Betamethasone Group Research Articles

Local Betamethasone Versus Triamcinolone Injection In Management of Thyroid Eye Disease-Related Upper Eyelid Retraction With Proptosis.

To compare the efficacy of local injection of both betamethasone and triamcinolone in the management of thyroid eye disease-related upper eyelid retraction with proptosis. This prospective, double-blind, randomized clinical trial was conducted at Assiut University Hospital, Upper Egypt in the period between December 2021 and December 2023. The study included 45 patients (77 eyes) and was divided into: A (betamethasone) group and B (triamcinolone) group. The steroid was injected peri-levator (1 ml) and retrobulbar (1.5 ml). The injection was repeated every month for up to 5 injections if there was an improvement in margin reflex distance 1 (MRD1) and Hertel measurements. The injection was stopped if measurements reached the normal value or if 2 successive injections caused no improvement. The postinjection outcome was divided into; 1) effective if measurements reached the normal (MRD1 ≤4.5 mm and Hertel ≤18 mm); 2) partially effective if measurements were improved but did not reach the normal; and 3) ineffective if there was no improvement in measurements. The follow-up ranged from 6 to 20 months. In group A, the injection was effective in 35 eyes (89.74%) and partially effective in 4 eyes (10.26%). In group B, the injection was effective in 22 eyes (57.9%), partially effective in 8 eyes (21.05%) and ineffective in 8 eyes (21.05%). The mean injection number was significantly lower in group A than in group B; 2.54 ± 0.51 versus 3.74 ± 1.18. This study's results suggest that betamethasone is more effective with a small number of injections than triamcinolone in the management of thyroid eye disease-related upper eyelid retraction with proptosis.

General health and social outcomes 50 years after exposure to antenatal betamethasone: follow-up of a randomised controlled trial

BackgroundAntenatal corticosteroids are recommended for women at risk of preterm birth from 24 to 34 weeks’ gestation as they reduce neonatal morbidity and mortality, but evidence regarding their long-term effects on offspring is limited. This study assessed general health and social outcomes 50 years after antenatal exposure to corticosteroids.MethodsWe assessed 424 adult offspring of women who participated in the first randomised, double-blind, placebo-controlled trial of antenatal betamethasone for the prevention of neonatal respiratory distress syndrome. The first 717 mothers received two intramuscular injections of betamethasone (6 mg betamethasone sodium phosphate and 6 mg betamethasone acetate) or placebo given 24 h apart and the subsequent 398 received two injections of double dose betamethasone (12 mg betamethasone sodium phosphate and 12 mg betamethasone acetate) or equivalent volume of placebo. Follow-up included a health questionnaire and consent for access to administrative data sources. Outcome categories included mental health (depression, anxiety, bipolar affective disorder, schizophrenia and treatment or hospital admission for any mental health disorder), general health (chronic kidney disease, cancer diagnosis, bone fracture, oral health, allergies, functional difficulties and physical activity) and social outcomes (educational attainment, employment and criminal convictions). Investigators remained blinded to treatment allocation. Analyses were adjusted for gestational age at entry, sex and clustering.ResultsWe assessed 424 adult offspring (46% of survivors; mean [SD] age 49.3 [1.0] years; 212 [50%] female). There was no difference in mental health, general health and social outcomes between those exposed to betamethasone and those exposed to placebo, with the exception that osteoporotic site fracture in adulthood was more likely to have occurred in the betamethasone group compared with placebo (adjusted relative risk 1.57, 95% CI 1.00, 2.48, p = 0.05). No dose–effect relationship was evident and there was no difference in the proportion with at least one fracture. Follow-up rate and lack of in-person assessments were the main limitations.ConclusionsThere is no evidence that antenatal corticosteroids have clinically important effects on general health and social outcomes up to 50 years of age.

Reproductive outcomes after antenatal corticosteroids: Secondary analysis of 50-year follow-up of the Auckland steroid randomized trial.

