AUTO-ACUSAR - Effects of Acupuncture on the Autonomic Nervous System in Seasonal Allergic Rhinitis Patients

NCT ID: NCT01271595

Last Updated: 2018-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-05-31

Brief Summary

There is inconclusive evidence whether acupuncture treatment is effective in the treatment of seasonal allergic rhinitis (SAR). Furthermore, the underlying mechanisms of acupuncture in SAR are only poorly understood. It was hypothesised that the therapeutic mechanism of acupuncture is related to changes in autonomic function. AUTO-ACUSAR is a sub-study of the DFG-funded three-arm randomized controlled trial ACUSAR trial investigating the efficacy of acupuncture vs. sham acupuncture vs. rescue medication in SAR. The aim of AUTO-ACUSAR was to investigate short and long-term effects of acupuncture vs. sham acupuncture on autonomic function in a sub-group of ACUSAR patients. Baseline values were compared to data from matched healthy controls.

Detailed Description

In AUTO-ACUSAR a subsample of ACUSAR patients from acupuncture or sham acupuncture groups were included. Tests of autonomic functions included measurement of heart rate variability during paced breathing, blood pressure, heart rate and salivary alpha amylase response to a cold pressure test (CPT) and cortisol awakening response before the first and the last of twelve treatment sessions. Healthy matched controls underwent the same measurement once only

Conditions

Seasonal Allergic Rhinitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

acupuncture

12 sessions of acupuncture according to TCM

Group Type: ACTIVE_COMPARATOR

sham acupuncture

Intervention Type: OTHER

12 sessions of sham acupuncture over 8 weeks

sham acupuncture

superficial acupuncture at non acupuncture sites

Group Type: SHAM_COMPARATOR

sham acupuncture

Intervention Type: OTHER

12 sessions of sham acupuncture over 8 weeks

Interventions

sham acupuncture

12 sessions of sham acupuncture over 8 weeks

Intervention Type: OTHER

Other Intervention Names

acupuncture

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
• Auto-immune 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

• intake of Beta-Blocker Medication
• use of pacemaker

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

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Benno Brinkhaus

Prof. Dr. Benno Brinkhaus

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benno Brinkhaus, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center

Locations

Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center

Berlin, , Germany

Countries

Germany

Other Identifiers

EA1/214/07a

Identifier Type: -

Identifier Source: org_study_id