A recent study (Clin Gastroenterol Hepatol 2014; 12: 1051-54) examined whether a sustained virological response (SVR) to hepatitis C (HCV)can be undermined by chemotherapy.
In this study with 30 patients who had an SVR before cancer diagnosis, chemotherapy, started at a median of 72 months after SVR, did not induce a viral relapse in any patient.
Three recent news items provide more up-to-date reasons for childhood vaccines.
1. Delaying vaccines may increase seizures –here’s the link and an excerpt (from NY Times):
“Some parents postpone their children’s vaccinations because they believe the delay decreases the risk. But a new study finds the opposite may be true.
The analysis, published online in Pediatrics, involved 5,496 children born from 2004 to 2008 who had seizures in the first two years of life.
For children who received any of their shots as recommended before age 1, there was no difference in the incidence of seizure in the 10 days after vaccination compared with the period before vaccination. But compared with giving it in the first year, giving the measles-mumps-rubella vaccine at 16 months doubled the incidence of seizure, and giving the measles-mumps-rubella-varicella vaccine at that age increased it almost six times.”
2. Rate of measles infections at 20 year high –here’s the link and an excerpt: (from USA Today)
“The USA has the most measles cases in 20 years…The confirmed case count for 2014, as of May 23, was 288 and growing, the CDC says. That number includes 138 cases from Ohio, where the biggest outbreak is ongoing – and where the actual count is 166 as of Thursday, according to the state Health Department.
The nationwide total is the highest for late May since 1994, when 764 cases were reported, the CDC says. It surpasses the 220 cases reported in all of 2011, which was the most in the post-2000 era.
“This is not the kind of record we want to break, but should be a wake-up call for travelers and for parents to make sure vaccination records are up to date,” said Anne Schuchat, director of the CDC’s National Center for Immunizations and Respiratory Diseases. Schuchat…Before the measles vaccine became available in 1963, the virus infected about 500,000 Americans a year, causing 500 deaths and 48,000 hospitalizations.
Cases this year have been reported in 18 states and New York City. Ninety percent have been among people who have not been vaccinated or have unknown vaccination status, according to the CDC. Most of the patients report religious, philosophical or personal reasons for avoiding vaccines.”
3. When parents withhold vaccines, vulnerable children get sick and sometimes die –here’s the link (reference noted from Eric Benchimol’s twitter feed) and an excerpt:
“Jason Lawson recalled a terrifying 10 days in B.C. Children’s Hospital when his son Beckett was six, after Beckett became severely ill from chicken pox.
At the time, Beckett was still receiving a maintenance dose of chemotherapy to kill potential cancer cells. That treatment also suppressed Beckett’s immune system.
When an unvaccinated child at the school passed on chicken pox, the consequences were dire — at one point the virus got into Beckett’s liver and started to do damage, which in some cases can be irreversible….
Lawson said he’s speaking out to remind families that protecting their friends and neighbours is another good reason to make the effort.“
Take home message: With every medical intervention, there are risks and benefits. Those who forego vaccines increase the risk for themselves, their families and friends.
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In my training, one of my mentors would be critical of the mentality “scope first, think second.” He was concerned that too many gastroenterologists/pediatric gastroenterologists used endoscopy as a tool simply “because if all you have is a hammer, the world looks like a nail.”
A recent publication (Clin Gastroenterol Hepatol 2014; 12: 963-69) on first glance, however, provides ammunition to the “scope first” gastroenterologists and undermines the concept that “functional” GI disorders vastly outnumber “organic” GI disorders. The key finding was that esophagogastroduodenoscopy (EGD) provided an “accurate” diagnosis in 38%. This included reflux esophagitis in 21%, eosinophilic esophagitis (EoE) in 5%, eosinophilic gastroenteritis (EGE) in 4%, H pylori in 2%, celiac disease 0.6%, and Crohn’s disease 0.4%. This finding is dramatically higher than previous studies. In fact, in a recent published study (Understanding Idiopathic Nausea | gutsandgrowth) on idiopathic nausea, a control group of patients with chronic abdominal pain had a normal endoscopy in 100%!
