Evidence map›Paper›PMID 31813058›Full record

Trial reportRheumatology international2020

Effect of mycophenolate mofetil (MMF) on systemic sclerosis-related interstitial lung disease with mildly impaired lung function: a double-blind, placebo-controlled, randomized trial.

G S R S N K Naidu, Shefali Khanna Sharma, M B Adarsh, Varun Dhir, Anindita Sinha, Sahajal Dhooria, Sanjay Jain

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Rheumatology international, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02896205 (A Randomized Controlled Trial to Compare the Efficacy of Oral Mycophenolate Mofetil With Placebo in Patients With Systemic Sclerosis Related Early Interstitial Lung Disease), which is not on this map. Cited by 32 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 9 pooled it
2.8field-weighted citation impact, top 9% 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.

NCT02896205 phase3completednot on this map

A Randomized Controlled Trial to Compare the Efficacy of Oral Mycophenolate Mofetil With Placebo in Patients With Systemic Sclerosis Related Early Interstitial Lung Disease

TypeinterventionalSponsorPost Graduate Institute of Medical Education and Research, ChandigarhRan2016 to 2017Enrolled41ConditionsSystemic Sclerosis, Scleroderma, Interstitial Lung DiseaseArmsMycophenolate mofetil, Placebo
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 9 syntheses or guidelines pooled it, 51 citations in OpenAlex.

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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

7 authors at 1 institution in 1 country.

G S R S N K NaiduDepartment of Internal Medicine, Post Graduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh, 160012, India.ORCID http://orcid.org/0000-0002-9727-044X
Shefali Khanna SharmaDepartment of Internal Medicine, Post Graduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh, 160012, India. sharmashefali@hotmail.com.ORCID http://orcid.org/0000-0002-8821-6652
M B AdarshDepartment of Internal Medicine, Post Graduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh, 160012, India.ORCID http://orcid.org/0000-0001-8091-1952
Varun DhirDepartment of Internal Medicine, Post Graduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh, 160012, India.ORCID http://orcid.org/0000-0002-3626-0694
Anindita SinhaDepartment of Radiodiagnosis and Imaging, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.ORCID http://orcid.org/0000-0002-5034-3488
Sahajal DhooriaDepartment of Pulmonary Medicine, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.ORCID http://orcid.org/0000-0003-3199-9163
Sanjay JainDepartment of Internal Medicine, Post Graduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh, 160012, India.ORCID http://orcid.org/0000-0002-0141-7655
Post Graduate Institute of Medical Education and Research · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The efficacy and safety of mycophenolate mofetil (MMF) has been studied in patients with systemic sclerosis (SSc)-related interstitial lung disease (ILD) with moderate-severe impairment. There is no study on its use in patients with mildly impaired lung function. The objective of this study is to determine the efficacy and safety of MMF for treating mild SSc-ILD (forced vital capacity (FVC) ≥ 70% predicted). This was a double-blind, randomized, placebo-controlled pilot trial. The subjects with SSc-ILD with FVC ≥ 70% were randomized to receive either MMF (2 g/day) or placebo for 6 months. FVC, diffusing capacity of lungs for carbon monoxide (DLCO), modified Rodnan skin score (mRSS), Short Form-36 (SF36v2), Mahler's Dyspnoea Index (MDI), and 6-min walk distance (6MWD) were recorded at baseline and at 6 months. Forty-one subjects were included in the study (MMF: 20, placebo: 21). FVC decreased by a median of 2.7% (range - 21 to 9) in MMF arm and increased by 1% (range - 6 to 10) in placebo arm (p = 0.131). SF36v2 scores improved in both the groups. Median change in MDI (3 vs 3), DLCO (1% vs 1.5%), and 6MWD (0 m vs 0 m) was similar between the study groups. MMF was effective in improving mRSS (- 5 vs - 1, p = 0.045) compared to placebo. Adverse events occurred with similar frequency in both the study groups. In this pilot study, MMF did not result in significant improvement in lung function in SSc-ILD with minimally impaired lung function, but was effective in reducing the skin tightness. Larger studies are needed to confirm these findings. This study was registered at ClinicalTrials.gov (NCT02896205).

Indexed as

AdultDouble-Blind MethodDyspneaEnzyme InhibitorsFemaleHumansLung Diseases, InterstitialMaleMiddle AgedMycophenolic AcidPatient Reported Outcome MeasuresPulmonary Diffusing CapacityScleroderma, SystemicSeverity of Illness IndexTomography, X-Ray ComputedTreatment OutcomeEnzyme InhibitorsMycophenolic AcidInterstitial lung diseaseModified Rodnan skin scoreMycophenolate mofetilQuality of lifeSpirometrySystemic sclerosis

Identifiers

PMID31813058
OpenAlexW2992404880

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.