Placebo Effects on Blood Pressure

Not Applicable

• Conditions: Blood Pressure
• Interventions: Other: Placebo with BP inc (written); Other: Placebo with BP dec (doctor); Other: Placebo with BP dec (written form); Other: Placebo info given (doc); Other: Placebo with BP inc (doctor); Other: Placebo info given (written)

• Registration Number: NCT00570271
• Lead Sponsor: Charite University, Berlin, Germany

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:

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Status Verified: 2007-11
• Study First Submitted: 2007-12-05
• Study First Submitted QC: 2007-12-07
• Last Update Submitted: 2007-12-07
• Study First Posted: 2007-12-10
• Last Update Posted: 2007-12-10
• Study Completion: 2008-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Placebo with BP inc (written)	-
2	Placebo with BP dec (doctor)	-
1	Placebo with BP dec (written form)	-
6	Placebo info given (doc)	-
4	Placebo with BP inc (doctor)	-
5	Placebo info given (written)	-

Primary Outcome Measures

Name	Time	Method
Mean arterial pressure	60 minutes

Secondary Outcome Measures

Name	Time	Method
Heart rate	60 minutes
skin conductance level	60 minutes
gastric activity	60 minutes

Trial Locations

Locations (1)

Department of Psychosomatic Medicine and Psychotherapy, Charité University; 🇩🇪 Berlin, Germany