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Comparison of Therapeutic Results with/without Additional Hyperbaric Oxygen Therapy in Idiopathic Sudden Sensorineural Hearing Loss: A Randomized Prospective Study.
Tong, B, Niu, K, Ku, W, Xie, W, Dai, Q, Hellström, S, Duan, M
Audiology & neuro-otology. 2021;(1):11-16
Abstract
OBJECTIVE To assess the efficacy of the combination of hyperbaric oxygen (HBO) and pharmacological treatment in patients with idiopathic sudden sensorineural hearing loss (ISSNHL) and define patients amenable for HBO therapy. METHODS Prospective, randomized, trial involving 136 cases with unilateral ISSNHL that were randomly divided into 2 groups: the pharmacological treatment (P) group and HBO + pharmacological treatment (HBO+P) group, which received additional HBO for 14 days besides the pharmacological treatments. Pure tone audiometry gain larger than 15 dBHL was defined as success, and the success rate of each group was calculated. RESULTS The overall success rate of the HBO+P group and the P group is 60.6% (40/66) and 42.9% (30/70), respectively (p < 0.05). Furthermore, patients with mild-moderate baseline hearing loss, aged ≤50 years, receiving treatment in ≤14 days, or without accompanied dizziness/vertigo in the HBO+P group had higher success rate than the P group (p < 0.05). CONCLUSIONS HBO combined with pharmacological treatments leads to better hearing recovery than pharmacological treatments alone.
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Response of Retinal Sensitivity to Intravitreal Anti-angiogenic Bevacizumab and Triamcinolone Acetonide for Patients with Diabetic Macular Edema over One Year.
Mylonas, G, Schranz, M, Scholda, C, Karst, S, Reiter, G, Baumann, L, Schmidt-Erfurth, U, Kriechbaum, K
Current eye research. 2020;(9):1107-1113
Abstract
AIM: The aim of this study was to evaluate and compare microperimetry changes in patients with clinically significant diabetic macular edema secondary to diabetes mellitus, following intravitreal injections of bevacizumab or triamcinolone during a follow-up of 1 year after treatment. MATERIALS AND METHODS 30 patients with clinically significant macular edema were randomized into two groups of 15 patients each. One group initially received three intravitreal injections of 2.5 mg bevacizumab at monthly intervals. The other received a single injection of 8 mg of triamcinolone followed by two sham interventions at monthly intervals. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were measured. Macular function was documented by microperimetry at baseline, 3, 6, 9 months and at the last visit of each patient. RESULTS In the bevacizumab group, the mean differential light threshold (±standard deviation) under therapy improved significantly from 8.40 (± 3.8) dB to 12.8 (±4.3) dB at the 12-month follow-up visit (p ≤ .05), whereas in the triamcinolone group it increased from 8.0 (± 2.4) dB at baseline to 9.3 (±3.6) dB at the last visit without reaching statistical significance (p > .05). The mean differential light thresholds between the two groups were not statistically significant at baseline or the last visit (p > .05). In the bevacizumab group, the improvement (slope) in mean differential light threshold was significantly superior to the Triamcinolone group (Estimate = 0.588, p ≤ .05). CONCLUSION Central macular function as measured by microperimetry in patients with acute DME improved in addition to anatomical restoration after intravitreal bevacizumab and triamcinolone injection. In our clinical study, the measures of the variables in patients receiving bevacizumab were superior to those receiving triamcinolone throughout the one-year observation period.
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Minodronate combined with alfacalcidol versus alfacalcidol alone for glucocorticoid-induced osteoporosis: a multicenter, randomized, comparative study.
Soen, S, Yamamoto, K, Takeuchi, T, Tanaka, Y, Tanaka, S, Ito, M, Nakano, T, Hagino, H, Hirakawa, A, Matsumoto, T
Journal of bone and mineral metabolism. 2020;(4):511-521
Abstract
INTRODUCTION This study compared the clinical usefulness of minodronate (50 mg/4 weeks) plus alfacalcidol (1 μg/day) (Group M) with that of alfacalcidol alone (1 μg/day) (Group A) for treating glucocorticoid-induced osteoporosis. MATERIALS AND METHODS The primary endpoints were the changes from baseline in lumbar spine (LS) bone mineral density (BMD) and the cumulative incidence of vertebral fracture at 24 months; secondary endpoints included the changes from baseline in total hip (TH) BMD and bone turnover markers. RESULTS Of 164 patients enrolled, 152 (Group M, n = 75; Group A, n = 77) were included in the analysis of efficacy. At each time point and at 24 months, LS BMD and TH BMD were significantly higher in Group M than in Group A. The 152 patients were divided into two subgroups that were previously treated with glucocorticoids for ≤ 3 months or > 3 months. In both subgroups, the changes from baseline in LS BMD and TH BMD from baseline at 24 months had increased more in Group M than in Group A. There were no differences found in the incidence of vertebral fracture between the groups, because the number of enrolled patients was lesser than that initially expected. In Group M, both bone formation and resorption markers significantly decreased from baseline at 3 months and maintained at 6, 12, and 24 months. CONCLUSIONS Minodronate plus alfacalcidol was more effective than alfacalcidol alone in increasing BMD and was effective in increasing BMD for both prevention and treatment. Therefore, minodronate can be a good candidate drug for the treatment of glucocorticoid-induced osteoporosis.