Antenatal corticosteroids are widely used to prevent morbidity and mortality after preterm birth, but there are ongoing concerns about the possible risk of long-term adverse effects, including perturbation of endocrine systems, with potential implications for reproduction. A small number of animal studies have suggested possible adverse effects on reproduction after antenatal exposure to corticosteroids, but there is a paucity of human data. This is a secondary cohort analysis of the 50-year follow-up of the Auckland Steroid Trial (1969-1974) comparing antenatal exposure to corticosteroids or placebo. Participants whose mothers took part in the placebo-controlled randomized trial of antenatal corticosteroids completed a questionnaire reporting reproductive outcomes at 50 years of age. The main outcome was at least one pregnancy ≥20 weeks or fathered at least one pregnancy ≥20 weeks. Additional outcomes included a number of pregnancies or fathered pregnancies ≥20 weeks, outcomes relating to female reproductive lifespan (including age at menarche and menopause), and outcomes relating to their offspring (including birthweight and gestation). Of 917 eligible participants, 415 (45% of eligible) completed the questionnaire at a mean (SD) age of 49.3 (1.0) years. The proportion of participants who had experienced at least one pregnancy ≥20 weeks or fathered at least one pregnancy ≥20 weeks was similar in betamethasone and placebo-exposed groups (163/217 [75%] vs. 136/190 [72%]; RR 1.08, (95% CI 0.95 to 1.22); p = 0.23). Participants exposed to betamethasone had a slightly higher number of pregnancies or fathered pregnancies ≥20 weeks compared to those exposed to placebo (mean 1.89 vs. 1.60; marginal mean difference 0.20, (95% CI 0.03-0.37); p = 0.03). Other outcomes, including female reproductive lifespan and offspring-related outcomes, were similar in both randomized groups. There were also no differences in any outcomes between those born preterm and those born at term. Antenatal exposure to corticosteroids appears to have no clinically important effect on reproductive outcomes to 50 years.

Comparative Study of the Safety and Efficacy of Intramuscular Dexamethasone, Betamethasone Phosphate, and Standard Management Protocol in Early-Term Scheduled Caesarean Delivery.

Background Babies born between 37 weeks +0 days and 38 weeks +6 days by scheduled caesarean delivery before the onset of labour are more prone to developing respiratory complications than babies delivered between 39 weeks +0 days and 40 weeks +0 days. Antenatal corticosteroids have been used in preterm births for lung maturity. The advantages of administering antenatal corticosteroids before a scheduled caesarean delivery in the early term remain a subject of debate. While some studies have reported benefits, including a reduction in respiratory issues, the evidence is still inconclusive. The study's main objective is to compare the efficacy and safety of intramuscular dexamethasone and betamethasone phosphate with standard treatment protocols in early-term infants. Methodology A total of 241 pregnant women scheduled for caesarean delivery were screened for eligibility to participate in the study. Out of these, 192 women met the inclusion criteria and were enrolled in the study after providing written informed consent; they were randomised into three groups, with 64 in each group, and were given either betamethasone phosphate or dexamethasone intramuscularly or were considered under standard management protocol (no administration of corticosteroids). The primary comparison was done to observe the development of respiratory distress syndrome, transient tachypnoea in newborns, and the need for neonatal intensive care unit (NICU) admission. Results Among 192 pregnant females observed, the incidence of development of respiratory distress syndrome did not differ significantly between the betamethasone, dexamethasone, and standard management groups, with rates of 6.25%, 7.81%, and 4.7%, respectively.Additionally, out of the 192 infants, 15 required neonatal intensive care, including 6 (9.4%) from the betamethasone group, 5 (7.8%) from the dexamethasone group, and 4 (6.3%) from the standard management group. All of these infants had a maximum stay of four days in the NICU, did not require mechanical support, and improved with oxygen therapy. Conclusion In our study, in early-term gestation, both the corticosteroid groups showed similar effects to those of the standard management group in reducing neonatal morbidity, with no significant statistical difference. Hence, the choice lies with the treating obstetrician to consider the administration of corticosteroids in early-term caesarean deliveries.

Association between prenatal glucocorticoid exposure and adolescent neurodevelopment: An observational follow-up study.

Prenatal exposure to supraphysiological glucocorticoid (GC) levels may lead to long-lasting developmental changes in numerous biological systems. Our prior study identified an association between prenatal GC prophylaxis and reduced cognitive performance, electrocortical changes, and altered autonomic nervous system (ANS) activity in children aged 8-9 years. This follow-up study aimed to examine whether these findings persisted into adolescence. Prospective observational follow-up study involving twenty-one 14- to 15-year-old adolescents born to mothers who received betamethasone for induction of fetal lung maturation in threatened preterm birth, but who were born with a normal weight appropriate for their gestational age (median 37+4 gestational weeks). Thirty-five children not exposed to betamethasone served as the reference group (median 37+6 gestational weeks). The primary endpoint was cognitive performance, measured by intelligence quotient (IQ). Key secondary endpoints included symptoms of attention-deficit/hyperactivity disorder (ADHD) and metabolic markers. Additionally, we determined electrocortical (electroencephalogram), hypothalamus-pituitary-adrenal axis (HPAA), and ANS activity in response to a standardized stress paradigm. No statistically significant group difference was observed in global IQ (adjusted mean: betamethasone 103.9 vs references 105.9, mean difference -2.0, 95% confidence interval [CI]: -7.12 to 3.12, p = 0.44). Similarly, ADHD symptoms, metabolic markers, the overall and stress-induced activity of the HPAA and the ANS did not differ significantly between groups. However, the betamethasone group exhibited reduced electrocortical activity in the frontal brain region (spectral edge frequency-adjusted means: 16.0 Hz vs 17.8 Hz, mean difference -1.83 Hz, 95% CI: -3.21 to -0.45, p = 0.01). In 14- to 15-year-old adolescents, prenatal GC exposure was not associated with differences in IQ scores or ANS activity compared to unexposed controls. However, decelerated electrocortical activity in the frontal region potentially reflects disturbances in the maturation of cortical and/or subcortical brain structures. The clinical significance of these changes remains unknown. Given the small sample size, selective participation/loss of follow-up and potential residual confounding, these findings should be interpreted cautiously. Further research is required to replicate these results in larger cohorts before drawing firm clinical conclusions.

