Mind-Body Interventions for Gastrointestinal Conditions

Prepared for:
Agency for Healthcare Research and Quality
U.S. Department of Health and Human Services
2101 East Jefferson Street
Rockville, MD 20852

Prepared by:
Southern California Evidence-based Practice Center/RAND

Ian D. Coulter
Mary L. Hardy
Joya T. Favreau
Pamela D. Elfenbaum
Sally C. Morton
Elizabeth A. Roth
Barbara J. Genovese
Paul G. Shekelle

This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. Endorsement by the Agency for Healthcare Research and Quality (AHRQ) or the Department of Health and Human Services (DHHS) of such derivative products may not be stated or implied.

The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-Based Practice Centers (EPCs), sponsors the development of evidence reports and technology assessments to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. The reports and assessments provide organizations with comprehensive, science-based information on common, costly medical conditions and new health care technologies. The EPCs systematically review the relevant scientific literature on topics assigned to them by AHRQ and conduct additional analyses when appropriate prior to developing their reports and assessments.

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The objective of this evidence report was to conduct a search of the literature on the use of all mind-body therapies for the treatment of health conditions and, on the basis of that search, to choose either a condition or a mind-body modality for a comprehensive review. The health condition chosen, based on the results of an initial search, was gastrointestinal problems. The specific questions addressed in this project were: (1) What mind-body therapies have been used in the literature, for which body systems/conditions, and using what kind of research design? (2) What is the efficacy of mind-body therapies for the treatment of gastrointestinal problems?

A research librarian performed an initial database search of MEDLINE, HealthSTAR, EMBASE, Allied and Complementary Medicine^TM, MANTIS^TM, PsycINFO, Social Science Citation Index, two files of Science Citation Index, and CINAHL. We used "mind/body relations (metaphysics)" and "mind body therapies" as the MeSH term and a set of synonyms for mind-body. A more focused search was conducted for gastrointestinal health problems and mind-body.

The literature search was confined to those mind-body therapies currently recognized as such by the National Center for Complementary and Alternative Medicine (NCCAM). In the initial search, all studies focusing on mind-body therapies were included. Those studies that focused on gastrointestinal (GI) problems were then identified. The mind-body therapies documented in the literature for treating GI problems included: behavioral therapy, biofeedback, cognitive therapy, guided imagery, hypnosis, placebo, relaxation therapy, and multimodal therapy.

All titles, abstracts, or articles were reviewed by two independent reviewers and entered into a database. The titles/or abstracts/or articles were analyzed and synthesized into a descriptive report. Particular attention was paid to the mind-body modality used, the target body systems/conditions, the outcomes measured, and the type of study design used. An in-depth analysis was conducted on those studies that focused on GI conditions. We identified 53 GI studies that included a concurrent comparison group. Because of the clinical heterogeneity of these trials, however, we did not conduct a meta-analysis. Instead, a qualitative synthesis was conducted.

In the search of mind-body studies, the most common body systems/conditions for which mind-body therapy literature was found are: neuropsychiatric; head/ear, nose, and throat (head/ENT); gastrointestinal; circulatory; and musculoskeletal. Regarding therapies, the most common ones for which published studies were found were: biofeedback, hypnosis, relaxation, behavioral, and cognitive.For GI conditions, the most commonly studied mind-body therapy was biofeedback (n = 22), and the most commonly studied conditions were irritable bowel syndrome (n = 15), followed by fecal incontinence/encopresis (n = 11). Studies with a comparison group were reviewed for biofeedback (n = 17), hypnosis (n = 8), relaxation therapy (n = 8), behavioral therapy (n = 8), multimodal therapy (n = 4), cognitive therapy (n = 4), guided imagery (n = 2), and placebo (n = 1).

Eleven of the biofeedback studies had a no biofeedback comparison group, and two reported a significant benefit from biofeedback. These studies were of adults with fecal incontinence and nausea/vomiting following chemotherapy. In the remaining nine biofeedback trials, seven of which were on children, biofeedback was not reported to have any benefit. There were seven studies of hypnosis that had a no hypnosis comparison group, six of which reported a significant benefit (for irritable bowel syndrome, two studies; nausea/vomiting, two studies; duodenal ulcer, one study; and ulcerative colitis, one study). Six of the eight relaxation-therapy controlled trials reported a significant benefit for irritable bowel syndrome (two studies), nausea/vomiting (two studies), ulcer (one study), and GI distress (one study). For the eight studies in behavioral therapy, six studies with a no behavioral therapy comparison group reported a significant benefit for encopresis (one study), nausea/vomiting (two studies), irritable bowel syndrome (two studies), and abdominal pain (one study). In cognitive therapy, four studies, all with a no cognitive therapy comparison group, reported a significant benefit. These were for irritable bowel (three studies) and ulcer (one study). In guided imagery therapy, one out of two studies with a no imagery comparison group reported a significant benefit. In placebo therapy there was only a single study. Four studies using a multimodal intervention, which does not enable a conclusion about individual therapies, were also reviewed.

