Post-Marketing Surveillance of Qishe Pill (芪麝丸) Use for Management of Neck Pain in a Chinese Patient Cohort to Determine its Safety, Tolerability and Effectiveness

Cui, Xue‐jun; Sun, Yue‐Li; Zhang, Changqing; Wu, Tao; Tan, Jun; Zhu, Zhiming; Chen, Yongqiang; Wang, Qiugen; Li, Ming; Wang, Yongjun

doi:10.1007/s11655-021-2868-x

Cited by 1 publication

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“…The experimental drug, Qishe speci cations are: 0.15 g per pill and 3.75 g per bag. This product was launched in 2009 and approved by the National Medical Product Administration of China) (Approval number: Z20090978).The control drug was mecobalamin (0.5mg per pill; Hainan Star Pharmaceutical, Hainan, China) (Approval number: H20050997) 10 .…”

Section: Product Descriptionmentioning

confidence: 99%

Effectiveness and safety of Qishe™ for treating postoperative symptoms after surgery for cervical spondylotic myelopathy: A prospective, randomized, controlled clinical trial

zhang,

Zhou,

et al. 2024

Preprint

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Objectives: With the increasing incidence and surgical management of cervical spondylotic myelopathy, residual postoperative pain and numbness have become challenging problems. Investigation into reducing postoperative symptoms and improving the quality of life of patients who have undergone surgery for cervical spondylotic myelopathy is urgently required. Qishe™ is a traditional Chinese compound herbal medicine, clinical trials have shown that it reduces limb numbness and pain in patients with cervical spondylosis. We conducted a prospective, randomized, controlled trial to evaluate the effectiveness and safety of Qishe in improving postoperative symptoms after surgery for cervical spondylotic myelopathy. Methods: We have recruited 72 patients who underwent anterior cervical decompression and fusion in Longhua and Long March Hospitals from December 2019 to August 2020. The study patients were randomly divided into treatment (36 cases) and control groups (36). The treatment group received Qishe and the control group mecobalamin. Trained researchers evaluated the patients at the time of enrollment, and 2, 4, 6 months after surgery. The outcomes included Japanese Orthopaedic Association scores, visual analogue scale, Neck Disability Index, 10-s grip and release test. Adverse reactions and postoperative complications were recorded. Results: A total of 71 subjects were analyzed (36 subjects in the Qishe group, 35 subjects in the control group). We found that Qishe improved postoperative limb sensation and motor function and reduced severity of pain and cervical dysfunction index scores. Its clinical efficacy was not inferior to that of mecobalamin (P=0.437). There were no serious adverse events in either group. Conclusion:Qishe is an effective and safe treatment for postoperative symptoms in patients who have undergone surgery for cervical spondylotic myelopathy.

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Section: Product Descriptionmentioning

confidence: 99%