PMID- 38205823
OWN - NLM
STAT- MEDLINE
DCOM- 20240112
LR  - 20240426
IS  - 1469-493X (Electronic)
IS  - 1361-6137 (Linking)
VI  - 1
IP  - 1
DP  - 2024 Jan 11
TI  - Alpha-lipoic acid for diabetic peripheral neuropathy.
PG  - CD012967
LID - 10.1002/14651858.CD012967.pub2 [doi]
LID - CD012967
AB  - BACKGROUND: Diabetic peripheral neuropathy (DPN) is a frequent complication in 
      people living with type 1 or type 2 diabetes. There is currently no effective 
      treatment for DPN. Although alpha-lipoic acid (ALA, also known as thioctic acid) 
      is widely used, there is no consensus about its benefits and harms. OBJECTIVES: 
      To assess the effects of alpha-lipoic acid as a disease-modifying agent in people 
      with diabetic peripheral neuropathy. SEARCH METHODS: On 11 September 2022, we 
      searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, 
      Embase, and two clinical trials registers. We also searched the reference lists 
      of the included studies and relevant review articles for additional references 
      not identified by the electronic searches. SELECTION CRITERIA: We included 
      randomised clinical trials (RCTs) that compared ALA with placebo in adults (aged 
      18 years or older) and that applied the study interventions for at least six 
      months. There were no language restrictions. DATA COLLECTION AND ANALYSIS: We 
      used standard methods expected by Cochrane. The primary outcome was change in 
      neuropathy symptoms expressed as changes in the Total Symptom Score (TSS) at six 
      months after randomisation. Secondary outcomes were change in neuropathy symptoms 
      at six to 12 months and at 12 to 24 months, change in impairment, change in any 
      validated quality of life total score, complications of DPN, and adverse events. 
      We assessed the certainty of the evidence using GRADE. MAIN RESULTS: Our analysis 
      incorporated three trials involving 816 participants. Two studies included people 
      with type 1 or type 2 diabetes, while one study included only people with type 2 
      diabetes. The duration of treatment was between six months and 48 months. We 
      judged all studies at high risk of overall bias due to attrition. ALA compared 
      with placebo probably has little or no effect on neuropathy symptoms measured by 
      TSS (lower score is better) after six months (mean difference (MD) -0.16 points, 
      95% confidence interval (CI) -0.83 to 0.51; 1 study, 330 participants; 
      moderate-certainty evidence). The CI of this effect estimate did not contain the 
      minimal clinically important difference (MCID) of 0.97 points. ALA compared with 
      placebo may have little or no effect on impairment measured by the Neuropathy 
      Impairment Score-Lower Limbs (NIS-LL; lower score is better) after six months (MD 
      -1.02 points, 95% CI -2.93 to 0.89; 1 study, 245 participants; low-certainty 
      evidence). However, we cannot rule out a significant benefit, because the lower 
      limit of the CI surpassed the MCID of 2 points. There is probably little or no 
      difference between ALA and placebo in terms of adverse events leading to 
      cessation of treatment within six months (risk ratio (RR) 1.48, 95% CI 0.50 to 
      4.35; 3 studies, 1090 participants; moderate-certainty evidence). No studies 
      reported quality of life or complications associated with DPN. AUTHORS' 
      CONCLUSIONS: Our analysis suggests that ALA probably has little or no effect on 
      neuropathy symptoms or adverse events at six months, and may have little or no 
      effect on impairment at six months. All the studies were at high risk of 
      attrition bias. Therefore, future RCTs should ensure complete follow-up and 
      transparent reporting of any participants missing from the analyses.
CI  - Copyright (c) 2024 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
FAU - Baicus, Cristian
AU  - Baicus C
AD  - Internal Medicine, Colentina University Hospital, Carol Davila University of 
      Medicine and Pharmacy, Bucharest, Romania.
FAU - Purcarea, Adrian
AU  - Purcarea A
AD  - Department of Fundamental, Prophylactic and Clinical Sciences, Faculty of 
      Medicine, Transilvania University, Brasov, Romania.
AD  - Internist.ro Clinic, Brasov, Romania.
FAU - von Elm, Erik
AU  - von Elm E
AD  - Cochrane Switzerland, Center for Primary Care and Public Health (Unisante), 
      University of Lausanne, Lausanne, Switzerland.
FAU - Delcea, Caterina
AU  - Delcea C
AD  - Internal Medicine, Colentina University Hospital, Carol Davila University of 
      Medicine and Pharmacy, Bucharest, Romania.
FAU - Furtunescu, Florentina L
AU  - Furtunescu FL
AD  - Public Health and Management, Carol Davila University of Medicine and Pharmacy, 
      Bucharest, Romania.
LA  - eng
PT  - Journal Article
PT  - Review
PT  - Systematic Review
DEP - 20240111
PL  - England
TA  - Cochrane Database Syst Rev
JT  - The Cochrane database of systematic reviews
JID - 100909747
RN  - 73Y7P0K73Y (Thioctic Acid)
SB  - IM
UOF - doi: 10.1002/14651858.CD012967
MH  - Adult
MH  - Humans
MH  - *Thioctic Acid/adverse effects
MH  - *Diabetic Neuropathies/drug therapy
MH  - *Diabetes Mellitus, Type 2/complications/drug therapy
MH  - Lower Extremity
MH  - MEDLINE
PMC - PMC10782777
COIS- CB: none known.
AP: none known.
EvE: none known.
CD: none known.
FLF: none known.
EDAT- 2024/01/11 12:42
MHDA- 2024/01/12 06:42
PMCR- 2025/01/11
CRDT- 2024/01/11 07:58
PHST- 2025/01/11 00:00 [pmc-release]
PHST- 2024/01/12 06:42 [medline]
PHST- 2024/01/11 12:42 [pubmed]
PHST- 2024/01/11 07:58 [entrez]
AID - CD012967.pub2 [pii]
AID - 10.1002/14651858.CD012967.pub2 [doi]
PST - epublish
SO  - Cochrane Database Syst Rev. 2024 Jan 11;1(1):CD012967. doi: 
      10.1002/14651858.CD012967.pub2.