Placebo Effects on Blood Pressure
Study Details
Study Description
Brief Summary
A relevant reduction of blood pressure (BP) in placebo-treated control groups is a phenomenon often observed in pharmacological studies of hypertension. This effect was shown to differ from spontaneous remission tendencies and regression to the mean effect by comparing placebo groups with untreated controls. However, it is not fully understood whether these effects are due to a global reaction of the autonomous nervous system (affecting the overall organ systems of the body) or a specific reaction (affecting the cardiovascular system only). We therefore aim to differentiate specific effects (reduction of blood pressure) from global effects (e.g. changes in electrodermal and gastric activity).
In our study we aim to test the following hypotheses:
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Placebo administration leads to a significant changes of blood pressure compared with untreated controls.
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The direction of blood pressure change depends on the type of suggestion (either decrease or increase)
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This effect is specific for blood pressure; changes in electrodermal and gastric activity do not differ between groups.
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The placebo response can be enhanced by a prestige intervention (information about the suggested drug action given by doctor or in written form).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Other: Placebo with BP dec (written form)
Placebo administration with a blood pressure decrease suggestion. Information provided to subjects in written form.
|
| Experimental: 2
|
Other: Placebo with BP dec (doctor)
Placebo administration with a blood pressure decrease suggestion. Information provided to subjects by doctor.
|
| Experimental: 3
|
Other: Placebo with BP inc (written)
Placebo administration with a blood pressure increase suggestion. Information provided to subjects in written form.
|
| Experimental: 4
|
Other: Placebo with BP inc (doctor)
Placebo administration with a blood pressure increase suggestion. Information provided to subjects by doctor.
|
| No Intervention: 5
|
Other: Placebo info given (written)
Subject informed about receiving placebo. Information provided to subjects in written form.
|
| No Intervention: 6
|
Other: Placebo info given (doc)
Subject informed about receiving placebo. Information provided to subjects by doctor.
|
Outcome Measures
Primary Outcome Measures
- Mean arterial pressure [60 minutes]
Secondary Outcome Measures
- Heart rate [60 minutes]
- skin conductance level [60 minutes]
- gastric activity [60 minutes]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Informed consent
Exclusion Criteria:
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Not meeting inclusion criteria
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Untreated hypertension (BP > 140/90) or hypotension(BP < 100/60)
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Severe systemic disorders (tumors, tbc, diabetes, asthma etc)
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Diseases with influence on cardiovascular or gastrointestinal system
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Pregnancy and lactation phase
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Body mass index > 30
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Regular intake of drugs with influence on the autonomic nervous system
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Insufficient compliance
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Simultaneous participation in another trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Psychosomatic Medicine and Psychotherapy, Charité University | Berlin | Germany | 12203 |
Sponsors and Collaborators
- Charite University, Berlin, Germany
Investigators
- Study Director: Hans-Christian Deter, MD, Charité University Berlin
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EA4/004/07
- EA4/004/07