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

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.

13 Tips for Living with Gastroparesis

By Ellen Lenox Smith, Columnist

Few people understand what it’s like to live with gastroparesis – a digestive disorder that slows or stops the movement of food from the stomach to the intestine. Not being able to digest food and eliminate waste properly causes abdominal pain and bloating.

Gastroparesis can develop when the vagus nerve is damaged by an injury or illness and the stomach muscles stop working properly. In my case, it was triggered by Ehlers-Danlos syndrome.

The most extreme cases of gastroparesis lead to severe nausea, vomiting, and dehydration, when urgent care may be required at a medical facility so IV fluids can be given.

You can’t allow partially digested food to ferment and become toxic in your body. There are cases where death has resulted from not being treated.

I have been searching for answers for two years now. I had times when things seemed semi-normal. But for the past three months, I have been having on and off luck with elimination and wanted to share some tips I’ve learned that may help if you also suffer from gastroparesis.

1. Changing eating habits can sometimes help control the severity of gastroparesis symptoms. It is suggested to eat six small meals a day instead of three large ones. Less food makes it easier for the stomach to empty.

2. Chew food slowly and thoroughly while drinking at least 8-ounces of non-carbonated, sugar-free, caffeine-free fluid with each meal.

3. Walking or sitting for 2 hours after a meal -- instead of lying down -- may assist with gastric emptying.

4. Avoid eating high-fat foods, because fat slows digestion. Red meat, pork and fowl should be ground.

5. Avoid raw vegetables and fruits. They are more difficult to digest and the undigested parts may remain in the stomach too long. Oranges and broccoli, in particular, contain fibrous parts that do not digest well. Acceptable vegetables might include avocado, summer squash, zucchini, or mashed pumpkin.

6. A person with severe symptoms may have to turn to liquid or puréed food, which empty more quickly from the stomach. Puréed fresh or cooked fruits and vegetables can be incorporated into shakes and soups.

7. Some doctors recommend a gluten free diet. Even mild gluten intolerance can result in the development of thyroid imbalance, which could worsen gastroparesis.

8. Fermented food rich in lacto-fermented foods such as sauerkraut, kimchi, black garlic, and kefir can also improve digestion. Bone broth is very nutritious and healing for your gut, as it contains calcium, magnesium, phosphorus, sodium, potassium, glucosamine, chondroitin, and glycine to ease digestion and soothe inflammation.

9. Believe it or not, chewing gum can make a big difference too. The act of chewing produces saliva, which not only contains digestive enzymes but also stimulates muscular activity in the stomach and relaxes the pylorus, the lower part of the stomach. Chewing gum for at least 1 hour after meals is a very effective treatment of gastroparesis.

10.  High-fiber laxatives such as Metamucil that contain psyllium should be avoided.

11.  You might want to considering giving acupuncture a try. Needles are believed to restore healthy immune and neurological function while removing blocks in your life-force energy called ‘chi’.

12.  Colonics is also something to consider and what I have had to turn to weekly to eliminate waste. A colonic is the infusion of water into the rectum to cleanse and flush out the colon.

13.  There are medications that can help. I had amazing and quick results using metoclopramide, but unfortunately ended up reacting to it and had to stop. That was heartbreaking!

Living with gastroparesis is not easy and most people connected to you have no idea the sensations it is creating in your body. Remember that eliminating is a natural and necessary process. You must rid your body of those toxins and not allow them to ferment inside you.

I hope that one or more of these suggestions will help to improve the quality of your life.

Ellen Lenox Smith suffers from Ehlers Danlos syndrome and sarcoidosis. Ellen and her husband Stuart live in Rhode Island. They are co-directors for medical marijuana advocacy for the U.S. Pain Foundation and serve as board members for the Rhode Island Patient Advocacy Coalition.

For more information about medical marijuana, visit their website. 

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