Eficácia e segurança da auriculoterapia na melhora da qualidade do sono de pessoas vivendo com HIV: Ensaio clínico randomizado

Abstract

People living with HIV (PLHIV) have more difficulty sleeping, which may be associated with the virus itself, stigma, and antiretroviral therapy (ART). As a non-pharmacological alternative, there is auriculotherapy, which is included in the National Policy on Integrative and Complementary Practices. The overall objective was to evaluate the effectiveness and safety of auriculotherapy in improving sleep quality in PLHIV and sleep disorders. This is a randomized, controlled clinical trial with a sample of 200 PLHIV, with 100 in the Auriculotherapy group and 100 in the Control group. Inclusion criteria: PLHIV over 18 years of age, on ART for at least three months, and a score higher than 10 on the Pittsburgh Sleep Quality Index (PSQI-BR). Exclusion criteria: mental illness, pregnant women, and ear injury/allergy. Discontinuation criteria: loss to follow-up, initiation of antiretroviral with sleep interference, adverse events, and inability to make telephone contact. PLHIV were recruited from three healthcare institutions in Fortaleza, Ceará, Brazil, and interviewed using the Sociodemographic, Epidemiological, and Clinical Form for PLHIV, the PSQI-BR, and the Insomnia Severity Index (ISI). After randomization, the intervention group received auriculotherapy with mustard seeds on 6 points: Neurasthenia, Neurasthenia area, Anxiety, Heart, Shen Men, and Occipital, with instructions to press them 3 times a day for 30 seconds. The Control group received microporous tape in the 6 points, but without seeds and without applying pressure to the sites. For both groups, after the first session, two more in-person sessions took place on days 7 and 14, with reapplication of the PSQI-BR and ISI. On day 21, a phone call was made and the PSQIBR and ISI were reapplied, with instructions to remove the microporous tapes and mustard seeds. On the 28th day, the PSQI-BR and ISI were reapplied by telephone to analyze the residual effect of auriculotherapy. In the analyses, the normality of distribution of the variables was verified, descriptive statistics were performed, and the area under the curve was calculated. A two-factor analysis of variance model with repeated measures was used. A p-value < 0.05 was considered statistically significant. GraphPad Prism v. 8.0 and IBM SPSS Statistics v. 23.0 software were used for analysis. The study was approved by Ethics Committee and the participants signed the informed consent form. The research was registered in the Brazilian Registry of Clinical Trials and followed the Consolidated Standards of Reporting Trials. Of the 402 PLHIV recruited, 277 were randomized to the Auriculotherapy (N=134) or Control (N=143) groups, with loss to follow-up of 25.5% and 30.0%, respectively. Differences were observed between the groups on days 7, 14, 21, and 28, with a reduction in the total PSQI-BR score in the Auriculotherapy group from day 7 onwards compared to day 0, in addition to differences compared to day 0 within the Auriculotherapy group. Seven days after the removal of materials from the ears, the effect of auriculotherapy lasted until the 28th day. The proportion of responsive patients in the Auriculotherapy group was higher than in the Control group, with a probability of clinical improvement 18.5 times greater in those who underwent auriculotherapy. The relative risk indicated a 72 times greater probability of remission in those undergoing auriculotherapy. In the overall assessment of sleep quality, the area under the curve was smaller in the Auriculotherapy group, due to the reduction in PSQI-BR scores. There were differences between the groups at D7, D14, D21, and D28, with a significant reduction in the total ISI score in the Auriculotherapy group from D7 onwards compared to D0. The proportion of patients without insomnia was higher in the Auriculotherapy group. Adverse events included pain, itching, and increased temperature at the ear points, as well as dizziness, all of which were considered mild. It was concluded that auriculotherapy was effective and safe in improving sleep quality in PLHIV and sleep disorders. Project funded (CNPq, Brazil, No 402380/2023-1).