Efficacy of nasal irrigation with 200 μg/mL amphotericin B after functional endoscopic sinus surgery: a randomized,placebo‐controlled,double‐blind study

Background

Previous studies have shown controversial results of topical amphotericin B (AMB) nasal irrigation for chronic rhinosinusitis (CRS). The purpose of this study was to evaluate the efficacy of 200 μg/mL AMB nasal irrigation as an adjuvant therapy after functional endoscopic sinus surgery (FESS).

Methods

Patients with CRS who had received FESS for treatment were recruited and assigned to 1 of 2 groups at random at 1 month postsurgery. In the AMB group patients received nasal irrigation with 200 μg/mL of AMB for 2 months on a daily basis. In the control group normal saline irrigation was given instead. Before FESS and before and after nasal irrigation, patients’ sinonasal symptoms were assessed through a questionnaire that was a Taiwanese version of the 22‐item Sino‐Nasal Outcome Test (TWSNOT‐22). In addition, patients received endoscopic examination, acoustic rhinometry, smell test, saccharine transit test, and bacterial cultures obtained from their middle meati.

Results

A total of 73 patients completed the study between December 2014 and January 2017. Among them, 37 received nasal irrigation with AMB solution, and 36 with saline. In the AMB group, scores of TWSNOT‐22 dropped significantly after irrigation compared with before (p = 0.005). In the control group, TWSNOT‐22 scores did not changed after irrigation (p = 0.451). However, there were no significant differences in TWSNOT‐22, endoscopic score, smell test, saccharine transit test, and bacterial culture rate after irrigation between 2 groups.

Conclusion

Our study showed that in post‐FESS care, nasal irrigation with 200 μg/mL of AMB did not provide additional benefit compared with saline irrigation.     

Efficacy of hyperbaric oxygen therapy in patients with radiation‐induced rectal ulcers: Report of five cases

For decades, hyperbaric oxygen therapy has been considered a treatment option in patients with chronic radiation‐induced proctitis after pelvic radiation therapy. Refractory cases of chronic radiation‐induced proctitis include ulceration, stenosis, and intestinal fistulas with perforation. Appropriate treatment needs to be given. In the present study, we assessed the efficacy of hyperbaric oxygen therapy in five patients with radiation‐induced rectal ulcers. Significant improvement and complete ulcer resolution were observed in all treated patients; no side‐effects were reported. Hyperbaric oxygen therapy has a low toxicity profile and appears to be highly effective in patients with radiation‐induced rectal ulcers. However, hyperbaric oxygen therapy alone failed to improve telangiectasia and easy bleeding in four of the five patients; these patients were further treated with argon plasma coagulation (APC). Although hyperbaric oxygen therapy may be effective in healing patients with ulcers, it seems inadequate in cases with easy bleeding. Altogether, these data suggest that combination therapy with hyperbaric oxygen therapy and APC may be an effective and safe treatment strategy in patients with radiation‐induced rectal ulcers.     

A phase 3 trial of mometasone furoate sinus implants for chronic sinusitis with recurrent nasal polyps

Background

Topical intranasal corticosteroid sprays (INCSs) are standard treatment for nasal polyps (NPs), but their efficacy is reduced by poor patient compliance and impaired access of drug to the sinus mucosa. A corticosteroid‐eluting sinus implant was designed to address these limitations in patients with recurrent polyposis after sinus surgery by delivering 1350 μg of mometasone furoate (MF) directly to the ethmoid sinus mucosa over approximately 90 days.

Methods

A randomized, sham‐controlled, double‐blind trial was undertaken in 300 adults with refractory chronic rhinosinusitis with NPs (CRSwNP), who were candidates for repeat surgery. Eligible patients were randomized (2:1) and underwent in‐office bilateral placement of 2 implants or a sham procedure. All patients used the MF INCS 200 μg once daily. Co‐primary efficacy endpoints were the change from baseline in nasal obstruction/congestion score and bilateral polyp grade, as determined by an independent panel based on centralized, blinded videoendoscopy review.

Results

Patients treated with implants experienced significant reductions in both nasal obstruction/congestion score (p = 0.0074) and bilateral polyp grade (p = 0.0073) compared to controls. At day 90, implants were also associated with significant reductions in 4 of 5 prespecified secondary endpoints compared to control: proportion of patients still indicated for repeat sinus surgery (p = 0.0004), percent ethmoid sinus obstruction (p = 0.0007), nasal obstruction/congestion (p = 0.0248), and decreased sense of smell (p = 0.0470), but not facial pain/pressure (p = 0.9130). One patient experienced an implant‐related serious adverse event (epistaxis).

Conclusion

Significant improvements over a range of subjective and objective endpoints, including a reduction in the need for sinus surgery by 61%, suggest that MF sinus implants may play an important role in management of recurrent NP.