Evidence map›Paper›PMID 23981814›Full record

Trial reportTrials2013

Combination of inositol and alpha lipoic acid in metabolic syndrome-affected women: a randomized placebo-controlled trial.

Immacolata Capasso, Emanuela Esposito, Nicola Maurea, Maurizio Montella, Anna Crispo, Michelino De Laurentiis, Massimiliano D'Aiuto, Giuseppe Frasci, Gerardo Botti, Maria Grimaldi and 6 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04881851 (Effects of Inositol Alone or Associated With Alpha-lipoic Acid in Polycystic Ovary Syndrome Treatment), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 24% 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.

NCT04881851 naterminatednot on this mapstarted 2015, after this paper: background citation

Effects of Inositol Alone or Associated With Alpha-lipoic Acid in Polycystic Ovary Syndrome Treatment

TypeinterventionalSponsorUniversita di VeronaRan2015 to 2025Enrolled76ConditionsPolycystic Ovary SyndromeArmsInositol + alpha lipoic acid, Inositol, Folic acid (placebo comparator)
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. Article
  6. Review
  7. Review
  8. Pharmacokinetics ofInternational journal of molecular sciences · 2022
    Article
  9. Review
  10. Inositols and metabolic disorders: From farm to bedside.Journal of traditional and complementary medicine · 2020
    Review
  11. Review
  12. Potential Protective Effect ofBioMed research international · 2019
    Article
  13. Article
  14. 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

16 authors at 1 institution in 1 country.

Immacolata CapassoDepartment of Senology, National Cancer Institute of Naples - Fondazione G, Pascale, Via Mariano Semmola, Naples 80131, Italy. icapasso@tiscali.it
Emanuela Esposito
Nicola Maurea
Maurizio Montella
Anna Crispo
Michelino De Laurentiis
Massimiliano D'Aiuto
Giuseppe Frasci
Gerardo Botti
Maria Grimaldi
Ernesta Cavalcanti
Giuseppe Esposito
Alfredo Fucito
Giuseppe Brillante
Giuseppe D'Aiuto
Gennaro Ciliberto
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInositol has been reported to improve insulin sensitivity since it works as a second messenger achieving insulin-like effects on metabolic enzymes. The aim of this study was to evaluate the inositol and alpha lipoic acid combination effectiveness on metabolic syndrome features in postmenopausal women at risk of breast cancer.

methodsA six-month prospective, randomized placebo-controlled trial was carried out on a total of 155 postmenopausal women affected by metabolic syndrome at risk of breast cancer, the INOSIDEX trial. All women were asked to follow a low-calorie diet and were assigned randomly to daily consumption of a combination of inositol and alpha lipoic acid (77 pts) or placebo (78 pts) for six months. Primary outcomes we wanted to achieve were both reduction of more than 20% of the HOMA-IR index and of triglycerides serum levels. Secondary outcomes expected were both the improvement of high-density lipoprotein cholesterol levels and the reduction of anthropometric features such as body mass index and waist-hip ratio.

resultsA significant HOMA-IR reduction of more than 20% was evidenced in 66.7% (P <0.0001) of patients, associated with a serum insulin level decrease in 89.3% (P <0.0000). A decrease in triglycerides was evidenced in 43.2% of patients consuming the supplement (P <0.0001). An increase in HDL cholesterol (48.6%) was found in the group consuming inositol with respect to the placebo group. A reduction in waist circumference and waist-hip ratio was found in the treated group with respect to the placebo group.

conclusionsInositol combined with alpha lipoic acid can be used as a dietary supplement in insulin-resistant patients in order to increase their insulin sensitiveness. Daily consumption of inositol combined with alpha lipoic acid has a significant bearing on metabolic syndrome. As metabolic syndrome is considered a modifiable risk factor of breast tumorigenesis, further studies are required to assess whether inositol combined with alpha lipoic acid can be administered as a dietary supplement in breast cancer primary prevention.

trial registrationCurrent Controlled Trial ISRCTN74096908.

Indexed as

Dietary SupplementsAgedBiomarkersBlood GlucoseBody Mass IndexBreast NeoplasmsCaloric RestrictionCholesterol, HDLDrug Therapy, CombinationFemaleHumansInositolInsulinInsulin ResistanceItalyMetabolic SyndromeBiomarkersBlood GlucoseCholesterol, HDLInositolInsulinThioctic AcidTriglycerides

Identifiers

PMID23981814
PMCPMC3765513
OpenAlexW1971301546

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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.