The Treatment of Anxiety in Patients with Somatoform Dysfunction, Reaction to Severe Stress and other Neurotic Disorders: A Multicenter Double-blind Placebo-controlled Randomized Trial

Abstract The existing treatment of somatoform dysfunction (SD), reaction to severe stress (RSS) and adjustment disorders (AjD) is insufficiently effective and safe. Anxiolytic drug Tenoten (Materia Medica Holding) is shown to be effective in clinical trials (CT). Objectives The aim of multicenter double-blind placebo-controlled randomized CT was to investigate the safety and efficacy of Tenoten in the anxiety treatment of adults with SD, RSS, AjD and other neurotic disorders (oNDs). Methods 390 adults with SD, RSS and AjD or oNDs with the Hospital Anxiety and Depression scale-anxiety (HADS-A) score≥11 were randomized into 4 groups (Tenoten group 14 tablets/day n=127; Tenoten group 3 8 tablets/day n=131, combined Placebo group 2+4 n= 132). The changes from baseline in the mean Hamilton Anxiety Rating Scale (HAM-A) score in groups 1 and 3 after 12 weeks was the primary outcome. Results The decrease in the HAM-A score from 18.81±5.81 to 7.26±4.63 (group 1) and from 18.38±4.3 to 6.40±4.02 (group 3) was observed post-treatment (p group 1/placebo =0.0055, p group 3/placebo <0.0001). The mean changes in the scores in the groups 1, 3 and the Placebo were 11.25, 11.91 and 9.71, respectively. In total, 46 AEs (28 AEs in the Tenoten groups, 18 in the Placebo) were registered in 37 patients (20 in the Tenoten groups, and 17 in the Placebo). No differences in frequency of AEs between groups were found. Conclusions Tenoten was shown to be significantly more effective than placebo in the anxiety treatment of adults with SD, RSS, AjD and oNDs (clinicaltrials.gov NCT03036293).

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The randomized clinical trial results of the anxiety treatment in patients with somatoform dysfunction and neurotic disorders

Scientific Reports ◽

10.1038/s41598-021-03727-5 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Vladimir Anatolevich Parfenov ◽

Pavel Rudolfovich Kamchatnov ◽

Dina Rustemovna Khasanova ◽

Enver Ibragimovich Bogdanov ◽

Tatiana Markovna Lokshtanova ◽

...

Keyword(s):

Rating Scale ◽

Depression Scale ◽

Study Groups ◽

Double Blind ◽

Neurotic Disorders ◽

Group 3 ◽

Anxiety Treatment ◽

Group 2 ◽

Clinical Trial Results ◽

Group 1

AbstractThe existing treatments for somatoform dysfunction (SfD), reaction to severe stress (RSS), and adjustment disorders (AjD) are insufficiently effective and safe. Anxiolytic drug Tenoten proved effective in clinical trials (CT). The aim of this multicenter double-blind placebo-controlled randomized CT was to investigate the safety and efficacy of Tenoten in the treatment of anxiety in adults with SfD, RSS, AjD and other neurotic disorders (oNDs). 390 adult patients with SfD, RSS and AjD or oNDs with the Hospital Anxiety and Depression scale-anxiety (HADS-A) score ≥ 11 were randomized into 4 groups (n = 127 in Tenoten group 1 (4 tablets/day); n = 131 in Tenoten group 3 (8 tablets/day), n = 132 in combined Placebo group 2 + 4). The changes from baseline in the mean Hamilton Anxiety Rating Scale (HAM-A) score in groups 1 and 3 after 12 weeks were the primary outcome. The decrease of the HAM-A score from 18.81 ± 5.81 to 7.26 ± 4.63 (in group 1) and from 18.38 ± 4.3 to 6.40 ± 4.02 (in group 3) was observed post-treatment (pgroup 1/placebo = 0.0055, pgroup 3/placebo < 0.0001). Overall, 46 adverse events (28 in the Tenoten groups and 18 in the Placebo) were reported without any difference between the study groups. Tenoten performed significantly more effective than placebo in the anxiety treatment of adults with SfD, RSS, AjD and oNDs (clinicaltrials.gov NCT03036293).

