Evidence map›Paper›PMID 36764707›Full record

ArticleBMJ open2023

Protocol for the RETHINK study: a randomised, double-blind, parallel-group, non-inferiority clinical trial comparing acetaminophen and NSAIDs for treatment of chronic pain in elderly patients with osteoarthritis of the hip and knee.

Makoto Endo, Shinya Kawahara, Taishi Sato, Masami Tokunaga, Toshihiko Hara, Taro Mawatari, Tsutomu Kawano, Sadamoto Zenda, Tempei Miyaji, Mototsugu Shimokawa and 6 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.0field-weighted citation impact, top 26% 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, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  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

16 authors at 7 institutions in 1 country.

Makoto EndoDepartment of Orthopaedic Surgery, Kyushu University, Fukuoka, Japan.ORCID 0000-0002-7956-2190
Shinya KawaharaDepartment of Orthopaedic Surgery, Kyushu University, Fukuoka, Japan.
Taishi SatoDepartment of Orthopaedic Surgery, Kyushu University, Fukuoka, Japan.
Masami TokunagaDepartment of Orthopaedic Surgery, Fukuoka Orthopaedic Hospital, Fukuoka, Japan.
Toshihiko HaraDepartment of Orthopaedic Surgery, Aso Iizuka Hospital, Iizuka, Fukuoka, Japan.
Taro MawatariDepartment of Orthopaedic Surgery, Hamanomachi Hospital, Fukuoka, Japan.
Tsutomu KawanoDepartment of Orthopaedic Surgery, Kyushu Rosai Hospital, Kitakyushu, Fukuoka, Japan.
Sadamoto ZendaDepartment of Radiation Oncology, National Cancer Centre Hospital East, Kashiwa, Chiba, Japan.ORCID 0000-0002-0421-5805
Tempei MiyajiDepartment of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Mototsugu ShimokawaDepartment of Biostatistics, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi, Japan.
Sanae SakamotoFukuoka Data Centre of Clinical Trials, Fukuoka, Japan.
Toshio TakanoAyumi Pharmaceutical Corporation, Tokyo, Japan.
Masumi MiyakeAyumi Pharmaceutical Corporation, Tokyo, Japan.ORCID 0000-0002-9021-8040
Hiroyuki AonoAyumi Pharmaceutical Corporation, Tokyo, Japan.ORCID 0000-0002-0091-7412
Yasuharu NakashimaDepartment of Orthopaedic Surgery, Kyushu University, Fukuoka, Japan nakashima.yasuharu.453@m.kyushu-u.ac.jp.
RETHINK study group
Kyushu University · JPAso Iizuka Hospital · JPHamanomachi Hospital · JPKyushu Rosai Hospital · JPNational Cancer Centre Japan · JPThe University of Tokyo · JPYamaguchi University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn patients with chronic pain, oral analgesics are essential treatment options to manage pain appropriately, improve activities of daily living abilities and achieve a higher quality of life (QOL). It is desirable to select analgesics for elderly patients based on comparative data on analgesic effect and risk of adverse events; however, there are few comparative studies so far. The purpose of this study is to determine whether the efficacy and safety of acetaminophen are non-inferior to non-steroidal anti-inflammatory drugs (NSAIDs) in the treatment of chronic pain associated with osteoarthritis of the hip and knee in elderly patients. METHODS AND ANALYSIS: This study is a multicentre, randomised controlled, double-blind, parallel-group study to compare the analgesic effect and adverse events between acetaminophen or NSAIDs (loxoprofen or celecoxib). A total of 400 elderly patients with osteoarthritis of the hip and knee will be recruited from five institutions in Japan. Patients of 65 years or older with osteoarthritis-related pain will be registered and randomly assigned to acetaminophen, loxoprofen or celecoxib with 2:1:1 allocation. The primary endpoint is change in the Brief Pain Inventory (BPI) item 3 (worst pain) score from baseline to week 8. The secondary endpoints are BPI item 3 score change from baseline to week 4, health-related QOL measured by Short Form-8 Health Survey, and occurrence of adverse events including gastrointestinal disorders and abnormal liver function. Data will be analysed in accordance with a predefined statistical analysis plan. ETHICS AND DISSEMINATION: This study protocol was approved by the Kyushu University Hospital Certified Institutional Review Board for Clinical Trials on 28 January 2021 (KD2020004) and the chief executive of each participating hospital. The results of the study will be submitted to international peer-reviewed journals, and the main findings will be presented at international scientific conferences. TRIAL REGISTRATION NUMBER: jRCTs071200112.

Indexed as

Chronic PainOsteoarthritis, HipOsteoarthritis, KneeAcetaminophenActivities of Daily LivingAgedAnalgesicsAnti-Inflammatory Agents, Non-SteroidalCelecoxibDouble-Blind MethodEquivalence Trials as TopicHumansMulticenter Studies as TopicPhenylpropionatesQuality of LifeRandomized Controlled Trials as TopicAcetaminophenAnalgesicsAnti-Inflammatory Agents, Non-SteroidalCelecoxibloxoprofenPhenylpropionatesorthopaedic & trauma surgerypain management

Identifiers

PMID36764707
PMCPMC9923306
OpenAlexW4319958295

What OpenQuestion holds

Textmetadata
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.