Comparison of clinical effectiveness of acupuncture and a Western drug on allergic rhinitis： study protocol for a randomized controlled trial

OBJECTIVE： To compare the efficacy of an acu- puncture regimen for persistent allergic rhinitis （PER）, aimed at improving a patient＇s mind or Shen in Traditional Chinese Medicine, to that of a sec- ond-generation H-receptor antagonist, cetirizine hydrochloride. METHODS： This multicenter, randomized, con- trolled 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 screen- ing period, 240 eligible participants with PER willbe randomized to receive acupuncture or pharma- cotherapy （1： 1） for 4 weeks with a 4-week fol- low-up. The primary outcome will be changes in 7-day average total nasal symptom score. Second- ary outcome measures include rhinoconjunctivitis quality of life questionnaire score and total non-na- sal symptom score. RESULTS： The presence and seriousness of psycho- logical and emotional impairments should be con- sidered in therapeutic programs for allergic rhinitis. No clinical trial for treating allergic rhinitis via acu- puncture regulation of psychological and emotion- al activities has been reported. CONCLUSION： The findings of the trial will allow us to determine the effects of the mind （Shen）-regula- tion treatment approach. We will also be able to confirm if the effects of acupuncture are equivalent to those of the conventional drug cetirizine hydro- chloride.