NCT00065715: PEP

Placebo: Physician or Pill? A Randomized Trial in a Common Cold Model Funded by NIH NCCAM Under RFA "The Placebo Effect in Clinical Practice"

Completed Phase 3 Last updated 3 December 2014

What this trial tests

Phase 3 trial testing Echinacea in Common Cold in 719 participants. Completed in 1 April 2013.

Timeline

1 September 2003

Primary endpoint
1 August 2008

1 April 2013

Quick facts

Lead sponsor	University of Wisconsin, Madison
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	719
Start date	1 September 2003
Primary completion	1 August 2008
Estimated completion	1 April 2013
Sites	1 location across United States

Drugs / interventions tested

• Echinacea — full drug profile →
• Blinded placebo

Conditions studied

• Common Cold — all drugs for Common Cold →

Sponsor

University of Wisconsin, Madison

Who can join

12 and older, any sex, with Common Cold. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Duration and severity of illness, as assessed by the Wisconsin Upper Respiratory Symptom Survey (WURSS-21)
  Time frame: twice daily during illness

Sponsor's own description

The design and interpretation of randomized trials is intimately connected to the use of "placebo". The nature and magnitude of placebo effects, however, is very poorly understood. This study will assess and compare placebo effects and physician interaction effects within a community-acquired common cold model. The goal of this study is to assess two kinds of placebo affects and how physician interaction effects;

1. The effect of receiving blinded placebo, compared to no treatment; and
2. The effect of receiving open-label active Echinacea treatment compared to blinded active treatment.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Perception of empathy in the therapeutic encounter: effects on the common cold.
   Rakel D, Barrett B, Zhang Z, Hoeft T, et al · · 2011 · cited 160× · PMID 21300514 · DOI 10.1016/j.pec.2011.01.009
2. Echinacea for treating the common cold: a randomized trial.
   Barrett B, Brown R, Rakel D, Mundt M, et al · · 2010 · cited 55× · PMID 21173411 · DOI 10.7326/0003-4819-153-12-201012210-00003
3. Modeling eye gaze patterns in clinician-patient interaction with lag sequential analysis.
   Montague E, Xu J, Chen PY, Asan O, et al · · 2011 · cited 29× · PMID 22046723 · DOI 10.1177/0018720811405986
4. Validation of the Nasal Mucus Index, a novel measurement of acute respiratory infection severity.
   Dorresteijn PM, Muller D, Xie Y, Zhang Z, et al · · 2016 · cited 3× · PMID 27657897 · DOI 10.2500/ajra.2016.30.4337