Morias 1979.
Methods | Randomised controlled trial conducted in Belgium | |
Participants | 59 people with chronic leg ulcers, 45/59 (76%) of venous aetiology, were recruited
Group 1: 29 people
Group 2: 30 people Median (range) baseline ulcer area (mm2): Group 1: 100 (4 to 3300); Group 2: 100 (3 to 4400) No information about baseline ulcer duration or infection status of wounds |
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Interventions | 1. Placebo tablet identical in appearance to levamisole
2. Levamisole dosed according to body weight ranging from 100 to 250 mg, given on 2 consecutive days every week until cure or failure or for 20 weeks Previously used topical treatment was continued for all participants; no information about whether this included compression |
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Outcomes | At 20 weeks
Number of ulcers cured
1. 22/29 (76%)
2. 30/30 (100%) Secondary outcomes: Adverse effects 1. Group 1: 0/29 (0%) 2. Group 2: 3/30 (10%) ‐ all were gastric complaints |
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Notes | Group 1: evident failure (8)
Group 2: evident failure (2) The trial authors state that double‐blind treatment was stopped before the end of the trial in eight participants in Group 1 and two participants in Group 2 because of "evident failure" (defined as no improvement). However, other information in the trial report suggests that all 59 participants were followed up for 20 weeks |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "All patients were sequentially numbered and received a bottle bearing their individual sequence number and containing double‐blind tablets. These tablets randomly contained either 50 mg of levamisole (30 patients) or a placebo (29 patients) and were identical in appearance." It was not stated how the randomisation sequence was generated |
Allocation concealment (selection bias) | Low risk | Reports "sequentially numbered drug containers of identical appearance" |
Blinding (performance bias and detection bias) Participant blinded to the intervention | Low risk | "these tablets randomly contained either 50mg of levamisole or a placebo and were identical in appearance" |
Blinding (performance bias and detection bias) Outcome assessor blinded to the intervention | Unclear risk | No information provided |
Incomplete outcome data (attrition bias) Drop out rate described | Low risk | Participants complete at analysis; no dropouts or withdrawals reported |
Incomplete outcome data (attrition bias) Drop out rate acceptable | Low risk | No withdrawals reported |
Incomplete outcome data (attrition bias) ITT analysis | Low risk | Participants complete, no exclusions |
Baseline factors comparable | Unclear risk | The two groups appeared comparable for baseline ulcer area. However, no information about baseline ulcer duration was available, and it was not stated whether wounds were clinically infected |