Pilot study on the efficacy and safety of berberine in people with metabolic syndrome and human immunodeficiency virus infection.

BACKGROUND: Antiretroviral therapy has increased the life expectancy of people living with HIV. However, this increase is not free of comorbidities, and metabolic syndrome is one of the most prevalent. Berberine is an alkaloid nutraceutical that has been shown to ameliorate metabolic disorders such as prediabetes, polycystic ovary syndrome, and non-alcoholic fatty liver disease. However, it has not been tested in HIV infection. Therefore, we conducted a randomized controlled trial to evaluate the efficacy of berberine in improving metabolic syndrome. METHODS AND RESULTS: In this double-blind, placebo-controlled trial, adults living with HIV under virological suppression and metabolic syndrome received either berberine 500 mg TID or placebo for 20 weeks. The primary outcomes were a composite of weight reduction, insulin resistance decrease, and lipid profile improvement. A total of 43 participants were randomized (22 in the berberine group and 21 in the placebo group); 36 participants completed the follow-up and were analyzed. The berberine group showed a reduction in weight and body mass index, lower insulin resistance, and a reduction in TNF-alpha. The control group had higher total cholesterol, c-LDL, and IL-6 concentration. CONCLUSION: In people living with HIV under virological suppression, berberine was safe and improves clinical and biochemical components of metabolic syndrome. However, further studies with more participants and longer intervention periods need to be explored.

Robotic transanal surgery: initial experience in a developing country / Cirugía robótica transanal: experiencia inicial en un país en vías de desarrollo

Background: Transanal minimally invasive surgery (TAMIS) is a surgical technique used for the excision of rectal neoplasia that gained popularity during the last decade. Due to the technical difficulty (non-articulated instruments, reduced workspace) and the long learning curve associated with this technique, the use of robotic platforms to improve resection results has been suggested and reported, at the same time that the learning curve decreases and the procedure is facilitated. Materials and Methods: From March 2017 to December 2019, all patients with rectal lesions eligible for TAMIS were offered the possibility to receive a robotic TAMIS (RTAMIS). We used a transanal GelPoint Path (Applied Medical Inc., Santa Margarita, CA, USA) in the anal canal to be able to do the Da Vinci Si (Intuitive Surgical, Sunnyvale, CA, USA) robotic platform docking, which we used to perform the excision of the rectal lesion as well as the resection site defect. Results: Five patients between 34 and 79 years of age underwent R-TAMIS. The mean distance to the anal verge was 8.8 cm. There were no conversions. The mean surgery time was 85 minutes, and the mean docking time was 6.6minutes. Conclusions: Robotic TAMIS is a feasible alternative to TAMIS, with a faster learning curve for experienced surgeons in transanal surgery and better ergonomics. Further studies are needed to assess the cost-benefit relationship. (AU)

Introdução: A cirurgia transanal minimamente invasiva (TAMIS, na sigla em inglês) é uma técnica que se tornou popular na última década para a excisão local de neoplasias no reto. Devido à dificuldade técnica (instrumentos não articulados, espaço de trabalho reduzido) e à longa curva de aprendizado representada por essa técnica, o uso de plataformas robóticas para melhorar os resultados da ressecção tem sido sugerido e relatado, aomesmo tempo emque a curva de aprendizado diminui e o procedimento é facilitado. Materiais e Métodos: De março de 2017 a dezembro de 2019, foi oferecida aos pacientes comlesões retais candidatos aoTAMIS a possibilidade de ressecção transanal robótica (R-TAMIS). Foi utilizada uma porta de acesso transanal GelPoint Path (Applied Medical Inc. Santa Margarita, CA, EUA), que foi introduzida no canal anal para posteriormente criar pneumoperitônio e realizar o acoplamento do sistema robótico Da Vinci Si (Intuitive Surgical, Sunnyvale, CA, EUA) para realizar a ressecção e o fechamento do defeito por robótica. Resultados: Cinco pacientes entre 79 e 34 anos foram submetidos à R-TAMIS. A distânciamédia àmargemanal foi de 8,8 cm. Não houve conversões. O tempo cirúrgico médio foi de 85 minutos, e o tempo médio de acoplamento foi de 6,6 minutos. Conclusões: A R-TAMIS é uma alternativa à TAMIS convencional, com menor curva de aprendizado para cirurgiões experientes em cirurgia transanalminimamente invasiva e melhor ergonomia para ressecção e fechamento. Outros estudos são necessários para avaliar a relação custo-benefício. (AU)

Patient Navigation to Improve Early Access to Supportive Care for Patients with Advanced Cancer in Resource-Limited Settings: A Randomized Controlled Trial.

