FDA Clears Ear Device for IBS Pain

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has cleared for marketing the first medical device to treat abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS).

The IB-Stim device is made by Innovative Health Solutions and is only available by prescription. It uses neuromodulation to stimulate cranial nerves around the ear to provide relief from IBS, a condition affecting the large intestines that causes abdominal pain and discomfort during bowel movements.

The battery powered device is placed behind the patient’s ear — much like a hearing aid — and emits low-frequency electrical pulses that disrupt pain signals. It is intended for use up to three consecutive weeks.  

“This device offers a safe option for treatment of adolescents experiencing pain from IBS through the use of mild nerve stimulation,” said Carlos Peña, PhD, director of the FDA’[s Office of Neurological and Physical Medicine Devices.

The FDA reviewed data from a placebo controlled study published in The Lancet that included 50 adolescent patients with IBS. During the study, patients were allowed to continue using medication to treat their abdominal pain. Most had failed to improve through the use of drugs.

IB-Stim treatment resulted in at least a 30% decrease in pain after three weeks in 52% of the treated patients, compared to 30% of patients who received the placebo. Six patients reported mild ear discomfort and three had an allergic reaction caused by an adhesive at the site of application.

IMAGE COURTESY OF INNOVATIVE HEALTH SOLUTIONS

IMAGE COURTESY OF INNOVATIVE HEALTH SOLUTIONS

Innovative Health Solutions is not disclosing any details about the potential cost of an IB-Stim or where it will be available.

“We are still working to finalize our pricing structure,” Ryan Kuhlman, National Director of Innovative Health Solutions, said in an email. “There are many factors that go into the final contract price with a hospital and will likely vary from hospital to hospital. We do want to make this treatment available and affordable as we work towards favorable insurance coverage.”  

The FDA reviewed the IB-Stim through a regulatory pathway for low- to moderate-risk medical devices. Clearance of the device creates a new regulatory classification, which means that similar devices for IBS may be cleared if they are substantially equivalent to an approved device. Similar ear devices have been cleared by the FDA to treat symptoms of opioid withdrawal and for use in acupuncture.

IBS is a group of symptoms that include chronic pain in the abdomen and changes in bowel movements, which may include diarrhea, constipation or both. A 2018 study found that hypnosis relieves pain in about a third of IBS patients.

Can Hypnosis Help Relieve Chronic Pain?

By Pat Anson, PNN Editor

Two new studies suggest that hypnotherapy can relieve pain for some patients with irritable bowel syndrome (IBS), complex regional pain syndrome (CRPS) and other chronic pain conditions.

The first study, published in The Lancet medical journal, involved nearly 500 IBS patients who were recruited from 11 hospitals in the Netherlands. IBS is a common condition characterized by repeated attacks of stomach pain, cramps, diarrhea and constipation.

Study participants were randomly assigned to one of three groups: individual hypnotherapy, group hypnotherapy, or support sessions that included dietary advice and education about IBS.  The hypnotherapy sessions were designed to reduce pain and discomfort from IBS.

After three months, 41% of the people in individual hypnotherapy and 33% of those in group hypnotherapy reported adequate relief, compared to less than 17% of those in education and support sessions.   

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The results from group hypnotherapy were even better after 9 months. Nearly half the patients in that group reported relief from IBS symptoms.

“The trial finding that hypnotherapy works better than educational support adds evidence to previous studies showing that hypnotherapy may have a helpful effect,” the UK’s National Health Service said in a review of the Dutch study. “The finding that group hypnotherapy works about as well as individual hypnotherapy is interesting, as this means many people could be treated by the same therapist at the same time, which could reduce waiting times and the cost of treatment.

“It also demonstrates that unfortunately, even with the best care, IBS can still be a difficult condition to treat. Half or more people receiving hypnotherapy still gained no symptom relief.”

Hypnosis and CRPS

Another hypnosis study, recently reported by Japanese researchers at the World Congress of Pain, involved 121 patients with refractory chronic pain – also known as intractable pain – who agreed to hypnotherapy either biweekly or in monthly 60 minute sessions. The patients all had chronic conditions that were difficult to treat, such as CRPS, phantom limb pain, neuropathic pain and cancer pain.

