Efficacy of cryotherapy plus topical Juniperus excelsa M. Bieb cream versus cryotherapy plus placebo in the treatment of Old World cutaneous leishmaniasis: A triple-blind randomized controlled clinical trial.
Cutaneous leishmaniasis is one of the highly prevalent endemic diseases in the Middle East and North Africa. Many treatment modalities have been recommended for this condition but success rates remain limited. Herbal remedies have also been used for treatment but evidence-based clinical trials with...
Published in: | PLOS Neglected Tropical Diseases |
---|---|
Main Authors: | , , , , , , , , |
Format: | Article in Journal/Newspaper |
Language: | English |
Published: |
Public Library of Science (PLoS)
2017
|
Subjects: | |
Online Access: | https://doi.org/10.1371/journal.pntd.0005957 https://doaj.org/article/279985116c714863b7b3cbf8f1c716ab |
id |
ftdoajarticles:oai:doaj.org/article:279985116c714863b7b3cbf8f1c716ab |
---|---|
record_format |
openpolar |
spelling |
ftdoajarticles:oai:doaj.org/article:279985116c714863b7b3cbf8f1c716ab 2023-05-15T15:18:25+02:00 Efficacy of cryotherapy plus topical Juniperus excelsa M. Bieb cream versus cryotherapy plus placebo in the treatment of Old World cutaneous leishmaniasis: A triple-blind randomized controlled clinical trial. Mohammad Mahdi Parvizi Farhad Handjani Mahmoodreza Moein Gholamreza Hatam Majid Nimrouzi Jafar Hassanzadeh Nasrin Hamidizadeh Hamid Reza Khorrami Mohammad Mehdi Zarshenas 2017-10-01T00:00:00Z https://doi.org/10.1371/journal.pntd.0005957 https://doaj.org/article/279985116c714863b7b3cbf8f1c716ab EN eng Public Library of Science (PLoS) http://europepmc.org/articles/PMC5655399?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0005957 https://doaj.org/article/279985116c714863b7b3cbf8f1c716ab PLoS Neglected Tropical Diseases, Vol 11, Iss 10, p e0005957 (2017) Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2017 ftdoajarticles https://doi.org/10.1371/journal.pntd.0005957 2022-12-31T02:44:16Z Cutaneous leishmaniasis is one of the highly prevalent endemic diseases in the Middle East and North Africa. Many treatment modalities have been recommended for this condition but success rates remain limited. Herbal remedies have also been used for treatment but evidence-based clinical trials with these products are sparse. In-vitro and in-vivo studies have shown the anti-leishmanial and curative effects of extract of fruits and leaves of Juniperus excelsa (J. excelsa). The aim of this study was to determine the efficacy of topical J. excelsa M. Bieb extract as an adjuvant to cryotherapy for the treatment of human CL.This study was designed as a two-arm triple-blind randomized placebo-controlled clinical trial using a parallel design. Seventy-two patients with clinical diagnosis of CL confirmed by leishmania smears were allocated to receive either a topical formulation of leaf of J. excelsa extract (group A) or placebo (group B) for 3 months. Both groups received cryotherapy as baseline standard treatment. Patients were evaluated before and weekly after the intervention was initiated until complete cure.Overall, 82% of patients in group A, experienced complete cure and 9% of them had partial cure. On the other hand, 34% in group B reported complete cure, while 14% of them had partial cure at the end of treatment protocol with a significant difference between the two groups (P< 0.001). The mean duration to healing of the lesions in patients who received J. excelsa extract was statistically significantly shorter than the placebo group (p = 0.04). No significant side effect was seen in the J. excelsa extract group except for mild to moderate local irritation after a few weeks in a few numbers of patients.The results of this study showed that topical J. excelsa extract can be used as an adjuvant treatment modality in addition to cryotherapy for accelerating the time to cure in addition to increasing the complete cure rate in CL.ClinicalTrials.gov IRCT2015082523753N1. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic PLOS Neglected Tropical Diseases 11 10 e0005957 |
institution |
Open Polar |
collection |
Directory of Open Access Journals: DOAJ Articles |
op_collection_id |
ftdoajarticles |
language |
English |
topic |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
spellingShingle |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Mohammad Mahdi Parvizi Farhad Handjani Mahmoodreza Moein Gholamreza Hatam Majid Nimrouzi Jafar Hassanzadeh Nasrin Hamidizadeh Hamid Reza Khorrami Mohammad Mehdi Zarshenas Efficacy of cryotherapy plus topical Juniperus excelsa M. Bieb cream versus cryotherapy plus placebo in the treatment of Old World cutaneous leishmaniasis: A triple-blind randomized controlled clinical trial. |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
