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FDA: Gadolinium retention prompts new GBCA class warning, safety measures
Gadolinium-based contrast agents (GBCAs) used for MRI will now carry a warning regarding their potential retention in the bodies and brains of treated patients, according to the Food and Drug Administration.
The FDA is requiring the new class warning, along with other safety measures, based on evidence showing that trace amounts of gadolinium can be retained in the body for months to years after treatment.
Specifically, the agency will require that patients receiving GBCAs first receive a Medication Guide and that GBCA manufacturers conduct human and animal studies to further assess GBCA safety. At this time, the only known adverse health effect of gadolinium retention is nephrogenic systemic fibrosis, which affects a small subgroup of patients with pre-existing kidney failure. No causal association has been established between gadolinium retention and reported adverse events in those with normal kidney function.
The FDA recommended that health care professionals consider the retention characteristics of GBCAs for patients who may be at higher risk for retention, including those requiring multiple lifetime doses, pregnant women, children, and patients with inflammatory conditions, but stressed that, although repeated GBCA imaging studies should be minimized when possible, they should not be avoided or deferred when they are necessary. In the safety alert, the FDA noted that administration of the GBCAs Dotarem (gadoterate meglumine), Gadavist (gadobutrol), and ProHance (gadoteridol) produce the lowest gadolinium levels in the body, and the three agents leave similar gadolinium levels in the body.
The agency encourages reports of adverse events or side effects related to the use of GBCAs to its MedWatch Safety information and Adverse Event Reporting Program. Reports can be submitted online at www.fda.gov/MedWatch/report or by calling 1-800-332-1088 to request a preaddressed form that can be mailed or faxed to 1-800-FDA-0178.
sworcester@frontlinemedcom.com
Gadolinium-based contrast agents (GBCAs) used for MRI will now carry a warning regarding their potential retention in the bodies and brains of treated patients, according to the Food and Drug Administration.
The FDA is requiring the new class warning, along with other safety measures, based on evidence showing that trace amounts of gadolinium can be retained in the body for months to years after treatment.
Specifically, the agency will require that patients receiving GBCAs first receive a Medication Guide and that GBCA manufacturers conduct human and animal studies to further assess GBCA safety. At this time, the only known adverse health effect of gadolinium retention is nephrogenic systemic fibrosis, which affects a small subgroup of patients with pre-existing kidney failure. No causal association has been established between gadolinium retention and reported adverse events in those with normal kidney function.
The FDA recommended that health care professionals consider the retention characteristics of GBCAs for patients who may be at higher risk for retention, including those requiring multiple lifetime doses, pregnant women, children, and patients with inflammatory conditions, but stressed that, although repeated GBCA imaging studies should be minimized when possible, they should not be avoided or deferred when they are necessary. In the safety alert, the FDA noted that administration of the GBCAs Dotarem (gadoterate meglumine), Gadavist (gadobutrol), and ProHance (gadoteridol) produce the lowest gadolinium levels in the body, and the three agents leave similar gadolinium levels in the body.
The agency encourages reports of adverse events or side effects related to the use of GBCAs to its MedWatch Safety information and Adverse Event Reporting Program. Reports can be submitted online at www.fda.gov/MedWatch/report or by calling 1-800-332-1088 to request a preaddressed form that can be mailed or faxed to 1-800-FDA-0178.
sworcester@frontlinemedcom.com
Gadolinium-based contrast agents (GBCAs) used for MRI will now carry a warning regarding their potential retention in the bodies and brains of treated patients, according to the Food and Drug Administration.
The FDA is requiring the new class warning, along with other safety measures, based on evidence showing that trace amounts of gadolinium can be retained in the body for months to years after treatment.
Specifically, the agency will require that patients receiving GBCAs first receive a Medication Guide and that GBCA manufacturers conduct human and animal studies to further assess GBCA safety. At this time, the only known adverse health effect of gadolinium retention is nephrogenic systemic fibrosis, which affects a small subgroup of patients with pre-existing kidney failure. No causal association has been established between gadolinium retention and reported adverse events in those with normal kidney function.
The FDA recommended that health care professionals consider the retention characteristics of GBCAs for patients who may be at higher risk for retention, including those requiring multiple lifetime doses, pregnant women, children, and patients with inflammatory conditions, but stressed that, although repeated GBCA imaging studies should be minimized when possible, they should not be avoided or deferred when they are necessary. In the safety alert, the FDA noted that administration of the GBCAs Dotarem (gadoterate meglumine), Gadavist (gadobutrol), and ProHance (gadoteridol) produce the lowest gadolinium levels in the body, and the three agents leave similar gadolinium levels in the body.
The agency encourages reports of adverse events or side effects related to the use of GBCAs to its MedWatch Safety information and Adverse Event Reporting Program. Reports can be submitted online at www.fda.gov/MedWatch/report or by calling 1-800-332-1088 to request a preaddressed form that can be mailed or faxed to 1-800-FDA-0178.
sworcester@frontlinemedcom.com
Radiofrequency ablation improves stent patency in malignant biliary strictures
In patients with malignant biliary strictures, radiofrequency ablation may improve stent patency and prolong survival, according to results of a recent meta-analysis.
Radiofrequency ablation was also safe and well tolerated. The report appears in Gastrointestinal Endoscopy (2017. doi: 10.1016/j.gie.2017.10.029).
Although the data to date are limited and mostly observational, radiofrequency ablation “may be a promising adjuvant therapy in patients with malignant biliary obstruction who otherwise have dismal outcomes with current standard of therapy,” wrote Aijaz Ahmed Sofi, MD, of the department of gastroenterology, Arizona Center for Digestive Health, Gilbert, and coauthors.
Use of radiofrequency ablation is thought to improve the patency of biliary stents placed as a palliative measure in patients with unresectable malignant biliary strictures. However, several studies evaluating this and other endpoints have produced “variable results,” the authors said in the report.
In a comprehensive literature search, Dr. Sofi and colleagues identified nine studies including 505 patients. Only one of the studies was randomized and controlled, and results from it were preliminary, they noted.
Combined results showed a 50.6-day pooled weighted mean difference in stent patency (95% confidence interval, 32.83-68.48) in favor of radiofrequency ablation, according to reported data. In addition, there was a significant difference in survival favoring use of radiofrequency ablation (hazard ratio, 1.395; 95% confidence interval, 1.145-1.7; P less than .001).
While there was no difference between groups in risk of cholangitis, pancreatitis, hemobilia, and acute cholecystitis, abdominal pain after the procedure was more frequent in the radiofrequency ablation group (31% vs. 20%, P = .003).
This is the first systematic review and meta-analysis evaluating radiofrequency ablation as an adjuvant therapy in patients who receive biliary stents for malignant biliary obstruction, according to the investigators.
Despite the findings, Dr. Sofi and colleagues were careful to emphasize the limitations of the analysis, writing that it provides “very low quality evidence” in favor of radiofrequency ablation therapy for management of malignant biliary strictures.
“The results of currently ongoing controlled studies examining the role of RFA [radiofrequency ablation] in malignant biliary obstruction are keenly awaited,” they wrote.
Dr. Sofi and colleagues reported no potential conflicts of interest associated with the study.
In patients with malignant biliary strictures, radiofrequency ablation may improve stent patency and prolong survival, according to results of a recent meta-analysis.
Radiofrequency ablation was also safe and well tolerated. The report appears in Gastrointestinal Endoscopy (2017. doi: 10.1016/j.gie.2017.10.029).
Although the data to date are limited and mostly observational, radiofrequency ablation “may be a promising adjuvant therapy in patients with malignant biliary obstruction who otherwise have dismal outcomes with current standard of therapy,” wrote Aijaz Ahmed Sofi, MD, of the department of gastroenterology, Arizona Center for Digestive Health, Gilbert, and coauthors.
