Evaluation of the effectiveness and safety of N-Chromosome Royal Jelly on the number of peripheral white blood cells in patients with acute lymphoblastic leukemia
Keywords:Acute Lymphoblastic Leukemia, N-Chromosome Royal Jelly, White Blood cell.
Objectives: This study to investigate the immune response blood cells following N-Chromosome RJ administration in patients with childhood ALL.
Methods: This single center before and after 12-weeks clinical trial was done in Ali-Asghar Children Hospital on twenty-six patients diagnosed with ALL during maintenance phase of chemotherapy. After collecting their demographics, patients received a starter dose of 2-gram processed new natural N-chromosome RJ before breakfast and were followed up each 2 weeks, counting their peripheral WBC, ANC and ALC by a blood cell count and differential analysis.
Results: A total of Twenty-six patients were enrolled in this study (16 males and 10 females). Mean Peripheral WBC count of total patients were raised significantly after administering N-RJ Being 2510 Â±1192 cells per cubic millimeter at the beginning and then raised to 4549Â±1500 cells per cubic millimeter at the end of trial. (P<0.005) None of patients suffered from any adverse reaction during the trial.
There was a positive statistical relationship between total peripheral WBC, ANC and ALC count and N-Chromosome Royal jelly increased dosage, Being more prominent at the beginning of trial (p<0.001) and the last two weeks of follow-ups. (p<0.0005)
Conclusion: This study has successfully demonstrated that N-chromosome RJ can be a promising immune- enhancing supplement in patients diagnosed with acute lymphoblastic leukemia in their complete remission and maintenance therapy time. In addition, it is a natural alternative for drugs like G-CSF, but without those long-term adverse effects, we can see in G-CSF drugs.
2. Inaba H, Greaves M, Mullighan CG. Acute lymphoblastic leukaemia. The Lancet. 2013;381(9881):1943-55.
3. Schmiegelow K, Attarbaschi A, Barzilai S, Escherich G, Frandsen TL, Halsey C, et al. Consensus definitions of 14 severe acute toxic effects for childhood lymphoblastic leukaemia treatment: a Delphi consensus. The Lancet Oncology. 2016;17(6):e231-e9.
4. Kato M. Pediatric Acute Lymphoblastic Leukemia: Springer; 2020.
5. Lieschke GJ, Burgess AW. Granulocyte colony-stimulating factor and granulocyte-macrophage colony-stimulating factor. New England Journal of Medicine. 1992;327(1):28-35.
6. Wang Y, Chen L, Liu F, Zhao N, Xu L, Fu B, et al. Efficacy and tolerability of granulocyte colony-stimulating factors in cancer patients after chemotherapy: A systematic review and Bayesian network meta-analysis. Scientific reports. 2019;9(1):1-12.
7. Pfeil AM, Allcott K, Pettengell R, von Minckwitz G, Schwenkglenks M, Szabo Z. Efficacy, effectiveness and safety of long-acting granulocyte colony-stimulating factors for prophylaxis of chemotherapy-induced neutropenia in patients with cancer: a systematic review. Supportive care in cancer. 2015; 23(2):525-45.
8. Bronchud MHâ€š Scarffe JHâ€š Thatcher Nâ€š et al. Phase I/II study of recombinant human granulocyte colony-stimulating factor in patients receiving intensive chemotherapy for small cell lung cancer. Br J Cancer. 1987; 56:809-813.
9. Heil G, Hoelzer D, Sanz MA, et al. A randomized, double-blind, placebo-controlled, phase III study of filgrastim in remission induction and consolidation therapy for adults with de novo Acute Myeloid Leukemia. Blood. 1997; 90:4710-4718.
10. Dale DCâ€š Bonilla MAâ€š Davis MWâ€š et al. A randomized controlled phase III trial of recombinant human granulocyte colony-stimulating factor (filgrastim) for treatment of severe chronic neutropenia. Blood. 1993; 81:2496-2502.
11. HIGHLIGHTS OF PRESCRIBING INFORMATION: These highlights do not include all the information needed to use NEUPOGEN safely and effectively; Initial FDA Approval: 1991.
12. Kaftanoglu O, Tanyeli A. The use of royal jelly during treatment of childhood malignancies. Bee Products: Springer; 1997. p. 179-83.
13. Gasic S, Vucevic D, Vasilijic S, Antunovic M, Chinou I, Colic M. Evaluation of the immunomodulatory activities of royal jelly components in vitro. Immunopharmacology and Immunotoxicology. 2007;29(3-4):521-36.
14. Mirabzadeh A. The use of N-chromosome Royal Jelly to treat H. InPilory Ulcers. Abstract-XXXXIII International Apicultural Congress (Vol. 29, pp. 76-77).
15. Smith MA, Seibel NL, Altekruse SF, Ries LA, Melbert DL, O'Leary M, et al. Outcomes for children and adolescents with cancer: challenges for the twenty-first century. Journal of clinical oncology. 2010;28(15):2625.
16. Kliegman RM SB, Geme JSt, Schor NF. Nelson, ed. t. Textbook of Pediatrics(Chapter 495): Philadelphia: Elsevier; ; 2016.
17. Badr M, Hassan T, Sakr H, Karam N, Rahman DA, Shahbah D, et al. Chemotherapyâ€‘induced neutropenia among pediatric cancer patients in Egypt: Risks and consequences. Mol Clin Oncol. 2016;5(3):300-6.
18. Ozer H, Armitage JO, Bennett CL, Crawford J, Demetri GD, Pizzo PA, et al. 2000 update of recommendations for the use of hematopoietic colony-stimulating factors: evidence-based, clinical practice guidelines. American Society of Clinical Oncology Growth Factors Expert Panel. Journal of clinical oncology: official journal of the American Society of Clinical Oncology. 2000;18(20):3558.
19. Zahran AM, Elsayh KI, Saad K, Eloseily EM, Osman NS, Alblihed MA, et al. Effects of royal jelly supplementation on regulatory T cells in children with SLE. Food & nutrition research. 2016;60:32963.
20. Shirzad M, Kordyazdi R, Shahinfard N, Nikokar M. Does Royal jelly affect tumor cells? Journal of HerbMed Pharmacology. 2013;2(2).
21. Gismondi A, Trionfera E, Canuti L, Di Marco G, Canini A. Royal jelly lipophilic fraction induces antiproliferative effects on SH-SY5Y human neuroblastoma cells. Oncology Reports. 2017;38(3):1833-44.