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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01271595
Recruitment Status : Unknown
Verified December 2010 by Charite University, Berlin, Germany.
Recruitment status was:  Active, not recruiting
First Posted : January 7, 2011
Last Update Posted : January 7, 2011
Information provided by:
Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Other: sham acupuncture Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Acupuncture in Seasonal Allergic Rhinitis- Effects on the Autonomic Nervous System (AUTO-ACUSAR)- an Explorative Substudy of ACUSAR
Study Start Date : August 2009
Actual Primary Completion Date : April 2010
Estimated Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: acupuncture
12 sessions of acupuncture according to TCM
Other: sham acupuncture
12 sessions of sham acupuncture over 8 weeks
Other Name: acupuncture

Sham Comparator: sham acupuncture
superficial acupuncture at non acupuncture sites
Other: sham acupuncture
12 sessions of sham acupuncture over 8 weeks
Other Name: acupuncture

Primary Outcome Measures :
  1. Heart Rate Variability [ Time Frame: 8 weeks ]
    RMSSD, LF, HF, HR, blood pressure

Secondary Outcome Measures :
  1. Salivary Amylase and Cortisol, Cortisol Awakening Response (CAR) [ Time Frame: 8 weeks ]
    Measurements were taken during the experimental setting 3 times , CAR by the patients the day before first and last acupuncture

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01271595

Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Principal Investigator: Benno Brinkhaus, Prof. Dr. Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center

Responsible Party: Dr. Miriam Ortiz, Institute for Socialmedicine, Epidemiology an Health Economics Charité University Medical Center Identifier: NCT01271595     History of Changes
Other Study ID Numbers: EA1/214/07a
First Posted: January 7, 2011    Key Record Dates
Last Update Posted: January 7, 2011
Last Verified: December 2010

Keywords provided by Charite University, Berlin, Germany:
autonomic nervous system
seasonal allergic rhinitis

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases