PMID- 36951835
OWN - NLM
STAT- MEDLINE
DCOM- 20230522
LR  - 20240324
IS  - 2168-6173 (Electronic)
IS  - 2168-6165 (Print)
IS  - 2168-6165 (Linking)
VI  - 141
IP  - 5
DP  - 2023 May 1
TI  - Pulsed Oral Azithromycin vs 6-Week Oral Doxycycline for Moderate to Severe 
      Meibomian Gland Dysfunction: A Randomized Clinical Trial.
PG  - 423-429
LID - 10.1001/jamaophthalmol.2023.0302 [doi]
AB  - IMPORTANCE: The treatment of moderate to severe meibomian gland dysfunction (MGD) 
      with oral doxycycline requires a 6-week course of treatment and has frequent 
      adverse effects (AEs), which may be associated with poor compliance. OBJECTIVE: 
      To determine if the AEs of a 3-week course of oral azithromycin were equivalent 
      to the AEs of a 6-week course of oral doxycycline. DESIGN, SETTING, AND 
      PARTICIPANTS: This double-masked randomized clinical trial was conducted at a 
      referral center in Thailand from September 2018 to May 2022. Participants with 
      moderate to severe MGD judged unresponsive to conservative management were 
      included. INTERVENTIONS: Patients were randomized 1:1 to receive oral 
      azithromycin (1 g once per week for 3 weeks) or oral doxycycline (200 mg daily 
      for 6 weeks). MAIN OUTCOMES AND MEASURES: After initiating therapy, the study 
      team assessed the total MGD score and Ocular Surface Disease Index (OSDI) score 
      at the initial visit, at 6 weeks, and at 8 weeks, and assessed AEs at 6 weeks and 
      8 weeks. The prespecified equivalence margins for MGD score and OSDI score were 
      set at +/-2 and +/-9, respectively. RESULTS: A total of 137 eyes from 137 patients 
      were randomized into groups, 68 eyes in the azithromycin group and 69 eyes in the 
      doxycycline group (female, 66.4%; mean age, 62.0 [SD, 15.1] years). The adjusted 
      mean difference of total MGD scores between groups at week 6 and week 8 were 
      -0.33 (95% CI, -1.70 to 1.03; P for equivalence = .01) and 0.13 (95% CI, -1.59 to 
      1.84; P for equivalence = .02), respectively. The adjusted mean difference of 
      OSDI between groups score at week 6 and week 8 was -1.20 (95% CI, -5.31 to 2.91; 
      P for equivalence  < .001) and -1.59 (95% CI, -5.73 to 2.55; P for equivalence 
       < .001), respectively. In addition, patients treated with azithromycin had fewer 
      gastrointestinal AEs (4.4% vs 15.9%; risk difference, 11.5%; 95% CI 1.6%-21.4%; 
      P = .03). CONCLUSIONS AND RELEVANCE: These data support an equivalency of effects 
      of azithromycin as compared with doxycycline for MGD score and OSDI score at both 
      follow-up times. The study did not show more gastrointestinal AEs in the 
      azithromycin group. The reduced dosing and potentially fewer gastrointestinal AEs 
      associated with azithromycin support its use as an alternative to doxycycline for 
      at least 6 weeks. TRIAL REGISTRATION: ThaiClinicalTrials.org Identifier: 
      TCTR20180810001.
FAU - Upaphong, Phit
AU  - Upaphong P
AD  - Department of Ophthalmology, Faculty of Medicine, Chiang Mai University, Chiang 
      Mai, Thailand.
FAU - Tangmonkongvoragul, Chulaluck
AU  - Tangmonkongvoragul C
AD  - Department of Ophthalmology, Faculty of Medicine, Chiang Mai University, Chiang 
      Mai, Thailand.
FAU - Phinyo, Phichayut
AU  - Phinyo P
AD  - Center for Clinical Epidemiology and Clinical Statistics, Faculty of Medicine, 
      Chiang Mai University, Chiang Mai, Thailand.
AD  - Department of Family Medicine, Faculty of Medicine, Chiang Mai University, Chiang 
      Mai, Thailand.
AD  - Musculoskeletal Science and Translational Research, Chiang Mai University, Chiang 
      Mai, Thailand.
LA  - eng
SI  - TCTR/TCTR20180810001
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - JAMA Ophthalmol
JT  - JAMA ophthalmology
JID - 101589539
RN  - 0 (Anti-Bacterial Agents)
RN  - 83905-01-5 (Azithromycin)
RN  - N12000U13O (Doxycycline)
SB  - IM
CIN - JAMA Ophthalmol. 2023 May 1;141(5):429-430. PMID: 36951825
EIN - JAMA Ophthalmol. 2023 May 4;:. PMID: 37140934
EIN - JAMA Ophthalmol. 2023 Jul 1;141(7):697. PMID: 37227706
MH  - Humans
MH  - Female
MH  - Middle Aged
MH  - *Anti-Bacterial Agents/therapeutic use
MH  - Azithromycin/adverse effects/administration & dosage
MH  - Doxycycline/adverse effects
MH  - *Meibomian Gland Dysfunction/drug therapy
MH  - Eye
PMC - PMC10037201
COIS- Conflict of Interest Disclosures: None reported.
EDAT- 2023/03/24 06:00
MHDA- 2023/05/22 06:43
PMCR- 2024/03/23
CRDT- 2023/03/23 11:33
PHST- 2023/05/22 06:43 [medline]
PHST- 2023/03/24 06:00 [pubmed]
PHST- 2023/03/23 11:33 [entrez]
PHST- 2024/03/23 00:00 [pmc-release]
AID - 2802901 [pii]
AID - eoi230007 [pii]
AID - 10.1001/jamaophthalmol.2023.0302 [doi]
PST - ppublish
SO  - JAMA Ophthalmol. 2023 May 1;141(5):423-429. doi: 
      10.1001/jamaophthalmol.2023.0302.