P-valor e dimensão do efeito em estudos clínicos e experimentais

Miola, Anna Carolina; Miot, Hélio Amante

doi:10.1590/1677-5449.210038

Cited by 22 publications

(15 citation statements)

References 38 publications

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“…15 Data analysis was performed with the IBM SPSS version 29.0 (IBM), and 1-tailed P values less than .05 were considered significant for the change of hair density. 16…”

Section: Discussionmentioning

confidence: 99%

“…The longitudinal comparison of patient outcomes between times was performed using a generalized linear model of mixed effects with a robust covariance matrix (Šidák post hoc correction) and adequate probability distribution for each sample . Data analysis was performed with the IBM SPSS version 29.0 (IBM), and 1-tailed P values less than .05 were considered significant for the change of hair density …”

Section: Methodsmentioning

confidence: 99%

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Oral Minoxidil vs Topical Minoxidil for Male Androgenetic Alopecia

Penha,

Miot,

Kasprzak

et al. 2024

JAMA Dermatol

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ImportanceThere has been increased interest in low-dose oral minoxidil for androgenetic alopecia (AGA) treatment. However, the efficacy of oral minoxidil for male AGA is yet to be evaluated in comparative therapeutic trials.ObjectiveTo compare the efficacy, safety, and tolerability of daily oral minoxidil, 5 mg, vs twice-daily topical minoxidil, 5%, for 24 weeks in the treatment of male AGA.Design, Setting, and ParticipantsThis double-blind, placebo-controlled randomized clinical trial was conducted at a single specialized clinic in Brazil. Eligible men with AGA aged 18 to 55 years classified using the Norwood-Hamilton scale as 3V, 4V, or 5V were included and randomized. Data were collected from January to December 2021, and data were analyzed from September 2022 to February 2023.InterventionsParticipants were randomized 1:1 into 2 groups: oral minoxidil, 5 mg, daily and topical placebo solution; or 1 mL of topical minoxidil, 5%, twice daily and oral placebo for 24 weeks.Main Outcomes and MeasuresThe primary outcome was change in terminal hair density on the frontal and vertex regions of the scalp. The secondary outcomes were change in total hair density and photographic evaluation.ResultsAmong 90 enrolled participants, 68 completed the study; of these, the mean (SD) age was 36.6 (7.8) years. A total of 33 participants were enrolled in the oral minoxidil group and 35 in the topical treatment group. Both groups were homogenous in terms of demographic data and AGA severity. For the frontal area, the mean change from baseline to week 24 between groups was 3.1 hairs per cm2 (95% CI, −18.2 to 21.5; P = .27) for terminal hair density and 2.6 hairs per cm2 (95% CI, −10.3 to 15.8; P = .32) for total hair density. For the vertex area, the mean change from baseline to week 24 was 23.4 hairs per cm2 (95% CI, −0.3 to 43.0; P = .09) for terminal density and 5.5 hairs per cm2 (95% CI, −12.5 to 23.5; P = .32) for total hair density. According to the photographic analysis, oral minoxidil was superior to topical minoxidil on the vertex (24%; 95% CI, 0 to 48; P = .04) but not on the frontal scalp (12%; 95% CI, −12 to 36; P = .24). The most common adverse effects in the oral minoxidil group were hypertrichosis (22 of 45 [49%]) and headache (6 of 45 [14%]).Conclusions and RelevanceIn this study, oral minoxidil, 5 mg, once per day for 24 weeks did not demonstrate superiority over topical minoxidil, 5%, twice per day in men with AGA.Trial RegistrationBrazilian Registry of Clinical Trials Identifier: RBR-252w9r

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“…15 Data analysis was performed with the IBM SPSS version 29.0 (IBM), and 1-tailed P values less than .05 were considered significant for the change of hair density. 16…”

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Oral Minoxidil vs Topical Minoxidil for Male Androgenetic Alopecia

Penha,

Miot,

Kasprzak

et al. 2024

JAMA Dermatol

Self Cite

View full text Add to dashboard Cite

show abstract

“…Significance was set as a p-value ≤0.05. 21 The sample size was preliminarily estimated to detect up to 70% of participants with a reduction of MAS score by 2 points from baseline (D0), or MAS = 0 if MAS = 1 at D0, at D90. Considering a standard error of 20%, alpha = 0.05 and power = 0.80, resulting in 20 treatments.…”

Section: Methodsmentioning

confidence: 99%

IncobotulinumtoxinA for the Treatment of Glabella and Forehead Dynamic Lines: A Real-Life Longitudinal Case Series

