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Treatment of Intermittent Claudication With Physical Training, Smoking Cessation, Pentoxifylline, or Nafronyl
A Meta-analysis
Bruno Girolami, MD;
Enrico Bernardi, MD;
Martin H. Prins, MD, PhD;
Jan Wouter ten Cate, MD, PhD;
Rohan Hettiarachchi, MD;
Paolo Prandoni, MD, PhD;
Antonio Girolami, MD;
Harry R. Büller, MD, PhD
Arch Intern Med. 1999;159:337-345.
Background There is no consensus on the efficacy of physical training, smoking cessation, and pharmacological therapy (pentoxifylline or nafronyl oxalate) in the treatment of patients with intermittent claudication at Fontaine stage II of disease.
Methods A MEDLINE and manual search was used to identify relevant publications. Uncontrolled or retrospective studies, double reports, and trials without clinically meaningful outcomes were excluded. Included studies were graded level 1 (randomized and double- or assessor-blind), level 2 (open randomized), or level 3 (nonrandomized). Pain-free and total walking distance were the main outcomes considered; when feasible, end-of-treatment results were combined with appropriate meta-analytical procedures.
Results In 5 level 2 studies, physical training increased pain-free and total walking distance significantly (139.0 m [95% confidence interval {CI}, 31.0 to 246.9 m] and 179.1 m [95% CI, 60.2 to 298.1 m], respectively). In a level 3 study, smoking cessation resulted in a nonsignificant increase in total walking distance of 46.7 m (95% CI, -19.3 to 112.7 m). In 6 level 1 studies, pentoxifylline increased both pain-free and total walking distance by 21.0 m (95% CI, 0.7 to 41.3 m) and 43.8 m (95% CI, 14.1 to 73.6 m), respectively. In 4 level 1 trials, nafronyl significantly increased pain-free walking distance (58.6 m [95% CI, 30.4 to 86.8 m]) and total walking distance (71.2 m [95% CI, 13.3 to 129.0 m]).
Conclusions Physical training increased pain-free and total walking distance in level 2 studies. Only level 3 studies support the usefulness of smoking cessation. In level 1 studies, pentoxifylline and nafronyl increased pain-free and total walking distance, but the average effects were relatively small.
From the Institute of Medical Semeiotics, University Hospital of Padua, Padua, Italy (Drs B. Girolami, Bernardi, Prandoni, and A. Girolami); and Department of Clinical Epidemiology and Biostatistics (Drs Prins and Hettiarachchi) and Center for Haemostasis, Thrombosis, Atherosclerosis, and Inflammation Research (Drs ten Cate and Büller), Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
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