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Coulter ID, Hardy ML, Favreau JT, et al. Mind-Body Interventions for Gastrointestinal Conditions. Rockville (MD): Agency for Healthcare Research and Quality (US); 2001 Jul. (Evidence Reports/Technology Assessments, No. 40.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

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Mind-Body Interventions for Gastrointestinal Conditions.

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2Methodology

We synthesize evidence from the scientific literature on the effectiveness of mind-body therapies for gastrointestinal conditions using the evidence review and synthesis methods of the Southern California Evidence-based Practice Center. This is one of the designated centers established by the Agency for Healthcare Research and Quality for the systematic review of literature on the evidence for benefits and harms of health care interventions. The project staff collaborated with the National Center for Complementary and Alternative Medicine, the project officer at AHRQ, and a group of technical experts representing diverse disciplines.

Scope of Work

Our literature review process consisted of the following steps:

  • Identify sources of evidence in the literature.
  • Conduct a search of the mind-body literature to identify topic areas with sufficient publications to support a detailed review.
  • Conduct a focused literature search on mind-body treatments for one topic with sufficient literature, in this case, for gastrointestinal conditions.
  • Assess the search strategy for completeness.
  • Evaluate potential evidence for methodological quality and relevance.
  • Extract study-level variables and results from studies meeting methodologic and clinical criteria.
  • Synthesize the results.
  • Submit the results to technical experts for review.
  • Incorporate the reviewers' comments into the report.

Objectives

We conducted a literature search of the field of mind-body research to establish the distribution of studies using mind-body interventions. These studies were then evaluated to determine if there was a sufficient body of literature in any one combination of disease and/or mind-body modality to enable a comprehensive systematic review. The mind-body topic was selected after extensive discussions with our panel of technical experts and with both AHRQ and NCCAM.

The initial search was guided by the following research questions:

  • What disease states/body systems are the major foci of the studies?
  • What modalities are the major foci of the studies?
  • What types of outcomes were measured?
  • What types of study design were used?
  • What languages other than English are predominant? Are they readily accessible?

Based on the results of this search and further discussions with our technical experts and the sponsoring agencies, we chose mind-body therapies for gastrointestinal conditions as the focus of the comprehensive review presented in this report.

Mind-Body Literature Search Design

Technical Expert Panel

We recruited a group of technical experts to advise us. The technical experts were from diverse disciplines including acupuncture, ayurvedic medicine, chiropractic, dentistry, general internal medicine, gastroenterology, integrative medicine, neurophysiology, nursing, pharmacology, psychiatry, psychoneuroimmunology, psychology, sociology, and traditional Chinese medicine. The technical experts assisted the project in several ways. They assisted the research group in defining and conducting the initial overall survey of the field of mind-body research. They reviewed the results for completeness and were consulted on what topics appeared to be good candidates for a comprehensive review. Members of the expert panel reviewed the search terms we used. (Some members of the panel also acted as reviewers of the preliminary report along with the reviewers listed in the Acknowledgments.) Members of the expert panel, along with their affiliations, are listed in the Acknowledgments.

Literature Search Terms

We used “mind/body metaphysics” and “mind body therapies” as our preliminary MeSH terms. We then generated a set of synonyms, based on reviewing recent citations, under which mind-body could occur:

  1. mind/body medicine
  2. mind/body wellness
  3. bodymind medicine
  4. mind/body therapies
  5. psychosomatics/psychosomatic/psychosomatic medicine
  6. wisdom of the body
  7. self healing
  8. placebo
  9. healing force of nature
  10. healing consciousness
  11. biopsychosocial
  12. psychoneuroimmunology2
  13. wellness

We further refined the search by confining it to the list of interventions recognized by NCCAM as being alternative or complementary mind-body modalities. Because this list is itself extensive, we restricted the search to those therapies that involve clinical interventions with some form of mind-body therapy. These include relaxation therapy, meditation, imagery/visualization, hypnosis, and biofeedback; placebo is included only when used as a therapeutic intervention. All of these therapies involve a conscious mind or awareness on the part of the patient. Furthermore, in an attempt to limit the search to original clinical research studies as opposed to background or descriptive articles, we included terms that would identify publications reporting on outcomes. Two expert reviewers in mind-body research evaluated the initial title search to determine if it was sufficiently inclusive. No new terms for the search were recommended.

Appendix A reports the details of the literature search strategies. We searched MEDLINE®, HealthSTAR, EMBASE®, Allied and Complementary Medicine™, MANTIS™, Psychological Abstracts, Social Science Citation Index®, and two files of Science Citation Index® (1990-99 and 1974-1989). We retrieved a total of 2474 items from these databases, resulting in 2460 unique citations after accounting for duplicate entries. After we selected GI as our focus topic, we conducted an additional search of the same terms in the CINAHL® database.

Concurrent with the review of mind-body research, the project team also conducted a literature search on ayurvedic medicine as part of a separate project. This search identified a small number (10) of mind-body studies, which were included in this report.

Mind-Body Study Review Strategy

Once we generated a list of article titles from the search, we reviewed each title and rejected ones that were clearly not related to mind-body treatment for human conditions, for example, studies that were purely pharmacological and ones that were conducted on animals. If it was unclear from the title whether or not the study included mind-body interventions, we included the study for more in-depth examination.

We then designed a screening form detailing article characteristics that we intended to abstract for each study. This form included items for data source (whether the information gathered was based on the title alone, the article's abstract, or the article itself); subject of the article (to screen out studies that were clearly not mind-body); language; focus (whether the article specifically attempted to study mind-body modalities or used a mind-body therapy in the course of studying a disease state or body system); body system(s) or disease states studied; outcomes measured; mind-body modalities used; subject population; and study design (see Appendix B). When any information was unclear from the title, we ordered abstracts, or articles if abstracts were themselves unclear or unavailable, to obtain this information. Two reviewers independently completed the screening form and together compared their answers, reconciling disagreements by consensus.

