Misleading presentations in functional food trials led by contract research organizations were frequently observed in Japan: meta-epidemiological study.

OBJECTIVES: The functional food market has experienced significant growth, leading to an uptick in clinical trials conducted by contract research organizations (CROs). Research focusing on CRO-managed trials and the communication of trial outcomes to the consumer market remains underexplored. This metaepidemiological study aims to evaluate the quality of randomized controlled trials (RCTs) facilitated by prominent CROs in Japan and to examine the quality of the representations used to convey their results to consumers. STUDY DESIGN AND SETTING: This study focused on the food trials that were registered in the University Hospital Medical Information Network Clinical Trial Registry or the International Clinical Trials Registry Platform by the top 5 CROs. Press releases of study results or advertisements of food products based on the study results were identified by conducting a Google search. The risk of bias in the RCT publications was independently assessed by 2 reviewers, who also evaluated the presence of "spin" in the abstracts and full texts. An assessment of "spin" in press releases/advertisements was undertaken. RESULTS: A total of 76 RCT registrations, 32 RCT publications, and 11 press releases/advertisements were included. Approximately 72% of the RCT publications exhibited a high risk of bias due to selective outcome reporting. "Spin" was present in the results of the abstract (72%), abstract conclusion (81%), full-text results (44%), and full-text conclusion (84%). "Spin" appeared in 73% of press releases/advertisements due to the selective outcome reporting. CONCLUSION: Functional food presentations in Japan frequently contained "spin." The Japanese government should more rigorously check whether food manufacturers report outcomes selectively.

Carotid artery stenting for stenosis after carotid artery replacement: An illustrative case report.

Background: There are few reports on the treatment of carotid artery stenosis after arterial vessel replacement. We report and discuss an illustrative case of carotid artery stenting (CAS) performed for stenosis after carotid artery replacement. Case Description: A woman in her 20s experienced injury to the right carotid artery during an operation for removal of a carotid body tumor 6 years before presentation. The right common carotid artery and internal carotid artery were replaced with an artificial vessel graft at that time. Intraluminal stenosis in the graft was not identified 3 years after surgery; however, 4 years after surgery, stenosis was recognized at the non-anastomotic site inside the artificial vessel graft. Subsequently, antiplatelet therapy was initiated. The stenosis was noted to progress gradually in follow-up appointments. Therefore, we decided to intervene because of the patient's young age and the risk of long-term hemodynamic stress. Angiography revealed pseudo-occlusion in the artificial vessel. Percutaneous transluminal angioplasty was performed for stenosis with distal protection; subsequently, CAS was performed. The patient was discharged without neurological deficits 4 days after the operation, and no apparent restenosis was observed as of the 1-year follow-up. Conclusion: Stenosis after cervical artery replacement can be safely treated with CAS. Inflation pressure and stent should be selected according to the pathology of the stenosis.

Two patients of visual disturbance and optic perineuritis after placement of a flow diverter.

The pathogenesis of new visual symptoms after flow diverter stent placement in the ophthalmic artery for internal carotid artery aneurysms remains unclear. We report two cases of patients who developed visual field disturbance and decreased visual acuity following flow diverter placement. The "doughnut sign" was found around the optic nerve on magnetic resonance imaging. The patients had progressive visual field defects and impairment on the side where the flow diverter was placed. Short tau inversion recovery coronal images showed a doughnut-shaped high-signal around the optic nerve on the affected side. Both patients were treated with steroid pulse therapy, and 1 received endovascular therapy. Their symptoms gradually improved, and the "doughnut sign" disappeared. The "doughnut sign" observed around the optic nerve on magnetic resonance imaging may be found alongside visual disturbance symptoms after paraclinoid aneurysm treatment. It is recommended that short tau inversion recovery sequences be performed preoperatively in patients presenting with visual impairment and in whom the possibility of postoperative exacerbation is suspected.

A Case of Scalp Arteriovenous Malformation Treated by Transvenous Embolization Using Onyx.

