Hegemony of economic values in conducting clinical trials with a placebo‐control group to investigate the treatment of periodontitis in lower‐middle‐income countries

2021 ◽  
Author(s):  
Carlos M. Ardila ◽  
Constanza E. Ovalle
Keyword(s):  
Clinical Trials ◽  
Control Group ◽  
Placebo Control ◽  
Economic Values ◽  
Middle Income ◽  
Middle Income Countries ◽  
Placebo Control Group

scholarly journals Effectiveness of Dentist-Prescribed, Home-Applied Tooth Whitening, A Meta-analysis

1999 ◽  
Vol 1 (4) ◽  
pp. 34-49 ◽  
Author(s):  
Richard Niederman ◽  
Maggie C. Tantraphol ◽  
Patricia Slnin ◽  
Catherine Hayes ◽  
Suzy Conway
Keyword(s):  
Clinical Trials ◽  
Meta Analysis ◽  
Control Group ◽  
Placebo Control ◽  
List Type ◽  
Tooth Whitening ◽  
Clinical Applicability ◽  
Placebo Control Group ◽  
The People ◽  
Shade Guide

Abstract Introduction Common clinical experience suggests that tooth whitening agents are 100% effective. This study uses meta-analysis of data from published randomized controlled clinical trials to determine the efficacy of tooth whitening agents. Methods A MEDLINE search strategy was developed and implemented to systematically identify clinical trials on dentist-prescribed, home-applied tooth whitening agents, using 10% carbamide peroxide, published between 1989-1999. Inclusion criteria (e.g., in English, human clinical trials) and exclusion criteria (e.g., not placebo controlled) were established and clinical trials that met these criteria were critically appraised for validity and clinical applicability. Meta-analysis was then used to quantitatively integrate the findings. Results Seven studies were identified that met the inclusion and validity criteria. These studies indicated that: Whitening results in a significant mean change of 6 4 shade guide units (p < 0.01), while the placebo control group exhibited little change (0.7 0.6, p > 0.05). 93% of the bleached patients exhibited 2 shade guide unit change, while 20% of the placebo control group exhibited this change. The brand of bleaching agent had a significant effect on tooth whitening, but the daily application time and duration of treatment did not. Whitening is maintained for 6 months for 1/2 of the people treated. Neither gingival indices nor plaque indices were adversely or favorably affected by bleaching. Clinical Applicability The data from the reviewed studies indicate that rather than being 100% effective, on average: 73% (93% for bleached group minus 20% placebo group) of people who whiten their teeth will exhibit a whitening that is 2 shade guide units greater than the placebo. 20% of the people who use dentist-prescribed, home-applied bleaching will achieve a mean whitening effect of 5 shade guide units. Re-treatment for 50% of people may be necessary to maintain this effect longer than 6 months. The methods used here are Internet applicable for other clinical topics.

ESTIMATING EFFECTS OF SYSTEMATIC TREATMENT ON RENAL FAILURE AND DEATH WITHOUT A PARALLEL PLACEBO CONTROL GROUP

Nephrology ◽  
2000 ◽  
Vol 5 (3) ◽  
pp. A97-A97
Author(s):  
Hoy We ◽  
Baker P ◽  
Wang Z ◽  
Cass A ◽  
Mathews Jd ◽  
...  
Keyword(s):  
Renal Failure ◽  
Control Group ◽  
Placebo Control ◽  
Systematic Treatment ◽  
Placebo Control Group

Use of a placebo in clinical trials

1998 ◽  
Vol 13 (5) ◽  
pp. 254-263 ◽  
Author(s):  
G Emilien ◽  
JM Maloteaux ◽  
A Seghers ◽  
G Charles
Keyword(s):  
Clinical Trials ◽  
Placebo Response ◽  
Drug Efficacy ◽  
Placebo Treatment ◽  
High Response Rate ◽  
Experimental Methodology ◽  
Necessary Condition ◽  
Control Group ◽  
Placebo Control ◽  
Experimental Drug

