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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
August 12, 2017

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Training Family Caregivers to Deliver Poststroke Rehabilitation
Low-FODMAP Diet plus a Probiotic for IBS
Nonsteroidal Anti-Inflammatory Drugs for Back Pain and Sciatica: A Meta-Analysis
Prostatectomy vs. Observation for Localized Prostate Cancer
Intranasal Oxytocin Improves Social Function in Kids with Autism
Partial Breast Irradiation After Breast-Conserving Surgery
Is Whole-Genome Sequencing in Primary Care Clinically Worthwhile?
Proton-Pump Inhibitors and Death — Association or Causation?

Lancet 2017 Jun 27
Training Family Caregivers to Deliver Poststroke Rehabilitation
No difference was seen in 6-month outcomes after stroke rehabilitation training for family caregivers.
The rising burden of mortality and disability from stroke is largely borne in a global stroke belt within the developing world, which has the most challenges and resource constraints for addressing the ongoing rehabilitation needs of stroke survivors. Families already provide much of the practical support for stroke patients in the acute and chronic recovery periods, so the idea of empowering family-nominated caregivers to provide ongoing rehabilitation is particularly appealing.
To test this idea, the ATTEND collaborative group conducted a pragmatic trial across centers in India. In this Australian government-funded trial, 1250 patients with recent stroke and residual disability were recruited from among 14 hospitals in India and openly randomized to intervention or usual care, which included some rehabilitation in hospital, with or without subsequent outpatient therapy. The intervention consisted of three 1-hour rehabilitation training sessions for a family-nominated caregiver that was delivered by specially trained nurses or therapists during the acute hospitalization, up to 6 home visits during the 2 months after discharge, and ongoing access to study coordinators for support and guidance.
The treatment groups did not differ significantly in the proportion of patients who were dead or dependent at 6 months (47% in both groups). In secondary analyses, no differences in length of stay, basic and extended activities of daily living, anxiety, depression, quality of life, or caregiver burden were demonstrated.
COMMENT: Although the concept of shifting stroke rehabilitation tasks to family caregivers seems promising in theory, particularly when resources are constrained, additional work will clearly be required to further develop this approach. As the accompanying editorial suggests, perhaps a more intensive intervention that leverages technology support to augment the dose of rehabilitation delivered, or an intervention that is more specifically tailored to both a patient's and a caregiver's needs, would be required to develop expanded access to effective rehabilitation for both low- and high-income countries alike.
CITATION(S): The ATTEND Collaborative Group.Family-led rehabilitation after stroke in India (ATTEND): A randomised controlled trial. Lancet 2017 Jun 27; [e-pub].
Kwakkel G and van Wegen EEH.Family-delivered rehabilitation services at home: Is the glass empty?Lancet 2017 Jun 27; [e-pub].
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Gastroenterology 2017 Jun 15
Low-FODMAP Diet plus a Probiotic for IBS
A bifidobacteria-containing probiotic prevents bifidobacteria depletion on a low-FODMAP diet.
Diets low in indigestible sugars (FODMAPs) improve symptoms of irritable bowel syndrome (IBS), particularly diarrhea, bloating, and excessive flatus. Low-FODMAP diets induce changes in fecal microbiota, including reductions of bifidobacteria. Low concentrations of bifidobacteria have been associated with higher pain levels in IBS, and may represent an unwanted and adverse outcome of low-FODMAP diets.
In a randomized, controlled trial, 104 patients with IBS (excluding constipation-predominant type, or IBS-C) were randomized to a low-FODMAP or sham diet for 4 weeks and to a placebo or probiotic supplement (VSL #3). In the per-protocol analysis, adequate symptom relief was significantly greater with the low-FODMAP versus sham diet (61% vs. 39%). The probiotic did not affect symptom relief but did maintain bifidobacteria in the feces in abundance compared with placebo. There was no interaction between low-FODMAP diet and probiotic for symptom relief or fecal Bifidobacterium species abundance.
