A randomized pharmacokinetic and pharmacodynamic trial of two regular human insulins demonstrates bioequivalence in type 1 diabetes and availability of biosimilar insulin may improve access to this medication.

AIMS: To compare the pharmacokinetic (PK) and pharmacodynamic (PD) effects and safety of therapeutic dosages of a regular insulin (experimental drug) produced by Bioton S.A. (Warsaw, Poland) versus Humulin® R, a regular insulin (reference drug) produced by Eli Lilly (Indianapolis, Indiana). MATERIALS AND METHODS: In a single-centre, randomized, double-blinded phase 1 crossover study, we used the manual euglycaemic clamp technique to compare PK and PD profiles between single subcutaneous doses (0.3 units/kg) of the two regular insulins in participants with type 1 diabetes (T1DM) with a washout period of 14 (± 7) days between tests. RESULTS: We evaluated 56 participants. The mean participant age and body mass index were 32.9 years and 22.9 kg/m2 , respectively. The ratios (experimental/reference) of the geometric means of maximum plasma insulin concentration and for plasma insulin area under the curve (AUC) were 0.909 (90% confidence interval [CI] 0.822-1.01) and 0.993 (90% CI 0.944-1.04), respectively. The ratios of the geometric means of maximum glucose infusion rate (GIR) and for GIR AUC were 0.999 (95% CI 0.912-1.09) and 1.04 (95% CI 0.962-1.12), respectively. CONCLUSIONS: The experimental product regular human insulin and comparator Humulin® R are bioequivalent in patients with T1DM. Wider entry to the pharmaceutical market of affordable, biosimilar regular insulins may substantially improve access to insulin for many socioeconomically disadvantaged patients with diabetes.

Success of lateral cervical spinal cord stimulation for the treatment of chronic neuropathic refractory pain.

BACKGROUND: Spinal cord stimulation (SCS) is traditionally performed by implanting surgical leads along the midline of the spinal cord, over the dorsal columns. Here, we present a patient who successfully underwent lateral cervical SCS to treat chronic refractory neuropathic pain. METHODS: A 46-year-old female, with a schwannoma involving the right axillary nerve, presented with a chronic refractory right upper extremity pain syndrome. The tumor was located between the fibers of the teres minor and the posterior deltoid, and measured 2.2 cm in diameter. After 8 months of analgesics, opioids, physiotherapy, and acupuncture, the patient underwent surgery; however, the tumor was unresectable (i.e., due to significant adjacent vascular/neural structures). Three months later, she had a midline C6-C7 laminectomy for placement of a right-sided epidural SCS lead (i.e., containing 16 electrode contacts). RESULTS: Within 4 days following this SCS procedure, the patient's pain completely resolved; at 10 postoperative months, she still remains pain free. CONCLUSION: Lateral SCS at the C6-C7 level provided a safe and effective option for the relief of chronic neuropathic pain attributed to an unresectable schwannoma of the right axillary nerve in a 46-year-old female.

An unusual case of lead migration in occipital nerve stimulation: A case report and literature review.

BACKGROUND: Lead migration is a complication associated with occipital nerve stimulation (ONS). We present a rare case in which fibrosis in the stress relief loop caused lead migration in the treatment of occipital neuralgia. CASE DESCRIPTION: A 30-year-old woman with a 5-year history of refractory occipital neuralgia, who had been under ONS therapy for 2 months, presented with a sudden onset of typical occipital neuralgia pain associated with cervical muscles spasms and myoclonus. A skull radiography showed lead migration. The patient underwent surgery for lead repositioning. During surgery, we identified extensive fibrosis throughout the stress relief loop that produced several constriction points. The fibrosis in the stress relief loop increased tension on the lead during head-and-neck movement, causing progressive migration of the lead. CONCLUSION: Although lead migration is a common complication of ONS, its association with fibrosis in the stress relief loop has not, to the best of our knowledge, been reported before. Lead migration can directly affect treatment outcome and it is, therefore, important to fully understand the possible mechanisms that can cause it and how to promptly manage them.

