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Electroacupuncture for mild-to-moderate dry eye: study protocol for a multicentre, randomised, single-blind,

Yun-Qiong Lu1, Guang Yang2, Mei-Yan Li3

  • 1Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

BMJ Open
|December 6, 2023
PubMed
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This study investigates electroacupuncture (EA) for dry eye (DE), aiming to provide robust evidence beyond a placebo effect. Results will clarify EA

Area of Science:

  • Ophthalmology
  • Integrative Medicine
  • Clinical Trials

Background:

  • Dry eye (DE) is a complex ocular condition with significant patient impact and limited effective long-term treatments.
  • Electroacupuncture (EA) shows potential for improving DE symptoms, but its efficacy compared to placebo is debated.

Purpose of the Study:

  • To provide rigorous clinical evidence for the effectiveness of electroacupuncture (EA) in treating dry eye (DE).
  • To evaluate EA's impact on tear secretion, tear film stability, and overall ocular surface health in DE patients.

Main Methods:

  • A multicentre, randomized, sham-controlled trial involving 168 DE patients.
  • Participants receive 4 weeks of either EA or sham EA, with follow-up extending to 24 weeks.
  • Primary outcome: change in non-invasive tear break-up time (NIBUT); secondary outcomes include various ocular surface assessments.
Keywords:
COMPLEMENTARY MEDICINECorneal and external diseasesOPHTHALMOLOGY

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Main Results:

  • Data collection and analysis are ongoing.
  • Primary outcome measures the change in NIBUT from baseline to week 4.
  • Secondary outcomes assess tear meniscus height, Schirmer I test, sensation, OSDI, staining, pain, and quality of life.

Conclusions:

  • The study is designed to definitively assess EA's therapeutic value for dry eye.
  • Findings will inform clinical practice regarding EA as a treatment option for DE.
  • Results will contribute to understanding the mechanisms underlying EA's effects on the ocular surface.