A pilot randomized controlled trial of WeiNaoKang (SaiLuoTong) in treating vascular dementia

J. Liu; Dennis Chang; D. Cordato; K. Lee; H. Dixson; Alan Bensoussan; Daniel Kam Yin Chan

doi:10.1002/agm2.12230

A pilot randomized controlled trial of WeiNaoKang (SaiLuoTong) in treating vascular dementia

J. Liu, Dennis Chang, D. Cordato, K. Lee, H. Dixson, Alan Bensoussan, Daniel Kam Yin Chan

Western Sydney University

Research output: Contribution to journal › Article › peer-review

4 Citations (Scopus)

Abstract

Objective: WeiNaoKang (or SaiLuoTong) is an herbal formula consisting of ginkgo, ginseng, and saffron. Our objective was to investigate if WeiNaoKang could improve cognitive function and cerebral perfusion in patients suffering from vascular dementia. Methods: A 16-week randomized double-blind, placebo-controlled trial was carried out in the setting of a memory disorder clinic at a single center. Patients with vascular dementia diagnosed clinically but supported by imaging and other investigations were invited to participate. The diagnoses were based on the National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIREN) criteria. An independent blinded assessor evaluated the effects of the formula. Intervention group was compared to the control group. A subgroup of participants was randomly chosen for further evaluation of cerebral perfusion by single photon emission computed tomography scans post-treatment. Results: Both groups were comparable in age (meanÃÂ =ÃÂ 74 ÃÂ± 7.2 years in the placebo group and 75 ÃÂ± 7.4 in the intervention group) and in other demographics. Sixty-two participants were included in final analysis. Alzheimer's Disease Assessment Scale – Cognitive Portion (ADAS-cog) was the primary outcome. By week 16, the mean ADAS-cog reduced from 24.48 to 20.30 (mean reductionÃÂ =ÃÂ 4.18) for those in the treatment group, and from 18.98 to 17.81 (mean reductionÃÂ =ÃÂ 1.18) for those in the placebo group. The difference in mean reduction of ADAS-cog was −3.00 (95% confidence interval [CI]ÃÂ =ÃÂ −4.910 to −1.100) in favor of the treatment group. Secondary outcomes of activities of daily living and quality of life measures also showed significant difference. In the perfusion scan analysis, the difference in the change in cerebral blood flow (t-scores) pre- and post-treatment between the intervention group (nÃÂ =ÃÂ 7) and the placebo group (nÃÂ =ÃÂ 11) was statistically significant (PÃÂ < 0.001). Conclusion: In this randomized, double-blind placebo-controlled trial, we demonstrated significant differences in improvement in cognitive function and activities of daily living. The clinical improvement is corroborated with improvement in cerebral perfusion in a subset of participants.

Original language	English
Pages (from-to)	246-256
Number of pages	11
Journal	Aging Medicine
Volume	5
Issue number	4
DOIs	https://doi.org/10.1002/agm2.12230
Publication status	Published - 2022

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© 2022 The Authors. Aging Medicine published by Beijing Hospital and John Wiley & Sons Australia, Ltd. This is an open access article under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

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10.1002/agm2.12230

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@article{5ff83631af2c4d4e9b6f3c82dbbed3d7,

title = "A pilot randomized controlled trial of WeiNaoKang (SaiLuoTong) in treating vascular dementia",

abstract = "Objective: WeiNaoKang (or SaiLuoTong) is an herbal formula consisting of ginkgo, ginseng, and saffron. Our objective was to investigate if WeiNaoKang could improve cognitive function and cerebral perfusion in patients suffering from vascular dementia. Methods: A 16-week randomized double-blind, placebo-controlled trial was carried out in the setting of a memory disorder clinic at a single center. Patients with vascular dementia diagnosed clinically but supported by imaging and other investigations were invited to participate. The diagnoses were based on the National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIREN) criteria. An independent blinded assessor evaluated the effects of the formula. Intervention group was compared to the control group. A subgroup of participants was randomly chosen for further evaluation of cerebral perfusion by single photon emission computed tomography scans post-treatment. Results: Both groups were comparable in age (mean{\~A}{\^A} ={\~A}{\^A} 74 {\~A}{\^A}± 7.2 years in the placebo group and 75 {\~A}{\^A}± 7.4 in the intervention group) and in other demographics. Sixty-two participants were included in final analysis. Alzheimer's Disease Assessment Scale – Cognitive Portion (ADAS-cog) was the primary outcome. By week 16, the mean ADAS-cog reduced from 24.48 to 20.30 (mean reduction{\~A}{\^A} ={\~A}{\^A} 4.18) for those in the treatment group, and from 18.98 to 17.81 (mean reduction{\~A}{\^A} ={\~A}{\^A} 1.18) for those in the placebo group. The difference in mean reduction of ADAS-cog was −3.00 (95% confidence interval [CI]{\~A}{\^A} ={\~A}{\^A} −4.910 to −1.100) in favor of the treatment group. Secondary outcomes of activities of daily living and quality of life measures also showed significant difference. In the perfusion scan analysis, the difference in the change in cerebral blood flow (t-scores) pre- and post-treatment between the intervention group (n{\~A}{\^A} ={\~A}{\^A} 7) and the placebo group (n{\~A}{\^A} ={\~A}{\^A} 11) was statistically significant (P{\~A}{\^A} < 0.001). Conclusion: In this randomized, double-blind placebo-controlled trial, we demonstrated significant differences in improvement in cognitive function and activities of daily living. The clinical improvement is corroborated with improvement in cerebral perfusion in a subset of participants.",

author = "J. Liu and Dennis Chang and D. Cordato and K. Lee and H. Dixson and Alan Bensoussan and Chan, {Daniel Kam Yin}",

year = "2022",

doi = "10.1002/agm2.12230",

language = "English",

volume = "5",

pages = "246--256",

journal = "Aging Medicine",

issn = "2475-0360",

publisher = "Wiley-Blackwell Publishing",

number = "4",

}

TY - JOUR

T1 - A pilot randomized controlled trial of WeiNaoKang (SaiLuoTong) in treating vascular dementia

AU - Liu, J.

