Acupuncture for Seasonal Allergic Rhinitis

NCT00610584 | Completed DMC

• 2 other identifiers: EA1/214/07DFG
• Study Type: interventional
• Target: 422
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Allergic Rhinitis

Keywords

seasonal allergic rhinitis; acupuncture; RCT; CAM

Outcome Measures

Primary Outcomes (1)

• 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).

  Weeks 6 and 8 of the first year (adjusted for baseline values).

Secondary Outcomes (1)

• 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.

  Baseline, 8 weeks and 16 weeks in the first year and baseline and week 8 in the second year

Study Arms (3)

1

EXPERIMENTAL

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

2

PLACEBO COMPARATOR

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

3

ACTIVE COMPARATOR

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)

Interventions

acupuncture 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))

1

minimal (sham)acupuncture 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))

2

cetirizine dihydrochloride (rescue medication) DRUG

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

3

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• German Research Foundation: collaborator

Study Sites (1)

Charité - Institute for Social Medicine

Berlin, State of Berlin, 10098, Germany

Location

Related Publications (4)

• 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.

  PMID: 29440045 DERIVED

• 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.

  PMID: 24708643 DERIVED

• 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.

  PMID: 23806461 DERIVED

• 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.

  PMID: 23420231 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Acupuncture Therapy; Cetirizine

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Stefan N Willich, MD, MBA

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD

Study Record Dates

• First Submitted: January 28, 2008
• First Posted: February 8, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: October 23, 2012

Record last verified: 2012-10

Locations

DE (1)