¹The First Clinical Medical College of Shandong University of Traditional Chinese Medicine, Jinan, 250014, China
²Liaocheng Traditional Chinese Medicine Hospital, Shandong Province, Jinan, 252000, China
³Department of Endocrinology, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, 250014, China

*Corresponding Author: Yanqin Huang, Department of Endocrinology, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, 250014, China.

Received: January 03, 2025; Published: February 14, 2025

Abstract

Background: This study selected the use of modified Shen-Ling baizhusan combined with external treatment as the research objective of a randomized controlled trial (RCT) on obese patients in the experimental group, and conducted meta-analysis. The effectiveness of the TSA method was further verified through sequential analysis of the experiment. The aim of this study is to evaluate the effect of modified Shen-Ling baizhusan combined with external treatment on obese patients, and to provide scientific evidence support for its clinical application.

Methods: This Meta is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors.

Retrieve randomized clinical trials published before May 31, 2024, on the treatment of obesity with modified Atractylodes macrocephala combined with external treatment, from the following Chinese and English databases: China National Knowledge Infrastructure (CNKI), Wanfang Database, China Science and Technology Journal Database (VIP), China Biomedical Literature Database (CBM), PubMed, Cochrane Library, Web of Science, and Scopus. According to the inclusion and exclusion criteria, the randomized controlled trials (RCT) that met the criteria were screened. The Cochrane handbook was used for the risk assessment，and the Revman 5.4 software was used for Meta analysis, the TSA 0.9 Beta software was used for sequential analysis.

Protocol and Registration: This Meta was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist. We registered the process of our review on the INPLASY website (http://inplasy.com) under registration number INPLASY202490032.

Results: The Meta-analysis results showed that the treatment group had done much better than controlled group at increasing the effective rate. The sequential analysis showed that the effective rate of the treatment group was higher than that of the controlied group with the possibility of false positive and more trials needed to be included for validation, but it confirmed the treatment group was more effective in total effective rate and BMI than the controlied group.

Conclusion: Based on existing research evidence, we need to improve the quality of RCT treatment for obesity using modified Shen-Ling baizhusan combined with external treatment. Meta analysis shows that the combination of modified Shen-Ling baizhusan and external treatment is superior to conventional treatment in terms of total effective rate, BMI, HDL, TC, TG, and FINS in the treatment of obesity. The TSA analysis further confirms the reliability of the above viewpoint.

 Keywords: Obesity; Overweight; Shen-Ling baizhusan; External Treatment; Meta-Analysis; TSA Trial Sequential Analysis; Randomized Controlled Trial

References

1. Wu Ziting., et al. “Epigenetic changes in obesity immune inflammation genes and regulation of traditional Chinese medicine”. Jiangxi Traditional Chinese Medicine2 (2023): 9-13.
2. Huang Qi., et al. “Genetic and epigenetic modification mechanisms of obesity”. Journal of Huazhong University of Science and Technology (Medical Edition)5: 644-647.
3. Piché Marie-Eve., et al. “Obesity Phenotypes, Diabetes, and Cardiovascular Diseases”. Circulation Research11 (2020): 1477-1500.
4. Perdomo Carolina M., et al. “Contemporary medical, device, and surgical therapies for obesity in adults”. Lancet (London, England), (2023).
5. Zhao Jie., et al. “Observation on the therapeutic effect of Wuling powder on type 2 diabetes with obesity of spleen deficiency and dampness excess”. Shanxi Traditional Chinese Medicine4 (2024): 22-24.
6. Wang Yufang., et al. “Observation on the therapeutic effect of Shenling Baizhu powder combined with acupoint catgut embedding in the treatment of simple obesity”. Hebei Medical Journal4 (2021): 664-669.
7. Ye Jinzhu. “Observation on the therapeutic effect of Shenling Baizhu Powder on obesity type 2 diabetes with spleen deficiency and dampness stagnation”. North Pharmaceutical Journal5 (2021): 52-53.
8. Zheng Ying and Tang Hongzhen. “Research progress on external use of traditional Chinese medicine for the treatment of simple obesity”. Guangxi Medical Journal15 (2020): 2008-2010.
9. Lin Tong and Liu Min. “Research on the Treatment of Simple Obesity with Traditional Chinese Medicine”. Chinese Journal of Basic Medicine of Traditional Chinese Medicine 6 (2021): 1036-1040.
10. Li Hui., et al. “Comprehensive diagnosis and treatment ideas and methods of traditional Chinese medicine for simple obesity”. Journal of Practical Traditional Chinese Medicine Internal Medicine11 (2023): 105-108.
11. Piché Marie-Eve., et al. “Obesity Phenotypes, Diabetes, and Cardiovascular Diseases”. Circulation Research11 (2020): 1477-1500.
12. Hernandez Adrian V., et al. “Meta-Analysis”. Chest1S (2020): S97-S102.
13. Mheissen Samer. “Trial sequential analysis: A simple guide for judging the conclusiveness of the effect”. Journal of Orthodontics (2024).
14. Ulijaszek Stanley. “Translating models of obesity to tackle common obesity”. Science Translational Medicine (2023).
15. Li Chang., et al. “The Mechanism of Traditional Chinese Medicine for the Treatment of Obesity”. Diabetes, Metabolic Syndrome and Obesity : Targets and Therapy 13 (2020).
16. Wang Chenye., et al. “The effect of modified Cangfu Daotan Tang combined with acupuncture on glucose and lipid metabolism and ovulation rate in obese patients with polycystic ovary syndrome”. Journal of Modern Integrated Chinese and Western Medicine36 (2016): 4056-4058
17. Su Jian., et al. “The effect of combined acupuncture and medicine on insulin resistance in obese polycystic ovary syndrome”. Shandong Journal of Traditional Chinese Medicine1 (2019): 30-32.
18. Bian Yunying. “Clinical study on the combination of traditional Chinese medicine and acupoint thread embedding treatment for obese polycystic ovary syndrome”. Chinese Academy of Traditional Chinese Medicine (2023).
19. Han Lulu., et al. “Clinical observation of Jianpi Tiaogan Yin combined with Yiyi navel acupuncture in the treatment of simple obesity with liver depression and spleen deficiency type”. Journal of Guangzhou University of Traditional Chinese Medicine1 (2022): 111-117.
20. Lin Chenjuan., et al. “Acupoint catgut embedding combined with modified Shen-Ling baizhusan powder for the treatment of 30 cases of simple obesity with spleen deficiency and dampness obstruction syndrome”. Zhejiang Journal of Traditional Chinese Medicine3 (2022): 217-218.
21. , et al. “Observation on the therapeutic effect of modified Peilian Ma Huang Fang combined with acupoint catgut embedding in the treatment of simple obesity with stomach heat and dampness obstruction syndrome”. Introduction to Traditional Chinese Medicine 29.12 (2023): 67-71
22. Huang Xiaojie., et al. “Analysis of the therapeutic effect of acupuncture combined with traditional Chinese medicine ointment on simple obesity”. Chinese and Foreign Medical Journal15 (2019): 169-172.

Citation

Citation: Yanqin Huang., et al. “Efficacy and Safety of Shen-Ling Baizhusan Combined with External Treatment for Obesity：A Systematic Review and Meta-Analysis with Trial Sequential Analysis”.Acta Scientific Medical Sciences 9.3 (2025): 76-86.

Copyright

Copyright: © 2025 Yanqin Huang., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.