Observational Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Orthop. Jun 18, 2023; 14(6): 443-457
Published online Jun 18, 2023. doi: 10.5312/wjo.v14.i6.443
Chondroitin sulfate and glucosamine combination in patients with knee and hip osteoarthritis: A long-term observational study in Russia
Alexander M Lila, Lyudmila I Alekseeva, Andrey A Baranov, Elena A Taskina, Natalya G Kashevarova, Natalia A Lapkina, Evgeny A Trofimov
Alexander M Lila, Director, Research Institute of Rheumatology Named after VA Nasonova, Moscow 115522, Moscow, Russia
Lyudmila I Alekseeva, Elena A Taskina, Natalya G Kashevarova, Bone and Joints Metabolic Diseases Laboratory, Research Institute of Rheumatology Named after VA Nasonova, Moscow 115522, Moscow, Russia
Andrey A Baranov, Natalia A Lapkina, Department of Therapy, Clinical Laboratory Diagnostics and Medical Biochemistry, Yaroslavl State Medical University, Yaroslavl 150000, Yaroslavl, Russia
Evgeny A Trofimov, Department of Therapy and Rheumatology, North-Western State Medical University named after I.I. Mechnikov, St. Petersburg 191015, St. Petersburg, Russia
Author contributions: Lila AM and Alekseeva LI were the guarantors and designed the study, and reviewed study protocol. Baranov AA, Taskina EA, Kashevarova NG, Lapkina NA, and Trofimov EA participated in the acquisition, analysis, and interpretation of the data. Alekseeva LI and Taskina EA drafted the initial manuscript; Lila AM, Baranov AA, Taskina EA, LapkinaNA, and Trofimov EA critically revised the article for important intellectual content.
Institutional review board statement: Intercollegiate Ethics Committee of the Russian Federation (protocol number 08/17 dated on September 14, 2017); Amendment 1 (protocol number 11/17 dated on December 14, 2017); Amendment 2 (protocol number 08/18 dated on September 20, 2018); and Bayer Therapeutic Review Committee (Protocol Review Committee meeting was held on June 14, 2017).
Informed consent statement: All study participants, or their legal guardian, provided informed written consent for data collection prior to study enrollment.
Conflict-of-interest statement: All the authors declare that they have no conflict of interest.
Data sharing statement: No additional data are available.
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: Elena A Taskina, MD, PhD, Senior Researcher, Bone and Joints Metabolic Diseases Laboratory, Research Institute of Rheumatology named after VA Naso-nova, Kashirskoe av., 34/1, Moscow 115522, Moscow, Russia. elena.taskina.msk@gmail.com
Received: March 6, 2023
Peer-review started: March 6, 2023
First decision: March 24, 2023
Revised: April 19, 2023
Accepted: May 12, 2023
Article in press: May 12, 2023
Published online: June 18, 2023
Processing time: 104 Days and 10 Hours
Abstract
BACKGROUND

Oral treatment of glucosamine (GA) combined with chondroitin sulfate (CS) was reportedly effective for pain relief and function improvement in osteoarthritis patients with moderate to severe knee pain in clinical trials. While the effectiveness of GA and CS on both clinical and radiological findings has been demonstrated, only a few high-quality trials exist. Therefore, controversy regarding their effectiveness in real-world clinical practice remains.

AIM

To investigate the impact of GA + CS on clinical outcomes of patients with knee and hip osteoarthritis in routine clinical practice.

METHODS

A multicenter prospective observational cohort study included 1102 patients of both genders with knee or hip osteoarthritis (Kellgren & Lawrence grades I-III) in 51 clinical centers in the Russian Federation from November 20, 2017, to March 20, 2020, who had started to receive oral capsules of glucosamine hydrochloride 500 mg and CS 400 mg according to the approved patient information leaflet starting from 3 capsules daily for 3 wk, followed by a reduced dosage of 2 capsules daily before study inclusion (minimal recommended treatment duration is 3-6 mo). Changes in subscale scores [Pain, Symptoms, Function, and Quality of Life (QOL)] of the Knee Injury and Osteoarthritis Outcome Score (KOOS)/Hip Disability and Osteoarthritis Outcome Score (HOOS) questionnaires during the observational period (up to 54-64 wk with a total of 4 visits). Patients’ treatment satisfaction, data on the combined oral use of glucosamine hydrochloride and CS, concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs), and adverse events (AEs) were also evaluated.

RESULTS

A total of 1102 patients with knee and hip osteoarthritis were included in the study. The mean patient age was 60.4 years, most patients were women (87.8%), and their average body mass index was 29.49 kg/m2. All subscale scores (Pain, Symptoms, Function, and QOL) of the KOOS and HOOS demonstrated clinically and statistically significant improvements. In patients with knee osteoarthritis, the mean score increases from baseline to the end of Week 64 were 22.87, 20.78, 16.60, and 24.87 on Pain, Symptoms, Physical Function (KOOS-PS), and QOL subscales (P < 0.001 for all), respectively. In patients with hip osteoarthritis, the mean score increases were 22.81, 19.93, 18.77, and 22.71 on Pain, Symptoms, Physical Function (HOOS-PS), and QOL subscales (P < 0.001 for all), respectively. The number of patients using any NSAIDs decreased from 43.1% to 13.5% (P < 0.001) at the end of the observation period. Treatment-related AEs occurred in 2.8% of the patients and mainly included gastrointestinal disorders [25 AEs in 24 (2.2%) patients]. Most patients (78.1%) were satisfied with the treatment.

CONCLUSION

Long-term oral GA + CS was associated with decreased pain, reduced concomitant NSAID therapy, improved joint function and QOL in patients with knee and hip osteoarthritis in routine clinical practice.

Keywords: Glucosamine; Chondroitin sulfate; Knee osteoarthritis; Hip osteoarthritis; Knee injury and osteoarthritis outcome score; Hip disability and osteoarthritis outcome score

Core Tip: Long-term 64-wk treatment by oral capsules of glucosamine hydrochloride 500 mg and chondroitin sulfate 400 mg three times a day for the first 3 wk, then twice daily, was associated with clinically significant improvements in all subscale scores (Pain, Symptoms, Function, and Quality of Life) of the Knee Injury and Osteoarthritis Outcome Score/Hip Disability and Osteoarthritis Outcome Score and a decreasing number of patients with knee and hip osteoarthritis receiving any non-steroidal anti-inflammatory drugs in real-world clinical practice. Incidence of drug-related adverse events was low, and their nature was consistent with known safety profile of glucosamine hydrochloride and chondroitin sulfate combination.