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Denosumab Versus Risedronate in Glucocorticoid-Induced Osteoporosis: Final Results of a Twenty-Four-Month Randomized, Double-Blind, Double-Dummy Trial.
Saag, KG, Pannacciulli, N, Geusens, P, Adachi, JD, Messina, OD, Morales-Torres, J, Emkey, R, Butler, PW, Yin, X, Lems, WF
Arthritis & rheumatology (Hoboken, N.J.). 2019;(7):1174-1184
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Abstract
OBJECTIVE Clinical trial results have shown that, in glucocorticoid-treated patients, treatment with denosumab 60 mg subcutaneously once every 6 months (Q6M) increased spine and hip bone mineral density (BMD) at month 12 significantly more than treatment with risedronate 5 mg orally once daily (QD). The present analysis was performed to compare efficacy and characterize safety through month 24. METHODS This phase III study enrolled men and women ≥18 years old who had received ≥7.5 mg daily prednisone or equivalent for <3 months (glucocorticoid-initiating) or for ≥3 months (glucocorticoid-continuing) before screening. All patients <50 years old had a history of osteoporotic fracture. Glucocorticoid-continuing patients ≥50 years old had T scores of -2.0 or less (or -1.0 or less with fracture history). Patients were randomized (1:1) to receive denosumab 60 mg subcutaneously Q6M or risedronate 5 mg orally QD for 24 months, with daily calcium and vitamin D. RESULTS Of 795 patients, 590 (74.2%) completed the study (in the glucocorticoid-initiating group, 109 of 145 patients treated with denosumab and 117 of 145 patients treated with risedronate; in the glucocorticoid-continuing group, 186 of 253 patients treated with denosumab and 178 of 252 patients treated with risedronate). Denosumab was superior to risedronate in increasing lumbar spine and total hip BMD at all time points assessed, among glucocorticoid-initiating patients (24-month lumbar spine: BMD increase of 6.2% versus 1.7%, respectively [P < 0.001]; 24-month total hip: BMD increase of 3.1% versus 0.0% [P < 0.001]) and among glucocorticoid-continuing patients (24-month lumbar spine: BMD increase of 6.4% versus 3.2% [P < 0.001]; 24-month total hip: BMD increase of 2.9% versus 0.5% [P < 0.001]). Adverse events, serious adverse events (including infections), and fractures were similar between treatment groups. CONCLUSION Denosumab was superior to risedronate in terms of increases in spine and hip BMD through month 24, and the safety profile was similar between treatment groups. Denosumab may offer a new osteoporosis treatment option for glucocorticoid-treated patients.
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Prospective randomised clinical trial of intravitreal bevacizumab versus triamcinolone in eyes with diabetic macular oedema undergoing cataract surgery: 6-month results.
Kandasamy, R, Constantinou, M, Rogers, SL, Sandhu, SS, Wickremasinghe, S, Al-Qureshi, S, Lim, LL
The British journal of ophthalmology. 2019;(12):1753-1758
Abstract
AIM: To report the 6-month results of a clinical trial that compared intravitreous bevacizumab (BVB) 1.25 mg versus triamcinolone acetonide (TA) 4 mg when administered as an adjunct during cataract surgery to patients with diabetic macular oedema (DMO). METHODS Prospective, double-masked, single-centre (Royal Victorian Eye and Ear Hospital, Melbourne) clinical trial. Patients with visually significant cataract and centre-involving DMO (either current or prior) were randomised (1: 1) to receive either intravitreous BVB 1.25 mg or TA 4 mg at the time of cataract surgery and if required at review. Main outcome measures were changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) from baseline to the 6-month time point of this 12-month study. RESULTS 61 eyes of 58 patients were enrolled. At baseline, both groups were similar in terms of BCVA and CMT (p>0.2). At 6 months, there was no significant difference in vision between the groups, with mean letter gain of +21.4 (95% CI +14.5 to +28.4) in the TA group and +17.3 (95% CI +12.1 to +22.6) in the BVB group (p=0.35). The TA group had a significant sustained anatomical improvement at 6 months, with a reduction in CMT (-51.4 µm; 95% CI -98.2 to -4.7) compared with thickening in the BVB group (+15.6 µm; 95% CI -26.4 to +57.7, p=0.04). CONCLUSIONS When given as an adjunct to cataract surgery, both TA and BVB improved visual outcomes at 6 months postoperatively. However, only TA resulted in sustained improvement in CMT, with the majority not requiring any further treatment postoperatively.