Efficacy of Medical Ozone for Treatment of Chronic Musculoskeletal Pain with Abnormal Mitochondrial Redox State: Prospective Randomized Clinical Trial

BACKGROUND: Chronic primary musculoskeletal pain is multifaceted and 20% of the adult population lives with severe chronic pain and experience symptoms such as intense pain, depression, weakness, sleep problems, decreased quality of life and decreased emotional well-being. OBJECTIVES: This paper studies the efficacy of trigger point injections with ozone compared to standard steroid injection or combination therapy for the treatment of chronic musculoskeletal pain in patients with abnormal mitochondrial redox state. STUDY DESIGN: This is a prospective randomized clinical study conducted with 51 patients experiencing chronic musculoskeletal pain. SETTING: Medical Research Institute Hospital, Alexandria University. METHODS: By computer-generated random numbers the 51 patients were divided into 3 groups. Group A (17 patients) received ozone injection, group B (17 patients) received betamethasone injection and group C (17 patients) received combined ozone and betamethasone injections. The groups were compared based on the intensity of pain and correction of mitochondrial redox state of the patients. RESULTS: Three days after intervention, the visual analog scale (VAS) scores reported by patients were lower in group A compared to group B (with a mean difference 1.27, 95% confidence interval (CI) of 0.15-2.39 (P < 0.02). One and 3 weeks after intervention, VAS scores of patients were lower in groups A and C compared to group B. At one week the mean difference between A and B was 1.2, with a 95% CI of 0.15-2.25 (P < 0.02) and the mean difference between C and B was 1.73 with a 95% CI of 0.69-2.78 (P < 0.001). At 3 weeks the mean difference between A and B was 1.5 with a 95% CI of 0.2-2.87 (P < 0.01) and the mean difference between C and B was 2.27 with a 95% CI of 0.93-3.60 (P < 0.0001). The reduced/oxidized glutathione ratio after intervention was higher in groups A and C compared to group B (P > 0.008). The mitochondrial copy number was higher in group A compared to group B (P < 0.002). LIMITATION: This study didn’t allow for the comparison of the experimental groups with a placebo or control group for musculoskeletal pain conditions in orderto establish the role of an abnormal mitochondrial redox state on the pathogenesis of patients from an ethical view. CONCLUSIONS: Ozone therapy or combined ozone and betamethasone treatment are effective techniques for management of pain since it produced a significant reduction of muscle pain and increase of the pain free interval experienced by patients. Ozone therapy causes pain improvement which increases with time and it improves muscle oxygenation and mitochondrial function. TRIAL REGISTRATION: This study was approved by the Ethics Committee of Medical Research Institute (IORH: IOR 00088812) and was registered at the Pan African Clinical Trial Registry (www.pactr.org) under the identification number PACTR201908620943471. The registration this experiment started on 07/08/2019. This study’s protocol followed the CONSORT guidelines and was performed under the relevant guidelines. KEY WORDS: Ozone, steroid, fibromyalgia, trigger point, redox state, antioxidant, chronic pain

Comparison of the Effect of Ketorolac and Betamethasone Injection on Post Complications of Third Molar Surgery (A Clinical Trial)

BACKGROUND: The aim of this study was to evaluate the effect of preoperative ketorolac and betamethasone injections on reducing postoperative complications mandibular third molar surgery. MATERIALS AND METHODS: In this randomized clinical trial, 134 patients at the age group of 18-40 years who required mandibular molars surgery were studied. Patients were randomly divided into two groups. In A group, 1 mL of betamethasone LA was injected into the master muscle before surgery, and in the A group, 30 mg of ketorolac per 1 mL was injected before surgery. On the second and seventh days after surgery, patients were evaluated for the variables of maximum mouth opening, pain, swelling, and general satisfaction with the surgery through telephone calls on the second and seventh days. Independent t-test and Mann-Whitney test were used to evaluate the variables. RESULTS: The mean of pain intensity and the swelling variables in the betamethasone group were lower than the ketorolac group in second and seventh days (P<0.05). The mean of maximum mouth opening and the patient satisfaction variables in the betamethasone group were higher than the ketorolac group in second day (P<0.05). There was no statistically significant difference in the patient satisfaction and maximum mouth opening variables on the seventh day (P>0.05). CONCLUSION: This study concluded that betamethasone performed significantly better in reducing swelling, pain, maximum mouth opening limitation, and general satisfaction.

Neurodevelopmental Outcomes After Late Preterm Antenatal Corticosteroids

The Antenatal Late Preterm Steroids (ALPS) trial changed clinical practice in the United States by finding that antenatal betamethasone at 34 to 36 weeks decreased short-term neonatal respiratory morbidity. However, the trial also found increased risk of neonatal hypoglycemia after betamethasone. This follow-up study focused on long-term neurodevelopmental outcomes after late preterm steroids. To evaluate whether administration of late preterm (34-36 completed weeks) corticosteroids affected childhood neurodevelopmental outcomes. Prospective follow-up study of children aged 6 years or older whose birthing parent had enrolled in the multicenter randomized clinical trial, conducted at 13 centers that participated in the Maternal-Fetal Medicine Units (MFMU) Network cycle from 2011-2016. Follow-up was from 2017-2022. Twelve milligrams of intramuscular betamethasone administered twice 24 hours apart. The primary outcome of this follow-up study was a General Conceptual Ability score less than 85 (-1 SD) on the Differential Ability Scales, 2nd Edition (DAS-II). Secondary outcomes included the Gross Motor Function Classification System level and Social Responsiveness Scale and Child Behavior Checklist scores. Multivariable analyses adjusted for prespecified variables known to be associated with the primary outcome. Sensitivity analyses used inverse probability weighting and also modeled the outcome for those lost to follow-up. Of 2831 children, 1026 enrolled and 949 (479 betamethasone, 470 placebo) completed the DAS-II at a median age of 7 years (IQR, 6.6-7.6 years). Maternal, neonatal, and childhood characteristics were similar between groups except that neonatal hypoglycemia was more common in the betamethasone group. There were no differences in the primary outcome, a general conceptual ability score less than 85, which occurred in 82 (17.1%) of the betamethasone vs 87 (18.5%) of the placebo group (adjusted relative risk, 0.94; 95% CI, 0.73-1.22). No differences in secondary outcomes were observed. Sensitivity analyses using inverse probability weighting or assigning outcomes to children lost to follow-up also found no differences between groups. In this follow-up study of a randomized clinical trial, administration of antenatal corticosteroids to persons at risk of late preterm delivery, originally shown to improve short-term neonatal respiratory outcomes but with an increased rate of hypoglycemia, was not associated with adverse childhood neurodevelopmental outcomes at age 6 years or older.

The effectiveness and pharmacoeconomic study of using different corticosteroids in the treatment of hypersensitivity pneumonitis

PurposeInterstitial lung diseases (ILDs) are caused by inflammation and/or fibrosis of alveolar walls resulting in impaired gas exchange. Hypersensitivity pneumonitis (HP) is the third most common type of ILDs. Corticosteroids are the mainstay treatment for HP. The use of intramuscular (IM) betamethasone or intravenous (IV) dexamethasone as weekly pulse doses has shown higher benefit than daily oral prednisolone for HP patients. The aim of this study is to directly compare different corticosteroids in terms of effectiveness and in monetary values and perform an economic evaluation.MethodsOne hundred and seven patients were tested for pulmonary function tests (PFTs) and inflammatory markers to assess the treatment effectiveness. A cost-effectiveness analysis (CEA) was performed. ICERs between 3 treatment groups were calculated.ResultsPost treatment, Krebs von den Lungen-6 (KL-6) levels significantly improved in betamethasone group from 723.22 ± 218.18 U/ml to 554.48 ± 129.69 U/ml (p = 0.001). A significant improvement in erythrocyte sedimentation rate (ESR) occurred in the dexamethasone group from 56.12 ± 27.97 mm to 30.06 ± 16.04 mm (p = 0.048). A significant improvement in forced expiratory volume (FEV1), forced vital capacity (FVC) and six-minute walk distance (6MWD) was observed within the three treatment groups. A significant improvement in oxygen desaturation percentage (SpO2) occurred within dexamethasone and betamethasone groups. Betamethasone and dexamethasone were found more cost-effective than prednisolone as their ICERs fell in quadrant C. Furthermore, ICER between betamethasone and dexamethasone was performed; a small difference in cost was found compared to the higher benefit of betamethasone.ConclusionBetamethasone and dexamethasone were found to be more effective than prednisolone in improving the inflammatory reaction and the clinical features of HP patients. Betamethasone was found to be the best intervention in terms of cost against the effect.

