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The British Journal of Dermatology Nov 2022Various treatments for acne vulgaris exist, but little is known about their comparative effectiveness in relation to acne severity. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Various treatments for acne vulgaris exist, but little is known about their comparative effectiveness in relation to acne severity.
OBJECTIVES
To identify best treatments for mild-to-moderate and moderate-to-severe acne, as determined by clinician-assessed morphological features.
METHODS
We undertook a systematic review and network meta-analysis of randomized controlled trials (RCTs) assessing topical pharmacological, oral pharmacological, physical and combined treatments for mild-to-moderate and moderate-to-severe acne, published up to May 2020. Outcomes included percentage change in total lesion count from baseline, treatment discontinuation for any reason, and discontinuation owing to side-effects. Risk of bias was assessed using the Cochrane risk-of-bias tool and bias adjustment models. Effects for treatments with ≥ 50 observations each compared with placebo are reported below.
RESULTS
We included 179 RCTs with approximately 35 000 observations across 49 treatment classes. For mild-to-moderate acne, the most effective options for each treatment type were as follows: topical pharmacological - combined retinoid with benzoyl peroxide (BPO) [mean difference 26·16%, 95% credible interval (CrI) 16·75-35·36%]; physical - chemical peels, e.g. salicylic or mandelic acid (39·70%, 95% CrI 12·54-66·78%) and photochemical therapy (combined blue/red light) (35·36%, 95% CrI 17·75-53·08%). Oral pharmacological treatments (e.g. antibiotics, hormonal contraceptives) did not appear to be effective after bias adjustment. BPO and topical retinoids were less well tolerated than placebo. For moderate-to-severe acne, the most effective options for each treatment type were as follows: topical pharmacological - combined retinoid with lincosamide (clindamycin) (44·43%, 95% CrI 29·20-60·02%); oral pharmacological - isotretinoin of total cumulative dose ≥ 120 mg kg per single course (58·09%, 95% CrI 36·99-79·29%); physical - photodynamic therapy (light therapy enhanced by a photosensitizing chemical) (40·45%, 95% CrI 26·17-54·11%); combined - BPO with topical retinoid and oral tetracycline (43·53%, 95% CrI 29·49-57·70%). Topical retinoids and oral tetracyclines were less well tolerated than placebo. The quality of included RCTs was moderate to very low, with evidence of inconsistency between direct and indirect evidence. Uncertainty in findings was high, in particular for chemical peels, photochemical therapy and photodynamic therapy. However, conclusions were robust to potential bias in the evidence.
CONCLUSIONS
Topical pharmacological treatment combinations, chemical peels and photochemical therapy were most effective for mild-to-moderate acne. Topical pharmacological treatment combinations, oral antibiotics combined with topical pharmacological treatments, oral isotretinoin and photodynamic therapy were most effective for moderate-to-severe acne. Further research is warranted for chemical peels, photochemical therapy and photodynamic therapy for which evidence was more limited. What is already known about this topic? Acne vulgaris is the eighth most common disease globally. Several topical, oral, physical and combined treatments for acne vulgaris exist. Network meta-analysis (NMA) synthesizes direct and indirect evidence and allows simultaneous inference for all treatments forming an evidence network. Previous NMAs have assessed a limited range of treatments for acne vulgaris and have not evaluated effectiveness of treatments for moderate-to-severe acne. What does this study add? For mild-to-moderate acne, topical treatment combinations, chemical peels, and photochemical therapy (combined blue/red light; blue light) are most effective. For moderate-to-severe acne, topical treatment combinations, oral antibiotics combined with topical treatments, oral isotretinoin and photodynamic therapy (light therapy enhanced by a photosensitizing chemical) are most effective. Based on these findings, along with further clinical and cost-effectiveness considerations, National Institute for Health and Care Excellence (NICE) guidance recommends, as first-line treatments, fixed topical treatment combinations for mild-to-moderate acne and fixed topical treatment combinations, or oral tetracyclines combined with topical treatments, for moderate-to-severe acne.
