Antiviral treatment for Ramsay Hunt syndrome: A systematic review and meta-analysis.

OBJECTIVE: This study aimed to reveal the efficacy and safety of antivirals in patients with Ramsay Hunt syndrome. METHODS: A literature search was conducted in PubMed, Ichushi-Web, and Cochrane Central Register of Controlled Trials. Published randomized controlled trials and observational studies, which compared antivirals versus placebo/no treatment for Ramsay Hunt syndrome, were included in the meta-analysis. The primary outcome was non-recovery at the end of the study follow-up. Data was analyzed using Review Manager Software, and pooled odds ratio (OR) with 95 % CI were calculated. RESULTS: Two randomized controlled trials and 7 cohort studies met the eligible criteria, and 474 individuals were included in the meta-analysis. The OR of antivirals for non-recovery was 0.68 (95 % CI 0.37-1.27, p = 0.22). In subgroup analysis, the OR were 0.48 (95 % CI 0.15-1.61, p = 0.24) in patients with antivirals monotherapy and 0.73 (95 % CI 0.34-1.57, p = 0.42) in patients treated with combination therapy of antivirals and systematic corticosteroid. CONCLUSION: This systematic review first shows the effectiveness of antivirals. Further study is needed to confirm the efficacy of antivirals.

Physical therapy for peripheral facial palsy: A systematic review and meta-analysis.

OBJECTIVE: This study aimed to reveal the efficacy of physical therapy for patients with peripheral facial palsy. METHODS: A literature search was conducted using PubMed, Ichushi-Web, and Cochrane Central Register of Controlled Trials. Published randomized controlled trials comparing the physical therapy versus placebo/non-treatment for peripheral facial palsy such as Bell's palsy, Ramsay Hunt syndrome, and traumatic facial palsy were included for meta-analysis. The primary outcome was non-recovery at the end of the follow-up. Non-recovery was defined according to the authors' definition. The secondary outcomes were the composite score of the Sunnybrook facial grading system and sequelae (presence of synkinesis or hemifacial spasm) at the end of the follow-up. Data was analyzed using Review Manager software and pooled risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI) were calculated. RESULTS: Seven randomized controlled trials met the eligible criteria. The data on non-recovery from four studies was obtained and included 418 participants in the meta-analysis. Physical therapy might reduce non-recovery (RR = 0.51 [95% CI = 0.31-0.83], low quality). Pooling the data of composite score of the Sunnybrook facial grading system from three studies (166 participants) revealed that physical therapy might increase the composite scores (MD = 12.1 [95% CI = 3.11-21.0], low quality). Moreover, we obtained data on sequelae from two articles (179 participants). The evidence was very uncertain about the effect of physical therapy on reduction of sequelae (RR = 0.64 [95% CI = 0.07-5.95], very low quality). CONCLUSION: The evidence suggested that physical therapy reduces non-recovery in patients with peripheral facial palsy and improves the composite score of the Sunnybrook facial grading system, whereas the efficacy of physical therapy in reducing sequelae remained uncertain. The included studies had high risk of bias, imprecision, or inconsistency; therefore, the certainty of evidence was low or very low. Further well-designed randomized controlled trials are needed to confirm its efficacy.

Redundant function of the Arabidopsis phosphatidylinositol 4-phosphate 5-kinase genes PIP5K4-6 is essential for pollen germination.

