Objectives:
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.
Keywords
Fibromyalgia syndrome - Homeopathy - Randomised Controlled Trials