Topics: Humans; Isotretinoin; Network Meta-Analysis; Acne Vulgaris; Anti-Bacterial Agents; Tetracycline
PubMed: 35789996
DOI: 10.1111/bjd.21739 -
Journal of Drugs in Dermatology : JDD Apr 2018Currently, only topical minoxidil (MNX) and oral finasteride (FNS) are approved by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the... (Review)
Review
INTRODUCTION
Currently, only topical minoxidil (MNX) and oral finasteride (FNS) are approved by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of androgenetic alopecia. Although FNS is efficacious for hair regrowth, its systemic use is associated with side effects limiting long-term utilization. Exploring topical FNS as an alternative treatment regimen may prove promising.
METHODS
A search was conducted to identify studies regarding human in vivo topical FNS treatment efficacy including clinically relevant case reports, randomized controlled trials (RCTs), and prospective studies.
RESULTS
Seven articles were included in this systematic review. In all studies, there was significant decrease in the rate of hair loss, increase in total and terminal hair counts, and positive hair growth assessment with topical FNS. Both scalp and plasma DHT significantly decreased with application of topical FNS; no changes in serum testosterone were noted.
CONCLUSION
Preliminary results on the use of topical FNS are limited, but safe and promising. Continued research into drug-delivery, ideal topical concentration and application frequency, side effects, and use for other alopecias will help to elucidate the full extent of topical FNS' use.
J Drugs Dermatol. 2018;17(4):457-463.
.Topics: 5-alpha Reductase Inhibitors; Administration, Topical; Alopecia; Drug Delivery Systems; Female; Finasteride; Humans; Male; Prospective Studies; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 29601622
DOI: No ID Found -
BMJ Clinical Evidence May 2015Seborrhoeic dermatitis affects a variable proportion of the general population, ranging from 3% to 10%. Malassezia yeast species (previously referred to as Pityrosporum)... (Review)
Review
INTRODUCTION
Seborrhoeic dermatitis affects a variable proportion of the general population, ranging from 3% to 10%. Malassezia yeast species (previously referred to as Pityrosporum) are thought to be the responsible organisms, and cause inflammation by still poorly defined mechanisms. Seborrhoeic dermatitis tends to relapse after treatment.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of topical treatments for seborrhoeic dermatitis of the scalp in adults? We searched: Medline, Embase, The Cochrane Library, and other important databases up to November 2013 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 14 studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: bifonazole, ciclopirox, ketoconazole, pyrithione zinc, selenium sulfide, tar shampoo, terbinafine, and topical corticosteroids (betamethasone valerate, clobetasol propionate, clobetasone butyrate, hydrocortisone, mometasone furoate).
Topics: Administration, Topical; Dermatitis, Seborrheic; Humans
PubMed: 26016669
DOI: No ID Found -
Dermatology and Therapy Jan 2022Microneedling (MN) is a minimally invasive procedure involving the induction of percutaneous wounds with medical-grade needles. In this literature review, we investigate... (Review)
Review
INTRODUCTION
Microneedling (MN) is a minimally invasive procedure involving the induction of percutaneous wounds with medical-grade needles. In this literature review, we investigate clinical data on MN for the treatment of hair loss disorders.
METHODS
A literature search was conducted through PubMed up to November 2021 to identify original articles evaluating the use of MN on hair loss disorders. The database was searched using the following keywords: "microneedling," "micro needling," "micro needle," "microneedle," "needle," "dermaroller" and "alopecia," "hair loss," "alopecia," "areata," "cicatricial," or "effluvium," RESULTS: A total of 22 clinical studies featuring 1127 subjects met our criteria for inclusion. Jadad scores ranged from 1 to 3, with a mean of 2. As an adjunct therapy, MN improved hair parameters across genders and a range of hair loss types, severities, needling devices, needling depths of 0.50-2.50 mm, and session frequencies from once weekly to monthly. Across 17 investigations totaling 911 androgenic alopecia (AGA) subjects, MN improved hair parameters when paired with 5% minoxidil, growth factor solutions, and/or platelet-rich plasma (PRP) topicals, or when introduced to subjects whose hair count changes had plateaued for ≥ 6 months on other treatments. Across four investigations on 201 alopecia areata (AA) subjects, MN improved hair parameters as a standalone therapy versus cryotherapy, as an adjunct to 5-aminolevulinic acid and photodynamic therapy, and equivalently when paired with topical PRP versus carbon dioxide laser therapy with topical PRP. Across 657 subjects receiving MN, no serious adverse events were reported.
CONCLUSIONS
Clinical studies demonstrate generally favorable results for MN as an adjunct therapy for AGA and AA. However, data are of relatively low quality. Significant heterogeneity exists across interventions, comparators, and MN procedures. Large-scale randomized controlled trials are recommended to discern the effects of MN as a standalone and adjunct therapy, determine best practices, and establish long-term safety.
PubMed: 34854067
DOI: 10.1007/s13555-021-00653-2 -
International Dental Journal Dec 2022Caries is the most prevalent chronic noncommunicable disease. Strategies to prevent its onset and early interventions to arrest the progression of early lesions have... (Review)
Review
Caries is the most prevalent chronic noncommunicable disease. Strategies to prevent its onset and early interventions to arrest the progression of early lesions have been emphasised throughout recent decades to avoid or delay the restorative spiral of the tooth. More individuals are retaining their natural teeth into old age, thereby necessitating ongoing restorative dentistry intervention for their maintenance. The aim of this systematic review was to update the state of the art regarding clinical studies reporting the effectiveness of different nonrestorative caries treatment options in the 5-year period from 2017 to 2022. Relevant articles were retrieved from 2 electronic databases, including randomised clinical trials (RCTs) published from January 2017 until April 2022, assessing effectiveness and secondary effects of at least one nonrestorative caries treatment option, carried out with adults and/or children with noncavitated or cavitated carious lesions on either primary or permanent teeth and diagnosed by radiographs or visual/tactile assessment. All 35 included articles presented the results of RCTs with a follow-up period ranging from 6 to 84 months. Most of these studies were considered high-quality articles with a low risk of bias. Sealants and fluoride gels and varnishes were mentioned in 12 studies as effective strategies to prevent the onset of caries lesions and to arrest them in the early stages. Resin infiltration reported high caries arresting rates in noncavitated proximal lesions in 10 publications. Silver diammine fluoride presented high caries-arresting rates in open dentin lesions, both in primary and permanent dentitions as well as in root caries lesions that were accessible for cleansing. New evidence has been published between 2017 and 2022 as the result of numerous clinical studies providing further evidence of the effectiveness of nonrestorative caries treatment options.
Topics: Child; Adult; Humans; Pit and Fissure Sealants; Dental Caries Susceptibility; Fluorides; Dental Caries; Fluorides, Topical; Dentition, Permanent
PubMed: 35879115
DOI: 10.1016/j.identj.2022.06.022 -
The Cochrane Database of Systematic... Jan 2022Recurrent vulvovaginal candidiasis (RVVC) affects up to 5% of women. No comprehensive systematic review of treatments for RVVC has been published. (Review)
Review
BACKGROUND
Recurrent vulvovaginal candidiasis (RVVC) affects up to 5% of women. No comprehensive systematic review of treatments for RVVC has been published.
OBJECTIVES
The primary objective was to assess the effectiveness and safety of pharmacological and non-pharmacological treatments for RVVC. The secondary objective was to assess patient preference of treatment options.
SEARCH METHODS
We conducted electronic searches of bibliographic databases, including CENTRAL, MEDLINE, Embase, and CINAHL (search date 6 October 2021). We also handsearched reference lists of identified trials and contacted authors of identified trials, experts in RVVC, and manufacturers of products for vulvovaginal candidiasis.
SELECTION CRITERIA
We considered all published and unpublished randomised controlled trials evaluating RVVC treatments for at least six months, in women with four or more symptomatic episodes of vulvovaginal candidiasis in the past year. We excluded women with immunosuppressive disorders or taking immunosuppressant medication. We included women with diabetes mellitus and pregnant women. Diagnosis of RVVC must have been confirmed by presence of symptoms and a positive culture and/or microscopy. We included all drug and non-drug therapies and partner treatment, assessing the following primary outcomes: • number of clinical recurrences per participant per year (recurrence defined as clinical signs and positive culture/microscopy); • proportion of participants with at least one clinical recurrence during the treatment and follow-up period; and • adverse events.
DATA COLLECTION AND ANALYSIS
Two authors independently reviewed titles and abstracts to identify eligible trials. Duplicate data extraction was completed independently by two authors. We assessed risk of bias as described in the Cochrane Handbook for Systematic Reviews of Interventions. We used the fixed-effects model for pooling and expressed the results as risk ratio (RR) with 95% confidence intervals (CI). Where important statistical heterogeneity was present we either did not pool data (I > 70%) or used a random-effects model (I 40-70%). We used the GRADE tool to assess overall certainty of the evidence for the pooled primary outcomes.
MAIN RESULTS
Studies: Twenty-three studies involving 2212 women aged 17 to 67 years met the inclusion criteria. Most studies excluded pregnant women and women with diabetes or immunosuppression. The predominant species found on culture at study entry was Candida albicans. Overall, the included studies were small (<100 participants). Six studies compared antifungal treatment with placebo (607 participants); four studies compared oral versus topical antifungals (543 participants); one study compared different oral antifungals (45 participants); two studies compared different dosing regimens for antifungals (100 participants); one study compared two different dosing regimens of the same topical agent (23 participants); one study compared short versus longer treatment duration (26 participants); two studies assessed the effect of partner treatment (98 participants); one study compared a complementary treatment (Lactobacillus vaginal tablets and probiotic oral tablets) with placebo (34 participants); three studies compared complementary medicine with antifungals (354 participants); two studies compared 'dermasilk' briefs with cotton briefs (130 participants); one study examined Lactobacillus vaccination versus heliotherapy versus ciclopyroxolamine (90 participants); one study compared CAM treatments to an antifungal treatment combined with CAM treatments (68 participants). We did not find any studies comparing different topical antifungals. Nine studies reported industry funding, three were funded by an independent source and eleven did not report their funding source. Risk of bias: Overall, the risk of bias was high or unclear due to insufficient blinding of allocation and participants and poor reporting. Primary outcomes: Meta-analyses comparing drug treatments (oral and topical) with placebo or no treatment showed there may be a clinically relevant reduction in clinical recurrence at 6 months (RR 0.36, 95% CI 0.21 to 0.63; number needed to treat for an additional beneficial outcome (NNTB) = 2; participants = 607; studies = 6; I² = 82%; low-certainty evidence) and 12 months (RR 0.80, 95% CI 0.72 to 0.89; NNTB = 6; participants = 585; studies = 6; I² = 21%; low-certainty evidence). No study reported on the number of clinical recurrences per participant per year. We are very uncertain whether oral drug treatment compared to topical treatment increases the risk of clinical recurrence at 6 months (RR 1.66, 95% CI 0.83 to 3.31; participants = 206; studies = 3; I² = 0%; very low-certainty evidence) and reduces the risk of clinical recurrence at 12 months (RR 0.95, 95% CI 0.71 to 1.27; participants = 206; studies = 3; I² = 10%; very low-certainty evidence). No study reported on the number of clinical recurrences per participant per year. Adverse events were scarce across both treatment and control groups in both comparisons. The reporting of adverse events varied amongst studies, was generally of very low quality and could not be pooled. Overall the adverse event rate was low for both placebo and treatment arms and ranged from less than 5% to no side effects or complications.
