title: Efficacy of combined treatment with S-carboxymethylcysteine (carbocisteine) and clarithromycin in chronic rhinosinusitis patients without nasal polyp or with small nasal polyp.
abstract: OBJECTIVE
  In Japan, fourteen-membered ring macrolides, antibacterial agents, and S-carboxymethylcysteine (SCMC; carbocisteine), a mucolytic, are commonly used to treat chronic rhinosinusitis (CRS), and they are also used in combination. However, no large-scale randomized study has examined the effects of these pharmacotherapies. The aim of this study is to evaluate the effect of combined administration of clarithromycin (CAM), a fourteen-membered ring macrolide, and SCMC, compared with CAM single therapy.
  
  
  METHODS
  Patients with CRS were centrally registered and randomly assigned to treatment with CAM (200mg/day) alone (monotherapy group) or CAM (200mg/day) in combination with SCMC (1500mg/day; combination group) for 12 weeks. We assessed the clinical efficacy of the treatments using measures of subjective symptoms and objective findings, health-related quality of life (HRQOL) determined by the 20-Item Sino-Nasal Outcome Test (SNOT-20) score and computed tomography (CT) score.
  
  
  RESULTS
  Four hundred twenty-five subjects were enrolled (combination group, 213; monotherapy group, 212). At week 12 of treatment, the rate of effectiveness was significantly higher in the combination group (64.2%) compared with the monotherapy group (45.6%; P=0.001). In addition, objective findings, including characteristics of nasal discharge (P=0.008) and post-nasal discharge (P=0.002) were significantly improved in the combination group. In both groups, SNOT-20 and CT scores were significantly improved from week 0 (P<0.001), and were not significantly different between groups.
  
  
  CONCLUSIONS
  The results indicated that long-term combination therapy with SCMC at a dose of 1500mg/day and CAM at a dose of 200mg/day is effective for improving subjective symptoms and objective findings in adult patients with CRS.
authors.affiliation: Ise Municipal General Hospital, 3038 Kusube-cho, Ise, Mie 516-0014, Japan. majima@hospital.ise.mie.jp
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Majima
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Kurono
authors.forename: Katsuhiro
authors.initials: K
authors.lastname: Hirakawa
authors.forename: Keiichi
authors.initials: K
authors.lastname: Ichimura
authors.forename: Shinichi
authors.initials: S
authors.lastname: Haruna
authors.forename: Harumi
authors.initials: H
authors.lastname: Suzaki
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Kawauchi
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Takeuchi
authors.forename: Kensei
authors.initials: K
authors.lastname: Naito
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Kase
authors.forename: Tamotsu
authors.initials: T
authors.lastname: Harada
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Moriyama
mesh_terms: D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002233:Carbocysteine / Q000627:therapeutic use*; D002908:Chronic Disease; D017291:Clarithromycin / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009298:Nasal Polyps; D011446:Prospective Studies; D011788:Quality of Life; D012220:Rhinitis / Q000188:drug therapy*; D012852:Sinusitis / Q000188:drug therapy*; D014057:Tomography, X-Ray Computed
chemical_list: D000900:Anti-Bacterial Agents; D002233:Carbocysteine; D017291:Clarithromycin