Observational study to assess the efficacy of “Opera? in reducing polyneuropatic symptoms
E.Pucci (1) , S.Cristina (1), G. Scarì (2) , R. Galante ( 3 )
(1) Department of Brain and Behavior Sciences, University of Pavia. IRCCS “C. Mondino? Pavia.
(2 ) Department of Biosciences, University of Milan
(3) GamFarma Srl. Milan.
ABSTRACT
Aims
Polyneuropathy is a very disabling disease of the peripheral nerves but there are few effective treatments often associated with side effects such as dizziness and drowsiness that can worsen the quality of life of patients. The antioxidant alpha-lipoic acid has proven useful in reducing pain . The aim of this study is to demonstrate benefits, safety and tolerability of Opera , a nutritional supplement, containing alpha-lipoic acid associated with boswellia serrata, methylsulfonylmethane and bromelain with anti-inflammatory, analgesic and anti-edema activity. Opera is developed with the innovative system Actibox “programmed release capsules ” , set up to carry and release substances in the target organs in typical pH lowering conditions of an inflammatory status.
Materials and Methods
Between November 2015 and April 2016, thirty consecutive adult patients attending at Neurological Institute C. Mondino with longer polyneuropathy, were treated with Opera, once a day , for 2 months. Patients were evaluated at baseline and after 2 months using Visual Analogue Scale (VAS) and Douleur Neuropathique en 4 Questions ( DN4 ) : data relative to efficacy and tolerability were collected. Patient’s characteristics :17 male, 13 female; median age 53 (range 38-72) ; diagnosis : diabetes 11, oncological disease 6, hepatitis C 2, post-herpes neuropathy 4, and compressive radiculopathy 7. At the baseline, average number of pain attacks was 5,2 (range 4-7), medium VAS 6,7 (range 5-8) and medium DN4 6,1 (range 4-8).
Results
Opera was well tolerated: in a numerical scale from 1 to 10 the average score was 8 ( range 7-10) ; the compliance of patients was optimal, no side effect related to product were reported and no weight gain in patients occurred. Regarding efficacy, at the end of treatment , all parameters analyzed were significantly improved (p<0.0001): average number of pain attacks was 1,2 ( range 0-2 ) , median VAS 1,7 ( range 0-4) and median DN4 1,4 ( range 0-3 ). Improvements were observed in all patients regardless of disease.
Conclusions
Our study has clearly demonstrated the benefits, safety, and good tolerability of Opera in polyneuropathy treatment, regardless of the underlying disease and the use of this medication should be taken in consideration as a good practice in this setting of patients. Data from our study are encouraging to be confirmed by further investigations.
