Abstract
Background: Although clinical trials are needed to evaluate the efficacy of liquid herbal medicinal products, design of feasible placebos that mimic the appearance, taste, and smell of such products is particularly challenging. Objective: The design and feasibility of a liquid placebo for STW5, an herbal medicinal product used for various gastrointestinal problems, was explored in this study. Design: Four sample products-STW5, a fresh and aged version of a placebo made from a seasoning mix (Maggi™), and a placebo with aged artificial flavor and food coloring-were compared in two organoleptic (sensory), single-blind trials with a total of 60 (N=60) healthy volunteers (n1=30, n2=30). Measurements: The appearance, smell, and taste of each solution were evaluated using a Likert scale questionnaire. Results: The liquid placebos evaluated were similar in regard to appearance, smell, and taste. However, participants indicated that for a clinical trial with STW5, the aged Maggi™ placebo would be more viable compared to the fresh Maggi placebo or the aged artificial food coloring placebo with licorice flavor. Participants also noted that the mint flavor and smell of STW5 was distinctly different from the placebo solutions. Limitations: The trials were conducted in healthy volunteers, not in actual patients. Conclusions: The aged Maggi™ liquid mix may be more favorable as a placebo than the artificially created one. However, further adjustment will need to be made to the Maggi™ placebo to simulate the complex aromatic composition of STW5 for clinical studies in the future.
| Original language | English |
|---|---|
| Pages (from-to) | 267-274 |
| Number of pages | 8 |
| Journal | Complementary Therapies in Medicine |
| Volume | 20 |
| Issue number | 5 |
| DOIs | |
| State | Published - Oct 1 2012 |
| Externally published | Yes |
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Keywords
- Herbal product
- Irritable bowel syndrome
- Liquid herbal
- Placebo
- STW5
ASJC Scopus subject areas
- Complementary and alternative medicine
- Advanced and Specialized Nursing
- Complementary and Manual Therapy
Cite this
Clinical evaluation of liquid placebos for an herbal supplement, STW5, in healthy volunteers. / Yoon, Saunjoo L.; Grundmann, Oliver; Keane, Devan; Urbano, Theodore; Moshiree, Baharak.
In: Complementary Therapies in Medicine, Vol. 20, No. 5, 01.10.2012, p. 267-274.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Clinical evaluation of liquid placebos for an herbal supplement, STW5, in healthy volunteers
AU - Yoon, Saunjoo L.
AU - Grundmann, Oliver
AU - Keane, Devan
AU - Urbano, Theodore
AU - Moshiree, Baharak
PY - 2012/10/1
Y1 - 2012/10/1
N2 - Background: Although clinical trials are needed to evaluate the efficacy of liquid herbal medicinal products, design of feasible placebos that mimic the appearance, taste, and smell of such products is particularly challenging. Objective: The design and feasibility of a liquid placebo for STW5, an herbal medicinal product used for various gastrointestinal problems, was explored in this study. Design: Four sample products-STW5, a fresh and aged version of a placebo made from a seasoning mix (Maggi™), and a placebo with aged artificial flavor and food coloring-were compared in two organoleptic (sensory), single-blind trials with a total of 60 (N=60) healthy volunteers (n1=30, n2=30). Measurements: The appearance, smell, and taste of each solution were evaluated using a Likert scale questionnaire. Results: The liquid placebos evaluated were similar in regard to appearance, smell, and taste. However, participants indicated that for a clinical trial with STW5, the aged Maggi™ placebo would be more viable compared to the fresh Maggi placebo or the aged artificial food coloring placebo with licorice flavor. Participants also noted that the mint flavor and smell of STW5 was distinctly different from the placebo solutions. Limitations: The trials were conducted in healthy volunteers, not in actual patients. Conclusions: The aged Maggi™ liquid mix may be more favorable as a placebo than the artificially created one. However, further adjustment will need to be made to the Maggi™ placebo to simulate the complex aromatic composition of STW5 for clinical studies in the future.
AB - Background: Although clinical trials are needed to evaluate the efficacy of liquid herbal medicinal products, design of feasible placebos that mimic the appearance, taste, and smell of such products is particularly challenging. Objective: The design and feasibility of a liquid placebo for STW5, an herbal medicinal product used for various gastrointestinal problems, was explored in this study. Design: Four sample products-STW5, a fresh and aged version of a placebo made from a seasoning mix (Maggi™), and a placebo with aged artificial flavor and food coloring-were compared in two organoleptic (sensory), single-blind trials with a total of 60 (N=60) healthy volunteers (n1=30, n2=30). Measurements: The appearance, smell, and taste of each solution were evaluated using a Likert scale questionnaire. Results: The liquid placebos evaluated were similar in regard to appearance, smell, and taste. However, participants indicated that for a clinical trial with STW5, the aged Maggi™ placebo would be more viable compared to the fresh Maggi placebo or the aged artificial food coloring placebo with licorice flavor. Participants also noted that the mint flavor and smell of STW5 was distinctly different from the placebo solutions. Limitations: The trials were conducted in healthy volunteers, not in actual patients. Conclusions: The aged Maggi™ liquid mix may be more favorable as a placebo than the artificially created one. However, further adjustment will need to be made to the Maggi™ placebo to simulate the complex aromatic composition of STW5 for clinical studies in the future.
KW - Herbal product
KW - Irritable bowel syndrome
KW - Liquid herbal
KW - Placebo
KW - STW5
UR - http://www.scopus.com/inward/record.url?scp=84864741983&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84864741983&partnerID=8YFLogxK
U2 - 10.1016/j.ctim.2012.04.003
DO - 10.1016/j.ctim.2012.04.003
M3 - Article
VL - 20
SP - 267
EP - 274
JO - Complementary Therapies in Medicine
JF - Complementary Therapies in Medicine
SN - 0965-2299
IS - 5
ER -