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

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

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.

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Other: sham acupuncture

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
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: acupuncture
Sham Comparator: sham acupuncture; superficial acupuncture at non acupuncture sites	Other: sham acupuncture; 12 sessions of sham acupuncture over 8 weeks; Other Names: acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate Variability	RMSSD, LF, HF, HR, blood pressure	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary Amylase and Cortisol, Cortisol Awakening Response (CAR)	Measurements were taken during the experimental setting 3 times , CAR by the patients the day before first and last acupuncture	8 weeks

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Benno Brinkhaus, Prof. Dr., Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: December 23, 2010
• First Submitted That Met QC Criteria: January 6, 2011
• First Posted (Estimate): January 7, 2011

Study Record Updates

• Last Update Posted (Actual): November 20, 2018
• Last Update Submitted That Met QC Criteria: November 19, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: acupuncture; autonomic nervous system; seasonal allergic rhinitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: EA1/214/07a