Effectivness and Safety of Acupuncture Combined With Moxibustion for Allergic Rhinitis

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

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.

Study Overview

• Status: Completed
• Conditions: Rhinitis, Allergic, Perennial
• Intervention / Treatment: Other: acupuncture combined moxibustion; Drug: Loratadine

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
    • Beijing, Beijing, China, 100700
      • Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
    • Beijing, Beijing, China, 102300
      • Mentougou Hospital of TCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture combined moxibustion; 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; 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.; Other Names: warming needle
Active Comparator: loratadine; Loratadine taken orally, 10mg/day in the morning	Drug: Loratadine; Loratadine will be taken orally at the dose of 10mg/day in the morning. Each treatment cycle will be given for continuous 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Zhao Hong
• Collaborators: Beijing Municipal Science & Technology Commission; China Academy of Chinese Medical Sciences
• Investigators: Principal Investigator: Liu Baoyan, Master, Vice President of China Academy of Chinese Medical Sciences

Publications and helpful links

General Publications

• Sun Y, Zhao H, Ye Y, Nie W, Bai W, Liu J, Li S, Wang F, Han M, He L. Efficacy and safety of using a warming needle for persistent allergic rhinitis: study protocol for a randomized controlled trial. Trials. 2016 Jun 30;17(1):305. doi: 10.1186/s13063-016-1432-z.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: January 13, 2015
• First Submitted That Met QC Criteria: January 14, 2015
• First Posted (Estimate): January 15, 2015

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: safety; acupuncture; efficacy; allergic rhinitis; moxibustion
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Histamine H1 Antagonists, Non-Sedating; Loratadine
• Other Study ID Numbers: AAMH001