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Completed

NCT Number: NCT01271595

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

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.

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Key information

Conditions

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

Age range

16 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Berlin, 10117, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sham Acupuncture

Other

12 sessions of sham acupuncture over 8 weeks

Other names: acupuncture

Primary outcomes

  1. Heart Rate Variability

    Time frame: 8 weeks

    RMSSD, LF, HF, HR, blood pressure

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: AUTO-ACUSAR

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jan 7, 2011
Registry last updated
Nov 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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