Table 2.
Baseline characteristics of patients allocated to treatment group (ITT population including withdrawals)
| Consultation-type allocation | Consultation |
No consultation |
|||
|---|---|---|---|---|---|
| Medication-type allocation | Individual | Complex | Placebo | Complex | Placebo |
| Treatment group | 1 (n = 16) | 2 (n = 14) | 3 (n = 16) | 4 (n = 15) | 5 (n = 16) |
| Females, n (%) | 13 (81.3) | 9 (64.3) | 13 (81.3) | 11 (73.3) | 8 (50.0) |
| Age, years | 62.19 (13.71) | 63.43 (11.65) | 65.75 (11.70) | 60.33 (14.90) | 64.88 (9.52) |
| Duration of arthritis in years | 10.75 (7.54) | 12.14 (9.91) | 12.44 (12.61) | 8.20 (6.39) | 11.44 (9.44) |
| Number of other medical complaints | 1.75 (1.48) | 1.53 (1.73) | 2.13 (2.22) | 1.56 (1.82) | 1.25 (2.05) |
| Number of RA medication on entry to study | 1.88 (1.15) | 2.36 (0.84) | 1.75 (0.93) | 2.27 (0.70) | 2.19 (1.05) |
| Baseline rheumatological measures | |||||
| DAS-28a (range 0–10) | 4.69 (0.84) | 4.23 (1.12) | 4.87 (0.96) | 4.68 (0.97) | 4.21 (1.09) |
| Swollen joint count (range 0–28) | 4.06 (3.30) | 4.43 (4.13) | 6.94 (7.32) | 2.93 (2.37) | 3.56 (2.68) |
| Tender joint count (range 0–28) | 8.06 (5.90) | 5.86 (8.48) | 7.94 (7.31) | 7.13 (6.36) | 6.13 (7.24) |
| Pain VAS (0–100) | 36.88 (19.72) | 46.57 (14.04) | 38.94 (16.10) | 39.27 (18.38) | 42.06 (21.38) |
| CRP, mg/l | 14.73 (20.00) | 11.62 (9.78) | 9.52 (8.29) | 15.00 (14.02) | 8.22 (5.46) |
| ESR, mm/h | 25.67 (11.35) | 18.29 (10.78) | 28.00 (15.71) | 30.00 (22.83) | 19.56 (13.72) |
| Other measures | |||||
| HAQ (range 1–3) | 1.21 (0.68) | 1.21 (0.76) | 1.19 (0.68) | 1.38 (0.61) | 1.34 (0.69) |
| Patient GA (VAS, range 0–100) | 45.94 (13.20) | 55.21 (13.54) | 49.81 (10.82) | 51.13 (13.09) | 55.13 (18.24) |
| Physician GA (VAS, range 0–100) | 41.94 (12.6) | 45.93 (12.7) | 45.94 (9.7) | 44.93 (12.7) | 41.75 (18.3) |
| Positive mood (PANAS; range 10–50) | 30.63 (7.82) | 31.14 (9.57) | 31.56 (9.08) | 28.73 (8.56) | 33.31 (6.49) |
| Negative mood (PANAS; range 10–50) | 20.75 (7.78) | 16.57 (4.99) | 17.94 (8.53) | 15.93 (4.48) | 19.50 (6.80) |
| Measure yourself medical outcome profile (range 0–6) | 3.57 (1.00) | 3.55 (0.73) | 3.44 (0.72) | 3.47 (0.66) | 3.72 (0.82) |
| Patient expectations of treatment (range 0–10) | 4.31 (0.95) | 4.79 (0.43) | 4.94 (0.68) | 4.67 (1.05) | 5.00 (0.37) |
| Homeopath expectations of treatment (consultation groups only; range 0–10) | 4.25 (1.13) | 4.14 (0.86) | 4.25 (1.13) | NA | NA |
| Physician expectation of treatment (range 0–10) | 4.75 (0.58) | 4.93 (0.27) | 4.88 (0.62) | 4.93 (0.26) | 4.69 (0.48) |
| Spirituality (range 22–154) | 84.88 (18.70) | 82.43 (12.24) | 79.60 (18.68) | 81.27 (16.55) | 84.38 (24.11) |
| Sense of coherence (range 3–15) | 8.56 (1.59) | 8.93 (1.82) | 8.69 (1.54) | 8.73 (1.94) | 8.94 (1.88) |
| Attitudes to, and beliefs about CAMb | |||||
| Natural treatment (range 0–36) | 34.38 (5.81) | 34.64 (5.83) | 36.19 (4.71) | 31.47 (7.05) | 32.81 (5.91) |
| Participation in treatment (range 0–30) | 26.38 (4.81) | 27.43 (5.20) | 26.44 (4.57) | 27.73 (5.04) | 27.73 (4.03) |
| Holistic health (range 0–36) | 31.93 (3.45) | 29.71 (5.01) | 31.73 (5.26) | 29.60 (3.50) | 31.44 (5.72) |
Values are means (s.d.) or number of patients (%) unless otherwise stated. aDAS is calculated by DAS-28 = 0.56 × sqrt(tender28) + 0.28 × sqrt(swollen28) + 0.70 × ln(ESR) + 0.014 × GH. A cut-off level of DAS = 1.6 or a DAS-28 = 2.6 corresponded with being in remission following the ARA criteria. bA higher positive score indicates more positive belief.