Clinical utility of LDL-apheresis in the treatment of sudden hearing loss:a prospective, randomized study

Although the pathogenesis of sudden hearing loss (SHL) is nor as yet known, the clinical picture and the frequent association with vascular risk facto rs make an ischaemic event likely. This study aimed to assess the effect of an extracorporeal procedure (H.E.L.P.) in removing LDL-cholesterol, fibrin ogen and lipoprotein (a) from the plasma, on the recovery of hearing SHL. T his procedure using the HELP-system was compared with the usual standard tr eatment with prednisolone, dextranes and pentoxifyllin. We undertook a sing le centre, prospective, randomized study in which 18 patients were assigned to H.E.L.P.-apheresis and 9 patients were assigned to standard treatment ( 2:1 randomization). Audiometric and laboratory testing was performed at bas eline, 24 h and 6 weeks after start of treatment. Primary endpoint was the improvement of the average pure-tone threshold between 0,125 and 8 kHz afte r 24 h. Twenty-four hours by 26.4 dB after 6 weeks. The recovery of hearing of the standard treated patients was 5.8 dB and 16.8 dB after 24 h and 6 w eeks respectively. LDL-cholesterol, fibrinogen and lipoprotein (a) were sig nificantly reduced in the HELP treated patients compared with standard ther apy, resulting in a significant improve in plasma viscosity, erythrocyte ag gregation and resistance to oxidative stress of LDL particles. Our results suggest that the clinical outcome of SHL after a single extracorporeal LDL- apheresis is superior or at least equal to the more expensive standard trea tment with prednisolone, dextranes and pentoxifyllin. Re-establishment of v ascular endothelial function and improved blood rheology may be the underly ing cause. These results must be confirmed in larger-scale trials.