Acupuncture for Seasonal Allergic Rhinitis - Full Text View

Sponsor:	Charite University, Berlin, Germany
Collaborator:	German Research Foundation
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00610584

Purpose

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.

Condition	Intervention
Seasonal Allergic Rhinitis	Procedure: acupuncture Procedure: minimal (sham)acupuncture Drug: cetirizine dihydrochloride (rescue medication)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Acupuncture for Seasonal Allergic Rhinitis (ACUSAR) - A Randomised Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture Acute Bronchitis Cold and Cough Medicines Hay Fever

Drug Information available for: Histamine Histamine phosphate Histamine dihydrochloride Cetirizine Cetirizine hydrochloride

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:

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). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	April 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 verum acupuncture plus rescue mediciation (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily))	Procedure: acupuncture 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 mediciation (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily))	Procedure: minimal (sham)acupuncture 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	Drug: cetirizine dihydrochloride (rescue medication) arm 3: rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily)) alone

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).

Eligibility

Ages Eligible for Study:	16 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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
Postive 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
Allergric 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610584

Contacts

Contact: Benno Brinkhaus, MD

+49-30-450529002

benno.brinkhaus@charite.de

Locations

Germany
Charité - Institute for Social Medicine	Recruiting
Berlin, Germany, 10098

Sponsors and Collaborators

Charite University, Berlin, Germany

German Research Foundation

Investigators

Principal Investigator:

Stefan N Willich, MD, MBA

Epidemiology, and Health Economics, Charité University Medical Center, 10098 Berlin, Germany

More Information

No publications provided

Responsible Party:	Stefan N. Willich, MD, MBA; Benno Brinkhaus, MD, Institute for Social Medicine, Charité University Medical Center Berlin
ClinicalTrials.gov Identifier:	NCT00610584 History of Changes
Other Study ID Numbers:	EA1/214/07, DFG
Study First Received:	January 28, 2008
Last Updated:	January 30, 2009
Health Authority:	Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:

seasonal allergic rhinitis
acupuncture
RCT
CAM

Additional relevant MeSH terms:

Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Histamine Antagonists

Cetirizine
Histamine H1 Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses
Histamine H1 Antagonists, Non-Sedating

ClinicalTrials.gov processed this record on February 09, 2012