COMMENT: As the FODMAP story continues to unfold, many clinicians are using low-FODMAP diets in selected patients with IBS. These data will suggest to many that a bifidobacteria-containing probiotic should be prescribed with a low-FODMAP diet.
CITATION(S): Staudacher HM et al. Diet low in FODMAPs reduces symptoms in patients with irritable bowel syndrome and probiotic restores Bifidobacterium species: A randomized controlled trial. Gastroenterology 2017Jun 15; [e-pub]. (http://dx.doi.org/10.1053/j.gastro.2017.06.010)
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Ann Rheum Dis 2017 Jul; 76:1269
Nonsteroidal Anti-Inflammatory Drugs for Back Pain and Sciatica: A Meta-Analysis
Only a small proportion of patients derived benefit from these drugs, and the benefit was modest.
Although nonsteroidal anti-inflammatory drugs (NSAIDs) are prescribed commonly for patients with low back and neck pain, randomized trials have not shown dramatic benefits. In this meta-analysis, researchers identified 35 randomized, placebo-controlled trials of NSAID therapy for acute or chronic low back pain or sciatica (33 trials) or neck pain (only 2 trials). Median study duration was 7 days; no study extended beyond 3 months.
On 100-point pain scales, mean differences in pain relief between NSAIDs and placebo were 9.2 points for studies lasting less than 2 weeks and 7.7 points for studies lasting 2 weeks to 3 months. Outcomes were in this general range for both acute and chronic pain and for both nonsciatic and sciatic pain. About six patients had to be treated to alleviate pain in one patient (based on the assumption that a clinically meaningful difference is ≥10 points). For disability, mean differences between NSAIDs and placebo were also less than 10 points on 100-point scales.
COMMENT: These results confirm my clinical experience: Only a small proportion of patients with back pain or sciatica perceive benefit from NSAIDs, and some of the perceived benefit reflects placebo effects or the tendency for these conditions to fluctuate or improve. Moreover, in recent meta-analyses, acetaminophen was ineffective for low back pain (NEJM JW Gen Med May 1 2015 and BMJ 2015; 350:h1225) and opioids were only marginally effective (NEJM JW Gen Med Jul 15 2016 and JAMA Intern Med 2016; 176:958). Taken together, these meta-analyses paint a pessimistic picture of drug treatment for back pain.
CITATION(S): Machado GC et al. Non-steroidal anti-inflammatory drugs for spinal pain: A systematic review and meta-analysis. Ann Rheum Dis 2017 Jul; 76:1269. (http://dx.doi.org/10.1136/annrheumdis-2016-210597)

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N Engl J Med 2017 Jul 13; 377:132
Prostatectomy vs. Observation for Localized Prostate Cancer
Surgery did not significantly lower all-cause or prostate cancer mortality.
Evolving evidence from randomized trials assessing the utility of surgery versus surveillance for localized prostate cancer has provided mixed results. Among the studies suggesting no benefit from prostatectomy is the randomized PIVOT study (N Engl J Med 2012 Jul 19; 367:203), which showed that among 731 men with localized disease, radical prostatectomy did not significantly reduce all-cause or prostate cancer mortality, as compared with observation, through a median of 10.0 years of follow-up. Now, the PIVOT investigators have updated these results through a median of 12.7 years and a maximum of 19.5 years of follow-up.
A total of 64% of the men died from any cause, and the 19.5-year cumulative incidence of death from any cause was similar with surgery versus observation (61.3% and 66.8%, respectively). A total of 9.4% of the men died from prostate cancer, and the 19.5-year cumulative incidence of death from prostate cancer was also similar with radical prostatectomy versus observation (7.4% and 11.4%). Treatment for disease progression occurred about 25% less frequently in patients treated with surgery, but the incidence of urinary incontinence, as well as erectile dysfunction, at 10 years was worse than in patients observed.
