Clinical effect of catgut implantation at acupoints for allergic rhinitis: study protocol for a randomized controlled trial.

BACKGROUND: Catgut implantation at acupoints has been used in China to treat allergic rhinitis (AR) for a long time. However, its efficacy and safety in the treatment of AR is controversial due to the poor quality of the clinical trial of this therapy. This study aims to identify whether catgut implantation at acupoints is indeed an effective and safe treatment for patients with persistent or intermittent allergic rhinitis (PER or IAR) by comparing with sham catgut implantation treatment. METHODS AND DESIGN: This study compares real versus sham catgut implantation at acupoints in 242 patients with a history of PER or IAR and with a positive skin prick test (SPT). The trial will be conducted in the Teaching Hospital of Chengdu University of Traditional Chinese Medicine. In the study, patients will be randomly assigned by computer-generated randomization list into two groups and assessed prior to treatment. Then, they will receive two sessions of treatments (once per 2 weeks) for 4 consecutive weeks and have a follow-up phase of 12 weeks. The administration of catgut implantation (or sham-control) at acupoints follows the guidelines for clinical research on acupuncture (WHO Regional Publication, Western Pacific Series No.15, 1995), and is performed double-blindly by a well-trained physician in acupuncture. The main outcome measures include the primary and secondary indicators. Primary indicators are subjective symptoms scores evaluated by visual analogue scales (VAS) and Rhinoconjunctivitis Quality of Life Questionnaires (RQLQ). The secondary indicators are the results of laboratory examinations, such as serum allergen-specific IgE, nasal inflammatory cells counts (mast cells, eosinophils, and T cells) and nitric oxide concentration in nasal excretion. The use of anti-allergic medication will also be recorded as one of the secondary indicators. Furthermore, adverse events will be recorded and analyzed. If any participants withdraw from the trial, intention-to-treat analysis (ITT) and per-protocol (PP) analysis will be performed. DISCUSSION: The important features of this trial include the randomization procedures, large sample, and a standardized protocol of catgut implantation at acupoints. This trial will be the first study with a high evidence level in China in order to assess the efficacy and safety of catgut implantation at acupoints in treatment of AR following a randomized, double-blind sham-controlled method. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR-TRC-12002191.

Measurements of nasal fractional exhaled nitric oxide with a hand-held device in patients with allergic rhinitis: relation to cedar pollen dispersion and laser surgery.

BACKGROUND: There has been an increasing interest in monitoring the fractional concentrations of exhaled NO (FeNO) levels in allergic rhinitis (AR) patients. In the present study, we examined whether the nasal FeNO measurement might reflect the degree of local allergic inflammation as well as subjective symptoms. METHODS: The FeNO measurement was performed using a handheld electrochemical analyzer (NObreath®) with a nose adaptor. In the cross-sectional study, 56 patients with perennial AR patients, 18 AR patients with bronchial asthma (BA), 12 patients with vasomotor rhinitis, and 30 normal subjects were enrolled. For the follow-up study, 12 seasonal allergic rhinitis (SAR) patients against Japanese cedar and 10 perennial AR patients who underwent laser surgery were examined. RESULTS: The AR patients and vasomotor rhinitis patients showed significantly higher oral FeNO levels as compared with the normal subjects. The nasal FeNO levels were significantly higher in the perennial AR patients with or without BA than in the normal subjects and vasomotor rhinitis patients. There were positive correlations between the nasal symptom scores and FeNO levels. The SAR patients showed a significant decrease in the nasal FeNO level after the pollen dispersion season. In addition, the therapeutic effects of laser surgery in the AR patients accompanied a significant reduction in the nasal FeNO levels one month after treatment. CONCLUSIONS: The nasal FeNO measurement by NObreath® is easy to perform and suitable for monitoring AR patients in various treatment modalities. Furthermore, it may have potential usefulness as a tool to improve daily clinical care.

[Clinical effect of bipolar radiofrequency thermotherapy on allergic rhinitis].

The clinical effect of bipolar radiofrequency thermotherapy on allergic rhinitis was evaluated. A bipolar radiofrequency system (CelonLab ENT) was used on 16 patients suffering from allergic rhinitis from February 2003 and August 2003. The thermotherapy was conducted under local anesthesia and data was collected by preoperative questionnaire and rhinomanometry and 2 months and 2 years postoperatively. Nearly all the patients reported relieved nasal patency, rhinorrhea, and sneezeing. Statistically significant improvements were observed for all the measured VAS scores: nasal patency, rhinorrhea, and sneezeing. Nasal resistance measured by anterior rhinomanometry also significantly improved. We concluded that CelonLab ENT is effective and safe in treating allergic rhinitis.

