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

NCT01271595 | Completed DMC

• 1 other identifier: EA1/214/07a
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Allergic Rhinitis

Keywords

acupuncture; autonomic nervous system; seasonal allergic rhinitis

Outcome Measures

Primary Outcomes (1)

• Heart Rate Variability

  RMSSD, LF, HF, HR, blood pressure

  8 weeks

Secondary Outcomes (1)

• Salivary Amylase and Cortisol, Cortisol Awakening Response (CAR)

  8 weeks

Study Arms (2)

acupuncture

ACTIVE COMPARATOR

12 sessions of acupuncture according to TCM

Other: sham acupuncture

sham acupuncture

SHAM COMPARATOR

superficial acupuncture at non acupuncture sites

Other: sham acupuncture

Interventions

sham acupuncture OTHER

12 sessions of sham acupuncture over 8 weeks

Also known as: acupuncture

acupuncture; sham acupuncture

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Benno Brinkhaus, Prof. Dr.

  Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Benno Brinkhaus

Study Record Dates

• First Submitted: December 23, 2010
• First Posted: January 7, 2011
• Study Start: August 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2011
• Last Updated: November 20, 2018

Record last verified: 2018-11

Locations

DE (1)