Korean Red Ginseng exhibits no significant adverse effect on disease activity in patients with rheumatoid arthritis: a randomized, double-blind, crossover study
Background: Panax ginseng is a well-known immune modulator, and there is concern that its immune-enhancing effects may negatively affect patients with rheumatoid arthritis (RA) by worsening symptoms or increasing the risk of adverse effects from other drugs. In this randomized, crossover clinical tr...
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doaj-00064e88075546569a1292ae483d741e2020-11-24T23:25:43ZengElsevierJournal of Ginseng Research1226-84532018-04-01422144148Korean Red Ginseng exhibits no significant adverse effect on disease activity in patients with rheumatoid arthritis: a randomized, double-blind, crossover studySoo-Kyung Cho0Dam Kim1Dasomi Yoo2Eun Jin Jang3Jae-Bum Jun4Yoon-Kyoung Sung5Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of KoreaDepartment of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of KoreaDepartment of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of KoreaDepartment of Information Statistics, Andong National University, Andong-si, Republic of KoreaDepartment of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of KoreaDepartment of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea; Corresponding author. Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul 133-792, Republic of Korea.Background: Panax ginseng is a well-known immune modulator, and there is concern that its immune-enhancing effects may negatively affect patients with rheumatoid arthritis (RA) by worsening symptoms or increasing the risk of adverse effects from other drugs. In this randomized, crossover clinical trial, we evaluated the impact of Korean Red Ginseng (KRG) on disease activity and safety in RA patients. Methods: A total of 80 female RA patients were randomly assigned to either the KRG (2 g/d, n = 40) treatment or placebo (n = 40) groups for 8 wk, followed by crossover to the other treatment group for an additional 8 wk. The primary outcome was the disease flare rate, defined as worsening disease activity according to the disease activity score 28 joints-erythrocyte sedimentation rate (DAS28-ESR). The secondary outcomes were development of adverse events (AEs) and patient reported outcomes. Outcomes were evaluated at baseline and 8 wk and 16 wk. The outcomes were compared using the Chi-square test. Results: Of the 80 patients, 70 completed the full study. Their mean age was 51.9 yr, and most exhibited low disease activity (mean DAS28-ESR 3.5 ± 1.0) at enrollment. After intervention, the flare rate was 3.7% in each group. During KRG treatment, 10 AEs were reported, while five AEs were developed with placebo; however, this difference was not statistically significant (p = 0.16). Gastrointestinal- and nervous system-related symptoms were frequent in the KRG group. Conclusion: KRG is not significantly associated with either disease flare rate or the rate of AE development in RA patients. Keywords: effect, Korean Red Ginseng, rheumatoid arthritis, safetyhttp://www.sciencedirect.com/science/article/pii/S1226845316302159 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Soo-Kyung Cho Dam Kim Dasomi Yoo Eun Jin Jang Jae-Bum Jun Yoon-Kyoung Sung |
spellingShingle |
Soo-Kyung Cho Dam Kim Dasomi Yoo Eun Jin Jang Jae-Bum Jun Yoon-Kyoung Sung Korean Red Ginseng exhibits no significant adverse effect on disease activity in patients with rheumatoid arthritis: a randomized, double-blind, crossover study Journal of Ginseng Research |
author_facet |
Soo-Kyung Cho Dam Kim Dasomi Yoo Eun Jin Jang Jae-Bum Jun Yoon-Kyoung Sung |
author_sort |
Soo-Kyung Cho |
title |
Korean Red Ginseng exhibits no significant adverse effect on disease activity in patients with rheumatoid arthritis: a randomized, double-blind, crossover study |
title_short |
Korean Red Ginseng exhibits no significant adverse effect on disease activity in patients with rheumatoid arthritis: a randomized, double-blind, crossover study |
title_full |
Korean Red Ginseng exhibits no significant adverse effect on disease activity in patients with rheumatoid arthritis: a randomized, double-blind, crossover study |
title_fullStr |
Korean Red Ginseng exhibits no significant adverse effect on disease activity in patients with rheumatoid arthritis: a randomized, double-blind, crossover study |
title_full_unstemmed |
Korean Red Ginseng exhibits no significant adverse effect on disease activity in patients with rheumatoid arthritis: a randomized, double-blind, crossover study |
title_sort |
korean red ginseng exhibits no significant adverse effect on disease activity in patients with rheumatoid arthritis: a randomized, double-blind, crossover study |
publisher |
Elsevier |
series |
Journal of Ginseng Research |
issn |
1226-8453 |
publishDate |
2018-04-01 |
description |
Background: Panax ginseng is a well-known immune modulator, and there is concern that its immune-enhancing effects may negatively affect patients with rheumatoid arthritis (RA) by worsening symptoms or increasing the risk of adverse effects from other drugs. In this randomized, crossover clinical trial, we evaluated the impact of Korean Red Ginseng (KRG) on disease activity and safety in RA patients. Methods: A total of 80 female RA patients were randomly assigned to either the KRG (2 g/d, n = 40) treatment or placebo (n = 40) groups for 8 wk, followed by crossover to the other treatment group for an additional 8 wk. The primary outcome was the disease flare rate, defined as worsening disease activity according to the disease activity score 28 joints-erythrocyte sedimentation rate (DAS28-ESR). The secondary outcomes were development of adverse events (AEs) and patient reported outcomes. Outcomes were evaluated at baseline and 8 wk and 16 wk. The outcomes were compared using the Chi-square test. Results: Of the 80 patients, 70 completed the full study. Their mean age was 51.9 yr, and most exhibited low disease activity (mean DAS28-ESR 3.5 ± 1.0) at enrollment. After intervention, the flare rate was 3.7% in each group. During KRG treatment, 10 AEs were reported, while five AEs were developed with placebo; however, this difference was not statistically significant (p = 0.16). Gastrointestinal- and nervous system-related symptoms were frequent in the KRG group. Conclusion: KRG is not significantly associated with either disease flare rate or the rate of AE development in RA patients. Keywords: effect, Korean Red Ginseng, rheumatoid arthritis, safety |
url |
http://www.sciencedirect.com/science/article/pii/S1226845316302159 |
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