TangBi Formula for Painful Diabetic Distal Symmetric Polyneuropathy: A Multicenter, Randomized, Double‐Blind, Placebo‐Controlled and Parallel‐Group Trial
ABSTRACT Objective To determine whether the use of herbal medicines combined with conventional treatment is more effective than conventional medication alone in improving clinical symptoms in patients with diabetic distal symmetric polyneuropathy (DSPN). Methods This multicenter, placebo‐controlled,...
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| Format: | Article |
| Language: | English |
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Wiley
2025-01-01
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| Series: | Journal of Diabetes |
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| Online Access: | https://doi.org/10.1111/1753-0407.70045 |
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| author | Xuefei Zhao Xuedong An Yashan Cui Liu Dong Zhaohui Fang Zhonghua Zheng Xinhe Zuo Huailin Gao Tianshu Gao Qing Ni Fengmei Lian Xiaolin Tong |
| author_facet | Xuefei Zhao Xuedong An Yashan Cui Liu Dong Zhaohui Fang Zhonghua Zheng Xinhe Zuo Huailin Gao Tianshu Gao Qing Ni Fengmei Lian Xiaolin Tong |
| author_sort | Xuefei Zhao |
| collection | DOAJ |
| description | ABSTRACT Objective To determine whether the use of herbal medicines combined with conventional treatment is more effective than conventional medication alone in improving clinical symptoms in patients with diabetic distal symmetric polyneuropathy (DSPN). Methods This multicenter, placebo‐controlled, double‐blind, randomized controlled clinical trial recruited patients from 6 clinical centers in mainland China. A total of 188 patients were randomly assigned in a 1:1 ratio to the treatment group (Tangbi Formula plus methylcobalamin) and the control group (placebo plus methylcobalamin). Subjects were reassessed after the 24‐week intervention. The primary outcomes were differences in changes in clinical signs and symptoms and changes in the Michigan Diabetic Neuropathy Score (MDNS) between the two groups before and after treatment. Secondary outcomes were changes in nerve conduction velocity (NCV) and single clinical signs and symptoms as measured by the visual‐analogue scale (VAS) and Toronto clinical scoring system (TCSS). Results Compared with the placebo group, after 24 weeks of treatment, the MDNS score of TangBi Formula group was significantly reduced (p < 0.001). There were no significant changes in NCV results in either group before or after treatment. Compared with baseline, the difference in the change value of VAS score between the two groups after treatment was statistically significant (p = 0.031). A statistically significant difference in the change value of TCSS after treatment compared to baseline was found between the two groups (p = 0.033 at 12 weeks and p = 0.030 at 24 weeks). No severe adverse events due to study participation or study intervention were reported. Conclusions and Relevance This trial demonstrated that combining Tangbi Formula with basal therapy can be safer and more effective in improving the symptoms of DSPN patients. |
| format | Article |
| id | doaj-art-5d4cdd6ca92c4ec28d9b5bf567b8a7e9 |
| institution | Kabale University |
| issn | 1753-0393 1753-0407 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Diabetes |
| spelling | doaj-art-5d4cdd6ca92c4ec28d9b5bf567b8a7e92025-01-28T04:44:58ZengWileyJournal of Diabetes1753-03931753-04072025-01-01171n/an/a10.1111/1753-0407.70045TangBi Formula for Painful Diabetic Distal Symmetric Polyneuropathy: A Multicenter, Randomized, Double‐Blind, Placebo‐Controlled and Parallel‐Group TrialXuefei Zhao0Xuedong An1Yashan Cui2Liu Dong3Zhaohui Fang4Zhonghua Zheng5Xinhe Zuo6Huailin Gao7Tianshu Gao8Qing Ni9Fengmei Lian10Xiaolin Tong11Guang'anmen Hospital China Academy of Chinese Medical Sciences Beijing ChinaGuang'anmen Hospital China Academy of Chinese Medical Sciences Beijing ChinaXiyuan Hospital China Academy of Chinese Medical Sciences Beijing ChinaGuang'anmen Hospital China Academy of Chinese Medical Sciences Beijing ChinaThe First Affiliated Hospital of Anhui University of Traditional Chinese