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

Charité University Medicine Berlin

Status

Completed

Conditions

Seasonal Allergic Rhinitis

Treatments

Other: sham acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT01271595

EA1/214/07a

Details and patient eligibility

About

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.

Full 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

Enrollment

60 patients

Sex

All

Ages

16 to 45 years old

Volunteers

No Healthy Volunteers

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