Endoscopic Versus Microscopic Stapedotomy: A Randomized Clinical Trial.

OBJECTIVE: To determine the outcomes and complications of endoscopic versus microscopic stapes surgery in patients with otosclerosis. STUDY DESIGN: Randomized, single-blinded clinical trial. METHODS: Patients with otosclerosis who underwent either trans-canal microscopic or endoscopic stapedotomy at a tertiary care hospital were compared. Thirty-two patients were randomly divided into two groups using blocked randomization. Group A consisted of 16 patients who underwent trans-canal microscopic stapedotomy, and group B consisted of 16 patients who underwent trans-canal endoscopic stapedotomy. Postoperative vertigo, ear pain, and complications such as tympanic membrane perforation or chorda tympani nerve injury were evaluated. Three months postoperatively, patients were assessed for dysgeusia and hearing improvement. RESULTS: The mean pre-operative air-bone gap (ABG) in the microscopic and endoscopic groups was 32.81 ± 6.82 and 30.00 ± 7.96, respectively. The mean improvement in the ABG was 25.45 ± 11.21 dB in the microscopic group and 23.21 ± 10.68 dB in the endoscopic group. Although both techniques showed improvement in auditory outcomes (p-value <0.001), there were no statistical differences between the endoscopic and microscopic groups in the pre-operative, post-operative, and mean improvement of ABG (p-value >0.05). There were no significant differences between the two methods in chorda tympanic nerve injury, vertigo scores, and the mean operating time (p-value >0.05), but the mean pain score was higher in the microscopic group (2.56 ± 1.55 in the microscopic group versus 1.31 ± 0.70 in the endoscopic group) (p-value = 0.003). CONCLUSIONS: Endoscopic stapes surgery can be a preferable alternative to conventional microscopic stapedotomy, as it yields similar hearing outcomes and lower pain scores. LEVEL OF EVIDENCE: 2 Laryngoscope, 134:2395-2400, 2024.

Betulin-rich hydroalcoholic extract of Daphne oleoides attenuates bleomycin-induced pulmonary fibrosis in rat.

Background and objective: Pulmonary fibrosis (PF) is a chronic and progressive respiratory disease representing the final stage of lung inflammatory disorders. Reactive oxygen species (ROS), an essential factor in the formation and progression of pulmonary fibrosis, are a significant adverse effect of Bleomycin (BLM). Antioxidant activities have been found in Daphne oleoides. In this study, we attempted to explore the function of hydroalcoholic extract of Daphne oleoides (D. oleoides) and Betulin in inhibiting bleomycin (BLM)-induced pulmonary fibrosis in rat". Materials and methods: The current experimental study used 36 male Wistar rats (180-220). Following a random process, the animals were divided into six groups six (n = 6). Group, I (the control group) received normal saline, while Group II (the hazardous group) received intratracheal BLM (7.5 units per kg). Following the administration of BLM, Groups V and VI received daily doses of vitamin E (500 mg/kg/d, p.o.) and Betulin (10 mg kg/d, p.o.), whereas Groups III and IV received daily doses of Daphne oleoides extract (300 and 600 mg/kg/d, p.o.). Then, blood samples from the hearts of the animals were taken to assess the plasma concentrations of nitric oxide (NO) and malondialdehyde (MDA). Finally, the rats were euthanized, and the lung tissues were taken out for histological analysis and assessments of the levels of lung hydroxyproline (HP), ferric-reducing ability (FRAP), NO, Glutathione Concentration (GSH), thiol content (tSH) and MDA. Findings: Elevated lung index, lung hydroxyproline, NO, and MDA plasma levels, and a reduction in total body thiol content (tSH) in the group receiving BLM were evidence of pulmonary toxicity. Treatment with D. oleoides extracts, Betulin, and Vit E, especially at 600 mg/kg, led to a marked reduction in the above parameters compared with the BLM-received group (p < 0.01). Histological Analysis of the BLM-treated group showed a considerable Lung injury with interstitial infiltration, collapsed alveolar spaces, and alveolar septal thickening. These changes were mitigated with D. oleoides 600, Betulin-, and vitamin E. These changes were mitigated with D. oleoides 600, Betulin-, and vitamin E. Conclusion: These findings suggest that D. oleoides and Betulin prevent bleomycin-induced lung fibrosis in rats by decreasing inflammatory and antioxidant markers. Daphne oleoides, therefore, have the potential to be used therapeutically to treat pulmonary fibrosis.

The effect of cannabidiol on seizure features and quality of life in drug-resistant frontal lobe epilepsy patients: a triple-blind controlled trial.

Background: Treatment-resistant epileptic seizures are associated with reduced quality of life (QoL). As polypharmacy with routine antiseizure medications has many side effects, novel add-on treatments are necessary. Recent research showed the efficacy of add-on therapy by cannabidiol (CBD) on refractory epilepsy. We attempted to extend data on the efficacy and safety profile of CBD in patients with frontal lobe treatment-resistant epilepsy. Methods: A total of 27 patients were recruited into two CBD (n = 12) and placebo (n = 15) groups. The CBD group received a highly purified liposomal preparation of the drug in addition to routine antiseizure medications. The placebo group only received antiseizure medications. This experiment followed a triple-blinding protocol. Outcome measures were seizure frequency, the Chalfont seizure severity scale (CSSS), and the quality of life questionnaire score (QOLIE-31) assessed at baseline, 4 weeks, and 8 weeks. Results: At 4 weeks, results indicated that a higher fraction of patients in the CBD group (66.67%) showed improvement in seizure, compared to the placebo group (20.00%). Before-after comparison revealed that CBD, unlike routine ADEs, was effective in reducing the occurrence of seizures at the study's final timepoint [mean difference 45.58, 95% CI (8.987 to 82.18), p = 0.009]. Seizure severity was not affected by study groups or time intervals (repeated-measures ANOVA p > 0.05). Post-hoc tests found that the QoLI-31 score was improved at 8 weeks compared to baseline [mean diff. -5.031, 95% CI (-9.729 to -0.3328), p = 0.032]. The difference in cases who experienced enhanced QoL was meaningful between the CBD and placebo groups at 8 weeks [RR: 2.160, 95% CI (1.148 to 4.741), p = 0.018] but not at 4 weeks (p = 0.653). A positive finding for QoL improvement was associated with a positive finding for seizure frequency reduction [r = 0.638, 95% CI (0.296 to 0.835), p = 0.001]. Interestingly, limiting the correlation analysis to cases receiving CBD indicated that QoL improvement was not linked with seizure parameters such as severity and frequency (p > 0.05). Conclusion: The present study suggests the benefit of a purified and highly efficient preparation of CBD for seizure frequency reduction and improvement of QoL in refractory frontal lobe epilepsy. Further study with longer follow-ups and larger sample size is advised. Clinical trial registration: https://www.irct.ir/trial/56790, identifier: IRCT20210608051515N1.