Marshall 2001.
Methods | Multicentre, placebo‐controlled RCT. | |
Participants | 159 participants with acute ST of leg, diagnosed on symptoms and signs only; 40 males, 116 females; mean age 53.8 years. Not reported if participants were hospitalised or non‐hospitalised. | |
Interventions | Wobenzym (4 tablets tid). Placebo. Study treatment given for 12‐16 days. |
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Outcomes | Reduction of pain to day 7 which had to amount to at least 4 points on the VRAS at baseline. | |
Notes | LMWH was allowed and administered to 4 participants. Paracetamol (maximal 2 g/day) + compression stockings were given to all participants. 9 participants had already been treated with other medications (no further details), which were stopped before the administration of study treatment. 4 participants had received LMWH before inclusion and continued LMWH throughout study. Funding: not stated. Disclosure of potential COI: not reported, no COI forms available. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐based. Participants assigned to treatment with a list generated by a computer. |
Allocation concealment (selection bias) | Low risk | Participants assigned to treatment with a list generated by a computer. Concealment of allocation was present since randomisation took place with a computer program called "Random V.5" by Firma Wiedey GmbH Konstanz. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind study. Study medication described as "similarly looking study medication [placebo]." |
Incomplete outcome data (attrition bias) All outcomes | High risk | 1 participant withdrew consent postrandomisation; 10 (6%) participants lost to follow‐up. |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes reported. |