PMID- 31701699 OWN - NLM STAT- MEDLINE DCOM- 20210908 LR - 20210908 IS - 2233-6087 (Electronic) IS - 2233-6079 (Print) IS - 2233-6079 (Linking) VI - 44 IP - 4 DP - 2020 Aug TI - gamma-Linolenic Acid versus alpha-Lipoic Acid for Treating Painful Diabetic Neuropathy in Adults: A 12-Week, Double-Placebo, Randomized, Noninferiority Trial. PG - 542-554 LID - 10.4093/dmj.2019.0099 [doi] AB - BACKGROUND: This study was a multicenter, parallel-group, double-blind, double-dummy, randomized, noninferiority trial to evaluate the efficacy and safety of gamma-linolenic acid (GLA) relative to alpha-lipoic acid (ALA) over a 12-week treatment period in type 2 diabetes mellitus (T2DM) patients with painful diabetic peripheral neuropathy (DPN). METHODS: This 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). RESULTS: Of 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 (delta(1)=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 (delta(2)=0.054). There were no serious adverse events associated with the treatments. CONCLUSION: GLA treatment in patients with painful DPN was noninferior to ALA in terms of reducing pain intensity measured by the VAS over 12 weeks. CI - Copyright (c) 2020 Korean Diabetes Association. FAU - Won, Jong Chul AU - Won JC AUID- ORCID: 0000-0002-2219-4083 AD - Division of Endocrinology and Metabolism, Department of Internal Medicine, Cardiovascular and Metabolic Disease Center, Inje University Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea. FAU - Kwon, Hyuk Sang AU - Kwon HS AD - Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea. FAU - Moon, Seong Su AU - Moon SS AD - Department of Internal Medicine, Dongguk University College of Medicine, Gyeongju, Korea. FAU - Chun, Sung Wan AU - Chun SW AD - Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, Korea. FAU - Kim, Chong Hwa AU - Kim CH AD - Division of Endocrinology and Metabolism, Department of Internal Medicine, Sejong General Hospital, Bucheon, Korea. FAU - Park, Ie Byung AU - Park IB AD - Division of Endocrinology and Metabolism, Department of Internal Medicien, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, Korea. FAU - Kim, In Joo AU - Kim IJ AD - Division of Endocrinology and Metabolism, Department of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea. FAU - Lee, Jihyun AU - Lee J AD - Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, Korea. FAU - Cha, Bong Yun AU - Cha BY AD - Division of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea. FAU - Park, Tae Sun AU - Park TS AUID- ORCID: 0000-0001-7216-8468 AD - Division of Endocrinology and Metabolism, Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Korea. pts@jbnu.ac.kr. LA - eng GR - Dalin Biotech Korea Co. Ltd/International PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20191104 PL - Korea (South) TA - Diabetes Metab J JT - Diabetes & metabolism journal JID - 101556588 RN - 73Y7P0K73Y (Thioctic Acid) RN - 78YC2MAX4O (gamma-Linolenic Acid) SB - IM MH - Aged MH - Diabetes Mellitus, Type 2 MH - *Diabetic Neuropathies/drug therapy MH - Female MH - Humans MH - Male MH - Middle Aged MH - Pain Measurement MH - Thioctic Acid/*therapeutic use MH - gamma-Linolenic Acid/*therapeutic use PMC - PMC7453980 OTO - NOTNLM OT - Diabetic neuropathies OT - Gamma-linolenic acid OT - Thioctic acid COIS- This study was supported by a grant from Dalin Biotech Korea Co. Ltd. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. EDAT- 2019/11/09 06:00 MHDA- 2021/09/09 06:00 PMCR- 2020/08/01 CRDT- 2019/11/09 06:00 PHST- 2019/05/22 00:00 [received] PHST- 2019/08/13 00:00 [accepted] PHST- 2019/11/09 06:00 [pubmed] PHST- 2021/09/09 06:00 [medline] PHST- 2019/11/09 06:00 [entrez] PHST- 2020/08/01 00:00 [pmc-release] AID - 43.e60 [pii] AID - 10.4093/dmj.2019.0099 [doi] PST - ppublish SO - Diabetes Metab J. 2020 Aug;44(4):542-554. doi: 10.4093/dmj.2019.0099. Epub 2019 Nov 4.