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Randomized controlled European multicenter trial on the prevention of cystoid macular edema after cataract surgery in diabetics: ESCRS PREMED Study Report 2.
Wielders, LHP, Schouten, JSAG, Winkens, B, van den Biggelaar, FJHM, Veldhuizen, CA, Murta, JCN, Goslings, WRO, Kohnen, T, Tassignon, MJ, Joosse, MV, et al
Journal of cataract and refractive surgery. 2018;(7):836-847
Abstract
PURPOSE To compare the efficacy of perioperative treatment strategies, in addition to topical bromfenac 0.09% and dexamethasone 0.1%, to reduce the risk for developing cystoid macular edema (CME) after uneventful cataract surgery in diabetic patients. SETTING Twelve European study centers. DESIGN Randomized clinical trial. METHODS Diabetic patients having phacoemulsification cataract surgery were randomly allocated to receive no additional treatment, a subconjunctival injection with 40 mg triamcinolone acetonide, an intravitreal injection with 1.25 mg bevacizumab, or a combination of both. The main outcomes were the difference in central subfield mean macular thickness, corrected distance visual acuity, and the incidence of CME and clinically significant macular edema within 6 and 12 weeks postoperatively. RESULTS The study comprised 213 patients. At 6 and 12 weeks postoperatively, the central subfield mean macular thickness was 12.3 μm and 9.7 μm lower, respectively, in patients who received subconjunctival triamcinolone acetonide than patients who did not (P = .007 and P = .014, respectively). No patient who received subconjunctival triamcinolone acetonide developed CME. Intravitreal bevacizumab had no significant effect on macular thickness. CONCLUSIONS Diabetic patients who received a subconjunctival injection with triamcinolone acetonide at the end of cataract surgery had a lower macular thickness and macular volume at 6 and 12 weeks postoperatively than patients who did not. Intravitreal bevacizumab had no significant effect.
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Comparison of intralesional verapamil versus intralesional corticosteroids in treatment of keloids and hypertrophic scars: A randomized controlled trial.
Abedini, R, Sasani, P, Mahmoudi, HR, Nasimi, M, Teymourpour, A, Shadlou, Z
Burns : journal of the International Society for Burn Injuries. 2018;(6):1482-1488
Abstract
BACKGROUND Keloids and hypertrophic scars are due to overgrowth of dermal collagen following trauma to the skin that usually cause major physical, psychological and cosmetic problems. METHODS In this randomized controlled trial, with a paired design, 50 patients with 2 or more keloids were included. In the control group (50 lesions), intralesional triamcinolone acetonide (40mg/mL) was injected at three-week intervals for a total of 18weeks. In the other group (50 lesions), lesions were treated by verapamil (2.5mg/mL) with the same therapeutic sessions. Scar evaluation at each stage and at the end of 3months follow up was done by serial photographic records as well as by Vancouver Scar Scale (VSS). RESULTS Mean zero VSS scores were achieved with only triamcinolone in respect of scar height (week 15th) and pliability (week 15th). No therapeutic event (parameter=0) or significant improvement was seen in verapamil group. CONCLUSION Our results did not support verapamil's capability in treatment of keloid nor hypertrophic scars.
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Trends and Determinants of Osteoporosis Treatment and Screening in Patients With Rheumatoid Arthritis Compared to Osteoarthritis.
