Treatment topical with silver nanoparticles and <i>Stryphnodendron Adstringens</i> (Mart.) <i>Coville</i> in cervical lesions: randomized clinical trial

Nascimento, Cristiane Araújo; Santos, Ana Caroline Melo dos; Silva, Denise Macedo da; Barbosa, Nirliane Ribeiro; Moura, Edilson Leite de; Silva, Veracilda Bezerra da; Balliano, Tatiane Luciano; Figueiredo, Elaine Virginia Martins de Souza; Farias, Karol Fireman de; Pitta, Guilherme Benjamin Brandão

doi:10.1590/1980-220X-REEUSP-2022-0338en

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Original Article • Rev. esc. enferm. USP 57 • 2023 • https://doi.org/10.1590/1980-220X-REEUSP-2022-0338en copy

Treatment topical with silver nanoparticles and Stryphnodendron Adstringens (Mart.) Coville in cervical lesions: randomized clinical trial

Tratamento tópico com nanopartículas de prata e Stryphnodendron Adstringens (Mart.) Coville em lesões cervicais: ensaio clínico randomizado

Tratamiento tópico con nanopartículas de plata y Stryphnodendron Adstringens (Mart.) Coville en lesiones cervicales: ensayo clínico aleatorizado

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

Objective:

To assess the feasibility of incorporating technology as a new alternative for treating topics on cervical lesions.

Method:

This is a randomized, double-blind, controlled clinical trial with a prospective design. During the realization of this study, 43 women were included and divided between groups A (ointment without silver nanoparticles n = 23) and B (ointment with silver nanoparticles n = 20) clinically healthy and who used the unified health system.

Results:

There were no significant differences when comparing before and after the use of ointment for IVA test (p = 0.15), Schiller test (p = 0.15), cellular changes (p = 0.47) and microbiological analysis (p = 0.89) through cytology. After use, no adverse reaction was observed in the sample studied.

Conclusion:

Based on the results identified in this study, identified that the product is safe and does not promote adverse events. Regarding the effectiveness of the product in uterine cervical lesions, it is necessary to continue the study in phase II. Registro de Ensaios Clínicos Brasileiros: UTN: U1111-1218-2820.

DESCRIPTORS
Squamous Intraepithelial Lesions of the Cervix; Uterine Cervical Neoplasms; Stryphnodendron barbatimam; Phytotherapy

Pap smear	Before		After
Pap smear	N	%	N	%
Sample evaluation
Satisfactory	38	88.4	39	90.7
Poor	5	11.6	4	9.3
Epithelium represented in the sample
Scaly glandular metaplastic	29	67.4	37	86
Scaly metaplastic	6	14	0	0
Scaly	3	7	2	4.7
Unsatisfactory	5	11.6	4	9.3
Representativeness of the transformation zone
Yes	33	76.8	36	83.7
Not	5	11.6	3	7
Poor	5	11.6	4	9.3
Benign reactive or repairing cellular changes
Inflammation. immature squamous metaplasia	10	23.3	7	16.3
Inflammation. atrophy with inflammation	4	9.3	32	74.4
Inflammation	22	51.2	0	0
Inflammation. nuclear activation	2	4.6	0	0
Poor	5	11.6	4	9.3
Microbiology
Lactobacillus sp.	26	60.5	26	60.5
Lactobacillus sp. Coconuts and other bacilli.	4	9.3	7	16.2
Lactobacillus sp. Coconuts. Candida sp.	4	9.3	0	0
Supracytoplasmic bacilli (suggestive of Gardnerella/ Mobiluncus)	1	2.3	6	14
Poor	8	18.6	4	9.3
Conclusion of the analysis
Negative for malignancy	32	74.4	35	81.4
Atypical cells of undetermined significance. Scaly: Possibly non-neoplastic (ASC-US)	6	14	4	9.3
Poor	5	11.6	4	9.3

