- Drug/Regimen
- γ-Linolenic Acid versus α-Lipoic Acid for Treating Painful
Diabetic Neuropathy in Adults: A 12-Week, Double-Placebo, Randomized, Noninferiority
Trial
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Jong Chul Won, Hyuk-Sang Kwon, Seong-Su Moon, Sung Wan Chun, Chong Hwa Kim, Ie Byung Park, In Joo Kim, Jihyun Lee, Bong Yun Cha, Tae Sun Park
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Diabetes Metab J. 2020;44(4):542-554. Published online November 4, 2019
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DOI: https://doi.org/10.4093/dmj.2019.0099
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Abstract
PDFSupplementary MaterialPubReader ePub
- Background
This study was a multicenter, parallel-group, double-blind, double-dummy, randomized,
noninferiority trial to evaluate the efficacy and safety of γ-linolenic acid
(GLA) relative to α-lipoic acid (ALA) over a 12-week treatment period in type 2
diabetes mellitus (T2DM) patients with painful diabetic peripheral neuropathy (DPN). MethodsThis study included 100 T2DM patients between 20 and 75 years of age who had painful
DPN and received either GLA (320 mg/day) and placebo or ALA (600 mg/day) and placebo for
12 weeks. The primary outcome measures were mean changes in pain intensities as measured
by the visual analogue scale (VAS) and the total symptom scores (TSS). ResultsOf the 100 subjects who initially participated in the study, 73 completed the 12-week
treatment period. Per-protocol analyses revealed significant decreases in the mean VAS
and TSS scores compared to baseline in both groups, but there were no significant
differences between the groups. The treatment difference for the VAS (95% confidence
interval [CI]) between the two groups was −0.65 (−1.526 to 0.213) and the
upper bound of the 95% CI did not exceed the predefined noninferiority margin
(δ1=0.51). For the TSS, the treatment difference was −0.05
(−1.211 to 1.101) but the upper bound of the 95% CI crossed the noninferiority
margin (δ2=0.054). There were no serious adverse events associated
with the treatments. ConclusionGLA treatment in patients with painful DPN was noninferior to ALA in terms of reducing
pain intensity measured by the VAS over 12 weeks.
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Citations
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Yaowei Lv, Xiangyun Yao, Xiao Li, Yuanming Ouyang, Cunyi Fan, Yun Qian Neural Regeneration Research.2024; 19(3): 598. CrossRef - Ranking Alpha Lipoic Acid and Gamma Linolenic Acid in Terms of Efficacy and Safety in the Management of Adults With Diabetic Peripheral Neuropathy: A Systematic Review and Network Meta-analysis
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- Clinical Diabetes & Therapeutics
- Effects of High-Dose α-Lipoic Acid on Heart Rate Variability of Type 2 Diabetes Mellitus Patients with Cardiac Autonomic Neuropathy in Korea
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Sol Jae Lee, Su Jin Jeong, Yu Chang Lee, Yong Hoon Lee, Jung Eun Lee, Chong Hwa Kim, Kyung Wan Min, Bong Yun Cha
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Diabetes Metab J. 2017;41(4):275-283. Published online July 6, 2017
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DOI: https://doi.org/10.4093/dmj.2017.41.4.275
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PDFPubReader
- Background
Diabetic cardiac autonomic neuropathy (CAN) is one of the important complications of diabetes. It is characterized by reduced heart rate variability (HRV). MethodsIn this randomized, double-blind, placebo-controlled, multicenter trial, 75 patients were randomly assigned to one of two groups. One group (n=41) received α-lipoic acid (ALA) at an oral dose of 600 mg/day for the first 12 weeks and then 1,200 mg/day for the next 12 weeks. The other group (n=34) received placebo treatment for 24 weeks. CAN was assessed by measuring HRVs in people with diabetes. ResultsMost of the baseline measures for HRVs were similar between the ALA and placebo groups. Although there were no statistically significant HRV changes in the ALA group compared to the placebo group after 24 weeks of trial, we found a positive tendency in some of the HRV parameters of the ALA group. The standard deviations of normal-to-normal RR intervals in the standing position increased by 1.87 ms in the ALA group but decreased by −3.97 ms in the placebo group (P=0.06). The power spectrum of the low frequency (LF) band in the standing position increased by 15.77 ms2 in the ALA group, whereas it declined by −15.04 ms2 in the placebo group (P=0.08). The high frequency/LF ratio in the upright position increased by 0.35 in the ALA group, whereas it declined by −0.42 in the placebo group (P=0.06). There were no differences between the two groups regarding rates of adverse events. ConclusionAlthough a slight improvement tendency was seen in HRV in the ALA group, there were no statistically significant HRV changes in the ALA group compared to the placebo group after 24 weeks of trial. However, the high oral dose of ALA was well-tolerated.
