Bradley 1994.
Methods | Randomised controlled trial 2‐arm parallel group design Trial duration: 4 weeks Randomisation stratified according to centre Multicentre trial with 2 centres Power calculation: reported and protocol based for 3 pain scales Funding by non‐profit organisation: no information provided | |
Participants | 48 patients were randomised in study centre A*, 33 in study centre B 81 patients with osteoarthritis were reported at baseline Affected joints: 81 knees Number of females: 41 of 48 (85%) in centre A, 7 of 33 (21%) in centre B Average age: 58 years in centre A, 63 years in centre B Average disease duration: 10.9 years in centre A, 12.4 years in centre B Radiographic severity of OA: (% grade 2/% grade 3) in site A: 62.5%/37.5% in SAMe, 54%/46% in placebo. In site B: 59%/41% in SAMe, 69%/31% in placebo | |
Interventions | Experimental intervention: S‐Adenosylmethionine, on 5 consecutive days intravenous 400 mg once daily, then oral 200 mg 3 times daily Control intervention: placebo, on 5 consecutive days intravenous once daily, then oral 3 times daily Treatment duration: 4 weeks Analgesics other than study drugs allowed, intake assessed and found to be lower in SAMe group compared to placebo at site A, and higher in SAMe compared to placebo at site B. | |
Outcomes | Extracted pain outcome: pain on walking after 4 weeks, described as "walking pain"
Extracted function outcome: walking disability after 4 weeks, described as "walking distance before having to stop because of knee pain" Primary outcome: > 2 reported; for HAQ pain, rest pain and walking pain |
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Notes | *In the original report the investigators presented results separately for site A and B, because the randomisation, although concealed, resulted in marked baseline differences between patients at the 2 sites with respect to demographic and disease related characteristics | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | Use of random‐number table |
Allocation concealment? | Low risk | Use of coded pharmacy |
Blinding of patients? | Low risk | The trial was described as a double‐blind study randomising patients to indistinguishable interventions |
Blinding of physicians? | Unclear risk | No information provided |
Blinding of outcome assessors? | Unclear risk | No information provided |
Interventions reported as indistinguishable? | Low risk | Quote: "Placebo Injectate and placebo tablets were employed that contained the same stabilizers and inert ingredients as the active agent and were packaged identically." |
Double‐dummy technique used? | High risk | — |
Intention‐to‐treat analysis performed? Pain | High risk | Center A: no information provided. Center B: 13 out of 17 (76%) in SAMe group, 14 out of 16 (87%) in placebo group analysed. |
Intention‐to‐treat analysis performed? Function | High risk | See above |
Funding by commercial organisation avoided? | High risk | Supported by a grant from Asta Medica |