In this prospective study of 290 children (ages 4-18 years with a mean age of 11.9 years), the primary indication for upper endoscopy was chronic abdominal pain. Of this 290, 216 had at least 1 alarm feature and 125 had at least 2 alarm features. Alarm features were considered to be the following:
There is little debate that abdominal pain in combination with true alarm symptoms (True red flags in recurrent abdominal pain | gutsandgrowth) merits further evaluation. The aspect of this report that is worthy of close inspection is the diagnostic yield in the 74 patients without alarm symptoms. The authors note that 25 (33.7%) had a diagnosis established with EGD including 16 with reflux esophagitis, 4 with EGE, 2 with EoE, 1 with erosive esophagitis, 1 with celiac and 1 with H pylori. The diagnostic criteria for EGE included ≥10 eosinophils per hpf in the stomach and ≥20 eosinophils per hpf in the duodenum.
The authors note that the diagnostic yield was based on gross endoscopic findings in procedure notes or histologic changes in biopsy reports; “final pathology report on biopsies provided the data source for histologic diagnosis.”
In my opinion there are multiple flaws of this prospective study.
1. There is a very high rate of reflux esophagitis in both the alarm group and the non-alarm group patients with chronic abdominal pain. Of the entire cohort (n=290), the authors identified reflux esophagitis in 21% and this was “primarily histologic esophagitis.” Furthermore, the authors state that “the presence or response to PPI therapy was not predictive of esophagitis or GERD.” So, the obvious problems:
2. In the entire cohort, the authors try to validate their findings by indicating that identification of a diagnosis led to medical therapy that was “effective in approximately 67%” of children with short-term followup. (Only 81% had short-term followup outcomes available). Yet, there is no control group. How many children with chronic abdominal pain will improve for a short period without an EGD-based diagnosis? The answer: a lot of them.
3. Limitations include selection bias toward those with more severe symptoms or alarm symptoms. In addition, this study included only a small number who were considered to have no alarm symptoms. Finally, the short-term followup makes conclusions about the response to therapy questionable.
This study will be a useful reference for any pediatric gastroenterologist who wants to justify the need for an endoscopy. The authors note “the majority of children in our study (93%) met criteria for functional gastrointestinal disorders, and a significant proportion (38%) still had significant histologic findings. Therefore, we conclude the Rome III criteria alone are not sufficient to identify children who require upper endoscopy, and screening for alarm symptoms has limited utility.”
In my opinion, the reliance on histology as well as selection bias weaken the findings of this study. If a patient with a histologic diagnosis of reflux (or several other entities) and a presentation of chronic abdominal pain does not improve, the pediatric gastroenterologist should remember that only “a poor carpenter blames his tools.”
Bottomline: EGD remains an important tool in evaluating abdominal pain. However, I think this study substantially overestimates its utility.
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Here is a link, bit.ly/1xb1kk8, (from JPGN) and the abstract to an article on the Specific Carbohydrate Diet in Children. This study shows clinical improvement and mucosal healing, confirmed by capsule endoscopy, in response to the specific carbohydrate diet (SCN). Congratulations to my colleagues/partners from GI Care for Kids who published this study in JPGN:
Objective: To prospectively evaluate clinical and mucosal responses to the specific carbohydrate diet (SCD) in children with Crohn’s disease (CD).
Methods: Eligible patients with active CD (Pediatric Crohn’s Disease Activity Index, PCDAI >= 15) underwent a patency capsule and if passed intact, capsule endoscopy (CE) was performed. Patients were monitored on SCD for 52 weeks while maintaining all prescribed medications. Demographic, dietary and clinical information, PCDAI, Harvey Bradshaw (HB) and Lewis score (LS) were collected at 0, 12 and 52 weeks. CE’s were evaluated by an experienced reader blinded to patient clinical information and timing.
