Tag Archives: Chronic

GI Symptoms and Chronic Fatigue May Persist Months After COVID-19

GI Symptoms and Chronic Fatigue May Persist Months After COVID-19

Gastrointestinal symptoms and chronic fatigue may persist months after the COVID-19 virus infection resolves, results of a recent cohort-controlled study suggest.

About 5 months after SARS-CoV-2 infection, relative risks of loose stools, somatization, and chronic fatigue were increased by approximately two- to three fold, compared to individuals who had not been infected, according to study results presented at the annual Digestive Disease Week® (DDW).

These longer-term consequences of SARS-CoV-2 appeared to be more severe in patients who had experienced diarrhea during the acute infection, according to investigator Daniele Noviello, MD, a second-year resident in gastroenterology and hepatology at the University of Milan.

This is the first cohort-controlled study that specifically investigates gastrointestinal symptoms and somatoform disorders, Noviello said in a virtual presentation of the results.

“Based on our data, chronic fatigue, gastrointestinal, and somatoform symptoms may have a common postinfectious origin, and they should be investigated in the follow-up of SARS-CoV-2 patients,” he said.

Links Between SARS-CoV-2 and Gastrointestinal Symptoms

Gastrointestinal symptoms are known to be relatively common during acute infection. According to Noviello, the most frequent gastrointestinal symptom associated with SARS-CoV-2 is diarrhea, occurring in 4% to nearly 40% of patients in case series to date.

However, data on the longer-term gastrointestinal impacts of SARS-CoV-2 remain scarce.

In one noncontrolled cohort study in China, loss of appetite, nausea, acid reflux, and diarrhea were seen in 15%-24% of patients 3 months after the infection, Noviello said. In another cohort study in China, diarrhea and vomiting were reported in 5% of patients 6 months after infection.

In any case, it is known that viral, bacterial, and protozoal infections of the gastrointestinal tract are a risk factor for development of functional disorders including irritable bowel syndrome (IBS), functional dyspepsia, and chronic fatigue, according to Noviello.

Accordingly, the results of the present study suggest that SARS-CoV-2 also “may affect the brain-gut axis in the long term,” Noviello and coauthors wrote in an abstract of the study.

It is plausible that SARS-CoV-2 infection could be a trigger for longer-term gastrointestinal symptoms, especially given the previous evidence linking infections and IBS symptoms, or postinfectious IBS, said Juan Pablo Stefanolo, MD, a physician with the neurogastroenterology and motility section, Hospital de Clínicas José de San Martín, Buenos Aires University.

“If it is demonstrated [that SARS-CoV-2 infection is a trigger], the microbiota-gut-brain axis concept in IBS pathophysiology is reinforced,” Stefanolo said in an interview.

In the meantime, practitioners may want to take into account COVID-19 infection history in the evaluation of a patient with IBS-like symptoms and, in case of a known positive COVID-19 result in an IBS patient, be aware of the possibility of symptom exacerbation, Stefanolo said.

Pandemic in Italy: Unique Study Opportunity

The severe outbreak in the Milan region early in the COVID-19 pandemic provided a “unique opportunity” to assess the long-term impact of infection on gastrointestinal and extraintestinal somatoform symptoms, said Noviello.

The investigators sent an online questionnaire to patients who had a molecular diagnosis of SARS-CoV-2 infection by nasal swab between February and April of 2020. To form a control group, they also sent questionnaires to hospital employees and health care providers who had tested negative over that same time period.

In all, 378 questionnaires were completed by 177 SARS-CoV-2–positive individuals and 201 controls. The SARS-CoV-2–positive patients were somewhat older (about 44 years vs. 40 years for controls), were less often female (40% vs. 61%), had a lower education level, and smoked less than did controls, according to the investigators.

A mean of 4.8 months had elapsed between the time of SARS-CoV-2 infection and when the questionnaires were compiled, said Noviello.

In the acute phase, diarrhea was the most common gastrointestinal symptom among virus-positive individuals, occurring in about 50% compared to 20% of controls (P < .001), data show. Other symptoms reported by 40% of SARS-CoV-2–infected individuals included fever, dyspnea, loss of smell or taste, weight loss, myalgia, arthralgia, and asthenia in the acute phase controls in the acute phase, Noviello said.

