scholarly journals Effect of a Novel Thermostatic Device on Meibomian Gland Dysfunction: A Randomized Controlled Trial in Chinese Patients

2021 ◽  
Author(s):  
Siyuan Li ◽  
Ke Yang ◽  
Jingyi Wang ◽  
Shang Li ◽  
Lei Zhu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Meibomian Gland ◽  
Chinese Patients ◽  
Meibomian Gland Dysfunction ◽  
Randomized Controlled ◽  
Thermostatic Device

Effect of a Novel Thermostatic Device on Meibomian Gland Dysfunction: A Randomized Controlled Trial in Chinese Patients

2021 ◽  
Author(s):  
Siyuan Li ◽  
Ke Yang ◽  
Jingyi Wang ◽  
Shang Li ◽  
Lei Zhu ◽  
...  
Keyword(s):  
Group Treatment ◽  
Controlled Trial ◽  
Anterior Segment ◽  
Meibomian Gland ◽  
Chinese Patients ◽  
Meibomian Gland Dysfunction ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Meibomian Glands ◽  
Thermostatic Device

Abstract BackgroundAs a chronic disease, meibomian gland dysfunction (MGD) which causes excessive evaporation of tears by changing the tear film composition, is considered a leading cause of dry eye. Although a variety of physical therapy equipment, there is currently no economical and effective treatment for MGD. The aim of this study was to evaluate the effectiveness and safety of the MiBoFlo Thermoflo® (Mibo Medical, Dallas, TX, USA), a new thermostatic device, on both objective symptoms and subjective signs in Chinese MGD patients.MethodsThis was a prospective, randomized, controlled clinical trial. 108 eyes of 54 MGD patients in Beijing Tongren Hospital were recruited and randomized 1:1 to MiBoFlo (n = 54 eyes) or LipiFlow® (TearScience, Morrisville, NC, USA) (n = 54 eyes) treatment group. In the MiBoFlo group, treatment for each eye took 10 minutes and proceeded every two weeks for a total of three times. Patients in the LipiFlow group received a single 12-minute treatment. Main Outcome Measures: The primary outcomes include changes in Ocular Surface Disease Index (OSDI) score, Meibomian Glands Yielding Liquid Secretion (MGYLS) score and Meibomian Glands Secretion (MGS) score from baseline to 2 months. The secondary outcomes include Tear Meniscus Height (TMH), Non-invasive Keratograph Break-up Time (NIKBUT), Corneal Fluorescein Staining (CFS) and Meibomian Glands (MG) loss from baseline to 2 months. Safety outcomes include visual acuity (VA), intraocular pressure (IOP), anterior segment and facial skin.ResultsThe OSDI score, MGYLS score and MGS score all improved from baseline to 1 month in both MiBoFlo and LipiFlow group, and these improvements were maintained at 2 months. CFS score, NIKBUT and MG loss had no significant change in both groups. CFS score improvement in MiBoFlo group were significantly more obvious than in LipiFlow group in the follow-up visit (p<0.01).ConclusionAs a portable and comfortable device, MiBoFlo treatment can offer an advancement for the treatment of MGD and a course of treatment results in at least two months of sustained improvement in both symptoms and meibomain gland function.

scholarly journals Acupuncture to Improve Symptoms for Stable Angina (AIMS-A): Study Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Judith Schlaeger ◽  
Hui Yan Cai ◽  
Alana D. Steffen ◽  
Veronica Angulo ◽  
Adhir R. Shroff ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Stable Angina ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Attention Control ◽  
Chinese Patients ◽  
Control Group ◽  
Mcgill Pain Questionnaire ◽  
Analgesic Effects ◽  
Randomized Controlled

BACKGROUND Acupuncture has demonstrated physiologic analgesic effects in Chinese patients with stable angina. One proposed mechanism of action for analgesic effects is the downregulation of M1 macrophages, Interleukin-1β, Interleukin-6, Interleukin-18, and tumor necrosis factor alpha (TNF-α). OBJECTIVE The purpose of this study is to test a 10-session, 5-week acupuncture treatment protocol as a complementary therapy for symptoms of stable angina for American patients, who vary from Chinese patients in healthcare systems and other salient variables. METHODS We are conducting a randomized controlled trial (RCT) of 69 adults (35 assigned to initial acupuncture and 34 to an attention control condition) with a medically confirmed diagnosis of stable angina, whose pain and associated symptoms have not been controlled to their satisfaction with guideline-directed medical management. Participants in the experimental group will receive a standardized Traditional Chinese Medicine (TCM) point prescription. The attention control group will view non-pain-related health education videos over 5 weeks equal to the 10 hours of treatment for the acupuncture group. Participants will complete the McGill Pain Questionnaire and the Seattle Angina Questionnaire-7, as well as have inflammatory cytokines measured at baseline and study completion. Primary outcomes are anginal pain and quality of life. RESULTS Results will be available upon completion of the randomized controlled trial and the analysis of the data. CONCLUSIONS We will generate data on feasibility, acceptability, effect sizes, and protocol revisions for a future fully powered RCT of the protocol. Findings will help determine if patients with persistent ischemic symptoms experience a pro-inflammatory state and/or hyperalgesia caused by multiple neural and immune processes not always relieved with medication. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT02914834

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