Comparison of clinical effectiveness of acupuncture and a Western drug on allergic rhinitis: study protocol for a randomized controlled trial |
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基金项目: | Supported by Capital Research on the Clinical Characteris- tic Application Projects, Beijing Municipal Science &Technol- ogy Commission (No. D101100050010022) |
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摘 要: | 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.
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关 键 词: | 随机对照试验 过敏性鼻炎 临床疗效 针灸 中国传统医学 盐酸西替利嗪 西药 联合治疗 |
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