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.
RCT Entities:
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.