Clinical trial NCT01271595: AUTO-ACUSAR - Effects of Acupuncture on the Autonomic Nervous System in Seasonal Allergic Rhinitis Patients
Official title: Acupuncture in Seasonal Allergic Rhinitis- Effects on the Autonomic Nervous System (AUTO-ACUSAR)- an Explorative Substudy of ACUSAR
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seasonal Allergic Rhinitis
Keywords: acupuncture
autonomic nervous system
seasonal allergic rhinitis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2011-01-07
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

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

Primary outcomes:
measure: Heart Rate Variability
timeFrame: 8 weeks
Secondary outcomes:
measure: Salivary Amylase and Cortisol, Cortisol Awakening Response (CAR)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center
Study officials:
affiliation: Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center
name: Benno Brinkhaus, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: