Evidence map›Paper›PMID 33881718›Full record

Observational studyChinese journal of integrative medicine2021

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

Xue-Jun Cui, Yue-Li Sun, Chang-Qing Zhang, Tao Wu, Jun Tan, Zhen-An Zhu, Yong-Qiang Chen, Qiu-Gen Wang, Ming Li, Yong-Jun Wang

Registry-linked trialAbstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Chinese journal of integrative medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01875562 (A Post-marketing Evaluation of a Compound Traditional Chinese Herbal Medicine, Qishe Pill, on Cervical Radiculopathy), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 39% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01875562 phase4unknown statusnot on this map

A Post-marketing Evaluation of a Compound Traditional Chinese Herbal Medicine, Qishe Pill, on Cervical Radiculopathy

TypeinterventionalSponsorShanghai University of Traditional Chinese MedicineRan2012 to 2013Enrolled2,400ConditionsCervical RadiculopathyArmsQishe Pill
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 8 institutions in 1 country.

Xue-Jun CuiSpine Research Institute, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
Yue-Li SunSpine Research Institute, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
Chang-Qing ZhangDepartment of Orthopedics, Shanghai Sixth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
Tao WuDepartment of Orthopedics, Huadong Hospital, Fudan University, Shanghai, 200040, China.
Jun TanDepartment of Orthopedics, Shanghai East Hospital, Tongji University, Shanghai, 200120, China.
Zhen-An ZhuDepartment of Orthopedics, Shanghai Ninth People's Hospital, Shanghai, 200011, China.
Yong-Qiang ChenDepartment of Orthopedics, Shanghai Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.
Qiu-Gen WangDepartment of Orthopedics, Shanghai First Hospital, Shanghai, 200080, China.
Ming LiDepartment of Orthopedics, Shanghai Changhai Hospital, Navy Medical University, Shanghai, 200435, China.
Yong-Jun WangSpine Research Institute, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China. yjwang8888@126.com.
Longhua Hospital Shanghai University of Traditional Chinese Medicine · CNShanghai University of Traditional Chinese Medicine · CNHuadong Hospital · CNSecond Military Medical University · CNShanghai East Hospital · CNShanghai First People's Hospital · CNShanghai Jiao Tong University · CNShanghai Ninth People's Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the safety and effectiveness of Qishe Pill () on neck pain in real-world clinical practice.

methodsA 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.

resultsResults 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.

conclusionThese findings showed that patients with cervical radiculopathy who received Qishe Pill experienced significant improvement on pain and function. (Registration No. NCT01875562).

Indexed as

Cervical VertebraeNeck PainChinaDrugs, Chinese HerbalHumansMiddle AgedProduct Surveillance, PostmarketingProspective StudiesTreatment OutcomeDrugs, Chinese HerbalqisheChinese medicinecomplementary and alternative medicineneck painpain assessmentpost-marketing surveillanceQishe Pill

Identifiers

PMID33881718
OpenAlexW3153416016

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.