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Adding Budesonide to Nasal Sinus Irrigation Does Not Help In Chronic Sinusitis

Figured I'd post an article discussing a recent study that tested a new chronic sinusitis treatment, since so much of this site is devoted to sinusitis  - both the latest research and treatments. Eh... I wasn't impressed with the study. Once again research was aimed at treating symptoms, rather than the actual microbial imbalance (dysbiosis) in the sinuses. No wonder it didn't work so well. The researchers added the corticosteroid drug budesonide to daily nasal saline irrigation in one group vs the other group just did daily nasal saline irrigation - both for 30 days. There were no statistically significant differences - both groups basically improved the same. 

The researchers felt that the budesonide group "trended" toward more of an improvement, but statistically there wasn't a difference. The study was nicely done: it was double-blind (no one knew who got what), it had a placebo group (the saline irrigation only group), and people were randomly put into one or the other group. The budesonide (a corticosteroid) was meant as an alternative to, and to see if it was better than using a corticosteroid nasal spray -  which many people with chronic sinusitis try for a while.

For those interested, here is the Sino-Nasal Outcome Test (SNOT-22) that people took before and after the 30 days of nasal irrigation, and which is used in many sinusitis studies.  Note that some of the questions, in my mind, are bizarre as a measure of sinusitis symptoms and totally not appropriate, especially these 3 questions: Sad? Embarrassed? Frustrated/restless/irritable? And some of the questions are too vague. They list "post nasal drip" which is vague. Where is a question about "phlegm dripping down the throat", and even perhaps "gagging on phlegm" or "constantly clearing throat"? Where is "waking up with a daily sore throat"? How about "constant headaches", or "constantly feeling sick", or "need to sleep semi-sitting up"? These are descriptions people give me again and again. So eh... the test could use improvement.

Bottom line: People with chronic sinusitis have for years been doing nasal saline irrigation to help treat sinusitis symptoms. It helps the symptoms a little, but typically doesn't cure.  From Medscape:

Does Budesonide Improve Outcome of Nasal Irrigation in Chronic Rhinosinusitis?

 In patients with chronic rhinosinusitis (CRS), addition of budesonide to daily large-volume, low-pressure saline sinus irrigation might lead to improved outcome, but the findings are not clear-cut. 

"In this study, we found that patients in both the nasal-saline-alone and nasal-saline-with-budesonide groups improved, but patients in the budesonide group experienced a greater improvement," Dr. Jay F. Piccirillo of Washington University School of Medicine in St. Louis, Missouri, told Reuters Health by email.

In a paper online June 7 in JAMA Otolaryngology-Head & Neck Surgery, Dr. Piccirillo and colleagues report on a study in which they randomly assigned 74 patients to receive a sinus-rinse kit including saline and identical-appearing capsules that contained either budesonide or lactose placebo. The patients were told to dissolve two capsules of the study drug into the sinus-rinse bottle along with the saline, and to irrigate the left and right nasal cavity with one-half of the contents of the nasal rinse once daily for 30 days.

Outcome was measured via patients' response to the Sino-Nasal Outcome Test (SNOT-22). This validated questionnaire captures the physical, functional and emotional consequences of rhinosinusitis. Scoring ranges from 0 to 5 for each of 22 questions covering items such as sneezing, nasal obstruction and fatigue.

There were no adverse events in either group and the average change in SNOT-22 scores was 20.7 points for those in the budesonide group and 13.6 points for controls (mean difference, 7 points; 95% confidence interval, -2 to 16). When excluding one non-compliant patient in the budesonide group, the mean difference in the change in SNOT-22 scores rose to 8.5 (95% CI, -0.6 to 18.0).

A total of 23 participants (79%) in the budesonide group experienced a clinically meaningful reduction in their SNOT-22 scores compared with 19 (59%) in the control group - also not a significant difference. The mean reduction in endoscopic scoring was also in favor of the budesonide group (3.4 points) compared to controls (2.7 points), though again the difference fell short of significance.

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