Placebo Effects on Blood Pressure

Charité University Medicine Berlin

Status: Unknown

Conditions: Blood Pressure

Treatments: Other: Placebo info given (written); Other: Placebo with BP dec (written form); Other: Placebo with BP dec (doctor); Other: Placebo info given (doc); Other: Placebo with BP inc (written); Other: Placebo with BP inc (doctor)

Study type: Interventional

Funder types: Other

Identifiers

NCT00570271

EA4/004/07

Details and patient eligibility

About

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:

1. Placebo administration leads to a significant changes of blood pressure compared with untreated controls.
2. The direction of blood pressure change depends on the type of suggestion (either decrease or increase)
3. This effect is specific for blood pressure; changes in electrodermal and gastric activity do not differ between groups.
4. The placebo response can be enhanced by a prestige intervention (information about the suggested drug action given by doctor or in written form).

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Informed consent

Exclusion criteria

• Not meeting inclusion criteria
• Untreated hypertension (BP > 140/90) or hypotension(BP < 100/60)
• Severe systemic disorders (tumors, tbc, diabetes, asthma etc)
• Diseases with influence on cardiovascular or gastrointestinal system
• Pregnancy and lactation phase
• Body mass index > 30
• Regular intake of drugs with influence on the autonomic nervous system
• Insufficient compliance
• Simultaneous participation in another trial

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 6 patient groups

1

Experimental group

Treatment:

Other: Placebo with BP dec (written form)

2

Experimental group

Treatment:

Other: Placebo with BP dec (doctor)

3

Experimental group

Treatment:

Other: Placebo with BP inc (written)

4

Experimental group

Treatment:

Other: Placebo with BP inc (doctor)

5

No Intervention group

Treatment:

Other: Placebo info given (written)

6

No Intervention group

Treatment:

Other: Placebo info given (doc)