Evaluation of acute and sub-chronic oral toxicities of Neoneaster in rats.

ETHNOPHARMACOLOGICAL RELEVANCE: Jaundice is a condition caused by the elevation of bilirubin level in the blood. Due to the neurological and neurodevelopmental sequalae of jaundice in newborns, the high cost of the treatment, and the side effects of the currently used therapies, novel therapeutically approaches are needed. Purgative manna (Shir-e-Khesht) has been used in Persian traditional medicine to reduce serum bilirubin levels of neonates. Neoneaster® is a natural health product formulated by a unique method from the manna of Cotoneaster nummularius Fisch. & C.A.Mey. for treating neonatal jaundice and managing constipation. The main component of Neoneaster®, mannitol, is an osmotic laxative which could increase intestinal transit and reduce the re-absorption of bilirubin in the enterohepatic cycle. AIM OF THE STUDY: We conducted this study to investigate acute and sub-chronic oral toxicities of Neoneaster in Wistar rats. MATERIALS AND METHODS: In the acute oral toxicity test, based on OECD 423 we administered Neoneaster to the Wistar rats at doses of 5, 50, 300, and 2000 mg/kg(OECD, 2002). Toxicological effects, including mortality and behavioral changes, were recorded for 14 days and compared to the control group. We also carried out histopathological assessments of the tissues of liver, heart, kidney, and spleen after this period. To evaluate sub-chronic toxicity, while administering 2000 mg/kg of Neoneaster daily to the Wistar rats, we recorded for changes in mortality and behavior for 45 days and compared these to the values of the control group. We also carried out biochemical, hematological, and histopathological assessments after this period. RESULTS: In both acute and sub-chronic oral toxicity tests, no mortalities, behavioral abnormalities, and histological signs of toxicity was observed in any of the administered doses in comparison to the control group. The percentage of weight gains in acute toxicity test and the weight gain in sub-chronic test were not significant (P>0/05). There were also no significant differences in hematological and biochemical markers (P>0/05). Based on our finding, Neoneaster can be classified as category 5 in the Globally Harmonized Chemical Classification and Labeling System (GHS) as its Lethal Dose 50 (LD50) is higher than 2000 mg/kg. CONCLUSIONS: This study suggests that Neoneaster is safe and can be classified as category 5 in the GHS system.

Efficacy and safety of date palm leaf-based ointment for treatment of cutaneous warts: A pilot clinical trial.

Despite the considerably high prevalence of cutaneous warts, no optimally effective and safe treatment is available. Leaves of date palm (Phoenix dactylifera L.; Arecaceae) have long been used in Iran's folk medicine as a remedy for warts. To assess the state-of-the-art evidence on using P. dactylifera L. for warts, we conducted a systematic review using CINAHL (via EBSCO), Embase, Medline (via PubMed), ProQuest, Scopus, and Web of Science. We conducted an open-label uncontrolled pilot clinical study to evaluate the efficacy and safety of a proprietary topical date palm leaf-based ointment for the treatment of various types of nongenital warts. This study consisted of an 8-week treatment phase and a 4-week follow-up phase. The assessed outcomes included complete clearance, patient satisfaction (on Likert scale), and the occurrence of any adverse effect. The systematic review demonstrated that the effects of date palm on warts have not been scientifically studied. Thirty patients entered the study with a mean age of 29.5 years (SD = 14.04); among which 17 were female and 13 were male. The patients presented diverse types of warts: verruca vulgaris 15 (50%), plantar 9 (30%), plane 2 (7%), periungual 2 (7%), and warts at multiple sites 2 (7%). In this trial, 19 patients (63.3%) experienced complete clearance and 5 patients (16.6%) experienced partial clearance. Eight patients (26.67%) dropped out during the study. 21 (70%) patients were very satisfied (score on Likert scale = 5) while 1 (3.3%) patient with partial clearance was somewhat satisfied (score on Likert scale = 4). No adverse effect was observed. The results of this pilot study indicate that the date palm leaf-based ointment is a promising treatment whose efficacy and safety should be further investigated in a randomized controlled clinical trial.