Jing Zhou1, Fei Liu1, WeiLing Jiang2, Ming Hu1. 1. Pharmaceutical Policy and Pharmacoeconomics Research Center, West China School of Pharmacy, Sichuan University, Chengdu, China. 2. InCROM CHINA, Shanghai, China.
Abstract
Objective: Traditional Chinese Medicines (TCMs), as well as physiotherapy and chemical drugs, are recommended for the treatment of cervical spondylosis by Chinese guidelines for cervical spondylosis diagnosis and treatment. The aim of this study was to evaluate whether TCM Jingshu Granules are cost-effective in patients with cervical radiculopathy in China. Methods: A multicenter, double-blinded, randomized placebo-controlled trial was performed. A total of 480 patients were recruited from 14 tertiary hospitals in China and were randomly divided into an experimental group (Jingshu Granules) or control group (placebo) at a 3:1 ratio. All patients received 4 weeks of treatment. Clinical outcomes and cost data were collected during the trial, including the neck disability index (NDI), visual analog scale (VAS) of pain, VAS of numbness, 36-Item Short Form Health Survey (SF-36) score, willingness to pay (WTP) for VAS of pain, direct medical costs, and transport costs. From a social perspective, a decision-tree model and cost-effectiveness analysis were conducted. Results: The treatment group has a significant advantage in reducing NDI (9.41 ± 10.51 vs. 4.83 ± 8.43, p < 0.05), VAS of pain (22.72 ± 15.08 vs. 12.86 ± 13.45, p < 0.05), and VAS of numbness (16.96 ± 17.53 vs. 11.64 ± 16.54, p < 0.05), respectively, while there was no significant difference in the improvement of quality of life (QoL; SF-36 score, p > 0.05). The expected mean cost of the experimental group was 1144.34 yuan, and the effective rates were 57.9% for NDI and 72.9% for VAS of pain. The expected mean cost of the control group was 767.41 yuan, and the effective rates were 33.3% for NDI and 51.6% for VAS of pain. For the primary indicators (VAS of pain and NDI), the incremental cost-effectiveness ratio was 17.69 and 15.32, respectively. The WTP per efficacy for pain resolution of patients was 19.10 yuan. Setting the WTP as threshold, Jingshu Granules were found to be a cost-effectiveness strategy, and sensitivity analysis showed that the effective rates and inspection fees of both groups had a greater impact on the results of both groups. Conclusions: Jingshu Granules were shown to be effective for treating patients with cervical radiculopathy. This treatment was found to be cost-effective when considering VAS of pain and NDI as clinical outcome indicators compared to no treatment (placebo). A clinical study with longer duration or real world study is needed to determine the impact on QoL of patients in the future.
RCT Entities:
Objective: Traditional Chinese Medicines (TCMs), as well as physiotherapy and chemical drugs, are recommended for the treatment of cervical spondylosis by Chinese guidelines for cervical spondylosis diagnosis and treatment. The aim of this study was to evaluate whether TCM Jingshu Granules are cost-effective in patients with cervical radiculopathy in China. Methods: A multicenter, double-blinded, randomized placebo-controlled trial was performed. A total of 480 patients were recruited from 14 tertiary hospitals in China and were randomly divided into an experimental group (Jingshu Granules) or control group (placebo) at a 3:1 ratio. All patients received 4 weeks of treatment. Clinical outcomes and cost data were collected during the trial, including the neck disability index (NDI), visual analog scale (VAS) of pain, VAS of numbness, 36-Item Short Form Health Survey (SF-36) score, willingness to pay (WTP) for VAS of pain, direct medical costs, and transport costs. From a social perspective, a decision-tree model and cost-effectiveness analysis were conducted. Results: The treatment group has a significant advantage in reducing NDI (9.41 ± 10.51 vs. 4.83 ± 8.43, p < 0.05), VAS of pain (22.72 ± 15.08 vs. 12.86 ± 13.45, p < 0.05), and VAS of numbness (16.96 ± 17.53 vs. 11.64 ± 16.54, p < 0.05), respectively, while there was no significant difference in the improvement of quality of life (QoL; SF-36 score, p > 0.05). The expected mean cost of the experimental group was 1144.34 yuan, and the effective rates were 57.9% for NDI and 72.9% for VAS of pain. The expected mean cost of the control group was 767.41 yuan, and the effective rates were 33.3% for NDI and 51.6% for VAS of pain. For the primary indicators (VAS of pain and NDI), the incremental cost-effectiveness ratio was 17.69 and 15.32, respectively. The WTP per efficacy for pain resolution of patients was 19.10 yuan. Setting the WTP as threshold, Jingshu Granules were found to be a cost-effectiveness strategy, and sensitivity analysis showed that the effective rates and inspection fees of both groups had a greater impact on the results of both groups. Conclusions: Jingshu Granules were shown to be effective for treating patients with cervical radiculopathy. This treatment was found to be cost-effective when considering VAS of pain and NDI as clinical outcome indicators compared to no treatment (placebo). A clinical study with longer duration or real world study is needed to determine the impact on QoL of patients in the future.