Biofeedback studies with a no-biofeedback control group

Two studies with a no-biofeedback control group reported a positive outcome using biofeedback for fecal incontinence in adults.

Guillemot, Bouche, Gower-Rousseau et al. (1994) examined the long-term results from a controlled clinical trial of biofeedback to treat fecal incontinence in adult males and females. There were 16 patients in the biofeedback arm and eight in the control group receiving antidiarrheal therapy or enema. The mean age was 62 years, and 53 percent of the patients were female. Anorectal manometry (upper and lower anal sphincter resting and squeezing pressures, anal reflex after distension, sensation threshold, maximum tolerable volume) was performed using a triple balloon probe. The biofeedback used a system where the data were digitized and displayed on a computer screen. Clinical scores were calculated before treatment and at followup at 24- to 36-month intervals. An intermediate score was calculated at 6 months. The clinical scores were based on frequency of soiling, incontinence of flatus only, or feces and flatus, type of feces, quality of feces, and time of soiling. The intervention was repeated at home, twice a day, four times weekly. The authors reported that the fecal incontinence score was significantly lower at 6 months for the biofeedback group than the score for the control group. However, the improvement deteriorated over time (30 months), although no biofeedback was given after 6 months. The Jadad score is 1.

Miner, Donnelly, and Read (1990) randomized 25 patients (68 percent female, ages 30 to 76) for a study of biofeedback to treat fecal incontinence. Thirteen patients were assigned to an active sensory training group. During three 20-minute sessions, these patients were taught how to recognize when a rectal balloon was inflated with small volumes of air and to reduce or eliminate their sensory delay. The 12 patients in the control group were taught the same procedure, but they received no instruction on how to improve their performance. After 1 month, the diary entries of the biofeedback patients were used to measure their degree of fecal incontinence. At this point the control group crossed over to active sensory training. After all subjects had completed the sensory training, they were again randomly allocated to two groups. One received strength training during three 20-minute sessions over 3 days. The subjects were taught how to develop maximum squeeze pressure with a manometric catheter in place, and they were given a 1-month exercise program to enhance muscle strength and endurance. The second group received coordination training. These patients were taught how to respond to balloon inflation with a voluntary squeeze in less than 0.5 seconds and to maintain anal pressure above preinflation values. The authors reported that active sensory training significantly reduced the patients' sensory threshold, corrected any sensory delay, and reduced the frequency of incontinence. The control intervention did not reduce the frequency of incontinence. Subsequent strength and coordination training did not significantly improve incontinence. The functional improvement was sustained over 2 years in those patients available for followup (73 percent). The Jadad score is 2.

There are nine studies with a no-biofeedback control group that showed no benefit from biofeedback. Of these studies, two are for adults and seven are for children.

McHugh, Walma, Diamant et al. (1986) reported on a randomized study of fecal incontinence in 18 subjects (67 percent female, mean age 55 years) that compared a dietary fiber intervention to a standardized biofeedback protocol (not described) and to a voluntary sphincter exercise. This study used a crossover design. The biofeedback included three sessions at 2- month intervals. The voluntary exercise was done using a home manometer. Outcomes measured included fecal incontinence, fecal staining, and number of bowel movements. The dietary fiber intervention benefited some subjects. However, there was no significant difference in treatment results between the biofeedback and the voluntary sphincter exercise. The Jadad score is 2.

Koutsomanis, Lennard-Jones, Roy et al. (1995) also compared a control group (which received muscular coordination training) to a group receiving the same intervention plus biofeedback in a study of adults with constipation (n = 59). There were 30 patients in the control group and 29 in the biofeedback group. The patients ranged in age from 20 to 63, and 86 percent were female. The biofeedback patients were taught to control and contract the anal canal in response to an inflated rectal balloon while watching the results of their action on an EMG trace monitor. The control group had the same training but without the visual display. The number of training sessions depended on what the patient and the doctor considered adequate. The biofeedback group required a mean of three sessions (range one to seven), and the muscular coordination control group required a mean of two sessions (range one to four). Outcomes measured included patient assessment of improvement, bowel frequency, number of straining episodes, digitations, abdominal pain, and laxative consumption. Outcome measurements were taken both before and at the end of treatment as well as at a later followup time (not given). This study found that adding biofeedback to muscular training had no additional benefit for treating intractable constipation compared with muscular training by itself. About 40 percent of the patients in both groups thought their symptoms had improved. The authors also found significant improvements in both groups for bowel frequency, straining episodes, and duration of abdominal pain. The Jadad score is 3.

