Evidence map›Paper›PMID 35191232›Full record

Trial reportJournal of Korean medical science2022

Efficacy and Safety of Pregabalin for Muscle Cramps in Liver Cirrhosis: A Double-Blind Randomized Controlled Trial.

Sohyun Ahn, Yoon-Ho Hong, Dong Hyeon Lee, Sae Kyung Joo, Yong Jin Jung, Sung-Yeon Sohn, Kyomin Choi, Won Kim

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of Korean medical science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01271660 (A Randomized, Double-blinded, Placebo-controlled Study Evaluating the Efficacy and Safety of 6-week Treatment of Pregabalin Against Frequent Muscle Cramp in Patients With Liver Cirrhosis), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.8field-weighted citation impact, top 30% 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.

NCT01271660 phase3completednot on this map

A Randomized, Double-blinded, Placebo-controlled Study Evaluating the Efficacy and Safety of 6-week Treatment of Pregabalin Against Frequent Muscle Cramp in Patients With Liver Cirrhosis

TypeinterventionalSponsorSeoul National University Boramae HospitalRan2011 to 2018Enrolled60ConditionsMuscle Cramp, Liver CirrhosisArmsPregabalin, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
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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

8 authors at 5 institutions in 1 country.

Sohyun AhnDepartment of Neurology, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-9206-1972
Yoon-Ho HongDepartment of Neurology, Neuroscience Research Institute, Seoul National University Medical Research Council, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea. yhh@snu.ac.kr.ORCID https://orcid.org/0000-0002-3325-6358
Dong Hyeon LeeDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0003-2044-6854
Sae Kyung JooDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-4615-7607
Yong Jin JungDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0001-8785-2254
Sung-Yeon SohnDepartment of Neurology, Ajou University Medical Center, Ajou University College of Medicine, Suwon, Korea.ORCID https://orcid.org/0000-0003-4928-2398
Kyomin ChoiDepartment of Neurology, Konkuk University Hospital, Konkuk University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0001-9730-3363
Won KimDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea. drwon1@snu.ac.kr.ORCID https://orcid.org/0000-0002-2926-1007
Seoul National University · KRAjou University · KRHallym University · KRKonkuk University Medical Center · KRSeoul Metropolitan Government · KR

Funding

Pfizer Pharmaceuticals Korea
6 · The paper itself

Abstract

backgroundMuscle cramp is possibly related to peripheral nerve hyperexcitability (PNH), and one of the most debilitating symptoms frequently encountered in patients with liver cirrhosis. We investigated whether pregabalin, a gamma-aminobutyric acid analogue, can suppress neuronal excitability and reduce muscle cramps in cirrhotic patients.

methodsWe conducted a randomized, double-blind, placebo-controlled trial in which study participants with cirrhosis from a single tertiary center were enrolled. Primary endpoint was the relative change in cramp frequency from the run-in to standard dose treatment phase (4 weeks per each). Secondary endpoints included the responder rate, and the changes in cramp frequency during sleep, pain intensity, health-related quality of life (Liver Disease Quality of Life Instrument, Short Form-36) and electrophysiological measures of PNH.

resultsThis study was terminated early because of insufficient accrual. 80% (n = 56) of the target number of participants (n = 70) were randomized to pregabalin (n = 29) or placebo (n = 27). Median baseline frequency of muscle cramps (interquartile range) was 5.8 (3.5-10) per week in the pregabalin group and 6.5 (4.0-10) in the placebo group (

conclusionWith multiple problems emerging from premature termination in mind, the results suggested an acceptable safety profile and favorable effect of pregabalin in reducing muscle cramps compared to placebo in cirrhotic patients.

trial registrationClinicalTrials.gov Identifier: NCT01271660.

Indexed as

Muscle CrampQuality of LifeAnalgesicsDouble-Blind Methodgamma-Aminobutyric AcidHumansLiver CirrhosisPregabalinTreatment OutcomeAnalgesicsgamma-Aminobutyric AcidPregabalinLiver CirrhosisMuscle CrampPeripheral NervePregabalin

Identifiers

PMID35191232
PMCPMC8860769
OpenAlexW4210911571

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.