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Preventive effect of Malva on urinary toxicity after radiation therapy in prostate cancer patients: A multi-centric, double-blind, randomized clinical trial.

Mofid B, Rezaeizadeh H, Jaladat AM, Atarzadeh F, Moeini R, Motevalian A, Mosalaie A, Farhan F, Rakhsha A, Kashi AS - Electron Physician (2015)

Bottom Line: They were instructed to use the medication, i.e., Malva or the placebo, three times a day for six weeks.The median age of the 68 patients was 66.The positive results of this study warrant further studies in this field.

View Article: PubMed Central - PubMed

Affiliation: Associate Professor, Shohada-e-Tajrish Hospital, Department of Radiation Oncology, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

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.

No MeSH data available.


Related in: MedlinePlus

Prophylactic effect of Malva on the severity of dysuria
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f2-epj-07-1220: Prophylactic effect of Malva on the severity of dysuria

Mentions: Twenty-one of 27 patients in placebo group (77.7%) had dysuria, while 23 of 33 patients (69.6%) who received Malva (odds ratio=2.70 for dysuria) had dysuria. The mean scale of dysuria was 2.5 in the placebo group and 1.1 in the Malva group. There were no differences between the placebo group and Malva group before EBRT based on the dysuria score (p = 0.79). After two, four, and six weeks of Malva treatment, 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). On the whole, dysuria due to EBRT in the Malva group compared to the placebo group had statistically significant differences (p < 0.001) (Table 2). Figure 2 also shows the prophylactic effect of Malva on the severity of dysuria. There were no differences between the control group and the Malva group before the start of EBRT based on the VPSS (p = 0.43). After two, four, and six weeks of Malva treatment, VPSS due to EBRT was lower in the Malva group than in the control group, with statistically significant differences (p = 0.003, p = 0.001, p = 0.009, respectively). Overall, VPSS due to EBRT in the Malva group compared to the placebo group had statistically significant differences (p < 0.001) (Table 2). Figure 3 also shows the prophylactic effect of Malva on VPSS.


Preventive effect of Malva on urinary toxicity after radiation therapy in prostate cancer patients: A multi-centric, double-blind, randomized clinical trial.

Mofid B, Rezaeizadeh H, Jaladat AM, Atarzadeh F, Moeini R, Motevalian A, Mosalaie A, Farhan F, Rakhsha A, Kashi AS - Electron Physician (2015)

Prophylactic effect of Malva on the severity of dysuria
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4590556&req=5

f2-epj-07-1220: Prophylactic effect of Malva on the severity of dysuria
Mentions: Twenty-one of 27 patients in placebo group (77.7%) had dysuria, while 23 of 33 patients (69.6%) who received Malva (odds ratio=2.70 for dysuria) had dysuria. The mean scale of dysuria was 2.5 in the placebo group and 1.1 in the Malva group. There were no differences between the placebo group and Malva group before EBRT based on the dysuria score (p = 0.79). After two, four, and six weeks of Malva treatment, 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). On the whole, dysuria due to EBRT in the Malva group compared to the placebo group had statistically significant differences (p < 0.001) (Table 2). Figure 2 also shows the prophylactic effect of Malva on the severity of dysuria. There were no differences between the control group and the Malva group before the start of EBRT based on the VPSS (p = 0.43). After two, four, and six weeks of Malva treatment, VPSS due to EBRT was lower in the Malva group than in the control group, with statistically significant differences (p = 0.003, p = 0.001, p = 0.009, respectively). Overall, VPSS due to EBRT in the Malva group compared to the placebo group had statistically significant differences (p < 0.001) (Table 2). Figure 3 also shows the prophylactic effect of Malva on VPSS.

Bottom Line: They were instructed to use the medication, i.e., Malva or the placebo, three times a day for six weeks.The median age of the 68 patients was 66.The positive results of this study warrant further studies in this field.

View Article: PubMed Central - PubMed

Affiliation: Associate Professor, Shohada-e-Tajrish Hospital, Department of Radiation Oncology, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

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.

No MeSH data available.


Related in: MedlinePlus