AUTHORS' CONCLUSIONS
In women with RVVC, treatment with oral or topical antifungals may reduce symptomatic clinical recurrences when compared to placebo or no treatment. We were unable to find clear differences between different treatment options (e.g. oral versus topical treatment, different doses and durations). These findings are not applicable to pregnant or immunocompromised women and women with diabetes as the studies did not include or report on them. More research is needed to determine the optimal medication, dose and frequency.
Topics: Antifungal Agents; Candidiasis, Oral; Candidiasis, Vulvovaginal; Female; Humans; Immunosuppressive Agents; Pregnancy
PubMed: 35005777
DOI: 10.1002/14651858.CD009151.pub2 -
General Dentistry 2017This study aimed to evaluate the scientific evidence regarding the effectiveness of silver diamine fluoride (SDF) in preventing and arresting caries in the primary... (Review)
Review
This study aimed to evaluate the scientific evidence regarding the effectiveness of silver diamine fluoride (SDF) in preventing and arresting caries in the primary dentition and permanent first molars. A systematic review (SR) was performed by 2 independent reviewers using 3 electronic databases (PubMed, ScienceDirect, and Scopus). The database search employed the following key words: "topical fluorides" AND "children" AND "clinical trials"; "topical fluorides" OR "silver diamine fluoride" AND "randomized controlled trial"; "silver diamine fluoride" AND "children" OR "primary dentition" AND "tooth decay"; "silver diamine fluoride" OR "sodium fluoride varnish" AND "early childhood caries"; and "silver diamine fluoride" AND "children". Inclusion criteria were articles published in English, from 2005 to January 2016, on clinical studies using SDF as a treatment intervention to evaluate caries arrest in children with primary dentition and/or permanent first molars. Database searches provided 821 eligible publications, of which 33 met the inclusion criteria. After the abstracts were prescreened, 25 articles were dismissed based on exclusion criteria. The remaining 8 full-text articles were assessed for eligibility. Of these, 7 publications were included in the SR. These included 1 study assessing the effectiveness of SDF at different concentrations; 3 studies comparing SDF with other interventions; 2 investigations comparing SDF at different application frequencies and with other interventions; and 1 study comparing semiannual SDF applications versus a control group. The literature indicates that SDF is a preventive treatment for dental caries in community settings. At concentrations of 30% and 38%, SDF shows potential as an alternative treatment for caries arrest in the primary dentition and permanent first molars. To establish guidelines, more studies are needed to fully assess the effectiveness of SDF and to determine the appropriate application frequency.
Topics: Cariostatic Agents; Child; Dental Caries; Fluorides, Topical; Humans; Molar; Quaternary Ammonium Compounds; Silver Compounds; Tooth, Deciduous
PubMed: 28475081
DOI: No ID Found -
The Lancet. Infectious Diseases Mar 2016Topical and oral antibiotics are routinely used to treat acne. However, antibiotic resistance is increasing, with many countries reporting that more than 50% of... (Review)
Review
Topical and oral antibiotics are routinely used to treat acne. However, antibiotic resistance is increasing, with many countries reporting that more than 50% of Propionibacterium acnes strains are resistant to topical macrolides, making them less effective. We reviewed the current scientific literature to enable proposal of recommendations for antibiotic use in acne treatment. References were identified through PubMed searches for articles published from January, 1954, to March 7, 2015, using four multiword searches. Ideally, benzoyl peroxide in combination with a topical retinoid should be used instead of a topical antibiotic to minimise the impact of resistance. Oral antibiotics still have a role in the treatment of moderate-to-severe acne, but only with a topical retinoid, benzoyl peroxide, or their combination, and ideally for no longer than 3 months. To limit resistance, it is recommended that benzoyl peroxide should always be added when long-term oral antibiotic use is deemed necessary. The benefit-to-risk ratio of long-term antibiotic use should be carefully considered and, in particular, use alone avoided where possible. There is a need to treat acne with effective alternatives to antibiotics to reduce the likelihood of resistance.
