RESUMO
BACKGROUND: Atopic dermatitis (AD) is a chronic recurrent inflammatory skin disease that affects 1-3% of adults worldwide. Currently, it is not possible to completely cure AD; therefore, alternative treatments need to be developed to meet the patients' needs. Here, based on our previous pilot study, we conducted the first confirmatory randomized controlled trial to evaluate the effect of acupuncture in patients with mild to moderate AD. METHODS: A randomized, participant- and assessor-blinded, sham-controlled trial was designed with an intervention period twice-weekly for 4 weeks and a 4-week follow-up. We equally allocated 36 participants to the verum acupuncture (VA) and sham acupuncture (SA) groups. The main outcome measure was the change in SCORing Atopic Dermatitis index (SCORAD) score before and after treatment. RESULTS: A total of 36 participants, aged 19 to 38 years, were enrolled, and 35 were included in the intention-to-treat analyses. The mean change in total SCORAD score differed significantly among the two groups at 4 weeks after randomization (P < .0001): the mean difference was - 11.83 (7.05) in the VA group and 0.45 (7.77) in the SA group. The mean SCORAD score substantially decreased 2-weeks after starting the acupuncture treatment and continued to improve for at least 4 weeks after the end of the treatment in the VA group compared to the SA group (each P < .0001). No serious adverse events were observed. CONCLUSIONS: Twice-weekly acupuncture treatment was effective in reducing AD symptoms in patients with mild to moderate AD without serious adverse events. TRIAL REGISTRATION: Clinical Research Information Service Identifier: KCT0002796 .
Assuntos
Terapia por Acupuntura , Dermatite Atópica/terapia , Adulto , Feminino , Humanos , Masculino , Resultado do Tratamento , Adulto JovemRESUMO
Atopic dermatitis (AD) is a chronic inflammatory skin disease with persistent itching, which impairs quality of life (QoL). Although various conventional treatments for AD exist, patients with AD often seek complementary and alternative therapies when conventional therapy has failed to relieve their AD symptoms or has had adverse effects. Acupuncture treatment may relieve AD symptoms, but controlled trials are needed to confirm this. Following our pilot study, which found that acupuncture treatment improves AD symptoms in mild-to-moderate AD patients, we will assess the effect of acupuncture treatment for symptom relief of AD using a trial with a complemented protocol. This is a two-arm, randomized, participant- and assessor-blinded, sham-controlled trial. A total of 36 mild-to-moderate AD patients will be randomly assigned in a 1:1 ratio to receive eight sessions twice weekly of either verum acupuncture (VA) or nonpenetrating sham acupuncture (SA) over four weeks. The primary outcome measured will be the change in the total Scoring Atopic Dermatitis (SCORAD) score. Secondary outcomes will be (1) changes in AD symptoms, QoL, dyspepsia symptoms, and electroencephalography (EEG) between baseline and week 4 and (2) changes in AD symptoms and QoL at baseline and at weeks 2, 4, and 8. This study will assess acupuncture treatment for the alleviation of AD symptoms in patients with mild-to-moderate AD. This clinical trial gas been registered in Korean Clinical Trial Registry (registration number: KCT0002796; date of registration: April 13, 2018).