Use of radiofrequency ablation is thought to improve the patency of biliary stents placed as a palliative measure in patients with unresectable malignant biliary strictures. However, several studies evaluating this and other endpoints have produced “variable results,” the authors said in the report.
In a comprehensive literature search, Dr. Sofi and colleagues identified nine studies including 505 patients. Only one of the studies was randomized and controlled, and results from it were preliminary, they noted.
Combined results showed a 50.6-day pooled weighted mean difference in stent patency (95% confidence interval, 32.83-68.48) in favor of radiofrequency ablation, according to reported data. In addition, there was a significant difference in survival favoring use of radiofrequency ablation (hazard ratio, 1.395; 95% confidence interval, 1.145-1.7; P less than .001).
While there was no difference between groups in risk of cholangitis, pancreatitis, hemobilia, and acute cholecystitis, abdominal pain after the procedure was more frequent in the radiofrequency ablation group (31% vs. 20%, P = .003).
This is the first systematic review and meta-analysis evaluating radiofrequency ablation as an adjuvant therapy in patients who receive biliary stents for malignant biliary obstruction, according to the investigators.
Despite the findings, Dr. Sofi and colleagues were careful to emphasize the limitations of the analysis, writing that it provides “very low quality evidence” in favor of radiofrequency ablation therapy for management of malignant biliary strictures.
“The results of currently ongoing controlled studies examining the role of RFA [radiofrequency ablation] in malignant biliary obstruction are keenly awaited,” they wrote.
Dr. Sofi and colleagues reported no potential conflicts of interest associated with the study.
In patients with malignant biliary strictures, radiofrequency ablation may improve stent patency and prolong survival, according to results of a recent meta-analysis.
Radiofrequency ablation was also safe and well tolerated. The report appears in Gastrointestinal Endoscopy (2017. doi: 10.1016/j.gie.2017.10.029).
Although the data to date are limited and mostly observational, radiofrequency ablation “may be a promising adjuvant therapy in patients with malignant biliary obstruction who otherwise have dismal outcomes with current standard of therapy,” wrote Aijaz Ahmed Sofi, MD, of the department of gastroenterology, Arizona Center for Digestive Health, Gilbert, and coauthors.
Use of radiofrequency ablation is thought to improve the patency of biliary stents placed as a palliative measure in patients with unresectable malignant biliary strictures. However, several studies evaluating this and other endpoints have produced “variable results,” the authors said in the report.
In a comprehensive literature search, Dr. Sofi and colleagues identified nine studies including 505 patients. Only one of the studies was randomized and controlled, and results from it were preliminary, they noted.
Combined results showed a 50.6-day pooled weighted mean difference in stent patency (95% confidence interval, 32.83-68.48) in favor of radiofrequency ablation, according to reported data. In addition, there was a significant difference in survival favoring use of radiofrequency ablation (hazard ratio, 1.395; 95% confidence interval, 1.145-1.7; P less than .001).
While there was no difference between groups in risk of cholangitis, pancreatitis, hemobilia, and acute cholecystitis, abdominal pain after the procedure was more frequent in the radiofrequency ablation group (31% vs. 20%, P = .003).
This is the first systematic review and meta-analysis evaluating radiofrequency ablation as an adjuvant therapy in patients who receive biliary stents for malignant biliary obstruction, according to the investigators.
Despite the findings, Dr. Sofi and colleagues were careful to emphasize the limitations of the analysis, writing that it provides “very low quality evidence” in favor of radiofrequency ablation therapy for management of malignant biliary strictures.
“The results of currently ongoing controlled studies examining the role of RFA [radiofrequency ablation] in malignant biliary obstruction are keenly awaited,” they wrote.
Dr. Sofi and colleagues reported no potential conflicts of interest associated with the study.
FROM GASTROINTESTINAL ENDOSCOPY
Key clinical point: Although data to date are limited and mostly observational, radiofrequency ablation appears to improve stent patency and may prolong survival in patients with malignant biliary strictures.
Major finding: There was a significant difference in survival (P less than .001) and 50.6-day pooled weighted mean difference in stent patency (95% CI, 32.83-68.48) in favor of radiofrequency ablation.
Data source: A meta-analysis of 505 patients from nine studies that were identified through a comprehensive literature search.
Disclosures: There was no funding source for the study. The authors reported no potential conflicts of interest.
VIDEO: Endoscopy surpasses surgery for acute necrotizing pancreatitis
ORLANDO – An endoscopic approach to treatment of acute necrotizing pancreatitis was substantially safer than was minimally invasive surgical treatment in a randomized study of 66 patients.
Performing drainage and necrosectomy endoscopically in 34 patients with necrotizing pancreatitis that was symptomatic, infected, or both resulted in a 12% rate of major adverse events over the 3 months following intervention compared with a 38% rate among 32 similar patients who underwent laparoscopic drainage followed by either internal debridement or video-assisted retroperitoneal debridement, Ji Young Bang, MD, said at the World Congress of Gastroenterology at ACG 2017.
This statistically significant reduction in the study’s primary endpoint was driven primarily by a major reduction in the incidence of pancreaticocutaneous fistula, which occurred in none of the endoscopy patients and in eight (25%) of the surgery patients, and a smaller reduction in enterocutaneous fistula, which occurred in none of the endoscopy patients and in four (13%) of the patients treated surgically, said Dr. Bang, a gastroenterologist at the Center for Interventional Endoscopy at Florida Hospital, Orlando.
Based on these results, the endoscopic approach “is the treatment of the future,” Dr. Bang said in a video interview. Although the randomized study had a modest number of patients, it was adequately powered to address the hypothesis that endoscopy caused fewer major adverse events than did minimally invasive surgery, and hence the findings should have “an important clinical impact” on the choice of endoscopy or a minimally invasive surgical approach. But Dr. Bang also stressed that a successful endoscopic approach as obtained in this study requires treatment at a center that can offer multidisciplinary expertise from gastrointestinal endoscopists, surgeons, and radiologists, as well as infectious disease physicians, to minimize infections.
Prior to this study, results from the Pancreatitis, Endoscopic Transgastric vs Primary Necrosectomy in Patients With Infected Necrosis (PENGUIN) study run in the Netherlands had also shown significantly fewer adverse events with endoscopic treatment compared with laparoscopic surgery in 20 randomized patients (JAMA. 2012 Mar 14;307[10]:1053-61).
The study reported by Dr. Bang, the Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) trial, enrolled patients with an average necrotic collection size of about 11 cm. The average age of the patients was 59 years. Nearly half of the patients had confirmed infected necrosis. More than 90% had American Society of Anesthesiologists class III or IV disease, and about half had systemic inflammatory response syndrome. All patients had disease that was amenable to both the endoscopic and minimally invasive surgical approaches.
The study’s primary endpoint included several other adverse events in addition to fistulas during 3-month follow-up: death, new-onset organ failure or multiple systemic dysfunction, visceral perforation, and intra-abdominal bleeding. The incidence of each of these outcomes was about the same in the two study arms.
The results also showed that endoscopy was significantly better than surgery for several other secondary outcomes, including new-onset systemic inflammatory response syndrome as well as the prevalence of this complication 3 days after intervention (21% compared with 66%), days in the ICU, average total procedure and hospitalization cost ($76,000 compared with $117,000), and physical quality of life 3 months after treatment. For all other measured outcomes the endoscopic approach and surgical approach produced similar outcomes, and no outcome measured showed that endoscopy was significantly inferior to surgery, Dr. Bang reported.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
ORLANDO – An endoscopic approach to treatment of acute necrotizing pancreatitis was substantially safer than was minimally invasive surgical treatment in a randomized study of 66 patients.
Performing drainage and necrosectomy endoscopically in 34 patients with necrotizing pancreatitis that was symptomatic, infected, or both resulted in a 12% rate of major adverse events over the 3 months following intervention compared with a 38% rate among 32 similar patients who underwent laparoscopic drainage followed by either internal debridement or video-assisted retroperitoneal debridement, Ji Young Bang, MD, said at the World Congress of Gastroenterology at ACG 2017.
This statistically significant reduction in the study’s primary endpoint was driven primarily by a major reduction in the incidence of pancreaticocutaneous fistula, which occurred in none of the endoscopy patients and in eight (25%) of the surgery patients, and a smaller reduction in enterocutaneous fistula, which occurred in none of the endoscopy patients and in four (13%) of the patients treated surgically, said Dr. Bang, a gastroenterologist at the Center for Interventional Endoscopy at Florida Hospital, Orlando.
Based on these results, the endoscopic approach “is the treatment of the future,” Dr. Bang said in a video interview. Although the randomized study had a modest number of patients, it was adequately powered to address the hypothesis that endoscopy caused fewer major adverse events than did minimally invasive surgery, and hence the findings should have “an important clinical impact” on the choice of endoscopy or a minimally invasive surgical approach. But Dr. Bang also stressed that a successful endoscopic approach as obtained in this study requires treatment at a center that can offer multidisciplinary expertise from gastrointestinal endoscopists, surgeons, and radiologists, as well as infectious disease physicians, to minimize infections.
Prior to this study, results from the Pancreatitis, Endoscopic Transgastric vs Primary Necrosectomy in Patients With Infected Necrosis (PENGUIN) study run in the Netherlands had also shown significantly fewer adverse events with endoscopic treatment compared with laparoscopic surgery in 20 randomized patients (JAMA. 2012 Mar 14;307[10]:1053-61).
The study reported by Dr. Bang, the Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) trial, enrolled patients with an average necrotic collection size of about 11 cm. The average age of the patients was 59 years. Nearly half of the patients had confirmed infected necrosis. More than 90% had American Society of Anesthesiologists class III or IV disease, and about half had systemic inflammatory response syndrome. All patients had disease that was amenable to both the endoscopic and minimally invasive surgical approaches.
The study’s primary endpoint included several other adverse events in addition to fistulas during 3-month follow-up: death, new-onset organ failure or multiple systemic dysfunction, visceral perforation, and intra-abdominal bleeding. The incidence of each of these outcomes was about the same in the two study arms.
The results also showed that endoscopy was significantly better than surgery for several other secondary outcomes, including new-onset systemic inflammatory response syndrome as well as the prevalence of this complication 3 days after intervention (21% compared with 66%), days in the ICU, average total procedure and hospitalization cost ($76,000 compared with $117,000), and physical quality of life 3 months after treatment. For all other measured outcomes the endoscopic approach and surgical approach produced similar outcomes, and no outcome measured showed that endoscopy was significantly inferior to surgery, Dr. Bang reported.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
ORLANDO – An endoscopic approach to treatment of acute necrotizing pancreatitis was substantially safer than was minimally invasive surgical treatment in a randomized study of 66 patients.
Performing drainage and necrosectomy endoscopically in 34 patients with necrotizing pancreatitis that was symptomatic, infected, or both resulted in a 12% rate of major adverse events over the 3 months following intervention compared with a 38% rate among 32 similar patients who underwent laparoscopic drainage followed by either internal debridement or video-assisted retroperitoneal debridement, Ji Young Bang, MD, said at the World Congress of Gastroenterology at ACG 2017.
This statistically significant reduction in the study’s primary endpoint was driven primarily by a major reduction in the incidence of pancreaticocutaneous fistula, which occurred in none of the endoscopy patients and in eight (25%) of the surgery patients, and a smaller reduction in enterocutaneous fistula, which occurred in none of the endoscopy patients and in four (13%) of the patients treated surgically, said Dr. Bang, a gastroenterologist at the Center for Interventional Endoscopy at Florida Hospital, Orlando.
Based on these results, the endoscopic approach “is the treatment of the future,” Dr. Bang said in a video interview. Although the randomized study had a modest number of patients, it was adequately powered to address the hypothesis that endoscopy caused fewer major adverse events than did minimally invasive surgery, and hence the findings should have “an important clinical impact” on the choice of endoscopy or a minimally invasive surgical approach. But Dr. Bang also stressed that a successful endoscopic approach as obtained in this study requires treatment at a center that can offer multidisciplinary expertise from gastrointestinal endoscopists, surgeons, and radiologists, as well as infectious disease physicians, to minimize infections.
Prior to this study, results from the Pancreatitis, Endoscopic Transgastric vs Primary Necrosectomy in Patients With Infected Necrosis (PENGUIN) study run in the Netherlands had also shown significantly fewer adverse events with endoscopic treatment compared with laparoscopic surgery in 20 randomized patients (JAMA. 2012 Mar 14;307[10]:1053-61).
The study reported by Dr. Bang, the Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) trial, enrolled patients with an average necrotic collection size of about 11 cm. The average age of the patients was 59 years. Nearly half of the patients had confirmed infected necrosis. More than 90% had American Society of Anesthesiologists class III or IV disease, and about half had systemic inflammatory response syndrome. All patients had disease that was amenable to both the endoscopic and minimally invasive surgical approaches.
The study’s primary endpoint included several other adverse events in addition to fistulas during 3-month follow-up: death, new-onset organ failure or multiple systemic dysfunction, visceral perforation, and intra-abdominal bleeding. The incidence of each of these outcomes was about the same in the two study arms.
The results also showed that endoscopy was significantly better than surgery for several other secondary outcomes, including new-onset systemic inflammatory response syndrome as well as the prevalence of this complication 3 days after intervention (21% compared with 66%), days in the ICU, average total procedure and hospitalization cost ($76,000 compared with $117,000), and physical quality of life 3 months after treatment. For all other measured outcomes the endoscopic approach and surgical approach produced similar outcomes, and no outcome measured showed that endoscopy was significantly inferior to surgery, Dr. Bang reported.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
AT THE WORLD CONGRESS OF GASTROENTEROLOGY
Key clinical point:
Major finding: Major adverse events occurred in 12% of patients treated endoscopically and in 38% of patients treated surgically.
Data source: MISER, a multicenter randomized study of 66 evaluable patients.
Disclosures: MISER received no commercial funding. Dr. Bang had no disclosures.
Better care reduces time to successful refeeding in acute pancreatitis
Enhanced recovery approaches were safe and effective at promoting earlier restoration of gut function in acute pancreatitis patients, according to a study presented at the World Congress of Gastroenterology at ACG 2017.
Patients recruited for the trial were admitted directly from an emergency department and received either enhanced care consisting of patient-directed oral intake, early ambulation, and nonopioid analgesia or received normal care consisting of opioid analgesia, physician-directed diet, and nursing parameters, Elizabeth Dong, MD, of the Kaiser Permanente Los Angeles Medical Center and her associates said.
Among the 46 patients included in the study, 61% had an etiology of gallstones, 15% had an etiology of alcohol, 13% had hyperglyceridemia, and 11% had a different etiology. Median age was 53.1 years, Dr. Dong and her associates noted.
Time to successful oral refeeding, the primary study endpoint, was significantly reduced in the enhanced treatment group, with a median time of 13.8 hours, compared with the normal treatment group, in which median time to oral refeeding was 124.8 hours. In addition, patients in the enhanced care group had a mean pancreatitis activity score of 43.5 after 48-72 hours, while patients in the control group had a mean score of 72.1.
Length of stay and frequency of 30-day readmission did not differ significantly between study groups.
The study was not funded by industry grants, and no disclosures were reported.
Enhanced recovery approaches were safe and effective at promoting earlier restoration of gut function in acute pancreatitis patients, according to a study presented at the World Congress of Gastroenterology at ACG 2017.
Patients recruited for the trial were admitted directly from an emergency department and received either enhanced care consisting of patient-directed oral intake, early ambulation, and nonopioid analgesia or received normal care consisting of opioid analgesia, physician-directed diet, and nursing parameters, Elizabeth Dong, MD, of the Kaiser Permanente Los Angeles Medical Center and her associates said.
Among the 46 patients included in the study, 61% had an etiology of gallstones, 15% had an etiology of alcohol, 13% had hyperglyceridemia, and 11% had a different etiology. Median age was 53.1 years, Dr. Dong and her associates noted.
Time to successful oral refeeding, the primary study endpoint, was significantly reduced in the enhanced treatment group, with a median time of 13.8 hours, compared with the normal treatment group, in which median time to oral refeeding was 124.8 hours. In addition, patients in the enhanced care group had a mean pancreatitis activity score of 43.5 after 48-72 hours, while patients in the control group had a mean score of 72.1.
Length of stay and frequency of 30-day readmission did not differ significantly between study groups.
The study was not funded by industry grants, and no disclosures were reported.
Enhanced recovery approaches were safe and effective at promoting earlier restoration of gut function in acute pancreatitis patients, according to a study presented at the World Congress of Gastroenterology at ACG 2017.
Patients recruited for the trial were admitted directly from an emergency department and received either enhanced care consisting of patient-directed oral intake, early ambulation, and nonopioid analgesia or received normal care consisting of opioid analgesia, physician-directed diet, and nursing parameters, Elizabeth Dong, MD, of the Kaiser Permanente Los Angeles Medical Center and her associates said.
Among the 46 patients included in the study, 61% had an etiology of gallstones, 15% had an etiology of alcohol, 13% had hyperglyceridemia, and 11% had a different etiology. Median age was 53.1 years, Dr. Dong and her associates noted.
Time to successful oral refeeding, the primary study endpoint, was significantly reduced in the enhanced treatment group, with a median time of 13.8 hours, compared with the normal treatment group, in which median time to oral refeeding was 124.8 hours. In addition, patients in the enhanced care group had a mean pancreatitis activity score of 43.5 after 48-72 hours, while patients in the control group had a mean score of 72.1.
Length of stay and frequency of 30-day readmission did not differ significantly between study groups.
The study was not funded by industry grants, and no disclosures were reported.
FROM WORLD CONGRESS OF GASTROENTEROLOGY
Key clinical point:
Major finding: Median time to successful oral refeeding was more than 4 days faster in patients who received enhanced care.
Data source: A pilot single-blind, randomized, controlled trial of 46 patients admitted from an emergency department between July 2016 and April 2017.
Disclosures: The study was not funded by industry grants, and no disclosures were reported.
PBC linked to low BMD, increased risk of osteoporosis
Patients with primary biliary cholangitis (PBC) have lower lumbar spine and hip bone mineral density (BMD) and are at an increased risk of osteoporosis and fracture, according to Junyu Fan, MD, and associates.
In a meta-analysis of 210 potentially relevant articles, only 8 met the study’s criteria. Of those, five studies were pooled and the overall relationship between PBC and osteoporosis risk was assessed. Results found a significant association between PBC (n = 504) and the prevalence of osteoporosis (P = .01), compared with the control group (n = 2,052).
The study additionally examined possible connection between PBC and bone fractures; more fracture events were reported in PBC patients (n = 929) than in controls (n = 8,699; P less than .00001). It is noted that there was no publication bias (P = .476).
“Further clinical management, follow-up, and surveillance issues should be addressed with caution,” researchers concluded. “Given the limited number of studies included, more high-quality studies will be required to determine the mechanisms underpinning the relationship between PBC and osteoporosis risk.”
Find the full study in Clinical Rheumatology (2017. doi: 10.1007/s10067-017-3844-x).
Patients with primary biliary cholangitis (PBC) have lower lumbar spine and hip bone mineral density (BMD) and are at an increased risk of osteoporosis and fracture, according to Junyu Fan, MD, and associates.
In a meta-analysis of 210 potentially relevant articles, only 8 met the study’s criteria. Of those, five studies were pooled and the overall relationship between PBC and osteoporosis risk was assessed. Results found a significant association between PBC (n = 504) and the prevalence of osteoporosis (P = .01), compared with the control group (n = 2,052).
The study additionally examined possible connection between PBC and bone fractures; more fracture events were reported in PBC patients (n = 929) than in controls (n = 8,699; P less than .00001). It is noted that there was no publication bias (P = .476).
“Further clinical management, follow-up, and surveillance issues should be addressed with caution,” researchers concluded. “Given the limited number of studies included, more high-quality studies will be required to determine the mechanisms underpinning the relationship between PBC and osteoporosis risk.”
Find the full study in Clinical Rheumatology (2017. doi: 10.1007/s10067-017-3844-x).
Patients with primary biliary cholangitis (PBC) have lower lumbar spine and hip bone mineral density (BMD) and are at an increased risk of osteoporosis and fracture, according to Junyu Fan, MD, and associates.
In a meta-analysis of 210 potentially relevant articles, only 8 met the study’s criteria. Of those, five studies were pooled and the overall relationship between PBC and osteoporosis risk was assessed. Results found a significant association between PBC (n = 504) and the prevalence of osteoporosis (P = .01), compared with the control group (n = 2,052).
The study additionally examined possible connection between PBC and bone fractures; more fracture events were reported in PBC patients (n = 929) than in controls (n = 8,699; P less than .00001). It is noted that there was no publication bias (P = .476).
“Further clinical management, follow-up, and surveillance issues should be addressed with caution,” researchers concluded. “Given the limited number of studies included, more high-quality studies will be required to determine the mechanisms underpinning the relationship between PBC and osteoporosis risk.”
Find the full study in Clinical Rheumatology (2017. doi: 10.1007/s10067-017-3844-x).
FROM CLINICAL RHEUMATOLOGY
Consider PBC in diagnosing hepatobiliary disorders in UC patients
While primary sclerosing cholangitis (PSC) is the most common hepatobiliary disorder associated with ulcerative colitis, primary biliary cholangitis (PBC) should not be forgotten, according to Erietta Polychronopoulou, MD, and her associates.
In two case studies, a 67-year-old woman and a 71-year-old man presented with long-standing cases of asymptomatic elevation of cholestatic enzymes. Both patients had long histories of ulcerative colitis, but both were in remission. Both patients had previous clinical diagnoses of either small duct PSC or drug-induced liver injury. Both patients denied drug use, and imaging studies revealed nothing in either patient.
In testing for hepatobiliary disorders, both patients showed high titers of antimitochondrial antibodies, the hallmark of PBC. Despite the asymptomatic nature of the PBC, both patients were treated with 13 mg/kg per day ursodeoxycholic acid and have remained stable for 17 and 18 months, respectively.
“The relationship of PBC with UC [ulcerative colitis] remains obscure as there are few reported cases regarding the combined presentation of these diseases. Although the pathogenesis of either disease has not yet been completely clarified, environmental and genetic factors are considered important in the susceptibility to both diseases, suggesting that the two diseases may share common immunopathogenetic pathways,” the investigators noted.
Find the full report in BMJ Case Reports (2017 Sep 25. doi: 10.1136/bcr-2017-220824).
While primary sclerosing cholangitis (PSC) is the most common hepatobiliary disorder associated with ulcerative colitis, primary biliary cholangitis (PBC) should not be forgotten, according to Erietta Polychronopoulou, MD, and her associates.
In two case studies, a 67-year-old woman and a 71-year-old man presented with long-standing cases of asymptomatic elevation of cholestatic enzymes. Both patients had long histories of ulcerative colitis, but both were in remission. Both patients had previous clinical diagnoses of either small duct PSC or drug-induced liver injury. Both patients denied drug use, and imaging studies revealed nothing in either patient.
In testing for hepatobiliary disorders, both patients showed high titers of antimitochondrial antibodies, the hallmark of PBC. Despite the asymptomatic nature of the PBC, both patients were treated with 13 mg/kg per day ursodeoxycholic acid and have remained stable for 17 and 18 months, respectively.
“The relationship of PBC with UC [ulcerative colitis] remains obscure as there are few reported cases regarding the combined presentation of these diseases. Although the pathogenesis of either disease has not yet been completely clarified, environmental and genetic factors are considered important in the susceptibility to both diseases, suggesting that the two diseases may share common immunopathogenetic pathways,” the investigators noted.
Find the full report in BMJ Case Reports (2017 Sep 25. doi: 10.1136/bcr-2017-220824).
While primary sclerosing cholangitis (PSC) is the most common hepatobiliary disorder associated with ulcerative colitis, primary biliary cholangitis (PBC) should not be forgotten, according to Erietta Polychronopoulou, MD, and her associates.
In two case studies, a 67-year-old woman and a 71-year-old man presented with long-standing cases of asymptomatic elevation of cholestatic enzymes. Both patients had long histories of ulcerative colitis, but both were in remission. Both patients had previous clinical diagnoses of either small duct PSC or drug-induced liver injury. Both patients denied drug use, and imaging studies revealed nothing in either patient.
In testing for hepatobiliary disorders, both patients showed high titers of antimitochondrial antibodies, the hallmark of PBC. Despite the asymptomatic nature of the PBC, both patients were treated with 13 mg/kg per day ursodeoxycholic acid and have remained stable for 17 and 18 months, respectively.
“The relationship of PBC with UC [ulcerative colitis] remains obscure as there are few reported cases regarding the combined presentation of these diseases. Although the pathogenesis of either disease has not yet been completely clarified, environmental and genetic factors are considered important in the susceptibility to both diseases, suggesting that the two diseases may share common immunopathogenetic pathways,” the investigators noted.
Find the full report in BMJ Case Reports (2017 Sep 25. doi: 10.1136/bcr-2017-220824).
FROM BMJ CASE REPORTS
The biliary tree and pancreas: An overview
The session titled “The biliary tree and pancreas” provided an overview of the most important pancreaticobiliary diseases, allowing experts to delineate their approaches to challenging aspects of these conditions.
Timothy Gardner, MD, MS, focused on the management and treatment of sequelae in patients with acute pancreatitis. He provided support for the use of lactated Ringer’s as the fluid of choice, cautioning against over-resuscitation. He advised early oral feeds, without clear preference for nasogastric or nasojejunal administration. Dr. Gardner emphasized the importance of classifying type of fluid collection to optimize clinical decision making. Endoscopic techniques appear to be safer and as efficacious as surgical approaches. Regarding thrombosis, anticoagulation was recommended unless an absolute contraindication exists. He also recommended addressing symptomatic ductal disruptions.
Douglas Adler, MD, AGAF, provided pointers on distinguishing between malignant and benign biliary strictures. Ruling out a malignant stricture entails use of multiple diagnostic modalities to image and to sample abnormalities, such as a dominant stricture in primary sclerosing cholangitis. Fluorescence in situ hybridization (FISH) and cholangioscopy are fairly widely used, while other techniques such as confocal laser endomicroscopy are used less frequently. Benign biliary strictures occur frequently in the liver transplant population, both anastomotic and nonanastomotic. Benign biliary strictures may also occur in chronic pancreatitis; importantly, these may mimic pancreatic cancer.
During my presentation, we focused on several aspects of pancreaticobiliary neoplasia. We reviewed the multiple genetic syndromes such as Peutz-Jeghers syndrome, hereditary pancreatitis, and Lynch syndrome, all of which confer increased risk for pancreatic cancer. Endoscopic ultrasound guidance and adjunctive techniques (e.g., elastography) may improve imaging in the pancreas and improve targeting of biopsies. Needle-based confocal laser endomicroscopy is also available to provide real time cellular data, improving our ability to accurately diagnose and differentiate pancreatic cystic neoplasms. Endoscopic ultrasound–guided needle injection and other therapeutic techniques allow endoscopists to intervene therapeutically. Accurate management of pancreatic cysts depends largely on the accurate identification of mucinous cystic neoplasms. Recent guidelines delineate high-risk stigmata and worrisome features of branch-duct intraductal papillary mucinous neoplasm. We also reviewed less common neoplasms such as pancreatic neuroendocrine tumors and biliary neoplasms.
Dr. Kim is an assistant professor of gastroenterology at Mount Sinai Hospital, acting director of endoscopy, and director of endoscopic ultrasound at Mount Sinai Hospital, New York. This is a summary provided by the moderator of one of the AGA Postgraduate Courses held at DDW 2017.
The session titled “The biliary tree and pancreas” provided an overview of the most important pancreaticobiliary diseases, allowing experts to delineate their approaches to challenging aspects of these conditions.
Timothy Gardner, MD, MS, focused on the management and treatment of sequelae in patients with acute pancreatitis. He provided support for the use of lactated Ringer’s as the fluid of choice, cautioning against over-resuscitation. He advised early oral feeds, without clear preference for nasogastric or nasojejunal administration. Dr. Gardner emphasized the importance of classifying type of fluid collection to optimize clinical decision making. Endoscopic techniques appear to be safer and as efficacious as surgical approaches. Regarding thrombosis, anticoagulation was recommended unless an absolute contraindication exists. He also recommended addressing symptomatic ductal disruptions.
Douglas Adler, MD, AGAF, provided pointers on distinguishing between malignant and benign biliary strictures. Ruling out a malignant stricture entails use of multiple diagnostic modalities to image and to sample abnormalities, such as a dominant stricture in primary sclerosing cholangitis. Fluorescence in situ hybridization (FISH) and cholangioscopy are fairly widely used, while other techniques such as confocal laser endomicroscopy are used less frequently. Benign biliary strictures occur frequently in the liver transplant population, both anastomotic and nonanastomotic. Benign biliary strictures may also occur in chronic pancreatitis; importantly, these may mimic pancreatic cancer.
During my presentation, we focused on several aspects of pancreaticobiliary neoplasia. We reviewed the multiple genetic syndromes such as Peutz-Jeghers syndrome, hereditary pancreatitis, and Lynch syndrome, all of which confer increased risk for pancreatic cancer. Endoscopic ultrasound guidance and adjunctive techniques (e.g., elastography) may improve imaging in the pancreas and improve targeting of biopsies. Needle-based confocal laser endomicroscopy is also available to provide real time cellular data, improving our ability to accurately diagnose and differentiate pancreatic cystic neoplasms. Endoscopic ultrasound–guided needle injection and other therapeutic techniques allow endoscopists to intervene therapeutically. Accurate management of pancreatic cysts depends largely on the accurate identification of mucinous cystic neoplasms. Recent guidelines delineate high-risk stigmata and worrisome features of branch-duct intraductal papillary mucinous neoplasm. We also reviewed less common neoplasms such as pancreatic neuroendocrine tumors and biliary neoplasms.
Dr. Kim is an assistant professor of gastroenterology at Mount Sinai Hospital, acting director of endoscopy, and director of endoscopic ultrasound at Mount Sinai Hospital, New York. This is a summary provided by the moderator of one of the AGA Postgraduate Courses held at DDW 2017.
The session titled “The biliary tree and pancreas” provided an overview of the most important pancreaticobiliary diseases, allowing experts to delineate their approaches to challenging aspects of these conditions.
