Evidence map›Paper›PMID 19892673›Full record

Trial reportChest2009

Treatment of scleroderma-interstitial lung disease with cyclophosphamide is associated with less progressive fibrosis on serial thoracic high-resolution CT scan than placebo: findings from the scleroderma lung study.

Jonathan Goldin, Robert Elashoff, Hyun J Kim, Xaiohong Yan, David Lynch, Diane Strollo, Michael D Roth, Philip Clements, Daniel E Furst, Dinesh Khanna and 3 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Chest, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 55 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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.

NCT00004563 phase3completednot on this map

Cyclophosphamide Versus Placebo in Scleroderma Lung Study

TypeinterventionalSponsorThe University of Texas Health Science Center, HoustonRan1999 to 2013Enrolled158ConditionsLung Diseases, Pulmonary Fibrosis, Systemic Scleroderma, Scleroderma, SystemicArmsCyclophosphamide, Placebo
NCT00883129 phase2completednot on this map

Mycophenolate vs. Oral Cyclophosphamide in Scleroderma Interstitial Lung Disease (Scleroderma Lung Study II)

TypeinterventionalSponsorMichael RothRan2009 to 2015Enrolled142ConditionsScleroderma, Interstitial Lung DiseaseArmsMycophenolate mofetil, Cyclophosphamide, Placebo
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Pulmonary function tests as outcomes for systemic sclerosis interstitial lung disease.European respiratory review : an official journal of the European Respiratory Society · 2018
    Pooled it
  4. Pooled it
  5. Trial
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  17. Article
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  19. 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
  20. Observational
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

13 authors.

Jonathan GoldinDepartment of Radiologic Sciences, School of Public Health, University of California Los Angeles, Los Angeles, CA.
Robert ElashoffDepartment of Biomathematics , School of Public Health, University of California Los Angeles, Los Angeles, CA.
Hyun J KimDepartment of Radiologic Sciences, School of Public Health, University of California Los Angeles, Los Angeles, CA.
Xaiohong YanDepartment of Biomathematics , School of Public Health, University of California Los Angeles, Los Angeles, CA.
David LynchDepartment of Radiologic Sciences, National Jewish Hospital, Denver, CO.
Diane StrolloUniversity of Pittsburgh School of Medicine, Pittsburgh, PA.
Michael D RothDepartment of Medicine, School of Public Health, University of California Los Angeles, Los Angeles, CA.
Philip ClementsDepartment of Medicine, School of Public Health, University of California Los Angeles, Los Angeles, CA.
Daniel E FurstDepartment of Medicine, School of Public Health, University of California Los Angeles, Los Angeles, CA.
Dinesh KhannaDepartment of Medicine, School of Public Health, University of California Los Angeles, Los Angeles, CA.
Srainnapha VasunilashornDepartment of Radiologic Sciences, School of Public Health, University of California Los Angeles, Los Angeles, CA.
Gang LiDepartment of David Geffen School of Medicine, and the Department of Biostatistics, School of Public Health, University of California Los Angeles, Los Angeles, CA.
Donald P TashkinDepartment of Medicine, School of Public Health, University of California Los Angeles, Los Angeles, CA. Electronic address: dtashkin@mednet.ucla.edu.

Funding

Women's CancersP30CA016042 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Beth A. Glenn · 1985 to 2026
$134.5M
UCLA Center for Excellence in Pancreatic DiseasesP01AT003960 · NCCIH · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI HINES, OSCAR JOE · 2007 to 2011
$5.6M
SCLERODERMA LUNG STUDYU01HL060587 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI TASHKIN, DONALD P · 1999 to 2003
$2.3M
SCLERODERMA LUNG STUDYU01HL060606 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ELASHOFF, ROBERT M · 1999 to 2006
$1.3M
Alveolitis and Fibrosis in Scleroderma Lung DiseaseR01HL072424 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI GOLDIN, JONATHAN G · 2002 to 2004
$745k
NCCIH NIH HHS P01 AT003960NCCIH NIH HHS P01AT003960NCI NIH HHS P30 CA016042NCI NIH HHS P30 CA016042-35NHLBI NIH HHS 5U01HL060606NHLBI NIH HHS 5U01 HL60587NHLBI NIH HHS R01 HL072424NHLBI NIH HHS U01 HL060587NHLBI NIH HHS U01 HL060606
6 · The paper itself

Abstract

backgroundThe Scleroderma Lung Study (SLS) demonstrated significant treatment-associated improvements in pulmonary function and symptoms when patients with scleroderma-related interstitial lung disease (SSc-ILD) were treated with a 1-year course of cyclophosphamide (CYC) in a randomized, double-blinded, placebo-controlled clinical trial. This study examined thoracic high-resolution CT (HRCT) scans obtained during the SLS for treatment-associated changes over time.

methodsNinety-eight of the 158 subjects (CYC group, 49 subjects; placebo group, 49 subjects) participating in the SLS underwent thoracic HRCT scans both at baseline and after 12 months of treatment, which were available for analysis. Two independent radiologists visually scored the baseline HRCT scans for the presence of ground-glass opacities (GGOs), fibrosis (FIB), and honeycomb cysts (HCs) on a scale of 0 to 4. The treatment effect at 12 months was assessed by a blinded comparison of baseline and follow-up scans for evidence of stability and improvement (not worse) or deterioration (worse).

resultsAt the end of treatment, FIB was significantly worse in the placebo treatment group than in the CYC treatment group (p = 0.014). Furthermore, differences in the 12-month change in FIB between the CYC and placebo groups correlated significantly with other outcome measures, including the 12-month changes in FVC (p < 0.05), total lung capacity (p < 0.05), and dyspnea (p < 0.001) scores. However, no differences were noted between the two groups with respect to changes in either GGOs or HCs.

conclusionsA 1-year course of treatment of SSc-ILD with CYC was associated with treatment-related changes in FIB scores on HRCT scans, which correlated with other measures of treatment response.

trial registrationClinicalTrials.gov Identifier: NCT00004563.

Indexed as

CyclophosphamideDisease ProgressionDouble-Blind MethodFemaleHumansLung Diseases, InterstitialMaleMiddle AgedPlacebosRadiography, ThoracicScleroderma, LocalizedSkinTomography, X-Ray ComputedTreatment OutcomeVital CapacityCyclophosphamidePlacebos

Identifiers

PMID19892673
PMCPMC2773360

What OpenQuestion holds

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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.