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

Seasonal Allergic Rhinitis Clinical Trial

— AUTO-ACUSAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01271595
• Other study ID #: EA1/214/07a
• Status: Completed
• Phase: N/A
• Start date: August 2009
• Est. completion date: May 2011

Study information

• Verified date: November 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Other:
• sham acupuncture
12 sessions of sham acupuncture over 8 weeks

Locations

Country	Name	City	State
Germany	Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate Variability	RMSSD, LF, HF, HR, blood pressure	8 weeks
Secondary	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