scholarly journals Efficacy and Safety of the Combination of Superoxide Dismutase, Alpha Lipoic Acid, Vitamin B12, and Carnitine for 12 Months in Patients with Diabetic Neuropathy

Nutrients ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 3254
Author(s):  
Triantafyllos Didangelos ◽  
Eleni Karlafti ◽  
Evangelia Kotzakioulafi ◽  
Zisis Kontoninas ◽  
Charalampos Margaritidis ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Superoxide Dismutase ◽  
Diabetic Neuropathy ◽  
Vitamin B12 ◽  
Lipoic Acid ◽  
Controlled Study ◽  
Alpha Lipoic Acid ◽  
Double Blind ◽  
Perception Threshold

Aim: To investigate the efficacy of Superoxide Dismutase, Alpha Lipoic Acid, Acetyl L-Carnitine, and Vitamin B12 (B12) in one tablet in Diabetic Neuropathy (DN). Patients–methods: In this prospective, double-blind, placebo-controlled study, 85 patients with Diabetes Mellitus Type 2 (DMT2) were randomly assigned, either to receive the combination of four elements (active group, n = 43), or placebo (n = 42) for 12 months. We used the Michigan Neuropathy Screening Instrument Questionnaire and Examination (MNSIQ and MNSIE), measured the vibration perception threshold (BIO), and Cardiovascular Autonomic Reflex Tests (CARTs). Nerve function was assessed by DPN Check [sural nerve conduction velocity (SNCV) and amplitude (SNAP)]. Pain (PS) and quality of life (QL) questionnaires were administered. Results: At follow-up, BIO, MNSIQ, QL, PAIN, and SNCV, SNAP, and B12 levels had significantly improved inactive group (p < 0.001, p < 0.001, p < 0.001, p < 0.001, p = 0.027, p = 0.031, and p < 0.001 respectively), whereas the inplacebo group MCR (mean circular resultant) and PAIN deteriorated (p < 0.001, p < 0.001). The changes in MNSIQ, QL, SNCV, BIO, and PAIN differed significantly between groups (p < 0.001, p < 0.001, p = 0.031, p < 0.001, and p < 0.001 respectively). Conclusions: The combination of the four elements in one tablet for 12 months in patients with DMT2 improved all indices of peripheral neuropathy, including SNAP and SNCV, pain, and Quality of Life perception, except CARTs and MNSIE.

scholarly journals The effects of the physical procedures in patients with diabetic neuropathy

2019 ◽  
Vol 76 (8) ◽  
pp. 787-794
Author(s):  
Vesna Grbovic ◽  
Srdjan Stefanovic ◽  
Svetlana Djukic ◽  
Jasmin Nurkovic ◽  
Natasa Zdravkovic-Petrovic ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Therapy ◽  
Diabetic Neuropathy ◽  
Lipoic Acid ◽  
Pain Reduction ◽  
Life Questionnaire ◽  
Alpha Lipoic Acid ◽  
Group A ◽  
Group B

Background/Aim. Neuropathy represents the most frequent complication in the patients with diabetes mellitus (DM). Symmetric distal sensorimotor polyneuropathy (DSP), which represents the most frequent type of diabetic neuropathy, is present in 30% of hospitalized diabetic patients. The aim of our study was to compare the effects of physical therapy (PT) and alpha-lipoic acid (ALA) supplementation on pain reduction and quality of life improvement in the DSP patients. Methods. The study was performed on 60 adult patients with DM type 2 and DSP. The patients were randomly divided into 2 groups: group A (n = 30) was treated by PT and group B (n = 30) was treated by ALA. The study lasted 6 months during which 3 diagnostictherapeutic cycles were performed. To asses their pain before and after every of 3 cycles, we used visual analog scale (VAS). We also evaluated quality of life before the 1st and after the 3rd cycle with the European Quality of Life Questionnaire (EQ-5D-3L). To analyze results between groups we used mixed between-within subjects ANOVA and statistical significance was set on p < 0.05. Results. Pain intensity showed statistically significant influence of both PT and ALA (? = 0.028; p < 0.001). A statistically significant difference between the effects of those two therapy modalities was observed (F = 4.78; p < 0.05): PT reduced pain to the greater extent than ALA. A statistically significant improvement was found in the domain of pain/discomfort both in the group A (? = 0.54, p < 0.001) and group B (? = 0.57, p < 0.001), as well as anxiety/depression (group A: ? = 0.32, p = 0.008; group B: ? = 0.22, p < 0.019) and EQ-VAS (both groups, p < 0.05). Conclusion. Our research showed that physical therapy had a greater influence in pain reduction than alpha-lipoic acid in the patients with DSP.