A Randomized Controlled Trial of Betamethasone on Fatigue in Patients With Advanced Cancer

ContextFatigue is one of the most uncomfortable physical symptoms seen in patients with advanced cancer. Previous studies have reported on the efficacy of corticosteroids from Western countries. ObjectivesTo assess the effectiveness of 4mg betamethasone improving fatigue among Japanese patients with advanced cancer. MethodsA randomized, double-blind, placebo-controlled trial enrolled eligible patients with advanced cancer expected to survive 1–2 months, with an Eastern Cooperative Oncology Group Performance Status of 2–3, and experiencing fatigue according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-15-palliative criteria. Participants received twice-daily oral administration of 2 mg betamethasone (4 mg/d) or placebo for seven days, with fatigue assessed using EORTC QLQ-C15-PAL subscale and numerical rating scale (NRS) score (at baseline and day seven). The trial was registered under the University Hospital Medical Information Network (UMIN)000011913. ResultsAmong the 267 screened patients, 81 were eligible, of which 70 were evaluable (betamethasone, 33; placebo, 37). The mean difference in the EORTC-QLQ-C15-PAL fatigue subscale was −8.2 (95% CIs: −22.3, 0.0; P = 0.178) and in a NRS for fatigue was −1.2 (95% CIs: −2.5, −0.01; P = 0.048), respectively. Emotional function, appetite loss, and global-health were slightly better in the betamethasone group than in the placebo group. ConclusionThe impact of betamethasone 4 mg/d on alleviating fatigue in patients with advanced cancer in the last weeks of life did not reach statistical significance in the EORTC-QLQ-C15-PAL as the primary endpoint, however, it was significant in the NRS, the secondary endpoint.

To study the role of tofacitinib and betamethasone pulse in the treatment of vitiligo at a tertiary care centre: an observational comparative study

Background: According to recent updates, both genetic and non-genetic factors play a role in the pathogenesis of vitiligo, and CD8T lymphocytes and interferon γ are also known to result in vitiligo. The new oral biologic tofacitinib, which is a Janus kinase inhibitor, is a new addition to the armamentarium of immunosuppressive therapy to halt disease progression in vitiligo. Tofacitinib is also known to inhibit IFN-γ mediated inflammation, which is an important step in the development of vitiligo lesions. Aims and objectives: The aim of this study was to compare tofacitinib with betamethasone pulse in reducing the disease activity with respect to reduction in VASI (vitiligo area severity index) and BSA (body surface area) in patients with vitiligo. The primary objective was to see the efficacy of tofacitinib over betamethasone in the treatment of vitiligo, and the secondary objective was to assess its safety in treating vitiligo patients. Methodology: All the patients with vitiligo of age >12 years attending the dermatology clinic of our institute and willing to give written informed consent were included in the study. Group A patients were prescribed betamethasone 4 mg twice weekly, and group B patients were given tofacitinib 5 mg twice daily, followed by sun exposure in both groups, and photography was done at each monthly visit. Results: The mean change in VASI and BSA in the tofacitinib group was better at each visit than in the betamethasone group. The mean VASI scores at baseline, 1st, 2nd, and 3rd visits were 13.64, 12.79, 11.57, and 10.57, respectively, and the mean BSA at baseline, 1st, 2nd, and 3rd visits were 10.80, 9.75, 8.30, and 7.75 respectively, in the betamethasone group. Similarly, in the tofacitinib group, mean BSA values from baseline to the 3rd visit were consecutively 11.47, 9.50, 7.50, and 5.25, and mean VASIs were 14.92, 12.46, 9.46, and 7.08, respectively. Further, mean changes in BSA and VASI from baseline at each visit. as depicted in graphs 1 and 2, were more in tofacitinib group. There was no side effect in either group at any of the visits. Conclusion: Tofacitinib, along with sun exposure, can cause faster repigmentation and faster control of disease activity, as evident from mean changes at each visit, than oral betamethasone pulse in vitiligo patients.

Comparing the Intensity of Pain and Incidence of Flare Reaction Following Trigger Finger Injections Using Betamethasone and Methylprednisolone: A Double-Blinded, Randomized Controlled Trial.

Considerable evidence supports corticosteroid injection as an effective treatment for trigger finger. One common side effect, the flare reaction, is a well-documented phenomenon of increased pain following steroid injections. Its incidence and intensity may be related to steroid composition. The purpose of this study was to determine whether betamethasone and methylprednisolone injections for trigger fingers have differing intensity of pain or incidence flare reaction. Patients with symptomatic trigger finger were recruited during their hand surgery visits. Patients were randomized into 2 treatment groups: betamethasone (40 mg) and methylprednisolone (6 mg) mixed with lidocaine 1%. Treatment group assignment was blinded to the patients and investigators. Visual analog scale pain measurements were taken prior to injection, 5 minutes postinjection, and daily thereafter for 7 days. Sixty-four patients were randomized into the 2 treatment groups. Patients in the betamethasone group reported slightly higher baseline pain compared with the methylprednisolone group, but lower pain on day 1. None of the following days showed a statistically significant difference. The incidence of flare and severe flare reactions of betamethasone injections for trigger finger management was roughly double that of methylprednisolone, but this difference was not statistically significant. Further studies are required to evaluate the relative course of nonflare postinjection pain for different corticosteroid injections for trigger finger injections.

