Samara Rosenfeld

Findings of a recent analysis indicated frozen fecal material from universal donors may be related to a higher rate of clinical remission among patients with 

The results produced positive evidence of the use of frozen fecal material.

Luciane de Fatima Caldeira, MS, and colleagues conducted a systematic review and meta-analysis to gather evidence on the efficacy and safety of fecal microbiota transplantation for IBD. They conducted searches in PubMed, Scopus, and Web of Science databases. The team searched for phrases including fecal microbiota transplantation, fecal microbiota, foecal microbiota, and faecal microbiota. Studies evaluated the efficacy/effectiveness or safety of fecal microbiota transplantation in patients of any age or gender diagnosed with IBD, with or without a treatment comparator and reporting response, remission, or adverse events.

Members of the team screened the titles and abstracts to identify irrelevant records. They used a standardized form to collect data on the general characteristics and clinical outcomes of the included studies.

The investigators included 60 studies for the qualitative synthesis and 36 were able to be used in the quantitative synthesis. The mean Newcastle-Ottawa Scale score for the quasi-experimental studies was 6 (range, 6-8).

The team noted 6 of 9 randomized controlled trials presented comparable data and were assessed in 2 meta-analyses—1 for clinical remission and 1 for clinical response. There were statistically significant differences observed for both outcomes, favoring fecal microbiota transplantation over placebo (355 patients, clinical remission: RR, 1.7 [95% CI, 1.12-2.56], I2=45%; clinical response: RR, 1.68 [95% CI, 1.04-2.72], I2=55%).

Overall, 24 quasi-experimental studies assessed clinical remission. An analysis resulted in a clinical remission prevalence of 32.3% (95% CI, 23.1-43.1), while the 9 randomized controlled trials resulted in a rate of 46% (95% CI, 31.4-61.4). There was an overall remission rate of 37% (95% CI, 28.8-45.9) and there was no significant difference between the 2 study designs (

In a stool type subgroup analysis, the clinical remission rate for fresh fecal material was 29.1%, while rates were 44.2% for frozen fecal matter, 57.2% when both types of stool were used, and 66.5% for capsules, with a statistical difference observed among the groups (

=.036).Patients who had Crohn disease presented a remission rate of 47.6% and those with ulcerative colitis demonstrated a remission rate of 35%.

For clinical response, 26 quasi-experimental studies and 7 randomized controlled trials resulted in a response of 53.5% and 54.4%, respectively. Those who received fresh fecal material had a clinical response of 52.1%, while patients who received frozen fecal material presented a response of 52.8%. If fecal material was received from relatives or acquaintances, the pooled clinical response was 37.1%. Those who received fecal material from universal donors had a response rate of 59.7%.

There was a frequency of 26.9% and 48.2% for adverse events among the quasi-experimental studies and randomized controlled trials, respectively. Among studies where fresh fecal material was transplanted, the frequency of any adverse event was 30.2%, while it was 43.2% among studies using frozen fecal material and 22.6% in those using capsules.

The investigators found fecal material transplantation for the management of patients with IBD demonstrated a response rate of 53.8% with a complete remission of 37%.

Fecal microbiota transplantation in inflammatory bowel disease patients: A systematic review and meta-analysis

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Fecal material transplantation for the management of patients with IBD demonstrates a response rate of 53.8% with a complete remission of 37%.

Positive Effects of Fecal Material Transplantation for IBD Management

Findings of a recent study do not indicate nocturnal oxygen has a positive or negative effect on survival or progression to long-term oxygen therapy in patients with chronic obstructive pulmonary disease (COPD).

Still, the trial was underpowered as it did not reach full enrollment.

Yves Lacasse, MD, and colleagues designed a double-blind, placebo-controlled, randomized trial to determine whether nocturnal oxygen provided for a period of 3-4 years would decrease mortality or the worsening of disease so patients could meet current specifications for long-term oxygen therapy. Patients included had COPD with nocturnal arterial oxygen desaturation without qualifying for long-term oxygen therapy. All patients had stable disease for at least 6 weeks before enrollment and had been nonsmokers for at least 6 months. The team defined nocturnal desaturation as a nocturnal home oximetry recording of at least 30% of the recording time with an oxygen saturation of less than 90%.

Lacasse and the investigators randomly assigned patients 1:1 to receive either home nocturnal oxygen from an oxygen concentrator or ambient air from a sham concentrator (placebo). At baseline, the team took clinical measurements including the Charlson comorbidity index, spirometry, lung volumes, carbon monoxide diffusion capacity, and arterial blood gas.