Persistent Gastrointestinal Symptoms After SARS-CoV-2

Persistent symptoms included loose stools, as measured by the Bristol Stool scale, occurring in 17.8% of SARS-CoV-2–positive individuals, but only 9.3% of the SARS-CoV-2–negative controls, according to Noviello, with an adjusted risk ratio of 1.88 (95% confidence interval, 0.99-3.54).

Chronic fatigue symptoms, as measured by the Structured Assessment of Gastrointestinal Symptoms questionnaire, were reported by about 30% of SARS-CoV-2–positive patients and about 15% of controls, for an adjusted risk ratio of 2.24 (95% CI, 1.48-3.37), according to Noviello’s presentation.

The mean t-score on the Symptom Checklist–12 for somatoform disorders was higher for the virus-positive patients compared to controls, according to Noviello. The scores were 54.6 and 50.5, respectively, with an adjusted score difference of 3.6 (95% CI, 1.0-6.2).

The longer-term sequelae of SARS-CoV-2 infection might be more severe in individuals who experienced diarrhea during acute infection, according to Noviello. In a post hoc analysis, reports of irritable bowel syndrome and loose stools were significantly higher in SARS-CoV-2–infected individuals who had diarrhea in the acute phase compared to those who did not experience diarrhea, he said.

Somatoform disorder scores were significantly higher, and reports of headache, back pain, and chronic fatigue were significantly more common, in individuals who had diarrhea at the time of SARS-CoV-2 infection, he added.

Noviello and coauthors reported no competing interests related to the study. Stefanolo had no disclosures to report.

This article originally appeared on MDedge.com, part of the Medscape Professional Network.

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

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This post originally appeared on Medscape Medical News Headlines

Vadadustat for Anemia in Chronic Kidney Disease: Questions Remain

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This post originally appeared on Medscape Medical News Headlines

Vadadustat for Anemia in Chronic Kidney Disease: Questions Remain

Oral vadadustat, one of a new class of hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs), is effective in the treatment of anemia in people with chronic kidney disease (CKD), but cardiovascular safety outcomes fall short of conventional injectable therapy among patients who are not dependent on dialysis, new data show.

“We found that, among patients with non–dialysis-dependent CKD, vadadustat was noninferior to darbepoetin alfa with regard to hematologic efficacy but did not meet the prespecified noninferiority criterion for cardiovascular safety, which was a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke,” say Glenn M. Chertow, MD, MPH, Stanford University School of Medicine, Palo Alto, California, and colleagues in their paper published this week in the New England Journal of Medicine.

In commenting on the research, Jay B. Wish, MD, medical director of the Out-Patient Dialysis Unit at Indiana University Hospital, Indianapolis, said the findings raise some concerns.

“There is little question regarding the efficacy of vadadustat — and HIF-PHIs in general, based on other studies, but there are still many questions to be answered regarding the safety of this new class of anemia agents,” he told Medscape Medical News.

“The lack of non-inferiority of vadadustat vs darbepoetin with regard to the time to a major adverse cardiovascular event (MACE) in the non-dialysis-dependent CKD population is of concern and may be a barrier to approval by the US Food and Drug Administration (FDA),” he added.

In an accompanying editorial, Adeera Levin, MD, head of the Division of Nephrology, University of British Columbia in Vancouver, Canada, agreed that the data offer pros — and notable cons.  

“The data are convincing that vadadustat is effective in increasing hemoglobin concentrations in both dialysis-dependent and non–dialysis-dependent populations but are less convincing with respect to safety,” she said.

Injectable Erythropoiesis-Stimulating Agents Have Safety Issues of Their Own

Anemia is a common concern among patients with CKD, affecting as many as 30% to 40% of patients who are not dependent on dialysis, and while injectable erythropoiesis-stimulating agents (ESAs) — along with iron deficiency correction — are recommended, ESAs carry a risk of cardiovascular events when treatment is targeted to near-normal levels of hemoglobin concentrations, resulting in a black-box warning requirement for the agents from the FDA.

