Haut SR, Lipton RB, Cornes S, Dwivedi AK, Wasson R, Cotton S, Strawn JR, Privitera M. Behavioral interventions as a treatment for epilepsy: A multicenter randomized controlled trial. Neurology. 2018 Mar 13;90(11):e963-e970.
To evaluate the effect of a stress-reduction intervention in participants with medication-resistant epilepsy.
Adults with medication-resistant focal epilepsy (n = 66) were recruited from 3 centers and randomized to 1 of 2 interventions: (1) progressive muscle relaxation (PMR) with diaphragmatic breathing, or (2) control focused-attention activity with extremity movements. Following an 8-week baseline period, participants began 12 weeks of double-blind treatment. Daily self-reported mood and stress ratings plus seizure counts were completed by participants using an electronic diary, and no medication adjustments were permitted. The primary outcome was percent reduction in seizure frequency per 28 days comparing baseline and treatment; secondary outcomes included stress reduction and stress-seizure interaction.
In the 66 participants in the intention-to-treat analysis, seizure frequency was reduced from baseline in both treatment groups (PMR: 29%, p < 0.05; focused attention: 25%, p < 0.05). PMR and focused attention did not differ in seizure reduction (p = 0.38), although PMR was associated with stress reduction relative to focused attention (p < 0.05). Daily stress was not a predictor of seizures.
Both PMR and the focused-attention groups showed reduced seizure frequency compared to baseline in participants with medication-resistant focal seizures, although the 2 treatments did not differ. PMR was more effective than focused attention in reducing self-reported stress.
"Despite advances in pharmacotherapy, at least one-third of individuals with epilepsy continue to experience seizures," the authors write.
This has led to an "increasing interest in behavioral interventions," especially in medically refractory seizures, because "stress is a frequently reported seizure trigger or precipitant in persons with epilepsy," they add.
Previous research suggests improved outcomes with a mindfulness-based approach or behavioral interventions, but these studies have been "limited by small sample sizes, inadequate control groups, and nonseizure primary outcomes."
To fill this gap, the researchers performed the first double-blind, randomized controlled trial of a stress-reduction intervention in people with medication-resistant epilepsy.
The primary outcome was percentage reduction in seizure frequency per 28 days between baseline and treatment…
Participants were randomly assigned to one of the two behavioral techniques.
The first, PMR, involved diaphragmatic breathing and a 16–muscle group practice, in which each muscle set was tensed vigorously without straining for 5 to 10 seconds, and then released.
The focused attention intervention was considered to be the control. Participants practiced a series of movements matched to PMR, but without the systematic muscle relaxation. They also engaged in other attentional tasks, such as writing down activities of the previous day.
Both groups were informed that they would engage in one of two possible behavioral techniques to be practiced daily but were not informed about which was hypothesized to be the active intervention…
Also commenting on the study for Medscape Medical News, Steven Schachter, MD, professor of neurology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, who was not involved with the study, called the relationship between stress, anxiety, and seizures in people with epilepsy "a fruitful area for research."
The authors "should be congratulated for their rigorous study design," and their "interesting results suggest a clinical benefit for behavioral interventions and highlight the need for further studies," Shachter said. Most participants in both treatment groups reported that stress, as well as seizures, was reduced by treatment, with no difference between the groups.
Haut acknowledged being surprised by the results.
"We were starting to get the feeling that patients were finding both inventions helpful during the study, although focused attention was not designed for relaxation and was our control group, with PMR being the treatment group," she said.
"People were finding that the experience of writing down how they were feeling on a regular basis multiple times a day was apparently having some benefit for them," she added.
She noted that the response both groups experienced "shows that there is the potential for different people to respond to different interventions."