A randomized study of temperature-controlled versus bipolar radiofrequency for inferior turbinate reduction.

UNLABELLED: The objective of this study is to compare outcomes of temperature-controlled radiofrequency (TCRF) and bipolar radiofrequency (BRF) for inferior turbinate reduction in patients with chronic rhinitis (CR). This was a prospective, randomized non-inferiority trial. Eighty-four adult patients with CR refractory to medication were randomized into two intervention groups: TCRF(42) or BRF(42). Primary outcomes consisted of patient-orientated visual analog scale (VAS; 0-10) of nasal obstruction at 4th postoperative week. Secondary subjective outcomes included VAS of nasal discharge, sneezing, hyposmia, and postnasal drip. Objective outcomes included crusting, mucociliary transportation time, minimal cross-sectional area, total nasal volume, and nasal airway resistance performed by blind assessors before and at 4th postoperative week and 1-year follow-up. Baseline and perioperative data showed no statistically significant difference between both groups, except for longer operative time in TCRF (481.5 ± 36.2 vs. 37.1 ± 3.0 s, p < 0.001) and slightly more crusts in BRF group (p = 0.04). Both intention-to-treat and per-protocol analyses, TCRF(39) versus BRF(41), revealed no significant difference among subjective and objective outcomes between two groups at 4th postoperative week. The 95% confidence intervals of mean differences of VAS scores of all subjective symptoms were within defined margin (-1.5 to 1.5), except for nasal discharge. At 1-year follow-up, there was still no significant difference in the outcomes. Minimal pain and minor bleeding without serious adverse effects from both interventions were reported. Both BRF and TCRF resulted in similar short-term outcomes, while less operative time was found in BRF group. Further studies, particularly, on cost-effectiveness should be conducted for better treatment selection. LEVEL OF EVIDENCE: 1b.

Acoustic rhinometry of Asian noses.

BACKGROUND: Each ethnic group has different nasal cavity geometries. The reference value of the minimal cross-sectional area (MCA) and the nasal volume (NV) is mandatory for rhinologic evaluation in regular practice and for research. This study was designed to study the normal value of acoustic rhinometry (AR) in Asian subjects in comparison with other ethnic groups. METHODS: AR was performed in 135 healthy Thai subjects. Subjects were divided into two groups: group I, with normal anterior rhinoscopic appearance; group II included subjects with asymptomatic, slightly deviated nasal septa. RESULTS: The mean of the MCA was 0.61 +/- 0.60 cm2 before decongestion and 0.64 +/- 0.14 cm2 after decongestion. The mean distance from the nostril to the point of MCA (D) was 1.66 +/- 0.59 cm before decongestion and 1.41 +/- 0.74 cm after decongestion. The mean of the NV measured between 0 and 4 cm was 3.66 +/- 0.67 cm3 before decongestion and 4.18 +/- 0.75 cm3 after decongestion. Before decongestion, there were no significant differences in the mean of the MCA, D, and NV between group I and group II subjects; however, there were significant differences in mean MCA and NV after decongestion. There were no differences in the parameters between male and female subjects before decongestion, except for the D, but after decongestion the mean values of the MCA, D, and NV were significantly higher in male subjects compared with female subjects. CONCLUSION: The results of this study can be used as a reference value for Asian ethnicities. Thai subjects had measurements comparable with those of the European study and somewhat different from the study in black populations.

An open label, randomized comparative study of levofloxacin and amoxicillin/clavulanic acid in the treatment of purulent sinusitis in adult Thai patients.

The objective of the study was to compare the clinical efficacy and bacteriological response of levofloxacin and amoxicillin/clavulanic acid (co-amoxiclav) in the treatment of purulent maxillary sinusitis. Sixty patients randomly received either levofloxacin 300 mg orally once daily (LEV group) or co-amoxiclav 625 mg three times a day (COA group) for 14 days. Thirty four patients were in the LEV group and 26 patients were in the COA group. The mean total symptom score was significantly decreased after treatment and was comparable between both groups. Radiological improvement was 61.8% in the LEV group (41.2% resolution, 20.6% improvement) and 61.5% in the COA group (26.9% resolution, 34.6% improvement). Pretreatment maxillary antral aspiration cultures were positive in 28 patients (82.4%) in the LEV group and 20 patients (76.9%) in the COA group. Bacteriological eradication was 78.5% in the LEV group and 70.0% in the COA group, which was not significantly different. In the LEV group, the eradication rate for major pathogens of acute sinusitis was 100% for H. influenzae (both betalactamase +ve and -ve), 100% for S. pneumoniae and S. aureus, 100% for Neisseria species, and 66.7% for P. aeruginosa. The eradication rate in the COA group was 75% for H. influenzae (both betalactamase +ve and -ve), 100% for S. pnumoniae and S. aureus, 50% for Neisseria species, and 0% for P. aeruginosa. There were no significant changes in vital sign measurements or hemato-biochemical parameters at the end of treatment as compared to baseline values, in both groups. Adverse events were found in 8.8% of patient in the LEV group and in 7.7% of patients in the COA group. Adverse events included nausea, abdominal pain, and diarrhea. All the adverse events in both groups were mild and resolved spontaneously. This study demonstrated that levofloxacin 300 mg orally once daily was as effective and safe as amoxicillin/clavulanic acid 625 mg three times a day in the treatment of maxillary sinusitis, either acute or acute exacerbation. Both drugs showed bacteriological efficacy that was not significantly different. The once daily dosage regimen is more applicable, convenience and has better compliance.

An open-label, prospective study of an oral polyvalent bacterial lysate (Luivac) in the treatment of recurrent respiratory tract infections in Thai patients.

An open-label, non-comparative study was performed in the Department of Otolaryngology, Siriraj Hospital, Bangkok, Thailand, to assess the safety, tolerability, acceptability and efficacy of an oral polyvalent bacterial lysate (Luivac) in the treatment of recurrent respiratory tract infections (RTIs) in Thai patients. Thirty-three patients were included in this study, 18 males and 15 females, with a mean age of 34.0 +/- 14.7 years. The mean number of RTIs during the 12-month period preceding the study was 9.5 per patient. During the study each patient received one tablet of Luivac daily for 28 days followed by a treatment-free period of 28 days. This was followed with another 28 days on Luivac, after which there was a 28-day treatment-free follow-up period. This study lasted 4 months with five scheduled patient visits (V1-V5). Laboratory studies were done at baseline (V1) and after treatment (V4), which included complete blood count and serum immunoglobulins (IgA, IgE, IgG and IgM). The incidence of all adverse events was 15.2% and no case was related to the studied drug. There were no clinical relevant changes in laboratory parameters after treatment. The reduction rate of RTIs per month at the end of the study period was 63.5% when compared to the average RTIs rate per month during the 12 months preceding the study. A comparison of the first study period (V1-V3) and the second study period (V3-V5) showed a reduction in duration of RTIs (23.1%), in the clinical infection score (17.5%), in the number of antibiotics used (2.1%), in the number of symptomatic treatments (3.5%), and in the number of days absent from school or work (50.0%). Overall tolerability and acceptability were assessed as very good and good in 96.8% of the patients. This study suggests that oral polyvalent bacterial lysate (Luivac) was safe and also showed a tendency to be effective in preventing RTIs in Thai patients with or without risk factors for recurrent RTIs. Other clinical advantages were reduction in the severity and duration of infection as well as in reduction of the cost of treatment and the number of days absent from school or work.