Owning Up

Owning Up

Allergic reactions to high pollen counts can lead to sinusitis (an overproduction of mucus that causes swelling and sinus headaches). But if you’re diagnosed with sinusitis this spring and your doctor prescribes the antibiotic Ketek, you should know two things: 1) There are effective alternatives, and 2) the FDA recently recognized that Ketek is too risky for use as a sinusitis treatment.

Respiratory relief

For many centuries the oil of eucalyptus has been used to relieve coughs and headaches associated with respiratory infections and allergies. In 2004, a team of German scientists designed a trial to test cineole – the active compound of eucalyptus oil – in the treatment of sinusitis.

More than 150 patients with acute sinusitis were divided into two groups. One group took 200 mg of cineole three times each day for seven days. The second group received a placebo.

The researchers used ultrasound techniques to examine sinus passages and assess the severity of specific symptoms at day four and again at the conclusion of the study. Writing in the journal Laryngoscope, researchers noted that differences between the two groups were clinically relevant at four days, and significant at seven days.

Results showed that more than 90 percent of the cineole subjects improved in over half of the symptoms, which included nasal obstruction, frontal headache, headache on bending, sensitivity of pressure points and secretion. In comparison, only 45 percent in the placebo group showed improvement in more than half of the symptoms.

Ultrasound results revealed that well over 90 percent in the cineole group had no swelling or fluid in the sinuses after seven days, while about half of the placebo group showed the same result.

Eucalyptus oil is known to cause side effects such as stomachache and digestive problems. In this study two subjects in the cineole group reported mild side effects: heartburn for one subject and a rash for another. Pregnant women and children are cautioned to not use eucalyptus oil.

Protective substitute

If cineole supplements don’t do the trick, allergy patients might try another natural product called SneezEze.

People with seasonal allergies often don’t have adequate mucus in their nasal passages to protect the passages from pollen and other airborne pollutants. SneezeEze contains an organic powdered plant extract that creates a gel when it comes into contact with moisture, generating a protective substitute for the missing mucus.

In a 2003 study, SneezEze effectively helped hay fever patients cope with their worst symptoms at the peak of the hay fever season. And in the e-Alert “What the Nose Knows” (7/28/04), I told you about a Greek study that tested 40 subjects who were diagnosed with perennial allergic rhinitis (which means their allergies can occur at any time, and may be triggered a variety of factors). More than 75 percent of the subjects reported either complete or major relief while using SneezEze, and an additional 15 percent reported noticeable relief of allergy symptoms.

You can read more about SneezEze at the product web site: sneezeze.com. Outside the U.S., SneezEze is sold under the name NasalEze, which can be found at nasaleze.com.

Going off the grid

Nowback to Ketek.

In 2004, the FDA approved the use of Ketek in the treatment of sinusitis, bronchitis and pneumonia. But trouble soon developed. According to a 2006 report in the New York Times, Ketek use had been linked to liver failure in 14 patients, and 23 others experienced serious liver injury. The Times also noted that Ketek might cause blurred vision and loss of consciousness.

Last month, an FDA advisory panel voted 17-2 to discontinue the official approval of Ketek use in treating sinusitis and bronchitis, but voted to keep the approval of Ketek use for community acquired pneumonia (that’s pneumonia that’s not picked up in a nursing home or hospital).

In other words, Ketek will still be available, and doctors will still be able to prescribe it “off-label” for sinusitis and bronchitis. Will doctors take heed of the new Ketek boxed warning and medication guide, as well as the FDA panel’s recommendation that the risks of the antibiotic outweigh the benefits for sinusitis and bronchitis patients?

Some will, some won’t. Patients, beware.

You can read more about the dangers of Ketek in the e-Alert “Wake Up, Joe!” available at this link: http://www.hsionline.com/ealerts/ea200607/ea20060727.html