A methodological exploration of evaluating placebo blinding simulation effect in a clinical trial of whole nutrition formulas
10.3760/cma.j.cn115822-20230427-00069
- VernacularTitle:一项全营养配方临床试验中关于安慰剂设盲模拟效果评价的方法学探索
- Author:
Jie YUAN
1
;
Xiayan CHEN
;
Huijuan LI
Author Information
1. 北京大学临床研究所 100191
- Keywords:
Placebo;
Blinding;
Clinical trial;
Simulation effect;
Evaluation
- From:
Chinese Journal of Clinical Nutrition
2023;31(5):307-311
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the simulation effect of the placebo in a clinical trial of whole nutrition formula, and to inform the preparation of placebo in the clinical trial of foods for special medical purposes.Methods:Evaluators assessed the appearance, color, smell, and taste, and made the distinction between the placebo and the experimental product independently. The similarity and consistency between the placebo and experimental product were also assessed using a manual scoring method.Results:In the group assessing experimental product, 40% evaluators made the correct judgment while 50% did not. In the group assessing placebo, 10% evaluators made the correct judgment while 70% did not. Compared with the reference product, the experimental product and placebo were scored 9.75±0.79 vs. 6.63±3.73 for appearance, 9.75±0.79 vs. 7.25±3.99 for color, 8.75±3.17 vs. 8.50±3.16 for smell, and 9.00±1.29 vs. 7.75±2.99 for taste. The intra-evaluator consistency rate for the appearance, color, smell and taste of different products was 80%, 80%, 90%, and 90%, respectively. Conclusions:The blinding effect of placebo was relatively satisfactory in the trial we assessed. The placebo was comparable with the experimental product in terms of color, smell, and taste, but not appearance. The approaches for preparing and evaluating placebo in this clinical trial could give some clues for similar trials involving foods for special medical purposes.
