La confezione di TEOFARMA Folina 5 mg comprende 60 capsule di color rosso vivo divise in fogli di plastica da 20 capsule ciascuno. Sull'Acido folico dirò più avanti.

Anzitutto un'analisi che non vedo mai fare da nessuno e che invece mi sembra fondamentale: l'analisi degli ingredienti del rivestimento delle capsule. Nessuno vi presta attenzione eppure vi sono ingredienti che assumiamo in modo costante e più volte al giorno.

Non mi convince la composizione dell'involucro esterno di queste capsule. D'accordo che le quantità sono minime, ma i parabeni (Propile paraidrossibenzoato sodico ed Etile paraidrossibenzoato sodico) non vorrei ingerirli. Ci sono poi altri componenti, sempre nel rivestimento delle capsule (hanno un bel colore rosso vivo), che preferisco evitare accuratamente : E171 titanio diossido sul quale c'è molta letteratura per quanto riguarda la sicurezza (E171 - Biossido di titanio - Titanium Dioxide) e l'Ossido di ferro (Ossido di ferro E172 CI 77492). 

Cos'è il Biossido di titanio

Ho parlato col mio medico e messo da parte questa confezione e ho quindi acquistato lo stesso farmaco, ma quello generico: ACIDO FOLICO DOC Generici 5mg che, tra l'altro, costa anche meno e non ha il Biossido di titanio. Sono più tranquillo. In ogni caso in farmacia vi sono numerosi altri prodotti simili che non contengono il Biossido di titanio.

E ora le informazioni sull'Acido folico o vitamina B9 :

Cos'è la vitamina B9 o Acido Folico

E' una vitamina composta da acido pteroylglutamic e da acido oligoglutamic

Dove si trova

Non viene prodotta dall'organismo umano, ma viene assunta con gli alimenti che la contengono e che sono :

• carni
• legumi
• latte

Questa vitamina è importante per :

• evitare malformazioni nei neonati
• evitare rischi di ipertensione gestazionale in gravidanza (1)
• sintesi del DNA (2)
• formazione dell'emoglobina
• formazione dei tessuti
• riduzione del rischio ictus (3)

11-6-2019 Ho scritto alla Direzione europea per la salute e la sicurezza alimentare (DG SANTE) riproponendo i dubbi sulla sicurezza dei parabeni e dell'E171 titanio diossido. Finalmente anche da questo ente è arrivata la risposta che chiarisce ogni dubbio:

"Per quanto riguarda l'uso di metil- e propilparaben come eccipienti nei medicinali per uso umano per uso orale, vi consiglierei di guardare le informazioni fornite dall'Agenzia Europea dei Medicinali su https://www.ema.europa.eu/en/use-methyl-propylparaben-excipients-human-medicinal-products-oral-use Questo documento di riflessione si occupa di metil- e propilparaben, poiché questi sono i parabeni usati prevalentemente nelle formulazioni farmaceutiche orali. Il focus di questo documento è sui possibili effetti di interferenza endocrina negli esseri umani.

Per quanto riguarda il biossido di titanio, l'Autorità europea per la sicurezza alimentare ha pubblicato il suo parere il 6 maggio 2021 e ha concluso che, sulla base di tutte le prove disponibili, non si può escludere una preoccupazione per la genotossicità, e date le molte incertezze, E 171 non può più essere considerato sicuro se usato come additivo alimentare. Come menzionato in un tweet dello stesso giorno, a seguito del nuovo parere scientifico dell'EFSA sull'additivo alimentare E171, proporremo di vietarne l'uso nell'UE. https://twitter.com/food_eu/status/1390347410476523521

Per quanto riguarda i medicinali, la Commissione ha chiesto all'Agenzia europea per i medicinali di valutare l'effetto sull'uso del TiO2 nei medicinali e la fattibilità di alternative per sostituire il TiO2, se possibile, senza impatto sulla qualità, sicurezza ed efficacia dei medicinali. Una decisione sarà presa dalla Commissione sulla base dell'analisi fornita dall'Agenzia."

