ABSTRACT

The proliferation of supplements alongside their widespread and acclaimed benefits is an important clinical and socio-economic issue. The study aimed at assessing the safety and efficacy of cannabidiol (CBD) oil in users based on the drug’s clinical impact on chronic health conditions. A follow-up questionnaire was developed to relate telephone conversations with participants to EQ-5D and EQ-VAS instruments’ relevant data biweekly. Patients were divided into 9 groups (hypertensive, diabetic, arthritis, inflammatory/pain, glaucoma, cancer, peptic ulcer disease, epilepsy, and asthma) based on their previously diagnosed clinical conditions. Index scores were calculated with a follow-up period of 8 weeks. A total of 157 participants across southern Nigeria states were recruited for the study. The response rate was 75.8% with 119 participants (49, 41.2 % male and 70, 58.8 % females). The medical classifications of participants in the study were cardiology (13, 11%), endocrinology (16, 13%), gastroenterology (15, 13%), oncology (8, 7%), psychiatry (13, 11%), ophthalmology (9, 8%) and others (48, 40%). The hypertensive and diabetes groups revealed improved QoL based on the statistically significant higher EQ-5D indices relating to clinical manifestations over the follow-up periods compared with the baseline features. Other groups similarly presented statistically improved health-related QoL. The study revealed the safety and efficacy of CBD in the various groups studied.

Key Words: Cannabidiol (CBD), Quality-of-life, Medical conditions, Efficacy, Safety

[1]    Broglio KR, Berry DR. Detecting an overall survival benefit that is derived from progression-free survival. J Natal Cancer Inst. 2009;101(23):1642-9.

[2]    Baker SG, Kramer BS. Surrogate endpoint analysis: an exercise in extrapolation. J Natal Cancer Inst. 2013;105(5):316-20.

[3]    Faller EM, Hernandez MT, Hernandez AM, Gabriel JR. Emerging Roles of Pharmacists in Global Health: An Exploratory Study on their Knowledge, Perception, and Competency. Arch Pharm Pract. 2020;11(1):40-6.

[4]    Eltayeb LB, Al-Zahrani SA, Al-Hoechel LH, Ali H. Bacteriological and Parasitological Assessment of Apparently Healthy Food Handlers at Al-Kharj Province/KSA: A Cross-Sectional Prospective Study. Int J Pharm Phytopharmacol Res. 2020;10(4):103-11.

[5]    Kantor ED, Lampe JW, Navarro SL, Xiaoling S, Milne GL, White W. Associations between glucosamine and chindroitin supplement use and biomarkers of systemic inflammation. J Alt Complement Med. 2016;20(6):479-85.

[6]    FDA [Internet]. Guidance for industry: Food labeling guide. [Accessed 15th November2019]. Available from: www.fda.gov>guidance-industry-f., 2013.

[7]    NAFDAC [Internet]. Guidelines for labeling. [Accessed 25th December 2019]. Available from: www. nafdac.gov.ng 2020.

[8]    Stanescu S, Kirby SE. A systematic review of psychological, physical health factors, and quality of life in adult asthma. NPJ Prim Care Respir Med. 2019;29(37):10-7. doi:10.1038/s41533-019-0149-3.

[9]    Pazdur R. Endpoints for assessing drug activity in clinical trials. Oncologist. 2008;13(Suppl 2):19-21.

[10] Delay MC, Ballman RV, Marandet J, Sorgent D. Taking the long view: how to design a series of phase III trials to maximize cumulative therapeutic benefits. Clin Trials. 2012;3(9):283-92.

[11] Radwan MM, Elsohly MA, Slade D, Ahmed SA, Khan IA, Ross SA. Non-cannabinoid constituents from a high potency Cannabis Sativa.  Phytochemistry. 2008;69(14):2627-33.

[12] Elsaid S, Le Foll B. The complexity of pharmacology of cannabidiol (CBD) and its implications in the treatment of brain disorders. Neuropsychopharmacol. 2020;45(1):229-30. doi:10.1038/s41386-019-0518-1.

[13] Kucerova J, Tabiova K, Drago F, Micale V. Therapeutic potentials of Cannabinoids in Schizophrenia. Recent Pat CNS Drug Discov. 2014;9(1):13-25.

[14] Micale V, Di Marzo V, Sulcova A, Wetjak CT, Drago F. Endocannabinoid system and mood disorders. Priming a target for new therapies. Pharmacol Ther. 2013;138 (1):18-37.

[15] Golombek P, Müller M, Barthlott I, Sproll C, Lachenmeier DW. Conversion of Cannabidiol (CBD) into Psychotropic Cannabinoids Including Tetrahydrocannabinol (THC): A Controversy in the Scientific Literature. Toxics. 2020;8(2):41. doi:10.3390/toxics8020041

[16] Godwin M, Ruhland L, Casson I. Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity. BMC Med Res Methodol. 2003;3(1):28-35. doi:10.1186/1471-2288-3-28

[17] Wilson MC, Karareasis KO, Oza M. Outcomes and endpoints in trials of cancer treatment: The past present, and future. Lancet Oncol. 2015;16(1):e32-e42.

[18] Lipscomb J, Grotay CC, Synder CF. Patient-reported outcomes in cancer. A review of recent-research and policy initiative, CA. Cancer J Clin. 2007;57(5):279-300.

[19] Russo ST. Cannabinoid in the management of difficult to treat pain. Ther Clin Risk Manag. 2008;4(1);245-59.

[20] Ong KL, Cheung BM, Man YB, Lau CP, Lam KS. Prevalence awareness, treatment and control of hypertension among US adults 1999-2003. Hypertension. 2007;49(1):69-75.

[21] Vuolo F, Abreu SC, Michels M, Xaslo DG, Blanco NG, Hallack JE, et al. Cannabidiol reduces airway inflammation and fibrosis in experimental allergic asthma. Eur J Pharmacol. 2019;15(843):251-9.

[22] Lattanzi S, Brigo F, Trinka G, Zaccara G, Cagneltti C, Del Glovance C, et al. Efficacy and safety of cannabidiol in epilepsy. A systematic Review and Meta-Analysis. Drugs. 2018;78(17):1791-804.

[23] Soni RK, Porter AC, Lash JP, Unruh ML. Health-related quality of life in hypertension, chronic kidney disease and co-existent chronic health conditions. Adv Chronic Kidney Dis. 2010;17(4):e17-e26.

[24] Tomida I, Pertwee RG, Azuara-Blanco A. Cannabinoids and glaucoma. Br J Opthalmol. 2004;88(5):708-13.

[25] Siena S, Peeters M, Van Cutsem E, Humblet Y, Conte P, Bajetta E, et al. Association of progression-free survival with patient-reported outcomes and survival results from a randomized phase 3 trial of panitimumals. Br J Cancer. 2007; 97(11):1469-74.

[26] Likar R, Kostenberger M, Nahlar G. Cannabinoid in Cancer treatment. Schmerz. 2020;34(2):117-22.