Drug-eluting stents are effective in reducing the need for target-vessel revascularization in patients at highest risk for restenosis, without a significantly increased rate of death or myocardial infarction.
OBJECTIVEHyperbaric oxygen therapy (HBOT) is used for the treatment of chronic diabetic foot ulcers (DFUs). The controlled evidence for the efficacy of this treatment is limited. The goal of this study was to assess the efficacy of HBOT in reducing the need for major amputation and improving wound healing in patients with diabetes and chronic DFUs.
RESEARCH DESIGN AND METHODSPatients with diabetes and foot lesions (Wagner grade 2-4) of at least 4 weeks' duration participated in this study. In addition to comprehensive wound care, participants were randomly assigned to receive 30 daily sessions of 90 min of HBOT (breathing oxygen at 244 kPa) or sham (breathing air at 125 kPa). Patients, physicians, and researchers were blinded to group assignment. At 12 weeks postrandomization, the primary outcome was freedom from meeting the criteria for amputation as assessed by a vascular surgeon. Secondary outcomes were measures of wound healing.
RESULTSOne hundred fifty-seven patients were assessed for eligibility, with 107 randomly assigned and 103 available for end point adjudication. Criteria for major amputation were met in 13 of 54 patients in the sham group and 11 of 49 in the HBOT group (odds ratio 0.91 [95% CI 0.37, 2.28], P = 0.846). Twelve (22%) patients in the sham group and 10 (20%) in the HBOT group were healed (0.90 [0.35, 2.31], P = 0.823). All other indices of wound healing were also not statistically significantly different between groups.
CONCLUSIONSHBOT does not offer an additional advantage to comprehensive wound care in reducing the indication for amputation or facilitating wound healing in patients with chronic DFUs.
Published literature on this topic was identified by using MEDLINE (1966 to December 2006), the ACP Journal Club database, the Cochrane Central Register of Controlled Trials (no date limits), the Cochrane Database of Systematic Reviews (no date limits), Web sites of the United Kingdom National Institute of Health and Clinical Excellence (no date limits), and the United Kingdom Health Technology Assessment Program (January 1998 to December 2006). Searches were limited to English-language publications and human studies. Keywords for search included terms for osteoporosis, osteopenia, low bone density, and the drugs listed in the key questions. This guideline grades the evidence and recommendations according to the ACP's clinical practice guidelines grading system. RECOMMENDATION 1: ACP recommends that clinicians offer pharmacologic treatment to men and women who have known osteoporosis and to those who have experienced fragility fractures (Grade: strong recommendation; high-quality evidence). RECOMMENDATION 2: ACP recommends that clinicians consider pharmacologic treatment for men and women who are at risk for developing osteoporosis (Grade: weak recommendation; moderate-quality evidence). RECOMMENDATION 3: ACP recommends that clinicians choose among pharmacologic treatment options for osteoporosis in men and women on the basis of an assessment of risk and benefits in individual patients (Grade: strong recommendation; moderate-quality evidence). RECOMMENDATION 4: ACP recommends further research to evaluate treatment of osteoporosis in men and women.
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