Dataset Information

Efficacy and safety of acupuncture at a single BL1 acupoint in the treatment of moderate to severe dry eye disease: Protocol for a randomized, controlled trial.

ABSTRACT:

Background

Dry eye disease (DED) is a very common disease. Although several current treatments offer some symptomatic relief, moderate to severe DED is still difficult to cure at present. Acupuncture may be effective for DED via its promotion of tear secretion and ability to improve symptoms, but evidence of its effectiveness is limited. The aim of this study is to evaluate the effect of acupuncture versus artificial tears in moderate to severe DED.

Methods/design

A total of 120 participants with moderate to severe DED will be randomly assigned to either an acupuncture group or an artificial tear group at a ratio of 1:1. Participants in the acupuncture group will undergo treatments on a single BL1 acupuncture point 3 times per week for 8 weeks. Participants in the control group will use artificial tears 4 times per day for 8 weeks. The primary outcome will be the change from baseline in a mean Schirmer-I test (SIT) at week 8. The secondary outcomes will include the visual analog score (VAS) for the improvement of ocular symptoms, the ocular surface disease index (OSDI), the tear film break-up time (TBUT), and corneal fluorescein staining (CFS) at weeks 4, 8, and 32. Acupuncture acceptance will be evaluated at week 8. Adverse events will also be monitored and documented. A follow-up assessment will be conducted 24 weeks after the treatment.

Discussion

We expect to verify that acupuncture is better than artificial tears toward improving the mean SIT values of patients with moderate to severe DED.

SUBMITTER: Zhang X

PROVIDER: S-EPMC6392551 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Efficacy and safety of acupuncture at a single BL1 acupoint in the treatment of moderate to severe dry eye disease: Protocol for a randomized, controlled trial.

Zhang Xue X Liu Zhishun Z Ding Wentao W Zhang Jun J Shi Huan H Zhu Wenzeng W

Medicine 20180601 22

<h4>Background</h4>Dry eye disease (DED) is a very common disease. Although several current treatments offer some symptomatic relief, moderate to severe DED is still difficult to cure at present. Acupuncture may be effective for DED via its promotion of tear secretion and ability to improve symptoms, but evidence of its effectiveness is limited. The aim of this study is to evaluate the effect of acupuncture versus artificial tears in moderate to severe DED.<h4>Methods/design</h4>A total of 120 p ...[more]

PMID: 29851826

Similar Datasets

Project description:BackgroundThe global incidence of dry eye disease (DED) is very high. DED seriously affects the quality of life of patients; however, the current curative effect of medicine for moderate to severe DED is poor. This randomized clinical trial was planned to investigate the effect of acupuncture compared with artificial tears (AT) on moderate to severe DED.MethodsA randomized clinical trial was performed at 2 hospitals in China. 120 DED patients were randomly equally divided into an acupuncture and an artificial tear group. Either acupuncture or artificial tears was performed for an 8-week period, and a 24-week follow-up was performed. The primary outcome measure was the Schirmer-I test (SIT) change from baseline. The secondary outcome measures included the numerical rating scale (NRS) change from baseline for improvement in ocular symptoms, the ocular surface disease index (OSDI), the tear-film break-up time (TBUT), corneal fluorescein staining (CFS), and acupuncture acceptability. Adverse events also were monitored and documented.ResultsFor the primary outcome, the mean changes from baseline in the SIT values were significantly different between the acupuncture (5.75 [2.53-9.75]) and AT (0.52 [- 1.18-2.46]) groups at week 8 with a between difference of 5.23 (P < 0.05). Between-group differences of 8.49 in OSDI score change from baseline differed significantly at week 8 (P < 0.05). However, between-group differences of the changes in the average symptom NRS score, TBUT, and CFS did not differ significantly at week 8. Five cases experienced acupuncture-related adverse events.ConclusionsThis randomized clinical trial found that acupuncture at BL1 significantly promoted tear secretion. Acupuncture showed greater benefits than AT for moderate to severe DED. However, the study findings warrant verification.Trial registrationRegistration number: ChiCTR1800015831. Name of trial registry: Efficacy and safety of acupuncture in the treatment of moderate to severe dry eye disease: a randomized controlled trial. Registered on 23 April 2018 ( https://clinicaltrials.gov/ ).

Project description:ImportanceDry eye disease (DED) is a common public health problem with significant impact on vision-related quality of life and well-being of patients. Medications with rapid onset of action and a good tolerability profile remain an unmet need.ObjectiveTo assess efficacy, safety, and tolerability of a water-free cyclosporine ophthalmic solution, 0.1% (CyclASol [Novaliq GmbH]), applied twice daily in DED compared with vehicle.Design, setting, and participantsCyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (ESSENCE-2) was a phase 3, multicenter, randomized, double-masked, vehicle-controlled clinical study conducted from December 5, 2020, to October 8, 2021. Following a 14-day run-in period with an artificial tear administered 2 times per day, eligible participants were randomly assigned 1:1 to the treatment groups. Patients with moderate to severe DED were included in the study.InterventionsCyclosporine solution vs vehicle administered 2 times per day for 29 days.Main outcomes and measuresThe primary end points were changes from baseline in total corneal fluorescein staining (tCFS; 0-15 National Eye Institute scale) and in dryness score (0-100 visual analog scale) at day 29. Conjunctival staining, central corneal fluorescein staining, and tCFS responders were also assessed.ResultsA total of 834 study participants were randomly assigned to cyclosporine (423 [50.7%]) or vehicle (411 [49.3%]) groups at 27 sites. Participants had a mean (SD) age of 57.1 (15.8) years, and 609 (73.0%) were female individuals. The majority of participants self-identified in the following race categories: 79 Asian (9.5 %), 108 Black (12.9%), and 635 White (76.1%). Participants treated with cyclosporine solution had greater improvement in tCFS (-4.0 grades) than the vehicle group (-3.6 grades) at day 29 (change [∆] = -0.4; 95% CI, -0.8 to 0; P = .03). The dryness score showed treatment benefits from baseline in both groups: -12.2 points for cyclosporine and -13.6 points for vehicle (∆ = 1.4; 95% CI, -1.8 to 4.6; P = .38). In the cyclosporine group, 293 participants (71.6%) achieved clinically meaningful reductions of 3 grades or higher in tCFS vs 236 (59.7%) in the vehicle group (∆ = 12.6%; 95% CI, 6.0%-19.3%; P < .001). These responders showed greater improvement in symptoms at day 29 including dryness (∆ = -4.6; 95% CI, -8.0 to -1.2; P = .007) and blurred vision (Δ = -3.5; 95% CI, -6.6 to -4.0; P = .03) compared with nonresponders.Conclusions and relevanceThe ESSENCE-2 trial confirmed that treatment with a water-free cyclosporine solution, 0.1%, results in early therapeutic effects on the ocular surface compared with vehicle. The responder analyses suggest that the effect is clinically meaningful in 71.6% of participants in the cyclosporine group.Trial registrationClinicalTrials.gov Identifier: NCT04523129.

Dataset Information

Efficacy and safety of acupuncture at a single BL1 acupoint in the treatment of moderate to severe dry eye disease: Protocol for a randomized, controlled trial.

Background

Methods/design

Discussion

Publications

Efficacy and safety of acupuncture at a single BL1 acupoint in the treatment of moderate to severe dry eye disease: Protocol for a randomized, controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets