1. A multicenter, open-label, parallel-group, randomized controlled trial of Tongluo-Qutong rubber plaster for the treatment of cervical spondylotic radiculopathy.
- Author
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Xie, Xing-Wen, Wang, Chun-Xiao, Zhao, Yong-Li, Luo, Yong-Sheng, Wang, Zhong-Hua, Liu, Jing, Li, Hui, and Li, Ding-Peng
- Subjects
CHINESE medicine ,PAIN measurement ,RESEARCH funding ,HERBAL medicine ,STATISTICAL sampling ,QUESTIONNAIRES ,VISUAL analog scale ,TREATMENT effectiveness ,RANDOMIZED controlled trials ,DESCRIPTIVE statistics ,SPONDYLOSIS ,RADICULOPATHY ,DICLOFENAC ,PAIN ,RESEARCH ,CERVICAL vertebrae ,THERAPEUTICS - Abstract
BACKGROUND: In China, Tongluo-Qutong rubber plaster (TQRP) is commonly used for cervical spondylotic radiculopathy, but lacks high-quality trials. OBJECTIVE: This study aimed to conduct a multicenter, open-label, parallel-group, randomized controlled trial in China to investigate the practical efficacy and safety of TQRP in the treatment of CSR. METHODS: A total of 240 patients diagnosed with CSR were recruited for the investigation from multiple hospitals in Gansu province, China. The patients were randomly assigned to either an experimental or a control group. The experimental group received treatment with TQRP, whereas the control group was administered a diclofenac sodium patch (DSP) for a maximum duration of 21 days. The visual analogue scale (VAS) score for pain, the proportion of patients experiencing 50% or more pain relief, the neck disability index (NDI), changes as per the Eaton trial, and recurrence during the follow-up period were evaluated for both groups. The safety and adverse events associated with the concurrent drug therapy were also evaluated. RESULTS: At each time point, the mean VAS and NDI scores of both groups demonstrated a downward trend. The experimental group exhibited a greater decline in VAS score at each time point compared to the control group (P < 0.01). In the Eaton trial, both the percentage of patients experiencing pain relief of 50% or more and the number of abnormal results exhibited improvement. However, the outcomes in the 21 ± 3d experimental group were significantly superior to those in the control group (P < 0.01). During the follow-up period, the recurrence events in the experimental group were reduced compared to the control group. The difference between the two groups was statistically significant (P < 0.05). The incidence of adverse reactions was 1.74% for TQRP and 3.54% for DSP. CONCLUSION: TQRP is effective and safe in the treatment of CSR. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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