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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acupuncture | Active Comparator | 12 sessions of acupuncture according to TCM |
|
| sham acupuncture | Sham Comparator | superficial acupuncture at non acupuncture sites |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sham acupuncture | Other | 12 sessions of sham acupuncture over 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Variability | RMSSD, LF, HF, HR, blood pressure | 8 weeks |
| 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 |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Benno Brinkhaus, Prof. Dr. | Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center | Berlin | 10117 | Germany |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |