Post-Marketing Surveillance of Qishe Pill () Use for Management of Neck Pain in a Chinese Patient Cohort to Determine its Safety, Tolerability and Effectiveness.
10.1007/s11655-021-2868-x
- Author:
Xue-Jun CUI
1
;
Yue-Li SUN
1
;
Chang-Qing ZHANG
2
;
Tao WU
3
;
Jun TAN
4
;
Zhen-An ZHU
5
;
Yong-Qiang CHEN
6
;
Qiu-Gen WANG
7
;
Ming LI
8
;
Yong-Jun WANG
9
Author Information
1. Spine Research Institute, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
2. Department of Orthopedics, Shanghai Sixth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
3. Department of Orthopedics, Huadong Hospital, Fudan University, Shanghai, 200040, China.
4. Department of Orthopedics, Shanghai East Hospital, Tongji University, Shanghai, 200120, China.
5. Department of Orthopedics, Shanghai Ninth People's Hospital, Shanghai, 200011, China.
6. Department of Orthopedics, Shanghai Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.
7. Department of Orthopedics, Shanghai First Hospital, Shanghai, 200080, China.
8. Department of Orthopedics, Shanghai Changhai Hospital, Navy Medical University, Shanghai, 200435, China.
9. Spine Research Institute, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China. yjwang8888@126.com.
- Publication Type:Journal Article
- Keywords:
Chinese medicine;
Qishe Pill;
complementary and alternative medicine;
neck pain;
pain assessment;
post-marketing surveillance
- From:
Chinese journal of integrative medicine
2021;27(6):408-416
- CountryChina
- Language:English
-
Abstract:
OBJECTIVE:To evaluate the safety and effectiveness of Qishe Pill () 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).
