Alternative herbal medicine for hemorrhoids, effect of Arum maculatum on the quality of life of patients: A randomized controlled trial

Serafeim Zisis; Konstantinos Giannakou; Giagkos Lavranos; Demetris Lamnisos

doi:10.7324/JAPS.2019.S105

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Abstract

Hemorrhoids is a common disorder and a leading cause of rectal bleeding, with unpleasant discomfort and pain for the patient. Medication and surgery are the standard treatments of hemorrhoids. In this study, we are investigating an alternative herbal treatment of hemorrhoids using the Arum maculatum L. (Araceae). A randomized controlled trial was conducted with a test treatment period of 2 weeks using a sample of 53 diagnosed patients from Greece to assess the efficacy of Arum maculatum in treating symptomatic hemorrhoids. The patients randomly assigned to consume a liquid mixture of Arum maculatum or a standard antihemorrhoid cream. The primary outcome was the health-related quality of life measured by the SF-36 health survey at the baseline and 2 weeks after the end of treatment. The mixed ANOVA statistical method was used to compare the groups. Participants in the treatment group had significantly greater improvement in all measures of the SF-36. Particularly the treatment effect for the physical health summary was 5.0 [95% confidence interval (CI): 0.9–9.1] while for the mental health summary was 4.7 (95% CI: 1.3–8.0). This trial shows that treatment with Arum maculatum improves the quality of life of patients with hemorrhoids, but further studies are needed to confirm these results.

Keyword: Alternative herbal medicine Hemorrhoids Arum maculatum Quality of life Randomized controlled trial.

Citation:

Zisis S, Giannakou K, Lavranos G, Lamnisos D. Alternative herbal medicine for hemorrhoids, Effect of Arum maculatum on the quality of life of patients: A randomized controlled trial. J Appl Pharm Sci, 2019; 9(S1): 040–045.

Copyright: © The Author(s). This is an open-access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Reference

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Garratt A, Schmidt L, Mackintosh A, Fitzpatrick R. Quality of life measurement: bibliographic study of patient assessed health outcome measures. BMJ, 2002; 324:1417–21. https://doi.org/10.1136/bmj.324.7351.1417
Garratt A, Schmidt L, Mackintosh A, Fitzpatrick R. Quality of life measurement: bibliographic study of patient assessed health outcome measures. BMJ, 2002; 324:1417–21. https://doi.org/10.1136/bmj.324.7351.1417
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Johanson JF, Sonnenberg A. The prevalence of hemorrhoids and chronic constipation: an epidemiologic study. Gastroenterology, 1990; 98(2):380–6. https://doi.org/10.1016/0016-5085(90)90828-O
Kochmarov V, Kozuharova E, Naychov Z, Momekov G, Mincheva I. Ethnobotany and ethnopharmacology of Arum maculatum L. (Araceae) in Bulgaria with an emphasis on its effect against haemorrhoids. IJPCBS, 2015; 5(2):394–402.
Kültür Åž. Medicinal plants used in KÄ±rklareli Province (Turkey). J Ethnopharmacol, 2007; 111(2):341–64. https://doi.org/10.1016/j.jep.2006.11.035
Lee CW, Chi KN. The standard of reporting of health-related quality of life in clinical cancer trials. J Clin Epidemiol, 2000; 53:451–8. https://doi.org/10.1016/S0895-4356(99)00221-8
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Man KM, Chen WC, Wang HM, Chen HY, Shen JL, Chen LD, Tsai FJ, Chen YH, Yu DX, Chiang FF. A randomized, double-blind, placebo-controlled trial of a Chinese herbal Sophora flower formula in patients with symptomatic haemorrhoids: a preliminary study. Afr J Tradit Complement Altern Med, 2013; 10(2):343–51. https://doi.org/10.4314/ajtcam.v10i2.21
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Pappa E, Kontodimopoulos N, Niakas D. Validating and norming of the Greek SF-36 Health Survey, Qual Life Res 2005; 14:1433–8. https://doi.org/10.1007/s11136-004-6014-y
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Taft C, Karlsson J, Sullivan M. Do SF-36 summary component scores accurately summarize subscale scores? Qual Life Res, 2001; 10(5):395–404. https://doi.org/10.1023/A:1012552211996
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WHO (World Health Organization). The world traditional medicines situation, in traditional medicines: global situation, issues and challenges, Geneva, Switzerland: WHO Press pp 1–14, 2011.
World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Med Assoc, 2013; 27:2191–4.

