DOI QR코드

DOI QR Code

Comparative study of the efficacy and safety of Abexol (suspension versus tablets) in patients with gastrointestinal symptoms

  • 투고 : 2023.03.14
  • 심사 : 2023.06.19
  • 발행 : 2024.01.01

초록

Background/Aims: Abexol is a mixture of primary aliphatic alcohols purified from beeswax (Apis mellifera), that produces anti-inflammatory, antioxidant and gastroprotective effects, as well as it is safe and well tolerated. To investigate and compare the efficacy and safety of Abexol (suspension versus tablets) in patients with gastrointestinal symptoms. Methods: Monocentric study, open-label, randomized design, with two parallel groups receiving Abexol tablets (150 mg/d) or Abexol suspension (75 mg/d) for 8 weeks. Primary efficacy variable (significant improvement in the total score of Gastrointestinal Symptom Rating Scale [GSRS]). Significant reduction in the intensity of the gastrointestinal-symptoms and the reduction in the consumption of antacids are considered secondary efficacy variable. Short form-36 (SF-36) quality of life questionnaire was evaluated as collateral variable. Data were analyzed as per intention to treat. Results: A significantly decrease in the overall score of the survey was observed with respect to the baseline level (p < 0.001) of 81.4% in the Abexol suspension group and 77.9% in the Abexol tablets group. At the end of the trial, most gastrointestinal-symptoms disappeared or reduced significantly. The frequency of consumption of neutralizing antacids was low. The significantly improvement in the perception of the state of health obtained in the Abexol is in correspondence with the improvement achieved in some of the components evaluate in the SF-36 questionnaire. Both treatments were safe and well tolerated. Conclusions: Abexol suspension showed efficacy and safety similar to Abexol tablets in patients with gastrointestinal symptoms, but using half the dose.

키워드

과제정보

This study was support by the National Centre for Scientific Research, as part of its research-development projects.