Objective: We treated a case of scalp arteriovenous malformation (sAVM) by transvenous embolization using Onyx. Case Presentation: We describe the case of a 17-year-old woman with a pulsatile mass at the right temporal area. DSA identified sAVM with the venous pouch between the right occipital artery (OA) and the right two occipital veins (OVs), which was also fed by multiple branches of the right posterior auricular artery (PAA) and superficial temporal artery (STA). The shunts were completely occluded by the reverse pressure cooker technique (RPCT), which involves navigating the balloon catheters just distal to the shunt point in the OVs approaching from the right external jugular vein (EJV) and injecting Onyx to each feeder retrogradely with balloons inflated. Conclusion: This technique may be useful for treating sAVM with venous angioarchitecture enabling a transvenous approach.

A Case of Pterygopalatine Fossa Arteriovenous Malformation Treated by Transarterial Embolization Using a Dual-Lumen Balloon Catheter.

Objective: We report a rare case of pterygopalatine fossa arterial venous shunt disease with venous congestion of the superior ophthalmic vein (SOV) that was treated by transarterial balloon-assisted embolization. Case Presentation: A 57-year-old man presented with congestion of the right bulbar conjunctiva, protrusion, and swelling of the right eyelid was admitted to our hospital. Angiography demonstrated an arteriovenous fistula (AVF) forming small congregated vessels in the pterygopalatine fossa fed by the branch of the ophthalmic artery (OA) and artery of the superior orbital fissure, draining into the SOV via the inferior ophthalmic vein (IOV). From the artery of the superior orbital fissure, transarterial embolization (TAE) with ONYX using a dual-lumen balloon catheter was performed. The patient was treated without complications. Conclusion: TAE using transarterial balloon-assisted embolization with ONYX is effective for periorbital arteriovenous shunts, although special care is necessary to prevent the migration of ONYX into the OA.

Cavernous Sinus Dural Arteriovenous Fistulas: General Aspects.

Cavernous sinus (CS) dural arteriovenous fistulas (AVF), which are most common in middle-aged females, present with benign symptoms such as exophthalmos, chemosis, and orbital bruit. Benign CS dural AVF without cortical venous drainage (CVD) have the rare potential for development of CVD with neurological symptoms, even without treatment. On the other hand, aggressive type AVF with CVD can cause more aggressive symptoms such as cerebral hemorrhage. As symptoms are highly related to the drainage pattern, it is important to understand the anatomy of the CS itself, shunt point, and draining vein when treating the lesion. In general, the drainage route is gradually diminished by thrombosis and compartmentalization within the CS according to progression of the angiographical stage. At the restrictive stage, the disease is usually treated by endovascular treatment, particularly transvenous embolization.

Supine No-Retractor Method in Microvascular Decompression for Hemifacial Spasm: Results of 100 Consecutive Operations.

Objectives In microvascular decompression (MVD) for hemifacial spasm (HFS), the patient is placed in the lateral or park-bench position that is complicated and uncomfortable for anesthesiologists, nurses, and even the patient. Careless retraction of the cerebellum by a spatula could be the major cause of surgical complications. In our method, a patient is laid supine avoiding the complicated positioning. The subfloccular approach from a small cranial window sited on the more lateral and basal side of the occipital cranium enables the surgeon to reach all the segments of the facial nerve root without a spatula. We introduce our surgical procedures in detail along with our excellent results. Methods A total of 100 consecutive patients experiencing primary HFS were operated on with MVD by a single surgeon in our institution from August 2012 to April 2014. Results Overall, 94 patients showed the complete disappearance or a satisfactory alleviation of HFS. De novo neurologic deficits were not encountered after surgery including hearing impairment. In 47 cases, multiple offending vessels were observed in multiple possible affected sites in addition to the root entry/exit zone. Conclusions We believe this approach is superior for the safe and precise decompression of any part of the facial nerve root.