A multicenter, open-label, parallel-group, randomized controlled trial of Tongluo-Qutong rubber plaster for the treatment of cervical spondylotic radiculopathy
Affiliations: [a] Affiliated Hospital of Gansu University of Chinese Medicine, Lanzhou, China | [b] Tianshui City Hospital of Traditional Chinese Medicine, Tianshui, China | [c] Gansu Provincial Hospital of Traditional Chinese Medicine, Lanzhou, China | [d] Affiliated Hospital of Northwest University for Nationalities, Lanzhou, China
Correspondence:
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Corresponding authors: Xing-Wen Xie, Affiliated Hospital of Gansu University of Chinese Medicine, 732 Jiayuguan West Road, Chengguan District, Lanzhou, 730000 Gansu, China. Tel.: +86 15002591615; E-mail: [email protected]. Yong-Li Zhao, Affiliated Hospital of Gansu University of Chinese Medicine, 732 Jiayuguan West Road, Chengguan District, Lanzhou, 730000 Gansu, China. Tel.: +86 13679440739; E-mail: [email protected].
Note: [1] Xing-Wen Xie and Chun-Xiao Wang contributed equally to this work and are co-first authors.
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.
Keywords: Cervical spondylotic radiculopathy, Chinese traditional medicine, TQRP, rubber plaster