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Nalbuphine ER Tablets for Uremic Pruritus

American Journal of Nephrology ◽

10.1159/000484573 ◽

2017 ◽

Vol 46 (6) ◽

pp. 450-458 ◽

Cited By ~ 29

Author(s):

Vandana S. Mathur ◽

Jayant Kumar ◽

Paul W. Crawford ◽

Howard Hait ◽

Thomas Sciascia ◽

...

Keyword(s):

Rating Scale ◽

Numerical Rating Scale ◽

Controlled Trial ◽

Hemodialysis Patients ◽

Opioid Antagonist ◽

Opioid Agonist ◽

Double Blind ◽

Double Blind Placebo ◽

Uremic Pruritus ◽

The Mean

Background: Pruritus is a distressing hallmark of the uremic condition, affecting approximately 60% of hemodialysis patients. Abnormal endogenous opioid ligand activity at μ and κ-opioid receptors has been postulated as a mechanism in uremic pruritus. Nalbuphine is a μ-opioid antagonist and κ-opioid agonist. Methods: In this multicenter, randomized, double-blind, placebo-controlled trial, 373 hemodialysis patients with moderate or severe uremic pruritus were randomized in a 1: 1:1 ratio to nalbuphine extended-release tablets 120 mg (NAL 120), 60 mg (NAL 60), or placebo and treated for 8 weeks. Three hundred seventy-one were analyzed for efficacy. The primary endpoint was the change from baseline to treatment weeks 7 and 8 in itching intensity on a Numerical Rating Scale (NRS, 0 [no itching]; 10 [worst possible itching]) using an intent-to-treat approach. The aim was to evaluate the safety and antipruritic efficacy of NAL. Results: The mean duration of itching was 3.2 years. From a baseline NRS of 6.9 (1.5), the mean NRS declined by 3.5 (2.4) and by 2.8 (2.2) in NAL 120 mg and the placebo groups, respectively (p = 0.017). There was no evidence of tolerance. A trend for less sleep disruption due to itching (p = 0.062, NAL 120 vs. placebo) was also observed. There were no significant differences between NAL 60 vs. placebo. Serious adverse events occurred in 6.7, 12.7, and 15.4% in the NAL 120, NAL 60, and placebo groups respectively. Conclusions: In this largest-to-date randomized controlled trial in uremic pruritus, NAL 120 durably and significantly reduced the itching intensity among hemodialysis patients.

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Stress-protective effects of micronized progesterone in treatment of anxiety disorders in pregnant women after in vitro fertilisation

GYNECOLOGY ◽

10.26442/20795696.2021.4.201091 ◽

2021 ◽

Vol 23 (4) ◽

pp. 346-353

Author(s):

Natalya I. Tapilskaya ◽

Mikhail S. Nekrasov ◽

Inna O. Krikheli ◽

Ksenia V. Ob'edkova ◽

Alexander M. Gzgzyan ◽

...

Keyword(s):