Oral Alpha Lipoic Acid Treatment for Symptomatic Diabetic Peripheral Neuropathy: A Randomized Double-Blinded Placebo-Controlled Study

2020 ◽  
Vol 20 (9) ◽  
pp. 1531-1534 ◽  
Author(s):  
Mamdouh R. El-Nahas ◽  
Ghada Elkannishy ◽  
Hala Abdelhafez ◽  
Enas T. Elkhamisy ◽  
Amr A. El-Sehrawy
Keyword(s):  
Peripheral Neuropathy ◽  
Lipoic Acid ◽  
Diabetic Peripheral Neuropathy ◽  
Study Groups ◽  
Controlled Study ◽  
Alpha Lipoic Acid ◽  
Disability Score ◽  
Perception Threshold ◽  
Outcome Parameters ◽  
Double Blinded

Background: Alpha-lipoic acid (ALA) was used in the treatment of diabetic peripheral neuropathy (DPN) using different routes, doses and treatment durations. The aim of this work is to assess the efficacy of oral 600mg ALA twice daily over 6 months in the treatment of patients with DPN. Methods: This is a prospective, single-center, double-blinded, placebo-controlled study conducted at the outpatient clinic of Mansoura Specialized Hospital, Mansoura University. A total of 200 patients with DPN were randomly assigned to add on treatment with either oral 600mg twice daily ALA (n=100) or placebo (n=100) for 6 months. Treatment outcome was assessed using vibration perception threshold (VPT), neurological symptom score (NSS), neurological disability score (NDS), and visual analog scale (VAS) for pain at baseline and at each visit (1, 3 and 6 months) after the start of treatment. Results: Comparison between the study groups regarding the baseline data revealed no statistically significant differences. with respect to the outcome parameters, no significant differences were found between the studied groups at baseline. However, in subsequent visits, ALA-treated patients had significantly better results regarding almost all the outcome parameters (NSS, NDS, VAS, VPT). Mild nausea was reported in 6 patients. None of the studied patients discontinued treatment. Conclusions: Oral 600mg ALA twice-daily treatment for DPN over 6 months is effective, safe and tolerable.

ISA247: Quality of Life Results from a Phase II, Randomized, Placebo-Controlled Study

2008 ◽  
Vol 12 (6) ◽  
pp. 268-275 ◽  
Author(s):  
Aditya K. Gupta ◽  
Richard G. Langley ◽  
Charles Lynde ◽  
Kirk Barber ◽  
Wayne Gulliver ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Phase Ii ◽  
Life Quality ◽  
Skin Condition ◽  
Controlled Study ◽  
Double Blind ◽  
Plaque Type ◽  
Psoriasis Disability Index ◽  
Stable Plaque

Background: Psoriasis is a chronic skin condition that can negatively affect a patient's quality of life (QoL), often hindering social functioning. ISA247, a novel psoriatic agent, has shown clinical efficacy in moderate to severe psoriasis sufferers, but its effect on QoL is currently not reported. Objective: The objective of this study was to assess the effect of ISA247 on the QoL in patients with stable, plaque-type psoriasis. Methods: A phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter study assessed the effects of ISA247 doses of 0.5 mg/kg/d ( n = 77) or 1.5 mg/kg/d ( n = 83) compared with placebo ( n = 41) for 12 weeks. QoL was assessed using the Dermatology Life Quality Index (DLQI) and Psoriasis Disability Index (PDI) scales. Results: ISA247 treatment (pooled groups) significantly improved QoL scores as assessed by both the DLQI and the PDI compared with those receiving placebo ( p < .05). Treatment with the higher dose of 1.5 mg/kg/d demonstrated a significantly greater response to many of the QoL scales compared with the 0.5 mg/kg/d group ( p < .05). Conclusions: ISA247 appears to improve the QoL while also providing effective treatment for chronic, moderate to severe, plaque-type psoriasis.

scholarly journals Efficacy of Lactobacillus paracasei HA-196 and Bifidobacterium longum R0175 in Alleviating Symptoms of Irritable Bowel Syndrome (IBS): A Randomized, Placebo-Controlled Study

Nutrients ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 1159 ◽  
Author(s):  
Erin D. Lewis ◽  
Joseph M. Antony ◽  
David C. Crowley ◽  
Amanda Piano ◽  
Renu Bhardwaj ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Irritable Bowel Syndrome ◽  
Bifidobacterium Longum ◽  
Well Being ◽  
Lactobacillus Paracasei ◽  
Controlled Study ◽  
Double Blind ◽  
Gi Symptoms ◽  
Irritable Bowel

Specific probiotic strains can alleviate the gastrointestinal (GI) symptoms and psychiatric comorbidities of irritable bowel syndrome (IBS). In this randomized, double-blind, placebo-controlled study, the efficacy of Lactobacillus paracasei HA-196 (L. paracasei) and Bifidobacterium longum R0175 (B. longum) in reducing the GI and psychological symptoms of IBS was evaluated in 251 adults with either constipation (IBS-C), diarrhea (IBS-D), or mixed-pattern (IBS-M). Following a 2-week run-in period, participants were randomized to one of three interventions: L. paracasei (n = 84), B. longum (n = 83) or placebo (n = 81). IBS symptoms, stool frequency and consistency and quality of life were assessed by questionnaires. The differences from baseline in the severity of IBS symptoms at 4 and 8 weeks were similar between groups. Participants in this study were classified, after randomization, into subtypes according to Rome III. Within the L. paracasei group, complete spontaneous and spontaneous bowel movement frequency increased in participants with IBS-C (n = 10) after 8 weeks of supplementation (both p < 0.05) and decreased in participants with IBS-D (n = 10, p = 0.013). Both L. paracasei and B. longum supplementation improved the quality of life in emotional well-being and social functioning compared with baseline (all p < 0.05). In conclusion, L. paracasei and B. longum may reduce GI symptom severity and improve the psychological well-being of individuals with certain IBS subtypes.

scholarly journals Evaluation of efficacy and safety of montelukast and levocetirizine FDC tablet compared to montelukast and levocetirizine tablet in patients with seasonal allergic rhinitis: a randomized, double blind, multicentre, phase III trial

2020 ◽  
Vol 7 (1) ◽  
pp. 83
Author(s):  
Sagar Panchal ◽  
Saiprasad Patil ◽  
Hanmant Barkate
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Seasonal Allergic Rhinitis ◽  
Phase Iii ◽  
Fixed Dose ◽  
Controlled Study ◽  
Global Evaluation ◽  
Double Blind ◽  
Nasal Symptoms

<p class="abstract"><strong>Background:</strong> To evaluate efficacy, safety and tolerability of Montelukast 10 mg+levocetirizine 5 mg  FDC compared to either montelukast 10 mg or levocetirizine 5 mg given alone in seasonal allergic rhinitis (SAR) patients.</p><p class="abstract"><strong>Methods:</strong> Phase III, multicentre, randomized, double blind, parallel group, active controlled study was conducted in 279 SAR patients at 16 sites across India. Efficacy was assessed using daytime nasal symptoms score (Primary efficacy outcome), night-time symptoms score, daytime eye symptom score, patient's global evaluation, physician's global evaluation, rhino-conjunctivitis quality-of-life score.  </p><p class="abstract"><strong>Results:</strong> At end of treatment there was statistically significant evidence from the per protocol analysis that patients on FDC had a greater improvement in change from baseline in daytime nasal symptoms score than patients who received Montelukast (p=0.0266) or Levocetirizine (p=0.0409). These results were consistent with the Intent to treat analysis. Analysis of the secondary efficacy endpoints provided numerically greater improvement in the nighttime symptoms score, daytime eye symptoms score, and rhinoconjunctivitis quality-of-life scores in the FDC group as compared to the Montelukast group or Levocetirizine group. The FDC of Montelukast and Levocetirizine was found to be safe and generally well tolerated. The majority of adverse events were mild in severity, resolved without treatment and were unrelated to study medication.</p><p class="abstract"><strong>Conclusions:</strong> Fixed dose combination of Montelukast and Levocetirizine was safe, generally well tolerated and superior on efficacy compared to Montelukast or Levocetirizine in patients of seasonal allergic rhinitis.</p>

Daflon 500 mg: Symptoms and Edema

Angiology ◽  
2005 ◽  
Vol 56 (6_suppl) ◽  
pp. S25-S32 ◽  
Author(s):  
Albert-Adrien Ramelet
Keyword(s):  
Quality Of Life ◽  
Controlled Study ◽  
Venous Disease ◽  
Double Blind Study ◽  
Life Questionnaire ◽  
Double Blind ◽  
Randomized Controlled ◽  
Randomized Controlled Studies ◽  
Significant Difference

Patients suffering from any class of the Clinical, Etiological, Anatomical, Pathophysiological (CEAP) classification of chronic venous disease (CVD) may be symptomatic (C0s-C6s). Leg heaviness, discomfort, itching, cramps, pain, paresthesia, and edema (C3) are the most frequent manifestations of CVD and a major reason for medical consultation. Daflon 500 mg (micronized purified flavonoid fraction [MPFF]) is an effective treatment for symptoms and edema in CVD as demonstrated in several randomized controlled studies. A 2-month, double-blind study in 40 patients established the superiority of Daflon 500 mg over placebo with regard to symptoms and objective signs. This was confirmed in another double-blind, placebo-controlled trial (2 months’ treatment, 160 patients), and in the Reflux assEssment and quaLity of lIfe improvEment with micronized Flavonoids (RELIEF) study. The latter included 5,052 patients in 23 countries, using a visual analog scale for evaluating pain, leg heaviness, cramps, and a sensation of swelling. All symptoms showed significant and progressive improvement. The quality-of-life results (scores on the ChronIc Venous Insufficiency quality of life Questionnaire [CIVIQ]) paralleled those of symptoms. The decrease in the ankle and calf circumferences was significantly greater (p<0.001) in the group of patients treated with Daflon 500 mg in two studies, and correlated well with the improvement in the sensation of swelling (p<0.001). This was confirmed with more sophisticated measurement techniques as in the RELIEF study or in a trial assessing edema with an optoelectronic volumeter in 20 patients. A further double-blind, randomized, controlled study established a statistically significant difference in favor of Daflon 500 mg in comparison with diosmin, both on symptoms and edema. The therapeutic efficacy of Daflon 500 mg on CVD symptoms and edema has been demonstrated in double-blind, randomized, controlled studies. Further studies using a new approach may define the most precise and validated methodology for application in future research in phlebology.

Sign in / Sign up

Export Citation Format

Share Document