The following seven studies of children using a no-biofeedback control group reported no benefit from biofeedback. Three are from the same research team and should not be considered as independent studies. Three studies were on encopresis, three on constipation, and one on abdominal pain.

In a study of the long-term outcome for biofeedback to treat chronic constipation and encopresis in children, Loening-Baucke (1995) combined two studies to give a total sample of 63 patients who received biofeedback and 66 patients who had conventional care. Patients in the first study were randomized to either conventional care (n = 19) or to conventional treatment plus biofeedback (n = 21). In the second study, 42 patients received biofeedback after 6 months in conventional care during which they had not recovered. In the combined sample, the mean age was 12 years with 48 percent female patients. The conventional care included laxatives, enemas, and treatment for social and psychological problems, including education about constipation. Patients in the biofeedback group were shown normal manometric and EMG tracings compared with their own tracings. A rectal balloon was used to record the data. During training, the children received constant verbal, visual, and audio reinforcement to encourage them to correct their external anal sphincter (EAS) contraction and relaxation. At least two but up to six training sessions were conducted, depending on how soon the child learned to relax the EAS. Each training session lasted approximately 45 minutes, and they were given 7 days apart. Outcome measures included quality of stools, soiling, medication diary, abdominal pain, defecation dynamics, and urinary incontinence. Abdominal and rectal examinations were conducted. Recovery was defined as having three or more bowel moments per week and two or fewer soilings per month while not receiving laxatives for 4 weeks. The average followup time for the patients was 4.1 ± 1.5 years. Eighty-six percent of the conventionally treated patients and 87 percent of those in the biofeedback group had improved in encopresis. In addition, 62 percent of the conventionally treated patients, 50 percent of those in the biofeedback group, and 23 percent of patients who were unsuccessful biofeedback-treated patients had recovered from chronic constipation and encopresis. Recovery rates were similar for patients in both groups who learned normal defecation dynamics. Learning normal defecation dynamics with biofeedback training did not increase long-term recovery rates in children with chronic constipation, encopresis, and abnormal defecation dynamics above the rates achieved with conventional care alone. The length of followup was significantly related to recovery. The Jadad score for this study is 3.

Loening-Baucke (1994) in a study of constipation in children (age and gender not provided) evaluated the long-term effect of biofeedback on abnormal anorectal function including anismus (paradoxical contraction of the striated pelvic floor muscles, indicated in this study by the designation cEAS). In past studies children with chronic constipation and encopresis who also had cEAS had significantly lower recovery rates compared with children who could relax their striated pelvic floor muscles (rEAS). A total of 215 children with chronic constipation and encopresis (86 with rEAS and 129 with cEAS) were treated with timed toilet sittings (no description provided) and laxatives. Of the 129 children with cEAS, 63 were given biofeedback (technique not described), and 50 of them learned rEAS in approximately three biofeedback sessions. Recovery was defined as three or more bowel movements per week and two or fewer soilings per month while off laxatives for at least 1 month. At a mean followup time of 4 years, patients with rEAS, with BFrEAS (biofeedback + rEAS), and with cEAS had similar recovery rates: 62, 50, and 62 percent, respectively. Soiling frequency per week and stool frequency per week were similar in all groups at the beginning of the study. Both conditions had decreased significantly in all groups at followup, but they were not different between the groups. Biofeedback did not affect the long-term outcome in patients with cEAS. The Jadad score is 0.