Respiratory benefit in preterm lambs is progressively lost when the concentration of fetal plasma betamethasone is titrated below two nanograms per milliliter.

Antenatal steroid therapy is the standard of care for women at imminent risk of preterm delivery. Current dosing regimens use suprapharmacological doses to achieve extended fetal steroid exposures. We aimed to determine the lowest fetal plasma betamethasone concentration sufficient to achieve functional preterm lung maturation. Ewes with single fetuses underwent surgery to install a fetal jugular catheter. Adopting a stepwise design, ewes were randomized to either a saline-only group (negative control group; n = 9) or one of four betamethasone treatment groups. Each betamethasone group fetus received a fetal intravenous infusion to target a constant plasma betamethasone level of either 1) 2 ng/mL (2 ng/mL positive control group, n = 9); 2) 1 ng/mL, (1 ng/mL group, n = 10); 3) 0.5 ng/mL (0.5 ng/mL group, n = 10); or 4) 0.25 ng/mL (0.25 ng/mL group, n = 10). Fetuses were infused for 48 h, delivered, and ventilated. The positive control group, negative control group, and mid-point 0.5 ng/mL group animals were tested first. An interim analysis informed the final betamethasone group tested. Positive control group animals had large, statistically significant improvements in respiratory function. Based on an interim analysis, the 1.0 ng/mL group was studied in favor of the 0.25 ng/mL group. Treatment efficacy was progressively lost at plasma betamethasone concentrations lower than 2 ng/mL. We demonstrated that the acute respiratory benefit conveyed by antenatal steroid exposure in the fetal sheep is progressively lost when constant fetal plasma betamethasone concentrations are reduced below a targeted value of 2 ng/mL.NEW & NOTEWORTHY Lung maturation benefits in preterm lambs were progressively lost when fetal plasma betamethasone concentrations fell below 2 ng/mL. The effective floor threshold for a robust, lung-maturing exposure likely lies between 1 and 2 ng betamethasone per milliliter of plasma. Hypothalamic pituitary adrenal axis signaling and immunocyte populations remained materially disrupted at subtherapeutic steroid concentrations. These data demonstrate the potential to improve antenatal steroid therapy using reduced dose regimens informed by glucocorticoid pharmacokinetics and pharmacodynamics.

Does Betamethasone Injection Into the Pterygomandibular Space Affect the Postoperative Outcomes of Impacted Lower Third Molar Surgery?

Pain, swelling, and trismus are common outcomes following impacted lower third molar surgery. The purpose of the study was to evaluate the effect of betamethasone injection into the pterygomandibular space on the aforementioned sequelae of third molar surgery. A split-mouth, double-blind, randomized clinical trial was conducted on 40 patients with symmetrical bilateral impacted lower third molars. The surgeries were performed at an outpatient clinic under local anesthesia. The predictor variable is the steroid treatment. The experimental group received a 1mL (6mg) betamethasone injection into the pterygomandibular space, while the control group received a normal saline. The primary outcome variable was postoperative pain assessed using a visual analog scale. The secondary outcome variables were the number of analgesic tablets consumed, facial swelling, and trismus. The age and sex of the patients, the direction of impaction, and the duration of surgery were recorded. Comparisons between the groups were carried out using an unpaired t test. An analysis of variance test was used to assess intragroup differences. The significance was considered at P≤.05. Of the 265 patients initially screened for study enrollment, the final sample included 40 subjects, with a mean age of 28.3years (±7.4), 28 (70%) were mal and 12 (30%) were female. There was no significant difference between the two groups concerning postoperative pain or the number of consumed analgesic tablets. However, the betamethasone group exhibited significantly reduced facial swelling and increased mouth opening. On the first postoperative day, the visual analog scale pain score did not significantly differ between the betamethasone group (6.0±1.7) and the control group (6.8±1.4), with a P value of 0.112. On the first postoperative day, facial swelling measured 4.2±1.3mm in the betamethasone group compared to 6.0±0.9mm in the control group (P<.001). Mouth opening in the betamethasone group was 30.8±6.7mm, while in the control group, it measured 21.9±5.5mm(P<.001). Local betamethasone has no effect on pain after third molar surgery, but facial swelling and trismus are significantly reduced.

PRECeDe Pilot: Prevention of neonatal respiratory distress with antenatal corticosteroids before elective caesarean section in women with diabetes - a feasibility randomised trial.