When screening was reasonably complete, we analyzed the data to describe the general characteristics of the mind-body field. This was an important first step in defining our focused review. Although this process was crucial in refining the research questions for this particular project, it has a wider importance in that it measures significant parameters of the general field of mind-body research, such as the general distribution of study designs, modalities, and body systems examined.

We discuss the specific outcomes of this analysis in Chapter 3, “Results.” We used this analysis to help inform the choice of GI conditions as our focus for a detailed review.

Focused Search

We used the initial search to identify the breadth of studies in mind-body. We then conducted a second, more focused search to identify studies specific to mind-body interventions for GI conditions. We searched the same online databases as in the initial search but substituted the general “outcomes” terms with ones that would identify articles on GI conditions specifically. This search identified 6065 titles. The total number of records was culled to remove studies that were clearly not related to mind-body therapy, and duplicate entries were removed. This resulted in a final total of 1888 titles being entered into our database for mind-body.

We wished to verify that our two searches were sufficiently defined so as to be as comprehensive and unbiased as possible. Several external reviewers suggested additional searches that might also generate research studies in mind-body in general, as well as for mind-body applied to GI conditions. As a result of these suggestions, we conducted four additional searches. First, we searched for all GI terms from the focused search, plus terms for psychophysiology, plus the word “human.” We also added a search for the terms “mind-gut” or “brain-gut” and one for terms relating to hypertension. Finally, we conducted the initial and focused searches in the CINAHL® databases (see Appendix A for details of all of these searches). We scanned the results from all of these new searches for studies that were relevant to mind-body and were possibly original research studies; we found that our first round of initial and focused searches had identified the vast majority of relevant studies that these additional searches generated

The Review Process

The multi-step search and review process is shown in Diagram 1.

Diagram 1 Mind-Body Literature Search and Review Strategy.

Figure

Diagram 1 Mind-Body Literature Search and Review Strategy.

As described in the previous section, the initial online search identified 2460 unique titles of the mind-body literature. The focused search of GI conditions produced 1888 titles, and 49 came from other sources. This produced a total of 4397 titles. Two reviewers independently screened each title for relevance to mind-body, and disagreements were resolved by consensus. We accepted 1362 titles as either definitely or possibly mind-body; the remaining 3035 titles were excluded as not being clearly relevant to mind-body. We used the following criteria for exclusion:

  1. Those conditions that are behavioral/mental, such as phobias, panic disorder, obsessive/compulsive disorders, posttraumatic stress disorders, and fears.
  2. Therapies such as dance and music therapy, which are not included in this review unless combined with one of the included therapies.
  3. Those articles dealing with an assessment tool and not a therapy.
  4. Those studies not conducted on humans.
  5. Those studies not focused on any body system/condition.

The titles that passed the initial title screening for relevance to mind-body included studies of depression, insomnia, and placebo. However, studies of placebo were only included among the accepted titles if this treatment was used as a deliberate mind-body intervention therapy.

The 1362 accepted titles were screened to collect basic data using the short form shown in Appendix B. For each article, this review identified the body system and/or disease focused on in the study, the mind-body modality used, the outcomes measured, and the type of research design used (plus other variables as shown on the form). Based on this review, we rejected an additional 123 articles and accepted 1239 for analysis (details discussed Chapter 3).

After we analyzed these 1239 articles, 1162 were deemed not acceptable for detailed review, and 77 were identified as possibly meeting the full criteria for inclusion in the study, that is, they were mind-body interventions for GI conditions assessed using a controlled trial design. Of these studies, on further review 53 were identified as RCTs or CCTs and contributed data to our analysis.

The full articles (or abstracts, if that was all that had been published) of the 53 approved titles were then subjected to a detailed review using the long form (Appendix C).

We assessed the completeness of the library search by reviewing the references in articles identified as review articles and from selected publications in the field by frequently cited authors. These articles were entered into the title database to identify duplications or new citations. If the articles were duplications, they were rejected; if new citations, they were added. These new titles were then taken through the steps outlined above.

Data Extraction/Data Synthesis

The information from both the short screening form (Appendix B) and the long screening form (Appendix C) provide the data for the quantitative analysis that follows. For each study, a score was calculated using a system developed by Jadad (1996) to assess the trials for quality.3

We determined that the 53 studies that met the criteria for inclusion (RCT or CCT) were clinically too heterogeneous to support meta-analysis. Therefore, our in-depth analysis of these studies is, by necessity, qualitative.

The qualitative analysis involved review of each article in terms of the condition studied, the subject population (age, gender), size of the sample in the comparison arm, the interventions used, length of the intervention, outcomes measured, method of measurement, length of interval for measuring outcomes, and the outcome. From these reviews, data were then synthesized in terms of the outcomes for each modality, for each condition studied, and for modalities by conditions.

Footnotes

2

Psychoneuroimmunology is such a vast field in its own right that we confined our focus to those articles that either specifically indicate a mind-body therapy or indicate a specific diagnosis.

3

Trials were scored for quality according to criteria developed by Jadad (1996). These criteria were developed from published clinical trial data and assess details of blinding and randomization, and accounting for patient dropouts. The 0 to 5 quality scoring system has been shown to discriminate between clinical trials, with a score of 3 and above indicating “high quality” or “good quality” (Moher et al., 1998). Disagreements were resolved by an independent third review. A fuller description of the scoring system is given in Chapter 3 under “Synthesis of the Evidence.”

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