Can metformin relieve tibiofemoral cartilage volume loss and knee symptoms in overweight knee osteoarthritis patients? Study protocol for a randomized, double-blind, and placebo-controlled trial

Ruan, Guangfeng1,2; Yuan, Shiwen3; Lou, Aiju4; Mo, Yingqian5; Qu, Yuan6; Guo, Dongmei7; Guan, Shangqi8; Zhang, Yan2; Lan, Xiaoyong9; Luo, Jun9; Mei, Yifang8; Zhang, Hongwei7; Wu, Weirong4; Dai, Lie5; Yu, Qinghong6; Cai, Xiaoyan3; Ding, Changhai1,2

2022-05-21

10.1186/s12891-022-05434-2

BMC MUSCULOSKELETAL DISORDERS   影响因子和分区

1471-2474

["Background: Osteoarthritis (OA) is the most common joint disease, and is most frequently seen in the knees. However, there is no effective therapy to relieve the progression of knee OA. Metformin is a safe, well-tolerated oral medication that is extensively used as first-line therapy for type 2 diabetes. Previous observational studies and basic researches suggested that metformin may have protective effects on knee OA, which needs to be verified by clinical trials. This study, therefore, aims to examine the effects of metformin versus placebo on knee cartilage volume loss and knee symptoms in overweight knee OA patients by a randomized controlled trial over 24 months.","Methods: This protocol describes a multicenter, randomized, double-blind, and placebo-controlled clinical trial aiming to recruit 262 overweight knee OA patients. Participants will be randomly allocated to the two arms of the study, receiving metformin hydrochloride sustained-release tablets or identical inert placebo for 24 months (start from 0.5 g/day for the first 2 weeks, and increase to 1 g/day for the second 2 weeks, and further increase to 2 g/day for the remaining period if tolerated). Primary outcomes will be changes in tibiofemoral cartilage volume and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score over 24 months. Secondary outcomes will be changes in visual analogue scale (VAS) knee pain, tibiofemoral cartilage defects, effusion-synovitis volume, and tibiofemoral bone marrow lesions maximum size over 24 months. The primary analyses will be intention-to-treat analyses of primary and secondary outcomes. Per-protocol analyses will be performed as the secondary analyses.","Discussion: If metformin is proved to slow knee cartilage volume loss and to relieve knee symptoms among overweight knee OA patients, it will have the potential to become a disease modifying drug for knee OA. Metformin is a convenient intervention with low cost, and its potential effects on slowing down the structural progression and relieving the symptoms of knee OA would effectively reduce the disease burden worldwide."]

Knee osteoarthritis Metformin Randomized controlled trial

SCI

英语

其他

Guangdong Basic and Applied Basic Research Foundation[2019A1515110620]

Orthopedics ; Rheumatology

Orthopedics ; Rheumatology

WOS:000798484900001

BMC

CLINICAL MEDICINE

Web of Science

1.South China Univ Technol, Guangzhou Peoples Hosp 1, Clin Res Ctr, Sch Med, Guangzhou, Peoples R China
2.Southern Med Univ, Zhujiang Hosp, Clin Res Ctr, Guangzhou, Guangdong, Peoples R China
3.South China Univ Technol, Guangzhou Peoples Hosp 1, Sch Med, Dept Rheumatol, Guangzhou, Guangdong, Peoples R China
4.Liwan Cent Hosp Guangzhou, Dept Rheumatol & Immunol, Guangzhou, Guangdong, Peoples R China
5.Sun Yat Sen Univ, Sun Yat Sen Mem Hosp, Dept Rheumatol, Guangzhou, Guangdong, Peoples R China
6.Southern Med Univ, Zhujiang Hosp, Rheumatol & Clin Immunol Dept, Guangzhou, Guangdong, Peoples R China
7.Foshan First Peoples Hosp, Dept Rheumatol, Foshan, Guangdong, Peoples R China
8.Southern Univ Sci & Technol, Peoples Hosp Shenzhen 3, Dept Rheumatol, Affiliated Hosp 2, Shenzhen, Guangdong, Peoples R China
9.Nanchang Univ, Dept Rehabil Med, Affiliated Hosp 2, Nanchang, Jiangxi, Peoples R China

Ruan, Guangfeng,Yuan, Shiwen,Lou, Aiju,et al. Can metformin relieve tibiofemoral cartilage volume loss and knee symptoms in overweight knee osteoarthritis patients? Study protocol for a randomized, double-blind, and placebo-controlled trial[J]. BMC MUSCULOSKELETAL DISORDERS,2022,23(1).

Ruan, Guangfeng.,Yuan, Shiwen.,Lou, Aiju.,Mo, Yingqian.,Qu, Yuan.,...&Ding, Changhai.(2022).Can metformin relieve tibiofemoral cartilage volume loss and knee symptoms in overweight knee osteoarthritis patients? Study protocol for a randomized, double-blind, and placebo-controlled trial.BMC MUSCULOSKELETAL DISORDERS,23(1).

Ruan, Guangfeng,et al."Can metformin relieve tibiofemoral cartilage volume loss and knee symptoms in overweight knee osteoarthritis patients? Study protocol for a randomized, double-blind, and placebo-controlled trial".BMC MUSCULOSKELETAL DISORDERS 23.1(2022).