Gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) in Degenerative Knee Osteoarthritis Patients: Lessons and Responders from a Multicenter Randomized Placebo-Controlled Double-Blind Clinical Trial.

Myung Kwan Kim,Jeeyong Kim,Jae-Uk Sul,In Chul Jung,Hee-Geun Jo,Young Il Kim,Ju-Hyun Jeon,Sang-Hoon Yoon,Jungtae Leem,Eunseok Kim,Yang Chun Park

doi:10.1155/2020/2376581

Abstract

Background Gyejigachulbutang (GUI-ZHI-JIA-SHU-FU-TANG, GCB) is an herbal formula widely prescribed in traditional East Asian medicine practice for arthritis and muscle pain. We evaluated the efficacy and safety of GCB for degenerative knee osteoarthritis (KOA). Methods Eighty patients with KOA were randomly assigned to the GCB group or the placebo group in a 1 : 1 ratio in two Korean medicine hospitals. Patients took GCB or placebo three times a day for 4 weeks. Primary outcome was the change in the visual analogue scale (VAS) score for knee pain from baseline to 4th week. Secondary outcomes were the change in the VAS score from baseline to 2nd week and 8th week, Korean Western Ontario and McMaster Universities Osteoarthritis Index (K-WOMAC), European Quality of Life Five Dimensions questionnaire (EQ-5D), and safety. Results There was no significant difference between the compared indicators of the GCB and placebo groups. However, in subgroup analysis, GCB was effective for subjects with a BMI lower than 25 kg/m2. The dose of pain medication was significantly lower in the GCB group than in the placebo group after four weeks (p=0.016). There were no serious adverse events in the GCB group. Conclusions GCB was not effective in primary outcome analysis. In exploratory subgroup analysis, GCB might be effective for individuals with BMI lower than 25 kg/m2 for the treatment of degenerative KOA. GCB may also help reduce the consumption of pain medication. Furthermore, research is required for our hypothesis. This trial is registered with KCT0003024.

Highlights

Degenerative knee osteoarthritis (KOA) is the most common degenerative disease in adults [1]. e main symptoms are knee pain, dysfunction, swelling, and crepitation during exercise [2]
Eighty patients were enrolled in this study and randomly allocated to the GCB or the placebo group in a 1 : 1 ratio. e study flowchart and trial design are shown in Figure 1 and Table 1, respectively. e recommended items for a clinical trial protocol and related documents are presented according to the SPIRIT 2013 checklist [21]
E trial was approved by the Institutional Review Boards (IRBs) of both Korean medical hospitals (DJDSKH18-DR-10 and CYIRB-2018-04-002). is study has been registered with the Clinical Research Information Service (CRIS), which is one of the primary registrars of the World Health Organization’s (WHO) International Clinical Trial Registration Platform (KCT0003024). e study adhered to the specifications of the Helsinki Declaration (2013)

Summary

Introduction

Degenerative knee osteoarthritis (KOA) is the most common degenerative disease in adults [1]. e main symptoms are knee pain, dysfunction, swelling, and crepitation during exercise [2]. Degenerative knee osteoarthritis (KOA) is the most common degenerative disease in adults [1]. We evaluated the efficacy and safety of GCB for degenerative knee osteoarthritis (KOA). Eighty patients with KOA were randomly assigned to the GCB group or the placebo group in a 1 : 1 ratio in two Korean medicine hospitals. Primary outcome was the change in the visual analogue scale (VAS) score for knee pain from baseline to 4th week. In subgroup analysis, GCB was effective for subjects with a BMI lower than 25 kg/m2. E dose of pain medication was significantly lower in the GCB group than in the placebo group after four weeks (p 0.016). GCB might be effective for individuals with BMI lower than 25 kg/m2 for the treatment of degenerative KOA. Research is required for our hypothesis. is trial is registered with KCT0003024

Methods

Results

Conclusion