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

• ClinicalTrials.gov Identifier: NCT00065715
• Recruitment Status: Completed
• First Posted: August 1, 2003
• Last Update Posted: December 4, 2014
• Sponsor: University of Wisconsin, Madison
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): University of Wisconsin, Madison

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Common Cold	Dietary Supplement: Echinacea; Other: Blinded placebo	Phase 3

Detailed Description:

As per Brief Summary

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 719 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Placebo: Physician or Pill? A Randomized Trial in a Common Cold Model Funded by NIH NCCAM Under RFA "The Placebo Effect in Clinical Practice"
• Study Start Date: September 2003
• Actual Primary Completion Date: August 2008
• Actual Study Completion Date: April 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Duration and severity of illness, as assessed by the Wisconsin Upper Respiratory Symptom Survey (WURSS-21) [ Time Frame: twice daily during illness ]

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Wisconsin

University of Wisconsin-Madison Department of Family Medicine

Madison, Wisconsin, United States, 53706-1490

Sponsors and Collaborators

University of Wisconsin, Madison

National Center for Complementary and Integrative Health (NCCIH)

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Bruce Barrett, MD PhD; University of Wisconsin, Madison

More Information

Additional Information:

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00065715
• Other Study ID Numbers: R01AT001428 ( U.S. NIH Grant/Contract ); R01AT001428 ( U.S. NIH Grant/Contract ); BarrettB
• First Posted: August 1, 2003
• Last Update Posted: December 4, 2014
• Last Verified: December 2014

Keywords provided by University of Wisconsin, Madison:

head cold; common cold; echinacea; placebo

Additional relevant MeSH terms:

Common Cold; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases