Effect of Gargle Containing Honeysuckle and Semen Oroxyli
Condition: Obstructive Sleep Apnea; Complication; Pain
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      Surgery All patients included in this study underwent UPPP under general anesthesia with a
      low-temperature plasma ablation apparatus (PLA-600; Zhongyuan Medical Equipment Co., Ltd.;
      Shandong, China). Briefly, the surgery was carried out under general anesthesia using a nasal
      cannula. A 70# low-temperature plasma cutter head was used to perform bilateral epicapsular
      ablation of the tonsils. Inverted "U" incisions were made on the bilateral soft palate
      respectively, and the 70# cutter head progressively melted the adipose tissue and other soft
      tissues in the the veli palatine region. Subsequently, a 55# low-temperature plasma cutter
      head was used to perform perforation and ablation from between the two mucosal layers of the
      soft palate to the direction of the hard palate, with 2-3 holes on each side, and each
      ablation time was 8-12 s.

      Treatments Patients in both the 2 groups received amoxicillin sodium suspension every 8 hours
      for 7 days after UPPP. Except for these drugs, patients in the treatment group were
      instructed to gargle the suspension solution containing honeysuckle and semen oroxyli (25 mL)
      for 5 minutes. The solution was given 4 times a day for 2 weeks. The patients in the control
      group were instructed to gargle normal saline (25 mL) at the same schedule. No NSAIDs were
      administered unless requested by the patient.

      Data collection The post-operative resting throat pain and swallowing throat pain were
      evaluated at 0 week (12 hours after surgery), 1 week and 2 weeks after UPPP by the patients
      themselves using a visual analog scale (VAS) based on a linear scale from 0 to 10, where 0
      represented an absence of pain and 10 represented maximal pain. Then, the changes of scores
      from week 0 to week 2 between the 2 groups were compared. The VAS scores related to patient
      comfort level were also evaluated by patients themselves, with 0 representing very much worse
      and 10 very much comfort. Furthermore, the researchers who were blinded to the therapeutic
      regimens evaluated the improvement in postoperative pain of patients within the 2-week
      postoperative period based on the clinical global impression of improvement (CGI-I score)
      questionnaire. In this questionnaire, the researchers used a seven-point scale from 1 (very
      much improved) to 7 (very much worse) to rate the improvement of body pain of the patients
      (10).

      The post-operative complications, such as wound infection and wound bleeding, were collected
      and analyzed. The baseline characteristics of the patients in 2 groups including age, gender,
      body mass index (BMI), OSA severity, American Society of Anesthesiologist (ASA)
      classification and pre-operative complications were also collected. The venous blood was
      collected at 12 h and 1 week after operation to detect the levels of hs-CRP, hemoglobin,
      neutrophil% and white blood cell count (WBC).

      Statistical analysis The data in this study were analyzed by the SPSS software (version
      22.0). Normal distribution quantitative data were described as mean ± SD. The difference
      between groups were compared by the Student's t test. Non-normal distribution quantitative
      data were described as median with range and compared with Mann-Whitney U test. Categorical
      data were described as numbers and percentages and compared using the Chi-square test or
      Fisher's exact test. P < 0.05 was considered as statistical significance.
    


Intervention name(s): honeysuckle and semen oroxyli solution
Intervention type(s): Drug
Intervention description(s): The patients in the treatment group were instructed to gargle the solution containing honeysuckle and semen oroxyli (25 mL) four times a day for 2 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment