What has been the impact of the Traditional Herbal Registration (THR) scheme in the UK on information provided with herbal products bought over the counter?

BACKGROUND: In 2011 there was a strengthening of European Union (EU) legislation on the licencing of herbal products which, in the UK, resulted in the introduction of the Traditional Herbal Registration (THR) scheme. This scheme sets out standards for the safety and quality of herbal medicines and includes the provision of information to the customer on the safe use of the product. The aim of this study is to replicate a survey undertaken in 2011, prior to the implementation of the THR scheme, and evaluate the impact of this scheme on the information provided with herbal products bought over-the-counter. METHODS: We undertook a survey on 5 herbal products commonly available over-the-counter (St John's wort, echinacea, Ginkgo biloba, Asian ginseng, garlic). The information was searched for key safety messages identified by the National Center for Complementary and Integrative Health (NCCIH). We also explored the presence of risk of harm information. RESULTS: We recorded a rise in the number of products registered with the THR scheme (37% in 2016 compared to 7% in 2011). We also identified a reduction in the number of products that did not contain key safety information (75% in 2011 compared to 20% of products obtained in 2016). Risk of harm information was only communicated in products containing a PIL. We identified more products containing frequency of risk of harm information but this was not statistically significant. CONCLUSION: The introduction of the THR scheme appears to be associated with an increase in the provision of information about key safety messages on the safe use of herbal products. However, it is important to note that at least half of the products on the market that are not included in the THR scheme do not contain any information about their safe use; this includes information about precautions, interactions and side effects. The use of NCCIH herbal monographs replicated the methods used in the previous study; we recognise that the use of a different resource might effect the appraisal of the information provided. We also acknowledge that surveying presence of information does not assure that the latter is effectively communicated to patients, for which a close textual analysis would be required. While it is promising that more information is available after the introduction of the THR scheme, the public needs to be informed about ways to optimise safe use of all herbal products.

LINC01013 Is a Determinant of Fibroblast Activation and Encodes a Novel Fibroblast-Activating Micropeptide.

Myocardial fibrosis confers an almost threefold mortality risk in heart disease. There are no prognostic therapies and novel therapeutic targets are needed. Many thousands of unannotated small open reading frames (smORFs) have been identified across the genome with potential to produce micropeptides (< 100 amino acids). We sought to investigate the role of smORFs in myocardial fibroblast activation.Analysis of human cardiac atrial fibroblasts (HCFs) stimulated with profibrotic TGFß1 using RNA sequencing (RNA-Seq) and ribosome profiling (Ribo-Seq) identified long intergenic non-coding RNA LINC01013 as TGFß1 responsive and containing an actively translated smORF. Knockdown of LINC01013 using siRNA reduced expression of profibrotic markers at baseline and blunted their response to TGFß1. In contrast, overexpression of a codon-optimised smORF invoked a profibrotic response comparable to that seen with TGFß1 treatment, whilst FLAG-tagged peptide associated with the mitochondria.Together, these data support a novel LINC01013 smORF micropeptide-mediated mechanism of fibroblast activation. TGFß1 stimulation of atrial fibroblasts induces expression of LINC01013, whose knockdown reduces fibroblast activation. Overexpression of a smORF contained within LINC01013 localises to mitochondria and activates fibroblasts.

Intestinal anastomosis with the biofragmentable anastomosis ring.

BACKGROUND: The fear of anastomotic complications prevents the spread of the use of the biofragmentable anastomosis ring (BAR) in intestinal surgery. PATIENTS AND METHODS: A total of 453 patients underwent intestinal resection and anastomosis with the BAR. RESULTS: In all, 514 anastomoses have been carried out, 424 (83%) in elective settings, and 90 (18%) in emergency. Fifty-one patients had multiple anastomoses. Reoperation was performed in 4 patients (1%) who had a complete anastomotic leakage. In 13 patients (3%), anastomotic leakage was partial, and only 1 patient required reoperation. No postoperative intestinal obstruction occurred. Four patients (1%) developed late anastomotic strictures, which have been treated by endoscopic dilation. CONCLUSIONS: The results of our experience and those of other large clinical series definitely confirm the effectiveness of the BAR method, which seems to be a standard, easy, rapid, and safe technique either in elective or emergency surgery.

[Spontaneous pneumomediastinum: radiologic and CT study]. / Pneumomediastino spontaneo. Studio radiologico e TC.

Pneumomediastinum may be due to various diseases. In young adults without thoracic trauma or pulmonary or mediastinal diseases pneumomediastium is secondary to mild strain or cough. This disease is defined as spontaneous pneumomediastinum or Hamman's syndrome, with a good prognosis, and doesn't need any treatment. X-ray and CT of the chest can provide correct diagnosis and adequate treatment.

[Lateral cysts and fistulas of the neck. Diagnosis and treatment]. / Cisti e fistole laterali del collo. Diagnosi e trattamento.

Lateral neck cysts and fistulae are considered to be a well-defined clinical entity which needs a precise knowledge of the development of the branchial system to have an appropriate and subsequent successful treatment. According to the recent classification cysts of I and II type and fistulae of I, II and III type can be recognized. In the former ultrasonography and Computerized Tomography represent the most appropriate diagnostic tools, while in the latter fistulography is preferred. An elective surgical excision seem to be resolutive in the majority of cases: on the contrary emergency surgery is related to a certain relapse of this pathology. 45 cases of branchial pathology are reported; diagnostic and therapeutic choices are then discussed.

[Complex duodenopancreatic injuries]. / I traumi complessi del blocco duodenopancreatico.

Injuries of the duodenopancreatic region are rare and difficult to diagnose and treat. The related high mortality is mainly due to the presence of associated lesions. Complex traumas (AAST grade IV and V lesions) require difficult surgical treatment with high postoperative morbidity and mortality rates. In a review of 200 pancreaticoduodenectomies performed for pancreatic head traumas the postoperative mortality was 31%. The authors present 6 cases of complex duodenopancreatic traumas, treated from 1995 to 1999. The aetiology was blunt trauma in 5 cases (83%) and a shotgun wound in 1 case (17%). In 3 cases, with a grade V lesion of the pancreatic head, a pancreaticoduodenectomy was performed. A case of a grade IV lesion of the tail of the pancreas was treated with distal splenopancreatectomy. Two cases of grade IV lesions of the third part of the duodenum were submitted to duodenal resection with direct anastomosis. One postoperative death was observed in a patient treated with duodenal resection. The overall mortality was 16%. A pancreatic fistula, which healed spontaneously, was observed in a case of pancreaticoduodenectomy.

[Carcinoma of the splenic flexure]. / Il carcinoma della flessura splenica.

The Authors report their experience in the management of 25 cancers of the splenic flexure corresponding to 4.8% of large bowel cancers overall observed. Twelve patients underwent elective surgery consisting in a left hemicolectomy, which in 1 of the 12 cases required an associated distal splenopancreatectomy. Operative mortality was null, whereas morbidity involved 1 case of anastomotic dehiscence. Thirteen patients presenting with complete obstruction underwent emergency surgery: a two-stage resection with primary colostomy was performed in 5 cases, a sub-total colectomy with one-stage ileo-rectal anastomosis or ileo-sigmoid anastomosis was performed in 8 cases. In this last group of 8 patients mortality rate was 12.5% (1 pt.) and diarrhoea was the most important sequela. On this regard the Authors point out the opportunity to perform an ileo-sigmoidostomy, which reduces the incidence of such complication.

[Respiratory complications in compressive goiters]. / Complicanze respiratorie nei gozzi compressivi.

Authors' experience in respiratory complications of compressive goiter is reviewed. Three cases with typical symptoms, relative therapy and outcome are reported. Appearance of respiratory distress should urge to avoid delay in elective surgery performing. In case of acute respiratory failure, immediate emergency tracheostomy is mandatory, subsequently followed by elective intervention. In case of malignancy, if radical surgery is not possible, tracheostomy is the short and medium-term palliative surgical treatment of choice.

[Diverticulosis of the small intestine. Observations on a complicated case]. / La diverticolosi dell'intestino tenue. Osservazioni su di un caso complicato.

Small bowel diverticula, particularly the jejunal ones, are a rare disease with a poor and vague symptomatology. Sometimes detected by change under X-ray examinations or at surgery, they do not need any surgical treatment: only clinical and X-ray controls are required. Prophylactic resection of symptomatic low jejunal diverticula is controversial: patient's age and status will affect the indication to surgical treatment. Jejunal diverticulosis may generate serious, though not dramatic, symptoms: intestinal obstruction, inflammatory complications, haemorrhage, perforation of the diverticula are the most frequent emergencies which require an immediate surgical procedure. A clinical case is here reported.

