This news release describes the outcomes of a small randomized placebo controlled study on the use of N-acetylcysteine, an inexpensive over-the-counter supplement, along with cognitive behavioral therapy in male veterans with PTSD and substance use disorder (SUD). Overall, the release provides a balanced report on the results and the limitations of the study. We think that with the addition of cost and a more in-depth discussion of harms it could have been even better.
Post-traumatic stress is a huge problem among veterans who have seen combat, and the effects of PTSD can be lifelong and debilitating. Since PTSD is also found in police officers, firefighters and other emergency personnel, a safe and effective treatment for it might have wide ranging applications. This trial on a small number of veterans who suffered both from PTSD and substance use disorders could very much add to available therapies in which there are few effective treatments but many sufferers. This could also be significant to the 7 to 8 percent of Americans who develop PTSD at some point in their life.
There is no discussion of the cost of N-acetylcysteine although it is on the World Health Organization’s list of essential medicines, is available over-the-counter and is not very expensive. An online search reveals prices ranging from about $6 for 100 capsules containing 600 mg to around $12 for 50 high-dose capsules containing 700 mg.
The intent of the pilot study was to determine the effect of N-acetylcysteine on PTSD symptoms, cravings and substance use. All three endpoints are described in the news release albeit in relative terms.
We are told that the 8-week trial randomized 35 veterans with PTSD and substance use disorder. Some received N-acetylcysteine and others a placebo, but all of the participants received cognitive behavioral therapy (CBT).
The release reported that “Veterans in the NAC-treated group showed a 46% reduction in PTSD symptoms, compared with a 25% reduction in the placebo group on the Clinical-Administered PTSD Scale (CAPS), which assesses trauma history and symptom severity. The threshold CAPS score for diagnosis of PTSD is 50.”
The release quotes the lead author: “As a group, the NAC-treated veterans were below diagnostic level for PTSD at the end of treatment.” This establishes that the benefit was clinically meaningful. But we prefer to see absolute rather than relative numbers as used here. For example, the actual before and after scores on the PTSD scale would have better illustrated how large the benefit was.
The release explains that the drug used “does not cause side effects at the doses used in the study, but it degrades quickly when stored, is contraindicated in patients with asthma, and can cause nausea at higher doses and so should always be obtained and administered under a physician’s supervision.” However, the published study notes a higher incidence of adverse events in the N-acetylcysteine treated group that in those treated with placebo (66.7% vs. 47.1%). N-acetylcysteine can cause “nausea, vomiting, and diarrhea or constipation. Rarely, it can cause rashes, fever, headache, drowsiness, low blood pressure, and liver problems,” according to WebMD.
This news release does not exaggerate the benefits found in the study, and added helpful caveats about the limitations of the study, its applicability to the general population and its small size.
We’d have preferred to see some specific language cautioning about the short duration of the study (just 8 weeks) and the fact that the results might not hold up over time.
There is no obvious disease-mongering here. However, when the release notes that 7-8 percent of Americans have experienced PTSD at some point in their lives it could have been noted that the PTSD experienced by military veterans — leaving them ‘difficult-to-treat’ — is in a different category than what civilians might experience.
The release clearly states the funding sources and it would be very unlikely that these researchers would have a financial interest in the product under study since it is off-patent and generically available without a prescription.
The news release mentions other treatments for PTSD (such as SSRI antidepressants) even though we don’t learn how effective those treatments are compared to N-acetylcysteine. The lead researcher very helpfully mentions that the drug should not be used without cognitive behavioral therapy or other forms of psychological counseling.
The news release places the results of the study in a positive light noting, “Currently, there are no well-explored pharmacological treatments for patients with co-occurring PTSD/SUD. Although selective serotonin reuptake inhibitors have been approved by the FDA for treatment of PTSD, pharmacological treatments for co-occurring PTSD/SUD have yielded suboptimal results.”
While SSRI’s have been the most studied to date, other drugs that have been studied in preliminary trials could have been mentioned, including prozosin, prazosin, guanfacine, atomoxetine, topiramate, memantine, acamprosate, and ketamine. A 2014 article in Addictive Behaviors journal describes some of these: “Pharmacological treatment of comorbid PTSD and substance use disorder: recent progress.” (Addictive behaviors 39.2 (2014): 428-433.)
We learn it is sold over-the-counter and available everywhere.
The release claims novelty with these statements: “This trial is the first to use NAC as a pharmacotherapy for PTSD and a broad range of SUDs” and “NAC treatment with CBT would be a novel approach to treat co-occurring PTSD and SUD.”
This does appear to be the first such clinical trial of the supplement to address this combination of disorders.
There is no use of unjustifiable language. In fact, we were pleased to see the consistent use of “substance use disorder” or SUD to describe the inappropriate use of illegal and legal drugs. Our recent post on ways to put people first when talking about addiction shows how careful terminology improves accuracy and reduces stigma.