Phosphatidylinositol 4-phosphate 5-kinase (PIP5K) is a key enzyme producing the signaling lipid phosphatidylinositol 4,5-bisphosphate [PtdIns(4,5)P2 ] in eukaryotes. Although PIP5K genes are reported to be involved in pollen tube germination and growth, the essential roles of PIP5K in these processes remain unclear. Here, we performed a comprehensive genetic analysis of the Arabidopsis thaliana PIP5K4, PIP5K5, and PIP5K6 genes and revealed that their redundant function is essential for pollen germination. Pollen with the pip5k4pip5k5pip5k6 triple mutation was sterile, while pollen germination efficiency and pollen tube growth were reduced in the pip5k6 single mutant and further reduced in the pip5k4pip5k6 and pip5k5pip5k6 double mutants. YFP-fusion proteins, PIP5K4-YFP, PIP5K5-YFP, and PIP5K6-YFP, which could rescue the sterility of the triple mutant pollen, preferentially localized to the tricolpate aperture area and the future germination site on the plasma membrane prior to germination. Triple mutant pollen grains under the germination condition, in which spatiotemporal localization of the PtdIns(4,5)P2 fluorescent marker protein 2xmCHERRY-2xPHPLC as seen in the wild type was abolished, exhibited swelling and rupture of the pollen wall, but neither the conspicuous protruding site nor site-specific deposition of cell wall materials for germination. These data indicate that PIP5K4-6 and their product PtdIns(4,5)P2 are essential for pollen germination, possibly through the establishment of the germination polarity in a pollen grain.

Early mobilization for acute heart failure: A scoping and a systematic review.

Early mobilization of hospitalized patients is beneficial under certain circumstances. This has been applied in clinical practice for patients with acute heart failure (HF). However, its current definition, effectiveness, and safety are not well established. This review aimed to clarify the current definition of "early mobilization," and summarize its effectiveness and safety in acute HF. We conducted a scoping review to define early mobilization (Part 1) and a systematic review and meta-analysis (Part 2) to evaluate its effectiveness and safety. For Part 1, we searched MEDLINE (Ovid), and for Part 2, we searched the Cochrane Central Register of Controlled Trials, MEDLINE (Ovid), Embase (ProQuest Dialog), CINAHL, and PEDro. We included 12 studies in Part 1 and defined early mobilization as protocol-based interventions or walking within 3 days of admission. Based on this definition, two observational studies were included in Part 2, with no randomized controlled trials. Early mobilization may result in a large reduction in the readmission rate compared with that of the control (two studies, 283 participants: odds ratio 0.25, 95 % confidence interval 0.14 to 0.42; I2 = 0 %; low certainty evidence). We could not define frequency, intensity, or quantity because many of the included studies did not describe them. In conclusions, our review suggests that early mobilization, defined as protocol-based interventions or walking within 3 days of admission, may be associated with a low readmission rate in patients with acute HF. Future studies are essential, to investigate the causal relationship between early mobilization and possible outcomes.

Epley manoeuvre's efficacy for benign paroxysmal positional vertigo (BPPV) in primary-care and subspecialty settings: a systematic review and meta-analysis.

BACKGROUND: Although previous studies have reported general inexperience with the Epley manoeuvre (EM) among general physicians, no report has evaluated the effect of EM on benign paroxysmal positional vertigo (BPPV) in primary care by using point estimates or certainty of evidence. We conducted this systematic review and meta-analysis and clarified the efficacy of EM for BPPV, regardless of primary-care and subspecialty settings. METHODS: Systematic review and meta-analysis of randomised sham-controlled trials of EM for the treatment of posterior canal BPPV in primary-care and subspecialty settings. A primary-care setting was defined as a practice setting by general practitioners, primary-care doctors, or family doctors. A systematic search was conducted in January 2022 across databases, including Cochrane Central Resister of Controlled Trial, MEDLINE, Embase, Cumulative Index of Nursing and Allied Health Literature, World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. Primary outcomes were the disappearance of subjective symptoms (vertigo), negative findings (Dix-Hallpike test), and all adverse events. We evaluated the certainty of evidence using the Grading of Recommendations, Assessment, Development and Evaluation approach. RESULTS: Twenty-seven randomised controlled trials were identified. In primary-care settings, EM reduced the subjective symptoms [risk ratio (RR), 3.14; 95% confidence interval (CI), 1.96-5.02]; however, there was no applicable article for all adverse events. In the subspeciality setting, EM reduced the subjective symptoms (RR, 2.42; 95% CI, 1.64-3.56), resulting in an increase in negative findings (RR, 1.81; 95% CI, 1.40-2.34). The evidence exhibited uncertainty about the effect of EM on negative findings in primary-care settings and all adverse events in subspecialty settings. CONCLUSIONS: Regardless of primary-care and subspecialty settings, EM for BPPV was effective. This study has shown the significance of performing EM for BPPV in primary-care settings. EM for BPPV in a primary-care setting may aid in preventing referrals to higher tertiary care facilities and hospitalisation for follow-up. TRIAL REGISTRATION: The study was registered in protocols.io (PROTOCOL INTEGER ID: 51,464) on July 11, 2021.

