A closer look at the evidence (Part 1)

10120260443_560161d92b_b You may have heard that the unlikely crew of Newt Gingrich, Patrick Kennedy & Van Jones have taken interest in addressing the opioid crisis. More allies is a great thing.

They strongly advocate for medication-assisted treatment as the standard of care:

Medication assisted treatment, or MAT, is the use of FDA-approved medicine in concert with behavioral counseling for opioid addiction that has proven efficacy. Multiple studies have shown that MAT is essential to effective long-term recovery, by reducing cravings and the risk of fatal overdose and increasing abstinence and time in treatment. And we have known this for a long time. In 2003, a multicenter clinical trial published in the New England Journal of Medicine (NEJM) found that buprenorphine reduced the craving to use an opiate by roughly 50 percent and increased the odds of not taking an opiate by about 3.5 times. MAT is the widely accepted and scientifically proven method for successfully treating opioid addiction – and the National Institute on Drug Abuse, the World Health Organization, UNAIDS and many other physician groups all recommend it as the standard of care.

They use the word “recovery” in the title of their article and conflate recovery with access to MAT.

Is that accurate? Fortunately, they provided sources for their statements so we can take a look at their evidence.

But first, consider what you want out of treatment. What would you consider a successful outcome?

Returning to work/school?
Restoration of family life?
Restoration/creation of supportive social networks?
Participation in community life?

Well, they provide 2 studies for their evidence.

The first is a meta-analysis (a study of studies) and the second is a regular old study.

The outcomes these studies measure are: retention in treatment; decrease in illegal opioid use; decrease in mortality; decrease in nonopioid drug use; decrease in criminal activity; decrease in risk behaviors related to HIV and hepatitis C.

These are very important outcomes, especially the ones that could be the difference between life and death. However, I think it’s fair to say that most patients and families would consider these necessary but not sufficient.

A closer look at the evidence

Over the course of several posts, I’m going to dig into the findings from these studies.

The meta-analysis provides a review of the 19 studies and a summary of each.

Let’s look at the studies. Some of them consider the effects of various doses and other factors. I’m just going to report on the outcomes above.

Study 1

The summary reports “fewer positive urine drug screens”. I wanted a little more info, so I went to the original study. It doesn’t report exact percentages, but I found this graphic.

study1

So, it looks like approximately 70-75% of male subjects receiving buprenorphine tested positive for opioids and about 90% of female subjects tested positive.

Study 2

This study compared buprenorphine vs high-dose methadone vs low-dose methadone and it was a year long (that’s really good!). Here’s the summary: “At 26 and 52 weeks, the high-dose MMT group had better retention (31% versus 20% at 52 weeks, p=.009) and less opioid use (p=.002) than the low-dose MMT or fixed-dose BMT groups.”

So, high-dose methadone lost 69% of the patients, while buprenorphine and low-dose methadone lost 80% of the patients.

I was curious about “less opioid use” and went to the original study. The researchers did drug screens for opioids and other drugs. “Urine samples were considered to be opioid-free if the test reading was less than 300 mg/mL.” For patients that were retained for all 52 weeks there were 156 drug tests. This outcome was measured by giving 1 point for each opioid-free test. A single patient got 156 points. The median scores were 59 for high-dose methadone, 16 for buprenorphine, and 24 for low-dose methadone.

Study 3

This study compared different doses of buprenorphine. “For retention, 40% in 1-mg group completed treatment, 51% in 4-mg group, 52% in 8-mg group, and 61% in 16-mg group.” 61% retention sounds more encouraging, but over what period of time? Unfortunately, it’s only 16 weeks long.

The summary also reported that the “8-mg group had significantly fewer positive screens than the 1-mg group”. This got me curious about these drug use outcomes.

Here’s what I found:

“42% (306/736) failed to contribute a single urine negative for opioids”
“36% (68/188) of the 8 mg group” failed to contribute a single urine negative for opioids
“Not a single patient contributed the full complement of negative urines”
“only 18% (132/736) provided more than 24 negative urines” (i.e. 50% of the maximum possible)

The original study also had the following sentence, “Acceptance of the efficacy of buprenorphine as a maintenance treatment has to be tempered by the reality that the drug use status of many patients will not be altered by buprenorphine.”

Study 4

This study compared buprenorphine maintenance in a primary care setting vs buprenorphine delivered in a methadone clinic. The study is short (12 weeks) and small (23 subjects per treatment condition).

Here’s the summary: “A trend toward higher retention at 12 weeks was noted in the primary care setting (78% versus 52%, p=.06). Patients in that setting had significantly lower rates of illicit opioid use as measured by urine drug tests (63% versus 85%, p,.01) but no difference in rates of cocaine use.”

78% retention is great, but it’s only for 12 weeks.

And, the better outcome for drug use was 63% of drug screens being positive for opioids. (I went to the original paper and found that 30.5-38.5% of tests were positive for cocaine.)

The closest they came to measuring abstinence was this, “The proportion of patients who achieved 3 or more consecutive weeks of abstinence from opioids, as determined by thrice weekly urine toxicology testing, was also higher in the primary care setting (44%, 10 of 23) than in the drug treatment setting (13%).”

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Note: This is not an argument against access to any kind of care. It’s just a push for good informed consent that empowers patients to advocate and choose for themselves.

A closer look at the evidence (Part 1)