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A New and Validated, Randomised, Controlled Placebo Water Development Trial for Medicinal Water-based Research.
Balazs Nemeth1,2, Adrienn Hanzel1, Karoly Berenyi1
1Department of Public Health Medicine, Medical School, University of Pécs, Pécs, Hungary.
In Vivo (Athens, Greece)
|August 19, 2021
Summary
This study developed an effective and affordable method to create tap water placebos for medicinal water trials. The validated placebo proved indistinguishable from medicinal water in patient assessments.
Area of Science:
- Hydrotherapy research
- Clinical trial methodology
- Evidence-based medicine
Background:
- Medicinal water efficacy trials require reliable placebos.
- Existing placebo methods may be costly or complex.
- A simple, inexpensive placebo is needed for tap water-based therapies.
Purpose of the Study:
- To develop and validate an easy-to-use and cheap placebo from tap water.
- To assess the feasibility of using tap water as a placebo in medicinal water trials.
Main Methods:
- Patients were randomized into medicinal water and tap water groups.
- A single 20-minute bath treatment was administered.
- Patients reported their perceived treatment (medicinal water, tap water, or undecided) four times during the bath.
Main Results:
- 174 patients were enrolled, with no significant differences in scores or responses between groups.
- Familiarity with the specific medicinal water did not affect correct answer rates.
- No statistically significant difference in opinion changes was observed between the groups.
Conclusions:
- The developed method effectively produces a validated placebo using tap water.
- Tap water serves as an appropriate and indistinguishable placebo in this context.
- This method supports the integrity of medicinal water efficacy trials.
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