中国结合医学杂志（英文版）Chinese Journal of Integrative Medicine

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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

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KeyWord:neck pain, pain assessment, post-marketing surveillance, Qishe Pill, Chinese medicine, complementary and alternative medicine

Author Name	Affiliation	E-mail
CUI Xue-jun, SUN Yue-li, ZHANG Chang-qing
WANG Yong-jun	Spine Research Institute, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai (200032), China	yjwang8888@126.com

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Abstract:

Objective: To evaluate the safety and effectiveness of Qishe Pill (芪麝丸) on neck pain in real world clinical practice. Methods: A multi-center, prospective, observational surveillance in 8 hospitals across Shanghai was conducted. During patients receiving 4-week Qishe Pill medication, Visual Analogue Scale (VAS) and Neck Disability Index (NDI) assessments have been used to assess their pain and function, while safety monitoring have been observed after 2 and 4 weeks. Results: Results from 2,023 patients (mean age 54.5 years) suggest that the drug exposure per unit of body mass was estimated at 3.41± 0.62 g/kg. About 8.5% (172/2,023) of all participants experienced adverse events (AEs), while 3.8% (78/2,023) of all participants experienced adverse reaction. The most common AEs were gastrointestinal events and respiratory events. The VAS score (pain) and NDI score (function) significantly decreased after 4-week treatment. An effect-quantitative analysis was also conducted to show that the normal clinical dosage may be consider as 3–4 g/kg, at which dosage the satisfactory pain-relief effect may achieve by 40-mm reduction in VAS. Conclusion: These findings showed that patients with cervical radiculopathy who received Qishe Pill experienced significant improvement on pain and function. (Registration No. NCT01875562)