Evidence map›Paper›PMID 38320260›Full record

Trial reportDiabetes2024

Acetyllevocarnitine Hydrochloride for the Treatment of Diabetic Peripheral Neuropathy: A Phase 3 Randomized Clinical Trial in China.

Lixin Guo, Qi Pan, Zhifeng Cheng, Zhiyong Li, Hongwei Jiang, Fang Zhang, Yufeng Li, Wei Qiu, Song Lu, Junhang Tian and 3 more

Open access · bronzeAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in Diabetes, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
3.6field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Review
  7. Diabetic neuropathy: cutting-edge research and future directions.Signal transduction and targeted therapy · 2025
    Review
  8. Article
  9. Article
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 10 institutions in 1 country.

Lixin GuoDepartment of Endocrinology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China.ORCID 0009-0000-5947-8293
Qi PanDepartment of Endocrinology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China.
Zhifeng ChengDepartment of Endocrinology, Fourth Hospital of Harbin Medical University, Harbin, China.
Zhiyong LiDepartment of Endocrinology, Yongchuan Hospital of Chongqing Medical University, Chongqing, China.
Hongwei JiangDepartment of Endocrinology, First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China.
Fang ZhangDepartment of Endocrinology, Kaifeng Hospital of Traditional Chinese Medicine, Kaifeng, China.
Yufeng LiDepartment of Endocrinology, Beijing Pinggu Hospital, Beijing, China.
Wei QiuDepartment of Endocrinology, Xinxiang First People's Hospital, Affiliated People's Hospital of Xinxiang Medical University, Xinxiang, China.
Song LuDepartment of Endocrinology, Chongqing General Hospital, Chongqing, China.
Junhang TianDepartment of Endocrinology, Luoyang Third People's Hospital, Luoyang, China.
Yanqin FuDepartment of Endocrinology, Second Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Fangqiong LiHaisco Pharmaceutical Group Co., Ltd., Chengdu, China.
Danqing LiHaisco Pharmaceutical Group Co., Ltd., Chengdu, China.
Chinese Academy of Medical Sciences & Peking Union Medical College · CNBeijing Anding Hospital · CNChongqing Medical University · CNFirst Affiliated Hospital of Henan University of Science and Technology · CNFirst People's Hospital of Chongqing · CNHarbin Medical University · CNKaifeng University · CNSecond Affiliated Hospital of Zhengzhou University · CNThird People 's Hospital of Liaoyang · CNXinxiang Medical University · CN

Funding

Haisco Pharmaceutical Group Co., Ltd.
6 · The paper itself

Abstract

Diabetic peripheral neuropathy (DPN) is a highly prevalent chronic complication in type 2 diabetes (T2D) for which no effective treatment is available. In this multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial in China, patients with T2D with DPN received acetyllevocarnitine hydrochloride (ALC; 1,500 mg/day; n = 231) or placebo (n = 227) for 24 weeks, during which antidiabetic therapy was maintained. A significantly greater reduction in modified Toronto clinical neuropathy score (mTCNS) as the primary end point occurred in the ALC group (-6.9 ± 5.3 points) compared with the placebo group (-4.7 ± 5.2 points; P < 0.001). Effect sizes (ALC 1.31 and placebo 0.85) represented a 0.65-fold improvement in ALC treatment efficacy. The mTCNS values for pain did not differ significantly between the two groups (P = 0.066), whereas the remaining 10 components of mTCNS showed significant improvement in the ALC group compared with the placebo group (P < 0.05 for all). Overall results of electrophysiological measurements were inconclusive, with significant improvement in individual measurements limited primarily to the ulnar and median nerves. Incidence of treatment-emergent adverse events was 51.2% in the ALC group, among which urinary tract infection (5.9%) and hyperlipidemia (7.9%) were most frequent. ARTICLE HIGHLIGHTS:

Indexed as

Diabetes Mellitus, Type 2Diabetic NeuropathiesChinaDouble-Blind MethodHumansPainTreatment Outcome

Identifiers

PMID38320260
PMCPMC11043058
OpenAlexW4391558646

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.