The development of oral HIF-PHIs has meanwhile been greeted with excitement as potentially offering more convenience and adherence to treatment, and some agents in this class, including roxadustat, have already been approved in some countries.

To comprehensively compare the HIF-PHI vadadustat with the commonly used ESA, darbepoetin alfa (Aranesp), for safety and efficacy, researchers conducted two pooled analyses, each involving two open-label, noninferiority trials, with one analysis involving patients with CKD who did not require dialysis and another of patients who were undergoing dialysis.

In the first, Chertow and co-authors looked at the pooled data from two randomized, phase 3 noninferiority trials of patients with CKD who were not on dialysis, and who either were previously treated with an ESA (n = 1725) or were not previously treated with an ESA (n = 1751).

With a median follow-up of 1.63 and 1.80 years in the two studies, vadadustat did achieve noninferiority compared with darbepoetin alfa for hematologic efficacy, with least-squares mean changes in hemoglobin concentration from baseline to weeks 24 through 36 of 1.43±0.05 g per deciliter in the vadadustat group and 1.38±0.05 g per deciliter in the darbepoetin alfa group, falling withing the prespecified noninferiority margin.

However, in the primary safety endpoint of the time to first MACE — a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke — pooled across the two trials, a first MACE occurred in 22% in the vadadustat group and 19.9% in the darbepoetin alfa group, for a hazard ratio of 1.17, which failed to meet the prespecified noninferiority margin of 1.25.

The authors note that an analysis of events in the trials suggested that the higher risk in the vadadustat group was largely the result of an excess of nonfatal myocardial infarctions and a higher incidence of death from noncardiovascular causes; however, the causes of the higher noncardiovascular deaths could not be determined.

No Increased Risk Seen in Dialysis-Dependent Patients

In the second study, by Kai-Uwe Eckardt, MD, of the Department of Nephrology and Medical Intensive Care, Charité–Universitätsmedizin, Berlin, Germany, and colleagues, also published in NEJM this week, the researchers looked at two trials with a combined 3923 patients who were dependent on dialysis. This also showed that vadadustat was noninferior to darbepoetin alfa in the correction and maintenance of hemoglobin concentration, with target hemoglobin concentrations achieved in both trials.

However, unlike the analysis of non–dialysis-dependent patients, the incidence of a first MACE event was similar between the two agents, therefore achieving noninferiority.

“The two international phase 3 clinical trials…met the prespecified noninferiority margins for cardiovascular safety, pooled across the two trials, and hematologic efficacy, assessed separately for each trial,” Eckardt and coauthors write.

Nevertheless, the possibility of safety issues that may exceed those already seen with ESAs is troublesome, Wish, the Indiana U. nephrologist, further commented.

“The FDA already considers ESAs to be dangerous enough to merit a black-box warning, and the restrictions regarding its use in non–dialysis-dependent patients (target Hb 10-10 g/dL) are even greater than those for dialysis-dependent patients (target Hb 10-11 g/dL),” he said. 

“So, an agent that may be even less safe than ESAs in the non–dialysis-dependent population may be considered by the FDA too toxic for approval.”

Higher Risk in Patients Not Dependent on Dialysis Seen Before

While the higher risk seen among patients who are not dependent on dialysis is puzzling, Wish noted that it’s not the first time this pattern has been observed.

Peginesatide (Omontys) [an erythropoiesis-stimulating agent that was recalled by the FDA in 2013 due to some cases of fatal anaphylaxis] had this exact same issue with demonstration of non-inferiority in dialysis-dependent patients, but lack of non-inferiority in non–dialysis-dependent patients,” he noted.

“The possible explanations are that there is an adverse cardiovascular risk property of vadadustat that is somehow blunted in the dialysis-dependent population, or that the adverse risk property of darbepoetin is greater in the dialysis-dependent population,” he explained.

Other considerations, in addition to MACE, include “long-term effects that may be due to off-target gene transcription induced by HIF-PHIs,” Wish added. 

