Improving diabetic and hypertensive retinopathy with a medical food containing L-methylfolate: a preliminary report

Background:Homocysteine and vitamin D may play a role in the development of diabetic and hypertensive retinopathy in patients with diabetes mellitus(DM)and hypertension.Supplementing food with L-methylfolate and vitamin D theoretically may improve diabetic and hypertensive retinopathy,however,the outcome of these nutritional approaches has not been fully examined.A retrospective case review was done of cases of retinopathy reversal in patients on Ocufolin^(TM) and a similar nonprescription multivitamin,Eyefolate^(TM).In this study,they were administered L-methylfolate(2.7 mg and 3.0 mg,respectively)and vitamin D3(4500 IU each).These dosages are significantly above the RDA but well below levels associated with toxicity.Case presentation:Seven patients had nonproliferative diabetic retinopathy(NPDR)and some of them had hypertension.One patient had only hypertensive retinopathy.All patients were instructed to take Ocufolin^(TM)medical food as a food supplement.Baseline genetic testing for MTHFR polymorphisms was conducted.Fundus photography was used to document the fundus condition of the enrolled eyes in 8 NPDR patients at the initial and follow-up visits.Microaneurysms(MA)and exudates were observed to be improved in some trial patients.All subjects had one or more MTHFR polymorphisms.All had diabetic retinopathy,hypertensive retinopathy,or both.MAs were resolved,and exudates were decreased in 8/8 cases after taking the medical food.Retinal edema was found in 2/8 cases and improved or resolved in both cases after taking the medical food or the supplement.The best corrected visual activity was stable or improved in 8/8 cases.Conclusion:We report a series of diabetic and hypertensive retinopathy cases with MTHFR polymorphisms and the improvement of retinal microvasculature(mainly MAs)in serial fundus photography after taking a medical food or supplement containing L-methylfolate and vitamin D.It appears that the use of nutritional supplements and medical foods containing L-methylfolate and vitamin D may be effective in facilitating the improvement of diabetic and hypertensive retinopathy.

Comparative Study between the Use of Regular Folic Acid Supplement versus the Use of L-Methyl Folate in Patients with Methyl Tetrahydrofolate Reductase (MTHFR) Gene Mutation with Recurrent Pregnancy Loss

Background: Methylfolate is the active metabolite of folate that is important for DNA repair, synthetized under the effect of MTHFR (methyl-tetrahydro-folatereductase) enzyme. Patients with MTHFR gene mutation have low levels of biologically active methyfolate. Those patients have high homocysteine levels causing vasculopathy and inadequate feto-maternal circulation. Aim of the Work: To predict the potential benefit of use of methylfolate instead of use of the regular folic acid in patients with MTHFR gene mutation with history of RPL (recurrent pregnancy loss). Subjects and Methods: Study was performed on 100 women. All women had experienced at least two consecutive miscarriages first trimester abortion. All patients were positive of having MTHFR gene mutation. Patients were divided into two groups in terms of 1st trimester drug intake. The 1st group recieved a regular folic acid supplement in a dose of 5 mg per day starting from the day of positive pregnancy test till the end of the first trimester. The 2nd group recieved L-methylfolate supplement in a dose of 1000 mcg per day starting from the day of positive pregnancy test till the end of the first trimester. Then both groups were compared in terms of abortion rates, pregnancy continuation rates and the development of other major obstetric complications. Results: Patients in 1st group had no associated pregnancy related complications in 56%, PE in 14%, PROM in 18% and PTL in 12% of cases. On the other hand, patients in 2nd group had no associated pregnancy related complications in 78%, PE in 6%, PROM in 8% and PTL in 8% of cases 54% of patients on folate group ended in abortion, while only 16% of patients on methylfolate group had abortion. 24% of patients on folate group had PTL, compared to 8% of patient who had had PTL in methylfolate group. 22% of patients in the 1st group continued pregnancy to full term, while 60% of 2nd group continued pregnancy to full term. Conclusion and Recommendations: The use of methyl-folate supplement during the first trimester of in patients with history of RPL and positive MTHFR gene mutation should be a routine practice instead of the regular folate supplement as it improves pregnancy continuation rates and decreases occurrence of associated pregnancy co-morbidities as preterm labor and preeclampsia.

Erratum to “Addition of Metanx in Pregabalin Partial Responders for Painful Diabetic Neuropathy”

Objective: To study the effect of addition of Metanx?on burning parasthesias in patients with symptomatic diabetic neuropathy who had obtained only partial symptom resolution with pregabalin. Research design and methods: This was an open-label pilot study. There were 16 patients (7 males, 9 females) in the study group and 8 patients (3 males, 5 females) in the control group. A patient numeric rating scale (0 - 10) of neuropathy associated pain was obtained at?baseline and at 20 weeks. The control group continued on a fixed dosage of pregabalin without additional medication, while the study group was supplemented with Metanx?(a proprietary blend of bioactive B-vitamins), in addition to being continued on a fixed dosage of pregabalin. Results:?After 20 weeks, significantly more patients in the study group experienced pain relief compared to the control group (87.5% vs. 12.5%, respectively, p?=0.005). The average pain score reduction after 20 weeks in the study group was 3 compared to0.25 inthe control group (p < 0.001). Conclusion: Our study suggested that addition of Metanx?may be used for the relief of pain in patients that have obtained only partial resolution of symptomatology from pregabalin.

