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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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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)

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Author information

Authors and Affiliations

  1. Spine Research Institute, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China

    Xue-jun Cui, Yue-li Sun & Yong-jun Wang

  2. Department of Orthopedics, Shanghai Sixth People’s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China

    Chang-qing Zhang

  3. Department of Orthopedics, Huadong Hospital, Fudan University, Shanghai, 200040, China

    Tao Wu

  4. Department of Orthopedics, Shanghai East Hospital, Tongji University, Shanghai, 200120, China

    Jun Tan

  5. Department of Orthopedics, Shanghai Ninth People’s Hospital, Shanghai, 200011, China

    Zhen-an Zhu

  6. Department of Orthopedics, Shanghai Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China

    Yong-qiang Chen

  7. Department of Orthopedics, Shanghai First Hospital, Shanghai, 200080, China

    Qiu-gen Wang

  8. Department of Orthopedics, Shanghai Changhai Hospital, Navy Medical University, Shanghai, 200435, China

    Ming Li

Authors
  1. Xue-jun Cui
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  2. Yue-li Sun
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  3. Chang-qing Zhang
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  4. Tao Wu
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  5. Jun Tan
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  6. Zhen-an Zhu
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  7. Yong-qiang Chen
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  8. Qiu-gen Wang
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  9. Ming Li
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  10. Yong-jun Wang
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Contributions

Cui XJ and Sun YL conducted the study and wrote the manuscript, they contributed equally to this work as co-first authors. Sun YL, Zhang CQ, Wu T, Tan J, Zhu ZA, Chen YQ, Wang QG and Li M collected data and provided clinical assistance. Wang YJ initiated and oversaw the study.

Corresponding author

Correspondence to Yong-jun Wang.

Additional information

Conflicts of Interest

The current study was sponsored by Shanghai Huanghai Pharmaceutical CO. Ltd) for post-marketing surveillance of the Qishe Pill with regard to its tolerability and effectiveness on cervical radiculopathy participants in Shanghai. Dr. Cui Xue-jun is a member of the CJIM editorial board. The paper went through a rigorous peer review process. As the author, he did not participate in the review of the manuscript by the journal or its related decisions. The authors declare that they have no competing interest.

Data Share Statements

The data used to support the findings of this study are available from the corresponding author upon request.

Supported by the National Science Fundation for Young Scholars of China (No. 81804115, No. 81873317, No. 81930116 and No. 82074454), the State Key Program of National Natural Science of China (No. 81330085 and No. 81930116), Shanghai Sailing Program (No. 18YF1423800); Shanghai TCM Medical Center of Chronic Disease (No. 2017ZZ01010), Municipal Science and Technology Commission of Shanghai-TCM Key Project (No. 16401970100), and National Thirteenth Five-Year Science and Technology Major Special Project for New Drug Innovation and Development (No. 2017ZX09304001)

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Cui, Xj., Sun, Yl., Zhang, Cq. et al. 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. Chin. J. Integr. Med. 27, 408–416 (2021). https://doi.org/10.1007/s11655-021-2868-x

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  • DOI: https://doi.org/10.1007/s11655-021-2868-x

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