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Comparison of clinical effectiveness of acupuncture and a Western drug on allergic rhinitis:study protocol for a randomized controlled trial 被引量:9

Comparison of clinical effectiveness of acupuncture and a Western drug on allergic rhinitis:study protocol for a randomized controlled trial
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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. 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 H1-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 willbe randomized to receive acupuncture or pharmacotherapy(1∶1) for 4 weeks with a 4-week follow-up. The primary outcome will be changes in7-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 emotionalactivitieshasbeenreported.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.
出处 《Journal of Traditional Chinese Medicine》 SCIE CAS CSCD 2014年第3期254-260,共7页 中医杂志(英文版)
基金 Supported by Capital Research on the Clinical Characteristic Application Projects,Beijing Municipal Science & Technology Commission(No.D101100050010022)
关键词 ACUPUNCTURE RHINITIS Psychologicaland emotional impairment Mind (Shen)-regula-tion Randomized controlled trial 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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