학술논문

Real-World Effectiveness and Safety of Hydrogen Inhalation in Chinese Patients with Type 2 Diabetes: A Single-Arm, Retrospective Study
Document Type
article
Author
Source
Diabetes, Metabolic Syndrome and Obesity, Vol Volume 16, Pp 2039-2050 (2023)
Subject
type 2 diabetes
observational study
hydrogen inhalation
glycemic control
real world study
Specialties of internal medicine
RC581-951
Language
English
ISSN
1178-7007
Abstract
Hongxiang Ji,1 Ziyi Zhao,2 Zeyu Liu,3 Ruitao Sun,3 Yuquan Li,1 Xiaoheng Ding,2 Tongshang Ni4 1College of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine, Jinan, People’s Republic of China; 2Department of Hand and Foot, Microsurgery, The Affiliated Hospital of Qingdao University, Qingdao, People’s Republic of China; 3School of Clinical Medicine, Department of Medicine, Qingdao University, Qingdao, People’s Republic of China; 4Center of Integrated Traditional Chinese and Western Medicine, School of Basic Medicine, Qingdao University, Qingdao, People’s Republic of ChinaCorrespondence: Tongshang Ni, Center of Integrated Traditional Chinese and Western Medicine, School of Basic Medicine, Qingdao University, No. 308, Ningxia Road, Qingdao, Shandong, People’s Republic of China, Email neetongshang@126.com Xiaoheng Ding, Department of Hand and Foot, Microsurgery, The Affiliated Hospital of Qingdao University, No. 59, Haier Road, Qingdao, Shandong, People’s Republic of China, Email dxhqd@126.comAim: To evaluate the real-life effectiveness and safety of Chinese patients with type 2 diabetes mellitus (T2DM) receiving hydrogen inhalation (HI) treatment as a supplementary treatment.Methods: This retrospective, multicenter, observational 6-months clinical study included T2DM patients maintaining HI, visited at 4 time points. The primary outcome is the mean change in glycated hemoglobin (HbA1c) at the end of the study compared to baseline. The secondary outcome is analyzing the mean change of fasting plasma glucose (FPG), weight, lipid profile, insulin dose and homeostasis model assessment. Linear regression and logistics regression are applied to evaluate the effect of HI after the treatment.Results: Of the 431 patients comprised, it is observed a significant decrease in HbA1c level (9.04± 0.82% at baseline to 8.30± 0.99% and 8.00± 0.80% at the end, p< 0.001), FPG (165.6± 40.2 mg/dL at baseline to 157.1± 36.3mg/dL and 143.6± 32.3mg/dL at the end, p< 0.001), weight (74.7± 7.1kg at baseline to 74.8± 10.0kg and 73.6± 8.1kg at the end, p< 0.001), insulin dose (49.3± 10.8U/d at baseline to 46.7± 8.0U/d and 45.2± 8.7U/d, p< 0.001). The individuals in subgroup with higher baseline HbA1c and longer daily HI time duration gain greater HbA1c decrease after 6 months. Linear regression shows that higher baseline HbA1c level and shorter diabetes duration are significantly in relation to greater HbA1c reduction. Logistics regression reveals that lower weight is associated with a higher possibility of reaching HbA1c< 7%. The most common adverse event is hypoglycemia.Conclusion: HI therapy significantly improves glycemic control, weight, insulin dose, lipid metabolism, β-cell function and insulin resistance of patients with type 2 diabetes after 6 months. Higher baseline HbA1c level and shorter diabetes duration is related to greater clinical response to HI.Keywords: type 2 diabetes, observational study, hydrogen inhalation, glycemic control, real-world study