Clinical trial NCT00065715: Echinacea Versus Placebo Effect in Common Cold (Physician Echinacea Placebo)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Common Cold
Keywords: head cold
common cold
echinacea
placebo
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2003-08-01
Enrollment: 719
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: As per Brief Summary

Eligibility 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

Primary outcomes:
measure: Duration and severity of illness, as assessed by the Wisconsin Upper Respiratory Symptom Survey (WURSS-21)
timeFrame: twice daily during illness
Secondary outcomes:
measure: SF-8 general health-related quality of life
timeFrame: daily during illness
measure: perceived stress PSS-4
timeFrame: daily during illness
measure: optimism LOT
timeFrame: two days after enrollment
measure: patient satisfaction CARE
timeFrame: after doctor patient interaction
measure: feeling thermometer - EuroQol VAS
timeFrame: daily during illness
measure: IL-8 (inflammatory cytokine)from nasal wash
timeFrame: 2 days after enrollment
measure: neutrophil count from nasal wash
timeFrame: two days after enrollment
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison Department of Family Medicine
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Bruce Barrett, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.