Effects of herbal medicines (Eunkyosan/Yin qiao san and Samsoeum/Shen su yin) for treating the common cold: A randomized, placebo-controlled, multicenter clinical trial
Background: Eunkyosan (EKS) and Samsoeum (SSE), which are called Yin qiao san and Shen su yin in Chinese, are commonly used herbal medicines for the common cold in East Asian countries. This study aimed to evaluate the effectiveness and safety of EKS and SSE for treating the common cold. Methods: A...
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Elsevier
2023-12-01
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| Series: | Integrative Medicine Research |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2213422023000847 |
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| author | Kwan-Il Kim Minna Hong Yang-Chun Park Beom-Joon Lee Kitae Kim Byoung Kab Kang Jun-Yong Choi |
| author_facet | Kwan-Il Kim Minna Hong Yang-Chun Park Beom-Joon Lee Kitae Kim Byoung Kab Kang Jun-Yong Choi |
| author_sort | Kwan-Il Kim |
| collection | DOAJ |
| description | Background: Eunkyosan (EKS) and Samsoeum (SSE), which are called Yin qiao san and Shen su yin in Chinese, are commonly used herbal medicines for the common cold in East Asian countries. This study aimed to evaluate the effectiveness and safety of EKS and SSE for treating the common cold. Methods: A randomized, patient-assessor-blind, placebo-controlled, parallel, and multicenter clinical trial was conducted. Adult participants who had one or more cold within 48 h before screening, were randomly allocated to EKS, SSE, or placebo groups. The recruitment goal was planned to be 375 participants. They took an EKS, SSE, or placebo, thrice daily for up to 8 days. The primary outcome was the change in the total score of the Wisconsin Upper Respiratory Symptom Scale-21-Korean version (WURSS-21-K) on day 6 compared to the baseline. The secondary outcomes included visual analog scale (VAS) scores and the duration of symptoms was assessed throughout the trial. Results: A total of 128 participants were enrolled and 44, 42, and 42 were allocated to the EKS, SSE, and placebo groups, respectively. This study was prematurely terminated due to the COVID-19 pandemic, and we were unable to recruit all the planned participants (n = 375). EKS showed significant clinical effectiveness over the placebo group in the treatment of the common cold, as assessed by the total, symptom, and quality of life scores of WURSS-21-K and VAS, whereas SSE showed significant improvement over the placebo group in terms of WURSS-21-K symptom score. No severe adverse events were reported. Conclusions: Although EKS and SSE demonstrated statistically significant clinical effectiveness and safety in patients with the common cold, we failed to recruit our pre-planned number of participants. Future definitive full-scale studies are needed to confirm these results. Trial registration: ClinicalTrials. gov, registration number: NCT04073511. Registered on 29 August 2019. |
| format | Article |
| id | doaj-art-faee8b53bfc44e7c9a6d174dad262576 |
| institution | OA Journals |
| issn | 2213-4220 |
| language | English |
| publishDate | 2023-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Integrative Medicine Research |
| spelling | doaj-art-faee8b53bfc44e7c9a6d174dad2625762025-08-20T02:04:56ZengElsevierIntegrative Medicine Research2213-42202023-12-0112410100510.1016/j.imr.2023.101005Effects of herbal medicines (Eunkyosan/Yin qiao san and Samsoeum/Shen su yin) for treating the common cold: A randomized, placebo-controlled, multicenter clinical trialKwan-Il Kim0Minna Hong1Yang-Chun Park2Beom-Joon Lee3Kitae Kim4Byoung Kab Kang5Jun-Yong Choi6Department of Clinical Korean Medicine, College of Korean Medicine, Kyung Hee University, Seoul, South Korea; Division of Allergy, Immune and Respiratory System, Department of Internal Medicine, College of Korean Medicine Kyung Hee University, Kyung Hee University Medical Center, Seoul, South KoreaDepartment of Korean Medicine, The Graduate School, Pusan National University, Yangsan, South Korea; Department of Korean Internal Medicine, Korean Medicine Hospital of Pusan National University, South KoreaDepartment of Internal Medicine, College of Korean Medicine, Daejeon University, Daejeon, South KoreaDepartment of Clinical Korean Medicine, College of Korean Medicine, Kyung Hee University, Seoul, South Korea; Division of Allergy, Immune and Respiratory System, Department of Internal Medicine, College of Korean Medicine