참고문헌

  1. Peery AF, Crockett SD, Murphy CC, et al. Burden and cost of gastrointestinal, liver, and pancreatic diseases in the United States: update 2018. Gastroenterology 2019;156:254-272.e11.  https://doi.org/10.1053/j.gastro.2018.08.063
  2. Rawla P, Barsouk A. Epidemiology of gastric cancer: global trends, risk factors and prevention. Prz Gastroenterol 2019;14:26-38.  https://doi.org/10.5114/pg.2018.80001
  3. Malik TF, Gnanapandithan K, Singh K. Peptic Ulcer Disease. In: StatPearls [Internet]. Traeasure Island, FL: StatPearls Publishing, 2022. 
  4. Azer SA, Akhondi H. Gastritis. In: StatPearls [Internet]. Traeasure Island, FL: StatPearls Publishing, 2022. 
  5. Fass R, Boeckxstaens GE, El-Serag H, Rosen R, Sifrim D, Vaezi MF. Gastro-oesophageal reflux disease. Nat Rev Dis Primers 2021;7:55. 
  6. Bhattacharyya A, Chattopadhyay R, Mitra S, Crowe SE. Oxidative stress: an essential factor in the pathogenesis of gastrointestinal mucosal diseases. Physiol Rev 2014;94:329-354.  https://doi.org/10.1152/physrev.00040.2012
  7. Kavitt RT, Lipowska AM, Anyane-Yeboa A, Gralnek IM. Diagnosis and treatment of peptic ulcer disease. Am J Med 2019;132:447-456.  https://doi.org/10.1016/j.amjmed.2018.12.009
  8. Mas R. D-002: Beeswax alcohols. Drugs of the Future 2001;26:731-744.  https://doi.org/10.1358/dof.2001.026.08.630956
  9. Menendez R, Amor AM, Gonzalez RM, Jimenez S, Mas R. Inhibition of rat microsomal lipid peroxidation by the oral administration of D002. Braz J Med Biol Res 2000;33:85-90.  https://doi.org/10.1590/S0100-879X2000000100012
  10. Molina V, Valdes S, Carbajal D, Arruzazabala L, Menendez R, Mas R. Antioxidant effect of D-002 on gastric mucosa of rats with experimentally induced injury. J Med Food 2001;4:79-83.  https://doi.org/10.1089/109662001300341734
  11. Perez Y, Oyarzabal A, Mas R, Molina V, Jimenez S. Protective effect of D-002, a mixture of beeswax alcohols, against indomethacin-induced gastric ulcers and mechanism of action. J Nat Med 2013;67:182-189.  https://doi.org/10.1007/s11418-012-0670-y
  12. Carbajal D, Molina V, Valdes S, Arruzazabala L, Mas R. Anti-ulcer activity of higher primary alcohols of beeswax. J Pharm Pharmacol 1995;47:731-73s3. 
  13. Molina V, Ravelo Y, Zamora Z, Mas R. Effects of D-002 on non-steroidal anti-inflammatory drugs-induced gastric ulcer in rats. Int J Pharm Sci Rev Res 2015;30:253-257. 
  14. Carbajal D, Molina V, Valdes S, et al. Possible cytoprotective mechanism in rats of D-002, an anti-ulcerogenic product isolated from beeswax. J Pharm Pharmacol 1996;48:858-860.  https://doi.org/10.1111/j.2042-7158.1996.tb03987.x
  15. Carbajal D, Molina V, Noa M, et al. Effect of D-002 on gastric mucus composition in ethanol-induced ulcer. Pharmacol Res 2000;42:329-332.  https://doi.org/10.1006/phrs.2000.0693
  16. Zamora Z, Molina V, Mas R, et al. D-002 treatment attenuates esophagitis in a model of chronic gastro-esophageal reflux in rats. IOSRPHR 2015;5:36-40. 
  17. Noa M, Mas R, Carbajal D, Valdes S. Effect of D-002 on acetic acid-induced colitis in rats at single and repeated doses. Pharmacol Res 2000;41:391-395.  https://doi.org/10.1006/phrs.1999.0596
  18. Perez Y, Oyarzabal A, Ravelo Y, Mas R, Jimenez S, Molina V. Inhibition of cyclooxygenase and 5-lipooxygenase enzymes by D-002 (beeswax alcohols). Curr Top Nutraceutical Res 2014;12:13-18. 
  19. Molina CV, Valle CM, Ravelo CY, Carbajal QD, Mas FR. Efectos del D-002 en la ulcera gastrica inducida por aspirina. Rev Cub Tox 2012;1. 
  20. Menendez R, Mas R, Illnait J, et al. Effects of D-002 on lipid peroxidation in older subjects. J Med Food 2001;4:71-77.  https://doi.org/10.1089/109662001300341725
  21. Lopez E, Illnait J, Molina V, et al. Effects of D-002 (Beeswax alcohols) on lipid peroxidation in middle-aged and older subjects. Lat Am J Pharm 2008;27:695-703. 
  22. Menendez R, Mas R, Amor AM, et al. Antioxidant effects of D002 on the in vitro susceptibility of whole plasma in healthy volunteers. Arch Med Res 2001;32:436-441.  https://doi.org/10.1016/S0188-4409(01)00315-0
  23. Rodriguez I, Illnait J, Molina V, et al. Comparison of the antioxidant effects of D-002 (Beeswax alcohols) and grape seed extract (GSE) on plasma oxidative variables in healthy subjects. Lat Am J Pharm 2010;29:255-262. 
  24. Hano O, Illnait J, Mas R, Fernandez L, Pinol F, Fernandez JC. Effects of D-002, a product isolated from beeswax, on duodenal ulcer: a double-blind, placebo-controlled study. Curr Ther Res 2001;62:394-407.  https://doi.org/10.1016/S0011-393X(01)89004-4
  25. Illnait J, Terry H, Mas R, Fernandez L, Carbajal D. Effects of D-002, a product isolated from beeswax, on gastric symptoms of patients with osteoarthritis treated with piroxicam: a pilot study. J Med Food 2005;8:63-68.  https://doi.org/10.1089/jmf.2005.8.63
  26. Rodriguez I, Illnait J, Terry H, et al. Effects of Abexol® (beeswax alcohols) on gastrointestinal symptoms in middle- aged and older subjects. Rev CENIC Cien Biol 2009;40:147-154. 
  27. Illnait J, Rodriguez I, Molina V, et al. Effects of D-002 (Beeswax alcohols) on gastrointestinal symptoms and oxidative markers in middle-aged and older subjects. Lat Am J Pharm 2013;32:166-174. 
  28. Fernandez JC, Rodriguez I, Illnait J, et al. Effects of Abexol (beeswax alcohols) in patients with gastric symptoms. Rev CENIC Cien Biol 2012;43:9-16. 
  29. Fernandez L, Terry H, Quinones AM, et al. Effects of Abexol in middle-aged and older subjects: an open follow-up. Rev CENIC Ciencias Biologicas 2008;39:3-8. 
  30. Rodeiro I, Aleman C, Noa M, et al. Preclinical oral toxicology in rats of D-002, a natural drug with antiulcer effects. Drug Chem Toxicol 1998;21:151-162.  https://doi.org/10.3109/01480549809011644
  31. Aleman C, Rodeiro I, Noa M, et al. One-year dog toxicity study of D-002, a mixture of aliphatic alcohols. J Appl Toxicol 2001;21:179-184.  https://doi.org/10.1002/jat.705
  32. Rodeiro I, Gamez R, Acosta P, Fernandez S, Mas R, Aleman C. Estudio genotoxico del D-002, un producto con actividad antiulcerosa. Rev Tox 1998;15:117-121. 
  33. Gamez R, Fernandez I, Acosta PC, et al. Evaluacion mutagenica del D-002 en el ensayo de micronucleos en medula osea en ratas Sprague Dawley de ambos sexos. Rev. CNIC Cienc Biol 1999;30:70-72. 
  34. Asociacion Medica Mundial. Declaracion de Helsinki. Principios eticos para las investigaciones con seres humanas. Fortaleza: Asociacion Medica Mundial, 2013. 
  35. Svedlund J, Sjodin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci 1988;33:129-134.  https://doi.org/10.1007/BF01535722
  36. Alonso J, Prieto L, Anto JM. [The Spanish version of the SF-36 Health Survey (the SF-36 health questionnaire): an instrument for measuring clinical results]. Med Clin (Barc) 1995;104:771-776. Spanish. 
  37. Centro para el Control Estatal de los Medicamentos, Equipos y Dispositivos Medicos (CECMED). Requerimientos para la notificacion y el reporte de eventos adversos graves e inesperados en los ensayos clinicos. Regulacion No. 45-2007. La Habana: Ministerio de Salud Publica, 2007. 
  38. Burton LL, Hilal-Dandan R, Knollman BC. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill Education, 2018. 
  39. Castellas Jorda F, Lopez Vivancos J. Evaluacion de la calidad de vida en las enfermedades digestivas. Gastroenterol Hepatol 2004;27:58-68.  https://doi.org/10.1157/13056428
  40. Fuchs KH, Musial F, Eypasch E, Meining A. Gastrointestinal quality of life in gastroesophageal reflux disease: a systematic review. Digestion 2022;103:253-260. https://doi.org/10.1159/000524766