Ozen, G, Kamen, DL, Mikuls, TR, England, BR, Wolfe, F, Michaud, K
Arthritis care & research. 2018;(5):713-723
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OBJECTIVE To profile osteoporosis (OP) care in patients with rheumatoid arthritis (RA) over the past decade. METHODS Patients with RA or osteoarthritis (OA) were followed from 2003 through 2014. OP care was defined as receipt of OP treatment (with the exception of calcium/vitamin D) or screening (OPTS). Adjusted trends over followup, and the factors associated with OP care, were examined using multivariable Cox proportional hazards. RESULTS OPTS was reported in 67.4% of 11,669 RA patients and in 64.6% of 2,829 OA patients during a median (interquartile range) 5.5 (2-9) years of followup. In patients for whom treatment was recommended by the 2010 American College of Rheumatology (ACR) glucocorticoid-induced OP (GIOP) guidelines (48.4% of RA patients and 17.6% of OA patients), approximately 55% overall reported OP medication use. RA patients were not more likely to undergo OPTS compared to OA patients (hazard ratio 1.04 [95% confidence interval 0.94-1.15]). Adjusted models showed a stable trend for OPTS between 2004 and 2008 compared to 2003, with a significant downward trend after 2008 in both RA and OA patients. Factors associated with receipt of OP care in RA patients were older age, postmenopausal state, prior fragility fracture or diagnosis of OP, any duration of glucocorticoid treatment, and use of biologic agents. CONCLUSION Approximately half of RA patients for whom treatment was indicated never received an OP medication. OP care in RA patients was not better than in OA patients, and the relative risk of the application of this care has been decreasing in RA and OA patients since 2008 without improvement after the release of the 2010 ACR GIOP guideline.
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Plantar Fasciitis-A Comparison of Treatment with Intralesional Steroids versus Platelet-Rich Plasma A Randomized, Blinded Study.
Acosta-Olivo, C, Elizondo-Rodriguez, J, Lopez-Cavazos, R, Vilchez-Cavazos, F, Simental-Mendia, M, Mendoza-Lemus, O
Journal of the American Podiatric Medical Association. 2017;(6):490-496
Abstract
BACKGROUND Many treatment options for plantar fasciitis currently exist, some with great success in pain relief. The objective of our study was to compare the use of intralesional steroids with platelet-rich plasma (PRP), using pain scales and functional evaluation, in patients with plantar fasciitis who did not respond to conservative treatment. METHODS A controlled, randomized, blinded clinical assay was performed. Patients were assigned to one of the two groups by selecting a sealed envelope. The steroid treatment group received 8 mg of dexamethasone plus 2 mL of lidocaine as a local anesthetic. The PRP treatment group received 3 mL of PRP activated with 0.45 mL of 10% calcium gluconate. All of the patients were evaluated at the beginning of the study, and at 2, 4, 8, 12, and 16 weeks post-treatment with the Visual Analog Scale (VAS), Foot and Ankle Disability Index (FADI), and American Orthopedic Foot and Ankle Society (AOFAS) scale. RESULTS The right foot was the most frequently affected foot (63%). The average age of the patients was 44.8 years (range, 24-61 years). All scales used (VAS, FADI and AOFAS) showed that the difference was not statistically significant between the two groups. CONCLUSIONS We can conclude that the use of PRP is an effective treatment method for patients with plantar fasciitis who do not respond to conservative treatment because PRP demonstrates an efficacy equal to that of steroids. However, the cost and the time for preparation the PRP are two of the disadvantages of this treatment.
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Comparison of the effects of nasal steroids and montelukast on olfactory functions in patients with allergic rhinitis.
Dalgic, A, Dinc, ME, Ulusoy, S, Dizdar, D, Is, A, Topak, M
European annals of otorhinolaryngology, head and neck diseases. 2017;(4):213-216
Abstract
OBJECTIVE Olfactory dysfunction is one of the comorbidities associated with allergic rhinitis (AR) and AR is one of the common causes of olfactory problems. We aimed to evaluate by the Sniffin' Sticks test the effects on olfactory functions of nasal steroids and leukotriene antagonists used for allergic rhinitis. METHODS Thirty patients with seasonal rhinitis were included in this study. Patients were randomly divided into three groups of 10 patients; group 1 received montelukast sodium and mometasone furoate (MF) therapy, group 2 received only montelukast, and group 3 only MF. Patients' olfactory functions were determined using the Sniffin' Sticks olfactory test before and after a month treatment. RESULTS Threshold, discrimination, identification, and the sum of threshold, discrimination, and identification (TDI) values were not significantly different among the groups before treatment. For Group 1 and Group 3 patients, there were statistically significant differences in threshold, discrimination, identification, and TDI values before and after treatment (P<0.05) (Wilcoxon signed ranks analysis). For Group 2 patients, the before and after treatment values of threshold, discrimination, identification, and TDI showed no significant difference (P>0.05). CONCLUSION According to the findings of our study, MF is superior to montelukast in improving olfactory function. Although montelukast has been shown to be effective against AR symptoms, its effect on olfactory function was not demonstrated in this study.