Evidence map›Paper›PMID 33658841›Full record

ArticleJournal of pain research2021

Efficacy and Safety of Pregabalin for Fibromyalgia in a Population of Chinese Subjects.

Xiao Zhang, Huji Xu, Zhiyi Zhang, Yang Li, Lynne Pauer, Shanmei Liao, Fengchun Zhang

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Journal of pain research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01387607 (A 14-week, Randomized, Double-blind Placebo-controlled Study For Pregabalin In Subjects With Fibromyalgia), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 10% 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.

NCT01387607 phase3completednot on this map

A 14-week, Randomized, Double-blind Placebo-controlled Study For Pregabalin In Subjects With Fibromyalgia

TypeinterventionalSponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.Ran2012 to 2016Enrolled343ConditionsFibromyalgiaArmspregabalin, placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. 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

7 authors at 6 institutions in 2 countries.

Xiao ZhangDepartment of Rheumatology, Guangdong General Hospital, Guangdong, People's Republic of China.
Huji XuDepartment of Rheumatology and Immunology, Shanghai Changzheng Hospital, Affiliated to Second Military Medical University, Shanghai, People's Republic of China.ORCID 0000-0002-8588-118X
Zhiyi ZhangSchool of Clinical Medicine, The First Affiliated Hospital of Harbin Medical University, Harbin, People's Republic of China.
Yang LiDepartment of Rheumatology and Immunology, The Second Affiliated Hospital of Harbin Medical University, Harbin, People's Republic of China.
Lynne PauerGlobal Research and Development, Pfizer, Groton, CT, USA.
Shanmei LiaoPfizer China Statistics Department, Global Innovative Pharma Business, Shanghai, People's Republic of China.
Fengchun ZhangDepartment of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Beijing, People's Republic of China.
Harbin Medical University · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNGuangdong General Hospital · CNPfizer (China) · CNPfizer (United States) · USSecond Military Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeFibromyalgia (FM) may go underdiagnosed and untreated in China in part due to a lack of awareness and understanding of the condition, and limited available treatments. PATIENTS AND

methodsThis randomized, double-blind, Phase III local registration trial compared the efficacy and safety of pregabalin (flexibly dosed 300-450 mg/day) versus placebo for the management of pain in Chinese adults diagnosed with FM according to American College of Rheumatology 1990 criteria, across 22 centers within China. Patients reported pain score of ≥40 mm on 100-mm scale (from 0 "no pain" to 100 "worst possible pain"). The primary efficacy endpoint was change from baseline to Week 14 in mean pain score (MPS). Secondary endpoints included measures of sleep and sleep interference. Safety and tolerability were monitored throughout.

resultsMedian pregabalin dose was 335 mg/day. A significant reduction from baseline to Week 14 in weekly MPS was seen for patients treated with pregabalin (n=170) versus placebo (n=164) (least-squares mean difference [95% confidence interval]: -0.73 [-1.10 to -0.36];

conclusionPregabalin (300-450 mg/day) is a safe and effective treatment for reducing pain and improving sleep in native Chinese subjects with FM. CLINICALTRIALSGOV IDENTIFIER: NCT01387607.

Indexed as

Chinachronic painFMLyricapain managementsleep

Identifiers

PMID33658841
PMCPMC7920593
OpenAlexW3132444531

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.