Evidence map›Paper›PMID 29343266›Full record

SynthesisBMC musculoskeletal disorders2018

Identification of pain categories associated with change in pain in patients receiving placebo: data from two phase 3 randomized clinical trials in symptomatic knee osteoarthritis.

Asger Reinstrup Bihlet, Inger Byrjalsen, Anne-Christine Bay-Jensen, Jeppe Ragnar Andersen, Claus Christiansen, Bente Juel Riis, Ivo Valter, Morten A Karsdal, Marc C Hochberg

2 registry-linked trialsOpen access · goldAbstract readMeta-Analysis
In one paragraph

Synthesis in BMC musculoskeletal disorders, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
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.

NCT00486434 phase3completednot on this map

A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Subjects With Knee Osteoarthritis

TypeinterventionalSponsorNordic Bioscience A/SRan2007 to 2010Enrolled1,176ConditionsOsteoarthritisArmsSMC021 Oral Calcitonin, SMC021 Placebo
NCT00704847 phase3terminatednot on this map

A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Subjects With Knee Osteoarthritis

TypeinterventionalSponsorNordic Bioscience A/SRan2008 to 2011Enrolled1,030ConditionsOsteoarthritisArmsOral Salmon Calcitonin, Oral Salmon Calcitonin (Placebo)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. 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

9 authors at 3 institutions in 3 countries.

Asger Reinstrup BihletNordic Bioscience, Herlev Hovedgade 207, DK2730, Herlev, Denmark. abi@nordicbioscience.com.ORCID 0000-0002-6944-1731
Inger Byrjalsen
Anne-Christine Bay-JensenNordic Bioscience, Herlev Hovedgade 207, DK2730, Herlev, Denmark.
Jeppe Ragnar AndersenNordic Bioscience, Herlev Hovedgade 207, DK2730, Herlev, Denmark.
Claus ChristiansenNordic Bioscience, Herlev Hovedgade 207, DK2730, Herlev, Denmark.
Bente Juel RiisNordic Bioscience, Herlev Hovedgade 207, DK2730, Herlev, Denmark.
Ivo ValterBioclinica, Tallinn, Estonia.
Morten A KarsdalNordic Bioscience, Herlev Hovedgade 207, DK2730, Herlev, Denmark.
Marc C HochbergUniversity of Maryland School of Medicine, Baltimore, USA.
Nordic Bioscience (Denmark) · DKBio-Competence Centre of Healthy Dairy Products (Estonia) · EEUniversity of Maryland, Baltimore · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPain is the principal clinical symptom of osteoarthritis (OA), and development of safe and effective analgesics for OA pain is needed. Drug development of new analgesics for OA pain is impaired by substantial change in pain in patients receiving placebo, and more data describing clinical characteristics and pain categories particularly associated with this phenomenon is needed. The purpose of this post-hoc analysis was to investigate clinical characteristics and pain categories and their association with radiographic progression and placebo pain reduction (PPR) in OA patients as measured the Western Ontario and McMasters Arthritis (WOMAC).

methodsPooled data from the placebo groups of two phase III randomized clinical trials in patients with knee OA followed for 2 years were analyzed. Differences between individual sub-scores and pain categories of weight-bearing and non-weight bearing pain over time were assessed. Selected patient baseline characteristics were assessed for association with PPR. Association between pain categories and radiographic progression was analyzed.

resultsThe reduction of pain in placebo-treated patients was significantly higher in the composite of questions related to weight-bearing pain compared to non-weight-bearing pain of the target knee. Baseline BMI, age and JSW were not associated with pain change. Pain reduction was higher in the Target knee, compared to the Non-Target knee at all corresponding time-points. A very weak correlation was found between weight-bearing pain and progression in the non-target knee.

conclusionsThese results indicate that the reduction in pain in patients treated with placebo is significantly different between pain categories, as weight-bearing pain was significantly more reduced compared to non-weight-bearing pain. Further research in pain categories in OA is warranted.

trial registrationNCT00486434 (trial 1) and NCT00704847 (trial 2).

Indexed as

ArthralgiaClinical Trials, Phase III as TopicHumansOsteoarthritis, KneePain MeasurementPlacebo EffectRandomized Controlled Trials as TopicPain categoriesPlacebo-responseRadiographic progression

Identifiers

PMID29343266
PMCPMC5773024
OpenAlexW2795475386

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.