Efficacy and safety of a Chinese herbal formula Maxing Ganshi Decoction in children with community-acquired pneumonia: A randomized, double-blind, placebo-controlled, multicenter trial
Background: As one of the most commonly used Chinese medicine formula in the manage of respiratory diseases, Maxing Ganshi Decoction (MGD) has been demonstrated to improve the clinical symptoms of pneumonia. To evaluate the efficacy and safety of MGD in treating children with community-acquired pneu...
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| Format: | Article |
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Frontiers Media S.A.
2022-09-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2022.948831/full |
| _version_ | 1798025252350984192 |
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| author | Yujiao Zheng Yujiao Zheng Changren Shi Changren Shi Yaowei Han Xinmin Li Lijing Dong Yan Li Hui Chen Yushui Wang Jinsong Li Geli Liu Rong Ma Fengmei Lian Xiaolin Tong |
| author_facet | Yujiao Zheng Yujiao Zheng Changren Shi Changren Shi Yaowei Han Xinmin Li Lijing Dong Yan Li Hui Chen Yushui Wang Jinsong Li Geli Liu Rong Ma Fengmei Lian Xiaolin Tong |
| author_sort | Yujiao Zheng |
| collection | DOAJ |
| description | Background: As one of the most commonly used Chinese medicine formula in the manage of respiratory diseases, Maxing Ganshi Decoction (MGD) has been demonstrated to improve the clinical symptoms of pneumonia. To evaluate the efficacy and safety of MGD in treating children with community-acquired pneumonia (CAP), we conducted the clinical trial.Methods: A randomized, double-blind, placebo-controlled, multicenter trial was conducted in 3 study sites in Tianjin, China. MDG or placebo were randomly given to patients aged 3–6 years with onset of CAP within 48 h. Changes in disease efficacy during the study period (which was measured as recovery, significant effect, improvement and no effect) was evaluated as the primary outcome. Time from enrollment to fever resolution was assessed as the secondary outcome. The adverse event was analyzed as safety evaluation.Results: A total of 71 patients (36 in MGD and 35 in placebo) were randomized and completed the whole study. The patient demographics and other characteristics at baseline were similar between the 2 groups (p > 0.05). After 10 days of intervention, the proportion of recovered and significant effective patients was increased significantly in the MGD group (34.85% [95% CI, 12.44%–57.26%]; p < 0.05) compared with the control group. Besides, the symptom score of the MGD group was lowered significantly (p < 0.001). The estimated time to fever resolution in the MGD group was also reduced compared with the control group (p < 0.05). During the whole study, no side effects were observed in both MGD and control groups.Conclusion: MGD was effective in improving disease efficacy, clinical symptoms and reducing time to fever resolution in patients with childhood CAP, which suggested that MGD may be used as an alternative therapy in the treatment of childhood CAP.Clinical Trial Registration: http://www.chictr.org.cn/showproj.aspx?proj=5612, identifier 13003955. |
| first_indexed | 2024-04-11T18:15:44Z |
| format | Article |
| id | doaj.art-d6f9cd883d0d4ad19044557b693b6e42 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-04-11T18:15:44Z |
| publishDate | 2022-09-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-d6f9cd883d0d4ad19044557b693b6e422022-12-22T04:09:56ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122022-09-011310.3389/fphar.2022.948831948831Efficacy and safety of a Chinese herbal formula Maxing Ganshi Decoction in children with community-acquired pneumonia: A randomized, double-blind, placebo-controlled, multicenter trialYujiao Zheng0Yujiao Zheng1Changren Shi2Changren Shi3Yaowei Han4Xinmin Li5Lijing Dong6Yan Li7Hui Chen8Yushui Wang9Jinsong Li10Geli Liu11Rong Ma12Fengmei Lian13Xiaolin Tong14Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaCollege of Traditional Chinese Medicine, Anhui University of Chinese Medicine, Hefei, ChinaThe Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University, Wenzhou, ChinaFirst Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaFirst Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaFirst Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaBinhai New Area Hangu Hospital of Traditional Chinese Medicine, Tianjin, ChinaBinhai New Area Hangu Hospital of Traditional Chinese