The effect of a unique propolis compound (PropoelixTM) on clinical outcomes in patients with dengue hemorrhagic fever

Abstract

BackgroundDengue fever is a mosquito-borne virus belonging to the family Flaviviridae. It is an old virus that has re-emerged globally over the past 20 years and now causes a global burden of 50 million infections per year across approximately 100 countries. Despite this, there is no safe vaccine available, and therapy is largely supportive. Its pathogenesis is multifaceted and currently still poorly understood, leading to a lack of disease-specific therapy. Propolis is a natural antiviral and anti-inflammatory product derived from the saps of plants and mixed with the saliva of honeybees. Propoelix™ is a uniquely potent and water-soluble extract of propolis containing high concentrations of anti-inflammatory compounds like caffeic acid phenethyl ester.ObjectiveThe primary objective is to determine the effectiveness of a unique propolis extract (Propoelix™) on the clinical course of patients with dengue hemorrhagic fever (DHF). The secondary objective is to examine the effect of Propoelix™ on tumor necrosis factor-α (TNF-α) levels in patients with DHF.MethodsA double-blind, randomized, placebo-controlled trial was conducted at the Department of Internal Medicine, Gatot Soebroto Central Army Hospital in Jakarta, Indonesia, from May 2012 to July 2013. Sixty-three patients who met the inclusion criteria were enrolled in the trial. Patients were randomized to receive either two capsules of Propoelix™ 200 mg three times a day or placebo daily for 7 days. Clinical and laboratory variables of both groups, including the anti-inflammatory marker TNF-α, were investigated. Patients were deemed technically fit for discharge if their platelet counts had recovered and exceeded 100,000/μL but were all observed as inpatients for 7 days.ResultsThere were 31 patients in the Propoelix™ treatment group and 32 patients in the placebo group. Platelet counts in the Propoelix™-treated group showed a trend toward a faster recovery by day 3 of admission and became statistically significant by day 6 (101.42±48.79 vs 80.78±43.35 [103/mL], P=0.042) and day 7 (146.67±64.68 vs 107.84±57.22 [103/mL], P=0.006). Patients treated with Propoelix™ had a significantly greater decline in TNF-α levels on day 7 of therapy compared with patients in the placebo group (P=0.018). They also had a significantly shorter length of hospitalization compared with those in the placebo group (4.69±0.78 days vs 5.46±1.16 days, P=0.012).ConclusionPropoelix™ appears to hasten the improvement in platelet counts and TNF-α levels and shortens the duration of hospitalization in patients with DHF.

<p>Antiviral and immunomodulatory effects of polyphenols on macrophages infected with dengue virus serotypes 2 and 3 enhanced or not with antibodies</p>

“…CLEC5A has been also implicated in the induction of apoptosis and damage of endothelial cells in a murine model of DENV infection, in which the release of large amounts of TNF-α, as well as IL-6 and MCP-1, conduced to several vascular leakage, organ damage, extensive hemorrhage and death of infected mice 40. A clinical trial showed the relevance of TNF-α measurement as part of the indicators of recovery in patients with severe dengue and thrombocytopenia; indeed, treatment with Propoelix TM induced faster recovery in platelet counts and shorter length of hospitalization that were associated with lower levels of TNF-α in the treated group 52. Additional evidence of the role of TNF-α, IL-6 and other cytokines in dengue immunopathology comes from a study that prevent endothelial lesions in a murine model of dengue by direct blocking with antibodies against each cytokine 13.…”

Propolis and its potential against SARS-CoV-2 infection mechanisms and COVID-19 disease

“…Another relevant clinical trial was conducted by Soroy et al [ 225 ] on dengue hemorrhagic fever patients. Their double-blind, randomized and placebo-controlled trial evaluated the propolis product Propoelix TM (two 200 mg capsules, three times a day), demonstrating an improvement in platelet counts and a decrease in TNF-alfa, promoting a reduction in the duration of hospitalization time of the patients.…”

“…For preventive purposes, 30 drops/day or one capsule, are usually taken. However, considering the dosage safely used by Soroy et al [ 225 ] of 1200 mg/day, in more severe cases of COVID-19, dosages higher than 500 mg/day could be useful.…”

Standard methods forApis melliferapropolis research

“…Propolis extracts have been tested for many different types of biological and pharmacological activities (Burdock, 1998;Farooqui & Farooqui, 2010;Sforcin & Bankova, 2011), including in clinical trials (Henshaw et al, 2014;Hoheisel, 2001;Paulino, Coutinho, Coutinho, & Scremin, 2014;Soroy, Bagus, Yongkie, & Djoko, 2014;Vaz Coelho et al, 2007). Most significant is the number of clinical trials in dentistry (Anauate-Netto et al, 2014;Pereira et al, 2011;Prabhakar, Karuna, Yavagal, & Deepak, 2015;Purra, Mushtaq, Acharya, & Saraswati, 2014;Torwane et al, 2013).…”