TY - JOUR
T1 - Benefits and harms of doxycycline treatment for Gulf War Veterans' illnesses
T2 - A randomized, double-blind, placebo-controlled trial
AU - Donta, Sam T.
AU - Engel, Charles C.
AU - Collins, Joseph F.
AU - Baseman, Joel B.
AU - Dever, Lisa L.
AU - Taylor, Thomas
AU - Boardman, Kathy D.
AU - Kazis, Lewis E.
AU - Martin, Suzanne E.
AU - Horney, Rebecca A.
AU - Wiseman, Annette L.
AU - Kernodle, Douglas S.
AU - Smith, Raymond P.
AU - Baltch, Aldona L.
AU - Handanos, Christine
AU - Catto, Brian
AU - Montalvo, Luis
AU - Everson, Michael
AU - Blackburn, Warren
AU - Thakore, Manisha
AU - Brown, Sheldon T.
AU - Lutwick, Larry
AU - Norwood, Dorothy
AU - Bernstein, Jack
AU - Bacheller, Catherine
AU - Ribner, Bruce
AU - Church, L. W.Preston
AU - Wilson, Kenneth H.
AU - Guduru, Prabhakar
AU - Cooper, Robert
AU - Lentino, Joseph
AU - Hamill, Richard J.
AU - Gorin, Arnold B.
AU - Gordan, Victor
AU - Wagner, David
AU - Robinson, Cliff
AU - DeJace, Pierre
AU - Greenfield, Ronald
AU - Beck, Lisa
AU - Bittner, Marvin
AU - Schumacher, H. Ralph
AU - Silverblatt, Fredric
AU - Schmitt, James
AU - Wong, Edward
AU - Ryan, Margaret A.K.
AU - Figueroa, Javier
AU - Nice, Christopher
AU - Feussner, John R.
PY - 2004/7/20
Y1 - 2004/7/20
N2 - Background: It has been hypothesized that certain Mycoplasma species may cause Gulf War veterans' illnesses (GWVIs), chronic diseases characterized by pain, fatigue, and cognitive symptoms, and that affected patients may benefit from doxycycline treatment. Objective: To determine whether a 12-month course of doxycycline improves functional status in Gulf War veterans with GWVIs. Design: A randomized, double-blind, placebo-controlled clinical trial with 12 months of treatment and 6 additional months of follow-up. Setting: 26 U.S. Department of Veterans Affairs and 2 U.S. Department of Defense medical centers. Participants: 491 deployed Gulf War veterans with GWVIs and detectable Mycoplasma DNA in the blood. Intervention: Doxycycline, 200 mg, or matching placebo daily for 12 months. Measurements: The primary outcome was the proportion of participants who improved more than 7 units on the Physical Component Summary score of the Veterans Short Form-36 General Health Survey 12 months after randomization. Secondary outcomes were measures of pain, fatigue, and cognitive function and change in positivity for Mycoplasma species at 6, 12, and 18 months after randomization. Results: No statistically significant differences were found between the doxycycline and placebo groups for the primary outcome measure (43 of 238 participants [18.1%] vs. 42 of 243 participants [17.3%]; difference, 0.8 percentage point [95% CI, -6.5 to 8.0 percentage points]; P > 0.2) or for secondary outcome measures at 1 year. In addition, possible differences in outcomes at 3 and 6 months were not apparent at 9 or 18 months. Participants in the doxycycline group had a higher incidence of nausea and photosensitivity. Limitations: Adherence to treatment after 6 months was poor. Conclusion: Long-term treatment with doxycycline did not improve outcomes of GWVIs at 1 year.
AB - Background: It has been hypothesized that certain Mycoplasma species may cause Gulf War veterans' illnesses (GWVIs), chronic diseases characterized by pain, fatigue, and cognitive symptoms, and that affected patients may benefit from doxycycline treatment. Objective: To determine whether a 12-month course of doxycycline improves functional status in Gulf War veterans with GWVIs. Design: A randomized, double-blind, placebo-controlled clinical trial with 12 months of treatment and 6 additional months of follow-up. Setting: 26 U.S. Department of Veterans Affairs and 2 U.S. Department of Defense medical centers. Participants: 491 deployed Gulf War veterans with GWVIs and detectable Mycoplasma DNA in the blood. Intervention: Doxycycline, 200 mg, or matching placebo daily for 12 months. Measurements: The primary outcome was the proportion of participants who improved more than 7 units on the Physical Component Summary score of the Veterans Short Form-36 General Health Survey 12 months after randomization. Secondary outcomes were measures of pain, fatigue, and cognitive function and change in positivity for Mycoplasma species at 6, 12, and 18 months after randomization. Results: No statistically significant differences were found between the doxycycline and placebo groups for the primary outcome measure (43 of 238 participants [18.1%] vs. 42 of 243 participants [17.3%]; difference, 0.8 percentage point [95% CI, -6.5 to 8.0 percentage points]; P > 0.2) or for secondary outcome measures at 1 year. In addition, possible differences in outcomes at 3 and 6 months were not apparent at 9 or 18 months. Participants in the doxycycline group had a higher incidence of nausea and photosensitivity. Limitations: Adherence to treatment after 6 months was poor. Conclusion: Long-term treatment with doxycycline did not improve outcomes of GWVIs at 1 year.
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U2 - 10.7326/0003-4819-141-2-200407200-00006
DO - 10.7326/0003-4819-141-2-200407200-00006
M3 - Article
C2 - 15262663
AN - SCOPUS:3142659580
SN - 0003-4819
VL - 141
SP - 85-94+I-12
JO - Annals of Internal Medicine
JF - Annals of Internal Medicine
IS - 2
ER -