Evidence map›Paper›PMID 29611892›Full record

Trial reportEuropean journal of neurology2018

MLC901 (NeuroAiD II™) for cognition after traumatic brain injury: a pilot randomized clinical trial.

A Theadom, S Barker-Collo, K M Jones, P Parmar, R Bhattacharjee, V L Feigin

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in European journal of neurology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 4 pooled it
–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

22 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  20. TheAlzheimer's & dementia (New York, N. Y.) · 2019
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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

6 authors.

A TheadomNational Institute for Stroke and Applied Neurosciences, School of Public Health and Psychosocial Studies, Auckland University of Technology, Auckland.ORCID 0000-0003-0351-6216
S Barker-ColloDepartment of Psychology, University of Auckland, Auckland, New Zealand.
K M JonesNational Institute for Stroke and Applied Neurosciences, School of Public Health and Psychosocial Studies, Auckland University of Technology, Auckland.
P ParmarNational Institute for Stroke and Applied Neurosciences, School of Public Health and Psychosocial Studies, Auckland University of Technology, Auckland.
R BhattacharjeeNational Institute for Stroke and Applied Neurosciences, School of Public Health and Psychosocial Studies, Auckland University of Technology, Auckland.
V L FeiginNational Institute for Stroke and Applied Neurosciences, School of Public Health and Psychosocial Studies, Auckland University of Technology, Auckland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeTreatments to facilitate recovery after traumatic brain injury (TBI) are urgently needed. We conducted a 9-month pilot, randomized placebo-controlled clinical trial to examine the safety and potential effects of the herbal supplement MLC901 (NeuroAiD II™) on cognitive functioning following TBI.

methodsAdults aged 18-65 years at 1-12 months after mild or moderate TBI were randomized to receive MLC901 (0.8 g capsules 3 times daily) or placebo for 6 months. The primary outcome was cognitive functioning as assessed by the CNS Vital Signs online neuropsychological test. Secondary outcomes included the Cognitive Failures Questionnaire, the Rivermead Post-concussion Symptom Questionnaire (neurobehavioral sequelae), Quality of Life after Brain Injury, Hospital Anxiety and Depression Scale, Modified Fatigue Impact Scale and extended Glasgow Outcome Scale (physical disability). Assessments were completed at baseline and at 3-, 6- and 9-month follow-up. Linear mixed-effects models were conducted, with the primary outcome time-point of 6 months.

resultsA total of 78 participants [mean age 37.5 ± 14.8 years, 39 (50%) female] were included in the analysis. Baseline variables were similar between groups (treatment group, n = 36; control group, n = 42). Linear mixed-effects models controlling for time, group allocation, repeated measurements, adherence and baseline assessment scores revealed significant improvements in complex attention (P = 0.04, d = 0.6) and executive functioning (P = 0.04, d = 0.4) at 6 months in the MLC901 group compared with controls. There were no significant differences between the groups for neurobehavioral sequelae, mood, fatigue, physical disability or overall quality of life at 6 months. No serious adverse events were reported.

conclusionsMLC901 was safe and well tolerated post-TBI. This study provided Class I/II evidence that, for patients with mild to moderate TBI, 6 months of MLC901 improved cognitive functioning.

Indexed as

CognitionAdolescentAdultAgedBrain Injuries, TraumaticCognition DisordersDisability EvaluationDouble-Blind MethodDrugs, Chinese HerbalExecutive FunctionFemaleGlasgow Outcome ScaleHumansMaleMiddle AgedNeuroprotective AgentsDrugs, Chinese HerbalNeuroaidNeuroprotective Agentscognitive deficitsconcussionMLC901NeuroAiD II™quality of lifetraumatic brain injury

Identifiers

PMID29611892
PMCPMC6055867

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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.