Efficacy and Safety of Co-Administered St. John’s Wort and Ginkgo biloba Extracts in Patients with Subjective Tinnitus: A Preliminary Prospective Randomized Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Participants
2.2. Assessments
2.3. Randomization
2.4. Intervention
2.5. Outcomes
2.6. Statistical Analyses
3. Results
3.1. Characteristics of the Groups before Drug Administration
3.2. Changes in the Tinnitogram before and after Extract Administration
3.3. The Tinnitus Handicap Inventory (THI) Questionnaire Responses before and after Drug Administration
3.4. The Beck Depression Inventory (BDI) and the Pittsburgh Sleep Quality Index (PSQI)
3.5. Changes of the Quality of Life Using the Short Form-36 Health Survey (SF-36)
3.6. Multivariate Analysis of Factors Affecting the THI Score
3.7. Adverse Events
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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St John’s Wort & Ginkgo biloba (n = 20) | Ginkgo biloba (n = 26) | p-Value * | |
---|---|---|---|
Age | 50.3 (9.6) | 51.3 (8.9) | 0.724 |
Gender | 0.275 ** | ||
Female | 4 (20.0%) | 9 (34.6%) | |
Male | 16 (80.0%) | 17 (65.4%) | |
Height (cm) | 168.6 (7.9) | 165.6 (9.5) | 0.258 |
Weight (kg) | 69.5 (11.9) | 67.2 (11.4) | 0.504 |
Blood pressure (BP) | |||
Systolic BP | 131.1 (13.0) | 126.9 (18.3) | 0.383 |
Diastolic BP | 81.4 (9.8) | 81.5 (11.4) | 0.972 |
Pulse (bpm) | 81.7 (9.0) | 77.7 (9.3) | 0.158 |
Body temperature (°C) | 36.7 (0.3) | 36.6 (0.2) | 0.493 |
Pure-tone thresholds (dB) *** | |||
Right ear | 13.0 (5.7) | 15.6 (5.2) | 0.109 |
Left ear | 15.1 (7.7) | 15.0 (6.0) | 0.953 |
36-Item Short Form Survey (SF-36) | |||
Physical Functioning (PF) | 91.5 (11.0) | 85.8 (16.8) | 0.234 |
Role-Physical (RP) | 75.0 (35.4) | 77.1 (32.9) | 0.847 |
Bodily Pain (BP) | 78.0 (21.4) | 78.4 (23.6) | 0.954 |
General Health (GH) | 49.7 (23.9) | 55.4 (21.1) | 0.403 |
Vitality (VT) | 58.2 (18.0) | 52.0 (19.2) | 0.300 |
Social Functioning (SF) | 74.5 (21.5) | 75.7 (18.6) | 0.851 |
Role-Emotional (RE) | 88.2 (28.8) | 82.0 (34.1) | 0.539 |
Mental Health (MH) | 72.0 (12.6) | 66.9 (14.9) | 0.258 |
Beck Depression Inventory (BDI) | 7.6 (4.7) | 7.7 (5.9) | 0.930 |
Pittsburgh Sleep Quality Index (PSQI) | 6.5 (4.0) | 6.6 (3.4) | 0.944 |
Tinnitus Handicap Inventory (THI) | 34.7 (15.9) | 30.5 (16.7) | 0.396 |
St John’s Wort & Ginkgo biloba (n = 20) | Baseline | 12 Weeks after | Difference from Baseline to 12 Weeks * | p-Value ** |
Total score | 34.7 (15.9) | 29.6 (16.0) | 5.1 (14.7) | 0.102 |
Functional domain | 13.5 (9.4) | 13.5 (7.3) | 0.0 (8.0) | 0.965 |
Emotional domain | 10.8 (7.2) | 9.8 (6.7) | 1.0 (6.8) | 0.304 |
Catastrophic domain | 6.8 (4.6) | 6.3 (4.7) | 0.5 (4.9) | 0.627 |
Ginkgo biloba (n = 26) | Baseline | 12 Weeks after | Difference from Baseline to 12 Weeks * | p-Value ** |
Total score | 30.5 (16.7) | 25.6 (17.1) | 4.9 (11.6) | 0.046 |
