Evidence map›Paper›PMID 30725315›Full record

Trial reportClinical drug investigation2019

Efficacy and Safety of Loxoprofen Hydrogel Transdermal Patch Versus Loxoprofen Tablet in Chinese Patients with Myalgia: A Double-Blind, Double-Dummy, Parallel-Group, Randomized, Controlled, Non-Inferiority Trial.

Dongbao Zhao, Zhiwei Chen, Shaoxian Hu, Jianhao Lin, Zengwu Shao, Guochun Wang, Weiguo Xiao, Yi Zheng, Zhiyi Zhang, Yeqing Shi and 1 more

Abstract readComparative StudyEquivalence TrialMulticenter Study
In one paragraph

Trial report in Clinical drug investigation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–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

12 citing papers in PubMed.

  1. Trial
  2. Review
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  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Healthcare and Scientific Treatment of Knee Osteoarthritis.Journal of healthcare engineering · 2022
    Review
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  12. 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

11 authors.

Dongbao ZhaoDepartment of Rheumatology, Changhai Hospital of Shanghai, Shanghai, China.
Zhiwei ChenDepartment of Rheumatology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Shaoxian HuDepartment of Rheumatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Jianhao LinDepartment of Orthopaedics, Peking University People's Hospital, Beijing, China.
Zengwu ShaoDepartment of Orthopaedics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Guochun WangDepartment of Rheumatology, China-Japan Friendship Hospital, Beijing, China.
Weiguo XiaoDepartment of Rheumatology, The First Hospital of China Medical University, Shenyang, China.
Yi ZhengDepartment of Rheumatology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.
Zhiyi ZhangDepartment of Rheumatology, The First Affiliated Hospital of Harbin Medical University, Harbin, China.
Yeqing ShiDepartment of Rheumatology, Changhai Hospital of Shanghai, Shanghai, China.
Zhanguo LiDepartment of Rheumatology and Immunology, Peking University People's Hospital, No. 11 Xizhimen South Street, Xicheng District, Beijing, People's Republic of China. lzg20140310@sina.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveLoxoprofen (LOX) is a nonsteroidal anti-inflammatory drug (NSAID). Although oral administration of LOX has been widely prescribed, clinical guidelines for osteoarthritis generally recommend topical rather than oral NSAIDs in specific patients. However, there is limited information on the effects of loxoprofen sodium oral (LOX-O) versus loxoprofen sodium hydrogel transdermal patch (LOX-T) in myalgia patients. Hence, this non-inferiority study was designed to compare the efficacy and safety of LOX-O versus LOX-T in Chinese patients with myalgia.

methodsIn this double-blind, double-dummy, parallel-group, randomized controlled trial, 182 Chinese patients were enrolled and randomized equally to either LOX-T or LOX-O treatment for 2 weeks. Patients in the LOX-T group applied one sheet of the active LOX-T once a day on the affected site and took one placebo tablet three times a day immediately after meals, whereas patients in the LOX-O group applied one sheet of the placebo patch once a day and took one active LOX-O three times a day. Primary endpoint was the proportion of patients with 50% overall improvement or higher at the final visit. The cutoff value of a non-inferiority difference was set as - 10%.

resultsIn the full analysis set, the primary endpoint of final efficacy rate was 81.3% (n = 91) in the LOX-T group and 72.2% (n = 88) in the LOX-O group. The difference between the two groups was 9.1% [95% confidence interval (CI) - 3.1 to 21.3%], which showed that LOX-T was non-inferior compared with LOX-O. No serious adverse events occurred in either group.

conclusionsThis trial showed the non-inferiority of LOX-T compared with LOX-O in efficacy and safety in Chinese patients with myalgia. Also, the characteristic features of topical LOX-T, such as better compliance and lower risk-benefit ratio, make it more favorable for clinical practice.

trial registrationThe study was registered in the isrctn.com registry (ISRCTN trial ID: ISRCTN16227145).

Indexed as

Transdermal PatchAdministration, OralAdultAgedAnti-Inflammatory Agents, Non-SteroidalChinaDouble-Blind MethodFemaleGastrointestinal DiseasesHumansHydrogelsMaleMiddle AgedMyalgiaPhenylpropionatesTabletsAnti-Inflammatory Agents, Non-SteroidalHydrogelsloxoprofenPhenylpropionatesTablets

Identifiers

PMID30725315
PMCPMC6443607

What OpenQuestion holds

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Registered trials

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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.