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Incidences of diarrhoea and loose stools are reported up to 50% in patients starting treatment with auranofin. Moreover, +/-4% of patients discontinue treatment because of severe diarrhoea. We investigated whether a water binding agent would diminish the incidence of loose stools and diarrhoea. Endpoints were the patient's general impression of the quality of stools and a daily assessment of stool's frequency/consistency and adverse events. Secondly, some disease activity parameters were used to evaluate whether the bulkforming agent influences the efficacy of auranofin. In this study 269 patients suffering from Rheumatoid Arthritis (RA) were treated with auranofin 6 mgr daily for a period of six months. Simultaneously the patients were randomly treated with either a bulkforming agent (Volcolon: psyllium fibres) or placebo. Results show a 15% incidence of loose stools and diarrhoea during treatment with auranofin. During the treatment period the patients' general impression of defecation consistency showed a shift to softer types. The changes in defecation consistency was not significantly different between groups (Intention-to-treat analysis: C2=4.01; p=0.13). Also, the percentage of patients experiencing episodes of diarrhoea (reported as an adverse experience) was not different (14% of the patients treated with bulkformer versus 15% with placebo). During the first month 7% (n=5) of placebo treated patients reported short episodes of watery stools versus none in the bulkformer treated group. The percentage of days with loose or watery stools, reported on the diary cards, was consistently lower in bulkformer treated patients. Both groups improved equally with respect to disease activity parameters. Sixty-eight percent of patients continued auranofin treatment after the study period. In conclusion, these data do not support adjuvant therapy with a bulkforming agent on initiation of auranofin therapy. The overall low incidence of loose stools and diarrhoea suggests that a dose increase to 9 mgr daily is an option to enhance the efficacy of auranofin treatment.
H J van Beusekom, and
M A van de Laar, and
M J Franssen, and
J A van Valburg, and
W P Gijzel, and
J E Couvée
January 1990,
Zeitschrift fur Rheumatologie,
H J van Beusekom, and
M A van de Laar, and
M J Franssen, and
J A van Valburg, and
W P Gijzel, and
J E Couvée
October 1986,
Tidsskrift for den Norske laegeforening : tidsskrift for praktisk medicin, ny raekke,
H J van Beusekom, and
M A van de Laar, and
M J Franssen, and
J A van Valburg, and
W P Gijzel, and
J E Couvée
January 1997,
Clinical and experimental rheumatology,
H J van Beusekom, and
M A van de Laar, and
M J Franssen, and
J A van Valburg, and
W P Gijzel, and
J E Couvée
January 1998,
Scandinavian journal of rheumatology,
H J van Beusekom, and
M A van de Laar, and
M J Franssen, and
J A van Valburg, and
W P Gijzel, and
J E Couvée
December 2016,
Fortschritte der Neurologie-Psychiatrie,
H J van Beusekom, and
M A van de Laar, and
M J Franssen, and
J A van Valburg, and
W P Gijzel, and
J E Couvée
January 1986,
Scandinavian journal of rheumatology. Supplement,
H J van Beusekom, and
M A van de Laar, and
M J Franssen, and
J A van Valburg, and
W P Gijzel, and
J E Couvée
February 1990,
Psychiatry research,
H J van Beusekom, and
M A van de Laar, and
M J Franssen, and
J A van Valburg, and
W P Gijzel, and
J E Couvée
April 2009,
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,
H J van Beusekom, and
M A van de Laar, and
M J Franssen, and
J A van Valburg, and
W P Gijzel, and
J E Couvée
October 1984,
British journal of pharmacology,
H J van Beusekom, and
M A van de Laar, and
M J Franssen, and
J A van Valburg, and
W P Gijzel, and
J E Couvée
November 2007,
The Journal of pediatrics,
