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Has Anyone Used The Peach 5 In 1 A4 Size Paper Trimmer With Corner Rounder – Morgenstern, J. The PEACH trial of stroke prophylaxis for intracranial bleeding: Not a peach, , 10 Oct 2022. Available at:
I first heard of this article in Scott Weingart’s RACC Lit review where he discussed it as a practice-changing document. In that regard, I read it with enthusiasm. I downloaded it as soon as I got out of the car. I’ll admit I was pretty biased at first because Scott is right about almost everything, so I started writing with a very positive slant. The more time I spend with this paper, the worse it seems. (We are talking about the PEACH study, an RCT of prophylactic levetiracetam in spontaneous intracerebral hemorrhage.)
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The PEACH Study: Peter-Derex L, Philippeau F, Garnier P, et al. Safety and efficacy of prophylactic levetiracetam for the prevention of epileptic seizures in the acute phase of intracerebral hemorrhage (PEACH): a randomized, double-blind, placebo-controlled phase 3 trial. Lancet Neurol. Sep 2022;21(9):781-791. doi: 10.1016/S1474-4422(22)00235-6. PMID: 35963261 ClinicalTrials.gov NCT02631759
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Adult patients with spontaneous supratentorial intracerebral hemorrhage (diagnosed on CT or MRI) have a 24-hour onset of symptoms.
Exclusions: NIHSS score greater than 25, bleeding considered secondary to trauma, vascular malformation, tumor or ischemic stroke, concurrent antiepileptic drug use, major depression or psychotic disorder, known terminal illness, pregnancy, and seizure occurrence between study entry and initiation treatment.
Levetiracetam 500 mg IV BID for 2 days, 500 mg PO BID for 1 month, then tapering for 2 weeks. (Note: these are much lower doses than we give for status epilepticus.)
They enrolled 50 patients (of the 102 they planned to enroll) and included 42 in their statistical analysis. There were significant baseline differences between groups.
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For the primary outcome of any seizure at 72 hours, there was a large and statistically significant difference between groups, with 16% in the levetiracetam group and 43% in the placebo group experiencing seizures (OR 0.16, 95% CI 0.03-0 .94, p=0.043).
None of the clinical outcomes had statistically significant results, either as measured by change in NIHSS or mRS. Quality of life did not differ at 3, 6 or 12 months.
Although this is a reasonable question and an important attempt to make, I think this is clearly not a practice-changing paper. (Sorry Scott).
The primary outcome of this study is problematic. They only looked at the incidence of acute seizures, but admit in their introduction that it is not clear whether acute seizures are important. Some studies have found an association with long-term outcomes, but others have not. Acute seizures are used as a proxy outcome, but it is very unclear whether this is a proxy for anything important. In addition, they confound clinical seizures with seizures that are only identified by continuous EEG, which they say is not routinely performed in patients with intracerebral hemorrhage, and thus may represent complete overdiagnosis.
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This is particularly important because there was not a single clinical seizure. I’ll say it again: there were no clinical seizures in either group within 72 hours. During the 30-day treatment period, there was one clinical seizure in the placebo group and none in the treatment group, but this was apparently not statistically significant (p>0.99). The entire difference in this study was based on continuous EEG monitoring. Since they tell us that they do not use continuous EEG monitoring outside of the study, the full difference that this study reports would be completely invisible to them in the routine care of their patients. No one would know. This is a tree that falls into a forest situation, except that we decided to check this tree very carefully with advanced technology that we do not know how to interpret.
They followed these patients for 12 months using a combination of in-person visits and telephone follow-up. I’ve discussed before that the adjusted Rankin score is unreliable, especially when done over the phone, which could skew the results either way. However, no differences were observed in any of the clinical or patient-important outcomes. “The change in NIHSS scores at 72 hours, 1 month, or 3 months did not differ between groups, nor did the change in mRS scores at 3 months, 6 months, or 12 months.” In addition, “quality of life as assessed by the Stroke Impact Scale did not differ between groups at 3 months, 6 months, or 12 months.” So we are left with only a difference in a dubious surrogate outcome, with no difference in the long-term clinical outcomes we all care about.
This study is too small. Although the study was designed, it was too small. They base their power calculation on the assumption that they would see a 25% absolute treatment benefit, which is an absurdly large number when previous studies of seizure prophylaxis have shown no benefit. Based on this calculation, they determined that 102 patients needed to be enrolled, but in the end only 50 were enrolled, and the study was stopped early without a predetermined stopping point (due to slow enrollment, funding issues, and the COVID pandemic). In addition, they excluded another 8 patients from their analysis for various reasons, leaving only 42 patients in the main analysis. The result is a trial that is too small to assess important outcomes.
Not surprisingly, given that the study is relatively small, the groups look very different at baseline. The treatment group had more comorbidities, but the NIHSS score was higher in the placebo group and the hematoma size was twice as large in the placebo group. I would expect more severe strokes and larger hematomas to result in more seizures. (Seizures are harder to predict than other outcomes we see, so I don’t know how I expect this trial to be judged, but I think the discrepancy between the groups has a high chance of biasing the results.)
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Compliance was not great, but was about the same in both groups. Only about 75% of patients took the medication without interruption for 1 month. This would likely bias the treatment arm, although it likely represents real-world use and therefore the effects we would see in clinical practice.
As I described in the EBM bibliography, we see a disproportionate number of studies with p values just below the “significant” threshold. With a p-value of 0.043, this trial fits into this general theme. This in itself does not mean anything, as many trials will have legitimate p-values just below the threshold, but we know that as a whole, too many p-values are reported at this level. Therefore, p-hacking should occur in all drugs. I don’t know how to translate this information into a critical evaluation of a single article, but we should always be skeptical of individual articles with borderline statistical results. This is one of the many reasons why replication of research is absolutely necessary before we can assign any degree of certainty to the results.
Perhaps related to the p-hacking topic, it is very concerning when published tests do not match their registered protocols, especially when there is no explanation. This study is registered on Clinicaltrials.gov and it is very clear that it measured results over a 48 hour period. This is not mentioned in the manuscript at all, instead they report on 72 hour outputs. As they state that “the median time between the onset of symptoms of intracerebral hemorrhage and the first recorded electrographic seizure was 45.7 h [IQR 30.6-55.7] in the levetiracetam group and 49.8 h [32.4 – 53 ·9]”, at least half of the seizures appear to have occurred outside the original time frame of the study and it is very likely that if they had followed the study protocol this would have been a negative study.
I do not believe that the PEACH study should change practice. There is no change in clinical attacks or change in clinical outcomes. Levetiracetam may reduce the number of seizures seen with continuous EEG monitoring (although I think this is a low-certainty result due to study size, early termination, and arm imbalance). However, EEG seizures are a surrogate outcome with no clear association with clinical outcomes. Larger studies focusing on clinical outcomes are needed to change clinical practice.
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Peter-Derex L, Philippeau F, Garnier P, et al. Safety and efficacy of prophylactic levetiracetam for the prevention of epileptic seizures in the acute phase of intracerebral hemorrhage (PEACH): a randomized, double-blind, placebo-controlled phase 3 trial. Lancet Neurol. Sep 2022;21(9):781-791. doi: 10.1016/S1474-4422(22)00235-6. PMID: 35963261
An emergency physician works in the community. FOAM from Evidence-Based Medicine Junkie. “One particular advantage of a skeptical mind is that one never mourns when one finds one was wrong after all.” – William OsleHome / Products / (4 in 1) Peach Cocktail Tree – 4 different peaches on one plant (Cocktail Peach Plant) Belle of Georgia, June Gold, Red Haven, Hale Haven, Elberta
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