Timothy Gardner, MD, MS, focused on the management and treatment of sequelae in patients with acute pancreatitis. He provided support for the use of lactated Ringer’s as the fluid of choice, cautioning against over-resuscitation. He advised early oral feeds, without clear preference for nasogastric or nasojejunal administration. Dr. Gardner emphasized the importance of classifying type of fluid collection to optimize clinical decision making. Endoscopic techniques appear to be safer and as efficacious as surgical approaches. Regarding thrombosis, anticoagulation was recommended unless an absolute contraindication exists. He also recommended addressing symptomatic ductal disruptions.
Douglas Adler, MD, AGAF, provided pointers on distinguishing between malignant and benign biliary strictures. Ruling out a malignant stricture entails use of multiple diagnostic modalities to image and to sample abnormalities, such as a dominant stricture in primary sclerosing cholangitis. Fluorescence in situ hybridization (FISH) and cholangioscopy are fairly widely used, while other techniques such as confocal laser endomicroscopy are used less frequently. Benign biliary strictures occur frequently in the liver transplant population, both anastomotic and nonanastomotic. Benign biliary strictures may also occur in chronic pancreatitis; importantly, these may mimic pancreatic cancer.
During my presentation, we focused on several aspects of pancreaticobiliary neoplasia. We reviewed the multiple genetic syndromes such as Peutz-Jeghers syndrome, hereditary pancreatitis, and Lynch syndrome, all of which confer increased risk for pancreatic cancer. Endoscopic ultrasound guidance and adjunctive techniques (e.g., elastography) may improve imaging in the pancreas and improve targeting of biopsies. Needle-based confocal laser endomicroscopy is also available to provide real time cellular data, improving our ability to accurately diagnose and differentiate pancreatic cystic neoplasms. Endoscopic ultrasound–guided needle injection and other therapeutic techniques allow endoscopists to intervene therapeutically. Accurate management of pancreatic cysts depends largely on the accurate identification of mucinous cystic neoplasms. Recent guidelines delineate high-risk stigmata and worrisome features of branch-duct intraductal papillary mucinous neoplasm. We also reviewed less common neoplasms such as pancreatic neuroendocrine tumors and biliary neoplasms.
Dr. Kim is an assistant professor of gastroenterology at Mount Sinai Hospital, acting director of endoscopy, and director of endoscopic ultrasound at Mount Sinai Hospital, New York. This is a summary provided by the moderator of one of the AGA Postgraduate Courses held at DDW 2017.
PBC incidence remains stable in rural parts of U.S.
The incidence of primary biliary cholangitis (PBC) in rural parts of the midwestern United States has remained stable over the last 2 decades, allowing better prognosis and improved survival rates.
In a population-based cohort study, Rajan Kanth, MD, and his associates researched 79 incident PBC cases observed in the Marshfield Epidemiologic Study Area (MESA) of 24 zip codes in central and northern Wisconsin between 1992 and 2011. The overall age- and sex-standardized PBC incidence rate was 4.9 cases per 100,000 person-years. The annual incidence rate of PBC increased; however, it was not significant (P = .114) during the 20-year study time frame. In women, PBC ranged from a low of 6.9 cases per 100,000 person-years in 1992-1996 to a high of 11.3 cases per 100,000 person-years in 2002-2006. The sex-specific comparisons were not significant at any time during the 5-year period.
After a mean follow-up of 7.3 years, 23 (29%) patients with PBC died. The estimated 10-year survival of PBC cases in MESA was 76%.
Researchers noted the MESA source population grew over the 20-year study time frame, going from a low of 364,722 MESA person-years in 1992-1996 to a high of 409,670 person-years in 2007-2011. The proportion of men and women in MESA were consistent throughout the study, but there was a general population aging trend with a 29% increase in the number of individuals aged 40-69 years in 2007-2011 relative to 1992-1996.
“The overall incidence of PBC in a Midwestern population of the United States has remained relatively stable over the last two decades,” researchers concluded. “Results suggest that the overall incidence of PBC in the United States is not rising quickly, and that patients with PBC have generally improved prognosis and survival.”
Find the full study in Clinical Medicine & Research (2017. doi: 10.3121/cmr.2017.1351).
The incidence of primary biliary cholangitis (PBC) in rural parts of the midwestern United States has remained stable over the last 2 decades, allowing better prognosis and improved survival rates.
In a population-based cohort study, Rajan Kanth, MD, and his associates researched 79 incident PBC cases observed in the Marshfield Epidemiologic Study Area (MESA) of 24 zip codes in central and northern Wisconsin between 1992 and 2011. The overall age- and sex-standardized PBC incidence rate was 4.9 cases per 100,000 person-years. The annual incidence rate of PBC increased; however, it was not significant (P = .114) during the 20-year study time frame. In women, PBC ranged from a low of 6.9 cases per 100,000 person-years in 1992-1996 to a high of 11.3 cases per 100,000 person-years in 2002-2006. The sex-specific comparisons were not significant at any time during the 5-year period.
After a mean follow-up of 7.3 years, 23 (29%) patients with PBC died. The estimated 10-year survival of PBC cases in MESA was 76%.
Researchers noted the MESA source population grew over the 20-year study time frame, going from a low of 364,722 MESA person-years in 1992-1996 to a high of 409,670 person-years in 2007-2011. The proportion of men and women in MESA were consistent throughout the study, but there was a general population aging trend with a 29% increase in the number of individuals aged 40-69 years in 2007-2011 relative to 1992-1996.
“The overall incidence of PBC in a Midwestern population of the United States has remained relatively stable over the last two decades,” researchers concluded. “Results suggest that the overall incidence of PBC in the United States is not rising quickly, and that patients with PBC have generally improved prognosis and survival.”
Find the full study in Clinical Medicine & Research (2017. doi: 10.3121/cmr.2017.1351).
The incidence of primary biliary cholangitis (PBC) in rural parts of the midwestern United States has remained stable over the last 2 decades, allowing better prognosis and improved survival rates.
In a population-based cohort study, Rajan Kanth, MD, and his associates researched 79 incident PBC cases observed in the Marshfield Epidemiologic Study Area (MESA) of 24 zip codes in central and northern Wisconsin between 1992 and 2011. The overall age- and sex-standardized PBC incidence rate was 4.9 cases per 100,000 person-years. The annual incidence rate of PBC increased; however, it was not significant (P = .114) during the 20-year study time frame. In women, PBC ranged from a low of 6.9 cases per 100,000 person-years in 1992-1996 to a high of 11.3 cases per 100,000 person-years in 2002-2006. The sex-specific comparisons were not significant at any time during the 5-year period.
After a mean follow-up of 7.3 years, 23 (29%) patients with PBC died. The estimated 10-year survival of PBC cases in MESA was 76%.
Researchers noted the MESA source population grew over the 20-year study time frame, going from a low of 364,722 MESA person-years in 1992-1996 to a high of 409,670 person-years in 2007-2011. The proportion of men and women in MESA were consistent throughout the study, but there was a general population aging trend with a 29% increase in the number of individuals aged 40-69 years in 2007-2011 relative to 1992-1996.
“The overall incidence of PBC in a Midwestern population of the United States has remained relatively stable over the last two decades,” researchers concluded. “Results suggest that the overall incidence of PBC in the United States is not rising quickly, and that patients with PBC have generally improved prognosis and survival.”
Find the full study in Clinical Medicine & Research (2017. doi: 10.3121/cmr.2017.1351).
FROM CLINICAL MEDICINE & RESEARCH
EASL publishes new PBC guidelines
The European Association for the Study of the Liver has published a new guideline for the diagnosis, treatment, and management of primary biliary cholangitis.
PBC is likely in patients with persistent cholestatic symptoms or who have pruritis and fatigue. A diagnosis of PBC can be made if a patient has elevated alkaline phosphatase and antimitochondrial antibody, although elevated antimitochondrial antibody alone is not enough to diagnose PBC. Liver biopsy is not recommended, and liver imaging is not necessary to prove PBC but can be used to eliminate extrahepatic causes of cholestasis.
Pruritis, fatigue, and sicca complex are the most common symptoms of PBC and can significantly effect quality of life. Pruritis can be treated with cholestyramine or rifampicin. Clinicians should seek out and treat associated and alternate causes of fatigue and advise patients on strategies to avoid compounding fatigue problems. Sicca complex should be treated appropriately and, if patients develop refractory symptoms, referred to a specialist.
Complications of liver disease caused by PBC include osteoporosis, fat-soluble vitamin substitution, hyperlipidemia, varices, hepatocellular carcinoma, and need for liver transplant, though the need for liver transplant in PBC patient has decreased over time.
“Treatment guidelines facilitate a holistic life-long approach to the management of patients with PBC, and care pathways should be developed locally to capture the needs of patients. These can be subject to independent quality evaluation,” EASL concluded.
Find the full clinical guideline in the Journal of Hepatology (2017. doi: 10.1016/j.jhep.2017.03.022).
The European Association for the Study of the Liver has published a new guideline for the diagnosis, treatment, and management of primary biliary cholangitis.
PBC is likely in patients with persistent cholestatic symptoms or who have pruritis and fatigue. A diagnosis of PBC can be made if a patient has elevated alkaline phosphatase and antimitochondrial antibody, although elevated antimitochondrial antibody alone is not enough to diagnose PBC. Liver biopsy is not recommended, and liver imaging is not necessary to prove PBC but can be used to eliminate extrahepatic causes of cholestasis.
Pruritis, fatigue, and sicca complex are the most common symptoms of PBC and can significantly effect quality of life. Pruritis can be treated with cholestyramine or rifampicin. Clinicians should seek out and treat associated and alternate causes of fatigue and advise patients on strategies to avoid compounding fatigue problems. Sicca complex should be treated appropriately and, if patients develop refractory symptoms, referred to a specialist.
Complications of liver disease caused by PBC include osteoporosis, fat-soluble vitamin substitution, hyperlipidemia, varices, hepatocellular carcinoma, and need for liver transplant, though the need for liver transplant in PBC patient has decreased over time.
“Treatment guidelines facilitate a holistic life-long approach to the management of patients with PBC, and care pathways should be developed locally to capture the needs of patients. These can be subject to independent quality evaluation,” EASL concluded.
Find the full clinical guideline in the Journal of Hepatology (2017. doi: 10.1016/j.jhep.2017.03.022).
The European Association for the Study of the Liver has published a new guideline for the diagnosis, treatment, and management of primary biliary cholangitis.
PBC is likely in patients with persistent cholestatic symptoms or who have pruritis and fatigue. A diagnosis of PBC can be made if a patient has elevated alkaline phosphatase and antimitochondrial antibody, although elevated antimitochondrial antibody alone is not enough to diagnose PBC. Liver biopsy is not recommended, and liver imaging is not necessary to prove PBC but can be used to eliminate extrahepatic causes of cholestasis.
Pruritis, fatigue, and sicca complex are the most common symptoms of PBC and can significantly effect quality of life. Pruritis can be treated with cholestyramine or rifampicin. Clinicians should seek out and treat associated and alternate causes of fatigue and advise patients on strategies to avoid compounding fatigue problems. Sicca complex should be treated appropriately and, if patients develop refractory symptoms, referred to a specialist.
Complications of liver disease caused by PBC include osteoporosis, fat-soluble vitamin substitution, hyperlipidemia, varices, hepatocellular carcinoma, and need for liver transplant, though the need for liver transplant in PBC patient has decreased over time.
“Treatment guidelines facilitate a holistic life-long approach to the management of patients with PBC, and care pathways should be developed locally to capture the needs of patients. These can be subject to independent quality evaluation,” EASL concluded.
Find the full clinical guideline in the Journal of Hepatology (2017. doi: 10.1016/j.jhep.2017.03.022).
FROM THE JOURNAL OF HEPATOLOGY
For chronic abdominal pain, THC resembled placebo
Seven weeks of treatment with delta-9-atetrahydrocannabinol (THC) did not improve chronic abdominal pain in a placebo-controlled trial of 65 adults.
Treatment “was safe and well tolerated,” but did not significantly reduce pain scores or secondary efficacy outcomes, Marjan de Vries, MSc, and her associates wrote in the July issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2016.09.147). Studies have not clearly shown that THC improves central pain sensitization, a key mechanism in chronic abdominal pain, they noted. Future studies of THC and central sensitization include quantitative sensory testing or electroencephalography, they added.
Source: American Gastroenterological Association
Treatment-refractory chronic abdominal pain is common after abdominal surgery or in chronic pancreatitis, wrote Ms. de Vries of Radboud University Medical Center, Nijmegen, the Netherlands. Affected patients tend to develop central sensitization, or hyper-responsive nociceptive central nervous system pathways. When this happens, pain no longer couples reliably with peripheral stimuli, and therapy targeting central nociceptive pathways is indicated. The main psychoactive compound of Cannabis sativa is THC, which interacts with CB1 receptors in the central nervous system, including in areas of the brain that help regulate emotions, such as the amygdala. Emotion-processing circuits are often overactive in chronic pain, and disrupting them might help modify pain perception, the investigators hypothesized. Therefore, they randomly assigned 65 adults with at least 3 months of abdominal pain related to chronic pancreatitis or abdominal surgery to receive oral placebo or THC tablets three times daily for 50-52 days. The 31 patients in the THC group received step-up dosing (3 mg per dose for 5 days, followed by 5 mg per dose for 5 days) followed by stable dosing at 8 mg. Both groups continued other prescribed analgesics as usual, including oxycontin, fentanyl, morphine, codeine, tramadol, paracetamol, anti-epileptics, and nonsteroidal anti-inflammatories. All but two study participants were white, 25 were male, and 24 were female.
At baseline, all patients reported pain of at least 3 on an 11-point visual analogue scale (VAS). By days 50-52, average VAS scores decreased by 1.6 points (40%) in the THC group and by 1.9 points (37%) in the placebo group (P = .9). Although a strong placebo effect is common in studies of visceral pain, that did not prevent pregabalin from significantly outperforming placebo in another similarly designed randomized clinical trial of patients from this study group with chronic pancreatitis, the investigators noted.
The THC and placebo groups also resembled each other on various secondary outcome measures, including patient global impression of change, pain catastrophizing, pain-related anxiety, measures of depression and generalized anxiety, and subjective impressions of alertness, mood, feeling “high,” drowsiness, and difficulties in controlling thoughts. The only exception was that the THC group showed a trend toward improvement on the Short Form 36, compared with the placebo group (P = .051).
Pharmacokinetic analysis showed good oral absorption of THC. Dizziness, somnolence, and headache were common in both groups, but were more frequent with THC than placebo, as was nausea, dry mouth, and visual impairment. There were no serious treatment-related adverse events, although seven patients stopped THC because they could not tolerate the maximum dose.
Some evidence suggests that the shift from acute to chronic pain entails a transition from nociceptive to cognitive, affective, and autonomic sensitization, the researchers noted. “Therefore, an agent targeting particular brain areas related to the cognitive emotional feature of chronic pain, such as THC, might be efficacious in our chronic pain population, but might be better measured by using affective outcomes of pain,” they concluded.
The trial was supported by a grant from the European Union, the European Fund for Regional Development, and the Province of Gelderland. The THC was provided by Echo Pharmaceuticals, Nijmegen, the Netherlands. The investigators reported having no conflicts of interest.
