Ficus septica exudate, a traditional medicine used in Papua New Guinea for treating infected cutaneous ulcers: in vitro evaluation and clinical efficacy assessment by cluster randomised trial
Por:
Deli, J, Gonzalez-Beiras, C, Guldan, GS, Moses, RL, Dally, J, Moseley, R, Lundy, FT, Corbacho-Monne, M, Walker, SL, Cazorla, MU, Ouchi, D, Fang, R, Briggs, M, Kiapranis, R, Yahimbu, M, Mitja, O and Prescott, TAK
Publicada:
1 may 2022
Ahead of Print:
1 mar 2022
Resumen:
Background and objectives: Infected cutaneous ulcers are major health problems for children living in rural areas of Papua New Guinea. The inaccessibility of affected populations and lack of access to basic healthcare, make a local plant-based therapy an attractive treatment option. We assessed Ficus septica exudate in biological assays relevant to wound healing. We then carried out a clinical trial to determine the exudate's efficacy in healing small cutaneous ulcers compared with Savlon antiseptic cream, and soap and water washing. Methods: Pre-clinical in vitro assessment of the exudate was carried out using assays to monitor the pro inflammatory responses of M1 macrophages and neutrophils, antibacterial assays using known ulcer pathogens, an Ames test for mutagenicity and LC-MS chemical analysis of the exudate. An open label cluster randomised clinical trial was performed, enrolling participants from three different clusters with skin lesions less than 1 cm in diameter. Each cluster comprising 50 participants was randomly assigned to one of three treatment arms namely topical exudate, topical Savlon antiseptic cream, and standard care (soap and water treatment), all administered daily for 2 days. The primary outcome was clinical healing/improvement measured at days 7 and 14, assessed by three dermatologists using blinded photographs. The primary analysis was assessed as non-inferiority of F. septica treatment based on the risk difference for healing/improvement. Results: In vitro, the exudate which is rich in the alkaloid ficuseptine, was found to be non-mutagenic whilst also inhibiting pro-inflammatory responses and exhibiting antibacterial activity. When administered to participants enrolled in the clinical trial, no significant differences were observed between the healing efficacy of F. septica exudate and the two comparator treatments (Savlon antiseptic cream and soap/water treatment). At day 14, but not at day 7, the efficacy of F. septica exudate for healing/improving the ulcers was non-inferior to Savlon antiseptic cream or water/soap treatment. Conclusions: F. septica exudate is non-mutagenic and has both bactericidal and anti-inflammatory properties. When applied topically to small cutaneous ulcers, the exudate has a healing effect that is non-inferior to Savlon antiseptic cream and standard treatment with soap and water at day 14. Our findings, which should be confirmed in larger clinical trials, have important public health implications.
Filiaciones:
Deli, J:
Univ Papua New Guinea, Sch Med & Hlth Sci, Div Publ Hlth, Port Moresby, Papua N Guinea
:
Univ Autonoma Barcelona, Hosp Univ Germans Trias & Pujol, Fight AIDS & Infect Dis Fdn, Barcelona, Spain
Guldan, GS:
Univ Papua New Guinea, Sch Med & Hlth Sci, Div Publ Hlth, Port Moresby, Papua N Guinea
Moses, RL:
Cardiff Univ, Sch Dent, Cardiff Inst Tissue Engn & Repair, Oral & Biomed Sci, Cardiff, Wales
Dally, J:
Cardiff Univ, Sch Dent, Cardiff Inst Tissue Engn & Repair, Oral & Biomed Sci, Cardiff, Wales
Moseley, R:
Cardiff Univ, Sch Dent, Cardiff Inst Tissue Engn & Repair, Oral & Biomed Sci, Cardiff, Wales
Lundy, FT:
Queens Univ Belfast, Sch Med Dent & Biomed Sci, Wellcome Wolfson Inst Expt Med, Belfast BT9 7BL, Antrim, North Ireland
:
Univ Autonoma Barcelona, Hosp Univ Germans Trias & Pujol, Fight AIDS & Infect Dis Fdn, Barcelona, Spain
Walker, SL:
London Sch Hyg & Trop Med, London, England
Cazorla, MU:
Univ Autonoma Barcelona, Hosp Univ Germans Trias & Pujol, Fight AIDS & Infect Dis Fdn, Barcelona, Spain
Ouchi, D:
Univ Autonoma Barcelona, Hosp Univ Germans Trias & Pujol, Fight AIDS & Infect Dis Fdn, Barcelona, Spain
Fang, R:
Royal Bot Gardens, Richmond TW9 3AB, Surrey, England
Briggs, M:
Royal Bot Gardens, Richmond TW9 3AB, Surrey, England
Kiapranis, R:
Papua New Guinea Forest Res Inst, Papua New Guinea, Lae, Papua N Guinea
Yahimbu, M:
Univ Papua New Guinea, Sch Med & Hlth Sci, Div Publ Hlth, Port Moresby, Papua N Guinea
:
Univ Autonoma Barcelona, Hosp Univ Germans Trias & Pujol, Fight AIDS & Infect Dis Fdn, Barcelona, Spain
Lihir Med Ctr Int SOS, Lihir Isl, Papua N Guinea
Prescott, TAK:
Royal Bot Gardens, Richmond TW9 3AB, Surrey, England
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