Fibromyalgia Impact Questionnaire McGill Pain Questionnaire Healthcare provided by a Homeopath as an Adjunct to Usual Care for Fibromyalgia Relton C1, Smith CM2, Raw J3, Walters C3, Adebajo AO3, Thomas KJ4 1University of Sheffield, Sheffield, United Kingdom; 2 Research and Development, Barnsley Hospital NHS FT, Barnsley, United Kingdom; 3Rheumatology, Barnsley Hospital NHS FT, Barnsley, United Kingdom; 4University of Leeds, Leeds, United Kingdom Abstract Purpose: Efficacy of homeopathic medicines in the treatment of Fibromyalgia Syndrome (FMS) has been established in two RCTs. However, to inform clinical decision making, evidence is also needed of the effectiveness of treatment by a homeopath. We report the conduct and results of a pilot RCT of the clinical effectiveness of adjunctive healthcare by a homeopath. The objective is to assess the feasibility of an RCT design for patients with FMS of usual care compared to usual care plus adjunctive healthcare by a homeopath. Methods: Using an open pragmatic parallel group RCT design, adults with a diagnosis of FMS (ACR criteria) were randomly allocated to usual care or usual care plus adjunctive healthcare by a homeopath. Healthcare by a homeopath consisted of five in depth interviews plus individualised homeopathic medicines. The primary outcome measure was the difference between the groups FIQ Total scores at 22 weeks. Results: 47 patients were recruited. Drop out rates in the usual care group were higher than the homeopath care group (8/24 vs 3/23). Mean baseline FIQ total scores for recruited patients were significantly higher (65 vs 42 - 58) than those usually reported. Adjusted for baseline, there was a significantly greater mean reduction in the FIQ Total score in the homeopath care group than the usual care group (-7.62 vs 3.63). Using unpaired t-tests, there were significantly greater reductions in the homeopath care group in the McGill VAS pain score FIQ Fatigue score, & Tiredness upon Waking score. In order to make comparisons to the treatments recommended in the EULAR guidelines, we analysed our results in terms of effects size for Pain & Function and NNH (number needed to harm) using threshold values of >0.2=small, >0.5=medium and >0.8=large. Effect sizes with 95% confidence intervals were calculated using Cohen’s d. This pilot study reported a small Pain effect size of 0.21 (95%CI -1.42 to 1.84) as measured by FIQ q15; and a large Function effect size of 0.81 (95% CI -8.17 to 9.79). The function effect size (0.8) from this pilot RCT is within the range reported for recommended pharmacological (0.19 - 0.61) and non pharmacological (0.06-2.08) treatments for FMS. These findings however must be interpreted with caution as the 95% CI of both effect sizes spans zero (as is the case for most effects sizes reported in EULAR guidelines). NNH could not be calculated as no adverse events were reported. Conclusions: Given the acceptability of the treatment and the large function effect size of the intervention in this pilot, there is a need for a main study to assess the clinical and cost effectiveness of adjunctive healthcare by a homeopath for patients with FMS. Background and Aims Fibromyalgia accounts for 15% of outpatient rheumatology visits Adequate symptom control is the treatment goal Treatment with homeopathic medicines has shown promising results [1,2] Evidence is needed as to clinical effectiveness of healthcare by a homeopath (a complex intervention consisting of a series of in-depth interviews with a strong focus on the patient’s subjective experience, plus individually tailored homeopathic medicines) This pilot was designed to Assess the feasibility of the design Obtain data on recruitment and drop out rates and changes to mean outcome measures to facilitate a power calculation for a full study Methodology Design: open pragmatic parallel group RCT Participants: Adults with diagnosis of Primary FMS (ACR criteria), recruited