Characteristics of included randomised controlled trials of bee venom acupuncture for rheumatoid arthritis
| Lee et al34 | |
|---|---|
| Methods | Design: prospective randomised controlled trial |
| Participants Country: South Korea Number of patients included (completed/randomised): A. 37/40 B. 32/40 Mean age (years) A. 49.2±9.6 B. 47.3±8.9 Duration of disease (years)(A) 9.2±7.0 (B) 7.3±4.6 Follow-up: 1 and 2 months | |
| Intervention | (A) BVA (ashi points, acupoints near the inflammation point, two times a week for 2 months) |
| Control | (B) Placebo (normal saline injection on ashi points, acupoints near the inflammation point, two times a week for 2 months) |
| Outcomes | Primary outcomes 1. Morning stiffness, MD, −0.70 (−2.00 to 0.60), p<0.05 2. HAQ, MD, 0.00 (−0.08 to 0.08), p<0.05 3. VAS-pain, MD, −18.10 (−23.71 to −12.49), p<0.05 Secondary outcomes 1. Tender joint count, MD, −1.30 (−1.91 to −0.69), p<0.0001p<0.05 Secondary outcomes 2. Swollen joint count, MD, −1.10 (−1.72 to −0.48), p=0.005 3. ESR, MD, 20.10 (−22.80 to −17.40), p<0.00001 4. CRP, MD, −1.90 (−2.86 to −0.94), p=0.0001 |
| Note | Treatment rationale: TKM theory, clinical experience Adverse effect: NR Funding: Korea Research Foundation Grant and Kyung Hee University Language: Korean Publication: full paper Withdrawal/dropouts: yes Intention-to-treat: no Author comment: these results suggest that bee venom therapy could be an effective method in the treatment of patients with RA |
| Risk of bias | ||
|---|---|---|
| Item | Authors’ judgement | Description |
| Random sequence generation (selection bias) | Unclear risk | Described as randomised but information not available |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding of participants and personnel (performance bias) all outcomes | Low risk | Described as double blinding |
| Blinding of outcome assessment (detection bias), all outcomes | Unclear risk | Not stated |
| Incomplete outcome data (attrition bias), all outcomes | High risk | Data from 11 participants were not included in the analysis |
| Selective reporting (reporting bias) | Low risk | Protocol not available, but all expected outcomes reported |
| Other bias | Unclear risk | Small sample size |
BVA, bee venom acupuncture; CRP, C reactive protein; ESR, erythrocyte sedimentation rate; HAQ, health assessment questionnaire; MD, mean differences; NR, not reported; RA, rheumatoid arthritis; TKM, traditional Korean medicine; VAS, visual analogue scale.