The journal of headache and pain 2017, 18 (suppl 1):111 p187

Efficacy of KUZIK® in the prophylaxis of migraine without aura: a retrospective observational study

A migraine without aura is the most common type of migraine headache (about 60% to 80% of all migraines). In recent years there is growing interest in the use of nutraceuticals for the prevention of migraine, as there are no specific drugs for this indication. A new kudzu based food supplement (Kuzik), thanks to its innovative mechanism of action, has attracted our interest in this use.

Materials and Methods 
January and April 2017, 30patients with migraine without aura were treated with Kuzik, once a day for 2 months, recruited in various neurological structures including university centers, general hospitals, territorial structures and private outpatient clinic; for all patients, the diary was completed and full fill the headache card (IHS criteria). Patients were evaluated at baseline and after 2 months regarding number of crisis, headache days and VAS (Visual Analogue Scale): data relative to efficacy and tolerability were collected. Patient’s characteristics: 25 female and 5 male; median age 34 (range 22-56); median years of disease 9,4 (range 2-30) and previous treatments 1,2 (range 1-2). At the baseline average number of crisis was 4 (range 2-10) , headache days 7,4 (range 3-14) and medium VAS 7,1 (range 5-10).


Kuzik was well tolerated: in a numerical scale from 1 to 10 the average score was 8 (range 6 -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: average number of crisis was 1,2 (range 0-3), headache days 2 (range 0-5) and medium VAS 1,9 (range 0-4) .


Our study has clearly demonstrated the benefits, safety, and good tolerability of Kuzik in the prophylaxis of migraine without aura 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.


Pubblicato su medical oncology march 2017, 34:46

Use of an alpha lipoic, methylsulfonylmethane and bromelain dietary supplement (Opera®) for chemotherapy-induced peripheral neuropathy management, a prospective study


Chemotherapy-induced peripheral neuropathy (CIPN) is a major clinical problem associated with a number of cytotoxic agents. OPERA® (GAMFARMA srl, Milan, Italy) is a new dietary supplement where α-lipoic acid, Boswellia Serrata, methylsulfonylmethane and bromelain are combined in a single capsule.  The aim of this prospective study was to determine the efficacy and safety of OPERA® supplementation in a series of patients affected by CIPN. We selected 25 subjects with CIPN evolving during or after chemotherapy with potentially neurotoxic agents. Patients were enrolled at the first clinical manifestation of neuropathy. CIPN was assessed at the enrollment visit and subsequently repeated every 3 weeks until 12 weeks. Primary endpoint was the evaluation of changes of measured scores after 12 weeks of therapy compared to baseline evaluation. Secondary endpoints were the evaluation of neuropathy reduction at 12 weeks after beginning of therapy with OPERA®. Analysis of VAS data showed reduction in pain perceived by patients. According to NCI-CTC sensor and motor score, mISS scale and TNSc scale, both pain and both sensor and motor neuropathic impairment decreased after 12 weeks of treatments. Treatment with OPERA supplement was well tolerated; no increase in the toxicity profile of any of the therapeutic regimen that the patients were undergoing was reported. OPERA® was able to improve CIPN symptoms in a prospective series of patients treated with neurotoxic chemotherapy, with no significant toxicity or interaction. Prospective RCT in a selected patients’ population is warranted to confirm its promising activity.



Poster presentato al congresso nazionale di neurologia (sin) a venezia 2017

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.



>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


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).


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.


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.


Pubblicato su anticancer research 35: 5687-5692 (2015)

Nutritional Supplement Based on Zinc, Prebiotics, Probiotics and Vitamins to Prevent Radiation-related Gastrointestinal Disorders


Aim: The present phase II study aimed to evaluate the tolerance and safety of Dixentil, a nutritional supplement based on zinc with the addition of prebiotics (galacto-oligosaccharides), tyndalized probiotics (Lactobacillus acidophilus and L. casei) and vitamins B1, B2 and B6, and nicotinamide, given as prophylaxis to patients undergoing pelvic radiotherapy and its efficacy in the prevention and reduction of radiation-related gastrointestinal disorders.

Patients and Methods:Forty consecutive patients who were candidates for pelvic radiotherapy received Dixentil before starting and during radiotherapy. The primary end-point was to evaluate the safety and tolerance of Dixentil. Secondary end-points were incidence and severity of radiation-induced diarrhea and number of patients who discontinued radiotherapy because of diarrhea.