Pap smear	Before								After
	Barbatimão ointment					X²	GL	p¹	Barbatimão ointment					X²	GL	p^1a
	No silver nanoparticles		With silver nanoparticles						No silver nanoparticles		With silver nanoparticles
	N^b	%	N^b	%	Total				N^b	%	N^b	%	Total
Epithelia represented in the sample					34	3.848	1	0.05					41	0.024	1	0.87
Scaly. glandular. metaplastic	17	50.0	11	32.4	28				20	48.8	17	41.5	37
Scaly. metaplastic	1	2.9	5	14.7	6				–	–	–	–
Scaly	–	–	–	–	0				2	4.9	2	4.9	4
Benign reactive or repairing cellular changes					37	3.446	6	0.75					42	1.389	2	0.49
Inflammation. metaplasia. scaly immature	5	13.5	2	5.4	7				2	4.8	4	9.5	6
Inflammation. atrophy with inflammation	3	8.1	2	5.4	5				19	45.2	14	33.3	33
Inflammation	11	29.7	12	32.4	22				2	4.8	1	2.4	3
Inflammation. nuclear activation	1	2.7	1	2.7	2				–	–	–	–	0
Microbiology					34	8.133	6	0.22					39	2.414	4	0.66
Lactobacillus sp.	11	32.4	10	29.4	21				11	28.2	13	33.3	24
Lactobacillus sp. Coconuts and other bacilli.	3	8.8	5	14.6	8				5	11.9	3	7.7	8
Lactobacillus sp. Coconuts. Candida sp.	3	8.8	1	2.9	4				–	–	–	–	0
Supracytoplasmic bacilli (suggestive of Gardnerella/Mobiluncus)	1	2.9	0	0	1				5	12.8	2	5.1	7
Conclusion of the analysis					37	0.047	1	0.82					39	0.27	1	0.87
Negative for malignancy	17	45.9	14	37.8	31				19	48.7	16	41.0	35
Atypical cells of undetermined significance. Scaly: Possibly non-neoplastic (ASC-US)	3	8.1	3	8.1	6				2	5.1	2	5.1	4
Sample observation					30	0.213	3	0.97					43	4.686	4	0.32
Nonspecific chronic cervicitis with squamous metaplasia	9	30.0	6	20.0	15				6	14.0	10	23.3	16
Chronic bacterial cervicitis with squamous metaplasia and nuclear activation	4	13.3	3	10.0	7				6	14.0	4	9.3	10
Chronic mycotic cervicitis with squamous metaplasia	1	3.3	1	3.3	2				3	7.0	2	4.7	5
Suggested colposcopy with directed biopsy.	3	10.0	3	10.0	6				8	18.6	3	7.0	11
Poor	–	–	–	–	0				0	0.0	1	2.3	1

Culture of vaginal secretion	Before								After
	Barbatimão ointment					X ²	GL	p ¹	Barbatimão ointment					X ²	GL	p ¹	p ^a
	No silver nanoparticles		With silver nanoparticles						No silver nanoparticles		With silver nanoparticles
	N	%	N	%	Total N				N	%	N	%	Total N
Presence of Microorganism					43	0.414	1	0.52					43	0.022	1	0.883	1.00^c
Absent	2	4.65	3	6.97	5				2	4.65	2	4.65	4
Present	21	48.8	17	39.5	38				21	48.8	18	41.8	39
Pathogenicity					43	1.082	1	0.29					43	0.393	1	0.531	0.02^b
Normal Microbiota	18	41.8	18	41.8	36				14	32.5	14	32.5	28
Pathogenic	5	11.6	2	4.65	7				9	20.9	6	13.9	15
Aerobic/Anaerobic					43	0	0	0					43	0.890	1	0.345	1.00^b
Optional anaerobic	23	53.4	20	46.5	43				22	51.1	20	46.5	42
Anaerobic	0	0.0	0	0.0	0				1	2.33	0	0.0	1
Antibiotic resistance					43	0.890	1	0.34					43	0.527	1	0.468	0.62^b
No	22	51.1	20	46.5	42				22	51.1	18	41.8	40
Yes	1	2.33	0	0.0	1				1	2.33	2	4.65	3
Gram positive/Gram negative					43	0.820	1	0.36					43	0.890	1	0.345	0.37^b
Positive	20	46.5	19	44.1	39				22	51.1	20	46.5	42
Variable	3	6.71	1	2.33	4				1	2.33	0	0.0	1
Search for Trichomonas vaginallis					43	0	0	0					43	0	0	0
Absent	23	53.4	20	46.5	43				23	53.4	20	46.5	43
Present	0	0.0	0	0.0	0				0	0.0	0	0.0	0
Search for Gardnerella vaginallis					43	0.225	1	0.63					43	1.082	1	0.298	0.12^b
Absent	21	48.8	19	44.1	40				18	41.8	18	41.8	36
Present	2	4.65	1	2.33	3				5	11.6	2	4.65	7
Search for Monilia					43	0.096	1	0.75					43	0.045	1	0.832	0.68^b
Absent	20	46.8	18	41.8	38				19	44.1	17	39.8	36
Present	3	6.70	2	4.65	5				4	9.30	3	6.70	7

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[1] Corresponding author: Guilherme Benjamin Brandão Pitta Rua Doutor Jorge de Lima, 113, Trapiche da Barra 57010-382 – Maceió, AL, Brazil guilhermebbpitta@gmail.com