XU Jinhai, WANG Guodong, SHEN Qixing, et al. Clinical study on Jinbi granules in treating cervical spondylosis radiculopathy: a randomized, double-blind and double-dummy controlled trail. [J]. Shanghai Journal of Traditional Chinese Medicine 54(2):54-60(2020)
DOI:
XU Jinhai, WANG Guodong, SHEN Qixing, et al. Clinical study on Jinbi granules in treating cervical spondylosis radiculopathy: a randomized, double-blind and double-dummy controlled trail. [J]. Shanghai Journal of Traditional Chinese Medicine 54(2):54-60(2020) DOI: 10.16305/j.1007-1334.2020.02.014.
Clinical study on Jinbi granules in treating cervical spondylosis radiculopathy: a randomized, double-blind and double-dummy controlled trail
Objective:To observe the clinical efficacy and safety of Jinbi granules in the treatment of cervical spondylosis radiculopathy (CSR). MethodsA randomized, double-blind and double-dummy controlled clinical trial was conducted with 72 patients being randomly divided into 2 groups (36 patients per group). The experimental group was administered the Jinbi granules and Celebrex simulated capsules, while the control group was given the Celebrex capsules and the Jinbi granules placebo. VAS, NDI and SF-36 quality of life scores were recorded before treatment, and at 1 week, 2 weeks and 8 weeks after treatment respectively. Patients’ adverse reactions were recorded and their clinical efficacy and safety were evaluated. Results:①There was one drop-out case in the experimental group and two drop-out cases in the control group. ②The difference between VAS scores of pain in the two groups before and after treatment was statistically significant (P<0.05), and the VAS scores gradually decreased, indicating a time effect; There was no significant difference in VAS scores between the two groups at different time points (P>0.05), indicating there was no grouping effect. There was no interaction between time factor and grouping factor (P>0.05). The 95 % confidence interval of the VAS scores difference between the two groups after 14 days of treatment and before treatment was in the range from 2.45 to 2.81. According to the preset non-inferiority standard of 20 %, the non-inferiority test was passed. ③The difference of NDI scores between the two groups compared before and after treatment at different time points was statistically significant (P<0.05), and NDI scores gradually decreased, suggesting a time effect. There was no significant difference in NDI scores between the two groups at different time points (P>0.05), i.e., there was no grouping effect. There was no interaction between time and grouping factors (P>0.05). The 95 % confidence interval of NDI score difference between the two groups after 14 days of treatment and before treatment was in the range from 4.88 to 9.78. According to the preset non-inferiority standard of 20 %, the non-inferiority test was passed. ④There was significant difference in SF-36-PCS score between the two groups at different time points after treatment and before treatment (P<0.05), and SF-36-PCS score gradually increased, suggesting a time effect; there was no significant difference in SF-36-PCS score at different time points between the two groups (P>0.05), i.e., there was no grouping effect. There was no interaction between time and grouping factors (P>0.05). ⑤There was significant difference in SF-36-MCS score between the two groups at different time points after treatment and before treatment (P<0.05), and SF-36-MCS score gradually increased, indicating a time effect. There was no significant difference in SF-36-MCS scores between groups before and 7 days after treatment (P>0.05); there was significant difference in SF-36-PCS scores between groups after 14 days of treatment and 2 months of follow-up (P<0.05), suggesting a grouping effect. There was interaction between time and grouping factors (P<0.05). ⑥No serious adverse events occurred in the experimental group and the control group. Conclusion:The clinical efficacy of Jinbi granules in the treatment of CSR, which is not inferior to that of Celebrex. Jinbi granules can reduce the pain of neck and shoulder, improve the dysfunction of cervical vertebra and the quality of life of patients, and improve the mental health problems in particular, reflecting the characteristics of “treating both mind and body” in traditional Chinese medicine.
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