RESUMEN
INTRODUCTION: This study is a prospective, assessor-blinded, parallel-group, randomized controlled pilot trial to explore the effectiveness of 12-week adjuvant moxibustion therapy for arthralgia in menopausal females at stage I to III breast cancer on aromatase inhibitor (AI) administration, compared with those receiving usual care. METHODS/DESIGN: Forty-six menopausal female patients with breast cancer who completed cancer therapy will be randomly allocated to either adjuvant moxibustion or usual care groups with a 1:1 allocation ratio. The intervention group will undergo 24 sessions of adjuvant moxibustion therapy with usual care for 12 weeks, whereas the control group will receive only usual care during the same period. The usual care consists of acetaminophen administration on demand and self-directed exercise education to manage AI-related joint pain. The primary outcome is the mean change of the worst pain level according to the Brief Pain Inventory-Short Form between the initial visit and the endpoint. The mean changes in depression, fatigue, and quality of life will also be compared between groups. Safety and pharmacoeconomic evaluations will also be included. DISCUSSION: Continuous variables will be compared by an independent t test or Wilcoxon rank-sum test between the adjuvant moxibustion and usual care groups. Adverse events will be analyzed using the chi-square or Fisher exact test. The statistical analysis will be performed by a 2-tailed test at a significance level of .05.
Asunto(s)
Inhibidores de la Aromatasa/efectos adversos , Artralgia/terapia , Neoplasias de la Mama/tratamiento farmacológico , Moxibustión , Anciano , Inhibidores de la Aromatasa/uso terapéutico , Artralgia/inducido químicamente , Artralgia/economía , Protocolos Clínicos , Análisis Costo-Beneficio , Femenino , Costos de la Atención en Salud , Humanos , Persona de Mediana Edad , Moxibustión/efectos adversos , Moxibustión/economía , Proyectos Piloto , Posmenopausia , Resultado del TratamientoRESUMEN
The herbal extract Angelica gigas (AG) has been applied as a vasodilating agent for patients suffering from vascular diseases for many years; however, the underlying mechanism has not been fully elucidated. The present study hypothesized that the antivasoconstrictive effect of AG may be effective in the treatment of abnormal coldmediated vasospasms that occur in Raynaud's phenomenon (RP). The effect of AG on the activity of ras homolog gene family member A (RhoA) was investigated in coldexposed vascular cells. Vascular cells were pretreated to AG, followed by a warm (37ËC) or cold (25ËC) incubation for 30 min and investigated with western blotting, ELISA and confocal microscopy. Cold treatment induced the activation of RhoA in pericytes and vascular endothelial cells, however this was reduced by treatment with AG. Furthermore, AG treatment reduced the endothelin1 (ET1)mediated RhoA activation in pericytes; however, coldinduced ET1 production by vascular endothelial cells was not affected by treatment with AG. In addition, AG treatment suppressed the formation of stress fibers and focal adhesion complexes, and the coldinduced phosphorylation of focal adhesion kinase, protooncogene tyrosineprotein kinase Src and extracellular signalrelated kinase. Therefore, AG treatment demonstrated an ability to reduce coldinduced RhoA activation in pericytes and vascular endothelial cells, and attenuated ET1mediated RhoA activation in pericytes. In conclusion, the present study indicated that AG may be useful for the treatment of RP.