Medicine Hefei Anhui Province ChinaZhengzhou Hospital of Traditional Chinese Medicine Zhengzhou ChinaHubei Provincial Hospital of Traditional Chinese Medicine Wuhan Hubei Province ChinaHebei Yiling Hospital Shijiazhuang Hebei Province ChinaThe First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Shenyang Liaoning Province ChinaGuang'anmen Hospital China Academy of Chinese Medical Sciences Beijing ChinaGuang'anmen Hospital China Academy of Chinese Medical Sciences Beijing ChinaGuang'anmen Hospital China Academy of Chinese Medical Sciences Beijing ChinaABSTRACT Objective To determine whether the use of herbal medicines combined with conventional treatment is more effective than conventional medication alone in improving clinical symptoms in patients with diabetic distal symmetric polyneuropathy (DSPN). Methods This multicenter, placebo‐controlled, double‐blind, randomized controlled clinical trial recruited patients from 6 clinical centers in mainland China. A total of 188 patients were randomly assigned in a 1:1 ratio to the treatment group (Tangbi Formula plus methylcobalamin) and the control group (placebo plus methylcobalamin). Subjects were reassessed after the 24‐week intervention. The primary outcomes were differences in changes in clinical signs and symptoms and changes in the Michigan Diabetic Neuropathy Score (MDNS) between the two groups before and after treatment. Secondary outcomes were changes in nerve conduction velocity (NCV) and single clinical signs and symptoms as measured by the visual‐analogue scale (VAS) and Toronto clinical scoring system (TCSS). Results Compared with the placebo group, after 24 weeks of treatment, the MDNS score of TangBi Formula group was significantly reduced (p < 0.001). There were no significant changes in NCV results in either group before or after treatment. Compared with baseline, the difference in the change value of VAS score between the two groups after treatment was statistically significant (p = 0.031). A statistically significant difference in the change value of TCSS after treatment compared to baseline was found between the two groups (p = 0.033 at 12 weeks and p = 0.030 at 24 weeks). No severe adverse events due to study participation or study intervention were reported. Conclusions and Relevance This trial demonstrated that combining Tangbi Formula with basal therapy can be safer and more effective in improving the symptoms of DSPN patients.https://doi.org/10.1111/1753-0407.70045diabetesdiabetic distal symmetric polyneuropathyherbal therapyTCM |
| spellingShingle | Xuefei Zhao Xuedong An Yashan Cui Liu Dong Zhaohui Fang Zhonghua Zheng Xinhe Zuo Huailin Gao Tianshu Gao Qing Ni Fengmei Lian Xiaolin Tong TangBi Formula for Painful Diabetic Distal Symmetric Polyneuropathy: A Multicenter, Randomized, Double‐Blind, Placebo‐Controlled and Parallel‐Group Trial Journal of Diabetes diabetes diabetic distal symmetric polyneuropathy herbal therapy TCM |
| title | TangBi Formula for Painful Diabetic Distal Symmetric Polyneuropathy: A Multicenter, Randomized, Double‐Blind, Placebo‐Controlled and Parallel‐Group Trial |
| title_full | TangBi Formula for Painful Diabetic Distal Symmetric Polyneuropathy: A Multicenter, Randomized, Double‐Blind, Placebo‐Controlled and Parallel‐Group Trial |
| title_fullStr | TangBi Formula for Painful Diabetic Distal Symmetric Polyneuropathy: A Multicenter, Randomized, Double‐Blind, Placebo‐Controlled and Parallel‐Group Trial |
| title_full_unstemmed | TangBi Formula for Painful Diabetic Distal Symmetric Polyneuropathy: A Multicenter, Randomized, Double‐Blind, Placebo‐Controlled and Parallel‐Group Trial |
| title_short | TangBi Formula for Painful Diabetic Distal Symmetric Polyneuropathy: A Multicenter, Randomized, Double‐Blind, Placebo‐Controlled and Parallel‐Group Trial |
| title_sort | tangbi formula for painful diabetic distal symmetric polyneuropathy a multicenter randomized double blind placebo controlled and parallel group trial |
| topic | diabetes diabetic distal symmetric polyneuropathy herbal therapy TCM |
| url | https://doi.org/10.1111/1753-0407.70045 |
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