Prospective Randomized Trial Comparing Outcomes of Combined Acupuncture and Lubricants Versus Lubricants Alone for Treatment of Dry Eyes in Singapore: Interim Analysis
Narrative Responses:
Purpose
Acupuncture therapy, a branch of Traditional Chinese Medicine, employs a holistic assessment of the patient in its treatment approach. Few studies have been published on the effectiveness of acupuncture on dry eyes. Hence, we aim to evaluate the effect of combining acupuncture and lubricants versus lubricants alone for dry eyes.
Methods
Outpatients from general Ophthalmology clinics and healthy volunteers were recruited. Inclusion criteria: TBUT (tear-film breakup time) <10seconds and ST (Schirmer’s test) <10millimeters. Patients were randomised into arm-A (6 weekly sessions of acupuncture and lubricants throughout) or arm-B (lubricants only); and evaluated at weeks 0, 6, 12, 24. Outcome measures included TBUT, ST, and Ocular Surface Disease Index (OSDI score) questionnaire. Twenty-six patients have completed the study; arm-A (14) and arm-B (12).
Results
Baseline characteristics of both arms (age, TBUT, ST, OSDI) had no significant difference, majority were females. Compared to baseline, arm-A showed mean increase in TBUT at week-7 [OD:2.18;p=0.006; OS:2.31;p=0.006], week-12 [OD:3.04;p=0.006; OS:2.81;p=0.018] and week-24 [OS:2.16;p=0.003]. Arm-A also showed mean increase in ST at week-7 [OD:2.14;p=0.012; OS:3.50;p=0.042]. Arm-B did not have significant increases in TBUT and ST at follow-up. Decrease in OSDI scores was seen in arm-B at week 12 [OD:12.85;p=0.024; OS:12.67;p=0.024]. Compared to arm-B, arm-A had a trend towards superior TBUT and ST at weeks 12 and 24, although not significant. No adverse events reported.
Conclusion
Our interim analysis suggests a synergistic effect of acupuncture with lubricants on increasing TBUT and ST, although the effect was not sustained in all patients at week-24. Further studies will be undertaken to investigate the potential role of acupuncture in reducing dependency on immunomodulatory eye-drops in patients with keratoconjunctivitis sicca.