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Agbo SP. Surgical management of hemorrhoids. J Surg Tech Case Report, 2011; 3:68–76. https://doi.org/10.4103/2006-8808.92797

Garratt A, Schmidt L, Mackintosh A, Fitzpatrick R. Quality of life measurement: bibliographic study of patient assessed health outcome measures. BMJ, 2002; 324:1417–21. https://doi.org/10.1136/bmj.324.7351.1417

Garratt A, Schmidt L, Mackintosh A, Fitzpatrick R. Quality of life measurement: bibliographic study of patient assessed health outcome measures. BMJ, 2002; 324:1417–21. https://doi.org/10.1136/bmj.324.7351.1417

JariÄ‡ S, MaÄUkanoviÄ‡-JociÄ‡ M, DjurdjeviÄ‡ L, MitroviÄ‡ M, KostiÄ‡ O, KaradÅ¾iÄ‡ B, PavloviÄ‡ P. An ethnobotanical survey of traditionally used plants on Suva planina mountain (south-eastern Serbia). J Ethnopharmacol, 2015; 175:93–108. https://doi.org/10.1016/j.jep.2015.09.002

Johanson JF, Sonnenberg A. The prevalence of hemorrhoids and chronic constipation: an epidemiologic study. Gastroenterology, 1990; 98(2):380–6. https://doi.org/10.1016/0016-5085(90)90828-O

Kochmarov V, Kozuharova E, Naychov Z, Momekov G, Mincheva I. Ethnobotany and ethnopharmacology of Arum maculatum L. (Araceae) in Bulgaria with an emphasis on its effect against haemorrhoids. IJPCBS, 2015; 5(2):394–402.

Kültür Åž. Medicinal plants used in KÄ±rklareli Province (Turkey). J Ethnopharmacol, 2007; 111(2):341–64. https://doi.org/10.1016/j.jep.2006.11.035

Lee CW, Chi KN. The standard of reporting of health-related quality of life in clinical cancer trials. J Clin Epidemiol, 2000; 53:451–8. https://doi.org/10.1016/S0895-4356(99)00221-8

Lohsiriwat V. Hemorrhoids: from basic pathophysiology to clinical management. World J Gastroenterol, 2012; 18(17):2009–17. https://doi.org/10.3748/wjg.v18.i17.2009

Man KM, Chen WC, Wang HM, Chen HY, Shen JL, Chen LD, Tsai FJ, Chen YH, Yu DX, Chiang FF. A randomized, double-blind, placebo-controlled trial of a Chinese herbal Sophora flower formula in patients with symptomatic haemorrhoids: a preliminary study. Afr J Tradit Complement Altern Med, 2013; 10(2):343–51. https://doi.org/10.4314/ajtcam.v10i2.21

Mosavat SH, Ghahramani L, Sobhani Z, Haghighi ER, Heydari M. Topical Allium ampeloprasum subsp Iranicum (Leek) extract cream in patients with symptomatic hemorrhoids: a pilot randomized and controlled clinical trial. J Evid Based Complementary Altern Med, 2015; 20(2):132–6. https://doi.org/10.1177/2156587214567954

Pappa E, Kontodimopoulos N, Niakas D. Validating and norming of the Greek SF-36 Health Survey, Qual Life Res 2005; 14:1433–8. https://doi.org/10.1007/s11136-004-6014-y

Riss S, Weiser FA, Schwameis K, Riss T, Mittlböck M, Steiner G, Stift A. The prevalence of hemorrhoids in adults. Int J Colorect Dis, 2012; 27(2):215–20. https://doi.org/10.1007/s00384-011-1316-3

Schulz KF, Altman DG, Moher D. For the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials. BMJ, 2010; 340:c332. https://doi.org/10.1136/bmj.c332

Taft C, Karlsson J, Sullivan M. Do SF-36 summary component scores accurately summarize subscale scores? Qual Life Res, 2001; 10(5):395–404. https://doi.org/10.1023/A:1012552211996

Ware JE Jr. SF-36 health survey update. Spine, 2000; 25(24):3130–9. https://doi.org/10.1097/00007632-200012150-00008

Ware JE, Sherbourne CD. The MOS 36-item short form health survey (SF-36): conceptual framework and items selection. Med Care, 1992; 30:473–83. https://doi.org/10.1097/00005650-199206000-00002

WHO (World Health Organization). The world traditional medicines situation, in traditional medicines: global situation, issues and challenges, Geneva, Switzerland: WHO Press pp 1–14, 2011.

World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Med Assoc, 2013; 27:2191–4.