Journal Information
Vol. 34. Issue. 3.May 2014
Pages 273-424
Vol. 34. Issue. 3.May 2014
Pages 273-424
DOI: 10.3265/Nefrologia.pre2014.Mar.12391
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Anorexia and megestrol acetate: treatment versus placebo controlled study
Anorexia y acetato de megestrol: estudio controlado de tratamiento frente a placebo
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Milagros Fernández-Lucasa, Martha E. Díaz-Domíngueza, Gloria Ruiz-Rosoa, Viviana Raocha, J. Luis Teruel-Brionesa, Carlos Quereda-Rodríguez-Navarroa
a Servicio de Nefrolog??a, Hospital Universitario Ram??n y Cajal, Madrid,
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To the Editor,

Loss of appetite is a frequent symptom in a dialysis patient, which causes anxiety and affects perceived quality of life. Deficient food intake as a result of anorexia is the main cause of type 1 uraemic malnutrition, which is not related to intercurrent inflammatory processes1. Megestrol acetate increases the appetite and improves the nutritional parameters in patients treated with periodic haemodialysis who suffer from anorexia2. Given the subjective nature of anorexia, there is doubt surrounding the extent to which the effect of megestrol acetate can be attributed to a placebo effect.3 In order to clarify this, we studied anorexia’s response to megestrol acetate in a randomised controlled study.

In 2011 and 2012, 122 patients were treated in our haemodialysis unit. 19 of the patients suffered from anorexia, without a known trigger factor. In order to diagnose anorexia, we used the appetite questionnaire from the HEMO and DOPPS studies4,5 in which the patient has to indicate how he/she regards his/her current appetite on a Likert scale with five possibilities: very good, good, normal, bad or very bad. The patient is then asked whether his/her appetite had improved, stayed the same or diminished in the last four weeks. Anorexia is diagnosed when a patient reports that his/her current appetite is normal, bad or very bad and that it has not changed or has diminished in the last four weeks. The 19 patients were treated randomly with megestrol acetate, 160mg/day (10 patients; 4 males and 6 females), or placebo (9 patients; 4 males and 5 females). We analysed anorexia evolution and evolution of nutrition-related clinical parameters over three months.

Initially, there were no differences between the treated group and the control group with respect to age (73±9 vs. 69±18 years, P=.544), time on dialysis (40±46 vs. 47±41 months, P=.731), dry weight (58.1±10.7 vs. 61.9±7.2kg, P=.377), weight loss in the last two months (0.6±1 vs. 0.6±0.5kg, P=.903), albumin concentration (3.25±0.62 vs. 3.33±0.57 g/dl, P=.781) or dialysis dose (Daurgidas spKt/V 1.70±0.28 vs. 1.79±0.22, P=.456). All the patients received dialysis three times a week, with high-flux biocompatible membrane and ultrapure dialysate.

After three months of treatment, 9 out of the 10 patients treated with megestrol acetate and 4 out of the 9 patients treated with placebo reported an improvement in appetite (P=.046, Fisher test). Evolution of weight and other nutritional parameters are shown in Table 1. An increase in weight and in concentrations of albumin, creatinine and urea, without modification to dialysis dose, were only observed in the group of patients treated with megestrol acetate. None of these parameters varied significantly in the group of patients treated with placebo.

The feeling of loss of appetite is partly subjective, which can be seen to be influenced by placebo administration. However the stimulating effect on appetite induced by megestrol acetate cannot be exclusively attributed to a placebo effect. The proportion of patients who reported an improvement in appetite following megestrol acetate treatment is higher than that reported by the placebo-treated control group. Most significantly, an improvement in the parameters related to nutrition status was only observed in the group of patients treated with megestrol acetate.

 

Conflicts of interest

 

The authors declare that they have no conflicts of interest related to the contents of this article.

12391_19157_58623_en_ref.1239129169_12391_19115_53894_es_12391_tabla1_copy1.doc

Table 1. Evolution of nutritional parameters.

Bibliography
[1]
Locatelli F, Fouque D, Heimburger O, Dr??cke TB, Cannata-And??a JB, H??rl WH, et al. Nutritional status in dialysis patients: a European consensus. Nephrol Dial Transplant 2002;17:563-72. [Pubmed]
[2]
Fern??ndez Lucas M, Teruel JL, Burguera V, Sosa H, Rivera M, Rodr??guez Palomares JR, et al. Tratamiento de la anorexia ur??mica con acetato de megestrol. Nefrologia 2010;30:646-52. [Pubmed]
[3]
Yeh SS, Marandi M, Thode HC, Levine DM, Parker T, Dixon T, et al. Report of a pilot, doubleblind, placebo-controlled study of megestrol acetate in elderly dialysis patients with caquexia. J Ren Nutr 2010;20:52-62. [Pubmed]
[4]
Burrowes JD, Larive B, Cockram DB, Dwyer J, Kusek JW, McLeroy S, et al. Effects of dietary intake, appetite, and eating habits on dialysis and non-dialysis treatment days in hemodialysis patients: cross-sectional results from the HEMO study. J Ren Nutr 2003;13:191-8. [Pubmed]
[5]
Lopes AA, Elder SJ, Ginsberg N, Andreucci VE, Cruz JM, Fukuhara S, et al. Lack of appetite in haemodialysis patients - associations with patients characteristics, indicators of nutritional status and outcomes in the international DOPPS. Nephrol Dial Transplant 2007;22:3538-46. [Pubmed]
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