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Original article
Acupuncture and herbal formulation compared with artificial tears alone: evaluation of dry eye symptoms and associated tests in randomised clinical trial
  1. Louis Tong1,2,3,4,
  2. Hla Myint Htoon1,3,
  3. Aihua Hou1,3,
  4. Rajendra Udyavara Acharya5,6,7,
  5. Jen-Hong Tan,
  6. Qi-Ping Wei8,
  7. Pat Lim9
  1. 1 Singapore Eye Research Institute, Singapore
  2. 2 Singapore National Eye Centre, Singapore
  3. 3 Duke-NUS Graduate Medical School, Singapore
  4. 4 Yong Loo Lin School of Medicine, National University of Singapore, Singapore
  5. 5 Ngee Ann Polytechnic, Singapore
  6. 6 Department of Biomedical Engineering, SIM University, Singapore
  7. 7 Department of Biomedical Engineering, University of Malaya, Kuala Lumpur, Malaysia
  8. 8 Beijing University of Chinese Medicine, Beijing, China
  9. 9 Singapore Chung Hwa Medical Institution, Singapore
  1. Correspondence to Dr Louis Tong; louis.tong.h.t{at}singhealth.com.sg

Abstract

Objective Dry 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 analysis Eligible 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.

Results Participants 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).

Conclusions AC 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 number ClinicalTrials.gov (NCT02219204)registered on 14 August 2014.

  • cornea
  • ocular Surface
  • tears
  • clinical trial

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjophth-2018-000150

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    Footnotes

    • Contributors LT conceived the study and wrote the initial manuscript, PL performed TCM treatment, with supervision from Q-PW, AHH analysed the cytokines, RUA, J-HT contributed to thermographic analysis and H-MH contributed to statistical analysis. All authors critically revised the paper for important intellectual content and approved the final version to be published. LT had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. LT and PL supervised the study and are the guarantors.

    • Funding This research is funded by Singapore Ministry of Health’s Traditional Chinese Medicine Clinical Research Grant (TCMCRG 3103001). This research is also supported by the Singapore National Research Foundation under its clinician scientist award NMRC/CSA/045/2012 and NMRC/CSA-SI/0017/2017, administered by the Singapore Ministry of Health’s National Medical Research Council.

    • Competing interests LT is supported by an award NMRC/CSA/045/2012 and NMRC/CSA-SI/0017/2017 from National Medical Research Council, Singapore.

    • Patient consent Not required.

    • Ethics approval The study was approved by the central Institutional Review Board of Singapore Health services, adhering to the tenets of the Declaration of Helsinki for human research.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement No additional data are available.