[Microbiological and cytological aspects of the aspirate bronchoscopy (author's transl)]. / Aspetti microbiologici e citologicic dei broncoaspirati

The Authors compare by microbiological and cytological aspect the result got by sputum and aspirate at bronchoscopy. They point out that aspirate at bronchoscopy permits a more significant etiological diagnosis by both microbiological or cytological point of view.

Biofragmentable anastomosis ring in emergency surgery.

BACKGROUND: The biofragmentable anastomosis ring (BAR) proved its usefulness in elective bowel surgery. AIMS: To verify the validity of the BAR in restoring bowel continuity in emergency. MATERIAL AND METHODS: The authors retrospectively evaluated the results of 62 intestinal resections and primary anastomoses with the BAR performed in 53 consecutive patients undergoing single-stage surgery for acute abdomen. No patients had either preoperative bowel preparation or intraoperative intestinal lavage. RESULTS: No proximal ileostomy or colostomy was used. A single anastomosis was made in 47 patients, while the remaining 6 patients underwent multiple intestinal resections with primary anastomoses. Forty-nine of the 53 patients had an uneventful recovery. Anastomotic leakage occurred in 2 patients (3.2%) operated on for an obstructing carcinoma of the left colon. One patient was successfully treated with a period of total parenteral nutrition, whereas the other required reoperation for a complete anastomotic leak due to failed closure of the device which was re-inserted successfully. Two patients (3.7%) died postoperatively of myocardial infarction and hepato-renal syndrome. CONCLUSIONS: Although this is a non-randomised trial, these results suggest that the BAR can be employed effectively in the emergency setting, even when single-stage intestinal surgery is performed.

Papillary-cystic tumour of the pancreas. Case report.

A papillary-cystic pancreatic tumour was excised in a 19-year-old girl, who was apparently free from recurrence 20 months later. Despite morphologic indications of malignancy, the prognosis after surgical removal of this uncommon tumour is good. Its origin probably is the epithelial cells of the small pancreatic ducts. The case is described and the literature is reviewed.

[Isolated blunt hepatic traumas: role of emergency CT in therapeutic choice].

INTRODUCTION: The purpose of the study was to establish the role of score-based CT classification of hepatic lesions, peritoneal and retroperitoneal bleeding in the blunt hepatic trauma. MATERIAL AND METHODS: CT examinations of 47 haemodynamically stable patients, with isolated traumatic hepatic lesions were reviewed. CT scans were obtained with a spiral CT (thickness mm 10, pitch of 1) before and after 60 seconds after from intravenous administration of 140 cc of contrast medium at a rate of 2 cc/sec). Eleven out of 47 patients underwent surgery immediately after the CT examination, 2/47 patients in 48 hours; 34/47 patients were treated conservatively with CT follow-up on days 3 and 7, and before dimission discharge. The hepatic lesions, and degree of peritoneal and retroperitoneal haemorrhage were classified using the following scale: 1-5 for the hepatic lesions, in according to the Mirvis classification; 0-3 for peritoneal haemorrhage (0=no haemorrhage, 1=minor mild haemorrhage, 2=moderate haemorrhage, 3=major massive haemorrhage); 0-2 for retroperitoneal haemorrhage (0=no haemorrhage, 1=haemorrhage confined to the anterior pararenal space, 2=haemorrhage in 2 or more retroperitoneal spaces). The score was correlated to the treatment decisions (follow-up or surgery). RESULTS: Based on the hepatic lesion scores, we classified: 4 patients as grade 1 of grade 1, 9 as grade 2, 22 as grade 3, 11 as grade 4, 1 as grade 5; based on peritoneal haemorrhage, 14 patients as grade 0, 9 as grade 1, 8 as grade 2, and 10 as grade 3; based on retroperitoneal haemorrhage, 36 patients as grade 0 of grade 0, 3 as grade 1, and 8 as grade 2. The overall scores of the 13 patients that who underwent surgery were: 6 in 6 patients, 7 in 4 patients, 8, 9, and 10 in 1 patient. DISCUSSION AND CONCLUSIONS: CT is the modality of reference for evaluating traumatic hepatic lesions. The selection of patients for surgery requires an accurate classification and grading of the lesions. The classification of hepatic lesions alone, however, is not sufficient, as it does not take into account peritoneal and retroperitoneal haemorrhage, that which often occurs, and are correlated with the need for exploratory laparotomy. Integrated score-based evaluation of the hepatic lesions, peritoneal and retroperitoneal haemorrhage shows a good correlation with treatment decisions and clinical outcome.