Acupuncture and herbal formulation compared with artificial tears alone: evaluation of dry eye symptoms and associated tests in randomised clinical trial

Abstract

ObjectiveDry eye is a common disease with great health burden and no satisfactory treatment. Traditional Chinese medicine, an increasingly popular form of complementary medicine, has been used to treat dry eye but studies have been inconclusive. To address this issue, we conducted a randomised investigator-masked study which included the robust assessment of disease mechanisms.Methods and analysisEligible participants (total 150) were treated with artificial tear (AT) alone, with added eight sessions of acupuncture (AC) or additional daily oral herb (HB) over a month.ResultsParticipants treated with AC were more likely to respond symptomatically than those on AT (88% vs 72%, p=0.039) with a difference of 16% (95% CI: 0.18 to 31.1). The number-to-treat with AC to achieve response in one person was 7 (3 to 157). Participants in the AC group also had reduced conjunctival redness (automatic grading with Oculus keratograph) compared with AT (p=0.043) and reduced tear T helper cell (Th1)-cytokine tumour necrosis factor α (p=0.027) and Th2-cytokine interleukin 4 concentrations (p=0.038). AC was not significantly superior to AT in other outcomes such as tear osmolarity, tear evaporation rates, corneal staining and tear break-up times. No significant adverse effects were encountered. HB was not significantly different in the primary outcome from AT (80% vs 72%, p=0.26).ConclusionsAC is safe and provides additional benefit in mild to moderate dry eye up to 1 month, compared with ATs alone. Treatment is associated with demonstrable molecular evidence of reduced inflammation. Provided that suitably qualified practitioners are available to implement standardised treatment, AC may be recommended as adjunctive therapy to AT.Trial registration numberClinicalTrials.gov (NCT02219204)registered on 14 August 2014.

Therapeutic effects of acupuncture in typical dry eye: a systematic review and meta‐analysis

“…We retrieved 21 RCTs of acupuncture in non‐specific DES from all articles published to June 2018. Only one more RCT has been until July 2020 through the databases of PubMed, Medline, Web of Science and Cochrane (Tong et al 2018), but it was not included in this study. The present meta‐analyses revealed the superiority of acupuncture in improving BUT, Schirmer test, CFS and SOS in typical DES, but also greater effects of the combination with artificial tears on the BUT and Schirmer test, compared with artificial tears alone.…”

Changes in Tear Proteome After Acupuncture Treatment in Dry Eye

“…Written informed consent was obtained from participants, and they had demonstrated lung-kidney yin deficiency by a questionnaire, and the inclusion, exclusion criteria, method of randomization of participants, group assignment, study procedures and clinical efficacy results have been previously published. 4 For ease of reference, these details are summarized in eSupplementary Table 1 . The dry eye criteria was dry eye symptom (Standardised Patient Evaluation of Eye Dryness) score >6, and signs of dry eye (tear break-up time <10 s or Schirmer’s test <10 mm/5 min) and any corneal fluorescein dye staining.…”

“…assignment, study procedures and clinical efficacy results have been previously published. 4 For ease of reference, these details are summarized in eSupplementary Table 1. The dry eye criteria was dry eye symptom (Standardised Patient Evaluation of Eye Dryness) score >6, and signs of dry eye (tear break-up time <10 s or Schirmer's test <10 mm/5 min) and any corneal fluorescein dye staining.…”

Acupuncture for the treatment of dry eye

“…Although the mechanism of AC for DE is still not completely clarified, an experimental study has revealed that AC could reduce the concentration of proinflammatory cytokines (TNF-α, IL-4, IL-12) in tears. [ 41 ] Other studies have shown that AC could alter the content of some proteins in tears and promote lacrimal gland secretion. [ 42 , 43 ]…”