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Steroids and/or Non-Steroidal Anti-Inflammatory Drugs as Postoperative Treatment after Trabeculectomy-12-Month Results of a Randomized Controlled Trial.

ABSTRACT: This prospective randomized controlled trial aimed to compare the efficacy and safety of topical preservative-free diclofenac (DICLO) to dexamethasone (DEX) eyedrops, and their combination (DEX+DICLO) after trabeculectomy. Sixty-nine patients with medically uncontrolled glaucoma were randomized to receive topical postoperative treatment with DICLO (n = 23), DEX (n = 23), or a combination of DEX and DICLO (n = 23). The primary outcome was the intraocular pressure (IOP) 12 months postoperatively. Secondary outcomes included surgical success, failure, visual field, and visual acuity from baseline to 12 months postoperatively. IOP reached the lowest point one day after trabeculectomy. At 12 months, IOP was 10.0 mmHg (95% CI, 8.4-11.6 mmHg) for DICLO, 10.9 mmHg (95% CI, 9.4-12.3 mmHg) for DEX, and 11.2 mmHg (95% CI, 9.1-13.3 mmHg) for DEX+DICLO. There were no significant differences in IOP, surgical success, failure, visual field, or visual acuity between the DICLO, DEX, or DEX+DICLO groups. We found that topical diclofenac was not statistically different from topical dexamethasone in controlling IOP 12 months after trabeculectomy. Combining diclofenac and dexamethasone offered no added IOP control compared to dexamethasone alone.

SUBMITTER: Ahmadzadeh A

PROVIDER: S-EPMC10856597 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature

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Steroids and/or Non-Steroidal Anti-Inflammatory Drugs as Postoperative Treatment after Trabeculectomy-12-Month Results of a Randomized Controlled Trial.

Ahmadzadeh Afrouz A Kessel Line L Schmidt Bo Simmendefeldt BS Kolko Miriam M Bach-Holm Daniella D

Journal of clinical medicine 20240202 3

This prospective randomized controlled trial aimed to compare the efficacy and safety of topical preservative-free diclofenac (DICLO) to dexamethasone (DEX) eyedrops, and their combination (DEX+DICLO) after trabeculectomy. Sixty-nine patients with medically uncontrolled glaucoma were randomized to receive topical postoperative treatment with DICLO (n = 23), DEX (n = 23), or a combination of DEX and DICLO (n = 23). The primary outcome was the intraocular pressure (IOP) 12 mon ...[more]

PMID: 38337581

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Project description:BackgroundHeavy menstrual bleeding (HMB) is an important cause of ill health in premenopausal women. Although surgery is often used as a treatment, a range of medical therapies are also available. Non-steroidal anti-inflammatory drugs (NSAIDs) reduce prostaglandin levels, which are elevated in women with excessive menstrual bleeding and also may have a beneficial effect on dysmenorrhoea.ObjectivesTo determine the effectiveness, safety and tolerability of NSAIDs in achieving a reduction in menstrual blood loss (MBL) in women of reproductive years with HMB.Search methodsWe searched, in April 2019, the Cochrane Gynaecology and Fertility specialised register, Cochrane Central Register of Studies Online (CENTRAL CRSO), MEDLINE, Embase, PsycINFO, the clinical trial registries and reference lists of articles.Selection criteriaThe inclusion criteria were randomised comparisons of individual NSAIDs or combined with other medical therapy with each other, placebo or other medical treatments in women with regular heavy periods measured either objectively or subjectively and with no pathological or iatrogenic (treatment-induced) causes for their HMB.Data collection and analysisWe identified 19 randomised controlled trials (RCTs) (759 women) that fulfilled the inclusion criteria for this review and two review authors independently extracted data. We estimated odds ratios (ORs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes from the data of nine trials. We described in data tables the results of the remaining seven cross-over trials with data unsuitable for pooling, one trial with skewed data, and one trial with missing variances. One trial had no data available for analysis.Main resultsAs a group, NSAIDs were more effective than placebo at reducing HMB but less effective than tranexamic acid, danazol or the levonorgestrel-releasing intrauterine system (LNG IUS). Treatment with danazol caused a shorter duration of menstruation and more adverse events than NSAIDs, but this did not appear to affect the acceptability of treatment, based on trials from 1980 to 1990. However, currently danazol is not a usual or recommended treatment for HMB. There was no clear evidence of difference between NSAIDs and the other treatments (oral luteal progestogen, ethamsylate, an older progesterone-releasing intrauterine system and the oral contraceptive pill (OCP), but most studies were underpowered. There was no evidence of a difference between the individual NSAIDs (naproxen and mefenamic acid) in reducing HMB. The evidence quality ranged from low to moderate, the main limitations being risk of bias and imprecision.Authors' conclusionsNSAIDs reduce HMB when compared with placebo, but are less effective than tranexamic acid, danazol or LNG IUS. However, adverse events are more severe with danazol therapy. In the limited number of small studies suitable for evaluation, there was no clear evidence of a difference in efficacy between NSAIDs and other medical treatments such as oral luteal progestogen, ethamsylate, OCP or the older progesterone-releasing intrauterine system.

Dataset Information

Steroids and/or Non-Steroidal Anti-Inflammatory Drugs as Postoperative Treatment after Trabeculectomy-12-Month Results of a Randomized Controlled Trial.

Publications

Steroids and/or Non-Steroidal Anti-Inflammatory Drugs as Postoperative Treatment after Trabeculectomy-12-Month Results of a Randomized Controlled Trial.

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