Evidence map›Paper›PMID 34792789›Full record

ArticlePain and therapy2022

Comparative Benefit-Risk Assessment for Lidocaine 700 mg Medicated Plaster and Pregabalin in Peripheral Neuropathic Pain Following a Structured Framework Approach.

Ingo Sabatschus, Irmgard Bösl, Marlou Prevoo, Mariëlle Eerdekens, Arne Sprünken, Oliver Galm, Michael Forstner

Open access · goldAbstract read
In one paragraph

Article in Pain and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 36% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Update on Musculoskeletal Pain Management.Revista brasileira de ortopedia · 2024
    Article
  3. Article
  4. 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 2 institutions in 1 country.

Ingo SabatschusGrünenthal GmbH, 52099, Aachen, Germany. ingo.sabatschus@grunenthal.com.ORCID http://orcid.org/0000-0002-5317-7171
Irmgard BöslGrünenthal GmbH, 52099, Aachen, Germany.
Marlou PrevooGrünenthal GmbH, 52099, Aachen, Germany.
Mariëlle EerdekensGrünenthal GmbH, 52099, Aachen, Germany.
Arne SprünkenGrünenthal GmbH, 52099, Aachen, Germany.
Oliver GalmGrünenthal GmbH, 52099, Aachen, Germany.
Michael ForstnerMesama-Consulting, Bärschwil, Switzerland.
Grünenthal Group (Germany) · DEGrünenthal Group (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPeripheral neuropathic pain (PNP) is difficult to treat. Several oral drugs are recommended as first-line treatments. Nevertheless, many patients cannot obtain sufficient pain relief or do not tolerate systemically active treatments. Topical treatments, with a lower risk of systemic side effects such as lidocaine 700 mg medicated plaster, are also recommended in treatment guidelines. This analysis compares the benefit-risk balance of topical 700 mg lidocaine medicated plaster with the benefit-risk balance of oral pregabalin administration for the treatment of PNP following current recommendations on benefit-risk assessment (BRA) methodology.

methodsThe Benefit-Risk Action Team (BRAT) framework was used as structured approach. Selection of key benefits and risks was supported by a patient survey. Published randomized controlled clinical trials were the main source to identify data related to key benefits and risks. The outcome of randomized clinical trials was compared with real-world evidence (RWE) data for consistency.

resultsIdentified key benefits were pain reduction and improvement in quality of life. Key risks identified were application site reactions, dizziness, confusion, weight gain, peripheral edema, and blurred vision. Overall, there was similarity in key benefits between the comparators; however, a clear advantage regarding key risks in favor of lidocaine 700 mg medicated plaster was observed. This observation was consistent across data from a direct comparison trial, randomized placebo-controlled trials, as well as data from RWE studies. The low number of randomized controlled trials for lidocaine 700 mg medicated plaster was the main limitation.

conclusionGuided by the opinion of patients regarding key benefits and risks deemed important for treatments of peripheral neuropathic pain, our analysis showed that lidocaine 700 mg medicated plaster has a more favorable benefit-risk balance compared to pregabalin (300 and 600 mg daily).

Indexed as

Benefit–Risk Action TeamBenefit–risk assessmentLidocaine 5% patchLidocaine 700 mg medicated plasterNeuropathic painPregabalinStructured framework

Identifiers

PMID34792789
PMCPMC8861254
OpenAlexW3211525533

What OpenQuestion holds

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LicenceCC BY-NC
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.