EXETER, ENGLAND — The benefits of complementary therapies such as hypnotherapy are likely to be underestimated when they are evaluated using conventional clinical trial designs and outcome measures, according to Lesley M. Roberts, M.D., of the department of primary care, University of Birmingham (England).
Gut-directed hypnotherapy has proved effective in more than a dozen studies in the past 20 years. But a clinical trial in which 81 patients with irritable bowel syndrome (IBS) were randomized to hypnotherapy or usual care by a primary care physician found little difference between the approaches.
Was this a case of “right intervention, wrong outcome?” Dr. Roberts asked at a symposium on alternative and complementary therapies sponsored by the universities of Exeter and Plymouth.
“My background is in conventional medicine, so we chose conventional tools for the study—symptom scores and [an] IBS quality of life tool,” she said. Such disease-specific tools are allegedly more sensitive than generic tools for evaluating conventional therapies.
Patients in the study had gastroenterologist-confirmed IBS of 6 weeks' duration or longer and had failed at least one conventional treatment. They were evaluated at baseline and at 3, 6, and 12 months.
Both groups improved over the course of the trial. Symptom scores, pain, and diarrhea were significantly superior in the hypnotherapy group at 3 months, but the difference was not maintained over time. There were no between-group differences at any time point for constipation or quality of life.
“However, when we asked patients in the hypnotherapy group about their experiences, 81% reported definite improvement, 55% reported improvement greater than they had anticipated, and 91% would recommend gut-directed hypnotherapy to their friends,” Dr. Roberts said.
“So the question we had to ask was, did our study miss some important benefits? Patients were saying they felt better. The treatment was very helpful for mental well being, and it gave them control—all generic quality of life concerns. Yet we didn't pick up any quality of life benefit using the IBS-specific quality of life tool,” she said.
Perhaps complementary and alternative medicine research should reconsider its emphasis on the use of conventional methodology in clinical studies and should instead use more generic outcome measures such as the subjective assessment questionnaire used in the Manchester protocol, she said. “I think the benefit of hypnotherapy is that patients are better able to cope, not that they necessarily have fewer symptoms. They feel empowered,” Dr. Roberts said.