Observational Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Jul 6, 2024; 12(19): 3854-3865
Published online Jul 6, 2024. doi: 10.12998/wjcc.v12.i19.3854
Therapeutic effect of San Bi Tang combined with glucosamine sulfate capsules in cold-dampness-type knee osteoarthritis
Hui-Ying Ni, Yao-Ping Zhang, Xiao-Feng Zhang
Hui-Ying Ni, Yao-Ping Zhang, Xiao-Feng Zhang, Department of Orthopedics and Traumatology, Hangzhou Fuyang Hospital of TCM Orthopedics and Traumatology, Hangzhou 311400, Zhejiang Province, China
Author contributions: Ni HY designed the study; Zhang YP performed the data collection and analysed the data; and Zhang XF wrote the manuscript; All authors reviewed the manuscript.
Institutional review board statement: This study was approved by the Medical Ethics Committee of Hangzhou Fuyang Hospital of TCM Orthopedics and Traumatology, No. 2020-LW-LC-001.
Informed consent statement: The data utilized in this study did not involve any personally identifiable information of the patients. All patient data collected, recorded, and managed were strictly for the purposes of this study and did not compromise patient welfare in any way. Therefore, the requirement for informed consent was waived by the Ethics Committee of Hangzhou Fuyang Hospital of TCM Orthopedics and Traumatology.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: Data for this study were obtained by contacting the corresponding author.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Xiao-Feng Zhang, BMed, Associate Chief Physician, Department of Orthopedics and Traumatology, Hangzhou Fuyang Hospital of TCM Orthopedics and Traumatology, No. 418 Fengpu Road, Fuchun Street, Fuyang District, Hangzhou 311400, Zhejiang Province, China. zh1x2f3@163.com
Received: April 8, 2024
Revised: May 11, 2024
Accepted: May 20, 2024
Published online: July 6, 2024
Processing time: 81 Days and 21.4 Hours
Abstract
BACKGROUND

Cold-dampness-type knee osteoarthritis is a common middle-aged and elderly disease, but its pathogenesis is not fully understood, and its clinical treatment has limitations. Glucosamine sulfate capsules are commonly used for treating arthritis, and San Bi Tang is a classic formula of traditional Chinese medicine (TCM) that has the effects of warming yang, dispelling dampness, relaxing muscles, and activating collaterals. This research hypothesized that the combination of modified San Bi Tang and glucosamine sulfate capsules could enhance the clinical efficacy of treating cold-dampness-type knee osteoarthritis through complementary effects.

AIM

To analyze the clinical efficacy of San Bi Tang combined with glucosamine sulfate capsules when treating cold-dampness-type knee osteoarthritis.

METHODS

A total of 110 patients with cold-dampness-type knee osteoarthritis were selected as research subjects and randomly divided into a control group and an experimental group of 55 cases each. The control group received only treatment with glucosamine sulfate capsules, while the experimental group received additional treatment with modified San Bi Tang for a duration of 5 wk. The patients’ knee joint functions, liver and kidney function indicators, adverse reactions, and vital signs were evaluated and analyzed using SPSS 26.0 software.

RESULTS

Before treatment, the two groups’ genders, ages, and scores were not significantly different, indicating comparability. Both groups’ scores improved after treatment, which could indicate pain and knee joint function improvement, but the test group had better scores. The TCM-specific symptoms and the clinical efficacy of the treatment in the test group were higher. Before and after treatment, there were no abnormalities in the patients’ liver and kidney function indicators.

CONCLUSION

The combination of modified San Bi Tang and glucosamine sulfate capsules is superior to treatment with sulfated glucosamine alone and has high safety.

Keywords: San Bi Tang; Combination therapy; Knee osteoarthritis; Aggravated by cold; Glucosamine sulfate capsules

Core Tip: This study evaluates the effectiveness and safety of modified San Bi Tang combined with glucosamine sulfate capsules in treating cold dampness type knee osteoarthritis (KO). It reveals that this combination therapy significantly improves pain, knee joint function, and traditional Chinese medicine (TCM)-specific symptoms compared to glucosamine sulfate alone. Utilizing visual simulation scores, osteoarthritis index scores, and functional tests, the research highlights the superior clinical efficacy of the combined treatment. Safety assessments indicate no adverse impacts on liver and kidney functions, suggesting a high safety profile. These findings advocate for the integration of TCM with conventional treatments in KO management, offering a promising alternative for patients seeking relief from osteoarthritis symptoms.