Zhaohui Fang1, Jindong Zhao2, Guobing Shi3, Yiqiong Shu3, Yingqun Ni3, Huan Wang3, Lei Ding3, Ruimin Lu3, Jiayun Li3, Xiaojin Zhu3, Senhua Cheng4, Xinyi Zhang3, Yan Liu5, Jun Wang6, Yuan Luo3, Qingyun Fan3, Chenglin Guo3, Ting Jiang3, Qian Wu3, Lihong Fan3, Hanpeng Ling3, Liqun Cui3, Yun Luo3, Hui Yang3, Robert M Anderson7. 1. Department of Endocrinology, the First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei 230031, Anhui Province, China; Institute of Chinese Medicine Prevention and Therapy Diabetes Mellitus, Anhui Academy of Chinese Medicine, Hefei 230031, Anhui Province, China. Electronic address: fangzhaohui1111@163.com. 2. Department of Endocrinology, the First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei 230031, Anhui Province, China; Institute of Chinese Medicine Prevention and Therapy Diabetes Mellitus, Anhui Academy of Chinese Medicine, Hefei 230031, Anhui Province, China. 3. Department of Endocrinology, the First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei 230031, Anhui Province, China. 4. Department of Endocrinology, Shangyu City Hospital of Chinese Medicine, Shangyu 312300, Zhejiang Province, China. 5. Department of Endocrinology, the Second Affiliated Hospital of Anhui University of Chinese Medicine, Hefei 230031, Anhui Province, China. 6. Department of Endocrinology, Wuhu City Hospital of Chinese Medicine, Wuhu 241000, Anhui Province, China. 7. Institute of Chinese Medicine Prevention and Therapy Diabetes Mellitus, Anhui Academy of Chinese Medicine, Hefei 230031, Anhui Province, China; The Department of Learning Health Sciences, University of Michigan Medical School, Ann Arbor, MI, USA.
Abstract
OBJECTIVE: The purpose of the study was to evaluate the clinical effects of the Shenzhu Tiaopi granule (SZTP) combined with a lifestyle intervention in patients with impaired glucose tolerance (IGT), who also had a spleen deficiency and damp overabundance syndrome (SDDOS). METHODS: After a one-month washout period, a total of 514 patients were randomly assigned to the control (lifestyle intervention) and experimental (SZTP plus lifestyle intervention) groups, with 257 patients in each group. Patients in the control group received the lifestyle intervention (diet and exercise) for 12 months, while the patients in the experimental group were treated with SZTP plus the lifestyle intervention for 12 months. The Traditional Chinese Medicinal (TCM) symptom scores were observed in each group before and after treatment; the conversion rates from IGT to diabetes mellitus (DM) were also measured. RESULTS: Following 12 months of treatment, the conversion rate from IGT to DM in the experimental group was significantly lower than in the control group (8.52% vs. 15.28%, P<0.05). A significantly higher number of patients with IGT reverted to normal blood glucose levels in the experimental group than in the control group (42.15% vs. 32.87%, P<0.05). In addition, after following the treatment for 12 months, the TCM symptoms of patients in the experimental group were markedly alleviated, as compared to the control group (P<0.01). CONCLUSION: The combination of SZTP and lifestyle intervention showed a reduction in the conversion from IGT to DM, and an increase in the conversion from IGT to normal blood glucose levels.
RCT Entities:
OBJECTIVE: The purpose of the study was to evaluate the clinical effects of the Shenzhu Tiaopi granule (SZTP) combined with a lifestyle intervention in patients with impaired glucose tolerance (IGT), who also had a spleen deficiency and damp overabundance syndrome (SDDOS). METHODS: After a one-month washout period, a total of 514 patients were randomly assigned to the control (lifestyle intervention) and experimental (SZTP plus lifestyle intervention) groups, with 257 patients in each group. Patients in the control group received the lifestyle intervention (diet and exercise) for 12 months, while the patients in the experimental group were treated with SZTP plus the lifestyle intervention for 12 months. The Traditional Chinese Medicinal (TCM) symptom scores were observed in each group before and after treatment; the conversion rates from IGT to diabetes mellitus (DM) were also measured. RESULTS: Following 12 months of treatment, the conversion rate from IGT to DM in the experimental group was significantly lower than in the control group (8.52% vs. 15.28%, P<0.05). A significantly higher number of patients with IGT reverted to normal blood glucose levels in the experimental group than in the control group (42.15% vs. 32.87%, P<0.05). In addition, after following the treatment for 12 months, the TCM symptoms of patients in the experimental group were markedly alleviated, as compared to the control group (P<0.01). CONCLUSION: The combination of SZTP and lifestyle intervention showed a reduction in the conversion from IGT to DM, and an increase in the conversion from IGT to normal blood glucose levels.