Evidence map›Paper›PMID 28986667›Full record

Trial reportDigestive diseases and sciences2017

Prolonged-Release Oxycodone/Naloxone Improves Anal Sphincter Relaxation Compared to Oxycodone Plus Macrogol 3350.

Jakob Lykke Poulsen, Christina Brock, Debbie Grønlund, Donghua Liao, Hans Gregersen, Klaus Krogh, Asbjørn Mohr Drewes

Abstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Digestive diseases and sciences, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.1field-weighted citation impact, top 21% 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

8 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Article
  6. Naldemedine: A New Option for OIBD.Journal of pain research · 2020
    Review
  7. Review
  8. 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

7 authors at 5 institutions in 2 countries.

Jakob Lykke PoulsenMech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Mølleparkvej 4, 9000, Aalborg, Denmark.
Christina BrockMech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Mølleparkvej 4, 9000, Aalborg, Denmark.
Debbie GrønlundMech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Mølleparkvej 4, 9000, Aalborg, Denmark.
Donghua LiaoGIOME Academia, Department of Clinical Medicine, Aarhus University, Nordre Ringgade 1, 8000, Aarhus, Denmark.
Hans GregersenGIOME, Department of Surgery, Prince of Wales Hospital, Chinese University of Hong Kong, Shatin, Hong Kong.
Klaus KroghNeurogastroenterology Unit, Department of Hepatology and Gastroenterology, Aarhus University Hospital, Nørrebrogade 44, 8000, Aarhus, Denmark.
Asbjørn Mohr DrewesMech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Mølleparkvej 4, 9000, Aalborg, Denmark. amd@rn.dk.
Aalborg University Hospital · DKAarhus University · DKAarhus University Hospital · DKPrince of Wales Hospital · CNUniversity of Copenhagen · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOpioid analgesics inhibit anal sphincter function and contribute to opioid-induced bowel dysfunction (OIBD). However, it is unknown whether the inhibition can be reduced by opioid antagonism with prolonged-release (PR) naloxone and how this compares to laxative treatment.

aimsTo compare the effects of combined PR oxycodone/naloxone or PR oxycodone plus macrogol 3350 on anal sphincter function and gastrointestinal symptoms.

methodsA randomized, double-blind, crossover trial was conducted in 20 healthy men. Participants were treated for 5 days with combined PR oxycodone/naloxone or PR oxycodone plus macrogol 3350. Resting anal pressure, anal canal distensibility, and relaxation of the internal sphincter to rectal distension were evaluated before treatment (baseline) and on day 5. The Patient Assessment of Constipation Symptom (PAC-SYM) questionnaire, stool frequency, and stool consistency were assessed daily.

resultsBoth PR oxycodone/naloxone and PR oxycodone plus macrogol treatment decreased sphincter relaxation compared to baseline (- 27.5%; P < 0.001 and - 14.7%; P = 0.01). However, sphincter relaxation was increased after PR naloxone/oxycodone treatment compared to macrogol (difference = + 17.6%; P < 0.001). Resting anal pressure and anal canal distensibility did not differ between treatments. PAC-SYM abdominal symptoms score was lower during PR naloxone compared to macrogol (0.2 vs. 3.2; P = 0.002). The number of bowel movements was lower during PR naloxone versus macrogol (4.2 vs. 5.4; P = 0.035).

conclusionRelaxation of the internal anal sphincter was significantly better after PR oxycodone/naloxone treatment compared to PR oxycodone plus macrogol 3350. These findings highlight that OIBD may require specific therapy against the complex, pan-intestinal effects of opioids.

Indexed as

AdolescentAdultAnal CanalAnalgesics, OpioidConstipationCross-Over StudiesDefecationDelayed-Action PreparationsDenmarkDouble-Blind MethodDrug CombinationsHealthy VolunteersHumansMaleMuscle RelaxationNaloxoneAnalgesics, OpioidDelayed-Action PreparationsDrug CombinationsNaloxoneNarcotic AntagonistsOxycodoneoxycodone naloxone combinationpolyethylene glycol 3350Polyethylene GlycolsAnal sphincterConstipationOpioids: adverse effectsRectoanal inhibitory reflex

Identifiers

PMID28986667
OpenAlexW2764073884

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.