Evidence map›Paper›PMID 20670047›Full record

Trial reportClinical drug investigation2010

Transdermal buprenorphine in non-oncological moderate-to-severe chronic pain.

Antonio Gatti, Mario Dauri, Francesca Leonardis, Giuseppe Longo, Franco Marinangeli, Massimo Mammucari, Alessandro Fabrizio Sabato

Abstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Clinical drug investigation, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. 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.

Antonio GattiEmergency Care, Critical Care Medicine, Pain Medicine and Anaesthesiology Department at Tor Vergata Polyclinic, University of Rome-Tor Vergata, Rome, Italy. antonio.gatti@ptvonline.it
Mario Dauri
Francesca Leonardis
Giuseppe Longo
Franco Marinangeli
Massimo Mammucari
Alessandro Fabrizio Sabato

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMusculoskeletal pathologies are among the most frequent causes of long-term non-oncological severe pain and consequent physical impairment. Aims of pharmacological and physical therapy are to reduce pain, promote functional recovery and improve overall quality of life. Pharmacological therapy may include the use of opioids.

objectiveTo evaluate the efficacy and tolerability of transdermal buprenorphine (TDS) in the long-term management of non-oncological, chronic, moderate-to-severe musculoskeletal pain. STUDY

designAn open-label, prospective, single-centre, 6-month study.

settingA 'real world' outpatient setting. PATIENTS: Adult patients with chronic moderate-to-severe musculoskeletal pain were enrolled consecutively.

interventionPatients initially received buprenorphine TDS 11.7 microg/h (one-third of 35 microg/h patch) every 72 hours. If required, patients could be up-titrated to 17.5 microg/h (one-half of 35 microg/h patch), 23.4 microg/h (two-thirds of 35 microg/h patch) or 35 microg/h. Concomitant antiemetics were allowed.

main outcome measuresThe primary endpoint was percentage mean reduction in static and dynamic pain visual analogue scale (VAS) scores at study end (10 being worst pain, 0 being no pain). Quality of life and tolerability were also assessed.

resultsWe enrolled 146 patients aged 41-94 years; their baseline mean +/- SD static and dynamic pain VAS scores were 6.87 +/- 1.89 and 7.70 +/- 1.74, respectively. Buprenorphine TDS initial dosages were 11.7 microg/h (n = 139), 17.5 microg/h (n = 4), 23.4 microg/h (n = 1) and 35 microg/h (n = 2). At 6 months, 89 patients were under treatment; 11% (n = 10) were receiving 11.7 microg/h, 30% (n = 27) 17.5 microg/h, 6% (n = 5) 23.4 microg/h and 53% (n = 47) 35 microg/h. Patients achieved a nonsignificant reduction in pain at rest and in movement; mean +/- SD static and dynamic pain VAS scores decreased to 1.56 +/- 2.05 and 3.54 +/- 2.02, respectively. The quality of life improved as shown by significant (p < 0.01) increases from baseline in all items relating to physical and mental health on the Short-Form 36 health survey. Patients experienced recovery of daily and social activities according to the significant (p < 0.01) increase in Karnofsky Performance Status sub-item scores. Twenty-three patients discontinued treatment because of adverse events, which were mainly gastrointestinal or CNS-related.

conclusionsLow-dose buprenorphine TDS had good analgesic efficacy, and quality of life improved as early as 1 month after treatment initiation. Our results suggest that buprenorphine TDS is a well tolerated long-term analgesic for patients experiencing chronic musculoskeletal pain of moderate-to-severe intensity.

Indexed as

Administration, CutaneousAdultAgedAged, 80 and overAnalgesics, OpioidBuprenorphineChronic DiseaseFemaleHumansItalyMaleMiddle AgedMusculoskeletal DiseasesPainProspective StudiesQuality of LifeAnalgesics, OpioidBuprenorphine

Identifiers

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.