Results: Sixteen patients were screened; 10 enrolled; and 9 completed the initial 12 week trial; receiving 85 % of estimated caloric needs prior to, and 101%, on the SCD. HB significantly decreased from 3.3 + 2.0 to 0.6 + 1.3 (p = 0.007) as did PCDAI (21.1 + 5.9 to 7.8 + 7.1; p = 0.011). LS declined significantly from 2153 + 732 to 960 + 433 (p = 0.012). Seven patients continued the SCD to 52 weeks with HB (0.1 + 0.4) and PCDAI (5.4 + 5.5) remaining improved (p = 0.016 and 0.027 compared to baseline) with mean LS at 1046 + 372 and 2 patients showing sustained mucosal healing.
Impressions: Clinical and mucosal improvements were seen in children with CD using the SCD over 12 and 52 weeks. Additionally, CE can monitor mucosal improvement in treatment trials for pediatric CD. Further studies are critically needed to understand the mechanisms underlying SCD’s effectiveness in children with CD.
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Here’s a different view of the VA, from a practicing physician, and an excerpt:
“Nowhere else than at the VA have I felt as much that I was a part of something greater than myself. We “care for him who shall have borne the battle” in a system that, for all its woes, remains a singular presence in the confused patchwork of medical care that is American medicine. Enter the VA medical system and you know that your critical medical data are available to every provider at every VA hospital in the country in ways unimaginable in the private sector; you know that care delivered in the VA system often meets or exceeds the quality standards of the private sector.1You know, moreover, that you and the person sitting next to you in the waiting room will get the same level of care, because there is no mysterious and fickle insurer to reckon with at the end of the appointment.
I don’t know what happened in Phoenix or elsewhere, what those hidden lists hold, what grief lies there. I wish those reporting on this scandal would do more to separate issues of access to care from problems with the quality of care. I do know that, all around the country, physicians who trained at the VA or who have chosen to live out their medical career with the VA have their own hidden lists, their indelible memories of men and women who entrusted their care to us. Let us continue to work for them.”
A second article “Watershed Moment,” summarizes the current problems and what needs to be done. Here’s an excerpt:
“Yet access to care, particularly to outpatient appointments, has been an enduring problem for the VA, as documented in multiple reports from the OIG and the Government Accountability Office (GAO)… A key reason was inconsistency in the recording and tracking of wait times according to the “desired date,” defined as the date by which a patient wants to be seen or a health care provider wants him or her to be seen.1 A preliminary VA audit showed that 13% of scheduling staff — at 64% of the 258 surveyed facilities — had been instructed to enter a different desired date than that requested by the veteran, though it remains unclear what proportion of these changes represents willful falsification.2
There is anecdotal evidence that scheduling issues led to adverse health outcomes for veterans in Phoenix and elsewhere; more systematic assessments are under way. However, there is precedent for concern, since a September 2013 OIG report concluded that delayed gastroenterology consultations for colon-cancer screening had led to delayed diagnoses for more than 50 veterans, some of whom ended up dying of colon cancer.3
Beyond access to care, health system performance should be evaluated on the basis of health outcomes, the quality and safety of the care delivered, patient satisfaction, and costs. In many of these domains, the VA has kept pace with or surpassed private-sector health systems
The VA is a historic institution with a long tradition of providing care to former military service members. In recent years, the agency has made progress in addressing a backlog of disability claims and in sharply reducing veterans’ homelessness. In the 1990s, VA health care, facing a similar crisis of confidence and bipartisan calls for privatization, was transformed into a more technologically advanced, decentralized, and quality-oriented system. Now it needs to protect the best elements of its infrastructure, built around longitudinal, holistic care of each veteran, while embarking on another round of reforms.“
Here’s a link to the abstract: gastrojournal.org/article/S0016-5085(14)00609-X/abstract …
Methods: “We performed a prospective trial of 3031 individuals at risk for celiac disease based on screens for EmA. Of 148 seropositive individuals, 40 fulfilled inclusion criteria and were randomly assigned to groups placed on a GFD or gluten-containing diets.”
Results: “The GFD group also had reduced indigestion (P=.006), reflux (P=.05), and anxiety (P=.025), and better health, based on the visual analog scale (P=.017), than the gluten-containing diet group.”