AU - Chang, Dennis

AU - Cordato, D.

AU - Lee, K.

AU - Dixson, H.

AU - Bensoussan, Alan

AU - Chan, Daniel Kam Yin

PY - 2022

Y1 - 2022

N2 - Objective: WeiNaoKang (or SaiLuoTong) is an herbal formula consisting of ginkgo, ginseng, and saffron. Our objective was to investigate if WeiNaoKang could improve cognitive function and cerebral perfusion in patients suffering from vascular dementia. Methods: A 16-week randomized double-blind, placebo-controlled trial was carried out in the setting of a memory disorder clinic at a single center. Patients with vascular dementia diagnosed clinically but supported by imaging and other investigations were invited to participate. The diagnoses were based on the National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIREN) criteria. An independent blinded assessor evaluated the effects of the formula. Intervention group was compared to the control group. A subgroup of participants was randomly chosen for further evaluation of cerebral perfusion by single photon emission computed tomography scans post-treatment. Results: Both groups were comparable in age (meanÃÂ =ÃÂ 74 ÃÂ± 7.2 years in the placebo group and 75 ÃÂ± 7.4 in the intervention group) and in other demographics. Sixty-two participants were included in final analysis. Alzheimer's Disease Assessment Scale – Cognitive Portion (ADAS-cog) was the primary outcome. By week 16, the mean ADAS-cog reduced from 24.48 to 20.30 (mean reductionÃÂ =ÃÂ 4.18) for those in the treatment group, and from 18.98 to 17.81 (mean reductionÃÂ =ÃÂ 1.18) for those in the placebo group. The difference in mean reduction of ADAS-cog was −3.00 (95% confidence interval [CI]ÃÂ =ÃÂ −4.910 to −1.100) in favor of the treatment group. Secondary outcomes of activities of daily living and quality of life measures also showed significant difference. In the perfusion scan analysis, the difference in the change in cerebral blood flow (t-scores) pre- and post-treatment between the intervention group (nÃÂ =ÃÂ 7) and the placebo group (nÃÂ =ÃÂ 11) was statistically significant (PÃÂ < 0.001). Conclusion: In this randomized, double-blind placebo-controlled trial, we demonstrated significant differences in improvement in cognitive function and activities of daily living. The clinical improvement is corroborated with improvement in cerebral perfusion in a subset of participants.

AB - Objective: WeiNaoKang (or SaiLuoTong) is an herbal formula consisting of ginkgo, ginseng, and saffron. Our objective was to investigate if WeiNaoKang could improve cognitive function and cerebral perfusion in patients suffering from vascular dementia. Methods: A 16-week randomized double-blind, placebo-controlled trial was carried out in the setting of a memory disorder clinic at a single center. Patients with vascular dementia diagnosed clinically but supported by imaging and other investigations were invited to participate. The diagnoses were based on the National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIREN) criteria. An independent blinded assessor evaluated the effects of the formula. Intervention group was compared to the control group. A subgroup of participants was randomly chosen for further evaluation of cerebral perfusion by single photon emission computed tomography scans post-treatment. Results: Both groups were comparable in age (meanÃÂ =ÃÂ 74 ÃÂ± 7.2 years in the placebo group and 75 ÃÂ± 7.4 in the intervention group) and in other demographics. Sixty-two participants were included in final analysis. Alzheimer's Disease Assessment Scale – Cognitive Portion (ADAS-cog) was the primary outcome. By week 16, the mean ADAS-cog reduced from 24.48 to 20.30 (mean reductionÃÂ =ÃÂ 4.18) for those in the treatment group, and from 18.98 to 17.81 (mean reductionÃÂ =ÃÂ 1.18) for those in the placebo group. The difference in mean reduction of ADAS-cog was −3.00 (95% confidence interval [CI]ÃÂ =ÃÂ −4.910 to −1.100) in favor of the treatment group. Secondary outcomes of activities of daily living and quality of life measures also showed significant difference. In the perfusion scan analysis, the difference in the change in cerebral blood flow (t-scores) pre- and post-treatment between the intervention group (nÃÂ =ÃÂ 7) and the placebo group (nÃÂ =ÃÂ 11) was statistically significant (PÃÂ < 0.001). Conclusion: In this randomized, double-blind placebo-controlled trial, we demonstrated significant differences in improvement in cognitive function and activities of daily living. The clinical improvement is corroborated with improvement in cerebral perfusion in a subset of participants.

UR - https://hdl.handle.net/1959.7/uws:78333

U2 - 10.1002/agm2.12230

DO - 10.1002/agm2.12230

M3 - Article

SN - 2475-0360

VL - 5

SP - 246

EP - 256

JO - Aging Medicine

JF - Aging Medicine

IS - 4

ER -

A pilot randomized controlled trial of WeiNaoKang (SaiLuoTong) in treating vascular dementia

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