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EGb 761® Does Not Affect Blood Coagulation and Bleeding Time in Patients with Probable Alzheimer's Dementia-Secondary Analysis of a Randomized, Double-Blind Placebo-Controlled Trial
Charlotte Kloft, Robert Hoerr. Healthcare (Basel, Switzerland), 2021-12-03
Topic: Drug trials: efficacy and safety
Following reports of bleeding upon Ginkgo intake, we assessed whether Ginkgo extract EGb 761® affects coagulation or platelet function or increases the risk of bleeding. In a double-blind, placebo-controlled trial, prothrombin time, activated partial thromboplastin time, international normalized ratio and bleeding time were measured in patients with Alzheimer's dementia at baseline, weeks 6 and 26. A total of 513 patients were randomized to 120 mg (n = 169) or 240 mg EGb 761® (n = 170) or placebo (n = 174). No relevant changes were found for coagulation parameters and bleeding time. Numbers of bleeding-related adverse events were similar in all groups. Concomitant intake of acetylsalicylic acid was documented for 68 patients in the placebo group and 105 in the EGb 761® groups. Within these groups, the means at baseline and week 26 differed by less than 1 unit for prothrombin time and bleeding time and less than 0.1 unit for international normalized ratio. Data on warfarin treatment in nine patients each taking placebo or EGb 761® did not indicate enhancement of warfarin effects by EGb 761®. No evidence was found that EGb 761® affects hemostasis or increases the bleeding risk. No pharmacodynamic interactions with warfarin or acetylsalicylic acid were found.
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APA 7th
Kloft, C., & Hoerr, R. (2021). EGb 761® Does Not Affect Blood Coagulation and Bleeding Time in Patients with Probable Alzheimer's Dementia-Secondary Analysis of a Randomized, Double-Blind Placebo-Controlled Trial. Healthcare (Basel, Switzerland). https://doi.org/10.3390/healthcare9121678
Vancouver
Kloft C, Hoerr R. EGb 761® Does Not Affect Blood Coagulation and Bleeding Time in Patients with Probable Alzheimer's Dementia-Secondary Analysis of a Randomized, Double-Blind Placebo-Controlled Trial. Healthcare (Basel, Switzerland). 2021. doi:10.3390/healthcare9121678. PMID: 34946404.
BibTeX
@article{kloft2021-34946404,
author = {Kloft, Charlotte and Hoerr, Robert},
title = {{EGb 761® Does Not Affect Blood Coagulation and Bleeding Time in Patients with Probable Alzheimer's Dementia-Secondary Analysis of a Randomized, Double-Blind Placebo-Controlled Trial}},
journal = {Healthcare (Basel, Switzerland)},
year = {2021},
doi = {10.3390/healthcare9121678},
pmid = {34946404},
url = {https://doi.org/10.3390/healthcare9121678}
}
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Key findings
- Concomitant intake of acetylsalicylic acid was documented for 68 patients in the placebo group and 105 in the EGb 761® groups.
- Within these groups, the means at baseline and week 26 differed by less than 1 unit for prothrombin time and bleeding time and less than 0.1 unit for international normalized ratio.
- Data on warfarin treatment in nine patients each taking placebo or EGb 761® did not indicate enhancement of warfarin effects by EGb 761®.
- No evidence was found that EGb 761® affects hemostasis or increases the bleeding risk.
- No pharmacodynamic interactions with warfarin or acetylsalicylic acid were found.
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Study details
- Participants169
- Evidence strengthHigh
How this study scored 61/100
Published in a peer-reviewed journal. Scored zero for study design and effect reported because the record does not state it. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record, institution's track record, multi-centre collaboration and free to read, so those were left out: it earned 34 of the 56 points we could judge it on, which is 61 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Healthcare (Basel, Switzerland)) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 3 / 5 | 2021 — within 6 year(s) of the newest study here |
| Sample size | 2 / 4 | 169 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 2 / 2 | Randomised and blinded or placebo-controlled (as stated in the record) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 34946404) |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 34 / 56 | Scored on 10 of 20 parts. We have no data for the rest, so they are left out: 34 of the 56 points we could judge it on is 61 out of 100. |
| Total | 61 / 100 | — |
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