Wald, Chandra, Gabel et al. (1987) evaluated biofeedback to treat childhood encopresis in 50 children (20 percent female, ages 6 to 15 years). Anorectal studies using a rectal balloon were performed on the proximal rectum, the internal anal sphincter, and the external anal sphincter. The children were then randomized to two treatment groups. One group (n = 26) received conventional treatment, which consisted of ingesting mineral oil. They were followed up at 2, 4, and 8 weeks. The second group (n = 24) received biofeedback. They viewed their manometric recordings, which were explained to them, and they were shown what these responses looked like during contraction and simulated defecation. Those with abnormal defecation dynamics were instructed to normalize the pattern through trial and error (generally during a 10- to 20- minute exercise). Those children with encopresis but with normal defecation dynamics simply repeated the exercise first with and then without biofeedback. All sessions lasted 25 to 30 minutes. After the sessions ended, the children were instructed to use the technique to normalize their defecation whenever they needed to defecate. Reinforcement biofeedback was given at 2, 4, and 8 weeks. Outcomes measured included frequency of defecation and the number of soiling episodes (stars were awarded for days when no soiling occurred) as recorded in a calendar kept for 12 weeks following initiation of therapy. Followup interviews occurred at 3, 6, and 12 months by a blinded assessor. There were no significant differences in clinical outcome between the two groups at 3, 6, and 12 months. However, at 12 months, six out of the nine children with abnormal defecation patterns in the biofeedback group were in remission compared with only three out of nine in the control (mineral oil) group. This difference in proportion, while large, is not statistically significant with this small sample size. The Jadad score is 2.

Nolan, Catto-Smith, Coffey et al. (1998) compared one group of children (n = 15) receiving usual and customary care (not described) to a second group (n = 14) receiving usual and customary care plus biofeedback to treat constipation and fecal incontinence in children 4 to 14 years old (gender not given). The principal outcome was remission of fecal incontinence and the lack of need for laxative treatment at the 6-month followup. Anorectal manometry using the balloon method was performed at baseline and at 6 months after randomization. During biofeedback training, electromyograms were recorded, and the patient focused on the EMG display, which indicated both visually and aurally if there was contraction or relaxation of the external sphincter. The aim of the biofeedback was to eliminate anismus during defecation attempts. Up to four sessions at weekly intervals were conducted for each patient, with each session involving 30 to 35 defecation attempts. If patients achieved 10 relaxations of the external anal sphincter without visual biofeedback in two successive sessions, they did not complete further sessions. The authors reported no lasting benefit for biofeedback at 6 months. This study also included a child behavior checklist (CBCL). Although the total behavior-problem scores from the CBCL were not significantly different between the two groups, the biofeedback group did have significantly better school scale scores, which form part of the CBCL. This study has a Jadad score of 2.

In a study by van der Plas, Benninga, Redekop et al. (1996), biofeedback was used to treat encopresis in a group of boys and girls (n = 32), with a median age of 9 years. One group received usual and customary care (high fiber, daily enemas, oral laxatives), and the other received usual and customary care plus biofeedback. The biofeedback involved showing the children normal manometric and EMG tracings. A balloon was used to develop rectal sensation and for evacuation. Both visual and verbal reinforcement was used. The treatment involved 6 weeks of intensive training and included home sessions as well. Outcome measures included defecation dynamics as determined by manometric measure, a child behavior checklist, a teacher report form, self and parent reports of frequency of defecation, soiling and/or encopresis, consistency and size of stool, pain, and other symptoms such as enuresis. Initially those children given usual and customary care and biofeedback had higher success rates, but the researchers reported that at 12 and 18 months, there were no differences between groups. The Jadad score for this study is 2.

In a similar study, van der Plas, Benninga, Buller et al. (1996) compared usual and customary care (laxatives, diet, toilet training) with usual and customary care plus biofeedback to treat boys and girls (n = 98) from 5 to 16 years old with constipation. The biofeedback training was identical to the previous study. Outcomes measured were defecation dynamics (manometry) and laxative use. The authors reported that at 1 year, although there were improvements in defecation dynamics in the biofeedback group, there were no differences among groups in clinical outcomes. The Jadad score is 3.

