The effect of royal jelly on the level of consciousness in patients with traumatic brain injury: A double-blind randomized clinical trial

Authors

1 Department of Critical Care Nursing, Zanian University of Medical Sciences, Zanjan, Iran

2 Department of Critical Care Nursing, Faculty of Nursing and Midwifery, Zanjan University of Medical Sciences, Zanjan, Iran

3 Department of Anesthesiology, Faculty of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran

Abstract

Background: Patients with traumatic brain injury (TBI) experience changes in their level of consciousness (LOC). Royal Jelly is used in the treatment of neurological diseases. Objective: This study aimed to examine the effect of royal jelly on the LOC of patients with TBI. Methods: This double-blind randomized trial was performed in 2020 on 61 patients with TBI admitted to the intensive care unit. The patients were recruited consecutively and randomly assigned to an intervention (n = 33) and a control (n = 28) group. Patients in the intervention group received 3000 mg of royal jelly orally each day for 14 days, while those in the control group received routine care. The LOC was evaluated using the Glasgow Coma Scale (GCS) and Full Outline of Unresponsiveness (FOUR) score from day 1 to day 14. Data were analyzed using the repeated measures analysis and analysis of covariance. Results: The mean baseline GCS scores of the intervention and the control group were 4.39 ± 0.61and 4.82 ± 0.77, respectively, and changed to 11.93 ± 2.41 and 7.60 ± 2.51 at the end of the 14th day (P < 0.001). Furthermore, the mean baseline FOUR scores of the intervention and the control groups were 6.06±0.93 and 6.42 ± 1.16, respectively, and changed to 13.88 ± 2.57 and 9.71 ± 2.40 at the end of the study (P < 0.001). Conclusion: Using royal jelly for 2 weeks could improve the LOC of patients with TBI. However, further studies are recommended to determine the dose and duration of the usage.