“There may be off-target beneficial effects as well, which along with long-term adverse effects, may only be answered with long-term follow-up studies and registries following drug approval.”

In her editorial, Levin further underscored the need for more research into these unanswered questions.

“The issues raised in these trials should motivate us to answer critical questions regarding goals of therapy, risks, and benefits with trials specifically designed to do so,” she writes.

“To enable us to have informed discussions with our patients, many more questions need to be asked and answered,” she concludes.

The studies were supported by Akebia Therapeutics and Otsuka Pharmaceutical. Wish disclosed that he has been invited to a vadadustat virtual advisory board meeting in May 2021 by Otsuka and Akebia. Levin disclosed that she has provided educational seminars on the topic of anemia and HIF-PHIs, some of which were funded by AstraZeneca.

N Eng J Med. Published April 29, 2021.

Chertow et al study. Abstract
Eckardt et al study. Abstract
Editorial

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Woman overcomes chronic ME to swim Oceans Seven in new Sky documentary

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This post originally appeared on Daily Express :: Health Feed

swim

Beth overcame ME to swim Oceans Seven (Image: Nyla Sammons)

As wild swimming gains ever more fans due to lockdown, a new documentary film Against The Tides follows Beth’s attempt to be the first person to swim the world’s seven most dangerous straits – known as the Oceans Seven – in a single year. “One of the things that surprises me is the ability of the body to endure,” says Beth. “It is not what drives you forward, but what is holding you back, which stops you from doing things.” The film shows the Briton go from Hawaii to Ireland, New Zealand to Gibraltar in her quest – some would call it foolhardy – to prove she could do it. 

And while the swimming is all very fascinating – at one point she’s swimming with a dangerous shark, at other times avoiding jellyfish, rocks and hyperthermia – it is the complex and extraordinarily strong woman at the heart of the story which makes the Sky documentary so compelling.

From the start you question what drives her; and whether the actions are inspiring or selfish. Even her own mother isn’t convinced, admitting: “I am not her number one supporter when it comes to her swimming.

“She is the single parent to a small child and I don’t like the idea of her swimming against tides or through shoals of jellyfish because I don’t want her to get hurt.”

But then the backstory comes out. Beth, now 43, from Somerset, is battling both the demons from her past and the challenges of her present. Pushing herself to the limit is one of the few ways she can take control.

Aged ten, a popular, sporty and academic child she had a painless bout of glandular fever. She then started getting strange pains in her limbs and an exhaustion would overcome her. Weeks would go by and she would be fine, but then the illness would take hold again until she spent more of her time feeling ill than well. 

“No one could explain what or why this was happening to me,” she recalls as we talk over Zoom. “All through my adolescence I would have these complete crashes where my glands would come up, I would feel so sick and the pain was so bad – in different places – that it felt like I had molten lava running through my veins.

beth

Covid has kept Beth away from the sea but she’s relaxing in a bathtub on her patio full of icy water (Image: NC)

“I got to the stage where I couldn’t even lift my hand up to brush my own hair.

“Sometimes I’d be fine for three months – I’d be completely well. And then I would crash for six months. And the hardest thing was not knowing what was wrong with me. The blood tests came back fine; there was nothing wrong with me as far as the doctors were concerned.

“It obviously led to mental health issues; I started self-harming, I became bulimic. I couldn’t trust my body. The doctors said it was all in my head when I knew it was my body.

“Aged 17 I couldn’t even sit up, let alone stand up and I was in a wheelchair. I didn’t even have the energy to brush my teeth or scratch an itch. All my muscles ached all the time.”

One of the only things that seemed to help was water.

The family farm had a pond and her father enlarged it; she would lie in it for hours, the weightlessness of being in the water provided a brief respite from real life.

At 17, after seven years of countless visits to different doctors, she received a diagnosis of ME or chronic fatigue syndrome. The downside was, there was no cure. 

“It was a relief to get a diagnosis, because my mental state was so fragile after everyone saying there was nothing wrong with me but being told there was no cure made me feel like my life was over,” she says.

sea

Cold water helps to soothe Beth’s physical symptoms of ME (Image: David Leyland)

“But I still had some fight in me and that was to rebel against myself, against this extreme lethargy. It became a compulsion to push myself as much as I could.”