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Citations
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- Cardiovascular autonomic neuropathy in diabetes: an update with a focus on management
Aikaterini Eleftheriadou, Vincenza Spallone, Abd A. Tahrani, Uazman Alam Diabetologia.2024;[Epub] CrossRef - Effect of Ramipril on Cardiac Autonomic Neuropathy in Patients With Type II Diabetes Mellitus
Chaitali A Chindhalore, Ganesh N Dakhale, Prathamesh H Kamble, Bharatsing D Rathod, Sunita Kumbhalkar, Mrunal S Phatak Cureus.2023;[Epub] CrossRef - Evaluating treatment options for cardiovascular autonomic neuropathy in patients with diabetes mellitus: a systematic review
Jasmine KaiLi Goh, Leroy Koh Diabetology International.2023; 14(3): 224. CrossRef - The effects of alpha lipoic acid (ALA) supplementation on blood pressure in adults: a GRADE-assessed systematic review and dose-response meta-analysis of randomized controlled trials
Mahdi Vajdi, Nooshin Noshadi, Shirin Hassanizadeh, Atefeh Bonyadian, Hooria Seyedhosseini-Ghaheh, Gholamreza Askari Frontiers in Cardiovascular Medicine.2023;[Epub] CrossRef - Combination Therapy of Alpha-Lipoic Acid, Gliclazide and Ramipril Protects Against Development of Diabetic Cardiomyopathy via Inhibition of TGF-β/Smad Pathway
George J. Dugbartey, Quinsker L. Wonje, Karl K. Alornyo, Louis Robertson, Ismaila Adams, Vincent Boima, Samuel D. Mensah Frontiers in Pharmacology.2022;[Epub] CrossRef - Diabetic Gastroenteropathy: Soothe the Symptoms or Unravel a Cure?
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Aliyu Tijani Jibril, Ahmad Jayedi, Sakineh Shab-Bidar Endocrine Connections.2022;[Epub] CrossRef - Cardiac Autonomic Neuropathy in Type 1 and 2 Diabetes: Epidemiology, Pathophysiology, and Management
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Federica Fogacci, Manfredi Rizzo, Christoffer Krogager, Cormac Kennedy, Coralie M.G. Georges, Tamara Knežević, Evangelos Liberopoulos, Alexandre Vallée, Pablo Pérez-Martínez, Eliane F.E. Wenstedt, Agnė Šatrauskienė, Michal Vrablík, Arrigo F.G. Cicero Antioxidants.2020; 9(10): 1011. CrossRef - Update on the Impact, Diagnosis and Management of Cardiovascular Autonomic Neuropathy in Diabetes: What Is Defined, What Is New, and What Is Unmet
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Jeongmin Lee, Jae Hyoung Cho Diabetes & Metabolism Journal.2017; 41(5): 417. CrossRef
- Exercise Treadmill Test in Detecting Asymptomatic Coronary Artery Disease in Type 2 Diabetes Mellitus
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Mee Kyoung Kim, Ki Hyun Baek, Ki Ho Song, Hyuk Sang Kwon, Jung Min Lee, Moo Il Kang, Kun Ho Yoon, Bong Yun Cha, Ho Young Son, Kwang Woo Lee
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Diabetes Metab J. 2011;35(1):34-40. Published online February 28, 2011
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DOI: https://doi.org/10.4093/dmj.2011.35.1.34
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25,798
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44
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16
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Abstract
PDFPubReader
- Background
The present study was designed to develop criteria for screening patients with type 2 diabetes mellitus (T2DM) for asymptomatic coronary artery disease (CAD). MethodsA total of 213 patients with T2DM without typical angina or chest pain were studied between 2002 and 2007. We also evaluated 53 patients with T2DM who had reported chest discomfort using an exercise treadmill test (ETT). ResultsThirty-one of the 213 asymptomatic patients had positive ETT results. We performed coronary angiography on 23 of the 31 patients with a positive ETT and found that 11 of them had significant coronary stenosis. The main differences between the patients with significant stenosis and those with a negative ETT were age (63.1±9.4 vs. 53.7±10.1 years, P=0.008) and duration of diabetes (16.0±7.5 vs. 5.5±5.7 years, P<0.001). The positive predictive value (PPV) of the ETT was calculated to be 47.8%. The PPV of the ETT increased to 87.5% in elderly patients (≥60 years) with a long duration of diabetes (≥10 years). The latter value is similar to that of patients with T2DM who presented with chest discomfort or exertional dyspnea. The PPV of the ETT in symptomatic patients was 76.9%. ConclusionIn the interest of cost-effectiveness, screening for asymptomatic CAD could be limited to elderly patients with a duration of diabetes ≥10 years.
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