Cunha¹,

Vasconcelos²,

Sessa³

et al. 2023

CCID

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Background There is substantial interpersonal variation in the patterns of muscular contraction that substantiates the use of personalized points of application and dosages in clinical practice to achieve optimal results. Nevertheless, there has been no real-life therapeutic series with botulinum toxin for aesthetic treatment of the face in which the subjects were systematically followed to assess its long-term benefit. Purpose To assess the performance and length of the treatment of glabellar and forehead lines with IncobotulinumtoxinA in a real-life setting. Patients and Methods We enrolled 20 adults with indications for the treatment of upper facial dynamic lines (glabella and forehead) with botulinum toxin. The protocols of injection points were personalized by the injectors. The participants were photographed under maximum facial contraction before the application (D0) and after 15, 90, 120, and 180 days. The photos were randomly assessed by two blinded experienced raters to consensually grade the dynamic lines according to the Merz Aesthetics Scales (MAS). Efficacy was defined as the reduction in the MAS score. Results At D15, 18 (90%; 95% CI: 80%–100%) participants reached the zero score, or a 2-point reduction on the MAS score from the forehead and 16 (80%; 95% CI: 65–90%) reached that reduction for the glabella. These values from D90 were 14 (70%; 95% CI: 55–85%) for both sites. At D120, these values were 11 (55%; 95% CI: 35–75%) and 8 (40%; 95% CI: 25–55%) for the forehead and glabella. At D180, 10 (50%; 95% CI: 30–70%) participants presented a MAS score for forehead or glabella dynamic lines lower than the score assessed at D0. Conclusion As much as 70% of the patients sustained a reduction of scores after 120 days of the treatment for dynamic glabellar and forehead lines. Half of the patients evidenced prolonged benefit at 180 days.

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“…Data were tabulated in MS Excel 2003® and analyzed using IBM SPSS 25.0 v 26 . Statistical significance was defined as P < 0.05 27 …”

Section: Methodsmentioning

confidence: 99%

Association between calcium channel blockers and the severity of actinic keratosis on face and scalp: a cross‐sectional study

Gioppo,

de Castro Martins,

Santos

et al. 2023

Int J Dermatology

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BackgroundActinic keratosis (AK) is a skin condition associated with age, sun exposure, and immunosuppression. Certain drugs, such as photosensitizing medications and calcium channel blockers (CCBs), have been linked to AK. This study explores the impact of individual, behavioral, and exposure factors on the severity of AKs on the face and scalp.MethodsA multicenter cross‐sectional study was conducted on immunocompetent individuals with at least one AK on their face or scalp and assessed demographic factors, sun exposure and protection, history of skin cancer, and medication use within the last 6 months. The primary outcome was the Actinic Keratosis Area and Severity Index (AKASI) score, and a hierarchical generalized linear model was used to evaluate the variation in AKASI scores, adjusting for gender, age, and skin phototype.ResultsTwo hundred seventy subjects between 39 and 92 years were evaluated. The majority had phototype I or II (77%), male gender (51%), personal history of skin cancer (55%), and low adherence to sunscreen use (29%). The use of photosensitizing medications was reported by 61%. Through multivariate analysis, older age (βSE = 0.14; P < 0.01), lighter skin phototype (βSE = 0.15; P = 0.01), history of skin cancer (βSE = 0.12; P < 0.01), sunburning (βSE = 0.12; P < 0.01), and use of CCBs (βSE = 0.11; P = 0.02) were identified as independent risk factors for AK severity. Photosensitizing drugs were not identified as risk factors.ConclusionOlder age, lower skin phototype classifications, and a personal history of skin cancer were confirmed as severity risk factors for AK, while the use of CCBs was associated with more severe AK.

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P-valor e dimensão do efeito em estudos clínicos e experimentais

Abstract: Copyright© 2021 Os autores. Este é um artigo publicado em acesso aberto (Open Access) sob a licença Creative Commons Attribution, que permite uso, distribuição e reprodução em qualquer meio, sem restrições desde que o trabalho original seja corretamente citado.

Cited by 22 publications

References 38 publications

Oral Minoxidil vs Topical Minoxidil for Male Androgenetic Alopecia

Oral Minoxidil vs Topical Minoxidil for Male Androgenetic Alopecia

IncobotulinumtoxinA for the Treatment of Glabella and Forehead Dynamic Lines: A Real-Life Longitudinal Case Series

Association between calcium channel blockers and the severity of actinic keratosis on face and scalp: a cross‐sectional study

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