Researchers found that 71% of the patients reported pain relief during the hypnosis sessions. And for many of them, the analgesic effect continued after the session ended.

“These patients have all undergone multidisciplinary pain treatment, including medication, physiotherapy and CBT (cognitive behavioral therapy),” Miyuki Mizutani, PhD, a clinical psychologist at Aichi Medical University, told Pain Medicine News. “And ultimately, they did not respond completely to those treatments. So we believe the untreatable part of the pain can be treated by hypnosis.”

Hypnotherapy even works for patients with CRPS, although they often require more hypnosis sessions before having an analgesic effect.

“I’ve now been performing hypnosis for 18 years, and have found it very effective in those patients, though it can be difficult to administer in chronic pain,” Mizutani said. “It takes time, and complete remission is not very common. However, our experience is that repeated analgesic experiences can lead to long-term improvements in chronic pain.”

Vitamin D Supplements Could Ease Symptoms of IBS

By Pat Anson, Editor

A new study suggests that Vitamin D supplements may help ease stomach cramps, constipation and other painful symptoms of irritable bowel syndrome (IBS).

In a systematic review (a study of studies) involving hundreds of patients around the world, British researchers found that over half the patients with IBS had low levels of Vitamin D in their blood serum. Vitamin D supplements helped improve symptoms for some patients, although the findings were mixed.

"The available evidence suggests that low vitamin D status is common among the IBS population and merits assessment and rectification for general health reasons alone,” said Claire Williams of the University of Sheffield, lead author of the study published in the European Journal of Clinical Nutrition.

"An inverse correlation between serum vitamin D and IBS symptom severity is suggested and vitamin D interventions may benefit symptoms."

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Williams and her colleagues cautioned that the evidence was not strong that supplements would help, and said larger studies were needed to build a case for Vitamin D as a treatment for IBS.

Britain’s National Health Service was also cautious about the findings.

“Although this possible link is worth investigating further, the evidence is currently very limited. The results seen in this study are an extremely mixed bag taken from studies of questionable quality," the NHS said in a review.

“The observational studies mainly just show that a number of these people with IBS also had a vitamin D deficiency. But you could select many other samples of people with IBS and find they have sufficient vitamin D levels, or other people who don't have IBS but who are vitamin D deficient.”

Both IBS and vitamin D deficiency are common in the western world. About 20% of adults in the UK are deficient in Vitamin D. Low levels of the “sunshine vitamin” have also been linked to fibromyalgia and multiple sclerosis

Most people get all the Vitamin D they need by being exposed to ultraviolet rays in sunlight. You can also get it by eating foods rich in Vitamin D, such as oily fish and eggs. Vitamin D has a wide range of positive health effects, such as strengthening bones and inhibiting the growth of some cancers.

Common Medical Conditions Linked to Fibromyalgia

By Lana Barhum, Columnist

People with fibromyalgia are more likely than others in the general population to have other chronic conditions. But doctors have yet to figure out why fibromyalgia often coexists with other diseases – what’s known as “comorbidity.”

Fibromyalgia sufferers often have migraines, autoimmune diseases, irritable bowel syndrome, depression, anxiety and sleep disturbances. Having multiple overlapping conditions isn’t easy, and increases physical pain and suffering. 

It is important for all of us with fibromyalgia to learn about these conditions and their symptoms.  Being knowledgeable about them will help us and our medical providers better control our symptoms, pain and overall health. 

Here are several common medical conditions faced by people who also have fibromyalgia:

Migraines:  Research indicates migraine sufferers are more likely to have fibromyalgia. One study from 2011, published in The Journal of Headache and Pain, suggests migraine headaches may even trigger fibromyalgia. Researchers believe preventing migraine headaches could potentially stop or slow down the development of fibromyalgia in some people, or minimize symptoms in fibromyalgia sufferers.

"These results suggest different levels of central sensitization in patients with migraine, fibromyalgia or both conditions and a role for migraine as a triggering factor for FMS. Prevention of headache chronification in migraine patients would thus appear crucial also for preventing the development of fibromyalgia in predisposed individuals or its worsening in co-morbid patients,” Italian researchers reported.

