This trial is active, not recruiting.

Condition seasonal allergic rhinitis
Treatment sham acupuncture
Sponsor Charite University, Berlin, Germany
Start date August 2009
End date April 2010
Trial size 60 participants
Trial identifier NCT01271595, EA1/214/07a


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose basic science
(Active Comparator)
12 sessions of acupuncture according to TCM
sham acupuncture acupuncture
12 sessions of sham acupuncture over 8 weeks
(Sham Comparator)
superficial acupuncture at non acupuncture sites
sham acupuncture acupuncture
12 sessions of sham acupuncture over 8 weeks

Primary Outcomes

Heart Rate Variability
time frame: 8 weeks

Secondary Outcomes

Salivary Amylase and Cortisol, Cortisol Awakening Response (CAR)
time frame: 8 weeks

Eligibility Criteria

Male or female participants from 16 years up to 45 years old.

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

Additional Information

Official title Acupuncture in Seasonal Allergic Rhinitis- Effects on the Autonomic Nervous System (AUTO-ACUSAR)- an Explorative Substudy of ACUSAR
Principal investigator Benno Brinkhaus, Prof. Dr.
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
Trial information was received from ClinicalTrials.gov and was last updated in January 2011.
Information provided to ClinicalTrials.gov by Charite University, Berlin, Germany.