An Adult Case of Pharyngeal Injury Caused by Toothbrush.

Most toothbrush-induced oral injuries occur in children and are relatively shallow, involving the oral mucous membranes and musculature, but rarely deeper layers. Here, the management of an adult case of pharyngeal injury caused by a toothbrush is discussed. A man fell while brushing his teeth, and his toothbrush stuck in his throat. Contrast-enhanced computed tomography showed a toothbrush stuck in the left parapharyngeal space, reaching the subcutaneous tissue of the posterior neck. The toothbrush was surgically removed because blind removal could damage major cervical arterioles and nerves. In intraoral injuries caused by deep penetrating toothbrushes, there is a risk that the injury extends to the major arterioles and nerves of the neck. The need for imaging studies, methods of removal, and possible complications should all be considered before taking an appropriate removal action.

Reference Values for Fetal Cardiac Dimensions, Volumes, Ventricular Function and Left Ventricular Longitudinal Strain Using Doppler Ultrasound Gated Cardiac Magnetic Resonance Imaging in Healthy Third Trimester Fetuses.

BACKGROUND: Recent advances in hardware and software permit the use of cardiac MRI of late gestation fetuses, however there is a paucity of MRI-based reference values. PURPOSE: To provide initial data on fetal cardiac MRI-derived cardiac dimensions, volumes, ventricular function, and left ventricular longitudinal strain in healthy developing fetuses >30 weeks gestational age. STUDY TYPE: Prospective. POPULATION: Twenty-five third trimester (34 ± 1 weeks, range of 32-37 weeks gestation) women with healthy developing fetuses. FIELD STRENGTH/SEQUENCE: Studies were performed at 1.5 T and 3 T. Cardiac synchronization was achieved with a Doppler ultrasound device. The protocol included T2 single shot turbo spin echo stacks for fetal weight and ultrasound probe positioning, and multiplanar multi-slice cine balanced steady state free precession gradient echo sequences. ASSESSMENT: Primary analyses were performed by a single observer. Weight indexed right ventricular (RV) and left ventricular (LV) volumes and function were calculated from short axis (SAX) stacks. Cardiac dimensions were calculated from the four-chamber and SAX stacks. Single plane LV longitudinal strain was calculated from the four-chamber stack. Interobserver variability was assessed in 10 participants. Cardiac MRI values were compared against available published normative fetal echocardiogram data using z-scores. STATISTICAL TESTS: Mean and SDs were calculated for baseline maternal/fetal demographics, cardiac dimensions, volumes, ventricular function, and left ventricular longitudinal strain. Bland-Altman and intraclass correlation coefficient analysis was performed to test interobserver variability. RESULTS: The mean gestational age was 34 ± 1.4 weeks. The mean RV and LV end diastolic volumes were 3.1 ± 0.6 mL/kg and 2.4 ± 0.5 mL/kg respectively. The mean RV cardiac output was 198 ± 49 mL/min/kg while the mean LV cardiac output was 173 ± 43 mL/min/kg. DATA CONCLUSION: This paper reports initial reference values obtained by cardiac MRI in healthy developing third trimester fetuses. MRI generally resulted in slightly larger indexed values (by z-score) compared to reports in literature using fetal echocardiography. EVIDENCE LEVEL: 1 TECHNICAL EFFICACY: Stage 2.