COMMENT: As noted by the authors, these findings are in line with those of the SPCG-4 study (N Engl J Med 2014; 370:932) and the recent ProtecT trial (N Engl J Med 2016; 375:1425). The take-home implications of these studies are that prostate cancer mortality remains low among most men with localized disease managed with some form of observation and that in men with low-risk/low–prostate-specific antigen disease, death from prostate cancer is uncommon. These results support ongoing efforts to integrate active surveillance into routine practice for appropriate men.
CITATION(S): Wilt TJ et al. Follow-up of prostatectomy versus observation for early prostate cancer. N Engl J Med2017 Jul 13; 377:132.
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Proc Natl Acad Sci U S A 2017 Jul 25; 114:8119
Intranasal Oxytocin Improves Social Function in Kids with Autism
Children whose social behavior improved significantly during active or placebo treatment showed escalations in oxytocin levels.
In animal models of autism spectrum disorder (ASD), trials generally have shown that oxytocin improves social behavior. However, results have been mixed in human trials of exogenous oxytocin administration. Investigators speculated that endogenous oxytocin levels, which are low in many (but not all) ASD patients; might explain the mixed results.
Researchers at Stanford conducted a randomized, double-blind trial in 32 children (age range, 6–12 years) with ASD. Pretreatment endogenous blood level of oxytocin was measured in each child. Daily intranasal oxytocin or placebo was administered for 4 weeks. When results were analyzed without reference to pretreatment oxytocin levels, improvement in social behaviors with treatment fell just short of statistical significance (P=0.06). However, when pretreatment levels were included in the analysis, social behavior of oxytocin-treated children was superior (P=0.02) ― particularly in kids with the lowest pretreatment levels. Moreover, children whose social behavior improved significantly during placebotreatment also showed escalations in endogenous levels of oxytocin.
COMMENT: This study shows that daily intranasal oxytocin improves social behavior in kids with ASD whose baseline endogenous blood oxytocin levels are low. Provocatively, it also suggests that the placebo response in ASD might involve a surge in endogenous production of oxytocin. Interestingly, although oxytocin treatment improved social functioning, it did not affect repetitive behaviors that also are seen in ASD patients. This study will encourage further evaluation of oxytocin treatment.
CITATION(S): Parker KJ et al. Intranasal oxytocin treatment for social deficits and biomarkers of response in children with autism. Proc Natl Acad Sci U S A 2017 Jul 25; 114:8119.

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Lancet 2017 Aug 2
Partial Breast Irradiation After Breast-Conserving Surgery
PBI was not inferior to standard whole-breast irradiation.
The use of breast radiotherapy after breast-conserving surgery has clearly been shown to reduce the risk for breast carcinoma recurrence. However, radiation delivered to the whole breast increases the chance of delivery to normal areas not at risk, such as normal breast tissue and the heart and lung.
To compare the safety and effectiveness of partial-breast irradiation (PBI) versus whole-breast irradiation (WBI) following lumpectomy, U.K. investigators conducted a multicenter randomized, controlled phase III noninferiority trial (UK IMPORT LOW) involving 2018 patients (age, >50 years; tumor size, ≤3 cm; 0–3 positive lymph nodes). Patients were randomized 1:1:1 to receive 15 daily fractions of WBI (40 Gy), PBI (40 Gy), or a combination of reduced-dose WBI (36 Gy) plus PBI (40 Gy).
At a median follow-up of 72.2 months, the 5-year cumulative incidence of local relapse was noninferior with either PBI or reduced-dose WBI plus PBI versus WBI (0.5%, 0.2%, and 1.1%, respectively). Also, patient-reported breast appearance and firmness were significantly improved with PBI or reduced-dose WBI plus PBI versus WBI.
COMMENT: These results demonstrate a strikingly low rate of local recurrence in all treatment groups and beg the question of whether appropriately selected patients might be able to avoid radiotherapy altogether. Results are eagerly awaited from other PBI trials, which are evaluating the effect of reducing the number of radiotherapy days to 5 or fewer. Because only about 3% of patients in the current trial had node-positive breast cancer, these results can't be generalized to this group of patients.
