OBJECTIVE: To compare the efficacy of an acupuncture regimen for persistent allergic rhinitis (PER), aimed at improving a patient's mind or Shen in Traditional Chinese Medicine, to that of a second-generation Hi-receptor antagonist, cetirizine hydrochloride. METHODS: This multicenter, randomized, controlled clinical trial on PER will be conducted at three institutions in China. The total study period will be 9 weeks. After a 1-week preparatory screening period, 240 eligible participants with PER will be randomized to receive acupuncture or pharmacotherapy (1:1) for 4 weeks with a 4-week follow-up. The primary outcome will be changes in 7-day average total nasal symptom score. Secondary outcome measures include rhinoconjunctivitis quality of life questionnaire score and total non-nasal symptom score. RESULTS: The presence and seriousness of psychological and emotional impairments should be considered in therapeutic programs for allergic rhinitis. No clinical trial for treating allergic rhinitis via acupuncture regulation of psychological and emotional activities has been reported. CONCLUSION: The findings of the trial will allow us to determine the effects of the mind (Shen)-regulation treatment approach. We will also be able to confirm if the effects of acupuncture are equivalent to those of the conventional drug cetirizine hydrochloride.
RCT Entities:
OBJECTIVE: To compare the efficacy of an acupuncture regimen for persistent allergic rhinitis (PER), aimed at improving a patient's mind or Shen in Traditional Chinese Medicine, to that of a second-generation Hi-receptor antagonist, cetirizine hydrochloride. METHODS: This multicenter, randomized, controlled clinical trial on PER will be conducted at three institutions in China. The total study period will be 9 weeks. After a 1-week preparatory screening period, 240 eligible participants with PER will be randomized to receive acupuncture or pharmacotherapy (1:1) for 4 weeks with a 4-week follow-up. The primary outcome will be changes in 7-day average total nasal symptom score. Secondary outcome measures include rhinoconjunctivitis quality of life questionnaire score and total non-nasal symptom score. RESULTS: The presence and seriousness of psychological and emotional impairments should be considered in therapeutic programs for allergic rhinitis. No clinical trial for treating allergic rhinitis via acupuncture regulation of psychological and emotional activities has been reported. CONCLUSION: The findings of the trial will allow us to determine the effects of the mind (Shen)-regulation treatment approach. We will also be able to confirm if the effects of acupuncture are equivalent to those of the conventional drug cetirizine hydrochloride.