For a therapy rooted in ancient ayurvedic medicine, it is perhaps not surprising that there have not been many startling developments regarding nasal irrigation for chronic rhinosinusitis. A slow but steady increase in popularity, a few seminal studies and a Cochrane review documenting its safety and efficacy were about all one could point to in the way of newsworthy trends.
Explore This IssueNovember 2012
That all changed in February, when the Centers for Disease Control and Prevention in Atlanta announced that two patients had died from primary amebic meningoencephalitis (PAM) that had likely been caused by sinus irrigation with contaminated tap water. The culprit? Naegleria fowleri, a rare and usually lethal thermophilic amoeba that had colonized both patients’ household plumbing, according to the CDC and other infectious disease specialists, noted in a full report on the cases published online in August (Clin Infect Dis. DOI:10.1093/cid/cis626).
As a result of these cases, both the CDC and the FDA warned that only distilled, boiled or properly filtered water should be used when preparing saline solutions for nasal washes.
That caution gained even more traction in October, when a study linked eight cases of treatment-resistant chronic rhinosinusitis to tap water contaminated with another potentially dangerous organism—Mycobacterium. As in the CDC report, the patients had been regular users of nasal irrigation; the bacteria was traced to household plumbing; and the researchers concluded that patients should avoid sinus rinses with tap water and use sterile water instead (Emerg Infect Dis. 2012;18(10):1612-1617; doi: 10.3201/eid1810.120164).
Jonathan S. Yoder, coordinator for the waterborne disease outbreak surveillance system at the CDC, helped put the risks posed by the N. fowleri infections, which have so far garnered the most attention, in perspective. “These are very rare and tragic infections,” he told ENT Today. “And although the risk to people using tap water for nasal irrigation is extremely low—remember, these are the first two cases of PAM associated with nasal irrigation ever reported in the United States—we still think it prudent to use water that is distilled, filtered or previously boiled.”
Yoder said he understands that following the recommendation will add an extra layer of logistics to the nasal irrigation process. But given the rapidly progressing nature of the rare N. fowleri infections—both patients died within a week of exhibiting symptoms and after repeated courses of treatment, including liposomal amphotericin B and rifampin—avoiding untreated tap water “is the prudent thing to do,” he said.
In fact, choosing appropriate water for preparing nasal irrigation solutions is the most effective means for preventing PAM because, according to the study, the salinity of nasal irrigation solutions does not begin to kill off N. fowleri for at least four to eight hours. And since the municipal water supply was found to be negative for the organism, all efforts to eradicate N. fowleri should be done at home at the source of the infection, said Yoder. (In the two cases reported, raising the heat of the water in the pipes killed off the N. Fowleri colonization.)
As if newspaper headlines announcing a “brain-eating disease” caused by N. fowleri are not enough of a scare, nasal irrigation may be suffering from another decidedly modern problem despite its antiquarian roots. For years, Yoder noted, the climate-sensitive ameba was thought to be isolated to southern-tier states, with infectious outbreaks usually tied to swimming in untreated water in small ponds and lakes. In the last two years, however, such cases of N. fowleri infections—some fatal—have been reported for the first time in Minnesota and Kansas, he and his colleagues reported.
Does that mean that it is more likely that N. fowleri could be found in premise plumbing in northern states, placing patients who use tap water for nasal irrigation at an increased risk? “There’s no direct evidence for that,” said Yoder. “But this bug’s geographical range is definitely showing signs of expansion, which points to the need for increased vigilance by physicians.”
Benefits in Children
Julie L. Wei, MD, an associate professor of otolaryngology-head and neck surgery at the University of Kansas School of Medicine in Kansas City, said she is aware of the CDC report on N. fowleri and nasal irrigation. “I haven’t had a single case where I thought untreated tap water was a problem, but of course one fatality is one too many in any physician’s practice,” she said.
