Healthcare provided by a homeopath as an adjunct to usual care for Fibromyalgia (FMS): results of a pilot Randomised Controlled Trial.
OBJECTIVE
To assess the feasibility of a Randomised Controlled Trial (RCT) design of usual care compared with usual care plus adjunctive care by a homeopath for patients with Fibromyalgia syndrome (FMS).


METHODS
In a pragmatic parallel group RCT design, adults with a diagnosis of FMS (ACR criteria) were randomly allocated to usual care or usual care plus adjunctive care by a homeopath. Adjunctive care consisted of five in depth interviews and individualised homeopathic medicines. The primary outcome measure was the difference in Fibromyalgia Impact Questionnaire (FIQ) total score at 22 weeks.


RESULTS
47 patients were recruited. Drop out rate in the usual care group was higher than the homeopath care group (8/24 vs 3/23). Adjusted for baseline, there was a significantly greater mean reduction in the FIQ total score (function) in the homeopath care group than the usual care group (-7.62 vs 3.63). There were significantly greater reductions in the homeopath care group in the McGill pain score, FIQ fatigue and tiredness upon waking scores. We found a small effect on pain score (0.21, 95% CI -1.42 to 1.84); but a large effect on function (0.81, 95% CI -8.17 to 9.79). There were no reported adverse events.


CONCLUSIONS
Given the acceptability of the treatment and the clinically relevant effect on function, there is a need for a definitive study to assess the clinical and cost effectiveness of adjunctive healthcare by a homeopath for patients with FMS.
School of Health and Related Research, University of Sheffield, Sheffield, UK; School of Healthcare, University of Leeds, Leeds, UK. c.relton@sheffield.ac.uk
Clare
C
Relton
C
C
Smith
J
J
Raw
C
C
Walters
A O
AO
Adebajo
K J
KJ
Thomas
T A
TA
Young
D000328:Adult; D003695:Delivery of Health Care / Q000379:methods*; D005260:Female; D005356:Fibromyalgia / Q000628:therapy*; D006705:Homeopathy; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects