Placebo Effects on Blood Pressure

Physiological Effects of Placebo Interventions to Increase or Decrease Blood Pressure

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).

Study Overview

• Status: Unknown
• Conditions: Blood Pressure
• Intervention / Treatment: Other: Placebo with BP dec (written form); Other: Placebo with BP dec (doctor); Other: Placebo with BP inc (written); Other: Placebo with BP inc (doctor); Other: Placebo info given (written); Other: Placebo info given (doc)

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frank Zimmermann-Viehoff, MD; Phone Number: +49-30-84454046; Email: frank.zimmermann@charite.de

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Recruiting
    • Department of Psychosomatic Medicine and Psychotherapy, Charité University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean arterial pressure	60 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Heart rate	60 minutes
skin conductance level	60 minutes
gastric activity	60 minutes

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Study Director: Hans-Christian Deter, MD, Charite University Berlin

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion: December 6, 2022
• Study Completion (Anticipated): February 1, 2008

Study Registration Dates

• First Submitted: December 5, 2007
• First Submitted That Met QC Criteria: December 7, 2007
• First Posted (Estimate): December 10, 2007

Study Record Updates

• Last Update Posted (Estimate): December 10, 2007
• Last Update Submitted That Met QC Criteria: December 7, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Keywords: placebo effect; blood pressure; autonomic nervous system; prestige; basic research on physiological placebo effects
• Other Study ID Numbers: EA4/004/07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No