Results: Radiation-induced enteritis occurred in 17 patients, grade I and grade II diarrhea was documented in 14 and 3 patients respectively; no grade III or IV diarrhea was observed. Radiotherapy was discontinued due to  treatment-induced enteritis only in two patients for 6 days.

Conclusion: Use of Dixentil is an easy, safe, and feasible approach to protect patients against the risk of radiation-induced diarrhea.

Fonte: www.ncbi.nlm.nih.gov


Pubblicato su nutrition and cancer 2015, 67(8), 1249–1254

Oral Lapacho-Based Medication: An Easy, Safe, and Feasible Support to Prevent and/or Reduce Oral Mucositis During Radiotherapy for Head and Neck Cancer.


The aim of our Phase II study is to demonstrate the benefits, safety, and tolerance of Orasol Plus, an easy and feasible Lapacho-based medication.  Orasol Plus is a nutritional, swallowable solution, useful to support the defenses of the oropharyngeal mucosa. Between January and June 2014, 40 consecutive adult patients affected by head and neck cancer were enrolled. Orasol Plus was administered 3 times a day from the first day till the end of radiotherapy. Primary endpoint was to evaluate tolerance and safety of Orasol Plus; secondary endpoint was to evaluate the effect of Orasol Plus on the incidence of treatment discontinuation.  Nearly all patients used Orasol Plus easily till the end of radiotherapy without interruptions. Only 11 (27.5%) patients developed oral mucositis (OM) Grade 2 and only 4 (10%) patients OM Grade 3, no patient developed OM Grade 4. No patient discontinued radiotherapy because of OM. Orasol Plus was well tolerated and the compliance of patients was optimal,  mainly due to the fact that it can be swallowed. Data from our study are encouraging and they need to be confirmed by a Phase III study.

Fonte: www.ncbi.nlm.nih.gov


Presentazione orale a ebmt 2013 – londra

Retrospective analysis of two cohorts of pts treated with Benzidamine or Orasol for mucositis prophylaxis affected by lymphoma and multiple myeloma undergoing autologous stem cell transplant (aHSCT) following melphalan (Mel) containing regimen

Background: Oral mucositis (OM) is one of the most common side effect of HSCT due to high dose chemotherapy. Mel is widely used in conditioning regimen known to have toxicity on the mucosa which can lead to complications. No oral solution has been shown to be superior to the other in the treatment of OM. Orasol has been recently introduced in the clinical area as nutritional supplement with antinflammatory, analgesic and antifungal activity with no alcohol so can be swallowed,allowing patient(pt)compliance and with activity on the esophageal mucosa.

Primary objective: compare the efficacy between treatment with Orasol to Benzidamine in the OM prophylaxis in pt undergoing aHSCT following HDMel. Secondary objective :to confront outcomes related to use of supportive drugs and days of hospitalization.

Methods: We have performed a retrospective analysis on pts receiving aHSCT from 2011 to 2012 following a Mel containing conditioning regimen and receiving Benzidamine (Group 1) or Orasol (Group 2). Each pt had a daily evaluation of OM according to WHO criteria. The treatment with both solutions was started the day before the conditioning regimen until the end of hospitalization.

Results: We reviewed data of 32 pt.16 pt received treatment with Benzidamine and 16 pt received treatment with Orasol. 7 pts in Group1 had OM WHO grade 0 and 9 pts had a OM grade1.At the end of treatment 1 pt had grade 0 OM,11 pts grade 1;3 pts grade2and 1 pt grade 3. In Group2,at the beginning of treatment 8 pts had grade 0 OM;8 pts had grade1,while at the end of treatment 14 pts had OM grade 0 and 2 had G1. The prophylactic antifungal therapy was given to all pts;6 pts from Group1 (37.5%) received antifungal therapy with liposoma Amfotericine B for worsening of mucositis while in group 2 the antifungal therapy was given to 2 pts. (12.5%). Morphine was administered to 7 pts from Group1 (43,75%) and to only 1 pt (6,25%) from Group2. In Group 1 the median duration of hospitalization was 20,9 days, while in Group2 it was 19,7days.

Conclusions: In our sample we observed that prophylactic treatment with Orasol appears to allow a better protection of oral mucosa compared with Benzidamine allowing, in case of mucositis reduction in the use of systemic analgesic and antifungal therapy. No significant difference was observed in days of hospitalization.

Fonte: Bone Marrow Transplantation Volume 48 supplement 2 april 2013 P. S 462