SummaryThe use of a placebo control group in the evaluation of a new product is today considered by most as a necessary condition of experimental drug research. Placebo response is an essential consideration in all clinical trials. If not properly controlled, incorrect and dangerous conclusion may be inferred for a product efficacy and safety profile. However, the inclusion of a placebo group in clinical trials in neuropsychiatric research raises several ethical and scientific questions. Whereas in certain indications, such as suicidal patients and severe and psychotic depression, the use of a placebo is generally not accepted, it is difficult to assess drug efficacy. This article discusses the concept of placebo in clinical trials, the occurrence of adverse events after placebo treatment and the high response rate of placebo in neuropsychiatric clinical research. The experimental methodology to adequately control all the factors involved is also analysed and discussed.

scholarly journals Using pictorial action instructions to build a basic humanitarian engineering project

2019 ◽  
Vol 14 (1) ◽  
pp. 60-70
Author(s):  
Kathleen Paco Cadman ◽  
Du Feng
Keyword(s):  
Self Efficacy ◽  
Intervention Group ◽  
Control Group ◽  
Low Literacy ◽  
Engineering Project ◽  
Middle Income ◽  
Middle Income Countries ◽  
Humanitarian Engineering ◽  
Engineering Projects ◽  
Low And Middle Income

Humanitarian engineering projects mitigate environmental hazards disproportionately affecting health in low- and middle-income countries. However, widespread literacy deficits can create barriers in training low-literacy adults to construct these projects, indicating a need for literacy-adapted training materials. A randomized control trial in rural Guatemala tested the usability of pictorial action instructions, compared to demonstration-only methods, in training low-literacy adults (N = 60; n = 30 per group) to construct a solar bottle bulb. Fourteen days after the training, participants individually constructed the solar bottle bulb. The intervention group received pictorial action instructions to guide them, and the control group completed construction based on memory. Usability was evaluated by measuring the effectiveness and efficiency of construction, as well as user satisfaction and self-efficacy levels. Effectiveness and self-efficacy were significantly better among those in the intervention group compared to the control group. Considering this, the findings support the use of pictorial action instructions in training low-literacy adults to construct humanitarian engineering projects. This method may allow more individuals in rural regions of low- and middle-income countries to successfully construct their own humanitarian engineering projects in a way that is sustainable and scalable. Further research is needed to test these instructions in different settings, on a larger scale, as well as to test the long-term effects of using pictorial action instructions. 

scholarly journals Efficacy and Safety of Ejiao (Asini Corii Colla) in Women With Blood Deficient Symptoms: A Randomized, Double-Blind, and Placebo-Controlled Clinical Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Li Zhang ◽  
Zhongju Xu ◽  
Tao Jiang ◽  
Jialu Zhang ◽  
Pinxian Huang ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Blood Cell ◽  
Control Group ◽  
Placebo Control ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Placebo Control Group ◽  
Sf 36

Equus asinus L [Equidae; Asini Corii Colla] (donkey-hide gelatin, Ejiao), a well-known traditional Chinese medicine, has been widely used to nourish the blood, especially for women. The aim of this study was to assess the efficacy and safety of Ejiao in blood-deficient patients. A total of 210 participants were recruited and randomly allocated into the placebo control group and Ejiao-treated group (6 g/day). The primary outcomes on the efficacy of Ejiao included traditional Chinese medicine symptom scores, blood indicators, and SF-36. The secondary outcomes were changes in fireness and safety evaluation. Results showed that Ejiao treatment for 8 weeks had significantly improved dizziness symptoms. Among the tested 24 blood biochemical parameters, the hematocrit and red blood cell numbers decreased in the placebo control group, but decreased significantly less in the Ejiao treatment group. The white blood cell and neutrophil counts increased in the Ejiao group but were within the normal range. In addition, the quality of life improved as the scores in SF-36 domains were significantly higher in the Ejiao group. At the same time, there was no significant change in the fire–heat symptoms score or other safety parameters. Considering all these, our study showed that Ejiao has a promising effect in women suffering from blood deficiency without obvious adverse effects.

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