There are limited data to support the efficacy of relaxation therapy, behavioral therapy, cognitive therapy and guided imagery as therapy for certain gastrointestinal conditions. There is no evidence to support the efficacy of biofeedback for children with gastrointestinal conditions, while for adults the evidence is mixed. The studies of hypnosis are limited by methodologic problems and no conclusions can be drawn.

This document is in the public domain and may be used and reprinted without permission except for any copyrighted material noted for which further reproduction is prohibited without the specific permission of copyright holders. AHRQ appreciates citation as to source and the suggested format is as follows:

Coulter ID, Hardy ML, Favreau JT, et al. Mind-Body Interventions for Gastrointestinal Conditions. Evidence Report/Technology Assessment No. 40 (Prepared by Southern California Evidence-based Practice Center/RAND under Contract No. 290-97-0001). AHRQ Publication No. 01-E030. Rockville (MD): Agency for Healthcare Research and Quality; July 2001.

The objective of this evidence report was to search the literature on the use of mind-body therapies for the treatment of health conditions and, on the basis of this search, to choose either a condition or mind-body modality for a comprehensive review. A broad search of mind-body therapies showed that there were sufficient studies regarding their use for gastrointestinal (GI) conditions to warrant a detailed review. GI conditions pose a significant health problem, and they can be challenging to manage. They also have been the focus of mind-body interventions, including: behavioral therapy, biofeedback, cognitive therapy, guided imagery, hypnosis, meditation, placebo therapy used as an intervention, relaxation therapy, and multimodal therapy. However, no studies of meditation were found that used a comparative treatment design. Therefore, this report reviews the use of behavioral therapy, biofeedback, cognitive therapy, guided imagery, hypnosis, placebo therapy, relaxation therapy, and multimodal therapy for the treatment of GI conditions.

The purpose of this work is to identify those mind-body therapies that have empirical support of efficacy. Such information can be used to help health care providers care for patients with GI conditions and to identify future research needs. The specific questions addressed in this report are:

What mind-body therapies have been reported in the literature, for which body systems/conditions, and using what kind of research design?
What is the efficacy of mind-body therapies for the treatment of gastrointestinal conditions?

An initial broad search of the mind-body literature yielded 2460 titles, of which 690 were judged possibly relevant to our investigation based on the use of a short screening form. This form screened for source of the article, subject, language, focus, body system, outcomes, modalities used, human/animal subjects, and study type. To answer our first major research question and to describe the basic characteristics of the published mind-body literature, we assessed these accepted articles for their target body systems or health conditions, for the mind-body modalities used, and for the study design. To answer our second research question, we further assessed this abridged group of articles and identified 53 studies of GI conditions that included a mind-body therapy in a trial. These studies provided evidence regarding the efficacy of mind-body therapies for the treatment of GI conditions.

A panel of technical experts representing diverse disciplines was established to advise us throughout the course of our research.

We searched the literature using the following online databases: MEDLINE, HealthSTAR, EMBASE, PsycINFO, Allied and Complementary Medicine^TM, MANTIS^TM, Psychological Abstracts, Social Science Citation Index, two files of Science Citation Index, and CINAHL.

We used the following MeSH terms: mind/body metaphysics, mind body therapies, mind/body medicine, mind/body wellness, bodymind medicine, mind/body therapies, psychosomatics/psychosomatic/psychosomatic medicine, wisdom of the body, self healing, placebo, healing force of nature, healing consciousness, biopsychosocial, psychoneuroimmunology ¹ , and wellness. We further restricted the search by including terms for selected mind-body modalities as defined by the National Center for Complementary and Alternative Medicine (NCCAM) plus terms that would identify research reporting any outcomes.

There was no language restriction. Additional articles were identified from citations of articles, particularly review articles, and citations suggested by external reviewers. All titles, abstracts, and articles were reviewed by two reviewers, whose disagreements were resolved by consensus.

We collected data on the articles generated by this search regarding body system, mind-body modality, and study design with a screening form developed for this purpose. We used titles, abstracts, and/or articles to collect this information. We analyzed these data, reported on the general characteristics of the field of mind-body research, and used this analysis to inform our selection of a topic for a focused review.

We then conducted a focused literature search on mind-body therapies specifically for the treatment of GI conditions, searching the same databases used for the earlier search. In addition to the mind-body search terms, we also used the more general "outcomes" terms for GI conditions. We collected data for these new articles using the same review technique employed in the initial search.

We selected all studies identified in either the initial or the focused search that studied GI conditions using a controlled study design with a concurrent comparison group. This yielded 53 GI studies that were then reviewed in-depth. However, because of the clinical heterogeneity of these trials, we did not conduct a meta-analysis. Instead, a qualitative analysis was conducted on these studies.

Future mind-body research needs to be better designed and implemented. Studies need to enroll adequate numbers of well-defined, clinically homogeneous populations, and they need to compare the mind-body therapy both to other potentially effective therapies and to a convincing control. They should employ randomization, use blinding where feasible, and measure outcomes that are meaningful to patients and that can be reliably assessed. Ultimately, only those studies with a control group for comparative analysis can address the question of the efficacy of mind-body therapies. A more focused research program might overcome the problem of too few studies found on too many GI conditions and variable patient populations.