Parathyroid carcinoma: impact of preoperative diagnosis on the choice of surgical procedure.

The operative procedure in the surgical treatment of parathyroid carcinoma differs from that of benign hyperparathyroidism. However, preoperative differentiation is often difficult. This study elucidated how clinicians diagnose parathyroid carcinoma and the relationship between preoperative diagnosis and the operative course. Using a retrospective chart review, twenty cases of parathyroid carcinoma from nine participating centers were examined. In 11 cases with preoperative suspicion of malignancy, at least one of these three features was found: elevated serum calcium level (>14 mg/dL), palpable mass, and irregular margin on ultrasonography. Although an intact parathyroid hormone (iPTH) threshold to suspect malignancy has not been established, six cases showed marked iPTH elevation exceeding 8.0 times the upper limit of normal. One case was excluded from analysis due to hemodialysis. Compared with the four cases that showed calcium elevation, the iPTH threshold might represent better sensitivity. Among 9 cases of benign preoperative diagnosis, six cases were performed with pericapsular resection. In three cases where malignancy was suspected in the middle of the operation, the recommended en bloc resection with ipsilateral thyroid lobectomy was not performed but a parathyroidectomy with surrounding soft tissue. In contrast, 10 preoperatively suspected cases underwent en bloc resection, and one case underwent pericapsular resection followed by supplementary ipsilateral hemithyroidectomy due to the uncertain pre- and intraoperative findings to determine the diagnosis. In conclusion, the surgical procedure for parathyroid carcinoma strongly depends on the preoperative diagnosis. The presence of excessive iPTH levels might contribute to improved preoperative diagnostic sensitivity for parathyroid carcinoma.

Obesity dominates early effects on cardiac structure and arterial stiffness in people with type 2 diabetes.

OBJECTIVE: Type 2 diabetes (T2D) and obesity are global epidemics leading to excess cardiovascular disease (CVD). This study investigates standard and novel cardiac MRI parameters to detect subclinical cardiac and central vascular dysfunction in inactive people with and without T2D. METHODS: Physically inactive age and BMI-similar premenopausal women and men with ( n  = 22) and without [ n  = 34, controls with overweight/obesity (CWO)] uncomplicated T2D were compared to an age-similar and sex-similar reference control cohort ( n  = 20). Left ventricular (LV) structure, function, and aortic stiffness were assessed by MRI. Global arterial pulse wave velocity (PWV) was assessed using carotid-to-femoral applanation tonometry. Regional PWV was measured via 2D phase-contrast MRI and 4D flow MRI. RESULTS: Global arterial PWV did not differ between CWO and T2D. 2D PC-MRI PWV in the ascending aorta was higher in people with T2D compared with CWOs ( P  < 0.01). 4D flow PWV in the thoracic aorta was higher in CWO ( P  < 0.01), and T2D ( P  < 0.001) compared with RC. End-diastolic volume, end-systolic volume, stroke volume, and cardiac output were lower in CWO and T2D groups compared with reference control. CONCLUSION: Subclinical changes in arterial stiffening and cardiac remodeling in inactive CWO and T2D compared with reference control support obesity and/or physical inactivity as determinants of incipient CVD complications in uncomplicated T2D. Future studies should determine the mechanistic causes of the CVD complications in greater detail in order to create therapeutic targets. CLINICAL TRIAL REGISTRATION: Cardiovascular Mechanisms of Exercise Intolerance in Diabetes and the Role of Sex (NCT03419195).

Versatile properties of dynein molecules underlying regulation in flagellar oscillation.

Dynein is a minus-end-directed motor that generates oscillatory motion in eukaryotic flagella. Cyclic beating, which is the most significant feature of a flagellum, occurs by sliding spatiotemporal regulation by dynein along microtubules. To elucidate oscillation generated by dynein in flagellar beating, we examined its mechanochemical properties under three different axonemal dissection stages. By starting from the intact 9 + 2 structure, we reduced the number of interacting doublets and determined three parameters, namely, the duty ratio, dwell time and step size, of the generated oscillatory forces at each stage. Intact dynein molecules in the axoneme, doublet bundle and single doublet were used to measure the force with optical tweezers. The mean forces per dynein determined under three axonemal conditions were smaller than the previously reported stall forces of axonemal dynein; this phenomenon suggests that the duty ratio is lower than previously thought. This possibility was further confirmed by an in vitro motility assay with purified dynein. The dwell time and step size estimated from the measured force were similar. The similarity in these parameters suggests that the essential properties of dynein oscillation are inherent to the molecule and independent of the axonemal architecture, composing the functional basis of flagellar beating.

Real-world efficacy of antibiotic prophylaxis for upper gastrointestinal bleeding in cirrhotic patients in Japan.

BACKGROUND AND AIMS: Antibiotic prophylaxis is recommended for cirrhotic patients with upper gastrointestinal bleeding (UGIB). However, the frequency of bacterial infection in such patients has remarkably decreased over the decades, which has reduced the necessity for prophylaxis. Therefore, here we investigated the real-world adherence and effectiveness of antibiotic prophylaxis in cirrhotic patients with UGIB in Japan. METHODS: This population-based study was conducted with a Japanese real-world database of the Health, Clinic, and Education Information Evaluation Institute. We enrolled cirrhotic patients who were hospitalized for UGIB between April 2010 and March 2020. After those who died within 24 h and who had aspiration pneumonia at admission were excluded, 1232 patients were analyzed. Rates of 6-week mortality, in-hospital bacterial infection, 30-day readmission, and length of hospital stay were evaluated. RESULTS: Prophylactic antibiotics were prescribed in 142 (11.5%) patients. Multivariate analysis revealed that antibiotic prophylaxis was not significantly associated with either 6-week mortality or bacterial infection. After propensity score matching, the rates of 6-week mortality (7.2% vs. 8.4%, P = 0.810), bacterial infection (9.6% vs. 4.2%, P = 0.082), and 30-day unexpected readmission (7.2% vs. 7.8%, P = 1.000) were similar in patients with and without prophylaxis, whereas the median length of hospital stay was significantly longer in patients with prophylaxis (17 days vs. 13 days, P = 0.013). CONCLUSIONS: Under current real-world circumstances in Japan, prophylactic antibiotics were prescribed in only 11.5% of cirrhotic patients with UGIB and were not associated with better clinical outcomes.

Prescription factors influencing baloxavir prescription during the 2018/2019 and 2019/2020 seasons: a administrative database study in Japan.

BACKGROUND: We aimed to evaluate the factors associated with baloxavir prescription in Japanese hospitals using a health insurance claim-based database (MDV analyzer), during the 2018/2019 and 2019/2020 influenza seasons. The MDV analyzer contains anonymized claims data from approximately 420 Diagnosis Procedure Combination hospitals, and does not contain data from clinics. METHODS: Data were collected for influenza patients treated with anti-influenza drugs during the 2018/2019 and 2019/2020 influenza seasons. Multivariate analysis was used to identify factors associated with baloxavir prescription. RESULTS: During the study period, 322,063 influenza patients were included for analyses. In multivariate analysis, children, female sex, inpatient, hospital bed capacity, and private hospitals were negatively associated with baloxavir prescription. Compared to elderly patients, the adjusted odds ratio (OR) for baloxavir prescription was 0.612 (95% confidence interval (CI), 0.587-0.637) in children aged 6-11 years, and 0.119 (95% CI, 0.111-0.128) in children aged 0-5 years. Compared to small hospitals (bed capacity, 20-299), the adjusted OR for baloxavir prescription was 0.559 (95% CI, 0.540-0.578) in large hospitals (bed capacity, ≥ 500). CONCLUSION: Children, female sex, inpatient, hospital bed capacity, and private hospitals were negatively associated with baloxavir prescription.