“Many of my parents and patients have asked me about this, and so I tell them if you want to be 100 percent safe, go ahead and boil tap water for nasal irrigation and then let it cool (a hassle), or buy distilled water from the local pharmacy.” Dr. Wei said that to avoid burns, the tap water should be allowed to cool until it reaches room temperature or slightly warm temperature. “I’ve also found that irrigation is most comfortable using water at those temperatures,” she said. Given the rare nature of these infections, however, “I have not yet taken the step of having everyone take these precautions.”
Dr. Wei is much less ambivalent when it comes to the benefits of nasal irrigation for treating children with symptoms of chronic rhinosinusitis. She is the lead author of a 34-patient study (Laryngoscope. 2011;121:1989-2000) showing that once-daily nasal irrigation alone, without use of other medications, yielded a nearly three-point gain in a quality-of-life (QOL) survey adapted to sinus disease, as well as significant or complete reversal of mucosal thickening on CT scans.
Nasal irrigation also proved to be well tolerated: Only a few side effects were noted, such as ear pain and acute otitis media, none of which were deemed serious based on an accepted adverse event scale. “Perhaps surprising to physicians, more than 90 percent of the children (aged 4 and higher) were able to comply with the once-daily irrigation protocol during a six-week period,” said Dr. Wei. She attributed that outcome to the detailed training and education on proper nasal irrigation techniques that she and her staff provide to parents and their young children (see “Tips for Treating Chronic Rhinosinusitis with Nasal Irrigation”).
One other finding in Dr. Wei’s study underscored another trend she has been seeing in clinical practice—antibiotic overuse. In the study, 14 of 19 patients in the saline group and 17 of 21 in a gentamicin group—the topical antibiotic yielded no significant additive benefits—reported completing up to nine courses of systemic antibiotic therapy in a six-month period prior to enrollment. “This finding illustrates the chronicity of this disease and it being [resistant] to routine medical therapy, including antibiotics, antihistamines, OTC decongestants and even leukotriene-receptor antagonists,” Dr. Wei said.
At least half of the patients in her study, she noted, had been on some combination of those medications. “Yet nearly all of them were so refractory that many came for another opinion after a previous otolaryngologist had recommended sinus surgery, which we were able to avoid with regular use of nasal irrigation.”
“For me, that can only mean one thing,” Dr. Wei said. “What many of us have historically been doing for these patients simply isn’t working.”
On the rare occasions that Dr. Wei does perform sinus surgery in children—she does so only in patients who have failed at least a six-week course of once-daily saline irrigation and who have evidence of persistent disease clinically and on CT scan—she sees signs of why those medications aren’t working. Specifically, “I don’t see pus or any other signs of active infection,” she said. “Instead, I see inflammation and mucosal thickening, which leads to significantly reduced mucociliary activity, resulting in buildup of thickened secretions or “gunk” in the sinuses and all the symptoms that we traditionally associate—wrongly—with acute sinus infections.”
Thus it’s not surprising, she said, that antibiotics often don’t work in such patients. Nasal irrigation, in contrast, has been shown in studies to improve mucociliary clearance, thin mucus and potentially decrease inflammation (Clin Otolaryngol. 2000;25:558-560; Laryngoscope. 1997;107:500-503), which may partly account for the efficacy of nasal irrigation.
“I’m not saying chronic sinusitis isn’t a disease; you certainly won’t get better until we fix you,” Dr. Wei said. “But we should not try to fix this problem with antibiotics.” Instead, “sinus irrigation should be recommended as a first-line treatment for pediatric rhinosinusitis—certainly before even considering sinus surgery and even adenoidectomy.”
More Evidence of Efficacy
Other physicians who treat children and adults with chronic sinusitis share Dr. Wei’s concerns about the overuse of antibiotics for the disease—as well as her view that nasal irrigation is a superior therapy in selected patients.
David Rabago, MD, an assistant professor of medicine in the department of family medicine at the University of Wisconsin in Madison, has published several studies on the modality, one of which, published in 2002, was given an “A” rating in a Cochrane review that concluded that nasal irrigation can be an effective adjunctive therapy for chronic rhinosinusitis (J Fam Pract. 2002;51:1049-1055; Cochrane Database Syst Rev. 2007;(3):CD006394).
