Preventive effect of Malva on urinary toxicity after radiation therapy in prostate cancer patients

A multi-centric, double-blind, randomized clinical trial

Authors

  • Amir Shahram Yousefi Kashi Assistant Professor, Shohada-e-Tajrish Hospital, Department of Radiation Oncology, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Keywords:

Malva, dysuria, radiation therapy, prostate cancer

Abstract

Background: For patients receiving external beam radiation therapy (EBRT) after radical prostatectomy as adjuvant treatment or patients receiving EBRT as definitive treatment, partial irradiation of the urinary bladder is common. Many of such patients experience some degree of radiation-induced cystitis during or after EBRT. There is currently no efficient treatment for preventing radiation cystitis. 

Objective: The aim of this study was to evaluate the effectiveness of one of the safe mucilaginous herbs (Malva) in preventing radiation-induced dysuria in patients who are undergoing EBRT for prostate cancer.

Methods: From April 2013 to August 2014, 68 patients were randomized into two groups using four block randomization, 34 to the drug (Malva) group and 34 to the placebo group. Of the 68 patients who began the study, 60 completed it. They were instructed to use the medication, i.e., Malva or the placebo, three times a day for six weeks. They were followed by a physician every two weeks for eight weeks, and urinary function was assessed in each visit by asking questions based on the Visual Prostate Symptom Score (VPSS) and a dysuria severity score. The changes in the VPSS and dysuria severity score between baseline and each follow-up visit were compared between the two groups in the study using repeated measures analysis of variance (ANOVA) and t-tests.

Results: The median age of the 68 patients was 66. Twenty-one of 27 patients in the control group (77.7%) suffered from dysuria, while dysuria was detected in 23 of 33 patients (69.6%) who received Malva (odds ratio=2.70 for dysuria). After two weeks, four weeks, and six weeks of treatment with Malva, dysuria due to EBRT was milder in the treatment group than in the control group, and the differences were statistically significant (p = 0.005, p = 0.004, p = 0.001, respectively).

Conclusion: To the best of our knowledge, our study is the first study to assess the protective effect of a mucilaginous herb (Malva) against urinary toxicity induced by EBRT. The positive results of this study warrant further studies in this field. 

Clinical Trial Registration: The study was registered in the Iranian Clinical Trial Registry Center (IRCT2012100711026N1).

Funding: This study was supported by a grant from Tehran University of Medical Sciences

References

Loeb S, Nadler RB. Management of the complications of external beam radiotherapy and brachytherapy.

Current Prostate Reports 2006; 4(1):14-22. Doi: 10.1007/s11918-006-0017-9

Dass R, Price PW, Goosey R, Spencer M, Prütz C, Ahlgren G, et al. Estimating Prevalence of Prostate

Cancer Clinical States Using a Dynamic Patient Progression Model. Value in Health 2013; 16(7):A397- A97. Doi: 10.1016/j.jval.2013.08.428

Rosewall T, Potvin M, Bayley A, Catton C, Currie G, Wheat J, et al. The Effects of External Beam

Radiotherapy on the Normal Urinary Bladder-A Histopathological Review. J Med Imag Radiat Sci2011;

(4):189-97. Doi: 10.1016/j.jmir.2011.03.002

Dunlap C, Enos E, Thom D, Zwickey H. An Integrative Approach to Interstitial Cystitis. Explore: Explore

(NY). 2013; 9(1):48-52. Doi: 10.1016/j.explore.2012.10.004. PMID: 23294821

Razavi SM, Zarrini G, Molavi G, Ghasemi G. Bioactivity of Malva sylvestris L., a medicinal plant from

Iran. Iran J Basic Med Sci. 2011; 14(6):574. PMID: 23493458, PMCID: PMC3586856

Gruenwald J, Brendler T, Jaenicke C. PDR for herbal medicines: Thomson PDR, 2004.

Aghili Khorasani shirazi MH, 1771. Makhzan-al-Advia Edited by Rahimi R, Shams Ardekani MR,

Farjadmand F. (in persian). Tehran: Tehran University of Medical Sciences, 2009. Available from:

http://aqlibrary.org/UserFiles/File/makhzan.pdf:71.