Topics: Acne Vulgaris; Anti-Bacterial Agents; Benzoyl Peroxide; Drug Resistance, Bacterial; Humans; Propionibacterium acnes; Retinoids
PubMed: 26852728
DOI: 10.1016/S1473-3099(15)00527-7 -
Clinical, Cosmetic and Investigational... 2023Androgenetic alopecia (AGA) has negative impacts on both men and women in terms of appearance and mental stress. Spironolactone is a synthetic aldosterone receptor... (Review)
Review
INTRODUCTION
Androgenetic alopecia (AGA) has negative impacts on both men and women in terms of appearance and mental stress. Spironolactone is a synthetic aldosterone receptor antagonist known to stimulate hair growth and has been widely used by dermatologists to treat AGA.
OBJECTIVE
To conduct a systematic review evaluating the efficacy and safety of topical and oral spironolactone in AGA treatment.
METHODS
We searched PubMed, Embase, the Cochrane Library, and the Web of Science until October 23rd, 2022, for human studies evaluating the efficacy of spironolactone for the treatment of AGA, regardless of doses and routes.
RESULTS
We retrieved 784 papers and ultimately 7 articles matched our inclusion criteria and comprised 618 AGA patients (65 men, 553 women), 414 of them received spironolactone treatment. Oral spironolactone doses ranged from 25mg to 200mg daily, with the vast majority between 80mg and 110 mg. Dosage forms for topical spironolactone use include gels of 1% and solutions of 5% twice daily. Both oral and topical spironolactone have been shown efficacy for alopecia recovery, but topical use has significantly fewer side effects and is suitable for any gender. It showed better efficacy in combination with other therapies such as oral or topical minoxidil compared with monotherapy.
CONCLUSION
Spironolactone is an effective and safe treatment of androgenic alopecia which can enhance the efficacy when combined with other conventional treatments such as minoxidil. Topical spironolactone is safer than oral administration and is suitable for both male and female patients, and is expected to become a common drug for those who do not have a good response to minoxidil. Furthermore, more high-quality clinical randomized controlled studies should be performed.
PubMed: 36923692
DOI: 10.2147/CCID.S398950 -
The Cochrane Database of Systematic... Oct 2022Dry eye disease (DED), arising from various etiologic factors, leads to tear film instability, ocular surface damage, and neurosensory changes. DED causes symptoms such... (Review)
Review
BACKGROUND
Dry eye disease (DED), arising from various etiologic factors, leads to tear film instability, ocular surface damage, and neurosensory changes. DED causes symptoms such as ocular dryness, burning, itching, pain, and visual impairment. Given their well-established anti-inflammatory effects, topical steroid preparations have been widely used as a short-term treatment option for DED. Because of potential risks of ocular hypertension, cataracts, and infections associated with the long-term use of topical steroids, published trials comparing the efficacy and safety of topical steroids (versus placebo) have mostly been of short duration (three to eight weeks).
OBJECTIVES
To evaluate the effectiveness and safety of topical corticosteroids compared with no treatment, placebo, other steroidal or non-steroidal therapies, or a combination of therapies for DED.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL, which contains the Cochrane Eyes and Vision Trials Register; 2021, Issue 8); Ovid MEDLINE; Ovid Embase; Latin American and Caribbean Health Sciences database (LILACS); ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), without restriction on language or year of publication. The date of the last search was 20 August 2021.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) in which topical corticosteroids, alone or in combination with tobramycin, were compared with no treatment, artificial tears (AT), vehicles, AT plus tobramycin, or cyclosporine A (CsA).
DATA COLLECTION AND ANALYSIS
We applied standard Cochrane methodology.
