Evidence map›Paper›PMID 26099553›Full record

Trial reportOsteoarthritis and cartilage2015

Huo-Luo-Xiao-Ling (HLXL)-Dan, a Traditional Chinese Medicine, for patients with osteoarthritis of the knee: a multi-site, randomized, double-blind, placebo-controlled phase II clinical trial.

L Lao, M Hochberg, D Y W Lee, A M K Gilpin, H H S Fong, P Langenberg, K Chen, E K Li, L S Tam, B Berman

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Osteoarthritis and cartilage, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00755326 (Dose Escalation Study Of Chinese Herbs In Osteoarthritis Of The Knee), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
1.3field-weighted citation impact, top 21% 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.

NCT00755326 phase2completednot on this map

Dose Escalation Study Of Chinese Herbs In Osteoarthritis Of The Knee

TypeinterventionalSponsorUniversity of Maryland, BaltimoreRan2007 to 2010Enrolled92ConditionsOsteoarthritis of the KneeArmsHLXL
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Paracetamol versus placebo for knee and hip osteoarthritis.The Cochrane database of systematic reviews · 2019
    Pooled it
  3. Article
  4. Article
  5. Article
  6. Review
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

10 authors at 4 institutions in 3 countries.

L LaoCenter for Integrative Medicine, School of Medicine, University of Maryland, Baltimore, USA; School of Chinese Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China. Electronic address: lxlao1@hku.hk.
M HochbergDivision of Rheumatology & Clinical Immunology, Department of Medicine, School of Medicine, University of Maryland, Baltimore, USA. Electronic address: mhochber@medicine.umaryland.edu.
D Y W LeeMailman Research Center, McLean Hospital, Harvard Medical School, Belmont, MA 02478, USA. Electronic address: dlee@mclean.harvard.edu.
A M K GilpinDepartment of Epidemiology and Public Health, School of Medicine, University of Maryland, Baltimore, USA. Electronic address: adele.gilpin@gmail.com.
H H S FongDepartment of Medicinal Chemistry and Pharmacognosy, College of Pharmacy, University of Illinois at Chicago, Chicago, IL, USA. Electronic address: hfong@uic.edu.
P LangenbergDepartment of Epidemiology and Public Health, School of Medicine, University of Maryland, Baltimore, USA. Electronic address: PLANGENB@epi.umaryland.edu.
K ChenDepartment of Family and Community Medicine, School of Medicine, University of Maryland, Baltimore, USA. Electronic address: KChen@som.umaryland.edu.
E K LiDepartment of Medicine and Therapeutics, Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong Special Administrative Region, China. Electronic address: edmundli@cuhk.edu.hk.
L S TamDepartment of Medicine and Therapeutics, Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong Special Administrative Region, China. Electronic address: lstam@cuhk.edu.hk.
B BermanCenter for Integrative Medicine, School of Medicine, University of Maryland, Baltimore, USA. Electronic address: BBerman@som.umaryland.edu.
University of Maryland, Baltimore · USChinese University of Hong Kong · HKHarvard University · USUniversity of Illinois Chicago · US

Funding

Scientific Analysis CoreP01AT002605 · NCCIH · UNIVERSITY OF MARYLAND BALTIMORE · PI BERMAN, BRIAN M · 2005 to 2009
$6.4M
NCCIH NIH HHS P01 AT002605
6 · The paper itself

Abstract

objectiveTo examine the efficacy and safety of Huo-Luo-Xiao-Ling (HLXL)-Dan, a Traditional Chinese Medicine (TCM), in patients with knee osteoarthritis (OA).

designA multi-site, randomized, double-blind, placebo-controlled phase II dose-escalation clinical trial was conducted. Eligible patients who fulfilled American College of Rheumatology criteria were randomized to receive either HLXL or placebo. Clinical assessments included measurement of knee pain and function with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), patient global assessment (PGA), and knee pain scores every 2 weeks. A Data and Safety Monitoring Board (DSMB) was established to review the data for ensuring the quality of the trial.

resultsIn the first stage, 28 participants were randomized to receive either low-dose HLXL-Dan (2400 mg/day) or placebo for 6 weeks. The results showed no statistical difference between the two groups. The study was then re-designed following the recommendation of DSMB. Ninety-two patients were enrolled in the second stage and were randomized to receive either high-dose HLXL-Dan (4000 mg/day for week 1-2, and 5600 mg/day for week 3-8) or placebo for 8 weeks. All outcome assessments showed significant improvements for both groups after 8 weeks but no significant between-group differences. The change (mean ± SD) of WOMAC pain and WOMAC function scores of HLXL and placebo group after 8 weeks were -1.2 ± 1.7 vs -1.4 ± 1.5, and -1.1 ± 1.6 vs -1.3 ± 1.5 respectively. No serious adverse events were reported.

conclusionAlthough safe to use, an 8-week treatment of HLXL-Dan was not superior to placebo for reduction in pain or functional improvement in patients with knee OA. CLINICAL TRIAL REGISTRATION NUMBER: Clinicaltrials.gov (NCT00755326).

Indexed as

AgedDose-Response Relationship, DrugDouble-Blind MethodDrugs, Chinese HerbalFemaleHumansMaleMedicine, Chinese TraditionalMiddle AgedOsteoarthritis, KneePainPain MeasurementTreatment OutcomeDrugs, Chinese Herbalhuo luo xiao ling danChinese herbsHuo-Luo-Xiao-Ling-DanKnee osteoarthritisRandomized controlled trialTraditional Chinese medicine

Identifiers

PMID26099553
PMCPMC4663117
OpenAlexW849946536

What OpenQuestion holds

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LicenceTDM
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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.