Functional domain | 12.6 (7.8) | 11.0 (7.0) | 1.6 (5.9) | 0.166 |
Emotional domain | 10.6 (7.2) | 9.5 (7.9) | 1.1 (5.2) | 0.290 |
Catastrophic domain | 6.7 (4.5) | 5.2 (4.5) | 1.5 (3.7) | 0.056 |
St John’s Wort & Ginkgo biloba (n = 20) | Baseline | 12 Weeks after | Difference from Baseline to 12 Weeks * | p-Value ** |
Physical Functioning (PF) | 91.5 (11.0) | 89.7 (13.2) | 1.8 (8.7) | 0.589 |
Role-Physical (RP) | 75.0 (35.4) | 79.4 (31.0) | –4.4 (15.9) | 0.257 |
Bodily Pain (BP) | 78.0 (21.4) | 76.9 (23.9) | 1.1 (24.6) | 0.753 |
General Health (GH) | 49.7 (23.9) | 55.0 (19.9) | –5.3 (14.7) | 0.240 |
Vitality (VT) | 58.2 (18.0) | 61.5 (16.8) | –3.2 (18.1) | 0.664 |
Social Functioning (SF) | 74.5 (21.5) | 83.9 (20.5) | –9.5 (15.7) | 0.047 |
Role-Emotional (RE) | 88.2 (28.8) | 94.1 (24.3) | –5.9 (17.7) | 0.180 |
Mental Health (MH) | 72.0 (12.6) | 71.1 (15.1) | 0.9 (10.4) | 0.607 |
Ginkgo biloba (n = 26) | Baseline | 12 Weeks after | Difference from Baseline to 12 Weeks * | p-Value ** |
Physical Functioning (PF) | 85.8 (16.8) | 83.8 (20.3) | 2.1 (9.0) | 0.395 |
Role-Physical (RP) | 77.1 (32.9) | 72.9 (35.3) | 4.2 (26.2) | 0.431 |
Bodily Pain (BP) | 78.4 (23.6) | 68.3 (22.6) | 10.2 (25.5) | 0.084 |
General Health (GH) | 55.4 (21.1) | 51.7 (17.9) | 3.8 (12.7) | 0.178 |
Vitality (VT) | 52.0 (19.2) | 55.6 (14.2) | –3.6 (16.0) | 0.294 |
Social Functioning (SF) | 75.7 (18.6) | 70.5 (16.0) | 5.2 (18.2) | 0.253 |
Role-Emotional (RE) | 82.0 (34.1) | 83.4 (31.1) | –1.5 (18.3) | 0.461 |
Mental Health (MH) | 66.9 (14.9) | 64.5 (16.7) | 2.5 (14.9) | 0.625 |
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Kim, H.; Ha, J.; Park, H.Y.; Choung, Y.-H.; Jang, J.H. Efficacy and Safety of Co-Administered St. John’s Wort and Ginkgo biloba Extracts in Patients with Subjective Tinnitus: A Preliminary Prospective Randomized Controlled Trial. J. Clin. Med. 2023, 12, 3261. https://doi.org/10.3390/jcm12093261
Kim H, Ha J, Park HY, Choung Y-H, Jang JH. Efficacy and Safety of Co-Administered St. John’s Wort and Ginkgo biloba Extracts in Patients with Subjective Tinnitus: A Preliminary Prospective Randomized Controlled Trial. Journal of Clinical Medicine. 2023; 12(9):3261. https://doi.org/10.3390/jcm12093261
Chicago/Turabian StyleKim, Hantai, Jungho Ha, Hun Yi Park, Yun-Hoon Choung, and Jeong Hun Jang. 2023. "Efficacy and Safety of Co-Administered St. John’s Wort and Ginkgo biloba Extracts in Patients with Subjective Tinnitus: A Preliminary Prospective Randomized Controlled Trial" Journal of Clinical Medicine 12, no. 9: 3261. https://doi.org/10.3390/jcm12093261
APA StyleKim, H., Ha, J., Park, H. Y., Choung, Y. -H., & Jang, J. H. (2023). Efficacy and Safety of Co-Administered St. John’s Wort and Ginkgo biloba Extracts in Patients with Subjective Tinnitus: A Preliminary Prospective Randomized Controlled Trial. Journal of Clinical Medicine, 12(9), 3261. https://doi.org/10.3390/jcm12093261