Kyung Hee University, Kyung Hee University Medical Center, Seoul, South KoreaDepartment of Korean Medicine, Semyung University, South KoreaClinical Research Coordinating Team, Korea Institute of Oriental Medicine, Daejeon, South KoreaDepartment of Korean Medicine, The Graduate School, Pusan National University, Yangsan, South Korea; Department of Korean Internal Medicine, Korean Medicine Hospital of Pusan National University, South Korea; School of Korean Medicine, Pusan National University, Yangsan, South Korea; Corresponding author at: School of Korean Medicine, Pusan National University, 20 Geumo-ro, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do 50612, South Korea.Background: Eunkyosan (EKS) and Samsoeum (SSE), which are called Yin qiao san and Shen su yin in Chinese, are commonly used herbal medicines for the common cold in East Asian countries. This study aimed to evaluate the effectiveness and safety of EKS and SSE for treating the common cold. Methods: A randomized, patient-assessor-blind, placebo-controlled, parallel, and multicenter clinical trial was conducted. Adult participants who had one or more cold within 48 h before screening, were randomly allocated to EKS, SSE, or placebo groups. The recruitment goal was planned to be 375 participants. They took an EKS, SSE, or placebo, thrice daily for up to 8 days. The primary outcome was the change in the total score of the Wisconsin Upper Respiratory Symptom Scale-21-Korean version (WURSS-21-K) on day 6 compared to the baseline. The secondary outcomes included visual analog scale (VAS) scores and the duration of symptoms was assessed throughout the trial. Results: A total of 128 participants were enrolled and 44, 42, and 42 were allocated to the EKS, SSE, and placebo groups, respectively. This study was prematurely terminated due to the COVID-19 pandemic, and we were unable to recruit all the planned participants (n = 375). EKS showed significant clinical effectiveness over the placebo group in the treatment of the common cold, as assessed by the total, symptom, and quality of life scores of WURSS-21-K and VAS, whereas SSE showed significant improvement over the placebo group in terms of WURSS-21-K symptom score. No severe adverse events were reported. Conclusions: Although EKS and SSE demonstrated statistically significant clinical effectiveness and safety in patients with the common cold, we failed to recruit our pre-planned number of participants. Future definitive full-scale studies are needed to confirm these results. Trial registration: ClinicalTrials. gov, registration number: NCT04073511. Registered on 29 August 2019.http://www.sciencedirect.com/science/article/pii/S2213422023000847Common coldHerbal medicineEunkyosan (Yin Qiao San)Samsoeum (Shen Su Yin) |
| spellingShingle | Kwan-Il Kim Minna Hong Yang-Chun Park Beom-Joon Lee Kitae Kim Byoung Kab Kang Jun-Yong Choi Effects of herbal medicines (Eunkyosan/Yin qiao san and Samsoeum/Shen su yin) for treating the common cold: A randomized, placebo-controlled, multicenter clinical trial Integrative Medicine Research Common cold Herbal medicine Eunkyosan (Yin Qiao San) Samsoeum (Shen Su Yin) |
| title | Effects of herbal medicines (Eunkyosan/Yin qiao san and Samsoeum/Shen su yin) for treating the common cold: A randomized, placebo-controlled, multicenter clinical trial |
| title_full | Effects of herbal medicines (Eunkyosan/Yin qiao san and Samsoeum/Shen su yin) for treating the common cold: A randomized, placebo-controlled, multicenter clinical trial |
| title_fullStr | Effects of herbal medicines (Eunkyosan/Yin qiao san and Samsoeum/Shen su yin) for treating the common cold: A randomized, placebo-controlled, multicenter clinical trial |
| title_full_unstemmed | Effects of herbal medicines (Eunkyosan/Yin qiao san and Samsoeum/Shen su yin) for treating the common cold: A randomized, placebo-controlled, multicenter clinical trial |
| title_short | Effects of herbal medicines (Eunkyosan/Yin qiao san and Samsoeum/Shen su yin) for treating the common cold: A randomized, placebo-controlled, multicenter clinical trial |
| title_sort | effects of herbal medicines eunkyosan yin qiao san and samsoeum shen su yin for treating the common cold a randomized placebo controlled multicenter clinical trial |
| topic | Common cold Herbal medicine Eunkyosan (Yin Qiao San) Samsoeum (Shen Su Yin) |
| url | http://www.sciencedirect.com/science/article/pii/S2213422023000847 |
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