Anxiety Disorders ◽

Pregnant Women ◽

Rating Scale ◽

Depression Scale ◽

Anxiety And Depression ◽

In Vitro Fertilisation ◽

Group 3 ◽

The Mean ◽

Micronized Progesterone

Aim. To study a stress-protective efficacy of micronized progesterone (MP) in pregnant women with anxiety disorders after in vitro fertilisation (IVF). Materials and methods. We conducted a prospective, comparative open-label randomized trial in two IVF-clinics. A total of 98 pregnant women after IVF with anxiety disorders were recruited at the 9th week of pregnancy. Progesterone supplementation after IVF for luteal phase support was administered out until 9 weeks gestation. Then, after randomization, group 1 (n=35) received 400 mg per day of MP vaginally, group 2 (n=33) received 400 mg of MP orally, group 3 (n=30) was comparative for the other groups. The duration of progesterone treatment was 12 weeks. The Spielberger State Trait Anxiety Inventory (STAI), the Montgomerysberg depression rating scale (MADRS), Hospital Anxiety and Depression Scale (HADS), and the Epworth Sleepiness Questionnaires (ESQ) were used to compare maternal mood at 9 weeks (day of randomization) after delivery and at 283, 565, 847 days after randomization. Results. The mean STAI sumscore in MP-groups was significantly lower than in group 3 starting from day 565 and continued until the end of the study. There were no significant differences between vaginal and oral administration of progesterone. There were no significant differences between the mean sumscores when questioning on the HADS, MADRS and ESQ. Conclusion. Prolonged use of MP in pregnant women with anxiety disorders led to the prevention of manifestations of an increase in anxiety and depression. The stress-protective and neuromodulating properties of MP can determine additional indications for its prolonged administration in women with anxiety disorders and/or premorbid history.

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Evolution of pain at 3 months by oral resveratrol in knee osteoarthritis (ARTHROL): protocol for a multicentre randomised double-blind placebo-controlled trial

BMJ Open ◽

10.1136/bmjopen-2017-017652 ◽

2017 ◽

Vol 7 (9) ◽

pp. e017652 ◽

Cited By ~ 4

Author(s):

Christelle Nguyen ◽

Isabelle Boutron ◽

Gabriel Baron ◽

Emmanuel Coudeyre ◽

Francis Berenbaum ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Knee Pain ◽

Rating Scale ◽

Controlled Trial ◽

Tertiary Care ◽

Double Blind ◽

Double Blind Placebo ◽

Knee Oa ◽

The Mean ◽

Anti Inflammatory

IntroductionOsteoarthritis (OA) pathophysiology is driven in part by joint inflammation. Resveratrol has in vitro anti-inflammatory properties. We aim to assess the efficacy of oral resveratrol for knee pain at 3 months in people with knee OA.Methods and analysisWe will conduct a randomised double-blind placebo-controlled trial. Overall, 164 individuals with knee OA fulfilling 1986 American College of Rheumatology criteria will be recruited in three tertiary care centres in France and randomised to receive oral resveratrol, 40 mg (two caplets) two times per day for 1 week, then 20 mg (one caplet) two times per day or a matching placebo for a total of 6 months. Randomisation will be centralised and stratified by centre. The allocation ratio of assignments will be 1:1. The primary outcome will be the mean change from baseline in knee pain on a self-administered 11-point pain Numeric Rating Scale at 3 months. Secondary outcomes will be the mean change in knee pain at 6 months, the function subscore of the Western Ontario and McMaster Universities Arthritis Index score, patient global assessment, proportion of responders according to the Osteoarthritis Research Society International–Outcome Measures in Rheumatology criteria at 3 and 6 months, and self-reported number of intra-articular injections of corticosteroids or hyaluronic acid and consumption of analgesics and non-steroidal anti-inflammatory drugs since the last contact. Other interventions will be allowed and self-reported. Adherence will be monitored by capsule counts and a booklet and adverse events recorded at 3 and 6 months. Statisticians, treating physicians and participants will be blinded to the allocated treatment.Ethics and disseminationThe oral resveratrol in knee osteoarthritis (ARTHROL) trial has been authorised by theAgenceNationale de Sécurité du Médicament et des Produits de Santéand ethics were approved by theComité deProtection des Personnes Île-de-FranceIII. The findings of the study will be published in a peer-reviewed journal and disseminated at conferences. The design of ARTHROL will warrant the translation of its findings into clinical practice.Trial registration numberClinicalTrials.gov identifier:NCT02905799. Pre-results. First received: 14 September 2016. Last updated: 16 September 2016. Status: not yet recruiting.

