RESUMO
OBJECTIVE: Aim of our study was to evaluate the effectiveness of the association between N-Palmitoylethanolamine and transpolydatin in the management of chronic pelvic pain related to EMS. STUDY DESIGN: This was a randomized, double-blind, parallel-group, placebo-controlled clinical trial involving 61 subjects, submitted to a first line laparoscopic conservative surgery, who were randomized into 3 groups receiving: group A (n=21) the association N-Palmitoylethanolamine-transpolydatin 400 mg + 40 mg twice a day for 3 months; group B (n=20) the placebo for 3 months; group C (n=20) a single course of Celecoxib 200mg twice a day for 7 consecutive days. Assessments of the severity of pelvic endometriosis (pelvic pain, dysmenorrhoea and dyspareunia) were recorded before and after treatment on a questionnaire and a 10-point VAS. Differences between groups were verified with Kruskal-Wallis ANOVA for non-parametric multiple comparisons. RESULTS: A marked decrease in dysmenorrhoea, dyspareunia and pelvic pain was observed in all groups, and the association between N-Palmitoylethanolamine and transpolydatin resulted to be more effective than placebo (P<.001). Additionally, the treatment with Celecoxib resulted in a decrease in pelvic pain more effective either than the association N-Palmitoylethanolamine and transpolydatin or placebo. CONCLUSION: These preliminary results show that the association between micronized N-Palmitoylethanolamine and transpolydatin is effective in the management of pelvic pain related to endometriosis after laparoscopy. Additionally, this association seems to be safe, shows an optimal control of pain and can be used in patients who are unable to receive other therapies.
Assuntos
Analgésicos/uso terapêutico , Endometriose/complicações , Glucosídeos/uso terapêutico , Ácidos Palmíticos/uso terapêutico , Dor Pélvica/tratamento farmacológico , Estilbenos/uso terapêutico , Adulto , Amidas , Método Duplo-Cego , Endocanabinoides , Endometriose/diagnóstico , Etanolaminas , Feminino , Humanos , Laparoscopia , Dor Pélvica/etiologia , Fitoterapia , Projetos Piloto , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: For long-term management of atopic eczema, the use of skin care creams is recommended, but effectiveness of this treatment is not well established. OBJECTIVE: The objective of this study was to yield data on the skin care properties of a cream with a unique lamellar matrix containing N-palmitoylethanolamine (PEA) and to assess quality-of-life variables in patients with mild to moderate atopic eczema. SETTING: In this multinational, multicentre, observational, non-controlled, prospective cohort study, patients between 2 and 70 years of age were enrolled. All patients were supplied with the study product sufficient for treatment over the entire study period. Outcome was followed in periods between 3 and 7 days and 4 and 6 weeks after study start. Data were gathered from doctor reports and patient self-assessments via patient questionnaires. RESULTS: Data from 2456 patients entered the database. The mean examination intervals were 6 days for the 3- to 7-day period and 38 days for the 4- to 6-week period. At study end, intensities of erythema, pruritus, excoriation, scaling, lichenification and dryness were significantly reduced with a combined score reduction of 58.6% in the entire population (57.7% in adults > 12 years and 60.5% in children = 12 years) according to doctors' reports. Patients reported a reduction of pruritus on visual analogue scales from 4.9 +/- 2.6 to 2.7 +/- 2.4 6 days after treatment start and a further reduction to 2.0 +/- 2.3 at study end (P < 0.001 each). Likewise, sleep quality improved significantly during the study period. Earlier-used topical corticosteroids were omitted by 56% of all patients (53.4% in adults and 62.5% in children) at study end, and the average weekly application rate decreased by 62% from 7.9 +/- 6.0 to 3.0 +/- 5.1 (P < 0.001). The tolerance was assessed as very good or good in 92% of cases by both patients and doctors. CONCLUSION: This study showed substantial relief of objective and subjective symptoms of atopic eczema after regular skin care with the study cream. The patient-related effectiveness (decline of pruritus and loss of sleep) indicated a gain in quality of life in these patients. The reduced use of topical corticosteroids is important in view of safety and pharmacoeconomic implications in the treatment of atopic eczema.
Assuntos
Anti-Inflamatórios não Esteroides/uso terapêutico , Dermatite Atópica/tratamento farmacológico , Emolientes/uso terapêutico , Ácidos Palmíticos/uso terapêutico , Adjuvantes Farmacêuticos , Administração Oral , Adolescente , Adulto , Idoso , Amidas , Anti-Inflamatórios não Esteroides/administração & dosagem , Anti-Inflamatórios não Esteroides/efeitos adversos , Criança , Pré-Escolar , Dermatite Atópica/fisiopatologia , Emolientes/administração & dosagem , Emolientes/efeitos adversos , Endocanabinoides , Etanolaminas , Feminino , Humanos , Cooperação Internacional , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Ácidos Palmíticos/administração & dosagem , Ácidos Palmíticos/efeitos adversos , Estudos Prospectivos , Qualidade de Vida , Resultado do TratamentoRESUMO
Regional distribution of exogenous N-palmitoylethanolamine in the rat brain was investigated in the study. Possible protective and adaptive effect of N-stearoylethanolamine under 2 Gy whole-body X-irradiation and changes of brain lipid composition were also studied. It was found that after per os administration to rats N-([9,10-3H]-palmitoyl)-ethanolamine was primarily accumulated in hypothalamus, pituitary and adrenal glands and the label amount in brain was 0.95% of the oral dose. Quantities of palmitic acid in total brain phospholipids and plasmalogen form of phosphatidylcholine were increased; free cholesterol and diacyl form of phosphatidylcholine were decreased in 2 weeks after irradiation. 11-OH-corticosteroid level in the blood of exposed rats was decreased in comparison with control animals. N-stearoylethanolamine pre-treatment prevented from increasing the plasmalogen form of phosphatidylcholine and decreasing its diacyl form and restored 11-OH-corticosteroid level in the blood of irradiated rats. Recovering of brain free cholesterol level was observed when N-stearoylethanolamine was post-treated. So, the accumulation of N-([9,10-3H]-palmitoyl)ethanolamine in brain indicates its penetration through blood-brain barrier and suggests the possible role of saturated N-acylethanolamines in brain functioning, particularly, in stress response regulation of the organism by hypothalamus-pituitary-adrenal system. N-stearoylethanolamine treatment of irradiated rats causes protective effect concerning the of irradiation induced changes in the brain lipid composition and in 11-OH-corticosteroid level and modifies phospholipid fatty acid composition.