The PRECeDe Pilot Trial was designed to determine the feasibility of undertaking a multicentre, randomised controlled trial (RCT) to assess the efficacy of antenatal corticosteroids administration within 7 days before elective caesarean section (CS) in women with pre-gestational diabetes (PGDM) or gestational diabetes (GDM). Triple blind, parallel group, placebo-controlled, pilot RCT. Single-centre tertiary maternity hospital in Melbourne, Australia. Pregnant women with PGDM (type 1 or type 2 diabetes) or GDM booked for a planned CS scheduled between 35+0 and 38+6 weeks of gestation. Eligible participants were randomised to receive two injections of either betamethasone 11.4 mg or normal saline placebo, 24 hours apart within 7 days before CS scheduled between 35+0 and 38+6 weeks of gestation. The proportion of eligible women who consented and were randomised. Australian and New Zealand Clinical Trials Registry ACTRN12619001475134. Of 537 women eligible, 182 were approached and 47 (26%) were recruited. Of these, 22 were allocated to the betamethasone group and 25 were allocated to the placebo group. There were no serious adverse events related to participation. It is feasible to undertake a triple-blind, placebo-controlled RCT investigating the efficacy of antenatal corticosteroids in preventing respiratory morbidity in infants of women with PGDM or GDM who are undergoing an elective CS between 35+0 and 38+6 weeks.

Effects of compound betamethasone on vocal fold wound healing in rabbit model: A preliminary study.

The compound betamethasone is widely used to prevent scarring in dermatology. This study aims to explore the effects of compound betamethasone on vocal fold (VF) wound healing. Prospective animal study in rabbits. Eighteen rabbits underwent bilateral VF stripping and three rabbits served as controls. 0.1 mL of compound betamethasone (1mL: betamethasone sodium phosphate 5mg and betamethasone dipropionate 2mg) was injected into the right VF of each rabbit, and 0.1mL 0.9% saline was injected into the contralateral VF. Endoscopy was performed for morphologic observation. Six larynges were harvested for histological analysis at 3 days, 7 days, and 1month. The VFs were stained with hematoxylin and eosin (H&E), Alcian blue, and Masson' trichrome staining. In morphological analysis, there was no visible difference between betamethasone-treated and saline-treated VFs at 3 and 7 days. After 1month, more VF scars appeared on the saline-treated VFs than the VFs treated with betamethasone. Inflammatory cell number showed significant difference between both VFs at 3 days (p=.037) and 7 days (p=.045). No significant different was found in epithelial thickness at 1month between the betamethasone and saline groups. The collagen in the saline-treated VFs was significantly denser than that of the betamethasone-treated group (p=.037). There was also a significant increase in the level of hyaluronic acid(HA) in betamethasone-injected VFs in comparison to the saline-injected VFs (p=.006). Based on this study, compound betamethasone can improve VF healing. Our findings suggest that VF injection with compound betamethasone helps to minimize scarring by increasing HA level and decreasing collagen density.

Effect of Antenatal Corticosteroids in Late Preterm Delivery on Neonatal Respiratory Morbidity: A Randomized Controlled Trial.

The use of antenatal corticosteroids beyond 34 weeks of gestation to prevent certain neonatal complications remains a debate. This study sought to determine the effect of the use of antenatal corticosteroids in late preterm delivery on neonatal morbidity. It was a randomized double-blind placebo and active-controlled multi-arm trial. There were two study groups and one control group. It was conducted at the Department of Obstetrics and Gynaecology and the Department of Paediatrics of Ahmadu Bello University Teaching Hospital Zaria, Nigeria. Pregnant women at 34 weeks to 36 weeks 6 days of gestation scheduled for elective delivery or who had emergency delivery were recruited for the study. The first study group had 2 doses of 12mg intramuscular dexamethasone and the second study group had 2 doses of 12mg betamethasone. The control group had 2 doses of a placebo. The primary outcome was the incidence of respiratory distress syndrome evidenced by tachypnoea with grunting, recession, or nasal flaring with diffuse reticulogranular infiltrate on X-ray or respiratory distress requiring the need for respiratory support by 72 hours of age. Secondary outcome measures included the need for neonatal resuscitation at birth, admission into the Special Care Baby Unit/Neonatal Intensive Care Unit, transient tachypnoea of the newborn, and apnoea. A total of 138 mothers and 146 preterm neonates were included. A pairwise analysis was done to test for differences between the groups. There was no difference in the incidence of respiratory distress syndrome between the groups. However, the need for neonatal resuscitation was significantly higher (RR: 7.0; CI: 2.49-19.4; p = <0.001) in the placebo group when compared to the betamethasone group and also significantly higher (RR:4.0; CI: 1.86-26.03; p= 0.01) in the placebo group when compared to the dexamethasone group. Antenatal corticosteroids may decrease the need for neonatal resuscitation at birth in late preterm neonates. The research was funded by the Tertiary Education Trust Fund (TETFUND) of Nigeria. Trial registration: ClinicalTrial.gov, NCT03446937.