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132 Effects of Valbenazine on Depression and Suicidality in Adults With Tardive Dyskinesia: Pooled Results of 3 Double-Blind, Placebo-Controlled Trials

CNS Spectrums ◽

10.1017/s1092852918000287 ◽

2018 ◽

Vol 23 (1) ◽

pp. 82-83

Author(s):

Gary Remington ◽

Dao Thai-Cuarto ◽

Joshua Burke ◽

Scott Siegert ◽

Grace S. Liang

Keyword(s):

Suicidal Ideation ◽

Mood Disorder ◽

Schizoaffective Disorder ◽

Rating Scale ◽

Depression Scale ◽

Controlled Trials ◽

Double Blind ◽

Once Daily ◽

Double Blind Placebo ◽

Safety Population

AbstractStudy ObjectivesValbenazine (INGREZZA; VBZ) is a novel and highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor that is approved for the treatment of tardive dyskinesia (TD) in adults. The randomized, double-blind, placebo (PBO)-controlled trials of VBZ evaluated the treatment of TD in patients with a primary psychiatric diagnosis (schizophrenia/schizoaffective disorder or mood disorder) while on concomitant psychiatric medications to manage these disorders. Since treatment-emergent depression and suicidal ideation/behavior are important clinical concerns in psychiatric patient populations, data from these trials were analyzed to assess the effectsof once-daily VBZ on depression and suicidality.MethodsData were pooled from three 6-week trials: KINECT (NCT01688037), KINECT 2 (NCT01733121), KINECT 3 (NCT02274558). Outcome data were analyzed in the safety population by pooled VBZ doses (40 mg, 80 mg) and PBO. Outcomes of interest included: treatment-emergent adverse events (TEAEs) related to depression or suicidality; mean score change from baseline to Week 6 in the Calgary Depression Scale for Schizophrenia (CDSS, for participants with schizophrenia/schizoaffective disorder) or the Montgomery-Åsberg Depression Rating Scale (MADRS, for participants with mood disorder); and, worsening from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation scores. All outcomes were analyzed descriptively.ResultsThere were 400 total participants in the pooled safety population; 286 participants had schizophrenia/schizoaffective disorder (40 mg, n=82; 80 mg, n=70; PBO, n=134) and 114 had a mood disorder (40 mg, n=28; 80 mg, n=42; PBO, n=44). Over one-third of participants had a lifetime history of suicidal ideation or behavior (40 mg, 45%; 80 mg, 39%; PBO, 37%). Few participants had a depression- or suicide-related TEAE, with no apparent differences between VBZ and PBO: suicidal ideation (40 mg, 3.6%; 80 mg, 0.9%; PBO, 2.2%); depression (40 mg, 0%; 80 mg, 1.8%; PBO, 1.1%); depressive symptom (40 mg, 0.9%; 80 mg, 0%; PBO, 0.6%); suicide attempt (40 mg, 0%; 80 mg, 0.9%; PBO, 0%). Mean changes from baseline to Week 6 in depression scale scores were generally small and similar across treatment groups: CDSS total score (40 mg, -0.5; 80 mg, -0.6; PBO, -0.3); MADRS total score (40 mg, -0.2; 80 mg, -1.7; PBO, 0.6). Few participants had a shift from no suicidal ideation at baseline (C-SSRS score=0) to any suicidal ideation during treatment (C-SSRS score=1-5): 40 mg, 3.9% (4/103); 80 mg, 0.9% (1/111); PBO, 2.9% (5/174).ConclusionData from 3 double-blind, placebo-controlled trials indicate that once-daily VBZ treatment was not associated with a worsening in depression-related symptoms or an increased risk of suicidal ideation or behavior.Funding AcknowledgementsThis study was funded by Neurocrine Biosciences, Inc.