BACKGROUND: The early integration of supportive care in oncology improves patient-centered outcomes. However, data are lacking regarding how to achieve this in resource-limited settings. We studied whether patient navigation increased access to multidisciplinary supportive care among Mexican patients with advanced cancer. MATERIALS AND METHODS: This randomized controlled trial was conducted between August 2017 and April 2018 at a public hospital in Mexico City. Patients aged ≥18 years with metastatic tumors ≤6 weeks from diagnosis were randomized (1:1) to a patient navigation intervention or usual care. Patients randomized to patient navigation received personalized supportive care from a navigator and a multidisciplinary team. Patients randomized to usual care obtained supportive care referrals from treating oncologists. The primary outcome was the implementation of supportive care interventions at 12 weeks. Secondary outcomes included advance directive completion, supportive care needs, and quality of life. RESULTS: One hundred thirty-four patients were randomized: 67 to patient navigation and 67 to usual care. Supportive care interventions were provided to 74% of patients in the patient navigation arm versus 24% in usual care (difference 0.50, 95% confidence interval [CI] 0.34-0.62; p < .0001). In the patient navigation arm, 48% of eligible patients completed advance directives, compared with 0% in usual care (p < .0001). At 12 weeks, patients randomized to patient navigation had less moderate/severe pain (10% vs. 33%; difference 0.23, 95% CI 0.07-0.38; p = .006), without differences in quality of life between arms. CONCLUSION: Patient navigation improves access to early supportive care, advance care planning, and pain for patients with advanced cancer in resource-limited settings. IMPLICATIONS FOR PRACTICE: The early implementation of supportive care in oncology is recommended by international guidelines, but this might be difficult to achieve in resource-limited settings. This randomized clinical trial including 134 Mexican patients with advanced cancer demonstrates that a multidisciplinary patient navigation intervention can improve the early access to supportive and palliative care interventions, increase advance care planning, and reduce symptoms compared with usual oncologist-guided care alone. These results demonstrate that patient navigation represents a potentially useful solution to achieve the adequate implementation of supportive and palliative care in resource-limited settings globally.

Symptom Assessment and Early Access to Supportive and Palliative Care for Patients With Advanced Solid Tumors in Mexico.

BACKGROUND: Early specialized palliative care improves quality of life of patients with advanced cancer, and guidelines encourage its integration into standard oncology care. However, many patients fail to obtain timely palliative/supportive care evaluations, particularly in limited-resource settings. We aimed to determine the proportion of patients with advanced cancer who received an assessment of symptoms and were referred to supportive and palliative care services during the first year after diagnosis in a Mexican hospital. METHODS: Individuals with newly diagnosed advanced solid tumors and 1 year of follow-up at the oncology clinics in the Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran in Mexico City from October 2015 to April 2016 were included in this retrospective study. RESULTS: Seventy-seven patients were included. Forty-two (54.5%) were referred to the various supportive care services during the first year after diagnosis, and 23 (29.8%) were referred to the palliative care clinic. The most commonly assessed symptoms by oncologists were pain (77.9%), anorexia (74.0%), fatigue (68.8%), and nausea (55.8%), while depression/anxiety were evaluated in 10 (12.9%) patients. The oncologist offered to clarify treatment goals in 39 (50.6%) cases and evaluated the understanding of diagnosis/illness and prognosis in 22 (28.5%). CONCLUSION: Palliative and supportive care services were widely underutilized, which may be related to a lack of standardized symptom assessments and poor end-of-life communication. Novel strategies are needed to improve the implementation of tools for systematic symptom assessment and to optimize the integration of supportive care interventions into oncology care in developing countries.

Bilateral Forearm Transplantation in Mexico: 2-Year Outcomes.

BACKGROUND: Patients with proximal forearm and arm transplantation have obtained and/or maintained function of the elbow joint and full active range of motion of the extrinsic muscles of the hand, but with diminished protective sensibility and a lack of good function of the intrinsic muscles. These patients have improved function, as measured by the Disabilities of the Arm, Shoulder and Hand questionnaire. METHODS: We report the case of a 52-year-old man who suffered a high-voltage electrical burn requiring amputation of his upper limbs. He underwent bilateral proximal forearm transplantation in Mexico City in May 2012. RESULTS: At 2-year follow-up, immunosuppressive treatment has not led to metabolic, oncologic, or infectious complications. Keloid scars developed at the graft-recipient interface. There have been 4 acute rejections: the fourth was treated with methylprednisolone, rituximab, and immunoglobulin. Chronic rejection has not been detected. The extrinsic muscles of the wrist and digits have good function. Although the intrinsic muscles demonstrated electrical activity 15 months postoperatively, clinically, they are nonuseful. After 2 years, hand function is sufficient to allow the patient to grasp lightweight and medium-sized objects. The patient's Disabilities of the Arm, Shoulder and Hand questionnaire score improved from 50.00 points to 30.83 points, and his Hand Transplantation Score System rating is good, at 69/73 (right/left) of 100. The patient and his family are very satisfied with the functional and aesthetic outcomes. CONCLUSIONS: Upper arm or proximal forearm transplantation is a reconstructive option for patients who have experienced amputation because of trauma.