Take-home message: A gluten free diet improves symptoms (even in “asymptomatic” patients) with celiac disease
A recent study has reviewed biologic therapies for ulcerative colitis (Ann Intern Med. 2014;160(10):704-711). Here’s the abstract link: bit.ly/1o5PpRX .
Data Synthesis: ..There were 7 double-blind, placebo-controlled trials that were rated as low risk of bias and showed that all biological agents (adalimumab, golimumab, infliximab, and vedolizumab) resulted in more clinical responses, clinical remissions, and mucosal healings than placebo for induction therapy. The results of network meta-analysis suggested that infliximab is more effective to induce clinical response (odds ratio, 2.36 [95% credible interval, 1.22 to 4.63]) and mucosal healing (odds ratio, 2.02 [95% credible interval, 1.13 to 3.59]) than adalimumab. No other indirect comparison reached statistical significance. For maintenance, 6 double-blind, placebo-controlled trials that were rated high risk of bias showed that all biological agents have greater clinical efficacy than placebo. The occurrence of adverse events was not different between biological agents and placebo.
Limitation: Few trials, no head-to-head comparisons, and inadequate follow-up in maintenance trials.
Conclusion: Biological agents are effective treatments for UC, but head-to-head trials are warranted to establish the best therapeutic option.
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A recent article from NY Times discusses the topic of advance directives and how physicians are likely to choose a “no code” status for themselves rather than heroic measures if faced with a terminal illness.
Here’s a link: What doctors would choose and an excerpt:
Young doctors… 88.3 percent would choose a do-not-resuscitate or “no code” status. An allow-me-to-die status, in other words. “Doctors see a lot,” Dr. Periyakoil told me later that day. Resuscitation attempts are so aggressive — likely to break an older patient’s ribs but unlikely to restore them to their previous state of health or function —that after witnessing several, “you know too much and you’re much more wary,” she said.
Perhaps readers here remember a much-circulated web essay by Dr. Ken Murray, a retired family practitioner, called “How Doctors Die.” He claimed that his fellow physicians largely reject the sort of high-tech care they routinely dispense to their patients.
Take-home message: Physicians frequently provide high-intensity heroic measures to many of their patients which they usually would reject for themselves. Even in pediatrics, frequently parents demand that “everything be done” when many physicians would advise otherwise.
According to a recent study in Obesity (2014; 22: 1415-21), during the first 12 weeks of a weight loss program water is not as helpful as non-nutritive sweetened drinks (eg. diet soda) when trying to lose weight (Thanks to Jeff Schwimmer for this reference).
The study describes the findings from the 12-week weight loss phase of a 1-year randomized, clinical trial to test the hypothesis that the amount of weight lost (12 weeks) and maintained (9 months) in a behavioral weight management program will be equivalent in participants consuming beverages containing non-nutritive sweetened beverages (NNS) compared to water.
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Pharmaceutical companies are not motivated to provide a definitive answer on the title question. A recent study (Clin Gastroenterol Hepatol 2014; 12: 811-17) states that “head-to-head clinical trials of anti-TNF therapies are unlikely to ever be undertaken because of the extreme cost to conduct such studies and the financial risk that such trials would entail for the manufacturers.” The two most popular biologics, infliximab (IFX) and adalimumab (ADA), for inflammatory bowel disease have been incredibly successful (Multi-billion dollar biologics | gutsandgrowth).
The current study is “one of the first to directly compare the effectiveness” of IFX and ADA for Crohn’s disease. The authors retrospectively examined a U.S. Medicare data cohort from 2006-2010 and identified new users with 1459 IFX and 871 ADA patients. While 94% of Medicare enrollees are >65 years, this study had a range of patient ages due to those who received Medicare due to disability. In fact, in the ADA group, ~60% were between 30-60 years and in the IFX group, ~44% were in this age group.
Key result:
While persistence is an imperfect measure of effectiveness, the fact that surgeries and hospitalizations were similar indicates that the medications are likely to have similar clinical effectiveness, at least in this population. Data on mucosal healing, more direct measures of effectiveness, and longer followup certainly would strengthen this conclusion.
