Evidence map›Paper›PMID 22129201›Full record

ArticleAlimentary pharmacology & therapeutics2012

The safety and efficacy of oral docosahexaenoic acid supplementation for the treatment of primary sclerosing cholangitis - a pilot study.

C R Martin, P G Blanco, J C Keach, J L Petz, M M Zaman, K R Bhaskar, J E Cluette-Brown, S Gautam, S Sheth, N H Afdhal and 2 more

Open access · bronzeAbstract read
In one paragraph

Article in Alimentary pharmacology & therapeutics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
1.9field-weighted citation impact, top 14% 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

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 41 citations in OpenAlex.

  1. Pooled it
  2. ACG Clinical Guideline: Primary Sclerosing Cholangitis.The American journal of gastroenterology · 2015
    Guideline
  3. Article
  4. Article
  5. Review
  6. An Overview on Primary Sclerosing Cholangitis.Journal of clinical medicine · 2020
    Review
  7. Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Review
  20. Review
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

12 authors at 2 institutions in 1 country.

C R MartinDepartment of Neonatology, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA.
P G Blanco
J C Keach
J L Petz
M M Zaman
K R Bhaskar
J E Cluette-Brown
S Gautam
S Sheth
N H Afdhal
K D Lindor
S D Freedman
Beth Israel Deaconess Medical Center · USMayo Clinic in Arizona · US

Funding

HARVARD CLINICAL AND TRANSLATIONAL SCIENCE CENTER (UL1)UL1RR025758 · NCRR · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2008 to 2011
$91.4M
NCRR NIH HHS UL1 RR 025758NCRR NIH HHS UL1 RR025758
6 · The paper itself

Abstract

backgroundPrimary sclerosing cholangitis (PSC) is characterised by progressive inflammatory and fibrotic destruction of the biliary ducts. There are no effective medical therapies and presently high dose ursodeoxycholic acid is no longer recommended due to significant adverse events in a recent clinical trial. Cystic fibrosis transmembrane conductance regulator (CFTR) dysfunction is associated with PSC in both children and adults. Since CFTR dysfunction leads to altered fatty acid metabolism, specifically reduced docosahexaenoic acid (DHA), we hypothesised that DHA supplementation might be an effective therapy for patients with PSC.

aimTo determine the safety and efficacy of oral DHA supplementation for the treatment of PSC.

methodsWe conducted a 12 month open-label pilot study to evaluate safety of oral DHA and its effects on serum alkaline phosphatase as a primary outcome measure in 23 patients with PSC. DHA was administered orally at 800 mg twice per day. Secondary outcomes included changes in other liver function tests and fibrosis biomarkers.

resultsA 1.7-fold increase in serum DHA levels was observed with supplementation. The mean alkaline phosphatase level (±S.E.) at baseline was 357.8 ± 37.1 IU compared to 297.1 ± 23.7 IU (P < 0.05) after 12 months of treatment. There were no changes in other liver function tests and fibrosis biomarkers. No adverse events were reported.

conclusionsOral DHA supplementation is associated with an increase in serum DHA levels and a significant decline in alkaline phosphatase levels in patients with PSC. These data support the need for a rigorous trial of DHA therapy in PSC.

Indexed as

Administration, OralAdultAlkaline PhosphataseBile DuctsBiomarkersCholangitis, SclerosingDietary SupplementsDocosahexaenoic AcidsFemaleHumansLiverLiver Function TestsMaleMiddle AgedPilot ProjectsAlkaline PhosphataseBiomarkersDocosahexaenoic Acids

Identifiers

PMID22129201
PMCPMC3715379
OpenAlexW1606531933

What OpenQuestion holds

Textmetadata
LicenceTDM
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.