Acupuncture for Seasonal Allergic Rhinitis

NCT ID: NCT00610584

Last Updated: 2012-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 422 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2011-04-30

Brief Summary

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.

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).

Conditions

Seasonal Allergic Rhinitis

Keywords

seasonal allergic rhinitis; acupuncture; RCT; CAM

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

verum acupuncture plus rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily))

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: PROCEDURE

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))

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))

Group Type: PLACEBO_COMPARATOR

minimal (sham)acupuncture

Intervention Type: PROCEDURE

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))

3

rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily))alone

Group Type: ACTIVE_COMPARATOR

cetirizine dihydrochloride (rescue medication)

Intervention Type: DRUG

arm 3: rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily)) alone

Interventions

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))

Intervention Type: 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))

Intervention Type: PROCEDURE

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Research Foundation

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Benno Brinkhaus

Prof. MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan N Willich, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Charité - Institute for Social Medicine

Berlin, State of Berlin, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 29440045 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24708643 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23806461 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23420231 (View on PubMed)

Other Identifiers

DFG

Identifier Type: -

Identifier Source: secondary_id

EA1/214/07

Identifier Type: -

Identifier Source: org_study_id