Hypnotherapy significantly relieved IBS patients' complaints about symptoms compared with educational supportive therapy at the primary and secondary care levels, Dutch researchers reported.
The effects of 3 months' treatment in the multicenter, randomized, controlled IMAGINE trial persisted for 9 months, and group hypnotherapy was also as effective as individual hypnotherapy, according to Carla E. Flik, PhD, of the University of Utrecht Medical Center in the Netherlands, and colleagues writing in .
Hypnotherapy did not, however, reduce symptom severity as measured with a standard rating scale.
At 3 months, patients in both individual and group hypnotherapy had better rates of adequate response on a symptom relief questionnaire than those receiving educational support: 40.8%, 33.2%, and 16.6%, respectively. At 12 months adequate relief was reported by 40.8% of patients in individual hypnotherapy, 49.5% of patients in group hypnotherapy, and 22.6% of controls.
"Hypnotherapy gives adequate relief of IBS complaints, not only for patients in tertiary care with refractory disease, but also for patients from primary and secondary care," they concluded. "Hypnotherapy can be considered as a treatment option for all patients with IBS, irrespective of symptom severity and IBS subtype. Group delivery could facilitate widespread use of hypnotherapy in daily practice."
To date, hypnotherapy has been used primarily in refractory IBS patients' symptoms in specialized tertiary-care facilities and delivered on an individual basis. A 2017 study had found home-based group hypnotherapy effective in children with IBS.
The current study enrolled 494 IBS patients ages 18 to 65 referred for psychological treatment from primary or secondary care at 11 Dutch hospitals during 2011-2016. Of these, 354 eligible participants were randomized to receive individual therapy (n=150) or group hypnotherapy (n=150) or a control group of educational supportive therapy (n=54).
Individual hypnotherapy was given in six 45-minute sessions every 2 weeks, while group treatment was delivered to six patients in six 60-minute sessions every 2 weeks. Most of the therapists were not experienced in treating IBS. The hypnotic sessions numbered half the typical 12 used in the U.K.'s and involved positive visualization to give patients suggestions for gaining control over their digestive system to reduce feelings of pain and discomfort. Patients were also given a homework CD for practicing self-hypnosis exercises at home for 15-20 minutes daily.
The primary outcome was adequate relief of IBS symptoms, with responders defined as patients who reported such relief when asked once weekly on three or four occasions over 4 consecutive weeks.
The final sample in the intention-to-treat population consisted of 142 patients in individual hypnotherapy, 146 in group hypnotherapy, and 54 in the control group. Dropout rates were fairly high, with 15% abandoning therapy in both hypnotherapy groups and 11% in the control group.
Although hypnotherapy improved patients' ability to cope with symptoms, it did not substantially reduce scores on the standard IBS Severity Scoring System. At 3 and 12 months, respectively, mean scores were 250.2 and 250.4 on the system's 500-point scale (from baseline 300.7) for individual therapy and 258.7 and 219.2 for group therapy (from baseline 286.0). Mean scores for educational therapy recipients fell from a baseline score of 305.8 to 269.4 and 263.2.
"What's striking about these findings is the extent to which patients' perception of their illness has an effect on their suffering, and that their perception of symptoms appears to be as important as actual symptom severity," Flik said in a news release.
Patients in all three groups showed improvements in quality of life, psychological complaints, cognition, and self-efficacy, and direct and indirect medical costs diminished, but inter-group differences were not significant. Treatment effects were more pronounced in patients referred from secondary care with higher psychological problem scores, but there were no notable inter-group differences in symptom severity and IBS subtype.
In accordance with the concept that can be predominantly either psychological or physical, Flik and co-authors concluded, "Hypnotherapy might work best for patients with more psychological complaints. In future research on the effect of hypnotherapy, stratification according to psychological symptoms should be considered."
They called for more research to determine the optimal number of hypnotherapy sessions, the impact of patient expectations on treatment outcome, and the extent outcomes are influenced by the magnitude of psychological complaints.
As for safety, eight unexpected serious adverse reactions were reported, six in the individual hypnotherapy group and two in the group hypnotherapy group, most of which were related to cancer or inflammatory bowel disease.
Asked to share his perspective on the findings, Olaf S. Palsson, PhD, of the University of North Carolina, in Chapel Hill, called the study "basically a very positive trial and a step in the right direction in answering to a very important question – whether hypnotherapy works not just for patients in tertiary care, who often have failed all other treatments, but a broader population reflecting most IBS patients." Palsson was not involved in the research but wrote an .
He told he was surprised that hypnotherapy did not have a more significant impact on secondary outcomes, as has been the case in other studies. "It may be that the reduced number of treatment sessions, which were half the usual amount, may have watered down the effect. But since many patients had borderline severe symptoms, it's not likely that their disease was too mild to benefit from hypnotherapy," he said. The results leave unanswered the question of whether gut-directed hypnotherapy is appropriate for patients in primary and secondary care, and future trials are needed to provide definitive answers, Palsson added.
Flik and colleagues noted several limitations to their study, including the possibility of other symptomatic diseases misdiagnosed as IBS. In addition, the presumptions the study used for the power calculation study may have been suboptimal, with the presumed hypnotherapy response rate possibly too high and the estimated response in the control group too low. Furthermore, a substantial number of patients withdrew from the study and a substantial number of the questionnaires sent out at 3 and 12 months were not returned, introducing potential bias, especially for the non-inferiority comparison. They also pointed out that most hypnotherapists lacked experience dealing specifically with IBS and that the reduced number of sessions might have led to underestimations of the effects of hypnotherapy.
Disclosures
This study received no funding. One co-author reported relationships with Danone Research and Allergan Pharma outside of the submitted work. All other authors declared no competing interests.
Palsson is a scientific advisory board member and stockholder of MetaMe Health, and has been a co-investigator with one of the study's co-authors.
Primary Source
The Lancet Gastroenterology & Hepatology
Flik CE, et al "Efficacy of individual and group hypnotherapy in irritable bowel syndrome (IMAGINE): a multicentre randomised controlled trial" Lancet Gastro Hepat 2018; DOI: 10.1016/S2468-1253(18)30310-8.
Secondary Source
The Lancet Gastroenterology & Hepatology
Palsson OS "Is hypnotherapy helpful for irritable bowel syndrome in primary and secondary care?" Lancet Gastro Hepat 2018; DOI: 10.1016/S2468-1253(18)30344-3.