Long-term efficacy of microdebrider-assisted inferior turbinoplasty with lateralization for hypertrophic inferior turbinates in patients with perennial allergic rhinitis.

OBJECTIVES: The aim of the study was to evaluate the long-term efficacy of microdebrider-assisted inferior turbinoplasty with lateralization (MAITL) compared to submucosal resection for hypertrophic inferior turbinates. STUDY DESIGN: Surgical outcomes were evaluated with respect to visual analogue scale, anterior rhinomanometry, and saccharin test results. METHODS: From January 2002 to December 2006 inclusively, 160 patients with perennial allergic rhinitis and hypertrophic inferior turbinates were enrolled into this study. The patients, all suffering from chronic nasal obstruction, were randomly classified into two groups, MAITL group or SR group, each comprised of 80 patients. Ten patients who did not display any nasal discomfort served as normal controls. For the submucosal resection group, patients underwent submucosal resection of the inferior turbinate, whereas patients in the MAITL group underwent microdebrider-assisted inferior turbinoplasty with lateralization. Assessments (visual analogue scale, anterior rhinomanometry, and saccharin test) were conducted prior to the surgery and 1, 2, and 3 years after completion of surgery. RESULTS: Compared to preoperative values, subjective complaints including nasal obstruction, sneezing, rhinorrhea, and snoring improved significantly in both groups at 1, 2, and 3 years after surgery in both groups (P < .05 for all). Rhinomanometric assessment also showed significant improvement at 1, 2, and 3 years postoperatively in both groups (P < .05 for all). Saccharin transit time was significantly decreased (P < .05 for all) compared to preoperative values 1, 2, and 3 years after surgery in both groups. CONCLUSION: Microdebrider-assisted inferior turbinoplasty with lateralization appears to be as effective as submucosal resection at relieving nasal symptoms and decreasing total nasal resistance and saccharin transit times for more than 3 years in patients with perennial allergic rhinitis who have had substantial nasal obstruction.

[Clinical effect of bipolar radiofrequency thermotherapy on allergic rhinitis].

The clinical effect of bipolar radiofrequency thermotherapy on allergic rhinitis was evaluated. A bipolar radiofrequency system (CelonLab ENT) was used to treat 16 patients suffering from allergic rhinitis between February 2003 and August 2003. The thermotherapy was performed under local anesthesia at the otolaryngology outpatient clinic of St. Marianna University Toyoko Hospital. Data were collected by questionnaire and rhinomanometry preoperatively and 2 months postoperatively. The mean visual analogue scale (VAS) score for intraoperative pain was 31 mm (range, 0-100), and nearly all the patients felt no or a subtle pain during the thermotherapy. Postoperative pain was also well tolerated, with nearly all the patients not requiring analgesic drugs. Postoperative bleeding was minor, and none of the patients required additional treatment for bleeding. Nearly all the patients reported an improvement in their nasal patency, rhinorrhea, headaches, and sleeping. Statistically significant improvements were observed for all the measured VAS scores: nasal patency, rhinorrhea, headache, and olfactory function. Nasal resistance, as measured by anterior rhinomanometry, significantly improved after treatment. The effect of decongestion was also measured using anterior rhinomanometry. The ratio of nasal resistance before and after decongestion was significantly higher after thermotherapy, suggesting that nasal decongestion had a smaller effect on nasal patency after treatment. The current results suggest that the CelonLab ENT device is an effective and safe treatment for allergic rhinitis.

Laser surgery of the inferior turbinate for allergic rhinitis with seasonal exacerbation: an acoustic rhinometry study.

Laser surgery has been used to successfully treat patients with perennial allergic rhinitis. We examined whether the numbers and types of sensitized allergens influence the effects of surgery. Two different groups (those allergic to house dust mites only, and those allergic to house dust mites and Japanese cedar pollen) prospectively underwent the same course of laser turbinectomy during the pollen dispersion season. The symptom scores for nasal obstruction significantly decreased in both groups, but the improvement of sneezing and rhinorrhea was less pronounced in the pollen group. We used acoustic rhinometry to measure postoperative changes in the nasal dimensions. Four months after treatment, the minimum cross-sectional area and nasal cavity volume had increased, respectively, by 61.7% and 30.7% in the house dust group, and by 30.7% and 16.2% in the pollen group. We conclude that laser surgery can be successfully applied to patients whose allergies show seasonal exacerbation by airborne pollen.