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The Effect of Desmopressin on Reducing Blood Loss in Cardiac Surgery – A Meta-Analysis of Double-Blind, Placebo-Controlled Trials

Thrombosis and Haemostasis ◽

10.1055/s-0038-1649883 ◽

1995 ◽

Vol 74 (04) ◽

pp. 1064-1070 ◽

Cited By ~ 76

Author(s):

Marco Cattaneo ◽

Alan S Harris ◽

Ulf Strömberg ◽

Pier Mannuccio Mannucci

Keyword(s):

Cardiac Surgery ◽

Blood Loss ◽

Meta Analysis ◽

Postoperative Blood Loss ◽

Controlled Trials ◽

Double Blind ◽

Double Blind Placebo ◽

Transfusion Requirements ◽

The Mean ◽

Excessive Blood Loss

SummaryThe effect of desmopressin (DDAVP) on reducing postoperative blood loss after cardiac surgery has been studied in several randomized clinical trials, with conflicting outcomes. Since most trials had insufficient statistical power to detect true differences in blood loss, we performed a meta-analysis of data from relevant studies. Seventeen randomized, double-blind, placebo-controlled trials were analyzed, which included 1171 patients undergoing cardiac surgery for various indications; 579 of them were treated with desmopressin and 592 with placebo. Efficacy parameters were blood loss volumes and transfusion requirements. Desmopressin significantly reduced postoperative blood loss by 9%, but had no statistically significant effect on transfusion requirements. A subanalysis revealed that desmopressin had no protective effects in trials in which the mean blood loss in placebo-treated patients fell in the lower and middle thirds of distribution of blood losses (687-1108 ml/24 h). In contrast, in trials in which the mean blood loss in placebo-treated patients fell in the upper third of distribution (>1109 ml/24 h), desmopressin significantly decreased postoperative blood loss by 34%. Insufficient data were available to perform a sub-analysis on transfusion requirements. Therefore, desmopressin significantly reduces blood loss only in cardiac operations which induce excessive blood loss. Further studies are called to validate the results of this meta-analysis and to identify predictors of excessive blood loss after cardiac surgery.

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Comparison of the ATRIA, CHA2DS2-VASc, and Modified Scores ATRIA-HSV, CHA2DS2-VASc-HS, for the Prediction of Coronary Artery Disease Severity

Angiology ◽

10.1177/0003319721991410 ◽

2021 ◽

pp. 000331972199141

Author(s):

Arafat Yildirim ◽

Mehmet Kucukosmanoglu ◽

Fethi Yavuz ◽

Nermin Yildiz Koyunsever ◽

Yusuf Cekici ◽

...

Keyword(s):

Coronary Artery Disease ◽

Coronary Artery ◽

Vascular Disease ◽

Operating Characteristics ◽

Coronary Artery Disease Severity ◽

Group 3 ◽

The Mean ◽

Group 2 ◽

Artery Disease ◽

Group 1

Many parameters included in the Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) and CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke, vascular disease, age 65-74 years, sex category) scores also predict coronary artery disease (CAD). We modified the ATRIA score (ATRIA-HSV) by adding hyperlipidemia, smoking, and vascular disease and also male sex instead of female. We evaluated whether the CHA2DS2-VASc, CHA2DS2-VASc-HS, ATRIA, and ATRIA-HSV scores predict severe CAD. Consecutive patients with coronary angiography were prospectively included. A ≥50% stenosis in ≥1epicardial coronary artery (CA) was defined as severe CAD. Patient with normal CA (n = 210) were defined as group 1, with <50% CA stenosis (n = 178) as group 2, and with ≥50% stenosis (n = 297) as group 3. The mean ATRIA, ATRIA-HSV, CHA2DS2-VASc, and CHA2DS2VASc-HS scores increased from group 1 to group 3. A correlation was found between the Synergy between PCI with Taxus and Cardiac Surgery score and ATRIA ( r = 0.570), ATRIA-HSV ( r = 0.614), CHA2DS2-VASc ( r = 0.428), and CHA2DS2-VASc-HS ( r = 0.500) scores ( Ps < .005). Pairwise comparisons of receiver operating characteristics curves showed that ATRIA-HSV (>3 area under curve [AUC]: 0.874) and ATRIA (>3, AUC: 0.854) have a better performance than CHA2DS2-VASc (>1, AUC: 0.746) and CHA2DS2-VASc-HS (>2, AUC: 0.769). In conclusion, the ATRIA and ATRIA-HSV scores are simple and may be useful to predict severe CAD.

