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

Abstract

BackgroundCutaneous 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.Materials and methodsThis 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.ResultsOverall, 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.ConclusionThe 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.Trial registrationClinicalTrials.gov IRCT2015082523753N1

Overview of herbal and traditional remedies in the treatment of cutaneous leishmaniasis based onTraditional Persian Medicine

“…Juniperus excelsa M. Bieb, called Abhol and Ors in traditional Persian manuscripts, is also cited as an effective herbal medicine for the treatment of chronic infectious ulcers that are resistant to commonly used treatments 21,22 …”

In vitro and in vivo Assessment of Anti-Leishmanial Efficacy of Leaf, Fruit, and Fractions of Juniperus excelsa Against Axenic Amastigotes of Leishmania major and Topical Formulation in BALB/c Mice

“…However, the anti-leishmanial activity appeared in the sixth week. In a clinical trial study, Parvizi et al topical cream 5% of J. excelsa reduced the lesion size in patients with CL without side effects (23). Another investigation examined a Copaiba oil sample on L. major induced in BALB/c mice.…”

“…Greek Juniper has been used by Iranian folk practitioners for a long time (21). In recent studies, the anti-leishmanial activity of leaves, fruit, and fractions of J. excelsa on leishmania promastigotes had a potent effect, moreover, in a clinical trial study, the topical form of J. excelsa was effective against leishmaniasis lesions (22,23). The anti-leishmanial activity of this plant may be regarded as the presence of components, such as alkaloids, monoterpene, diterpene, sesquiterpene, and saponins as well as flavonoids (24,25).…”

Essential Oils as a Potential Treatment Option for Pediculosis

“…It is used in traditional medicine due to its antiseptic, neuroprotective, and anti-inflammatory properties [73]. Furthermore, it also has antileishmanial [74] and acaricidal (e.g., Dermatophagoides farinae) activities [75]. Some species such as Juniperus oxycedrus were found to be effective against head lice [36].…”