Archive for the ‘COWS’ Category

The Bridge










A little over a year ago (October 2, 2016), I blogged about a new device being marketed to reduce opioid withdrawal symptoms. I didn’t give the name of the device, because of a lack of data showing it works. Earlier this month, the FDA authorized the company that makes the device to start marketing it, for use in easing opioid withdrawal symptoms.

This device, called the NSS-2 Bridge, is a little bigger than a hearing aid, and is attached behind the ear. The device delivers electrical impulses to three electrodes placed around the ear. The cost for a five-day course of treatment with the device is around $500, and the manufacturer says it eliminates opioid withdrawal symptoms.

Mistakenly, I thought the FDA only approved medications and medical devices after multiple studies showed the treatments were effective. That doesn’t appear to be correct. Instead, according to an article in Forbes magazine online, the FDA is relatively quick to authorize medical devices that appear to have low or moderate risk to the consumer, even if there’s limited data to support their efficacy. This may be particularly true for devices purported to help in any aspect of treatment for opioid use disorder, since so many people are desperate for relief. [1]

I hope this device works as well as it is advertised. A safe device that controls opioid withdrawal symptoms…that sounds great.

But after suffering through several courses in medical statistics, I learned not to assume a given treatment will work unless it’s backed by solid research. There have been far too many products promoted with great fanfare to desperate people that later were found to be no more effective than placebo.

So what evidence did the FDA consider when deciding to approve advertising for the NSS-2 Bridge for the purpose of reducing opioid withdrawal? There’s only one small study, published earlier this year in the American Journal of Drug and Alcohol Abuse.

This retrospective pilot study of 73 people showed the Bridge device significantly improved withdrawal symptoms. Patients had an average COWS (clinical opioid withdrawal scale) score of 20 before the device was placed, and the average score dropped to 7.5 twenty minutes after the device was turned on. After an hour of use, withdrawal scores went down to an average of 4.

These patients were ultimately transitioned to maintenance medications.

After reading this pilot study, I have questions. For example, the Bridge was being used to help patients get through the opioid withdrawal of early medication-assisted treatment. But if the device gets rid of withdrawal symptoms, how do physicians and patients find the dose of medication that suppresses withdrawal? And at what point did the researchers start the medication?

So far as I can tell, there’s no randomized placebo-controlled trials of this device. This type of trial is more reliable to find out if a treatment works or not.

In the Forbes article, Dr. Nora Volkow, the Director of the National Institute on Drug Abuse (NIDA) agreed, saying, “The only way that you can determine the extent by which this device has potential clinical effects is by doing a randomized controlled trial.”

She also went on to say that we shouldn’t perpetuate treatments that aren’t proven by evidence that they work, because patients with opioid withdrawal are desperate, and have a serious disease.

Thank you, Dr. Volkow. You’ve summed it up nicely.

The company that makes NSS-2 Bridge, Innovative Health Solutions (IHS), gave a sales presentation to a group of doctors several years ago. At that meeting, I asked some challenging questions, like why is the company marketing the device before they’ve done the necessary research. I didn’t get a satisfactory answer. The salesman claimed they didn’t have to do more research because it worked 100% of the time. At that time, the company’s credibility took a big hit with me. I don’t know of any legitimate treatment that works for 100% of patients.

Then another doctor said our company has enough patients to power a large study, if IHS wanted to do a good study. The salesman said great, but then indicated the patients would still have to pay for the device.

No, no, no. That’s not the way research works. The manufacturer of the product funds the research, or should be willing to do so, if they believe in their product.

Just think – if that company had started a randomized controlled trial two years ago at that meeting, they might have good data by now, showing if the product works or not. But maybe that’s what they want to avoid.

I will not be prescribing the Bridge until/unless I see randomized controlled studies of this product, proving it works. Because I don’t trust products with better marketing than research.


The COWS scale: how helpful is it?

COWS stands for Clinical Opioid Withdrawal Scale, and it’s probably the most commonly used tool to determine the degree of opioid withdrawal experienced by the patient. The scale has eleven items related to opioid withdrawal. Some are subjective, like the question about the degree of anxiety or irritability the patient is feeling. Some items are strictly objective, such as pupil size and pulse rate. And some are sort of a combination of objective and subjective, like the question asking about both nausea and vomiting. The patient may report nausea and score points on the scale, and if the patient vomits, this scores more points.

I’ve worked in clinics that used the COWS for each dose increase, and I’ve worked in clinics that didn’t use the COWS at all.

I think it’s a good tool, but has some drawbacks. I use it during dose induction, particularly on a patient new to medication-assisted treatment. Sometimes patients aren’t sure how they’re “supposed” to feel on replacement medication, and a COWS score gives me a better idea of how much withdrawal they are in.

For example, I had a patient who felt much fatigue in the evenings. He’s been on the program about a month, and had been dosing at 70mg for about a week. He worked at a strenuous job, and got off work around 5pm. One day, he told the nurses that he needed an increase, since it felt like his methadone “gave out” as soon as he got home, and he had to take a nap before his evening meal because he was so sleepy. When the nurses heard him say   “sleepy,” they correctly became worried he was on too much methadone, and sent him to see me. When I checked him just before dosing the next morning, his pupils were a wide 8 mm and reacted briskly to the bright light I shone in his eyes. He was in withdrawal and he felt better after a few dose increases. His use of the word sleepy was confusing, since to us, we worry “sleepy” means “headed towards a methadone overdose.”

Sometimes, a patient reports severe withdrawal but doesn’t score very high on the COWS. I don’t assume the patient is lying, because some patients don’t tolerate withdrawal symptoms easily. More commonly, I see patients, mostly long-term users, who are in what I would consider to be moderate or severe withdrawal by their COWS score, but they experience it as “not so bad, I’ve felt worse”

In another example, I had a patient on 110mg who reported terrible withdrawal, to the point she couldn’t function during the day. She was restless, anxious, jittery, and felt like her heart was racing. She wasn’t sleeping well. This was puzzling, since a month ago she’d been fine on that same dose. There were no new medications, no change in activities, and she wasn’t drinking alcohol (a common reason for drop in methadone blood level). On the COWS, she scored an 8, but when I looked at the actual COWS, she scored very high on the more subjective items, yet her pupils were pinpoint and her pulse rate in the 60’s

The more we talked, the more I suspected anxiety as the cause of her symptoms. She had a terribly stressful living situation. She was saving money to move out on her own, but felt like she had to endure the circumstances in the short term. In this case, she appeared to be blaming opioid withdrawal for her symptoms of anxiety, and anxiety was a normal response for what she was experiencing. She didn’t need a higher dose of methadone; she needed someone to help her think of better immediate options for safe housing.

I do not think a COWS score is helpful for fine-tuning a patient’s dose of methadone. Many times the COWS score doesn’t pick up subtle withdrawal, so I don’t tend to use it for higher dose changes.

COWS scores are helpful when defending one’s self from regulatory bodies. About five years ago, a state investigator took me to task for authorizing dose increases. “You just believe them when they say they’re in withdrawal?” she asked sarcastically. The investigator didn’t think I should increase the doses of those patients, and yet the studies clearly show methadone patients have better outcomes if they are on an adequate dose. By doing a COWS score, the patient’s signs and symptoms are recorded in the chart for an investigator to see.

In summary, the COWS scale is a useful tool, though probably more useful at lower doses. Like all tools, it’s helpful in some situations, but it’s not perfect. It should be used alongside our other tools, like talking and listening to our patients both before and after dosing, using blood levels in rare cases, and always asking about other medications or new medical problems.