In a third related study, Benninga, van der Plas, Taminiau et al. (1996) randomly allocated 29 children (55 percent female, median age 9 years) with recurrent abdominal pain to a control group receiving usual and customary care (enemas, laxatives, high fiber diet, and toilet training) or to a group receiving biofeedback plus usual and customary care. The type of biofeedback was not described, but it is assumed to be the same used in the previous two studies. Outcome measures included use of laxatives, abdominal pain, and manometry measures. The subjects were assessed at 6 weeks and at 6 months. The study found that the children with recurrent abdominal pain benefited equally from either biofeedback and usual and customary care or from usual and customary care alone. The Jadad score is 1.

In summary, our literature search identified 11 studies that provided information on the efficacy of biofeedback. Four of these studies were of adult patients, and they reported mixed results. Two studies of adult patients reported statistically significant benefits of biofeedback to treat fecal incontinence. Both studies had quality scores characterized as “poor.” One additional study of adult fecal incontinence did not report a benefit of biofeedback; this study also had a quality score characterized as “poor.” A fourth study of biofeedback, this time as treatment for adults with constipation, also did not report any benefits of biofeedback compared with muscular training.

In contrast to the mixed results for adults, all of the studies of biofeedback for children reported no statistically significant benefit of biofeedback compared to conventional care.

Biofeedback studies without a no-biofeedback control group

Six studies did not have a no-biofeedback control group; they used some form of biofeedback in all study arms. The types of biofeedback compared in these studies included visual manometry readings, EMG outputs (although where these were taken from varies), balloon sensory input, augmented biofeedback (a combination of audio and visual), direct visualization of the anus using a mirror, and contingent biofeedback (given in conjunction with the onset of a problem such as abdominal pain). Five of the six studies are identified as adult studies (one is indeterminate); and the conditions treated included constipation (four studies), fecal incontinence (two studies), abdominal pain (one study), irritable bowel syndrome (one study), and diarrhea (one study). One study was directed at more than one condition. Four of the studies involve females, one involves both males and females, and one is indeterminate with regard to gender. One study found that biofeedback without psychotherapy was insufficient; another found EMG biofeedback was superior to sensory biofeedback; two found no significant differences in results based on the type of biofeedback used; one found that an augmented type of biofeedback had the best outcomes; and one found that a contingent reinforcement biofeedback yielded the most significant results.

Leroi, Duval, Roussignol et al. (1996) treated sexually abused women (n = 15) for abdominal pain, constipation, diarrhea, and fecal incontinence. The women were divided into three groups based on their preference: one received biofeedback alone, another received biofeedback plus group therapy, and the third received biofeedback and individual psychotherapy. The biofeedback was generated by measuring pressure in the upper anal canal with a manometry probe and displaying the tracings on an oscillograph screen so the patient could see what normal and abnormal tracings looked like. The patients were then encouraged to become aware of the sensation of rectal distention while watching the change in their anal pressure on the screen. Those patients who could not tolerate a probe were shown an EMG recorded from the perineal skin. A third option offered to the women was viewing their anus with a mirror without having a probe inserted. The interval between biofeedback sessions varied, but it was generally 2 weeks. The length of the sessions is not described. The outcome measured was somatic symptoms. Biofeedback alone was initially chosen by all the women as the preferred treatment; none of the women initially chose treatment that included group or individual psychotherapy, but later some of the women did move into these groups. However, the researchers reported that biofeedback alone was not always sufficient to cure these abused patients at a 6- to 10-month followup (although 46 percent who received some biofeedback completely recovered from their symptoms). The study has a Jadad score of 1.

Glia, Gylin, Gullberg et al. (1997) used biofeedback to treat functional constipation and paradoxical puborectalis contractions in females and males (n = 13) with a mean age of 55 years. The authors reported that the treatment improved abnormal contractions and symptoms at 6 months. The patients were divided into two groups. One received biofeedback with EMG of the anal sphincter, which was produced by a needle electrode inserted into the puborectalis muscle. The second group received biofeedback with anal manometry, which measured maximum resting pressure, maximum squeeze pressure, and the length of the anal sphincter. Rectal evacuation was determined with a balloon expulsion test. Transit time was measured with radiopaque markers and radiographs. Defecation was monitored with cinedefecography (continuous fluoroscopy and video recording). Patients received biofeedback 1 to 2 times a week, up to a maximum of 10 sessions. The study reported a significant improvement in both bowel functioning (58 percent improved anorectal functioning) and abdominal symptoms (75 percent improvement) at a 6-month followup. Both biofeedback treatments were equally effective. This study has a Jadad score of 3.