Effectiveness of Unsupervised Exercise Therapy After Endovascular Treatment for an Iliac Occlusive Lesion.

OBJECTIVE: Exercise therapy has acceptable outcomes for patients with intermittent claudication (IC), but there are few reports on the results of continuous unsupervised exercise therapy after endovascular treatment (EVT) for an iliac lesion. The aim of this study is to analyze the long-term outcomes of unsupervised exercise therapy for patients after EVT. MATERIAL AND METHODS: A retrospective analysis was performed in 76 patients (93 limbs) with IC who underwent iliac EVT from 2012 to 2020 at our hospital. Maintenance of unsupervised exercise therapy was evaluated at 6 months after EVT. Long-term outcomes such as primary patency, clinically driven target lesion revascularization (CD-TLR), survival, and major adverse cardiovascular events (MACE) were compared between patients who continued (cET group) or discontinued (dET group) unsupervised exercise therapy. RESULTS: A total of 28 patients (37%) continued unsupervised exercise therapy until 6 months after EVT for an iliac lesion. There were no differences in patient background and procedural details between the cET and dET groups. The follow-up rate was 96% in a median follow-up period of 35 [25 - 42] months. The mean exercise time in the cET group was 52 ± 18 minutes daily, with a mean frequency of 5.8 ± 1.1 days per week. The median step count in the cET group was 5559 ± 2908 steps daily. At 3 years, the cET group had significantly higher rates for primary patency (97% vs 71%, P = .002), and freedom from CD-TLR (97% vs 79%, P = .007); and a tendency for higher survival (100% vs 94%, P = .074), and higher freedom from MACE (89% vs 73%, P = .12). CONCLUSION: The findings of this study suggested superior long-term outcomes, including primary patency, freedom from CD-TLR, survival, and freedom from MACE, in patients who maintained continuous unsupervised exercise therapy after EVT.

Effectiveness of the Vascular Quality Initiative Chronic Limb-Threatening Ischemia Mortality Prediction Model in Patents with Distal Bypass.

BACKGROUND: The purpose of this study is to evaluate the effectiveness of mortality prediction using the Vascular Quality Initiative (VQI) chronic limb-threatening ischemia (CLTI) model in patients with distal bypass. METHODS: Patients who underwent distal bypass for CLTI from 2009 to 2020 at a single center were retrospectively reviewed. Distal bypass was defined as any bypass with a distal anastomosis to the posterior tibial, anterior tibial, dorsalis pedis, plantar, or peroneal artery. Baseline characteristics, operative details, hospital outcomes, and medium-term outcomes were compared among patients with a low-, medium-, and high-risk of mortality based on a VQI CLTI calculation. The primary endpoints were survival and limb salvage. RESULTS: A total of 287 distal bypasses were performed in 230 patients (153 males; median age, 74 years; diabetes mellitus, 70%; end-stage renal disease [ESRD] with hemodialysis, 38%). These patients were stratified into 153 (66%) low-, 35 (15%) medium-, and 42 (18%) high-risk cases based on the VQI CLTI model. There were two hospital deaths (1%) within 30 days. During a mean follow-up period of 33 ± 29 months, 105 patients died and 26 limbs (9%) required major amputation. The 2-year survival rate of 81% in the low-risk group was significantly higher than those of 41% in the medium-risk group and 46% in the high-risk group (both P < 0.001). The 2-year survival rates did not differ significantly between the medium- and high-risk groups (P = 0.81). The 2-year limb salvage rate of 93% in the low-risk group was significantly higher than those of 81% in the medium-risk (P = 0.023) and those of 87% in the high-risk (P = 0.039) groups. There were no significant differences in graft patency and wound healing among the three groups. CONCLUSIONS: These results suggest that distal bypass is optimal treatment for patients with a low VQI-predicted risk of mortality. However, the lower limb salvage and higher mortality rates at 2 years suggest that the decision-making for VQI medium- and high-risk patients may be carefully considered.

