IB-Stim: A New Hope for Adolescents with IBS ?
Recently, the FDA approved a product focused on reducing pediatric IBS discomfort.1 The device developed by Innovative Solutions is known as IB-Stim.2 Its release of encouraging adolescent clinical data and FDA approval have excited both adolescent and adult IBS patients but, in my opinion, there is some reason to proceed with caution.
What is IB-Stim?
The company describes this as a percutaneous electrical nerve field stimulator (PENFS) system. It is available by prescription only and is approved for use in patients ages 11 – 18 y/o with functional abdominal discomfort with irritable bowel syndrome (IBS). IB-Stim may be utilized for up to 120 hours/week for up to 3 consecutive weeks.
Theorized mechanism of action
The PENFS device is applied behind the ear and stimulates a specific set of Cranial Nerves: V, VII, IX, X and the Occipital nerves. Cranial nerves differ from spinal cord nerves in that these nerves branch directly from the brain rather than the spinal cord.
Some functional studies of the brain in IBS patients demonstrate abnormal signaling from the amygdala.3 Application of the device to and around the ear promotes the device to send signals via the skin to the nerve endings of specific cranial nerves and the occipital nerve implicated in this pain pathway. The company theorizes that sending electrical impulses near nerve endings in and around the ear can impact pain signals that the withdrawal effect from opioids. Notably, the exact mechanism remains unknown.
To date, there is one double-blind, randomized, sham-controlled study assessing the efficacy of IB-Stim in IBS patients fulfilling Rome III criteria in ages 11 – 18 y/o.4 The study was conducted at a pediatric hospital, hence why adults > 18 y/o were not included in the study. The IBS patients included in the study were a mix of phenotypes (symptom predominance); some with a predominance of diarrhea, constipation or mixed (IBS-D, IBS-C, IBS-M, respectively). Per the study, ~70% of the patients had reportedly failed an average of 4 medications for IBS prior to study enrollment.
A double-blind study means that both the doctor and the patient were unaware as to what type of device was being applied to the patient’s outer ear. The device could have been the actual IB-Stim device or a sham non-active device as the placebo.
The authors specifically utilized the Pain Frequency-Severity-Duration Scale (PFSD) Score for assessing pain intensity, frequency, and duration. Also, they utilized validated scoring systems for nausea, anxiety, quality of life and disability impact as well.
Patients had either the active or non-active sham device applied for 5 days a week for 4 weeks. Notably, no efficacy data were collected at 4 weeks.
Does it work?
In regards to the primary endpoint of pain, 50 subjects were ultimately assessed in the final sub-analysis. By the end of 3 weeks, a 30% reduction in pain was considered significant. 16 of 27 patients (59%, PENFS median score 5.0 [IQR: 4.0-7.0]) in the active IB-Stim group vs 6 of 23 patients (26%, PENFS median score 7.0 [IQR: 5.0-9.0]) in the non-active sham group experienced this degree of relief. Please see the study results on their page for further secondary endpoint results.
- Cardiac pacemaker
- Psoriasis vulgaris
- 2.8% reported mild ear discomfort during active treatment
- 2.8% reported Adhesive Allergy during active treatment
- 0.9% Fainted due to Needle Phobia in the Placebo arm
*No data beyond 4 weeks exists with IB-Stim
*To date, no adverse events (AE’s) have been reported
Adverse Event = Medical occurrence (abnormal labs, signs or symptoms) observed during administration of a product that may or may not be related to the product being studied.
Is this right for adolescent IBS patients?
Well, it is certainly an interesting option since it is a non-pharmacologic intervention. As medications may be ideally avoided in adolescents, this device may be considered given this RCT study data. However, I personally have some concerns about the device and trial data. Please keep in mind, that these are strictly my own personal thoughts and opinions.
For adolescents, this device may provide some relief but it is not developed as permanent therapy. Also, it may be cost-prohibitive for some families as its twin device (see below) is estimated to cost several hundreds of dollars. I do not believe it is covered by insurance either. While digital wearables are all the rage these days, this device worn around the ear may also make some adolescents feel more image-conscious than they already may be amongst their peers. Some adolescents with needle phobia may not desire the small needle prick associated with the application pads in and around the ear. Also, I find it very limiting that the study only assessed patients up to 3 weeks out rather than a longer, more meaningful duration of time. 3 weeks is hardly enough respite from symptoms and patients can be the first to relate that their symptoms may go through periods of flare and well being. Hence, a 3-week assessment does not indicate the durability of response to me.
How about adult IBS patients?
I’ll keep this simple. There is no data or trials to my knowledge assessing adult IBS patients. The advantages and disadvantages of this adolescent study should help researchers design and spawn a better trial in adults. Also, it is not available to adults without prescription as it is only FDA approved in adolescents.
Anything else I should know?
The FDA has an approval pathway for devices that possess a low-moderate risk to patients. IB-Stim was reportedly passed through this approval pathway after the same company previously patented its first PNFS device to manage symptoms of opioid withdrawal known as the NSS-2-BRIDGE.5 The company’s product specific page illustrates how the device is theorized to function.
Notably, there are no available randomized, placebo sham-controlled trials of this Bridge device for opioid withdrawal. While there is one clinical trial by Innovative Solutions that is reported as actively enrolling since June 2018, no data have been released.6 Interestingly, another company is known as Diansys, Inc also markets a similar device with the same mechanism of action for opioid withdrawal.7 Per their website, they presented a January 2019 poster illustrating a randomized placebo sham-controlled study in diabetic peripheral neuropathy with some promising results.8
So what’s the verdict?
There is a plethora of evidence to suggest aberrant pain signaling pathways exist in IBS patients. This device may have some impact on those pathways. However, the lack of long-term data is concerning and the small size of the population studied with a diverse phenotype of IBS patients limits its generalizability and durability of response in adolescents and even adults. While this may be considered by some to be a low-risk option, its price point compels me to desire there to be better quality data available before recommending to patients. As always, please consult with your gastroenterologist specialist before making any decisions to pursue new therapies.
Do you think there is enough awareness of IBS?