from Rheumatology Outpatient Clinic at Barnsley Hospital NHS Foundation Trust, UK Randomisation: patients were randomly allocated to usual care or usual care plus healthcare by a homeopath. Healthcare by a homeopath consisted of an initial 1 hour interview followed by up to four 30 min interviews at 4-6 week intervals, with individually tailored homeopathic medicines prescribed as needed Outcome measures Primary: Difference between groups at 22 weeks in Fibromyalgia Impact Questionnaire (FIQ) total score Secondary: Differences between groups at 22 weeks in FIQ sub scores, Measure Your Medical Outcomes Profile (MYMOPS), EQ-5D, Hospital Anxiety and Depression Score (HADS), McGill Pain Questionnaire and the Tender Point Count (TPC) Analysis Intention to treat comparison of statistically significant differences between usual care group and homeopath care group, in the baseline and 22 week scores using unpaired t-tests and adjusted for baseline using ANCOVA. Change from baseline was assessed using a 1-sided t-test and comparison to zero for each group. Comparisons with EULAR Guidelines [3]: effect sizes with 95% CI were calculated using Cohen’s d, for pain (FIQ VAS scores) and function (FIQ total score). Values of >0.2 = small, >0.5 = medium and >0.8 = large. Results Sample Characteristics: 72 patients were referred over a period of 44 weeks. 18 were not interested and 7 were ineligible. 47 patients were randomised (usual care n = 24, homeopath care n = 23). Patients were predominantly female and Caucasian. There were no differences between group demographic characteristics or scores at baseline. Drop-out rates: 8/24 and 3/24 patients in the usual care and homeopath care groups respectively did not complete the study (p=0.17). Treatment Completers There was a significantly greater reduction in the Primary Outcome Measure (FIQ Total Score) and several secondary outcome measures in the homeopath group compare to usual care (Table) EULAR Comparison Pain Effect Size 0.21 (95% CI -1.42 to 1.94) Function Effect Size 0.81 (95%CI -8.17 to 9.79) Discussion This study successfully piloted a method of assessing the clinical effectiveness of adjunctive healthcare by a homeopath for the treatment of FMS Change in Outcomes at 22 weeks Group Outcome Measure Range Usual Care (n=16) Homeopath Care (n=20) Fibromyalgia Impact Questionnaire Total Score (0-100) 3.63 (12.1) -7.62 (15.4)$† No. days felt good (0-10) 0.06 (2.21) 0.95 (1.79)† Fatigue score 0.03 (1.69) -1.3 (2.11)*† Tiredness on Waking Score 0.38 (1.47) -1.30 (2.09)*† McGill Pain Questionnaire Affective Score (0-12) 1.31 (2.27)† -0.55 (3.62)! Sensory + Affective Score (0-45) 2.69 (7.43) -3.50 (10.56)! VAS 4.69 (25.05) -12.20 (21.36)*† Data presented as mean (SD). *p<0.05, !p<0.10; unpaired t-test, usual care vs. homeopath care. $p<005;ANCOVA, following adjustment for baseline, usual care vs. homeopath care. †p<0.05, 1-sample t-test, comparison to zero The homeopath care group showed a significant improvement in their symptoms over the 22 week study, in contrast to the usual care group, who showed no change. The effect sizes are within the range reported for pharmacological (0.19 to 0.61) and non-pharmacological (0.06 to 2.08) treatments. These finding should be interpreted with caution as the 95% CIs span zero (as is the case for almost all of the effect sizes reported in the EULAR guidelines) Given the acceptability of the intervention and the large function effect size there is now a need for a full scale trial to assess the cost-effectiveness of adjunctive healthcare by a homeopath in the treatment of FMS Acknowledgements Mrs B Hardware, Research Nurse; Dr T Young, statistical advice; Prof J Nicholl, design advice; Mr T Chater, data management References [1] Fisher P et al. BMJ 1989;299(6695):365-6 [2] Bell IR et al. Rheumatology 2004;43:577-582 [3] Carville SF et al. Ann Rheum Dis. Publ Online First: 20 July 2007. doi:10.1136/ard.2007.071522