The Role of Hymecromone in the Treatment of Biliary Tract Dysfunction: A Systematic Review and Meta-Analysis of Clinical Trials
https://doi.org/10.22416/1382-4376-2026-1995-5633
Abstract
Aim: comprehensive assessment of the efficacy and safety of hymecromone in the treatment of biliary tract dysfunction.
Materials and methods. A systematic review and meta-analysis of observational studies (n = 1117) selected from 5 databases (Central Scientific Medical Library, eLibrary, PubMed, Google Academy, Cochrane Library) without restrictions on publication date, devoted to the study of the use of hymecromone in patients with biliary tract dysfunction, including gallstone disease.
Results. During the meta-analysis, it was found that three-week therapy with hymecromone, 1200 mg/day, was accompanied by a change in pain intensity by –48.51 mm (95 % confidence interval (95% CI): –56.97…–40.05) on the Visual Analog Scale. Improvement in quality of life was observed according to the “Bodily Pain” subscale of the 36-Item Short-Form Health Survey (SF-36) with a mean increase of 21.69 points (95% CI: 18.23–25.16). Following three-week therapy with hymecromone, 1200 mg/day, the proportion of patients with abdominal pain relief was 70.0 % (95% CI: 59.0–81.0), flatulence — 77.0 % (95% CI: 60.0–95.0), bitter taste — 74.0 % (95% CI: 54.0–93.0). The proportion of patients with improvement of gallbladder motility was 91.0 % (95% CI: 82.0–100.0), and the proportion of patients with restoration of bile homogenicity was 70.0 % (95 % CI: 43.0–98.0). The proportion of patients with normal stool frequency increased from 60.0 % (95% CI: 9.0–100.0) to 78.0 % (95% CI: 34.0–100.0) after 3 weeks of hymecromone therapy (1200 mg/day). Monotherapy with hymecromone at doses of 600–1200 mg/day had a favorable safety profile. The probability of persistent unformed stool after 3 weeks of therapy was dose-dependent: at the end of treatment, the symptom persisted in 23.0 and 0 % of patients receiving 1200 or 600 mg/day of hymecromone, respectively.
Conclusions. Course therapy with hymecromone at the full therapeutic dose of 1200 mg/day results in regression of key clinical manifestations, including biliary pain and dyspeptic symptoms. The drug contributes to the restoration of gallbladder motility and improvement of bile rheological properties while demonstrating a favorable tolerability profile. These findings support the pathophysiological rationale for the use of hymecromone in biliary tract disorders and reinforce its applicability in routine clinical practice.
About the Authors
A. V. OkhlobystinRussian Federation
Alexey V. Okhlobystin — Cand. Sci. (Med.), Deputy Chief Physician for Science and Innovation in University Clinical Hospital No. 2; Associate Professor of the Department of Propaedeutics of Internal Diseases, Gastroenterology and Hepatology of the N.V. Sklifosovsky Institute of Clinical Medicine
119435, Moscow, Pogodinskaya str., 1, build. 1
Yu. O. Shulpekova
Russian Federation
Yulia O. Shulpekova — Cand. Sci. (Med.), Associate Professor of the Department of Internal Diseases Propedeutics, Gastroenterology and Hepatology of the N.V. Sklifosovsky Institute of Clinical Medicine
119435, Moscow, Pogodinskaya str., 1, build. 1
O. Yu. Zolnikova
Russian Federation
Oxana Yu. Zolnikova — Dr. Sci. (Med.), Professor of the Department of Internal Disease Propaedeutics, Gastroenterology and Hepatology, N.V. Sklifosovsky Institute of Clinical Medicine; Leading Researcher at the Scientific and Technological Institute of Metabolic Health
119435, Moscow, Pogodinskaya str., 1, build. 1
V. T. Ivashkin
Russian Federation
Vladimir T. Ivashkin — Dr. Sci. (Med.), Professor, Academician of the Russian Academy of Sciences, Head of the Department of Propaedeutics of Internal Diseases, N.V. Sklifosovsky Institute of Clinical Medicine; Chief of V.Kh. Vasilenko Clinic of Internal Disease Propaedeutics, Gastroenterology and Hepatology; Director of the Scientific and Technological Institute of Metabolic Health
119435, Moscow, Pogodinskaya str., 1, build. 1
References
1. Dai F., Cai Y., Yang S., Zhang J., Dai Y. Global burden of gallbladder and biliary diseases (1990–2021) with healthcare workforce analysis and projections to 2035. BMC Gastroenterol. 2025;25(1):249. DOI: 10.1186/s12876-025-03842-x
2. Zheng Y., Duan Y., He X., Luo H., Zheng X. Global, regional, and national burden of gallbladder and biliary tract diseases: A systematic analysis of prevalence, incidence, deaths, and disability-adjusted life years with projections to 2050. Ann Hepatobiliary Pancreat Surg. 2025;29(4):424–40. DOI: 10.14701/ahbps.25-142
3. Wilkins T., Agabin E., Varghese J., Talukder A. Gallbladder dysfunction: Cholecystitis, choledocholithiasis, cholangitis, and biliary dyskinesia. Prim Care. 2017;44(4):575–97. DOI: 10.1016/j.pop.2017.07.002
4. Cotton P.B., Elta G.H., Carter C.R., Pasricha P.J., Corazziari E.S. Rome IV. Gallbladder and sphincter of Oddi disorders. Gastroenterology. 2016;S0016-5085(16)00224-9. DOI: 10.1053/j.gastro.2016.02.033
5. Ivashkin V.T., Mayev I.V., Shulpekova Yu.O., Baranskaya E.K., Okhlobystin A.V., Trukhmanov A.S., et al. Diagnostics and treatment of biliary dyskinesia: Clinical guidelines of the Russian Gastroenterological Association. Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2018;28(3):63–80. (In Russ.). DOI: 10.22416/1382-4376-2018-28-3-63-80
6. Dicheva D.T., Goncharenko A.Yu., Zaborovskiy A.V., Privezentsev D.V., Andreev D.N. Functional disorders of the biliary tract: Modern diagnostic criteria and principles of pharmacotherapy. Medical Council. 2020;11:116–23. (In Russ.). DOI: 10.21518/2079-701X-2020-11-116-123
7. Okhlobystin A.V., Ufimtseva A.K. Hymecromone in the treatment of biliary diseases: options and prospects. Pediatric Nutrition. 2020;18(5):66–74. (In Russ.). DOI: 10.20953/1727-5784-2020-5-66-74
8. Plotnikova E.Yu. Known and unknown hymecromone: A review. Consilium Medicum. 2024;26(5):324–30. (In Russ.). DOI: 10.26442/20751753.2024.5.202877
9. Methley A.M., Campbell S., Chew-Graham C., McNally R., Cheraghi-Sohi S. PICO, PICOS and SPIDER: A comparison study of specificity and sensitivity in three search tools for qualitative systematic reviews. BMC Health Serv Res. 2014;14(1):579. DOI: 10.1186/s12913-014-0579-0
10. Liberati A., Altman D.G., Tetzlaff J., Mulrow C., Gøtzsche P.C., Ioannidis J.P., et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: Explanation and elaboration. J Clin Epidemiol. 2009;62(10):e1–34. DOI: 10.1016/j.jclinepi.2009.06.006
11. Slim K., Nini E., Forestier D., Kwiatkowski F., Panis Y., Chipponi J. Methodological index for non-randomized studies (MINORS): Development and validation of a new instrument. ANZ J Surg. 2003;73(9):712–6. DOI: 10.1046/j.1445-2197.2003.02748.x
12. Okhlobystin A.V., Tatarkina M.A., Okhlobystina O.Z., Budzinskiy S.A., Pavlov P.V., Labut L.A. Hymecromone efficacy in the treatment of biliary pancreatitis. Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2019;29(5):26–35. (In Russ.). DOI: 10.22416/1382-4376-2019-29-5-26-35
13. Okhlobystin A.V., Ufimtseva A.K., Tatarkina M.A., Okhlobystina O.Z., Ivashkin V.T. Efficacy of hymecromone in post-cholecystectomy patients. Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2021;31(4):37–44. (In Russ.). DOI: 10.22416/1382-4376-2021-31-4-37-44
14. Research report: Efficiency of using the drug Hymecromone in biliary pancreatitis. 2016. (Unpublished data) (In Russ.).