Acute Effect of Acupuncture on Glycemic Control in Type 2 Diabetes Measured by Continuous Glucose Monitoring: A Pilot Study.

Introduction: Acupuncture is a widely used technique for the treatment of diabetes in Asian countries. Nevertheless, there are few studies with appropriate methodological rigor evaluating its effectiveness and promoting a standardized procedure in the Western World. Objectives: Evaluate the short-term effect of acupuncture in the treatment of type 2 diabetes mellitus (DM2) using continuous glucose monitoring (CGM). Methods: In a randomized controlled prospective open-label study, we assigned 20 insulin-independent DM2 patients to undergo acupuncture (group 1) or control group (group 2). Participants underwent CGM for 14 days. In group 1, all patients were submitted to acupuncture 4, 8, and 12 days after installation of the monitoring system. Diabetes-specific treatment points were used in all patients (bladder 38, large intestine 4, kidney 24, stomach 36, and spleen 9). This study was approved by the ethics committee (CAAE-60576616.6.0000.5572). Results: There were no statistically significant differences in the baseline characteristics. In group 1, mean glucose level obtained through 14 days monitoring after acupuncture treatment was 143 ± 28.8 mg/dL, whereas in group 2, who did not receive acupuncture, the mean level was 165.8 ± 30.2 mg/dL (P = 0.015). Conclusion: In this randomized pilot study, there was an improvement in global glycemic control during the 14-day monitoring in the acupuncture group. Further studies with larger cohorts over a more extended period of time are needed. Clinical Trials: RBR-3m45y3.

Differential Diagnosis between Anomalous Experiences and Dissociation Disorder Using the Dissociative Disorders Interview Schedule (DDIS).

BACKGROUND: It is important to understand the most diverse cultural aspects related to religiosity. Scientifically, it is important to understand religious manifestations and their relation to health, and to differentiate them from psychopathological manifestations. OBJECTIVE: To evaluate the mental health of a group of mediums and compare it with that of a control group from the same religious context who do not manifest mediumship, using the Dissociative Disorders Interview Schedule (DDIS). METHODS: This was a cross-sectional study, evaluating 47 mediums (Group 1) and comparing them with 22 non-medium volunteers from the same religious context (Group 2) using the DDIS questionnaire. All results were matched with historical data from patients with dissociative identity disorder (DID) who answered the DDIS. RESULTS: Scores obtained from the DDIS were similar in both groups. The number of positive symptoms was comparable in a wide range of analyzed areas, involving but not being restricted to somatization disorder, major depressive episode, borderline personality disorder, extrasensory/paranormal experiences, physical/sexual abuse and five dissociative disorders. There were considerable differences when we compared these results with historical data from patients with DID. CONCLUSION: In agreement with the extant literature, these results showed that mediumship can be considered a non-pathological form of dissociative phenomena.

Understanding the barriers and improving care in type 2 diabetes: Brazilian perspective in time to do more in diabetes.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a complex disease, particularly in a continental country like Brazil. We attempted to understand and evaluate the perceptions and routines of Brazilians with T2DM and physicians, compared with other countries. METHODS: We compared the results from a 20-min online survey in Brazil with simultaneously collated data from India, Japan, Spain, UK and USA. RESULTS: In total, 652 adults with T2DM and 337 treating physicians were enrolled, of whom 100 patients and 55 physicians were from Brazil. The numbers of primary care physicians from the five countries were 221 versus 43 in Brazil, diabetes specialists were 61 versus 12. There was disconnect between the opinions of physicians and people with diabetes globally. Further, there were differences between clinical practices in Brazil versus the rest of the world, in many areas Brazilians were performing better. CONCLUSIONS: Communication between patients and physicians should be clearer. There is an urgent need to identify the deficits in education, in order to address the clinical inertia within the diabetes management team. There is a necessity to understand the specific requirements of the Brazilian population in order to contextualise international guidelines and implement local changes in practice.