Heymen, Wexner, Vickers et al. (1999) used biofeedback in a study of constipation in females (n = 36) with an average age of 61 years. All patients received weekly biofeedback sessions for 1 hour. The women were divided into four groups, each receiving a different treatment combination: (1) biofeedback (EMG activity of the pelvic floor muscles) with education and pelvic floor exercise; (2) biofeedback (EMG activity plus balloon sensory training) with education and pelvic floor exercise; (3) biofeedback (EMG activity plus home trainer using a portable EMG biofeedback unit) with education and pelvic floor exercise; and (4) biofeedback (EMG activity, balloon training, and home trainer) as well as behavioral therapy with education and pelvic floor exercise.

The outcomes measured were unassisted bowel movements and a decrease in the use of cathartics (laxatives, enemas, suppositories, or digitation). The researchers reported that biofeedback significantly improved bowel movements in groups 1, 2, and 4; groups 1 and 2 also reduced their use of cathartics as did group 3. No significant difference was found among the treatments. The EMG biofeedback alone was as effective as with the addition of balloon training, home training, or both. However, the treatment combination with a single biofeedback technique (group 1) was no more effective than the treatment combination that included behavioral therapy (group 4). The timeframe for this study was not reported. The Jadad score is 1.

Fynes, Marshall, Cassidy et al. (1999) reported significant improvement for fecal incontinence after 12 weeks of biofeedback in a study of females (n = 20) with a mean age of 32 years. The women were divided into two groups. One group received sensory pelvic floor biofeedback training using exercises to improve awareness and strength of the pelvic floor muscles. A perineometer was inserted into the vagina, and the patient performed both slow and fast twitch contraction. The second group received augmented biofeedback, which combined the audiovisual biofeedback from the perineometer with electrical stimulation from an edoanal probe connected to a monitor, which displayed vaginal contraction. Surface EMG readings were obtained. Outcomes measured were changes in continence scores (from a symptom questionnaire) and in anorectal physiology. The improvement in symptoms was greatest in the group receiving augmented biofeedback (audiovisual and electrical stimulation) rather than in the group receiving sensory biofeedback alone. Only the augmented biofeedback produced objective changes in anal canal pressures. The Jadad score is 3.

Bleijenberg and Kuijpers (1994) compared two methods of biofeedback for treatment of constipation in a study of 20 patients (20 to 50 years old, 80 percent female). The authors randomly assigned the patients to receive either EMG biofeedback or biofeedback using a balloon catheter during an 8-week period that involved both weekly clinical sessions and home exercises. All patients had been diagnosed by a gastroenterologist as having a spastic pelvic floor syndrome; the diagnosis was confirmed using EMG. Patients in the EMG biofeedback group received printouts that showed their results during training. During training, the patients were connected to a personal computer that calculated a quality score based on the EMG signal. The score measured relaxation during straining on a 0 to 100 scale -- the higher the quality score the better the straining behavior. Patients in the balloon biofeedback group were simply taught to sense the balloon catheter and its evacuation. Outcome assessments included EMG readings and a self-observation diary that reported psychological symptoms (such as anxiety, depression, hostility, neuroticism, etc.) and physical symptoms (such as constipation, defecation frequency, incidence of difficult defecation, incomplete defecation, hard stools, use of laxatives, and abdominal pain).

