Jump to content

Choose locationChoose Location
  • Sign in or Enroll
    • Open I want to choose my medical group or hospital
    • Clear my location
Change Location

We've expanded your view

You are now viewing all services in the Sutter Health network. You can change your location above to narrow your view to a medical group, hospital, city or zip.
Sutter Health
  • Video Visits
  • Find Doctors
  • Find Locations
  • Treatments & Services
  • Locations
  • Sign in or Enroll
    • Video Visits
    • Find Doctors
    • Find Locations
    • Treatments & Services
    • COVID-19 Resources
    • Pay a Bill
    • Symptom Checker
    • Get Care Today
    • Diseases & Conditions
    • Health & Wellness
    • Classes & Events
    • Research & Clinical Trials
    • For Patients
    • About Sutter Health
    • Giving
    • Volunteering
    • Careers
    • News
    • For Medical Professionals
    • Other Business Services
Close Search
  • Home
  • Research
  • Biostatistics
Content

Randomized placebo-controlled placebo trial to determine the placebo effect size.

Description

Gerdesmeyer L, Klueter T, Rahlfs VW, Muderis MA, Saxena A, Gollwitzer H, Harrasser N, Stukenberg M, Prehn-Kristensen A., Pain Physician. 20(5):387-396., 2017 Jul 01

Investigators

Amol Saxena, DPM

Abstract

BACKGROUND: It is the gold standard to use a placebo treatment as the control group in prospective randomized controlled trials (RCTs). Although placebo-controlled trials can reveal an effect of an active treatment, the pure effect of a placebo treatment alone has never been presented or evaluated. No evidence-based, placebo-therapeutic options are currently available, and no placebo-controlled trials have been performed to elucidate the pure placebo effect.

OBJECTIVES: To analyze the pure placebo effect on clinical, chronic pain through a blinded RCT.

STUDY DESIGN: A prospective, randomized, placebo-controlled trial.

SETTING: Medical University centers.

METHODS: One-hundred eighty-two patients suffering from chronic plantar heel pain for over 6 months,who failed to respond to conservative treatments, were screened and 106 of these patients were enrolled into this study. The patients were randomly assigned to receive either a blinded placebo shockwave treatment or an unblinded placebo shockwave treatment. The primary outcome measure was the differences in percentage change of visual analogue scale (VAS) scores 6 weeks after the intervention. The secondary outcome measure was the differences in Roles and Maudsley pain score (RMS) 6 weeks after intervention. As an exploratory outcome, 2-sided group comparisons for baseline characteristics between active treatment and controls were done using the Mann-Whitney-U tests for group comparisons; treatment efficiency was calculated by the effect size coefficient and benchmarks for the Mann-Whitney estimator according to the t-test of 2 independent samples for quantitative data, as well as the Fisher's exact test for binary data.

RESULTS: Patients from both groups did not differ with respect to heel pain ratings at baseline, for both the VAS (P = .476) and RMS (P = .810) scores. After 6 weeks, patients receiving the blinded placebo treatment reported less heel pain on both scales (VAS: P = .031; RMS: P = .004). Change scores of pain ratings were significantly higher in the blinded placebo group than in the un-blinded placebo group (VAS: P = .002; RMS: P = .002).

LIMITATIONS: As the study represents the first to use an inverse placebo RCT (IPRCT), further conceptual and methodological issues need to be addressed to describe detailed, underlying mechanisms. Specific contextual, intrapersonal, and interpersonal factors modulating the placebo effects should be addressed in future IPRCTs.

CONCLUSIONS: The present study indicated that true placebo effect sizes can be analyzed through a proper IPRCT design. Instead of treating high numbers of patients with placebos in a RCT, which increases the risk for subjects not receiving the active treatment, the IPRCT technique seems to be much more appropriate to analyze the effect sizes of any active treatment, in accordance with the Good Clinical Practice guidelines and Declarations of Helsinki.

Pubmed Abstract

Pubmed AbstractOpens New Window

Associated Topics

  • Biostatistics
  • Musculoskeletal Disorders
  • Pain

Related Publications

Using variable importance measures from causal inference to rank risk factors of schistosomiasis infection in a rural setting in China.

Sudat SE, Carlton EJ, Seto EY, Spear RC, Hubbard AE.
Epidemiol Perspect Innov. 7:3. doi: 10.1186/1742-5573-7-3.
2010 Jul 14

Predicting all-cause risk of 30-day hospital readmission using artificial neural networks.

Jamei M, Nisnevich A, Wetchler E, Sudat S, Liu E.
PLoS One. 12(7):e0181173. doi: 10.1371/journal.pone.0181173. eCollection 2017.
2017 Jul 14

Predicting need for advanced illness or palliative care in a primary care population using electronic health record data.

Jung K, Sudat SEK, Kwon N, Stewart WF, Shan NH.
J Biomed Inform. 92:103115.
2019 Apr 01

Causal inference and prediction in health studies: environmental exposures and schistosomiasis, HIV-1 genotypic susceptibility scores and virologic suppression, and risk of hospital readmission for heart failure patients.

Sudat, S.
UC Berkeley. ProQuest ID: Sudat_berkeley_0028E_12729. Merritt ID: ark:/13030/m5xw4pw5. Retrieved from https://escholarship.org/uc/item/9z03362s
2012 Jun 01

A comparison of two worlds: How does Bayes hold up to the status quo for the analysis of clinical trials?

Pressman AR, Avins AL, Hubbard A, Satariano WA.
Contemp Clin Trials. 32(4):561-8. doi: 10.1016/j.cct.2011.03.010. Epub 2011 Mar 29.
2011 Jul 01
The Sutter Health Network of Care
Expertise to fit your needs
Primary Care

Check-ups, screenings and sick visits for adults and children.

Specialty Care

Expertise and advanced technologies in all areas of medicine.

Emergency Care

For serious accidents, injuries and conditions that require immediate medical care.

Urgent Care

After-hours, weekend and holiday services.

Walk-In Care

Convenient walk-in care clinics for your non-urgent health needs.

About Sutter

  • About Our Network
  • Annual Report
  • Awards
  • Community Benefit
  • Contact Us
  • News
  • Giving
  • Find Care

  • Birth Centers
  • Care Centers
  • Emergency Rooms
  • Hospitals
  • Imaging
  • Labs
  • Surgery Centers
  • Urgent Care
  • Walk-In Care
  • View All >
  • Featured Services

  • Behavioral Health
  • Cancer Services
  • Family Medicine
  • Home Health and Hospice
  • Orthopedics
  • Pediatrics
  • Pregnancy
  • Primary Care
  • Women's Health
  • View All >
  • Patient Resources

  • Accepted Health Plans
  • Classes and Events
  • Estimate Costs
  • Flu Resources
  • Health and Wellness
  • Medical Records
  • Medicare
  • My Health Online
  • Pay a Bill
  • Symptom Checker
  • Our Team

  • For Employees
  • Physician Careers
  • Recruiting Events
  • Sutter Careers
  • Vendors
  • Volunteers
    • ADA Accessibility
    • Contact
    • Privacy
    • Do Not Sell My Personal Information

    • LinkedIn Opens new window
    • YouTube Opens new window
    • Facebook Opens new window
    • Twitter Opens new window
    • Glassdoor Opens new window
    • Instagram Opens new window

    Copyright © 2021 Sutter Health. All rights reserved. Sutter Health is a registered trademark of Sutter Health ®, Reg. U.S. Patent & Trademark office.

    Cookie Policy

    We use cookies to give you the best possible user experience. By continuing to use the site, you agree to the use of cookies. Privacy Policy Cookie Preferences

    Privacy Policy Cookie Preferences