Beth started listening to her body, learned to recognise her triggers. She refused to continue her education, knowing that the stress was making her ill. She would move when she could and kept pushing her body and, slowly, she began to recover.

“Recovery is an odd word because I still get the symptoms sometimes,” she says.

“My immune system is really bad and when I overdo things, I get this heavy feeling, but I’ve learned how to listen closely to my body. But at the same time, I felt like I had to prove myself and prove not only that I could do what others do, but to be almost superhuman.”

When she felt well enough, after years of being cooped up in her bedroom, she made a bucket list of things she wanted to do.

One of the first was flying to Hawaii. She initially went for a brief two-week holiday, but didn’t return to England for seven years; first training as a massage therapist in Hawaii before, briefly, becoming a Buddhist monk in Thailand where she was given lodgings at a monastery in exchange for English lessons. She willed herself to wellness.

Coming back to England, she met a man, fell in love and had her son, Dylan, but was left a single mother when they split up; a new challenge for someone who had already been through so much.

When Dylan, now 11, started school, she was forced to face yet more problems.

“I always saw Dylan as delightfully kooky,” she recalls. “He was outgoing and adventurous. But when he went to school, everything changed. They described a child I didn’t know – he would hide underneath tables and he would bite and scratch.

“Dylan just couldn’t cope. It was horrendous, he was six years old and he started talking about wanting to kill himself. So I took him out of school, took him away from all the things that triggered him and started home-schooling.”

One day a week her mother would look after Dylan, who has since been diagnosed with autism, ADHD, OCD, sensory issues, dyslexia and dyspraxia, and Beth, who works as a part-time masseur, started going to the local swimming pool for respite.

While there she decided to undertake a Channel swim challenge – swimming the length of the Channel in a month.

She did it in just a few days. It felt so amazing that she booked an organisation to help her swim the real Channel two years later. She knew she needed more time than normal to prepare her body, but she was hooked on the challenge.

Now Beth admits her reasons for swimming are complicated. “No one can hear me scream in the water,” she says, quietly. “I could swim it all out. It was a way of calming my body and my mind down. I needed to push myself because I was constantly feeling like I was on the verge of feeling like a failure.

“I had all these questions of guilt.

“And when your child has special needs you feel so alone the whole time. Swimming was a way of chasing the demons in my head. The best thing for me was the meditative calm which comes at the end of a good long swim.”

Dylan was always part of her challenges. 

beth

Beth, with Dylan, says her son is involved in the training for her challenges (Image: David Leyland)

They’d go down to the sea and she’d put him in a wetsuit and life jacket in a small dinghy attached to her leg. “He had a little gun and would squirt me in the face if he wanted to talk to me. He would point which way down the coast he wanted to go and I went swimming with him.”

As for the impact on Beth’s body, she says the actual swimming aspect has always been the easiest part: “You can train your mind to push through so many barriers and achieve what you want.” The tough bit was on land.

By the time the documentary was filmed two years ago, Dylan was nine and not as malleable as he was as a toddler. It features scenes of him terrified at the thought of her being attacked by sharks. The team she travelled with for each of the challenges – which cost more than £80,000 – also included a childminder for Dylan but he increasingly recoiled at being left with them.

Towards the end of the film, as Beth attempts her fifth swim, in Northern Japan, Dylan hides her swimming costume. She is forced to do some tough soul searching about what she was doing the swim for.

“Yes, there are people who criticised me for swimming when I had Dylan but others also said, ‘you are going to be such a great role model,'” she ponders. “No one can say how you should do this thing called motherhood; this is just my version of it.”

Her decision, which viewers will see, is an emotional surprise.

Since doing the challenge, Covid has kept Beth away from the sea but she and Dylan have been planning adventures for when the world opens up again. In the meantime, she has been forced to take her aquatic solace in a bathtub in her garden. “I am missing swimming so much, I miss the sea,” she sighs.