Patients in the EMG biofeedback group significantly increased their mean straining score (indicating better straining behavior), and their self-reports showed significant reductions in the percentage of difficult evacuations, incomplete evacuations, hard motions, false urges, and duration of pain, as well as in their abdominal complaint score. The constipation score was reduced significantly. In addition, this group showed progress on psychological symptom scales -- improvement was noted on the symptom subscales for depression and inadequacy. In contrast, patients in the balloon biofeedback group showed no significant changes in EMG readings, in self-observation diary entries, or in constipation scores. They improved only on the physical symptom scale and on interpersonal sensitivity, and hostility measures from the psychological scale. These results remained significant at followup (mean 14 months for the EMG group, 9 months for the balloon group). The authors calculated that 8 out of the 11 patients in the EMG biofeedback group had improved compared with only 2 out of the 9 patients in the balloon biofeedback group. Subsequently, five of the balloon biofeedback patients had the EMG treatment, and four of them had a good result. The Jadad score for this study is 2.

Welgan, Bondi, and Hoehler (1986) compared biofeedback and stress management and contingent biofeedback and contingent stress management for irritable bowel syndrome (IBS). Twenty patients (gender and age are not given) with IBS were divided into two groups and given 20 treatment sessions each lasting 1 hour. During these sessions, both groups were given 20-minute periods of biofeedback and stress management training. During the first 10 sessions, both groups were instructed to practice the techniques four times daily. During the last 10 sessions, one group was directed to use the technique only at the onset of abdominal pain or discomfort (contingent reinforcement) while the second group continued as before. Outcome measures included EMG, galvanic skin response, and bowel sounds, as well as abdominal pain and discomfort. The reported results showed that biofeedback and stress management significantly reduced central and autonomic arousal states and that EMG and bowel sounds declined significantly. Furthermore, the contingent-reinforcement group produced significantly more reports of reduced pain and discomfort than the group not instructed in contingent reinforcement. The Jadad score is 0.

In summary, our literature search identified six studies that assessed the efficacy of different types of biofeedback or of different therapies in addition to biofeedback. Four of the six studies had quality scores characterized as “poor.” Two studies reported no significant differences between types of biofeedback, while the other four each compared something different. No conclusions can be drawn, other than it is possible that there may be ways to improve the efficacy of biofeedback for gastrointestinal conditions.

Hypnosis studies with a no-hypnosis control group

Whorwell, Prior, and Faragher (1984) evaluated 30 patients in a randomized study of treatment for severe, refractory irritable bowel syndrome (23 to 54 years old, 87 percent female). The control arm received a placebo (not described) and psychotherapy (seven half-hour sessions). The intervention arm received seven half-hour sessions of hypnotherapy plus a tape for daily autohypnosis. Hypnotherapy involved only general relaxation for control of intestinal motility; there was no hypnoanalysis. At the end of 3 months of treatment, the hypnotherapy group (n = 15) reported either mild or absent symptoms, and the patients were significantly better in terms of abdominal pain, bowel habit, abdominal distention, and well being. The control group (n = 15) showed a small but significant improvement for all symptoms except bowel habit. The difference between the two groups reached significance by the fourth week of treatment for bowel habit, abdominal distention, and well being, and by the fifth week for abdominal pain. No long-term assessments were reported. The Jadad score is 1.

Colgan, Faragher, and Whorwell (1988) studied the use of hypnosis in a randomized study of 30 patients (mean age 40 years, 47 percent female) for relapse of duodenal ulcer. All patients had at least one confirmed relapse in the 6 months prior to the study. The treatment group (n = 15) received seven sessions of hypnotherapy (involving imagery/visualization for control of gastric secretion) and an audiotape for autohypnosis plus medication for the ulcer for 10 weeks after healing. The control group (n = 15) received only the medication regime and was seen as frequently as the treatment group. After the medication was stopped, the two groups were reviewed every 3 months for an additional year with the treatment group continuing to receive hypnotherapy during this time. All subjects had an endoscopic exam at the end of the study. At the 12-month followup, there was a statistically significant difference in relapse rates: 53 percent for the hypnosis treatment group and 100 percent for the control group. The Jadad score is 1.

