Evidence map›Paper›PMID 20602781›Full record

SynthesisBMC musculoskeletal disorders2010

Pregabalin in fibromyalgia--responder analysis from individual patient data.

Sebastian Straube, Sheena Derry, R Andrew Moore, Jocelyn Paine, Henry J McQuay

Open access · goldAbstract readMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in BMC musculoskeletal disorders, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 60 papers, 44 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 44 pooled it
5.6field-weighted citation impact, top 3% 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

60 citing papers in PubMed, 44 syntheses or guidelines pooled it, 126 citations in OpenAlex.

  1. Topical clonidine for neuropathic pain in adults.The Cochrane database of systematic reviews · 2022
    Pooled it
  2. Mirtazapine for fibromyalgia in adults.The Cochrane database of systematic reviews · 2018
    Pooled it
  3. Cannabis-based medicines for chronic neuropathic pain in adults.The Cochrane database of systematic reviews · 2018
    Pooled it
  4. Acupuncture for neuropathic pain in adults.The Cochrane database of systematic reviews · 2017
    Pooled it
  5. Pooled it
  6. Antiepileptic drugs for chronic non-cancer pain in children and adolescents.The Cochrane database of systematic reviews · 2017
    Pooled it
  7. Antidepressants for chronic non-cancer pain in children and adolescents.The Cochrane database of systematic reviews · 2017
    Pooled it
  8. Pooled it
  9. Pooled it
  10. Opioids for chronic non-cancer pain in children and adolescents.The Cochrane database of systematic reviews · 2017
    Pooled it
  11. Pooled it
  12. Opioids for cancer-related pain in children and adolescents.The Cochrane database of systematic reviews · 2017
    Pooled it
  13. Tramadol for neuropathic pain in adults.The Cochrane database of systematic reviews · 2017
    Pooled it
  14. Morphine for chronic neuropathic pain in adults.The Cochrane database of systematic reviews · 2017
    Pooled it
  15. Methadone for neuropathic pain in adults.The Cochrane database of systematic reviews · 2017
    Pooled it
  16. Oral nonsteroidal anti-inflammatory drugs for fibromyalgia in adults.The Cochrane database of systematic reviews · 2017
    Pooled it
  17. Gabapentin for fibromyalgia pain in adults.The Cochrane database of systematic reviews · 2017
    Pooled it
  18. Pooled it
  19. Fentanyl for neuropathic pain in adults.The Cochrane database of systematic reviews · 2016
    Pooled it
  20. Cannabinoids for fibromyalgia.The Cochrane database of systematic reviews · 2016
    Pooled it
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 3 institutions in 2 countries.

Sebastian StraubeDepartment of Occupational and Social Medicine, University of Göttingen, Waldweg 37 B, D-37073 Göttingen, Germany.
Sheena Derry
R Andrew Moore
Jocelyn Paine
Henry J McQuay
John Radcliffe Hospital · GBUniversity of Göttingen · DEUniversity of Oxford · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPopulation mean changes are difficult to use in clinical practice. Responder analysis may be better, but needs validating for level of response and treatment duration. A consensus group has defined what constitutes minimal, moderate, and substantial benefit based on pain intensity and Patient Global Impression of Change scores.

methodsWe obtained individual patient data from four randomised double blind trials of pregabalin in fibromyalgia lasting eight to 14 weeks. We calculated response for all efficacy outcomes using any improvement (>or= 0%), minimal improvement (>or= 15%), moderate improvement (>or= 30%), substantial improvement (>or= 50%), and extensive improvement (>or= 70%), with numbers needed to treat (NNT) for pregabalin 300 mg, 450 mg, and 600 mg daily compared with placebo.

resultsInformation from 2,757 patients was available. Pain intensity and sleep interference showed reductions with increasing level of response, a significant difference between pregabalin and placebo, and a trend towards lower (better) NNTs at higher doses. Maximum response rates occurred at 4-6 weeks for higher levels of response, and were constant thereafter. NNTs (with 95% confidence intervals) for >or= 50% improvement in pain intensity compared with placebo after 12 weeks were 22 (11 to 870) for pregabalin 300 mg, 16 (9.3 to 59) for pregabalin 450 mg, and 13 (8.1 to 31) for pregabalin 600 mg daily. NNTs for >or= 50% improvement in sleep interference compared with placebo after 12 weeks were 13 (8.2 to 30) for pregabalin 300 mg, 8.4 (6.0 to 14) for pregabalin 450 mg, and 8.4 (6.1 to 14) for pregabalin 600 mg. Other outcomes had fewer respondents at higher response levels, but generally did not discriminate between pregabalin and placebo, or show any dose response. Shorter duration and use of 'any improvement' over-estimated treatment effect compared with longer duration and higher levels of response.

conclusionsResponder analysis is useful in fibromyalgia, particularly for pain and sleep outcomes. Some fibromyalgia patients treated with pregabalin experience a moderate or substantial pain response that is consistent over time. Short trials using 'any improvement' as an outcome overestimate treatment effects.

Indexed as

AdolescentAdultAged, 80 and overAnalgesicsClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicDose-Response Relationship, DrugFemaleFibromyalgiagamma-Aminobutyric AcidHumansMaleMiddle AgedMulticenter Studies as TopicOutcome Assessment, Health CarePain MeasurementAnalgesicsgamma-Aminobutyric AcidPregabalin

Identifiers

PMID20602781
PMCPMC2906437
OpenAlexW2070284980

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.