RETRACTED: Effect of folate and mecobalamin on hip fractures in patients with stroke - A randomized controlled trial (Retracted article. See vol. 315, pg. 2405, 2016)

Context Stroke increases the risk of subsequent hip fracture by 2 to 4 times. Hyperhomocysteinemia is a risk factor for both ischemic stroke and osteoporotic fractures in elderly men and women. Treatment with folate and mecobalamin (vitamin B-12) may improve hyperhomocysteinemia. Objective To investigate whether treatment with folate and vitamin B12 reduces the incidence of hip fractures in patients with hemiplegia following stroke. Design, Setting, and Patients A double-blind, randomized controlled study of 628 consecutive patients aged 65 years or older with residual hemiplegia at least 1 year following first ischemic stroke, who were recruited from a single Japanese hospital from April 1, 2000, to May 31, 2001. Patients were assigned to daily oral treatment with 5 mg of folate and 1500 mug of mecobalamin, or double placebo; 559 completed the 2-year follow-up. Main Outcome Measure Incidence of hip fractures in the 2 patient groups during the 2-year follow-up. Results At baseline, patients in both groups had high levels of plasma homocysteine and low levels of serum cobalamin and serum folate. After 2 years, plasma homocysteine levels decreased by 38% in the treatment group and increased by 31 % in the placebo group (P<.001). The number of hip fractures per 1000 patient-years was 10 and 43 for the treatment and placebo groups, respectively (P<.001). The adjusted relative risk, absolute risk reduction, and the number needed to treat for hip fractures in the treatment vs placebo groups were 0.20 (95% confidence interval [CI], 0.080.50), 7.1 % (95% Cl, 3.6%-10.8%), and 14 (95% Cl, 9-28), respectively. No significant adverse effects were reported. Conclusion In this Japanese population with a high baseline fracture risk, combined treatment with folate and vitamin 131, is safe and effective in reducing the risk of a hip fracture in elderly patients following stroke.