In Dr. Rabago’s study, 76 patients with a history of frequent sinusitis and chronic sinus symptoms were randomized to treatment with nasal irrigation daily for six months with a commercially produced nasal irrigation system; 24 patients were included as controls.
The primary finding of the study was a statistically significant improvement in QOL scores related to chronic rhinosinusitis symptoms, Dr. Rabago reported. Specifically, scores for patients in the sinus irrigation group averaged 6.0 and 15.5 points higher than controls at three and six months, respectively (p<0.05).
Among the secondary outcomes in the study, “we were particularly struck by the reduction in antibiotic use we documented in the nasal irrigation group,” Dr. Rabago told ENT Today. Antibiotics were used for 10±0.02 weeks in the experimental group, compared with 19±0.04 weeks in the control arm (p<0.05).
“Given the small numbers in our study, we really didn’t expect to see such tight effectiveness data on medication use,” he said. “So even though this was not a primary outcome, it’s nevertheless an important finding, given the prevalence of antibiotic overuse and the problems with resistance that can cause.”
Dr. Rabago added an important caveat for any physician who wants to start recommending nasal irrigation for the control of sinus symptoms. “It’s very effective—provided you give patients adequate education and training.”
That observation, he noted, is not based solely on clinical experience: Dr. Rabago authored a study of patient attitudes regarding nasal irrigation, which found that certain training methods were favored by patients learning how to use proper technique (Ann Fam Med. 2006;4:295-301). “Videos, personal instruction, handouts—these were the tools that seem to work best at promoting adherence,” he said.
Benjamin F. Asher, MD, an otolaryngologist with an integrative medicine practice in New York City, isn’t ready to crown nasal irrigation as the front-line therapy for all patients with chronic sinusitis. In fact, “I only use it in patients with an active infection and who have had sinus surgery, with cavities and crusting,” Dr. Asher said. In other cases, he explained, “I’ve found there are treatments which are just as effective as nasal irrigation but are much less annoying to the patient and are easier to comply with.”
He cited, as an example, an over-the-counter nasal spray that contains xylitol, a 5-carbon sugar with antibacterial properties. “This is a product that I know is clean and sterile, and you just spray it four or five times in each nostril. I’ve seen great results with it, and clinical studies show that it can enhance bacterial killing [Proc Natl Acad Sci USA. 2000;97(21):11614-11619].”
Why not use nasal irrigation, often deemed a relatively benign therapy, in a more widespread fashion? “I’m not so sure how benign it is,” Dr. Asher said. “I think there are people who convert from an acute upper respiratory infection to a chronic sinus condition as a result of nasal irrigation.”
That may occur, he noted, “because patients sometimes don’t follow the correct procedure when irrigating or because the saline solution irritates their nose, which causes more swelling of the nasal mucosa and which then causes the sinuses to back up. But whatever the cause, I have definitely seen this in my practice.”
Dr. Asher said he has another reservation about widespread use of nasal irrigation for chronic sinusitis. “It ignores the fact that this condition isn’t just related to the lining of the nose,” he said. “In most people, it’s more of a systemic problem associated with compromised immune function, which in turn can promote mucosal inflammation and congestion. So my interventions—many from the ranks of complementary/alternative medicine [CAM]—focus on improving their immune function and reducing nasal inflammation.” (see “CAM Therapy Effective for Chronic Sinusitis”).
What Not To Do
Clearly, there are many differing views on how best to manage patients with chronic sinusitis. For Dr. Wei, the best way to find agreement, perhaps, is to focus not so much on what to do for these patients, but on what not to do. “We can’t just keep throwing ‘Z-Paks’ at the problem,” she said. “There’s enough study data and clinical evidence showing that that approach is not working. It’s time for something different, and nasal irrigation is a wonderful place to start.”