Outcomes of a bypass-first strategy in chronic limb-threatening ischemia based on the Global Vascular Guidelines.

OBJECTIVE: The Global Vascular Guidelines (GVGs) recommend initial revascularization (bypass or endovascular therapy) for chronic limb-threatening ischemia (CLTI) based on anatomical complexity and limb severity. This decision is made based on a prediction of the outcomes after endovascular intervention. This study was performed to evaluate outcomes after distal bypass in cases recommended for GVG bypass. METHODS: A total of 239 distal bypasses for CLTI were evaluated in 195 patients with a GVG bypass recommendation treated between 2009 and 2020 at a single center in Japan. Comparisons were made between crural and pedal bypass cases. RESULTS: The 195 patients (median age, 77 years; 67% male) underwent 133 crural bypasses (106 patients; 54%) and 106 pedal bypasses (89 patients; 46%). Hemodialysis was more common in pedal cases than in crural cases (P = .03). Hospital deaths occurred in two cases (1%) within 30 days. The whole cohort has a follow-up rate of 96% over a mean of 28 ± 26 months, with 3-year limb salvage rates of 87% and 3-year primary, assisted primary, and secondary patency rates of 40%, 65%, and 67%, all without significant differences between crural and pedal cases. The 1-year wound healing rate was 88% and tended to be higher in crural cases than in pedal cases (P = .068). The 3-year survival rate was 52% in the cohort and did not differ significantly between crural and pedal cases. CONCLUSIONS: Patients with CLTI with a GVG bypass recommendation had acceptable limb salvage, graft patency, wound healing, and survival after distal bypass, regardless of the bypass method. These findings indicate that a GVG bypass recommendation as an initial revascularization method is valid in the real world.

A double-blinded, randomized controlled clinical trial of hydrogen inhalation therapy for idiopathic sudden sensorineural hearing loss.

Background: Hydrogen (H2) has been reported to be effective in reducing hearing loss due to several causes in animal studies. However, no study has examined the effectiveness of H2 in treating hearing loss in humans. Thus, we investigated whether H2 is effective for the treatment of idiopathic sudden sensorineural hearing loss (ISSNHL). Materials and methods: We conducted a double-blind randomized controlled trial at six hospitals between June 2019 and March 2022. The study protocol and trial registration have been published in the Japan Registry of Clinical Trials (jRCT, No. jRCTs06119004). We randomly assigned patients with ISSNHL to receive either H2 (H2 group) or air as a placebo (control group) through inhalation combined with the administration of systemic glucocorticoids and prostaglandin E1. The primary outcome was the hearing threshold and changes in hearing threshold 3 months after therapy. In contrast, the secondary outcomes included the proportion of patients with a good prognosis (complete recovery or marked improvement). Results: Sixty-five patients with ISSNHL (31 and 34 in the H2 and control groups, respectively) were included in this study. The hearing threshold 3 months after treatment was not significantly different between the groups; 39.0 decibels (dB) (95% confidence interval [CI]: 28.7-49.3) and 49.5 dB (95% CI: 40.3-58.7) in the H2 and control groups, respectively. In contrast, the changes in hearing threshold 3 months after treatment was 32.7 dB (95% CI: 24.2-41.3) and 24.2 dB (95% CI: 18.1-30.3) in the H2 and control groups, respectively. Consequently, the changes in hearing threshold were significantly better in the H2 group than in the control group (P = 0.048). However, no adverse effects due to the inhalation of H2 gas have been reported. Conclusion: This is the first study to investigate the efficacy of H2 for the treatment of ISSNHL in humans. The results suggest that H2 therapy may be effective for ISSNHL treatment. Clinical trial registration: [https://jrct.niph.go.jp/re/reports/detail/10442], identifier [jRCTs06119004].