Hawkins, Liossi, Ewart, Hatira et al. (1995) conducted a randomized study of 30 children with cancer (5 to 17 years old, 60 percent female), comparing one group (n = 10) receiving usual care for nausea and vomiting (antiemetic medication) with a second group (n = 10) receiving both medication and hypnotherapy and with a third group (n = 10) receiving medication and therapist contact. All the children continued to receive the medication. Five days before inpatient admission, children in the hypnosis and therapist groups participated in a 1-hour training session either undergoing hypnosis or talking with the therapist. Hypnosis was induced by relaxation; visual imagery was used for self-hypnosis. The children were asked to practice self-hypnosis at home and to do the exercises prior to each chemotherapy session. After admission, the children receiving hypnosis had a 20-minute booster session while the others simply met for 20 minutes with their therapist. Outcome measures were assessments of retching and vomiting made retrospectively by the patients and by the nursing staff. The number of retching/vomiting episodes decreased by 33 percent in the hypnotherapy group and by 11 percent in the therapist contact group. However, it increased by 6 percent in the control group receiving usual care (antiemetic medication) alone. For anticipatory nausea, the severity decreased by 40 percent in the hypnosis group and by 20 percent in the therapist contact group, but it increased by 11 percent in the control group. The Jadad score is 2.

Zeltzer, LeBaron, et al. (1987) also examined the use of hypnosis for the treatment of chemotherapy-related nausea and vomiting in a study of 42 children (5 to 17 years old, gender not reported). The patients were randomized to a hypnosis, support, or control group. The number of children in each group is not known. Their reaction to two baseline courses of chemotherapy was compared with their reaction to two matched courses with intervention added. Assessment included patient, parent, and observer ratings before and after chemotherapy. Nausea and vomiting were significantly reduced for the hypnosis group, but patients in the support group stayed the same. Children in the control group reported a 20-percent increase in the extent to which the chemotherapy bothered them as well as a worsening of all symptoms over time. The Jadad score is 2.

Schmidt (1992) used hypnosis in the treatment of ulcerative colitis in 30 patients (60 percent female, ages not given). The patients were assigned to either a hypnosis group or to a control group and were monitored four times annually by blinded assessors. The hypnosis combined hypnotherapy and imaginative therapy, and the patients in this group meet weekly. The control group was treated with drugs and diet counseling while the study group added hypnosis. The study had a 5-year followup. Outcome measures included number of relapses, necessity of surgical intervention, and repeated inflammation. All patients in the hypnosis group were relapse-free after 50 months, while no one in the control group showed any continual improvement. The Jadad score for this study is 1.

Galovski and Blanchard (1998) used the Whorwell protocol (Whorwell, Prior, and Faragher, 1984) for hypnotherapy to treat irritable bowel syndrome. The study had 12 participants (23 to 58 years old, 83 percent female). Six matched pairs (matched for anxiety disorder scores, susceptibility to hypnosis, age, and gender) were randomly assigned half to a hypnosis treatment group and half to a control group. Subjects in the treatment group received half-hour to 1-hour hypnosis sessions weekly for 12 weeks. Subjects in the control group had their symptoms monitored, and they were crossed over to the treatment arm after 6 weeks. The subjects kept a daily diary of gastrointestinal symptoms. At the end of the 12 weeks, all participants completed two psychological tests. They were contacted 2 months later to complete another 2 weeks of diaries, psychological tests, and a global rating of treatment outcome. Outcome measures included pre- and post-treatment symptom ratings based on diary entries as well as global ratings of symptoms (pain, bowel regularity, general sense of well being) made at the 2-month followup. Symptoms improved significantly, and anxiety scores decreased, in the hypnosis group. Furthermore, when control group subjects crossed over to the treatment arm, they also showed improvements. The Jadad score for this study is 2.

Anton, Schoen, Mayer, and Fullerton (1997) studied the use of hypnosis to treat irritable bowel syndrome. In their study, subjects (gender and age not given) were randomized to either a treatment group (n = 11) receiving weekly individual hypnosis or to a control group (n = 7) receiving one-on-one attention. The hypnosis was not directed at specific irritable bowel symptoms. Outcomes measured included severity of abdominal pain, discomfort, number of bowel movements, and quality of life. There were no changes in any of the outcomes in the sample as a whole. At 6 weeks there were no significant differences in symptoms between the treatment group and the control group. Only the overall quality of life score showed a significant increase for the hypnosis group. The Jadad score is 2.