Addition of Metanx in pregabalin partial responders for painful diabetic neuropathy

Objective: To study the effect of addition of Metanx?on burning parasthesias in patients with symptomatic diabetic neuropathy who had obtained only partial symptom resolution with pregabalin. Research design and methods: This was an open-label pilot study. There were 16 patients (7 males, 9 females) in the study group and 8 patients (3 males, 5 females) in the control group. A patient numeric rating scale (0 - 10) of neuropathy associated pain was obtained at baseline and at 20 weeks. The control group continued on a fixed dosage of pregabalin (Lyrica) without additional medication, while the study group was supplemented with Metanx?(L-methylfolate, methylcobalamin, and pyridoxal 5- phosphate), in addition to being continued on a fixed dosage of pregabalin. Results: After 20 weeks, patients in the study group experienced greater pain relief compared to the control group, (87.5% vs. 25% respectively, p = 0.005). The average pain score reduction after 20 weeks in the study group was 3 compared to0.25 inthe control group (p < 0.001). Conclusion: Our study suggested that addition of Metanx?may be used for the relief of pain in patients that have obtained only partial resolution of symptomatology from pregabalin.

Nutritional and medical food therapies for diabetic retinopathy

Diabetic retinopathy(DR)is a form of microangiopathy.Reducing oxidative stress in the mitochondria and cell membranes decreases ischemic injury and end-organ damage to the retina.New approaches are needed,which reduce the risk and improve the outcomes of DR while complementing current therapeutic approaches.Homocysteine(Hcy)elevation and oxidative stress are potential therapeutic targets in DR.Common genetic polymorphisms such as those of methylenetetrahydrofolate reductase(MTHFR),increase Hcy and DR risk and severity.Patients with DR have high incidences of deficiencies of crucial vitamins,minerals,and related compounds,which also lead to elevation of Hcy and oxidative stress.Addressing the effects of the MTHFR polymorphism and addressing comorbid deficiencies and insufficiencies reduce the impact and severity of the disease.This approach provides safe and simple strategies that support conventional care and improve outcomes.Suboptimal vitamin co-factor availability also impairs the release of neurotrophic and neuroprotective growth factors.Collectively,this accounts for variability in presentation and response of DR to conventional therapy.Fortunately,there are straightforward recommendations for addressing these issues and supporting traditional treatment plans.We have reviewed the literature for nutritional interventions that support conventional therapies to reduce disease risk and severity.Optimal combinations of vitamins B1,B2,B6,L-methylfolate,methylcobalamin(B12),C,D,natural vitamin E complex,lutein,zeaxanthin,alpha-lipoic acid,and n-acetylcysteine are identified for protecting the retina and choroid.Certain medical foods have been successfully used as therapy for retinopathy.Recommendations based on this review and our clinical experience are developed for clinicians to use to support conventional therapy for DR.DR from both type 1 diabetes mellitus(T1DM)and type 2 diabetes mellitus(T2DM)have similar retinal findings and responses to nutritional therapies.

Nutritional and medical food therapies for diabetic retinopathy

Diabetic retinopathy(DR)is a form of microangiopathy.Reducing oxidative stress in the mitochondria and cell membranes decreases ischemic injury and end-organ damage to the retina.New approaches are needed,which reduce the risk and improve the outcomes of DR while complementing current therapeutic approaches.Homocysteine(Hcy)elevation and oxidative stress are potential therapeutic targets in DR.Common genetic polymorphisms such as those of methylenetetrahydrofolate reductase(MTHFR),increase Hcy and DR risk and severity.Patients with DR have high incidences of deficiencies of crucial vitamins,minerals,and related compounds,which also lead to elevation of Hcy and oxidative stress.Addressing the effects of the MTHFR polymorphism and addressing comorbid deficiencies and insufficiencies reduce the impact and severity of the disease.This approach provides safe and simple strategies that support conventional care and improve outcomes.Suboptimal vitamin cofactor availability also impairs the release of neurotrophic and neuroprotective growth factors.Collectively,this accounts for variability in presentation and response of DR to conventional therapy.Fortunately,there are straightforward recommendations for addressing these issues and supporting traditional treatment plans.We have reviewed the literature for nutritional interventions that support conventional therapies to reduce disease risk and severity.Optimal combinations of vitamins B1,B2,B6,L-methylfolate,methylcobalamin(B12),C,D,natural vitamin E complex,lutein,zeaxanthin,alpha-lipoic acid,and n-acetylcysteine are identified for protecting the retina and choroid.Certain medical foods have been successfully used as therapy for retinopathy.Recommendations based on this review and our clinical experience are developed for clinicians to use to support conventional therapy for DR.DR from both type 1 diabetes mellitus(T1DM)and type 2 diabetes mellitus(T2DM)have similar retinal findings and responses to nutritional therapies.