Jacob E. Teitelbaum, MD*1;
Barbara Bird, M.T.,C.L.S.*;
Robert M. Greenfield, MD1; Alan
Weiss, MD1; Larry Muenz, Ph.D2;
Laurie Gould, BS*3
Published in the Journal
of Chronic Fatigue Syndrome
Vol. 8, No. 2, 2001. PP3-28.
[*Annapolis Research Center
For Effective FMS/CFIDS
Therapies, 466 Forelands Rd.,
Annapolis, MD 21401; 1) Anne
Arundel Medical Center,
Annapolis, MD; 2) Gaithersburg,
MD; 3) USDA, Beltsville, MD]
No outside funding.
Multivitamins supplied by
Twinlab; Synthroid by Knoll;
Fibrocare and Valerian Rest by
To Your Health; Sporanox by
Janssen; Oxytocin and DHEA by
Belmar Pharmacy; Prozac by DISTA;
Zoloft by Roerig; Paxil by SKB;
Chromagen by Savage Labs;
Serzone by Bristol-Myers Squibb;
and Flagyl by Searle.
Background:
Hypothalamic dysfunction has
been suggested in Fibromyalgia
(FMS) and Chronic Fatigue
Syndrome (CFS). This dysfunction
may result in disordered sleep,
subclinical hormonal
deficiencies, and immunologic
changes. Our previously
published open trial showed that
patients usually improve by
using a protocol which treats
all the above processes
simultaneously. The current
study examines this protocol
using a randomized, double-blind
design with an intent-to-treat
analysis.
Methods: 72
FMS patients (38 active: 34
placebo; 69 also met CFS
criteria) received all active or
all placebo therapies as a
unified intervention. Patients
were treated, as indicated by
symptoms and/or lab testing,
for: (1) subclinical thyroid,
gonadal, and/or adrenal
insufficiency, (2) disordered
sleep, (3) suspected NMH, (4)
opportunistic infections, and
(5) suspected nutritional
deficiencies.
Results: At
the final visit, 16 active
patients were "much better," 14
"better," 2 "same," 0 "worse,"
and 1 "much worse" versus 3, 9,
11, 6, and 4, respectively, in
the placebo group (p < .0001,
Cochran-Mantel-Haenszel trend
test). Significant improvement
in the FMS Impact Questionnaire
(FIQ) scores (decreasing from
54.8 to 33.2 versus 51.4 to
47.7) and Analog scores
(improving from 176.1 to 310.3
versus 177.1 to 211.9) (both
with p < .0001 by random effects
regression), and Tender Point
Index (TPI) (31.7 to 15.5 versus
35.0 to 32.3, p < .0001 by
baseline adjusted linear model)
were seen. Long-term follow-up
(mean 1.9 years) of the active
group showed continuing and
increasing improvement over
time, despite patients being
able to wean off most
treatments.
Conclusions:
Significantly greater benefits
were seen in the active group
than in the placebo group for
all primary outcomes. Using an
integrated treatment approach,
effective treatment is now
available for FMS/CFS.