A comparative investigator-initiated pilot study on the efficacy and safety of biodegradable microneedle acupuncture and conventional intradermal acupuncture for dry eye patient: A superiority, assessor-blinded, randomized controlled trial

Abstract

Background: The prevalence of dry eye, which is a common lacrimal disease, is steadily increasing in modern society. However, fundamental treatment for it has not yet been established. This study aims to assess the efficacy and safety of a novel medical device, the biodegradable microneedle acupuncture (BMA), using a traditional intradermal acupuncture needle as the control acupuncture for dry eye. Method: This study will be an investigator-initiated, assessor-blinded, comparative, superiority pilot randomized controlled trial. A total of 30 patients with dry eye will be randomly assigned to the experimental or the control group in equal proportion. For the experimental group, the BMA will be applied to both sides of 5 acupoints including BL2, GB14, TE23, EX-HN5, and ST1. For the control group, conventional intradermal acupuncture will be applied to the same acupoints. The needles will be attached for 4 hours. Over 4 weeks, both the interventions will be performed 12 times in total. The primary outcome would be the ocular surface disease index. The secondary outcomes would be the visual analog scale for subjective symptoms, quality of life, Schirmer I test, and general assessment. Discussion: The findings of this study on the efficacy and safety of the BMA would be helpful for patients with dry eye in clinical practice. Further, these results would provide for the foundation of a large-scale BMA study.

Biodegradable microneedle acupuncture has equivalent efficacy to traditional intradermal acupuncture for dry eye disease: A pilot single-blinded, randomized controlled trial

“…This study was conducted according to a previously published study protocol in 2022. [ 15 ] The descriptions in this section partly reproduce the wording of this protocol.…”

Evaluation of Nursing Effect of Intradermal Acupuncture for Postoperative Flatulence

“…After the parturient has flatulence after cesarean section, it will make the parturient have abdominal distension; The increase of abdominal pressure will affect the healing effect of surgical incision, which will have a certain impact on the recovery effect of patients after delivery, and even have a certain probability to destroy the balance of gastrointestinal function of patients, which will lead to malnutrition and then affect the postpartum lactation efficiency of patients. Therefore, it is necessary to effectively prevent postoperative flatulence in clinic, so it is necessary to take effective measures to prevent flatulence for cesarean section women [1]. On the basis of routine nursing intervention measures, intradermal needle nursing can effectively prevent postoperative flatulence.…”