Authors: D Pawar R S Neve S Kalgane A Riva E Bombardelli M Ronchi G Petrangolini P Morazzoni
Publish Date: 2012/09/04
Volume: 21, Issue: 3, Pages: 827-834
Abstract
This randomised placebocontrolled singleblind trial investigated the safety and efficacy of SAMITAL® a formulation of highly standardised botanical extracts in the treatment of chemo/radiotherapyinduced oral mucositis OM in patients with head and neck cancerPatients received SAMITAL® or placebo four times daily for up to 50 days during scheduled chemo/radiotherapy Severity of OM was monitored according to a modified WHO severity scale and pain and qualityoflife assessments were based on the effect of symptoms of OM on relevant daily activities according to a visual analogue scaleMean scores for the severity of OM were significantly p 005 versus baseline reduced from day 31 until the end of treatment in patients treated with SAMITAL® n = 20 No significant improvement was observed in the placebo group n = 10 Pain reduction was significant from day 4 till end of treatment with SAMITAL® and from days 7 to 21 in placebo patients SAMITAL® also significantly improved quality of life as shown by improvements in scores for relevant daily activities including eating drinking and sleeping All SAMITAL® patients completed the treatment period but no placebo recipients completed treatment No severe adverse events were observed with SAMITAL® and systemic absorption of relevant active ingredients was undetectableSAMITAL® significantly decreased the severity of chemo/radiotherapyinduced OM in patients with head and neck cancer with no treatmentrelated adverse events Pain relief lasted through the treatment period and improvements in quality of life were reflected by the significant benefits of SAMITAL® on activities like drinking eating and speaking
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