Echinacea Versus Placebo Effect in Common Cold (Physician Echinacea Placebo) (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"

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.

Study Overview

• Status: Completed
• Conditions: Common Cold
• Intervention / Treatment: Other: Blinded placebo; Dietary supplement: Echinacea

Detailed Description

As per Brief Summary

• Study Type: Interventional
• Enrollment (Actual): 719
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53706-1490
      • University of Wisconsin-Madison Department of Family Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Suspected or known cold
• At least one of the following cold symptoms:

nasal discharge, nasal congestion, sneezing, or sore throat

• Enrolled in school, for children 12 to 17 years of age

Exclusion criteria:

• Pregnancy;
• Symptom duration > 36 hrs
• Concurrent use of antibiotics, antivirals, nasal steroids, decongestants or antihistamines;
• Anticipated need for symptom-relieving meds during cold
• Autoimmune/deficiency disease
• History of allergic rhinitis with current eye itching/sneezing
• History of asthma w/current cough/SOB
• Prior study entry
• Allergy to Echinacea

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: A; No pills
Placebo Comparator: B; Blinded placebo	Other: Blinded placebo; Blinded placebo - Coated tablet
Experimental: C; Echinacea - Blinded	Dietary supplement: Echinacea; Echinacea phytochemical profile Each tablet is comprised of the equivalent of 1275 mg of echinacea root, as follows: A) Echinacea purpurea - 675 mg root yields 112.5 mg dried extract, standardized to contain 2.1mg alkamides. B) Echinacea angustifolia - 600 mg root yields 150 mg dried extract, standardized to contain 2.0 mg alkamides. Each batch of tablets is analyzed by Reversed Phase - High Peformance Liquid Chromatography to determine the levels of alkamides and caffeic derivatives present. Caffeic acid derivative levels are typically as follows: caftaric acid = 0.5 to 2.0 mg/tablet; cichoric acid = 3.4 to 8.5 mg/tablet; chlorogenic acid = < 0.5 mg/tablet; dicaffeoyl quinic acids (including cynarin) = 0.7 to 2.0 mg/tablet; echinacoside = 1.0 to 1.7 mg/tablet
Experimental: D; Echinacea - Unblinded, Open Label	Dietary supplement: Echinacea; Echinacea phytochemical profile Each tablet is comprised of the equivalent of 1275 mg of echinacea root, as follows: A) Echinacea purpurea - 675 mg root yields 112.5 mg dried extract, standardized to contain 2.1mg alkamides. B) Echinacea angustifolia - 600 mg root yields 150 mg dried extract, standardized to contain 2.0 mg alkamides. Each batch of tablets is analyzed by Reversed Phase - High Peformance Liquid Chromatography to determine the levels of alkamides and caffeic derivatives present. Caffeic acid derivative levels are typically as follows: caftaric acid = 0.5 to 2.0 mg/tablet; cichoric acid = 3.4 to 8.5 mg/tablet; chlorogenic acid = < 0.5 mg/tablet; dicaffeoyl quinic acids (including cynarin) = 0.7 to 2.0 mg/tablet; echinacoside = 1.0 to 1.7 mg/tablet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
SF-8 general health-related quality of life	daily during illness
perceived stress PSS-4	daily during illness
optimism LOT	two days after enrollment
patient satisfaction CARE	after doctor patient interaction
feeling thermometer - EuroQol VAS	daily during illness
IL-8 (inflammatory cytokine)from nasal wash	2 days after enrollment
neutrophil count from nasal wash	two days after enrollment

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Bruce Barrett, MD PhD, University of Wisconsin, Madison

Publications and helpful links

General Publications

• Montague E, Xu J, Chen PY, Asan O, Barrett BP, Chewning B. Modeling eye gaze patterns in clinician-patient interaction with lag sequential analysis. Hum Factors. 2011 Oct;53(5):502-16. doi: 10.1177/0018720811405986.
• Barrett B, Brown R, Rakel D, Mundt M, Bone K, Barlow S, Ewers T. Echinacea for treating the common cold: a randomized trial. Ann Intern Med. 2010 Dec 21;153(12):769-77. doi: 10.7326/0003-4819-153-12-201012210-00003.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: July 31, 2003
• First Submitted That Met QC Criteria: July 31, 2003
• First Posted (Estimate): August 1, 2003

Study Record Updates

• Last Update Posted (Estimate): December 4, 2014
• Last Update Submitted That Met QC Criteria: December 3, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: placebo; common cold; head cold; echinacea
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Picornaviridae Infections; Common Cold
• Other Study ID Numbers: R01AT001428 (U.S. NIH Grant/Contract); BarrettB