NAPLES, Fla.-Doctors should consider extending the course of antibiotics in patients with chronic sinusitis before giving up on conservative medical therapy and going forward to surgery, according to research presented here at the meeting of the Southern Section of the Triological Society.
In a study of maximal medical therapy in his institution, Marc Dubin, MD, Assistant Professor of Rhinology and Sinus Surgery in the Department of Otolaryngology-Head and Neck Surgery at the Johns Hopkins University School of Medicine in Baltimore, Md., determined that adding three weeks to a standard antibiotic program produced added positive results in helping patients clear the stubborn infections.
‘Failure to Respond’ Timeline Uncertain
When a patient presents with chronic sinusitis, the doctor will usually place the individual on maximal medical therapy, he said. However, Dr. Dubin suggested that exactly how long that therapy should last before the patient moves on the next therapeutic step is controversial. Failure to respond, however, represents a major criterion for proposing surgery in these patients.
Dr. Dubin looked at patients undergoing maximal medical therapy to try to get clues as to how long treatment should continue before a doctor should determine that there is failure to respond.
He noted that he had little guidance as to where to begin his study. There are no controlled studies on the length of time a patient should remain on antibiotics, nor are there any studies on what the antibiotic choice should be in chronic sinusitis. In addition, there are no studies that indicate if a combination of antibiotics is required for maximal medical therapy, he said.
Controlled clinical trials will be required to answer a number of questions raised by this trial.
In his retrospective review of cases from the Georgia Nasal and Sinus Institute in Savannah, Dr. Dubin sought to objectively test whether three weeks of treatment with antibiotics was sufficient to clear chronic sinusitis or whether there was a benefit to continuing the antibiotic therapy for six weeks before determining if the patient had, indeed, failed to respond to maximal medical treatment.
There are no controlled studies on the length of time a patient should remain on antibiotics, nor are there any studies on what the antibiotic choice should be in chronic sinusitis. – -Marc Dubin, MD
The treatment progress would be tracked using computer-assisted tomography (CT) scans of the infected sinus cavity. The patients were scheduled to undergo a CT scan at baseline to confirm the disease state and then undergo follow-up scans after three weeks of treatment and after six weeks of treatment.
The patients were admitted for treatment of chronic sinusitis between September 1, 2004 and June 1, 2005. In order to be eligible for the medical protocol, patients had to be naïve to major sinusitis surgery in the past. Doctors also performed a CT examination to be certain that the patients had inflammatory disease at the initial visit.
If a culture indicated the particular bacteria that was causing the disease, the antibiotic most useful for combating that species was employed. Otherwise, the patients were treated with oral clindamycin 150 mg three times a day. If the patient was intolerant of clindamycin or suffered an allergic reactions to the drug, ampicillin/sulbactam was substituted.
The patients were not prescribed additional mucolytics, oral steroids, or topical steroids, but if the patients were already on these agents they were not taken off of them. The average patient had gone through 3.3 courses of antibiotic therapy before entering the study and had spent an average of 4.6 weeks on antibiotic therapy in attempts to cure their chronic sinusitis.
Of the 41 patients with confirmed chronic sinusitis, 19 completed all six weeks of therapy and received all three CT scans. CT’s were then retrospectively graded by the Lund-MacKay staging system. Nineteen of the original patients did not receive a scan at three weeks and three other patients did not complete the six weeks of antibiotics.
It was possible that the individuals who improved after three weeks of antibiotic treatment might have gotten better if their treatment after the first three weeks of antibiotics had instead simply been observation for three weeks.
Of the patients who had all three scans and completed all six weeks of antibiotics, 15 were on clindamycin, three were taking amoxicillin and clavulanic acid (Augmentin), and one was on doxycycline. In addition, one person was taking oral steroids to control asthma, two were on antihistamines, three were using intranasal steroids, and four patients were on leukotriene inhibitors.
Results Show Improvement
These patients began the trial with a Lund-McKay score of greater than five, with five representing normal function. The average score of the 19 patients who completed all aspects of the study was 9.90; this was the same average as all 41 patients at baseline, Dr. Dubin said.
After three weeks, the 19 patients who fulfilled the protocol had Lund-McKay scores that averaged 5.68; after six weeks those scores averaged 5.90. The differences from baseline were statistically significant, Dr. Dubin said.
The entire group of patients lowered their Lund-McKay scores from 9.90 at baseline to 6.76 at the end of the six weeks. That difference was also statistically significant, he said.
Dr. Dubin said that 7 of 19 patients normalized their sinus condition after three weeks of maximal medical treatment. However, another two patients were able to clear their infections with an addition three weeks of medical therapy.
Some May Benefit from Longer Course, but Questions Remain
There are patients who improve and radiographically clear disease with six instead of three weeks of antibiotics, Dr. Dubin said. Therefore, maximal medical therapy for chronic sinusitis may require six weeks of antibiotics to ensure maximal benefit.
He did note, however, that it was possible that the individuals who improved after three weeks of antibiotic treatment might have gotten better if their treatment after the first three weeks of antibiotics had instead simply been observation for three weeks. He suggested that doctors might have been witnessing a natural radiographic progression of chronic sinusitis.
The co-moderator of the session, Ramzi Younis, MD, Associate Professor of Otolaryngology and Pediatrics at the University of Miami School of Medicine (Fla.), said that a control group might have been useful in sorting out those issues. He also suggested that dosing patients with clindamycin 150 mg twice a day might be a more useful protocol.
Dr. Dubin acknowledged that controlled clinical trials will be required to answer a number of questions raised by his trial, including how long antibiotics should be delivered to patients with chronic sinusitis, optimal antibiotic choice for chronic sinusitis, and the role of adjunctive therapies, including the use of oral steroids in patients with chronic sinusitis.
©2006 The Triological Society