MAIN RESULTS
We identified 22 RCTs conducted in the USA, Italy, Spain, China, South Korea, and India. These RCTs reported outcome data from a total of 4169 participants with DED. Study characteristics and risk of bias All trials recruited adults aged 18 years or older, except one trial that enrolled children and adolescents aged between 3 and 14 years. Half of these trials involved predominantly female participants (median 79%, interquartile range [IQR] 76% to 80%). On average, each trial enrolled 86 participants (IQR 40 to 158). The treatment duration of topical steroids ranged between one week and three months; trial duration lasted between one week and six months. Eight trials were sponsored exclusively by industry, and four trials were co-sponsored by industry and institutional or governmental funds. We assessed the risk of bias of both subjective and objective outcomes using RoB 2, finding nearly half of the trials to be at high risk of bias associated with selective outcome reporting. Findings Of the 22 trials, 16 evaluated effects of topical steroids, alone or in combination with tobramycin, as compared with lubricants (AT, vehicle), AT plus tobramycin, or no treatment. Corticosteroids probably have a small to moderate effect on improving patient-reported symptoms by 0.29 standardized mean difference (SMD) (95% confidence interval [CI] 0.16 to 0.42) as compared with lubricants (moderate certainty evidence). Topical steroids also likely have a small to moderate effect on lowering corneal staining scores by 0.4 SMDs (95% CI 0.18 to 0.62) (moderate certainty evidence). However, steroids may increase tear film break-up time (TBUT) slightly (mean difference [MD] 0.70 s, 95% CI 0.06 to 1.34; low certainty evidence) but not tear osmolarity (MD 1.60 mOsm/kg, 95% CI -10.47 to 13.67; very low certainty evidence). Six trials examined topical steroids, either alone or in combination with CsA, against CsA alone. Low certainty evidence indicates that steroid-based interventions may have a small to moderate effect on improving participants' symptoms (SMD -0.33, 95% CI -0.51 to -0.15), but little to no effect on corneal staining scores (SMD 0.05, 95% CI -0.25 to 0.35) as compared with CsA. The effect of topical steroids compared to CsA alone on TBUT (MD 0.37 s, 95% CI -0.13 to 0.87) or tear osmolarity (MD 5.80 mOsm/kg, 95% CI -0.94 to 12.54; loteprednol etabonate alone) is uncertain because the certainty of the evidence is low or very low. None of the included trials reported on quality of life scores. Adverse effects The evidence for adverse ocular effects of topical corticosteroids is very uncertain. Topical corticosteroids may increase participants' risk of intraocular pressure (IOP) elevation (risk ratio [RR] 5.96, 95% CI 1.30 to 27.38) as compared with lubricants. However, when compared with CsA, steroids alone or combined with CsA may decrease or increase IOP elevation (RR 1.45, 95% CI 0.25 to 8.33). It is also uncertain whether topical steroids may increase risk of cataract formation when compared with lubricants (RR 0.34, 95% CI 0.01 to 8.22), given the short-term use and study duration (four weeks or less) to observe longer-term adverse effects. AUTHORS' CONCLUSIONS: Overall, the evidence for the specified review outcomes was of moderate to very low certainty, mostly due to high risk of bias associated with selective results reporting. For dry eye patients whose symptoms require anti-inflammatory control, topical corticosteroids probably provide small to moderate degrees of symptom relief beyond lubricants, and may provide small to moderate degrees of symptom relief beyond CsA. However, the current evidence is less certain about the effects of steroids on improved tear film quality or quantity. The available evidence is also very uncertain regarding the adverse effects of topical corticosteroids on IOP elevation or cataract formation or progression. Future trials should generate high certainty evidence to inform physicians and patients of the optimal treatment strategies with topical corticosteroids in terms of regimen (types, formulations, dosages), duration, and its time-dependent adverse profile.
Topics: Adolescent; Adult; Child; Child, Preschool; Female; Humans; Male; Adrenal Cortex Hormones; Cataract; Cyclosporine; Dry Eye Syndromes; Glucocorticoids; Loteprednol Etabonate; Lubricant Eye Drops; Randomized Controlled Trials as Topic; Tobramycin
PubMed: 36269562
DOI: 10.1002/14651858.CD015070.pub2