Seven weeks of treatment with delta-9-atetrahydrocannabinol (THC) did not improve chronic abdominal pain in a placebo-controlled trial of 65 adults.
Treatment “was safe and well tolerated,” but did not significantly reduce pain scores or secondary efficacy outcomes, Marjan de Vries, MSc, and her associates wrote in the July issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2016.09.147). Studies have not clearly shown that THC improves central pain sensitization, a key mechanism in chronic abdominal pain, they noted. Future studies of THC and central sensitization include quantitative sensory testing or electroencephalography, they added.
Source: American Gastroenterological Association
Treatment-refractory chronic abdominal pain is common after abdominal surgery or in chronic pancreatitis, wrote Ms. de Vries of Radboud University Medical Center, Nijmegen, the Netherlands. Affected patients tend to develop central sensitization, or hyper-responsive nociceptive central nervous system pathways. When this happens, pain no longer couples reliably with peripheral stimuli, and therapy targeting central nociceptive pathways is indicated. The main psychoactive compound of Cannabis sativa is THC, which interacts with CB1 receptors in the central nervous system, including in areas of the brain that help regulate emotions, such as the amygdala. Emotion-processing circuits are often overactive in chronic pain, and disrupting them might help modify pain perception, the investigators hypothesized. Therefore, they randomly assigned 65 adults with at least 3 months of abdominal pain related to chronic pancreatitis or abdominal surgery to receive oral placebo or THC tablets three times daily for 50-52 days. The 31 patients in the THC group received step-up dosing (3 mg per dose for 5 days, followed by 5 mg per dose for 5 days) followed by stable dosing at 8 mg. Both groups continued other prescribed analgesics as usual, including oxycontin, fentanyl, morphine, codeine, tramadol, paracetamol, anti-epileptics, and nonsteroidal anti-inflammatories. All but two study participants were white, 25 were male, and 24 were female.
At baseline, all patients reported pain of at least 3 on an 11-point visual analogue scale (VAS). By days 50-52, average VAS scores decreased by 1.6 points (40%) in the THC group and by 1.9 points (37%) in the placebo group (P = .9). Although a strong placebo effect is common in studies of visceral pain, that did not prevent pregabalin from significantly outperforming placebo in another similarly designed randomized clinical trial of patients from this study group with chronic pancreatitis, the investigators noted.
The THC and placebo groups also resembled each other on various secondary outcome measures, including patient global impression of change, pain catastrophizing, pain-related anxiety, measures of depression and generalized anxiety, and subjective impressions of alertness, mood, feeling “high,” drowsiness, and difficulties in controlling thoughts. The only exception was that the THC group showed a trend toward improvement on the Short Form 36, compared with the placebo group (P = .051).
Pharmacokinetic analysis showed good oral absorption of THC. Dizziness, somnolence, and headache were common in both groups, but were more frequent with THC than placebo, as was nausea, dry mouth, and visual impairment. There were no serious treatment-related adverse events, although seven patients stopped THC because they could not tolerate the maximum dose.
Some evidence suggests that the shift from acute to chronic pain entails a transition from nociceptive to cognitive, affective, and autonomic sensitization, the researchers noted. “Therefore, an agent targeting particular brain areas related to the cognitive emotional feature of chronic pain, such as THC, might be efficacious in our chronic pain population, but might be better measured by using affective outcomes of pain,” they concluded.
The trial was supported by a grant from the European Union, the European Fund for Regional Development, and the Province of Gelderland. The THC was provided by Echo Pharmaceuticals, Nijmegen, the Netherlands. The investigators reported having no conflicts of interest.
Seven weeks of treatment with delta-9-atetrahydrocannabinol (THC) did not improve chronic abdominal pain in a placebo-controlled trial of 65 adults.
Treatment “was safe and well tolerated,” but did not significantly reduce pain scores or secondary efficacy outcomes, Marjan de Vries, MSc, and her associates wrote in the July issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2016.09.147). Studies have not clearly shown that THC improves central pain sensitization, a key mechanism in chronic abdominal pain, they noted. Future studies of THC and central sensitization include quantitative sensory testing or electroencephalography, they added.
Source: American Gastroenterological Association
Treatment-refractory chronic abdominal pain is common after abdominal surgery or in chronic pancreatitis, wrote Ms. de Vries of Radboud University Medical Center, Nijmegen, the Netherlands. Affected patients tend to develop central sensitization, or hyper-responsive nociceptive central nervous system pathways. When this happens, pain no longer couples reliably with peripheral stimuli, and therapy targeting central nociceptive pathways is indicated. The main psychoactive compound of Cannabis sativa is THC, which interacts with CB1 receptors in the central nervous system, including in areas of the brain that help regulate emotions, such as the amygdala. Emotion-processing circuits are often overactive in chronic pain, and disrupting them might help modify pain perception, the investigators hypothesized. Therefore, they randomly assigned 65 adults with at least 3 months of abdominal pain related to chronic pancreatitis or abdominal surgery to receive oral placebo or THC tablets three times daily for 50-52 days. The 31 patients in the THC group received step-up dosing (3 mg per dose for 5 days, followed by 5 mg per dose for 5 days) followed by stable dosing at 8 mg. Both groups continued other prescribed analgesics as usual, including oxycontin, fentanyl, morphine, codeine, tramadol, paracetamol, anti-epileptics, and nonsteroidal anti-inflammatories. All but two study participants were white, 25 were male, and 24 were female.
At baseline, all patients reported pain of at least 3 on an 11-point visual analogue scale (VAS). By days 50-52, average VAS scores decreased by 1.6 points (40%) in the THC group and by 1.9 points (37%) in the placebo group (P = .9). Although a strong placebo effect is common in studies of visceral pain, that did not prevent pregabalin from significantly outperforming placebo in another similarly designed randomized clinical trial of patients from this study group with chronic pancreatitis, the investigators noted.
The THC and placebo groups also resembled each other on various secondary outcome measures, including patient global impression of change, pain catastrophizing, pain-related anxiety, measures of depression and generalized anxiety, and subjective impressions of alertness, mood, feeling “high,” drowsiness, and difficulties in controlling thoughts. The only exception was that the THC group showed a trend toward improvement on the Short Form 36, compared with the placebo group (P = .051).
Pharmacokinetic analysis showed good oral absorption of THC. Dizziness, somnolence, and headache were common in both groups, but were more frequent with THC than placebo, as was nausea, dry mouth, and visual impairment. There were no serious treatment-related adverse events, although seven patients stopped THC because they could not tolerate the maximum dose.
Some evidence suggests that the shift from acute to chronic pain entails a transition from nociceptive to cognitive, affective, and autonomic sensitization, the researchers noted. “Therefore, an agent targeting particular brain areas related to the cognitive emotional feature of chronic pain, such as THC, might be efficacious in our chronic pain population, but might be better measured by using affective outcomes of pain,” they concluded.
The trial was supported by a grant from the European Union, the European Fund for Regional Development, and the Province of Gelderland. The THC was provided by Echo Pharmaceuticals, Nijmegen, the Netherlands. The investigators reported having no conflicts of interest.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point: Tetrahydrocannabinol did not improve chronic abdominal pain more than did placebo.
Major finding: By days 50-52, average VAS scores decreased by 1.6 points (40%) in the THC group and by 1.9 points (37%) in the placebo group (P = .9).
Data source: A phase II, placebo-controlled study of 65 patients with chronic abdominal pain for at least 3 months who received either placebo or delta-9-atetrahydrocannabinol (THC), 8 mg three times daily.
Disclosures: The trial was supported by a grant from the European Union, the European Fund for Regional Development, and the Province of Gelderland. The THC was provided by Echo Pharmaceuticals, Nijmegen, the Netherlands. The investigators reported having no conflicts of interest.
