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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 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 .
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Intervention_Physical
acupuncture
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Intervention_Pharmacological
Western drug
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Intervention_Physical
acupuncture regimen
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Intervention_Pharmacological
Traditional Chinese Medicine
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Intervention_Pharmacological
second-generation Hi-receptor antagonist , cetirizine hydrochloride .
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Intervention_Physical
acupuncture
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Intervention_Pharmacological
pharmacotherapy
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Intervention_Physical
acupuncture
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Intervention_Pharmacological
cetirizine hydrochloride .
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Outcome_Other
clinical effectiveness
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Outcome_Other
7-day average total nasal symptom score
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Outcome_Other
rhinoconjunctivitis quality of life questionnaire score
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Outcome_Physical
and
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Outcome_Other
total non-nasal symptom score
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Participant_Condition
allergic rhinitis :
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Participant_Condition
persistent allergic rhinitis ( PER )
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Participant_Sample-size
240