Evidence map›Paper›PMID 39334395›Full record

Trial reportBMC health services research2024

Cost-effectiveness of MLC601 in post-stroke functional recovery compared with placebo - the CHIMES & CHIMES-E studies.

Christopher Li Hsian Chen, Jia Hui Chai, Yogesh Mahadev Pokharkar, Narayanaswamy Venketasubramanian

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC health services research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00554723 (A Double Blind, Placebo Controlled, Randomized, Multicenter Study to Investigate CHInese Medicine NeuroAid Efficacy on Stroke Recovery), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT00554723 phase3completednot on this map

A Double Blind, Placebo Controlled, Randomized, Multicenter Study to Investigate CHInese Medicine NeuroAid Efficacy on Stroke Recovery

TypeinterventionalSponsorCHIMES SocietyRan2007 to 2012Enrolled1,100ConditionsCerebral Infarction, StrokeArmsNeuroAid, NeuroAid matched Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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

4 authors.

Christopher Li Hsian ChenMemory Aging and Cognition Centre, Department of Pharmacology, Yong Loo Lin School of Medicine, National University of Singapore, Blk MD3, 16 Medical Drive, #04-01, Singapore, 117600, Singapore. cplhchen@yahoo.com.sg.ORCID http://orcid.org/0000-0002-1047-9225
Jia Hui ChaiSingapore Clinical Research Institute, Consortium for Clinical Research and Innovation Singapore, 23 Rochester Park, Singapore, 139234, Singapore.
Yogesh Mahadev PokharkarSingapore Clinical Research Institute, Consortium for Clinical Research and Innovation Singapore, 23 Rochester Park, Singapore, 139234, Singapore.
Narayanaswamy VenketasubramanianRaffles Neuroscience Centre, Raffles Hospital, 585 North Bridge Road, #09-00, Singapore, 188770, Singapore.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite progress in stroke therapy (e.g., revascularisation interventions by thrombolysis and/or thrombectomy, organised stroke care), many stroke survivors will have impairment of neurological function. We aimed to compare the cost-effectiveness of an oral natural formulation, MLC601, versus placebo in functional recovery among subjects receiving standard of care after an ischemic stroke of intermediate severity assessed with NIH Stroke Scale at baseline (b-NIHSS 8-14).

methodsA Markov cohort model with a 2-year time horizon was developed to simulate patients from a published randomised placebo-controlled clinical trial of MLC601 in their post-stroke functional recovery assessed by modified Rankin Score (mRS), from a health system perspective. Transition probabilities were derived from a multi-centre clinical trial in South East Asia. As cost and utility data were not collected in the trial, therefore we extracted them from the published literature. The main outcomes were incremental cost, incremental quality-adjusted life-year (QALY) gained, and incremental cost-effectiveness ratio (ICER). Besides base-case and sensitivity analyses, we performed subgroup analyses to explore the heterogeneity of patients with poor-prognosis factors (b-NIHSS 10-14, stroke onset to treatment time > 48 h, rehabilitation during first 3 month). All costs are expressed in 2022 Euro and USD, with an annual discount rate of 3% applied to costs and QALYs.

resultsBase-case analysis showed that MLC601 was cost-effective compared with placebo, with €5,080 saved and 0.45 QALY gained, resulting in an ICER of -€11,352.50 per QALY gained. Similarly, results from subgroup analyses indicated that the use of MLC601 was a dominant strategy in all subgroups with poor-prognosis factors. Sensitivity analyses revealed the results were robust.

conclusionCompared with placebo on top of standard stroke care, MLC601 was cost-effective in post-stroke functional recovery over two years. Due to the lack of cost and utility data from the study population, the results might not be generalizable to other settings. Further studies with country-specific data are needed to confirm the results of this study.

trial registrationURL http://www. CLINICALTRIALS: gov . Unique identifier NCT00554723 November 7, 2007.

Indexed as

Cost-Benefit AnalysisMarkov ChainsQuality-Adjusted Life YearsRecovery of FunctionStrokeAgedDrugs, Chinese HerbalFemaleHumansMaleMiddle AgedDrugs, Chinese HerbalNeuroaidCostCost-effectivenessCost-utilityFunctional recoveryMLC601MLC901NeuroAiDStroke

Identifiers

PMID39334395
PMCPMC11430337

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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.