Keywords


1. Liu T, Lu Y, Yu J, Kuang W, Wang X, Jiang Y, et al. Effect of
auricular electroacupuncture combined with body acupuncture
in improving the consciousness of patients after traumatic
brain injury: Study protocol for a randomized controlled trial.
Medicine (Baltimore) 2019;98:e16587.
2. Lucke‑Wold BP, Logsdon AF, Nguyen L, Eltanahay A,
Turner RC, Bonasso P, et al. Supplements, nutrition, and
alternative therapies for the treatment of traumatic brain injury.
Nutr Neurosci 2018;21:79‑91.
3. Cnossen MC, Polinder S, Andriessen TM, van der Naalt J,
Haitsma I, Horn J, et al. Causes and consequences of treatment
variation in moderate and severe traumatic brain injury:
A multicenter study. Crit Care Med 2017;45:660‑9.
4. Yuan H, Ma Q, Ye L, Piao G. The traditional medicine
and modern medicine from natural products. Molecules
2016;21:E559.
5. Kawahata I, Xua H, Takahashi M, Murata K, Han W,
Yamaguchi Y, et al. Royal jelly coordinately enhances
hippocampal neuronal expression of somatostatin and neprilysin
genes conferring neuronal protection against toxic soluble
amyloid‑β oligomers implicated in Alzheimer’s disease
pathogenesis. J Funct Foods 2018;51:28‑38.
6. Khazaei M, Ansarian A, Ghanbari E. New Findings on biological
actions and clinical applications of royal jelly: A review. J Diet
Suppl 2018;15:757‑75.
7. Pasupuleti VR, Sammugam L, Ramesh N, Gan SH. Honey,
propolis, and royal jelly: A comprehensive review of their
biological actions and health benefits. Oxid Med Cell Longev
2017;2017:1259510.
8. Minami A, Matsushita H, Ieno D, Matsuda Y, Horii Y, Ishii A,
et al. Improvement of neurological disorders in postmenopausal
model rats by administration of royal jelly. Climacteric
2016;19:568‑73.
9. Bogdanov S. Royal jelly, bee brood: Composition, health,
medicine: A review. Bee Product Sci 2011 ;3:8-19.
10. Guardia de Souza E Silva T, do Val de Paulo ME, da Silva JR,
da Silva Alves A, Britto LR, Xavier GF, et al. Oral treatment
with royal jelly improves memory and presents neuroprotective
effects on icv‑STZ rat model of sporadic Alzheimer’s disease.
Heliyon 2020;6:e03281.
11. Ali AM, Kunugi H. Royal Jelly as an intelligent anti‑aging
agent‑a focus on cognitive aging and Alzheimer’s disease:
A review. Antioxidants (Basel) 2020;9:E937.
12. Ali AM, Kunugi H. Apitherapy for Parkinson’s disease: A focus
on the effects of propolis and royal jelly. Oxid Med Cell Longev
2020;2020:1727142.13. Ghorbani M, Ghaem H, Rezaianzadeh A, Shayan Z, Zand F,
Nikandish R. A study on the efficacy of APACHE‑IV for
predicting mortality and length of stay in an intensive care unit
in Iran. F1000Res 2017;6:2032.
14. Moghadam F, PayamiBousari M, Faghih Zade S. Effect
of auditory stimulation by recitation of prayers (azan) on
consciousness level of comatose patients: A clinical trial. Prevent
Care Nurs Midwifery 2015;5:71‑9.
15. Reith FC, Van den Brande R, Synnot A, Gruen R, Maas AI. The
reliability of the Glasgow Coma Scale: A systematic review.
Intensive Care Med 2016;42:3‑15.
16. Vahdati SS, Ghobadi J, Bazavar M, Seifar F. Comparison of
interrater reliability and predictive validity of FOUR score and
Glasgow Coma Scale in multi traumatic patients. Adv Biosci
Clin Med 2017;5:17‑23.
17. Matsushita H, Shimizu S, Morita N, Watanabe K, Wakatsuki A.
Effects of royal jelly on bone metabolism in postmenopausal
women: A randomized, controlled study. Climacteric
2021;24:164‑70.
18. Bahonar E, Najafi Ghezeljeh T, Haghani H. Comparison of single
and combined effects of nature sounds and foot sole reflexology
massage on the level of consciousness in traumatic comatose
patients: A randomized controlled clinical trial. Holist Nurs Pract
2019;33:177‑86.
19. Çevik K, Namik E. Effect of auditory stimulation on the level of
consciousness in comatose patients admitted to the Intensive Care
Unit: A randomized controlled trial. J Neurosci Nurs 2018;50:375‑80.
20. Salmani F, Mohammadi E, Rezvani M, Kazemnezhad A. The
effects of family‑centered affective stimulation on brain‑injured
comatose patients’ level of consciousness: A randomized
controlled trial. Int J Nurs Stud 2017;74:44‑52.
21. Naseri‑Salahshour V, Varaei SH, Sajadi M, Tajdari S,
Sabzaligol M, Fayazi N. The effect of religious intervention on
the level of consciousness of comatose patients hospitalized in
an intensive care unit: A randomized clinical trial. Eur J Integr
Med 2018;51:53‑7.
22. Oshvandi KH, Aghamohammadi M, Kazemi F, Masoumi SZ,
Mazdeh M, Molavi Vardanjani M. Effect of royal jelly capsule on
quality of life of patients with multiple sclerosis: A double‑blind
randomized controlled clinical trial. Iran Red Crescent Med J
2020;22:e74.
23. El‑Seedi HR, Khalifa SA, Abd El‑Wahed A, Gao R, Guo ZH,
Tahir HE, et al. Honeybee products: An updated review of
neurological actions. Trends Food Sci Tech 2020;101:17‑27.
24. Rahardjo AK, Santoso MI. Effect of soursop leaf and royal jelly
on brain neuronal edema and apoptosis in rat cerebral contusion
model mediated by bdnf/il‑1β ratio. IOSR J Dent Med Sci
2016;15:1‑11.
25. Shi JL, Liao CH, Wang ZL, Wu XB. Effect of royal jelly on
longevity and memory‑related traits of Apis mellifera workers.
J Asia Pac Entomol 2018;21:1430‑3.
26. Bălan A, Moga MA, Dima L, Toma S, Elena Neculau A,
Anastasiu CV. Royal jelly – A traditional and natural remedy
for postmenopausal symptoms and aging‑related pathologies.
Molecules 2020;25:3291.
27. Sharif SN, Darsareh F. Effect of royal jelly on menopausal
symptoms: A randomized placebo‑controlled clinical trial.
Complement Ther Clin Pract 2019;37:47‑50.