Bozkurt 2006.
Methods | Design: randomised parallel‐group multicentre controlled clinical trial Setting : 12 major vascular centres Country: Turkey Loss to follow‐up: complete data from 162 participants presented in the analysis after a follow‐up of 4 and 24 weeks (19% of participants missing from analysis; 16% in iloprost group and 22% in sympathectomy group) Intention‐to‐treat: not stated |
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Participants | Number randomised n = 200 (iloprost n = 100; sympathectomy n = 100); number analysed at 24 weeks (iloprost n = 84; sympathectomy n = 78) Average age (range): 40.8 years (25 to 66) Gender: male: 97.6% No systemic comorbidities Inclusion criteria:
Exclusion criteria: not mentioned |
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Interventions | Prostanoid iloprost; intravenous infusion 1 ng/kg/min, six hours/day for 28 days Open surgical unilateral sympathectomy at lumbar levels 2, 3, 4 |
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Outcomes |
Reported in paper, used in review
Reported, not used
Sought from authors: not reported
Duration of follow‐up: 24 weeks |
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Notes | Funding: research fund of Istanbul University Comments: no conflicts of interest Trial was not registered |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote from report: "independent statistician prepared the randomisation list by the method of computer generated random numbers." |
Allocation concealment (selection bias) | Low risk | Use of randomly generated list prepared by an independent statistician |
Blinding (performance bias and detection bias) Subjective outcome (pain) | Unclear risk | Blinding of participants was not possible due to the nature of intervention ‐ a drug was being compared to a surgical procedure Pain is a subjective outcome and no data on objective recordings, e.g. using pain scores is reported; it was not reported if a blinded assessor or adjudication committee was used |
Blinding (performance bias and detection bias) Objective outcomes (amputation, healing) | Low risk | Amputation and ulcer healing are definite clinical outcomes, evidence of risk of bias for these outcomes is minimal. Data on objective documentation of ulcer healing are presented, which also reduces the risk of bias |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 162 of 200 randomised participants included in analysis; both groups had similar numbers of dropouts: iloprost n = 16, sympathectomy n = 22; study quoted missing participant data as "insufficient data for the remaining participants" with no further information on reasons so we judged attrition bias as unclear |
Selective reporting (reporting bias) | Low risk | Although the trial was not registered, all proposed outcome measures were reported adequately |
Other bias | Low risk | None detected by the review authors |
ABPI: ankle brachial pressure index SVS/ISCVS: Society for Vascular Surgery and the North American Chapter of the International Society for Cardiovascular Surgery