Ora, quanto occorrerà attendere prima che questi ingredienti vengano definitivamente rimossi dalle nostre medicine?

2024. Dopo 5 anni, il Biossido di Titanio è ancora presente nei medicinali.

Bibliografia_______________________________________________________________________

(1) Li Z, Ye R, Zhang L, Li H, Liu J, Ren A. Folic acid supplementation during early pregnancy and the risk of gestational hypertension and preeclampsia. Hypertension. 2013 Apr;61(4):873-9. doi: 10.1161/HYPERTENSIONAHA.111.00230. 

Abstract. Emerging evidence has suggested that folic acid-containing multivitamins may markedly reduce the risk of gestational hypertension or preeclampsia. We examined whether maternal supplementation with folic acid alone during early pregnancy can prevent the occurrence of gestational hypertension and preeclampsia. The data are from a large population-based cohort study established to evaluate the effectiveness of the campaign to prevent neural tube defects with folic acid supplementation in China. We selected participants who were registered in 2 southern provinces, had exact information on folic acid use, and were not affected by chronic hypertension or diabetes mellitus before 20 weeks gestation. A logistic regression model was used to adjust for the effects of the main potential confounders, including age, body mass index, education, occupation, parity, and multiple births. The study size had 99.9% power (α=0.05) to detect a decrease of 10% over the unexposed rate of 9.4% for gestational hypertension. Among the 193 554 women (47.9% took folic acid, 52.1% did not), the overall incidence of gestational hypertension and preeclampsia was 9.5% and 2.5%, respectively. The incidence of gestational hypertension and preeclampsia was 9.7% and 2.5% for women who took folic acid, and 9.4% and 2.4% for women who did not use it. The adjusted risk ratio associated with folic acid use was 1.08 (95% confidence interval, 1.04-1.11) for gestational hypertension and 1.11 (95% confidence interval, 1.04-1.18) for preeclampsia. Our findings suggest that daily consumption of 400 μg folic acid alone during early pregnancy cannot prevent the occurrence of gestational hypertension and preeclampsia.

(2) Luo S, Zhang X, Yu M, Yan H, Liu H, Wilson JX, Huang G. Folic acid acts through DNA methyltransferases to induce the differentiation of neural stem cells into neurons. Cell Biochem Biophys. 2013 Jul;66(3):559-66. doi: 10.1007/s12013-012-9503-6. 

Abstract. The present study investigated the roles of folic acid and DNA methyltransferases (DNMTs) in the differentiation of neural stem cells (NSCs). Neonatal rat NSCs were grown in suspended neurosphere cultures and identified by their expression of SOX2 protein and capacity for self-renewal. Then NSCs were assigned to five treatment groups for cell differentiation: control (folic acid-free differentiation medium), low folic acid (8 μg/mL), high folic acid (32 μg/mL), low folic acid and DNMT inhibitor zebularine (8 μg/mL folic acid and 150 nmol/mL zebularine), and high folic acid and zebularine (32 μg/mL folic acid and 150 nmol/mL zebularine). After 6 days of cell differentiation, immunocytochemistry and western blot analyses were performed to identify neurons by β-tubulin III protein expression and astrocytes by GFAP expression. We observed that folic acid increased DNMT activity which may be regulated by the cellular S-adenosylmethionine (SAM) and S-adenosylhomocysteine (SAH), and the abundance of neurons but decreased the number of astrocytes. Zebularine blocked these effects of folic acid. In conclusion, folic acid acts through elevation of DNMT activity to increase neuronal differentiation and decrease astrocytic differentiation in NSCs.

(3) Yang HT, Lee M, Hong KS, Ovbiagele B, Saver JL. Efficacy of folic acid supplementation in cardiovascular disease prevention: an updated meta-analysis of randomized controlled trials. Eur J Intern Med. 2012 Dec;23(8):745-54. doi: 10.1016/j.ejim.2012.07.004.