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A randomized, double-blind, placebo-controlled trial on the efficacy and tolerability of sertraline in Iranian veterans with post-traumatic stress disorder

Psychological Medicine ◽

10.1017/s0033291711000201 ◽

2011 ◽

Vol 41 (10) ◽

pp. 2159-2166 ◽

Cited By ~ 20

Author(s):

Y. Panahi ◽

B. Rezazadeh Moghaddam ◽

A. Sahebkar ◽

M. Abbasi Nazari ◽

F. Beiraghdar ◽

...

Keyword(s):

Placebo Group ◽

Post Traumatic Stress Disorder ◽

Traumatic Stress ◽

Stress Disorder ◽

Controlled Trial ◽

Post Traumatic Stress ◽

Double Blind ◽

Double Blind Placebo ◽

Post Traumatic ◽

The Mean

BackgroundUnlike civilian post-traumatic stress disorder (PTSD), the efficacy of sertraline for the treatment of combat-related PTSD has not yet been proven. The present study aimed to evaluate the clinical efficacy of sertraline against combat-related PTSD in a randomized, double-blind, placebo-controlled trial.MethodSeventy Iranian veterans of the Iran–Iraq war who met the DSM-IV criteria for diagnosis of PTSD were randomized to receive either flexibly dosed sertraline (50–200 mg/day) (n=35, completers=32) or placebo (n=35, completers=30) for 10 weeks. Efficacy was evaluated by the Impact of Event Scale – Revised (IES-R) and the Clinical Global Impression scale – Severity (CGI-S) and Improvement (CGI-I) ratings. Responder criteria were defined as a ⩾30% reduction in the IES-R total score plus a CGI-I rating of ‘much’ or ‘very much’ improved.ResultsOn both intention-to-treat (ITT) and per protocol (completer) methods of analysis, the mean reductions in the IES-R total and subscale (re-experiencing/intrusion, avoidance/numbing and hyperarousal) scores (p<0.001) and also in the CGI-S score (p<0.01) were significantly greater in the sertraline group than in the placebo group. For the CGI-I, the mean endpoint score was significantly lower in the sertraline group than in the placebo group (p⩽0.001). The number of responders in the sertraline group was significantly higher than in the placebo group (44% v. 3%, p⩽0.001). Sertraline was well tolerated, with a 6% discontinuation rate as a result of adverse reactions.ConclusionsThe results of this study suggest that sertraline can be an effective, safe and tolerable treatment for combat-related PTSD in Iranian veterans.

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The use of an antagonist 5-HT2a/c for depression and motor function in Parkinson' disease

Arquivos de Neuro-Psiquiatria ◽

10.1590/s0004-282x2009000300007 ◽

2009 ◽

Vol 67 (2b) ◽

pp. 407-412 ◽

Cited By ~ 25

Author(s):

Antonio Luiz dos Santos Werneck ◽

Ana Lucia Rosso ◽

Maurice Borges Vincent

Keyword(s):

