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Acupuncture for Seasonal Allergic Rhinitis (ACUSAR)

This study has been completed.
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Benno Brinkhaus, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00610584
First received: January 28, 2008
Last updated: October 22, 2012
Last verified: October 2012
  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:


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 ]

Enrollment: 422
Study Start Date: April 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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))
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 medication (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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Charité - Institute for Social Medicine
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 by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Benno Brinkhaus, Prof. MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00610584     History of Changes
Other Study ID Numbers: EA1/214/07, DFG
Study First Received: January 28, 2008
Last Updated: October 22, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
seasonal allergic rhinitis
acupuncture
RCT
CAM

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Cetirizine
Histamine Antagonists
Histamine H1 Antagonists
Anti-Allergic Agents
Histamine Agents
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014