Evidence map›Paper›PMID 27037091›Full record

Trial reportHealth and quality of life outcomes2016

Relationship between pain relief, reduction in pain-associated sleep interference, and overall impression of improvement in patients with postherpetic neuralgia treated with extended-release gabapentin.

Neel Mehta, Iwona Bucior, Shay Bujanover, Rajiv Shah, Amitabh Gulati

3 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Health and quality of life outcomes, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.6field-weighted citation impact, top 18% 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.

NCT00335933 phase3completednot on this map

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Patients With Postherpetic Neuralgia

TypeinterventionalSponsorDepomedRan2006 to 2007Enrolled378ConditionsNeuralgia, PostherpeticArmsGabapentin extended-release tablets
NCT00636636 phase3completednot on this map

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Patients With Postherpetic Neuralgia

TypeinterventionalSponsorDepomedRan2008 to 2009Enrolled452ConditionsNeuralgia,PostherpeticArmsGabapentin Extended Release tablets, Placebo
NCT01426230 completednot on this map

A Phase 4, Open Label, Study of Safety and Effectiveness of GRALISE™(Gabapentin) Tablets in the Treatment of Patients With Postherpetic Neuralgia in Clinical Practice

TypeobservationalSponsorDepomedRan2011 to 2012Enrolled201ConditionsPost Herpetic Neuralgia
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Gabapentin for chronic neuropathic pain in adults.The Cochrane database of systematic reviews · 2017
    Pooled it
  3. Trial
  4. Review
  5. Sleep as a Therapeutic Target for Pain Management.Current pain and headache reports · 2023
    Review
  6. Article
  7. Gabapentin for the treatment of alcohol use disorder.Expert opinion on investigational drugs · 2018
    Review
  8. Review
  9. Herpes zoster and the search for an effective vaccine.Clinical and experimental immunology · 2017
    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

5 authors at 4 institutions in 1 country.

Neel MehtaWeill Cornell Medical College of Cornell University, New York, NY, USA. nem9015@med.cornell.edu.
Iwona BuciorDepomed, Inc., Newark, CA, USA.
Shay BujanoverDepomed, Inc., Newark, CA, USA.
Rajiv ShahSt. Francis Hospital, Roslyn, NY, USA.
Amitabh GulatiMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Depomed (United States) · USCornell University · USMemorial Sloan Kettering Cancer Center · USSt. Francis Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPostherpetic neuralgia (PHN) interferes with patients' quality of life, and disturbed sleep is a prevalent complaint. Pain-associated sleep interference in turn enhances pain and/or reduces pain tolerance. Therefore, reducing sleep interference by pain, in addition to pain control, may improve patient care. To address this notion, we characterized relationships among changes in pain intensity, sleep interference, and overall impression of improvement in PHN patients treated with gastroretentive gabapentin (G-GR).

methodsPatients with PHN (n = 556) received G-GR 1,800 mg once-daily in two phase 3 and one phase 4 study. Visual Analog Scale (VAS) and Brief Pain Inventory (BPI) were completed at baseline and the end of study. Patients' Global Impression of Change (PGIC) was completed at the end of study. Regression analyses examined relationships between VAS, BPI sleep interference by pain, and PGIC.

resultsAt the end of treatment, 53.7 and 63.2 % of patients reported a ≥ 30 % reduction in VAS and BPI pain-associated sleep interference (BPISI) respectively; 46.3 % reported feeling "Much" or "Very Much" improved on the PGIC. There were positive correlations between the percent reductions in VAS and BPISI; both correlated with PGIC improvements. Percent changes in VAS and BPISI were significant (p < 0.0001 and p = 0.0082, respectively), and were independent predictors of feeling "Much" or "Very Much" improved on the PGIC.

conclusionsReductions in pain intensity and in BPISI were correlated, and both also correlated with overall impression of improvement for patients with PHN treated with G-GR. Both pain relief and improvement BPISI independently predicted improvement in PGIC. For optimal patient care, clinicians should consider reducing the impact of pain on quality of sleep as well as overall pain reduction.

trial registrationClinicalTrials.gov numbers, NCT00335933 , NCT00636636 , NCT01426230.

Indexed as

Quality of LifeAdolescentAdultAgedAged, 80 and overAminesAnalgesicsCyclohexanecarboxylic AcidsDelayed-Action PreparationsFemaleGabapentingamma-Aminobutyric AcidHumansMaleMiddle AgedNeuralgia, PostherpeticAminesAnalgesicsCyclohexanecarboxylic AcidsDelayed-Action PreparationsGabapentingamma-Aminobutyric AcidGabapentinGastroretentiveNeuropathic painPostherpetic neuralgiaQuality of lifeSleep

Identifiers

PMID27037091
PMCPMC4818513
OpenAlexW2312374521

What OpenQuestion holds

Textmetadata
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.