15. Research report: A non-interventional prospective observational study to compare the efficacy of Odeston tablets in patients for registered indications at doses of 600 mg and 1200 mg per day, manufactured by the Pabianice Pharmaceutical Plant Polfa SA, Poland. 2021. (Unpublished data) (In Russ.).
16. Nersesov A.V., Kaybullaeva D.A., Rakhmetova V.S., Lozinskaya I.A., Kurmangalieva A.K., Ayupova V.S., et al. Hymecromone administration in real clinical practice: Results of the prospective multicentre observational study in the Republic of Kazakhstan. Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2021;31(5):34–50. (In Russ.). DOI: 10.22416/1382-4376-2021-31-5-34-50
17. Baryshnikova N.V., Sousova Ya.V. Effectiveness of hymecromone monotherapy in treatment of patients with various pathologies of biliary tract. Medical Alphabet. 2021;(40):14–20. (In Russ.). DOI: 10.33667/2078-5631-2021-40-14-20
18. Nikitin I.G., Salikov A.V., Fedorov I.G., Ilchenko L.Yu. Hymecromone monotherapy in patients with biliary tract disorders: Clinical efficacy and safety profile. Lechebnoe Delo. 2023;3:34–40. (In Russ.). DOI: 10.24412/2071-5315-2023-12983
19. Minushkin O.N., Maslovskii L.V., Topchiy T.B., Burdina E.G., Kruchinina M.A., Chugunnikova L.I. Gallstone disease: Current pharmacotherapy options. Medical Council. 2024;18(15):95–102. (In Russ.). DOI: 10.21518/ms2024-421
20. Bordin D.S., Dubtsova E.A., Selezneva E.Ya., Kukoleva E.O., Lashko M.L., Chebotareva M.V., et al. Efficacy and safety of hymecromone various doses in patients who have undergone cholecystectomy. Effektivnaia Farmakoterapiia. 2021;17(39):34–8. (In Russ.). DOI: 10.33978/2307-3586-2021-17-39-34-38
21. Selezneva E.Y., Mechetina T.A., Orlova Y.N., Koricheva E.S., Voinovan I.N., Bezaeva I.V., et al. A comparative study of the effectiveness of UDCA monotherapy and the combination of UDCA with hymecromone in patients with stage 2 biliary sludge. Experimental and Clinical Gastroenterology. 2016;10:94–8. (In Russ.).
22. Karimov M.M., Rustamova M.T., Sobirova G.N., Khairullaeva S.S. Assessment of the clinical effectiveness of use of hymecromone in combination with ursodeoxycholic acid in biliary pathology. Experimental and Clinical Gastroenterology. 2024;3:65–70. (In Russ.). DOI: 10.31146/1682-8658-ecg-223-3-65-70
23. Wang H.H., Portincasa P., Liu M., Tso P., Wang D.Q.H. Similarities and differences between biliary sludge and microlithiasis: Their clinical and pathophysiological significances. Liver Res. 2018;2(4):186–99. DOI: 10.1016/j.livres.2018.10.001
24. Hill P.A., Harris R.D. Clinical importance and natural history of biliary sludge in outpatients. J Ultrasound Med. 2016;35(3):605–10. DOI: 10.7863/ultra.15.05026
25. Khokhlacheva N.A. Conservative treatment of patients with cholelithiasis. Health, demography, ecology of finno-ugric peoples. 2020;2:63–6. (In Russ.).
Review
For citations:
Okhlobystin A.V., Shulpekova Yu.O., Zolnikova O.Yu., Ivashkin V.T. The Role of Hymecromone in the Treatment of Biliary Tract Dysfunction: A Systematic Review and Meta-Analysis of Clinical Trials. Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2026;36(2):46-58. https://doi.org/10.22416/1382-4376-2026-1995-5633
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