(4) Nozari E, Ghavamzadeh S, Razazian N. The Effect of Vitamin B12 and Folic Acid Supplementation on Serum Homocysteine, Anemia Status and Quality of Life of Patients with Multiple Sclerosis. Clin Nutr Res. 2019 Jan 25;8(1):36-45. doi: 10.7762/cnr.2019.8.1.36.

Abstract. Plasma homocysteine level and megaloblastic anemia status are two factors that can affect the quality of life of patients with multiple sclerosis (MS). We conducted this study to determine the effect of vitamin B12 and folic acid supplementation on serum homocysteine, megaloblastic anemia status and quality of life of patients with MS. A total of 50 patients with relapsing remitting multiple sclerosis (RRMS) included in this study which divided into 2 groups. The vitamin group received 5 mg folic acid tablet daily and 3 doses of vitamin B12 (1,000 mcg) injection and the other group received placebo and normal saline injection (same doses). The quality of life was measured by using Multiple Sclerosis Quality of Life-54 questionnaire (MSQOL-54). Fully automated fluorescence polarization immunoassay was used to measure serum homocysteine, vitamin B12 and folate. Complete blood count blood test was conducted to determine the anemia status. The mean homocysteine level reduced by 2.49 ± 0.39 µmol/L (p = 0.001), hemoglobin increased from 11.24 ± 1.54 to 13.12 ± 1.05 g/dL (p = 0.001), and mean corpuscular volume decreased from 95.50 ± 6.65 to 89.64 ± 4.24 in the vitamin group (p = 0.001). There was a significant improvement in the mental field of life quality in the placebo group (37.46 ± 19.01 to 50.98 ± 21.64; p = 0.001), whereas both physical and mental fields of quality of life were improved significantly in the vitamin group (40.38 ± 15.07 to 59.21 ± 12.32 and 29.58 ± 15.99 to 51.68 ± 18.22, respectively; p = 0.001). Serum homocysteine level decrease and anemia status improvement with vitamin B12 and folic acid supplementation reveal the potential role of these two vitamins in improving the life quality of MS patients.

(5) Mottaghi T, Khorvash F, Maracy M, Bellissimo N, Askari G. Effect of folic acid supplementation on nerve conduction velocity in diabetic polyneuropathy patients. Neurol Res. 2019 Apr;41(4):364-368. doi: 10.1080/01616412.2019.1565180. Epub 2019 Feb 7. PMID: 30730785.

Abstract. Objectives: In diabetic polyneuropathy (DPN) patients, the effect of folic acid and homocysteine has been related to components of nerve conduction velocity (NCV). The objective of this study was to determine the effect of folic acid supplementation on NCV in DPN patients.....Conclusion: Our data suggest that supplementation with 1 mg of folic acid for 16 weeks may be useful for enhancing NCV in DPN patients.

(6) Saing S, Haywood P, van der Linden N, Manipis K, Meshcheriakova E, Goodall S. Real-World Cost Effectiveness of Mandatory Folic Acid Fortification of Bread-Making Flour in Australia. Appl Health Econ Health Policy. 2019 Apr;17(2):243-254. doi: 10.1007/s40258-018-00454-3. PMID: 30617458.

 Abstract. Background: In 2009, mandatory folic acid fortification of bread-making flour was introduced in Australia to reduce the birth prevalence of preventable neural tube defects (NTDs) such as spina bifida. Before the introduction of the policy, modelling predicted a reduction of 14-49 NTDs each year. Objective: Using real-world data, this study provides the first ex-post evaluation of the cost effectiveness of mandatory folic acid fortification of bread-making flour in Australia.....Conclusions: This study calculated the value of mandatory folic acid fortification using real-world registry data and demonstrated that the attained benefit was comparable to the modelled expected benefits. Mandatory folic acid fortification (in addition to policies including advice on supplementation and education) improved equity in certain populations and was effective and highly cost effective for the Australian population.