Medicine, Tianjin, ChinaSecond Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaTianjin Hospital of ITCWM Nankai Hospital, Tianjin, ChinaTianjin Union Medical Center Affiliated to Nankai University, Tianjin, ChinaTianjin Medical University General Hospital, Tianjin, ChinaFirst Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaGuang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaGuang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaBackground: As one of the most commonly used Chinese medicine formula in the manage of respiratory diseases, Maxing Ganshi Decoction (MGD) has been demonstrated to improve the clinical symptoms of pneumonia. To evaluate the efficacy and safety of MGD in treating children with community-acquired pneumonia (CAP), we conducted the clinical trial.Methods: A randomized, double-blind, placebo-controlled, multicenter trial was conducted in 3 study sites in Tianjin, China. MDG or placebo were randomly given to patients aged 3–6 years with onset of CAP within 48 h. Changes in disease efficacy during the study period (which was measured as recovery, significant effect, improvement and no effect) was evaluated as the primary outcome. Time from enrollment to fever resolution was assessed as the secondary outcome. The adverse event was analyzed as safety evaluation.Results: A total of 71 patients (36 in MGD and 35 in placebo) were randomized and completed the whole study. The patient demographics and other characteristics at baseline were similar between the 2 groups (p > 0.05). After 10 days of intervention, the proportion of recovered and significant effective patients was increased significantly in the MGD group (34.85% [95% CI, 12.44%–57.26%]; p < 0.05) compared with the control group. Besides, the symptom score of the MGD group was lowered significantly (p < 0.001). The estimated time to fever resolution in the MGD group was also reduced compared with the control group (p < 0.05). During the whole study, no side effects were observed in both MGD and control groups.Conclusion: MGD was effective in improving disease efficacy, clinical symptoms and reducing time to fever resolution in patients with childhood CAP, which suggested that MGD may be used as an alternative therapy in the treatment of childhood CAP.Clinical Trial Registration: http://www.chictr.org.cn/showproj.aspx?proj=5612, identifier 13003955.https://www.frontiersin.org/articles/10.3389/fphar.2022.948831/fullChinese medicinemaxing ganshi decoctioncommunity-acquired pneumoniarandomized clinical trialclinical efficacy |
| spellingShingle | Yujiao Zheng Yujiao Zheng Changren Shi Changren Shi Yaowei Han Xinmin Li Lijing Dong Yan Li Hui Chen Yushui Wang Jinsong Li Geli Liu Rong Ma Fengmei Lian Xiaolin Tong Efficacy and safety of a Chinese herbal formula Maxing Ganshi Decoction in children with community-acquired pneumonia: A randomized, double-blind, placebo-controlled, multicenter trial Frontiers in Pharmacology Chinese medicine maxing ganshi decoction community-acquired pneumonia randomized clinical trial clinical efficacy |
| title | Efficacy and safety of a Chinese herbal formula Maxing Ganshi Decoction in children with community-acquired pneumonia: A randomized, double-blind, placebo-controlled, multicenter trial |
| title_full | Efficacy and safety of a Chinese herbal formula Maxing Ganshi Decoction in children with community-acquired pneumonia: A randomized, double-blind, placebo-controlled, multicenter trial |
| title_fullStr | Efficacy and safety of a Chinese herbal formula Maxing Ganshi Decoction in children with community-acquired pneumonia: A randomized, double-blind, placebo-controlled, multicenter trial |
| title_full_unstemmed | Efficacy and safety of a Chinese herbal formula Maxing Ganshi Decoction in children with community-acquired pneumonia: A randomized, double-blind, placebo-controlled, multicenter trial |
| title_short | Efficacy and safety of a Chinese herbal formula Maxing Ganshi Decoction in children with community-acquired pneumonia: A randomized, double-blind, placebo-controlled, multicenter trial |
| title_sort | efficacy and safety of a chinese herbal formula maxing ganshi decoction in children with community acquired pneumonia a randomized double blind placebo controlled multicenter trial |
| topic | Chinese medicine maxing ganshi decoction community-acquired pneumonia randomized clinical trial clinical efficacy |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2022.948831/full |
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