Evidence map›Paper›PMID 32239322›Full record

Trial reportRheumatology international2020

Efficacy and safety of pirfenidone in systemic sclerosis-related interstitial lung disease-a randomised controlled trial.

Nupoor Acharya, Shefali Khanna Sharma, Debashish Mishra, Sahajal Dhooria, Varun Dhir, Sanjay Jain

Abstract 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. Cited by 68 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 9 pooled it
9.6field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

68 citing papers in PubMed, 9 syntheses or guidelines pooled it, 113 citations in OpenAlex.

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  20. Treating connective tissue disease-associated interstitial lung disease - think outside the box: a perspective.European respiratory review : an official journal of the European Respiratory Society · 2025
    Review

8 more citing papers are in PubMed but not listed here.

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

6 authors at 1 institution in 1 country.

Nupoor AcharyaPost Graduate Institute of Medical Education and Research, Chandigarh, India.ORCID http://orcid.org/0000-0002-2651-0864
Shefali Khanna SharmaPost Graduate Institute of Medical Education and Research, Chandigarh, India. shefalisania@gmail.com.ORCID http://orcid.org/0000-0002-8821-6652
Debashish MishraPost Graduate Institute of Medical Education and Research, Chandigarh, India.ORCID http://orcid.org/0000-0001-8411-2015
Sahajal DhooriaPost Graduate Institute of Medical Education and Research, Chandigarh, India.ORCID http://orcid.org/0000-0003-3199-9163
Varun DhirPost Graduate Institute of Medical Education and Research, Chandigarh, India.ORCID http://orcid.org/0000-0002-3626-0694
Sanjay JainPost Graduate Institute of Medical Education and Research, Chandigarh, 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

To assess the efficacy and safety of pirfenidone in systemic sclerosis-related interstitial lung disease (SSc-ILD). This was a double-blind, randomised, placebo-controlled, pilot study. Subjects with SSc-ILD and forced vital capacity (FVC) between 50 and 80% of the predicted (%pred) value were randomised in 1:1 ratio to receive either pirfenidone (2400 mg/day) or placebo for 6 months. Primary outcome was the proportion of subjects with either stabilisation or improvement in FVC at 6 months. Secondary outcomes were the absolute change in the %pred FVC, Mahler's dyspnoea index, 6-min walk distance (6MWD), modified Rodnan skin score (MRSS) and serum levels of tumour necrosis factor α (TNF-α) and transforming growth factor β (TGF-β). Thirty-four subjects with median (range) age of 41 (20-63) years (91.2% women) and median (range) %pred FVC of 65 (51-78) were enrolled. Stabilisation/improvement in FVC was seen in 16 (94.1%) and 13 (76.5%) subjects in the pirfenidone and placebo groups, respectively (p = 0.33). The median (range) absolute change in %pred FVC was - 0.55 (- 9 to 7%) and 1.0 (- 42 to 11.5%) in the treatment and control groups, respectively (p = 0.51). The changes in 6MWD, dyspnoea scores, MRSS, and levels of TNF-α and TGF-β were not significantly different between groups. Common adverse events were gastrointestinal disturbances and skin rash. We failed to find a significant beneficial effect of pirfenidone over placebo in improving/stabilising FVC, exercise capacity, symptoms, or skin disease. Study is underpowered to provide conclusive evidence. Larger studies with longer follow-up periods are required.

Indexed as

AdultDouble-Blind MethodFemaleHumansImmunosuppressive AgentsLung Diseases, InterstitialMaleMiddle AgedPilot ProjectsPyridonesScleroderma, SystemicTreatment OutcomeVital CapacityImmunosuppressive AgentspirfenidonePyridonesAutoimmuneConnective tissue diseaseDiffuse parenchymal lung diseaseInterstitial lung diseaseSclerodermaSystemic sclerosis

Identifiers

PMID32239322
OpenAlexW3014214319

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.