Gasparetto JC, Martins CAF, Hayashi SS, Otuky MF, Pontarolo R. Ethnobotanical and scientific aspects of

Malva sylvestris L.: a millennial herbal medicine. J Pharm Pharmacol. 2012; 64(2):172-89. Doi:

1111/j.2042-7158.2011.01383.x. PMID: 22221093

Thapa D, Ghosh R. Antioxidants for prostate cancer chemoprevention: Challenges and opportunities.

Biochem Pharmacol. 2012; 83(10):1319-30. Doi: 10.1016/j.bcp.2011.12.027. PMID: 22248733

Ravishankar D, Rajora AK, Greco F, Osborn HMI. Flavonoids as prospective compounds for anti-cancer

therapy. Int J Biochem Cell Biol. 2013; 45(12):2821-31. Doi: 10.1016/j.biocel.2013.10.004. PMID:

Jaladat AM, Atarzadeh F, Rezaiezadeh H, Amin G. Avicenna's dietary and herbal recipe for urethral

syndrome. Infect Dis Clin Pract. 2015;23(3):168. Doi: 10.1097/ipc.0000000000000244

Jaladat AM, Atarzadeh F, Rezaiezadeh H, Mofid B, Mosalaie A, Farhan F, et al. Botanicals: An alternative

remedy to radiotherapy-induced dysuria. Compl Ther Med. 2015;23(1):90-9. Doi:

1016/j.ctim.2014.11.004

Merrick GS, Butler WM, Wallner KE, Allen Z, Galbreath RW, Lief JH. Brachytherapy‐related dysuria.

BJU international 2005; 95(4):597-602. Doi: 10.1111/j.1464-410X.2005.05346.x. PMID: 15705087

Elshaikh MA, Ulchaker JC, Reddy CA, Angermeier KW, Klein EA, Chehade N, et al. Prophylactic

tamsulosin (Flomax) in patients undergoing prostate 125I brachytherapy for prostate carcinoma: final

report of a double-blind placebo-controlled randomized study. Int J Radiat Oncol Biol Phys 2005;

(1):164-9. Doi: 10.1016/j.ijrobp.2004.09.036. PMID: 15850917

Coleman CN, Kelly L, Riese Daly N, Beard C, Kaplan I, Lamb C, et al. Phase III study of ibuprofen versus

placebo for radiation-induced genitourinary side effects. Int J Radiat Oncol Biol Phys2002; 54(1):191-94.

Doi: 10.1016/S0360-3016(02)02907-3

Blaivas JG, Weiss JP, Jones M. The pathophysiology of lower urinary tract symptoms after brachytherapy

for prostate cancer. BJU international 2006; 98(6):1233-37. Doi: 10.1111/j.1464-410X.2006.06491.x.

PMID: 17125481

Barros L, Carvalho AM, Ferreira IC. Leaves, flowers, immature fruits and leafy flowered stems of Malva

sylvestris: a comparative study of the nutraceutical potential and composition.. Food Chem Toxicol. 2010;

(6):1466-72. Doi: 10.1016/j.fct.2010.03.012. PMID: 20233600

Bonetta A, Di Pierro F. Enteric-coated, highly standardized cranberry extract reduces risk of UTIs and

urinary symptoms during radiotherapy for prostate carcinoma. Cancer Manag Res. 2012;4: 281. PMID:

PMCID: PMC3437800

Campbell G, Pickles T, D'yachkova Y. A randomised trial of cranberry versus apple juice in the

management of urinary symptoms during external beam radiation therapy for prostate cancer.Clin Oncol.

; 15(6):322-28. Doi: 10.1016/S0936-6555(03)00161-4

Martinez Figueiras N, Rey Paz M, Teijeiro Alonso M. Cranberry prevention urinary toxicity. Rep Practical

Oncol Radiother. 2013; 18:S67-S67. Doi: 10.1016/j.rpor.2013.03.741

Published

2022-03-08