramine (e.g. Benadryl), brompheniramine (e.g. Dimetapp), and loratadine (e.g. Claritin).

Expectorants, also known as mucolytics, are medications that thin mucus in the bronchial passages making it easier to cough up phlegm from the lungs.  The most common  active ingredient in expectorants is guaifenesin which is contained in the brand name medications, Mucinex and Robitussin Chest Congestion.

Cough Suppressants (antitussives) work in an entirely different manner than expectorants. Instead of helping to remove phlegm from the lungs, suppressants, such as dextromethorphan or codeine, actually block the cough reflex.  The most appropriate use of cough suppressants is for a severe cough that is keeping someone up at night or interfering with activities. Otherwise, the removal of phlegm from the lungs should be encouraged.  If a cold medication’s name if followed by the letters, DM, CF, or AC, it most likely contains a cough suppressant. In some cases, cough suppressants and expectorants will appear in the same medication. This combination seems to be more of a marketing gimmick than a useful treatment.
 
Pain medications including NSAIDs and acetaminophen appear in many combination cold medications.  NSAIDs (non-steroidal anti-inflammatory medications) include ibuprofen (e.g. Advil) and naproxyn (e.g. Aleve). Acetaminophen is the active ingredients in Tylenol. While both can be effective for pain and fever associated with colds, it is important to note whether the cold medications that you are taking contains one of these medications so that you avoid taking the same medication from multiple sources.

Multisystem Cold Medications typically contain some combination of pain medication, decongestant, antihistamine, and/or cough suppressant. Examples of these include Delsym Multi-Symptom, Tylenol Cold Multi-Symptom, Theraflu Multi-Symptom, and others.  The active ingredients in these products vary depending on the symptoms they are designed to treat; however, most of them contain a decongestant. As mentioned previously, with so many different medicines containing acetaminophen, care must be taken to avoid overdosing.  Multisystem cold medications can simplify treatment of a cold, but in many cases it is better to direct treatment toward specific symptoms, for example gargling with salt water for sore throat or using a nasal decongestant for stuffy nose.