PMID- 17469162
OWN - NLM
STAT- MEDLINE
DCOM- 20070619
LR  - 20131121
IS  - 0004-3591 (Print)
IS  - 0004-3591 (Linking)
VI  - 56
IP  - 5
DP  - 2007 May
TI  - Impact of oral cyclophosphamide on health-related quality of life in patients 
      with active scleroderma lung disease: results from the scleroderma lung study.
PG  - 1676-84
AB  - OBJECTIVE: To assess the impact of cyclophosphamide (CYC) on the health-related 
      quality of life (HRQOL) of patients with scleroderma after 12 months of 
      treatment. METHODS: One hundred fifty-eight subjects participated in the 
      Scleroderma Lung Study, with 79 each randomized to CYC and placebo arms. The 
      study evaluated the results of 3 measures of health status: the Short Form 36 
      (SF-36), the Health Assessment Questionnaire (HAQ) disability index (DI), and 
      Mahler's dyspnea index, and the results of 1 preference-based measure, the SF-6D. 
      The differences in the HRQOL between the 2 groups at 12 months were calculated 
      using a linear mixed model. Responsiveness was evaluated using the effect size. 
      The proportion of subjects in each treatment group whose scores improved at least 
      as much as or more than the minimum clinically important difference (MCID) in 
      HRQOL measures was assessed. RESULTS: After adjustment for baseline scores, 
      differences in the HAQ DI, SF-36 role physical, general health, vitality, role 
      emotional, mental health scales, and SF-36 mental component summary (MCS) score 
      were statistically significant for CYC versus placebo (P < 0.05). Effect sizes 
      were negligible (<0.20) for all of the scales of the SF-36, HAQ DI, and SF-6D at 
      12 months. In contrast, a higher proportion of patients who received CYC achieved 
      the MCID compared with placebo in the HAQ DI score (30.9% versus 14.8%), 
      transitional dyspnea index score (46.4% versus 12.7%), SF-36 MCS score (33.3% 
      versus 18.5%), and SF-6D score (21.3% versus 3.8%). CONCLUSION: One year of 
      treatment with CYC leads to an improvement in HRQOL in patients with scleroderma 
      lung disease.
FAU - Khanna, Dinesh
AU  - Khanna D
AD  - University of Cincinnati, Cincinnati, Ohio 45267-0563, USA. Dinesh.Khanna@uc.edu
FAU - Yan, Xiaohong
AU  - Yan X
FAU - Tashkin, Donald P
AU  - Tashkin DP
FAU - Furst, Daniel E
AU  - Furst DE
FAU - Elashoff, Robert
AU  - Elashoff R
FAU - Roth, Michael D
AU  - Roth MD
FAU - Silver, Richard
AU  - Silver R
FAU - Strange, Charlie
AU  - Strange C
FAU - Bolster, Marcy
AU  - Bolster M
FAU - Seibold, James R
AU  - Seibold JR
FAU - Riley, David J
AU  - Riley DJ
FAU - Hsu, Vivien M
AU  - Hsu VM
FAU - Varga, John
AU  - Varga J
FAU - Schraufnagel, Dean E
AU  - Schraufnagel DE
FAU - Theodore, Arthur
AU  - Theodore A
FAU - Simms, Robert
AU  - Simms R
FAU - Wise, Robert
AU  - Wise R
FAU - Wigley, Fredrick
AU  - Wigley F
FAU - White, Barbara
AU  - White B
FAU - Steen, Virginia
AU  - Steen V
FAU - Read, Charles
AU  - Read C
FAU - Mayes, Maureen
AU  - Mayes M
FAU - Parsley, Ed
AU  - Parsley E
FAU - Mubarak, Kamal
AU  - Mubarak K
FAU - Connolly, M Kari
AU  - Connolly MK
FAU - Golden, Jeffrey
AU  - Golden J
FAU - Olman, Mitchell
AU  - Olman M
FAU - Fessler, Barri
AU  - Fessler B
FAU - Rothfield, Naomi
AU  - Rothfield N
FAU - Metersky, Mark
AU  - Metersky M
FAU - Clements, Philip J
AU  - Clements PJ
CN  - Scleroderma Lung Study Group
LA  - eng
GR  - 5-U01-H-660587/PHS HHS/United States
GR  - HD-051953/HD/NICHD NIH HHS/United States
GR  - U01-HL-60587/HL/NHLBI NIH HHS/United States
GR  - U01-HL-60606/HL/NHLBI NIH HHS/United States
GR  - U01-HL605/HL/NHLBI NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Arthritis Rheum
JT  - Arthritis and rheumatism
JID - 0370605
RN  - 0 (Antirheumatic Agents)
RN  - 8N3DW7272P (Cyclophosphamide)
SB  - IM
MH  - Adult
MH  - Antirheumatic Agents/*therapeutic use
MH  - Cyclophosphamide/*therapeutic use
MH  - Disability Evaluation
MH  - Double-Blind Method
MH  - Female
MH  - Health Status Indicators
MH  - Humans
MH  - Longitudinal Studies
MH  - Lung Diseases/*drug therapy/physiopathology/psychology
MH  - Male
MH  - Middle Aged
MH  - *Quality of Life
MH  - Reproducibility of Results
MH  - Scleroderma, Systemic/*drug therapy/physiopathology/psychology
MH  - Severity of Illness Index
MH  - Treatment Outcome
EDAT- 2007/05/01 09:00
MHDA- 2007/06/20 09:00
CRDT- 2007/05/01 09:00
PHST- 2007/05/01 09:00 [pubmed]
PHST- 2007/06/20 09:00 [medline]
PHST- 2007/05/01 09:00 [entrez]
AID - 10.1002/art.22580 [doi]
PST - ppublish
SO  - Arthritis Rheum. 2007 May;56(5):1676-84. doi: 10.1002/art.22580.