The nocturnal oxygen was delivered overnight from an electrically powered oxygen concentrated. Patients used supplemental oxygen throughout the night. The goal was to maintain a nocturnal oxygen saturation of more than 90% for at least 90% of the recording time. Oxygen adjustment was performed at home, starting with a rate of 2 liters per minute during a first test night and increased by increments of 1 liter per minute per night, up to 4 liters per minute.

Those in the control group received ambient air delivered through identical concentrators rendered ineffective by bypassing the sieve beds. Patients in this group also underwent a sham flow-rate adjustment procedure.

The primary outcome of the study was a composite of death from any cause or a requirement for long-term oxygen therapy. Additional outcomes included adherence to the intervention, exacerbation and hospitalization rates, and quality of life.

Overall, 243 patients were enrolled in the study—123 were randomly assigned to receive nocturnal oxygen and 120 received placebo. Of the patients, 79% met the definition for nocturnal desaturation on the 2 oximetry studies. There were 242 patients at the three-year follow-up and 231 patients at the four-year follow-up.

A majority of the patients, 97.5% who received oxygen had nocturnal saturation during the treatment within the target flow rate and 78.2% were given oxygen at a flow rate of 2 liters per minute. At 3 years of follow-up, 39% of those assigned to nocturnal oxygen and 42% of those assigned to placebo met the NOTT-defined criteria for long-term oxygen therapy or died (difference, -3 percentage points; 95% CI, -15.1 to 9.1; 

The investigators noted at 3 and 4 years of follow-up, the absolute differences between the 2 trial groups in the percentage of patients with a primary outcome event, the separate component of death, or the separate component of a requirement for long-term oxygen therapy were all no more than 6.5 percentage points. There was no significant difference between nocturnal oxygen and placebo in the composite outcome (HR, .87; 95% CI, .61-1.25; 

=.44) or its separate components of death (HR, .98; 95% CI, .6-1.63) and a requirement for long-term oxygen therapy (HR, .87; 95% CI, .57-1.34).

Randomized Trial of Nocturnal Oxygen in Chronic Obstructive Pulmonary Disease

Unclear Whether Nocturnal Oxygen Positively Affects COPD Patients

September is Pain Awareness Month, a time when various organizations work to raise public awareness of the issues of 

 and pain management. With that, it is important to recognize the different types of pain patients experience from a variety of disease states.

While there are traditional methods of treating pain, such as prescribing opioids, an epidemic has led to addiction, overdose, and death. According to 

 an average of 41 people died each day from overdoses involving prescription opioids in 2018, totaling nearly 15,000. Still, there was a 13.5% decrease in prescription opioid-involved death rates from 2017 to 2018.

Although typically opioids are prescribed to treat pain, guidances have been instilled to limit the number of pills prescribed to patients. And alternate therapies and technologies exist to completely remove opioids from the treatment plan of patients.

I had the opportunity to speak to Alan Kaye, MD, PhD, a pain interventionist and professor at LSU Health School of Medicine, to discuss the importance of recognizing Pain Awareness Month, which was first declared a medical holiday in 2001, alternate treatments for pain, drugs in the pipeline, caring for a patient with pain, and much more.

Podcasts

Alan Kaye, MD, PhD, joins DocTalk during Pain Awareness Month to discuss opioids, alternate pain therapies, and caring for patients with pain.

Alan Kaye, MD, PhD: Treating Pain Traditionally and with Alternate Therapies

Providers, experts, and patients alike are preparing for a combination of 

 outbreaks. That means healthcare providers and patients are poised for potential threats from various places, and there is a great need to be able to differentiate between all 3.

Flu and COVID-19 present similarly because they are both viral illnesses that can cause respiratory symptoms, Lakiea Wright, MD, allergy and immunology, Brigham and Women’s Hospital, said in a recent interview with 

®. Although flu and COVID-19 are similar, there are distinguishing factors between such viruses and allergies.

The CDC recently published a Venn diagram to help identify some overlapping and distinguishing factors.

For example, when talking about environmental allergies, fever is not associated, so it would not typically indicate solely allergies. Itchy and watery eyes and sneezing are typical of allergies but not flu or COVID-19.

Other distinguishing factors like body and muscle aches, vomiting, diarrhea, and loss of taste and smell could help indicate flu and COVID-19.

Fever, headache, sore throat, cough, and shortness of breath all overlap in 1 way or another, Wright said.

“So, it’s really important to focus on those distinguishing factors I mentioned,” she concluded.

Author | Samara Rosenfeld

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