Iron supplementation for unexplained fatigue in non-anaemic women: double blind randomised placebo controlled trial

doi:10.1136/bmj.326.7399.1124

BMJ 2003;326:1124 (24 May), doi:10.1136/bmj.326.7399.1124

Primary care

Iron supplementation for unexplained fatigue in non-anaemic women: double blind randomised placebo controlled trial

F Verdon, general practitioner¹, B Burnand, senior lecturer², C-L Fallab Stubi, pharmacist³, C Bonard, general practitioner¹, M Graff, general practitioner¹, A Michaud, general practitioner¹, T Bischoff, general practitioner¹, M de Vevey, general practitioner¹, J-P Studer, general practitioner¹, L Herzig, general practitioner¹, C Chapuis, general practitioner¹, J Tissot, general practitioner¹, A Pécoud, professor³, B Favrat, consultant of internal medicine³

¹ General Practice Unit, University of Lausanne, rue du Bugnon 44, 1011 Lausanne, Switzerland, ² Health Care Evaluation Unit, Institute of Social and Preventive Medicine, University of Lausanne, ³ Medical Outpatient Clinic, University of Lausanne

Correspondence to: B Favrat bernard.favrat{at}hospvd.ch

Objective To determine the subjective response to iron therapyin non-anaemic women with unexplained fatigue.

Design Double blind randomised placebo controlled trial.

Setting Academic primary care centre and eight general practicesin western Switzerland.

Participants 144 women aged 18 to 55, assigned to either oral ferrous sulphate (80 mg/day of elemental iron daily; n=75) orplacebo (n=69) for four weeks.

Main outcome measures Level of fatigue, measured by a 10 point visual analogue scale.

Results 136 (94%) women completed the study. Most had a lowserum ferritin concentration; $<=$ 20 µg/l in 69 (51%) women.Mean age, haemoglobin concentration, serum ferritin concentration,level of fatigue, depression, and anxiety were similar in bothgroups at baseline. Both groups were also similar for complianceand dropout rates. The level of fatigue after one month decreasedby -1.82/6.37 points (29%) in the iron group compared with -0.85/6.46 points (13%) in the placebo group (difference 0.95points, 95% confidence interval 0.32 to 1.62; P=0.004). Subgroupsanalysis showed that only women with ferritin concentrations $<=$ 50 µg/l improved with oral supplementation.

Conclusion Non-anaemic women with unexplained fatigue may benefit from iron supplementation. The effect may be restricted to womenwith low or borderline serum ferritin concentrations.

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