Cutaneous leishmaniasis is one of the highly prevalent endemic diseases in the Middle East and North Africa. Many treatment modalities have been recommended for this condition but success rates remain limited. Herbal remedies have also been used for treatment but evidence-based clinical trials with these products are sparse. In-vitro and in-vivo studies have shown the anti-leishmanial and curative effects of extract of fruits and leaves of Juniperus excelsa (J. excelsa). The aim of this study was to determine the efficacy of topical J. excelsa M. Bieb extract as an adjuvant to cryotherapy for the treatment of human CL.This study was designed as a two-arm triple-blind randomized placebo-controlled clinical trial using a parallel design. Seventy-two patients with clinical diagnosis of CL confirmed by leishmania smears were allocated to receive either a topical formulation of leaf of J. excelsa extract (group A) or placebo (group B) for 3 months. Both groups received cryotherapy as baseline standard treatment. Patients were evaluated before and weekly after the intervention was initiated until complete cure.Overall, 82% of patients in group A, experienced complete cure and 9% of them had partial cure. On the other hand, 34% in group B reported complete cure, while 14% of them had partial cure at the end of treatment protocol with a significant difference between the two groups (P< 0.001). The mean duration to healing of the lesions in patients who received J. excelsa extract was statistically significantly shorter than the placebo group (p = 0.04). No significant side effect was seen in the J. excelsa extract group except for mild to moderate local irritation after a few weeks in a few numbers of patients.The results of this study showed that topical J. excelsa extract can be used as an adjuvant treatment modality in addition to cryotherapy for accelerating the time to cure in addition to increasing the complete cure rate in CL.ClinicalTrials.gov IRCT2015082523753N1. |
format |
Article in Journal/Newspaper |
author |
Mohammad Mahdi Parvizi Farhad Handjani Mahmoodreza Moein Gholamreza Hatam Majid Nimrouzi Jafar Hassanzadeh Nasrin Hamidizadeh Hamid Reza Khorrami Mohammad Mehdi Zarshenas |
author_facet |
Mohammad Mahdi Parvizi Farhad Handjani Mahmoodreza Moein Gholamreza Hatam Majid Nimrouzi Jafar Hassanzadeh Nasrin Hamidizadeh Hamid Reza Khorrami Mohammad Mehdi Zarshenas |
author_sort |
Mohammad Mahdi Parvizi |
title |
Efficacy of cryotherapy plus topical Juniperus excelsa M. Bieb cream versus cryotherapy plus placebo in the treatment of Old World cutaneous leishmaniasis: A triple-blind randomized controlled clinical trial. |
title_short |
Efficacy of cryotherapy plus topical Juniperus excelsa M. Bieb cream versus cryotherapy plus placebo in the treatment of Old World cutaneous leishmaniasis: A triple-blind randomized controlled clinical trial. |
title_full |
Efficacy of cryotherapy plus topical Juniperus excelsa M. Bieb cream versus cryotherapy plus placebo in the treatment of Old World cutaneous leishmaniasis: A triple-blind randomized controlled clinical trial. |
title_fullStr |
Efficacy of cryotherapy plus topical Juniperus excelsa M. Bieb cream versus cryotherapy plus placebo in the treatment of Old World cutaneous leishmaniasis: A triple-blind randomized controlled clinical trial. |
title_full_unstemmed |
Efficacy of cryotherapy plus topical Juniperus excelsa M. Bieb cream versus cryotherapy plus placebo in the treatment of Old World cutaneous leishmaniasis: A triple-blind randomized controlled clinical trial. |
title_sort |
efficacy of cryotherapy plus topical juniperus excelsa m. bieb cream versus cryotherapy plus placebo in the treatment of old world cutaneous leishmaniasis: a triple-blind randomized controlled clinical trial. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2017 |
url |
https://doi.org/10.1371/journal.pntd.0005957 https://doaj.org/article/279985116c714863b7b3cbf8f1c716ab |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
PLoS Neglected Tropical Diseases, Vol 11, Iss 10, p e0005957 (2017) |
op_relation |
http://europepmc.org/articles/PMC5655399?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0005957 https://doaj.org/article/279985116c714863b7b3cbf8f1c716ab |
op_doi |
https://doi.org/10.1371/journal.pntd.0005957 |
container_title |
PLOS Neglected Tropical Diseases |
container_volume |
11 |
container_issue |
10 |
container_start_page |
e0005957 |
_version_ |
1766348618441162752 |