RETRACTED: Effect of folate and mecobalamin on hip fractures in patients with stroke - A randomized controlled trial (Retracted article.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)

被引:210
作者
Sato, Y
Honda, Y
Iwamoto, J
Kanoko, T
Satoh, K
机构
[1] Mitate Hosp, Dept Neurol, Tagawa 8260041, Japan
[2] Keio Univ, Sch Med, Dept Sports Med, Tokyo, Japan
[3] Hirosaki Univ, Sch Med, Inst Brain Sci, Dept Rehabil Med, Hirosaki, Aomori 036, Japan
[4] Hirosaki Univ, Sch Med, Inst Brain Sci, Dept Vasc Biol, Hirosaki, Aomori 036, Japan
来源
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2005年 / 293卷 / 09期
关键词
D O I
10.1001/jama.293.9.1082
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:1082 / 1088
页数:7
相关论文
共 41 条
[11]   Severity of prevalent vertebral fractures and the risk of subsequent vertebral and nonvertebral fractures: results from the MORE trial [J].
Delmas, PD ;
Genant, HK ;
Crans, GG ;
Stock, JL ;
Wong, M ;
Siris, E ;
Adachi, JD .
BONE, 2003, 33 (04) :522-532
[12]   Association between high homocyst(e)ine and ischemic stroke due to large- and small-artery disease but not other etiologic subtypes of ischemic stroke [J].
Eikelboom, JW ;
Hankey, GJ ;
Anand, SS ;
Lofthouse, E ;
Staples, N ;
Baker, RI .
STROKE, 2000, 31 (05) :1069-1075
[13]   Oxidative stress in the context of acute cerebrovascular stroke [J].
El Kossi, MMH ;
Zakhary, MM .
STROKE, 2000, 31 (08) :1889-1892
[14]   HOMOCYSTINURIA - PATHOGENETIC MECHANISMS [J].
GRIECO, AJ .
AMERICAN JOURNAL OF THE MEDICAL SCIENCES, 1977, 273 (02) :120-132
[15]   A familial risk profile for osteoporosis [J].
Henderson, LB ;
Adams, JS ;
Goldstein, DR ;
Braunstein, GD ;
Rotter, JI ;
Scheuner, MT .
GENETICS IN MEDICINE, 2000, 2 (04) :222-225
[16]   INTERNAL-FIXATION OF FRACTURES OF THE NECK OF THE FEMUR IN HEMIPLEGIC PATIENTS [J].
HOOPER, G .
INJURY-INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED, 1979, 10 (04) :281-284
[17]   REACTION OF HOMOCYSTEINE WITH ALDEHYDE - EXPLANATION OF COLLAGEN DEFECTS IN HOMOCYSTINURIA [J].
JACKSON, SH .
CLINICA CHIMICA ACTA, 1973, 45 (03) :215-217
[18]   METABOLIC EVIDENCE THAT DEFICIENCIES OF VITAMIN-B12 (COBALAMIN), FOLATE, AND VITAMIN-B6 OCCUR COMMONLY IN ELDERLY PEOPLE [J].
JOOSTEN, E ;
VANDENBERG, A ;
RIEZLER, R ;
NAURATH, HJ ;
LINDENBAUM, J ;
STABLER, SP ;
ALLEN, RH .
AMERICAN JOURNAL OF CLINICAL NUTRITION, 1993, 58 (04) :468-476
[19]   PLASMA HOMOCYSTEINE IN THE ACUTE AND CONVALESCENT PHASES AFTER STROKE [J].
LINDGREN, A ;
BRATTSTROM, L ;
NORRVING, B ;
HULTBERG, B ;
ANDERSSON, A ;
JOHANSSON, BB .
STROKE, 1995, 26 (05) :795-800
[20]  
MAHONEY F I, 1965, Md State Med J, V14, P61