- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00610584
Acupuncture for Seasonal Allergic Rhinitis (ACUSAR)
October 22, 2012 updated by: Benno Brinkhaus, Charite University, Berlin, Germany
Acupuncture for Seasonal Allergic Rhinitis (ACUSAR) - A Randomised Controlled Trial
Acupuncture is widely use by patients with seasonal allergic rhinitis (SAR), although there is only limited evidence of its effectiveness.
The aim of this three armed randomised controlled multicentre trial is to investigate the efficacy of acupuncture plus rescue medication vs. minimal (sham) acupuncture plus rescue medication vs.
(b) rescue medication alone in the treatment of seasonal allergic rhinitis.
Study Overview
Status
Completed
Conditions
Detailed Description
Acupuncture is widely use by patients with seasonal allergic rhinitis (SAR), although there is only limited evidence of its effectiveness.
The aims of this 3-armed, randomised controlled trial are to investigate whether acupuncture plus rescue medication is non-inferior (closed testing procedure: in case of success in non-inferiority: test of superiority) to minimal acupuncture plus rescue medication in the treatment of SAR (closed testing procedure: closed testing procedure: in case of success in non-inferiority: test of superiority), and whether acupuncture plus rescue medication is non-inferior to rescue medication alone consisting only of oral antihistamines for this indication.
The trial interventions will be performed in approximately 40 outpatient centres in Germany.
In total, 400 patients with SAR will be randomised to one of three groups: acupuncture plus rescue medication, minimal acupuncture (i.e.
superficial needling at non-acupuncture points) plus rescue medication, or rescue medication only.
Rescue medication will consist of oral antihistamines.
Acupuncture and minimal acupuncture will be administered by physicians specialised in acupuncture and will consist of 12 sessions per patient in the first 8 weeks.
Patients in the rescue medication group will receive 12 sessions of acupuncture after 8 weeks.
The primary outcome measures will be the mean of Rhinitis Quality of Life Questionnaire score (RQLQ scores between weeks 6 and 8 of the first year (adjusted for baseline values) and the Rescue Medication Score (RMS) between weeks 6 and 8 of the first year (adjusted for baseline values).
Study Type
Interventional
Enrollment (Actual)
422
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Berlin, Germany, 10098
- Charité - Institute for Social Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 45 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Female or male patients (aged 16-45 years) with seasonal allergic rhinitis, clinically positive and test positive (skin-prick test and/or RAST) to grass and birch pollen
- Patients with >2 years of moderate to severe SAR
- Positive skin-prick test and/or RAST (at least class 2) results
- Visual analogue scale >40mm and <80 mm for SAR symptoms during the past year
- Patients must be able to complete a diary for self-evaluation of symptoms and recording use of anti-symptomatic medication
- Use of, or indication for, oral antihistamines as anti-allergic medication
- Written informed consent
Exclusion Criteria:
- Perennial SAR or other types of chronic rhinitis
- Allergic asthma and/or moderate to severe atopic dermatitis
- Active tuberculosis
- Autoimmune disorders
- Severe chronic inflammatory diseases
- History of anaphylactic reactions
- Hypersensitivity to Rescue medication or related drugs used in study related drugs
- Specific immunotherapy >3 years
- Simultaneous participation in other clinical trials
- Serious acute or chronic organic disease or mental disorder
- Pregnancy or breast feeding
- Allergy desensitisation therapy (current, during the past two years, or planned in the next two years)
- Blood coagulation disorder and/or current use of anticoagulants
- Previous acupuncture treatment for SAR
- Any Complementary and alternative medicine treatment at the moment, in the last three months or planned in the next two years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
verum acupuncture plus rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily))
|
arm 1: verum acupuncture group: 12 interventions (semi-standardised): 8 in the first 4 weeks and 4 in the next 4 weeks + rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily))
|
Placebo Comparator: 2
minimal (sham) acupuncture plus rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily))
|
arm 2: minimal (sham) acupuncture group: 12 interventions (standardised): 8 in the first 4 weeks and 4 in the next 4 weeks + rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily))
|
Active Comparator: 3
rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily))alone
|
arm 3: rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily)) alone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rhinitis Quality of Life Questionnaire score (RQLQ scores between weeks 6 and 8 of the first year (adjusted for baseline values) and the Rescue Medication Score between weeks 6 and 8 of the first year (adjusted for baseline values).
Time Frame: Weeks 6 and 8 of the first year (adjusted for baseline values).
|
Weeks 6 and 8 of the first year (adjusted for baseline values).
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life (SF-36), responder rate (RQLQ score of 0.5 or more), global evaluation of treatment success, VAS (0-100 mm) overall symptom severity and nasal, eye, pharyngeal and common symptoms, safety, patients constitution, health economic analyses.
Time Frame: Baseline, 8 weeks and 16 weeks in the first year and baseline and week 8 in the second year
|
Baseline, 8 weeks and 16 weeks in the first year and baseline and week 8 in the second year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Stefan N Willich, MD, MBA, Epidemiology, and Health Economics, Charité University Medical Center, 10098 Berlin, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Adam D, Grabenhenrich L, Ortiz M, Binting S, Reinhold T, Brinkhaus B. Impact of acupuncture on antihistamine use in patients suffering seasonal allergic rhinitis: secondary analysis of results from a randomised controlled trial. Acupunct Med. 2018 Jun;36(3):139-145. doi: 10.1136/acupmed-2017-011382. Epub 2018 Feb 10.
- Ortiz M, Witt CM, Binting S, Helmreich C, Hummelsberger J, Pfab F, Wullinger M, Irnich D, Linde K, Niggemann B, Willich SN, Brinkhaus B. A randomised multicentre trial of acupuncture in patients with seasonal allergic rhinitis--trial intervention including physician and treatment characteristics. BMC Complement Altern Med. 2014 Apr 6;14:128. doi: 10.1186/1472-6882-14-128.
- Reinhold T, Roll S, Willich SN, Ortiz M, Witt CM, Brinkhaus B. Cost-effectiveness for acupuncture in seasonal allergic rhinitis: economic results of the ACUSAR trial. Ann Allergy Asthma Immunol. 2013 Jul;111(1):56-63. doi: 10.1016/j.anai.2013.04.008. Epub 2013 May 3.
- Brinkhaus B, Ortiz M, Witt CM, Roll S, Linde K, Pfab F, Niggemann B, Hummelsberger J, Treszl A, Ring J, Zuberbier T, Wegscheider K, Willich SN. Acupuncture in patients with seasonal allergic rhinitis: a randomized trial. Ann Intern Med. 2013 Feb 19;158(4):225-34. doi: 10.7326/0003-4819-158-4-201302190-00002.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
January 28, 2008
First Submitted That Met QC Criteria
January 28, 2008
First Posted (Estimate)
February 8, 2008
Study Record Updates
Last Update Posted (Estimate)
October 23, 2012
Last Update Submitted That Met QC Criteria
October 22, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
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, Seasonal
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Cetirizine
Other Study ID Numbers
- EA1/214/07
- DFG
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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