Evidence map›Paper›PMID 34218304›Full record

Trial reportEuropean journal of clinical pharmacology2021

Comparative study evaluating antihistamine versus leukotriene receptor antagonist as adjuvant therapy for rheumatoid arthritis.

Tarek Mohamed Mostafa, Sahar Kamal Hegazy, Salwa El-Morsy Abd El-Ghany, Fedaa Abd El-Monem Kotkata

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03770923 (Clinical Study Evaluating the Effect of Histamine 1 Receptor Antagonist and Leukotreine Receptor Antagonist on Patients With Rheumatoid Arithritis), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 34% 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.

NCT03770923 phase3recruitingnot on this map

Clinical Study Evaluating the Effect of Histamine 1 Receptor Antagonist and Leukotreine Receptor Antagonist on Patients With Rheumatoid Arithritis

TypeinterventionalSponsorSherief Abd-ElsalamRan2018 to 2027Enrolled75ConditionsRheumatoid ArthritisArmsRupatadine, Montelukast
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Advances in clinical application of HZhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2024
    Review
  2. Review
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

4 authors at 1 institution in 1 country.

Tarek Mohamed MostafaClinical Pharmacy Department, Faculty of Pharmacy, Tanta University, Tanta, 31527, Egypt.
Sahar Kamal HegazyClinical Pharmacy Department, Faculty of Pharmacy, Tanta University, Tanta, 31527, Egypt.
Salwa El-Morsy Abd El-GhanyRheumatology & Rehabilitation Department, Faculty of Medicine, Tanta University, Tanta, Egypt.
Fedaa Abd El-Monem KotkataClinical Pharmacy Department, Faculty of Pharmacy, Tanta University, Tanta, 31527, Egypt. Fedaa.kamaleldeen@pharm.tanta.edu.eg.ORCID http://orcid.org/0000-0002-0108-2517
Tanta University · EG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeInvestigating the efficacy and safety of rupatadine (RUP) versus montelukast (MON) as adjuvant therapy for patients with rheumatoid arthritis (RA).

methodsFrom December 2018 to December 2019, 75 patients with active RA were enrolled in this randomized double-blind placebo-controlled study. The patients were randomized into three groups (n = 25 in each group); methotrexate (MTX) group which received MTX 15-25 mg/week plus placebo tablet once daily; MTX/RUP group which received MTX plus RUP 10 mg once daily; and MTX/MON group which received MTX plus MON 10 mg once daily. The treatment duration was 3 months. At baseline and 3 months after treatment, blood samples were collected for the biochemical analysis of high-sensitivity C-reactive protein (hs-CRP), interleukins 8 and 17 (IL-8, IL-17), E-selectin, and clusterin (CLU) levels. Clinical and functional assessments using Disease Activity Score-CRP (DAS28-CRP) and Multidimensional Health Assessment Questionnaire (MDHAQ) were performed.

resultsBoth RUP and MON produced clinical and functional improvements which were translated by significant improvements in DAS28-CRP score and MDHAQ. Rupatadine significantly reduced all measured parameters (P < 0.05) except for IL-17 and CLU. Montelukast significantly decreased all measured variables (P < 0.05) except for E-selectin. Interleukin-8 was positively correlated with IL-17 and CLU, while hs-CRP was positively correlated with E-selectin and body mass index (BMI). Both drugs were well tolerated; somnolence was the common side effect for RUP. No neuropsychiatric events were reported with MON.

conclusionRupatadine or montelukast may serve as a potential adjuvant therapy for patients with rheumatoid arthritis secondary to the preliminary evidence of efficacy and safety. ClinicalTrials.gov identifier NCT03770923, December 10, 2018.

Indexed as

AcetatesAdultArthritis, RheumatoidBody Mass IndexClusterinC-Reactive ProteinCyclopropanesCyproheptadineDouble-Blind MethodDrug Therapy, CombinationEgyptE-SelectinFemaleHistamine AntagonistsHumansImmunosuppressive AgentsAcetatesClusterinC-Reactive ProteinCyclopropanesCyproheptadineE-SelectinHistamine AntagonistsImmunosuppressive AgentsInterleukinsLeukotriene AntagonistsMethotrexatemontelukastQuinolinesrupatadineSulfidesC-reactive proteinDose-dependent effectMontelukastPlatelet activation factorRheumatoid arthritisRupatadine

Identifiers

PMID34218304
OpenAlexW3181392240

What Socratic 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 Socratic graph.