CITATION(S): Coles CE et al. Partial-breast radiotherapy after breast conservation surgery for patients with early breast cancer (UK IMPORT LOW trial): 5-year results from a multicentre, randomised, controlled, phase 3, non-inferiority trial. Lancet 2017 Aug 2; [e-pub].
Jagsi R.Early-stage breast cancer: Falling risks and emerging options. Lancet 2017 Aug 2; [e-pub].
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Ann Intern Med 2017 Jun 27
Is Whole-Genome Sequencing in Primary Care Clinically Worthwhile?
For patients without family histories of highly heritable conditions, the answer probably is “no.”
The cost of genome sequencing has plummeted during the past 20 years, and the day of the “US$1,000 genome” — the cost of sequencing an individual's entire genome — has arrived. Does this relatively low cost make the procedure worthwhile for people without family histories of highly heritable conditions? To find out, researchers randomized 100 healthy primary care patients without such family histories (age range, 40–65) to receive family history reports alone (FH) or with whole-genome sequencing reports (FH+WGS). The patients then discussed their reports with their primary care physicians (PCPs).
Eleven patients in the FH+WGS group had single genes that substantially affect disease risk, but clinical evidence of disease was seen in only 2 of these patients. Patients in the FH+WGS group did not report more anxiety or depression than those in the FH group. PCPs in the FH+WGS group recommended new clinical actions somewhat more often (and patients reported health-related behavior changes somewhat more often) than those in the FH group. Geneticists judged that 80% of PCPs' recommendations were appropriate.
COMMENT: This small study does not provide particularly strong evidence of benefit when WGS is used routinely with healthy adults in primary care practices, partially because biomedicine has yet to derive robust clinical predictions from such data. With further development, WGS might become more valuable in primary care settings.
CITATION(S): Vassy JL et al. The impact of whole-genome sequencing on the primary care and outcomes of healthy adult patients: A pilot randomized trial. Ann Intern Med 2017 Jun 27; [e-pub].
Manolio TA.Incorporating whole-genome sequencing into primary care: Falling barriers and next steps. Ann Intern Med 2017 Jun 27; [e-pub].
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BMJ Open 2017 Jul 4; 7:e015735
Proton-Pump Inhibitors and Death — Association or Causation?
Observational data show a weak association without evidence of causality.
Recent observational studies indicate associations between proton-pump inhibitors (PPIs) and numerous long-term side effects. In another such study, investigators used a large Veterans Affairs database to identify patients beginning therapy with an H2 receptor antagonist (H2RA) or a PPI and followed them for a median of 6 years.
Compared with H2RA users, PPI users were more likely to die during the observation period (hazard ratio, 1.25). Comparisons between PPI users and nonusers, and between PPI users and nonusers of either PPIs or H2RAs, yielded similarly increased risk for death with PPI use. This increased risk was also seen in patients without gastrointestinal diseases. Propensity matching on multiple comorbidities and covariates produced similar results, and longer duration of PPI therapy increased mortality risk. The authors discuss several biological mechanisms that could theoretically explain a causal relation between PPIs and death.
COMMENT: Although this study featured an extensive statistical analysis, we must remember that statistics identify random variation but cannot correct for systemic biases and confounding. The authors estimate that the potential for residual confounding is small, but they acknowledge that confounding and biases could still explain the association. The limitations of the study include its observational nature, the highly selected population (veterans), the fact that PPI users were older and had more comorbidities, and failure to account for use of over-the-counter medications, such as nonsteroidal anti-inflammatory drugs. As with similar studies suggesting associations between PPI use and adverse events (NEJM JW Gastroenterol Aug 2017 and Gastroenterology 2017 May 18; [e-pub]) and the authors' prior study on chronic kidney disease (NEJM JW Gen Med Aug 2017 and Kidney Int 2017; 91:1482), these results suggest a weak association without evidence of causation and should not prevent patients from receiving PPI therapy for appropriate indications.
CITATION(S): Xie Y et al. Risk of death among users of proton pump inhibitors: A longitudinal observational cohort study of United States veterans. BMJ Open 2017 Jul 4; 7:e015735.

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