Parkinson Disease ◽

Motor Function ◽

Rating Scale ◽

Statistical Significance ◽

Psychotic Symptoms ◽

Initial Moment ◽

The Mean ◽

Group 2 ◽

To Receive ◽

Group 1

OBJECTIVE: To test the ability of a 5HT2a/c (trazodone) antagonist, to improve depression and motor function in Parkinson' disease (PD). METHOD: Twenty PD patients with and without depression were randomly assigned to receive trazodone (group 1) or not (group 2). They were evaluated through UPDRS and Hamilton Depression Rating Scale (HAM-D). RESULTS: For the UPDRS the mean score of group 2 was 33.1 ± 19.7 and 37.1 ± 18.0 at the end. For the group 1, the corresponding scores were 31.4 ± 11.3 and 25.9 ± 13.7. The variations in the Mann-Whitney test were 0.734 at the initial moment and 0.208 at the final moment. The variation in the comparison of the initial moment with the final moment was 0.005 providing statistical significance. For the HAM-D, the mean score went up 4 points in group 2, contrary to a 5.5 points decrease in group 1. CONCLUSION: Data analysis shows that this agent significantly improves depression, but the motor function improved only in the depressed patients. Because of the known anti-dopaminergic property of the 5-HT2c receptors, a possible approach for depression in PD could be the use of 5-HT2c antagonists, similarly to the use of atypical neuroleptics in case of psychotic symptoms.

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Comparison of Changes in Number of Hyperreflective Dots After İntravitreal Ranibizumab or Dexamethasone İmplant in Patients with Branch Retinal Vein Occlusion

10.21203/rs.3.rs-736656/v1 ◽

2021 ◽

Author(s):

Aylin Karalezli ◽

Sema Kaderli ◽

Ahmet Kaderli ◽

Cansu Kaya ◽

Sabahattin Sul

Keyword(s):

First Year ◽

Intravitreal Ranibizumab ◽

Retinal Layers ◽

Vein Occlusion ◽

Significant Difference ◽

Group 3 ◽

The Mean ◽

Group 2 ◽

Group 1

Abstract Purpose: To compare the effect of intravitreal ranibizumab (IVR) or intravitreal dexamethasone implants (IVD) on regression of hyperreflective dots (HRDs) on optical coherence tomography (OCT) B-scan in patients with branch retinal vein occlusion (BRVO). Methods: 37 eyes of 37 patients with cystoid macular edema who received IVR or IVD and followed up for at least 12 months were included in this study. The patients were divided into three groups according to intravitreal treatment. Group 1 consisted of 12 eyes who received only IVD, group 2 consisted of 10 eyes who received only IVR on a pro re nata and group 3 consisted of 15 eyes who received both IVD and IVR. OCT parameters (CMT, number of HRDs, status of external limiting membrane (ELM) and ellipsoid zone (EZ)) and best-corrected visual acuity (BCVA) were compared between the groups over the follow-up time. HRDs were categorized as HRD in inner retinal layers (from the internal limiting membrane to the inner nuclear layer) or HRD in outer retinal layers (from the outer plexiform layer to the outer border of the photoreceptor layer).Results: There was no significant difference between groups in terms of BCVA, CMT, HRDs in the inner and the outer retinal layers at baseline visit. (p˃0.05 for all) Comparing the baseline values in all groups, a significant decrease was observed in CMT in the first year. (For group 1; p=0.013, group 2; p=0.010; group 3, p<0.001) The BCVA was significantly increased after 1 year in all groups. (p=0.001, p=0.006, p<0.001) The mean number of HRDs in inner and outer retinal layers were significantly decreased in group 1 and group 3. (For group 1; p<0.001, p=0.001, for group 3; p<0.001, p<0.001) However, there was no significant difference in terms of the mean number of HRDs in inner and outer retinal layers for group 2. (p=0.134, p=0.477) At the first year, the number of HRDs in inner and outer retinal layers was significantly lower in group 1 and group 3 than group 2. (For inner HRDs; group 1 vs. group 2 p=0.007, group 2 vs. group 3 p<0.001. For outer HRDs group 1 vs. group 2 p<0.001, group 2 vs. group 3 p<0.001.) The BCVA was higher in group 3 than group 2 at 1year. (p=0.048). There was no significant difference in terms of post-treatment CMT and the number of HRDs between group 1 and group3 in posthoc tests (p=0.621, p=0.876, and p=0.632).Conclusion: The reduction in HRDs at 12 months and better BCVA after IVD intimates that the HRDs should be considered as inflammatory markers in the follow-up of CME in BRVO. Thus, IVD injection could be more appropriate for patients with higher HRDs after BRVO.

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