Comparing the Effectiveness of Betamethasone Gel with Lidocaine Gel Application on Endotracheal Tube in Preventing Post Operating Sore Throat

Objective: To compare the effectiveness of betamethasone gel and lidocaine gel application in reduction of post-operative sore throat. Study Design: Randomized controlled trial Place and Duration: Study was conducted at anesthesia department of Dow University of Health Sciences, Karachi with duration from May 2022 to October 2022. Methodology: A total of 54 patients were enrolled and divided into two groups Betamethasone and Lidocaine (Lignocaine) by lottery method. In one group betamethasone gel 0.05% was applied over endotracheal tube (ETT) and in other group lignocaine gel 4% was applied over the ETTT. SPSS version 23 was used for data analysis. Mean ± SD and frequency (percentage) were calculated for numerical and categorical data respectively. Results: Majority of the patients in betamethasone group, 15 (55.6%) patients, had not developed sore throat whereas mild and moderate sore throat was most common in lidocaine group. Further, 5 (18.5%) patients in lidocaine group and only 2 (7.4%) patients in betamethasone group was severe sore throat. (p=0.015). Practical implication: Sore throat is a common post-operative complication having potential to lead poor surgical results. This study will help the clinicians/anesthesiologists to overcome the problem and reduce the incidence of sore throat in routine practice. Conclusion: Application of betamethasone gel over endotracheal tube just before insertion is associated with reduced risk of sore throat as compare to lignocaine gel. Keywords: Lidocaine gel, Betamethasone gel, Post-operative sore throat, Laryngoscopy, Endotracheal tube.

Comparison of the Effect of Bromfenac versus Betamethasone Ophthalmic Solutions in Patients with Diabetic Macular Edema

Purpose To examine the effect of 0.1% bromfenac (BF) ophthalmic solution and 0.1% betamethasone (BM) ophthalmic solution on diabetic macular edema (DME). Methods This was a prospective trial. Nineteen patients (mean age of 66.6 ± 10.1 years) with DME and mean retinal thickness within a diameter of 1 mm from the fovea (central subfield thickness: CST) of 250–500 µm were randomized and instilled with BF or BM. CST, best-corrected visual acuity (BCVA), and intraocular pressure (IOP) were measured at 4, 8, and 12 weeks after administration. Results CST at baseline (p = .128) and that at 4, 8, and 12 weeks of administration was not significantly different between the BF (10 patients) and BM groups (9 patients). In patients with glycated hemoglobin (HbA1c) <8.0%, CST, compared with baseline, was significantly decreased in the BF group (seven patients) at 8 (p = .025) and 12 weeks (p = .043) of administration. When compared with the baseline, no significant changes in BCVA were observed at any point in time in either group. Baseline IOP was comparable between the groups. In the BM group, the values of change in IOP from baseline significantly increased at 8 (p = .025) and 12 weeks (p = .044) of administration, with no significant changes in IOP over the 12 weeks of administration in the BF group. Conclusions BF did not affect IOP even after 12 weeks of administration, suggesting its effect in reducing CST in DME with good glycemic control. Trial registration University Hospital Medical Information Network (UMIN-CTR); UMIN000026201, February 18, 2017; Japan Registry of Clinical Trials; jRCTs031180308, March 15, 2019

Betamethasone for Preterm Birth: Auckland Steroid Trial Full Results and New Insights 50 Years on

The objective of this study was to use modern analysis and reporting methods to present the full results of the first randomized trial of antenatal corticosteroids, performed 50years ago. In this single-center trial, women at risk of preterm birth at 24 to less than 37weeks of gestationwere randomized to receive 2 doses of betamethasone or placebo, 24hours apart. Women and their caregivers were blinded to treatment allocation. The primary outcome was respiratory distress syndrome. Secondary outcomes included measures of neonatal mortality and morbidity, mode of birth, and maternal infection. Between 1969 and 1974, 1115 women (1142 pregnancies) were randomized, 560 pregnancies (601 infants) to betamethasone and 582 (617 infants) to placebo. The risk of respiratory distress syndrome was significantly reduced in the betamethasone group compared with placebo (8.8% vs 14.4%, adjusted relative risk 0.62, 95% CI 0.45-0.86, P=.004). Subgroup analyses indicated greater efficacy in male than female infants but no effect of tocolytic therapy or doubling of betamethasone dose. Fetal or neonatal death, neonatal or maternal infection, neonatal hypoglycaemia, cesarean delivery, and lactation status at discharge were not different between the groups. Antenatal betamethasone administered to women at risk of preterm birth between 24 and less than 37weeks of gestation reduces the incidence of respiratory distress syndrome, with greater effect in male than in female infants. Doubling the dose of betamethasone does not provide additional benefit.