Autoimmune Diseases:  In about 25% of cases, fibromyalgia co-exists with an autoimmune condition, according to the Centers for Disease Control and Prevention.  Two serious autoimmune diseases that may accompany fibromyalgia are rheumatoid arthritis (RA) and lupus. 

Other studies show at least 20% of RA patients also have fibromyalgia, but researchers have yet to understand the connection. The pain of RA can trigger fibromyalgia flares, worsen pain and symptoms, and vice versa. 

In 2016, researchers in the UK tried to determine whether RA patients who also had fibromyalgia had lower levels of joint inflammation.  The results of their study, published in BMC Musculoskeletal Disorders, determined RA patients with fibromyalgia had "widespread soft tissue tenderness but fewer clinically inflamed joints, have higher disease activity scores but may have lower levels of synovial [joint] inflammation."

The researchers suggested that different approaches to treatment may benefit these patients.

"These patients are less likely to respond to escalation of inflammation-suppressing therapy and may be more suitable for other forms of treatment including alternative means of pain control and psychological support,” they wrote.

It is also not uncommon for lupus and fibromyalgia to co-occur.  However, fibromyalgia is no more common in lupus than other autoimmune diseases, according to researchers out of the National Data Bank for Rheumatic Diseases

Depression and Anxiety: People with fibromyalgia frequently experience depression and anxiety.

According to a 2011 report published in the journal Pain Research and Treatment, 90% of fibromyalgia patients have depressive symptoms at least once, and 86% of those people may suffer from a major depressive disorder. Depression and fibromyalgia occur at the same time in at least 40% cases -- a connection that researchers are still trying to understand.

The prevalence of anxiety symptoms in fibromyalgia patients ranges from 13% to about 71%,  according to Portuguese researchers. 

Irritable Bowel Syndrome: A majority of fibromyalgia patients – up to 70% - also suffer from irritable bowel syndrome (IBS), a digestive disorder characterized by abdominal pain, cramping, bloating, diarrhea and constipation.

Sleep Disturbances:  Most people with fibromyalgia report problems sleeping.  No matter how long they sleep, theyrarely feel rested. Restless leg syndrome, non-restorative sleep, and sleep apnea are all sleep issues associated with fibromyalgia.

People with fibromyalgia are more likely to have restless leg syndrome (RLS) than others in the general population, according to a study from the American Academy of Sleep Medicine (AASM). RLS is a disorder that causes uncomfortable feelings in the legs and/or the urge to keep moving the legs. The AASM study, published in the Journal of Clinical Sleep Medicine, finds 33% of people with fibromyalgia also have RLS.  

Up to 90% of fibromyalgia patients experience non-restorative sleep, a feeling of not getting refreshing sleep, despite appearing to have slept.

A 2013 study published in Clinical and Experimental Rheumatology reports that 61% of men with fibromyalgia suffer from sleep apnea, as well as 32% of women. Sleep apnea is a serious sleep disorder where breathing is interrupted during sleep.  

Living with Fibromyalgia and Co-Existing Conditions                 

In addition to suffering from fibromyalgia, I also suffer from three co-existing conditions -- rheumatoid arthritis, depression, and anxiety.  Having both RA and fibromyalgia, I have struggled with more severe symptoms, including muscle and joint pain and cognitive issues.  I know dealing with this debilitating pain results in both depression and anxiety, and both have been frequent visitors to my life.   

I am aware of the effect multiple conditions have on my well-being, and work hard at improving my overall health. I know I can still have a good quality of life, despite the many obstacles that fibromyalgia and its multiple co-occurring conditions present. 

There are other conditions linked to fibromyalgia that I have not mentioned, but they are still significant. Understanding how fibromyalgia and these conditions coexist may someday help researchers develop better treatments for fibromyalgia. 

Lana Barhum is a freelance medical writer, patient advocate, legal assistant and mother. Having lived with rheumatoid arthritis and fibromyalgia since 2008, Lana uses her experiences to share expert advice on living successfully with chronic illness. She has written for several online health communities, including Alliance Health, Upwell, Mango Health, and The Mighty.

To learn more about Lana, visit her website.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.