SynthesisBritish journal of clinical pharmacology2008
Enriched enrollment: definition and effects of enrichment and dose in trials of pregabalin and gabapentin in neuropathic pain. A systematic review.
Synthesis in British journal of clinical pharmacology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 80 papers, 59 of them syntheses that pooled it.
What it found
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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.
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.
Who cites it
80 citing papers in PubMed, 59 syntheses or guidelines pooled it, 171 citations in OpenAlex.
- Topical clonidine for neuropathic pain in adults.The Cochrane database of systematic reviews · 2022Pooled it
- Pregabalin for neuropathic pain in adults.The Cochrane database of systematic reviews · 2019Pooled it
- Mirtazapine for fibromyalgia in adults.The Cochrane database of systematic reviews · 2018Pooled it
- Cannabis-based medicines for chronic neuropathic pain in adults.The Cochrane database of systematic reviews · 2018Pooled it
- Acupuncture for neuropathic pain in adults.The Cochrane database of systematic reviews · 2017Pooled it
- Comparison of effect sizes between enriched and nonenriched trials of analgesics for chronic musculoskeletal pain: a systematic review.British journal of clinical pharmacology · 2017Pooled it
- Transcutaneous electrical nerve stimulation (TENS) for fibromyalgia in adults.The Cochrane database of systematic reviews · 2017Pooled it
- Antiepileptic drugs for chronic non-cancer pain in children and adolescents.The Cochrane database of systematic reviews · 2017Pooled it
- Antidepressants for chronic non-cancer pain in children and adolescents.The Cochrane database of systematic reviews · 2017Pooled it
- Non-steroidal anti-inflammatory drugs (NSAIDs) for chronic non-cancer pain in children and adolescents.The Cochrane database of systematic reviews · 2017Pooled it
- Paracetamol (acetaminophen) for chronic non-cancer pain in children and adolescents.The Cochrane database of systematic reviews · 2017Pooled it
- Opioids for chronic non-cancer pain in children and adolescents.The Cochrane database of systematic reviews · 2017Pooled it
- Non-steroidal anti-inflammatory drugs (NSAIDs) for cancer-related pain in children and adolescents.The Cochrane database of systematic reviews · 2017Pooled it
- Opioids for cancer-related pain in children and adolescents.The Cochrane database of systematic reviews · 2017Pooled it
- Tramadol for neuropathic pain in adults.The Cochrane database of systematic reviews · 2017Pooled it
- Gabapentin for chronic neuropathic pain in adults.The Cochrane database of systematic reviews · 2017Pooled it
- Morphine for chronic neuropathic pain in adults.The Cochrane database of systematic reviews · 2017Pooled it
- Methadone for neuropathic pain in adults.The Cochrane database of systematic reviews · 2017Pooled it
- Oral nonsteroidal anti-inflammatory drugs for fibromyalgia in adults.The Cochrane database of systematic reviews · 2017Pooled it
- Gabapentin for fibromyalgia pain in adults.The Cochrane database of systematic reviews · 2017Pooled it
20 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsEnriched enrollment study designs have been suggested to be useful for proof of concept when only a proportion of the diseased population responds to a treatment intervention. We aim to investigate whether this really is the case in trials of pregabalin and gabapentin in neuropathic pain.
methodsWe defined 'complete', 'partial' and 'non-enriched' enrollment, and examined pregabalin and gabapentin trials for the extent of enrichment and for effects of enrichment on efficacy and adverse event outcomes.
resultsThere were no studies using complete enriched enrollment; seven trials used partial enriched enrollment and 14 non-enriched enrollment. In pregabalin trials the maximum extent of enrichment was estimated at about 12%. Partial enriched enrollment did not change estimates of efficacy or harm. Over 150-600 mg maximum daily dose there was strong dose dependence for pregabalin.
conclusionsA benefit of partial over non-enriched enrollment could not be demonstrated because the degree of enrichment was rather small, and possibly because enrichment produced little enhancement of treatment effect. Whether a greater degree of enrichment would result in important differences is unknown. Researchers reporting clinical trials with any enrichment must describe both process and extent of enrichment. As things stand, the effects of enriched enrollment remain unknown for neuropathic pain trials.
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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.