Effects of conjugated linoleic acid and high oleic acid safflower oil in the treatment of children with HPV-induced laryngeal papillomatosis: a randomized, double-blinded and crossover preliminary study.
BACKGROUND
Surgery is the mainstay therapy for HPV-induced laryngeal papillomatosis (LP) and adjuvant therapies are palliative at best. Research revealed that conjugated-linoleic acid (CLA) may improve the outcome of virally-induced diseases. The effects of Clarinol™ G-80 (CLA) and high oleic safflower oil (HOSF) on children with LP (concomitant with surgery) were evaluated.


METHODS
A randomized, double-blinded, crossover and reference-oil controlled trial was conducted at a South African medical university. Study components included clinical, HPV type/load and lymphocyte/cytokine analyses, according to routine laboratory methods.


METHODS
Overall: ten children enrolled; eight completed the trial; five remained randomized; seven received CLA first; all treatments remained double-blinded.


METHODS
Children (4 to 12 years) received 2.5 ml p/d CLA (8 weeks) and 2.5 ml p/d HOSF (8 weeks) with a washout period (6 weeks) in-between. The one-year trial included a post-treatment period (30 weeks) and afterwards was a one-year follow-up period.


METHODS
Changes in numbers of surgical procedures for improved disease outcome, total/anatomical scores (staging system) for papillomatosis prevention/viral inhibition, and lymphocyte/cytokine counts for immune responses between baselines and each treatment/end of trial were measured.


RESULTS
After each treatment all the children were in remission (no surgical procedures); after the trial two had recurrence (surgical procedures in post-treatment period); after the follow-up period three had recurrence (several surgical procedures) and five recovered (four had no surgical procedures). Effects of CLA (and HOSF to a lesser extent) were restricted to mildly/moderately aggressive papillomatosis. Children with low total scores (seven/less) and reduced infections (three/less laryngeal sub-sites) recovered after the trial. No harmful effects were observed. The number of surgical procedures during the trial (n6/available records) was significantly lower [(p 0.03) (95% CI 1.1; 0)]. Changes in scores between baselines and CLA treatments (n8) were significantly lower: total scores [(p 0.02) (95% CI -30.00; 0.00)]; anatomical scores [(p 0.008) (95% CI -33.00: -2.00)]. Immune enhancement could not be demonstrated.


CONCLUSIONS
These preliminary case and group findings pave the way for further research on the therapeutic potential of adjuvant CLA in the treatment of HPV-induced LP.
Department Otorhinolaryngology, Faculty of Health Sciences, University of the Free State, Box 339G42, Bloemfontein 9300, South Africa. gnanll@ufs.ac.za
Louise
L
Louw
D002648:Child; D002675:Child, Preschool; D006801:Humans; D007113:Immunity, Innate / Q000187:drug effects; D007822:Laryngeal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D044243:Linoleic Acids, Conjugated / Q000008:administration & dosage*; D019301:Oleic Acid / Q000008:administration & dosage*; D010212:Papilloma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D027383:Papillomaviridae / Q000472:pathogenicity; D012450:Safflower Oil / Q000008:administration & dosage*; D013019:South Africa; D016896:Treatment Outcome
D044243:Linoleic Acids, Conjugated; D019301:Oleic Acid; D012450:Safflower Oil