“The closest I get to the feeling I get from swimming is jumping into an icy bathtub on the patio. When I am feeling stuck or stressed or lethargic or depressed, I jump in cold water and it is an instant reset.

“You can’t be anywhere but in the present because there is an overwhelming sensation which gives you an endorphin high. It’s insane.”

Against the Tides can be seen on Sky Documentary and is also available for digital download

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Eamonn Holmes addresses cause of chronic pain battle ‘I mysteriously dislocated my pelvis’

Eamonn Holmes addresses cause of chronic pain battle ‘I mysteriously dislocated my pelvis’

Yesterday, the journalist spoke out on his Twitter page as he thanked fans for their good wishes over the news he is to become a grandfather.

He wrote: “I have been very bad at answering and acknowledging so many ‘Grandpa’ good wishes today.

“Please forgive and understand how draining and debilitating this Back pain I’m suffering is.

“I’m drained. Had steroid injections today which will Hopefully turn the tide. #ChronicPain.”

Taking paracetamol can make chronic pain worse – Dr Philippa issues warning

Taking paracetamol can make chronic pain worse - Dr Philippa issues warning
Paracetamol is a common painkiller used to treat aches and pain. It can also be used to reduce a high temperature. People prone to chronic pain will naturally think to take paracetamol but Dr Philippa says to think again. Speaking on ITV’s This Morning on Monday, she explained painkillers could be potentially making your situation worse.
“There is a condition called paracetamol overuse headache where the paracetamol involved is the problem,” she warned.

Medication overuse headache is a type of headache that develops and gets worse with frequent use of any medication treatment for pain in people who have tension-type headache or migraine.

According to an article published in the British Medical Journal (BMJ), medication overuse headache is a common disorder, affecting one to two percent of the population.

It is also difficult to treat, notes the article.

 

“Symptoms usually worsen after withdrawal of analgesia and may take a number of weeks to get better although some do not improve and many will relapse,” reports the BMJ.

In light of these facts, “prescribing long-term paracetamol to patients with co-existent headache disorders needs to be considered carefully and should be avoided in the treatment of headache disorders,” the BMJ article states.

It is worth noting that only people who are prone to headaches develop this syndrome, generally those with migraine or a family history of migraine.

“It is generally not seen in people taking painkillers for reasons other than headaches, such as arthritis or back pain,” explains The Migraine Trust.

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Is it safe to take paracetamol with other painkillers?

According to the NHS, it’s safe to take paracetamol with other types of painkiller that don’t contain paracetamol, such as ibuprofen, aspirin and codeine.

“Do not take paracetamol alongside other medicines that contain paracetamol,” warns the health body.

If you take two different medicines that contain paracetamol, there’s a risk of overdose, it explains.

“Before taking any other medicines, check the label to see whether they contain paracetamol.”

How do painkillers work?

Different painkillers work in different ways.

“Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and aspirin work by changing the way your body responds to pain and swelling,” explains Bupa.

According to the health body, mild opiate painkillers such as codeine work by blocking pain messages in your brain and spinal cord.

“Doctors aren’t sure exactly how paracetamol works, but it’s thought that it may block pain signals to your brain.”

Alternative ways to alleviate pain

There a range of methods for alleviating chronic pain that do not involve taking medication.

“Staying physically active, despite some pain, can play a helpful role for people with some of the more common pain conditions, including low back pain, arthritis, and fibromyalgia,” explains Harvard Health.

Losing weight can also aid pain relief.

Harvard Health explains: “Many painful health conditions are worsened by excess weight.”

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Fibromyalgia: Chronic pain doctor says turmeric could help end a lot of suffering

Fibromyalgia: Chronic pain doctor says turmeric could help end a lot of suffering

Other ways to alleviate chronic pain

The old-fashioned treatment for persistent pain, also known as chronic pain, was bed rest for weeks or months on end.

This advice has now been shown to actually make chronic pain worse.

As the NHS explains, exercise and continuing to work are key to recovery.

Lying in bed for long periods may make the pain last longer because inactivity makes you stiffen up and your muscles and bones get weaker, warns the health body.

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