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| A literature study on the design and evaluation techniques of clinical trials for infantile anorexia |
| Hits 1300 Download times 982 Received:March 10, 2020 |
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| DOI
10.11656/j.issn.1672-1519.2020.05.15 |
| Key Words
infant;children;anorexia;feeding disorder;eating disorder;clinical trials;randomized |
| Author Name | Affiliation | E-mail | | QIU Yapeng | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China | | | LI Xiaoxuan | Tianjin Binhai New Area Women and Children Health and Family Planning Service Center, Tianjin 300459, China | | | CAI Qiuhan | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China | | | HU Siyuan | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China | husiyuan1963@sina.com |
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| Abstract
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| [Objective] To systematically evaluate and refine the technical points of clinical trial design and evaluation of infantile anorexia,so as to provide feasibility for the standardization of trial design and the comparison of trial results.[Methods] The radomized controlled trial(RCT) literatures of infantile anorexia/anorexia and its related diseases were searched in the authoritative database at home and abroad. The included literature required compliance with the diagnostic criteria for anorexia and related diseases. The intervention measures were Chinese medicine,chemical medicine and behavior therapy,and the languages were Chinese and English.[Results] A total of 1321 articles were retrieved and 21 were included. In its clinical positioning,14 domestic studies have focused on improving anorexia or increasing food intake,while 3 items were exploring the improvement of growth and nutritional status,7 foreign studies were mainly focused on improving feeding behavior,anorexia symptoms,food intake,child growth and nutritional status,which were 4 items,1 item,1 item and 1 item respectively. The overall design of the trial included 14 items of positive drugs,4 items of placebo,1 item of behavioral therapy and 2 items of blank control,10 items of double-blind method,9 items of multicenter trial,1 item of sample size estimation,19 items of difference test,1 item of non-inferiority test and 1 item of superiority test. The diagnostic criteria of Chinese and Western medicine mainly refer to or comply with the World Health Organization(WHO) international classification of diseases,professional societies or authoritative books at home and abroad,as well as the standard of teaching materials compiled by Chinese colleges and universities. Participants were selected with 21 items,18 items and 7 items respectively for inclusion criteria,exclusion criteria and shedding criteria. The intervention measures included 11 items of traditional Chinese medicine,4 items of chemical drugs,3 items of behavioral intervention and 3 items of combined therapy,and the course of treatment ranged from 10 days to 8 weeks,mostly from 2 to 4 weeks. Effectiveness evaluation,in 14 domestic studies,comprehensive evaluation of appetite appetite improvement was mainly 8 items,and overall evaluation of traditional Chinese medicine symptoms was 6 items;in 7 foreign studies,4 items were mainly evaluated by feeding behavior scale;improved appetite loss,tube feeding and oral caloric ratio,and body weight as the main indicators were 1 item respectively. Safety observation,there are 12 items have clear index design. In addition,there was only one was expressed in ethical approval in all 21 studies.[Conclusion] The RCT literature included in this paper has perfect information and high quality,and the research results cover the basic elements of clinical trial design of traditional Chinese medicine for children with anorexia,which can be used for reference value. |
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