Effectivness and Safety of Acupuncture Combined With Moxibustion for Allergic Rhinitis

Study Overview
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Brief Summary
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A multi-centre clinical trial done by us（ISRCEN90807007）showed that active acupuncture had significantly greater effect on symptoms of allergic rhinitis than either sham acupuncture or no active treatment. The object of that study was to evaluate the effectiveness and safety of acupuncture for allergic rhinitis. As an explanatory research, acupuncture was defined as the only intervention for treatment group and sham acupuncture, no active treatment as its control groups. Besides, acupuncture combined moxibustion showed better and longer effect than acupuncture on allergic rhinitis patients in our previous pilot study. According to this result, we are taking a pragmatic randomized controlled trial to further evaluate whether acupuncture combined moxibustion is more effective than conventional treatment.

Official Title
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Effect Comparison of Acupuncture Combined With Moxibustion and Loratadine for Perennial Allergic Rhinitis: a Randomized Controlled Trial

Conditions
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Rhinitis, Allergic, Perennial

Intervention / Treatment
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* Other: acupuncture combined moxibustion
* Drug: Loratadine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Each participant must have a diagnosis of AR by an otolaryngology doctor, according to the criteria listed in Allergic Rhinitis and its Impact on Asthma (ARIA 2008) Symptoms that had persisted for more than 4 days per week for more than four consecutive weeks. At least one of the following rhinitis-associated conditions: nasal obstruction, rhinorrhea, sneezing and nasal itching. At least one positive result on an allergy skin prick reaction test at screening. - Exclusion Criteria: Active tuberculosis Autoimmune disorders Severe chronic inflammatory diseases History of anaphylactic reactions Specific immunotherapy >3 years Simultaneous participation in other clinical trials Serious acute or chronic organic disease or mental disorder Congenital nasal abnormalities Pregnancy or breast feeding Blood coagulation disorder and/or current use of anticoagulants Allergy desensitisation therapy (current, during the past two years, or planned in the next two years) Previous systemically administered corticosteroids, antihistamines, or decongestants in the last 1 months prior to enrollment -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture combined moxibustion<br>Acupuncture at Hegu(LI4),Yingxiang(LI20),Chize(LU5),Sibai(ST2), Yintang(EX-HN3),Shangyingxiang(EX-HN8),Shangxing(GV23),Dazhui(Du14). Needle warming moxibustion at Dazhui(Du14). Patients will be treated once per day for 30 min, 3 times in a weeks for 4 weeks. | Other: acupuncture combined moxibustion<br>* Points: Hegu(LI4),Yingxiang(LI20),Chize(LU5),Sibai(ST2), Yintang(EX-HN3),Shangyingxiang(EX-HN8),Shangxing(GV23),Dazhui(Du14). Pierced the skin, needles are inserted 0.5 to 2cm into the acupoints. Each needle are roated until the participants and the practitioner felt de-qi sensation. After that, moxibustion is applied to Dazhui(Du14). A 1cm long moxa cone is putted on the top of the needle at the acupoint, then ignite moxa cone until the cone is burn. The needles are left in place for 30 minutes. once every two days, 3 times in a week for consecutive 4 weeks, 12 times altogether.<br>* Other names: warming needle;|
| Active Comparator: loratadine<br>Loratadine taken orally, 10mg/day in the morning | Drug: Loratadine<br>* Loratadine will be taken orally at the dose of 10mg/day in the morning. Each treatment cycle will be given for continuous 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the weekly average of the participants' total nasal symptom score (TNSS) at the 4th week. |  | at the 4th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the weekly average of the participants' total non-nasal symptom score (TNNSS) at the 4th week |  | at the 4th week | 
| Change from baseline in Quality of life questionnaire (QLQ) at the 4th week |  | at the 4th Week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allergic rhinitis, acupuncture, moxibustion, efficacy, safety