Amoxicillin-clavulanate for patients with acute exacerbation of chronic rhinosinusitis: a prospective, double-blinded, placebo-controlled trial.
The management of acute exacerbation of chronic rhinosinusitis (AECRS) is still under debate, especially because there are no adequate studies to support a best-evidence treatment for this condition. Antibiotic use for AECRS has been recommended based on extrapolation of data from acute rhinosinusitis (ARS) or non-placebo-controlled studies. This study aimed to evaluate whether antibiotic therapy modifies the course of AECRS in a randomized, placebo-controlled study.



Patients with AECRS were randomized in a double-blinded manner (2:1 ratio) to receive either amoxicillin-clavulanate 875 mg/125 mg twice daily (BID) (AMX-CLAV, n = 21) or placebo capsules (n = 11) during 14 days. All patients were also treated with mometasone furoate and nasal washes with saline. Global sinonasal symptoms (Severity Symptom Assessment [SSA]), quality of life (22-item Sino-Nasal Outcome Test [SNOT-22]), nasal endoscopic score (Lund-Kennedy), and microbiological evaluation were compared to evaluate the efficacy of antibiotic therapy in AECRS.



Despite the majority of bacteria cultured from the middle meatus swab were sensitive for AMX-CLAV (84%), both AMX-CLAV and placebo-treated groups presented the same clinical course, with no difference between groups. Both groups exhibited overall improvement of symptoms on day 14 compared to day 0 (p < 0.01), especially the items "nasal secretion" and "nasal obstruction" (p < 0.05). We also observed the same evolution of nasal endoscopic and quality of life scores between placebo and AMX-CLAV.



We concluded that AMX-CLAV for 14 days did not change the clinical course of AECRS compared with placebo. The addition of an oral antibiotic to ongoing topical intranasal steroid spray may not provide additional benefit during management of AECRS.
Department of Ophthalmology, Otorhinolaryngology, and Head and Neck Surgery, Division of Otorhinolaryngology, Ribeirão Preto Medical School, University of São Paulo (USP), São Paulo, Brazil.
Henrique Augusto Cantareira
HA
Sabino
Department of Ophthalmology, Otorhinolaryngology, and Head and Neck Surgery, Division of Otorhinolaryngology, Ribeirão Preto Medical School, University of São Paulo (USP), São Paulo, Brazil.
Fabiana Cardoso Pereira
FC
Valera
Department of Pediatrics, Ribeirão Preto Medical School, University of Sao Paulo, São Paulo, Brazil.
Davi Casale
DC
Aragon
Department of Ophthalmology, Otorhinolaryngology, and Head and Neck Surgery, Division of Otorhinolaryngology, Ribeirão Preto Medical School, University of São Paulo (USP), São Paulo, Brazil.
Marina Zilio
MZ
Fantucci
Department of Ophthalmology, Otorhinolaryngology, and Head and Neck Surgery, Division of Otorhinolaryngology, Ribeirão Preto Medical School, University of São Paulo (USP), São Paulo, Brazil.
Carolina Carneiro
CC
Titoneli
Department of Internal Medicine, Ribeirão Preto Medical School, University of São Paulo (USP), São Paulo, Brazil.
Roberto
R
Martinez
Department of Ophthalmology, Otorhinolaryngology, and Head and Neck Surgery, Division of Otorhinolaryngology, Ribeirão Preto Medical School, University of São Paulo (USP), São Paulo, Brazil.
Wilma T
WT
Anselmo-Lima
Department of Ophthalmology, Otorhinolaryngology, and Head and Neck Surgery, Division of Otorhinolaryngology, Ribeirão Preto Medical School, University of São Paulo (USP), São Paulo, Brazil.
Edwin
E
Tamashiro
D000208:Acute Disease; D000328:Adult; D000368:Aged; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000494:pharmacology / Q000627:therapeutic use*; D001419:Bacteria / Q000187:drug effects / Q000302:isolation & purification; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009296:Nasal Cavity / Q000382:microbiology; D011788:Quality of Life; D012220:Rhinitis / Q000188:drug therapy* / Q000382:microbiology; D012852:Sinusitis / Q000188:drug therapy* / Q000382:microbiology; D055815:Young Adult; D065093:beta-Lactamase Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*
D065093:beta-Lactamase Inhibitors; D019980:Amoxicillin-Potassium Clavulanate Combination
SNOT-22; bacteriology; chronic rhinosinusitis; disease severity; medical therapy of chronic rhinosinusitis