Hypnosis study without a no-hypnosis control

In a study of irritable bowel syndrome, Forbes, Macauley, and Chiotakakou-Faliakou (1999) compared individual gut-directed hypnotherapy with a prescribed audiotape in a randomized trial involving 52 patients (median age 37 years, range 19 to 71 years, 71 percent female). No description was provided about the type of hypnosis or tape used. The subjects kept a diary of symptoms for 3 months. At the end of the study, symptom scores fell in 76 percent of the subjects in the individual hypnosis group and in 56 percent of those in the audiotape group. In the intention to treat analysis there was a median reduction of −3 symptoms for the individual hypnosis group compared to −1 for the audiotape group. For those subjects who completed the protocol, this reduction reached statistical significance (−5.5 versus −1). A blinded assessor considered 52 percent in each group had improved; this increased to 67 percent and 57 percent, respectively, for those fully compliant in each group. The authors recommend using the tapes as initial treatment, given their low cost and ease of use, and substituting individual hypnosis sessions for treatment failures. The Jadad score for this study is 2.

Relaxation studies reporting a benefit

Of the five studies reporting a benefit, one dealt with the reduction of nausea, vomiting, and anxiety resulting from chemotherapy; one dealt with chronic pain from an ulcer; two were for irritable bowel syndrome; and one was for gastrointestinal distress.

Meyer (1983) reported on the use of relaxation in the treatment of nausea, vomiting, and anxiety resulting from chemotherapy. In this study, 37 patients (all over 18 years old, 68 percent females) were randomly assigned to one of three groups: a standard control group (n = 12), a systematic desensitization group (n = 13), and a relaxation training group (n = 12). The control group received no treatment. The desensitization group received training to modify anxiety and included progressive relaxation exercises. This group received one pretraining session, two treatment sessions, and one followup session. The relaxation group used meditation to achieve relaxation in two 1-hour relaxation training sessions. Outcomes measured were nausea, vomiting, and anxiety. Both desensitization and relaxation were effective against nausea and anxiety and somewhat effective against vomiting; however, desensitization was more beneficial than relaxation. The Jadad score is 3.

Giles (1978) reported the results of a randomized controlled study of gastrointestinal distress (type not specified). A total of 40 subjects (ages 18 to 33 years, gender not indicated) were randomly assigned to one of four treatment groups (n = 10 each): (1) stress management training (psychotherapy); (2) biofeedback relaxation; (3) combined treatment; and (4) a waiting list control. The stress management group received eight 50-minute therapy sessions. The biofeedback group had 50-minute training sessions, during which patients listened to half-hour relaxation tapes and practiced deep relaxation techniques. They received feedback on both muscle tension and body temperature as monitored by EMG and galvanic skin response. Treatment for both groups lasted about 8 weeks, although this could vary for individual patients as decided by the therapist. The combined treatment group received about 1 hour more stress management and biofeedback treatment per week during the 8-week period. The control group was simply a waiting list control. These patients could opt for treatment after the treatment period ended; therefore, the study no longer had a control group at the 8-month followup. Measurements taken before and immediately after treatment, as well as at the 8-month followup, included symptom reports along with psychological scales (e.g., locus of control) and psychiatric scales (e.g., Hopkins Symptom Checklist). For physical symptoms, all three treatment groups, but not the control group, had improved bowel movements and nausea; there was no reported difference for constipation among the four groups. The results were similar at the 8-month followup. The biofeedback relaxation group had better measures of loose bowel movement than did the combined treatment and stress management groups. For psychiatric symptoms, results for the combined treatment group were superior to those for the biofeedback and the stress management groups. The findings were similar for psychological measures. There were no significant differences among the groups for physician visits. The study concluded that the combination of biofeedback relaxation and stress management can be effective and that the effects continue for months after treatment. The Jadad score is 2.

Shaw and Ehrlich (1987) examined the use of progressive relaxation to treat chronic ulcer pain in a randomized study of 40 patients (ages 20 to 60, 50 percent female). One group received six treatment sessions of progressive relaxation over a 6-week period. These subjects were also given relaxation audiotapes and told to practice with them at home at least once a day. Patients in the control group were told that they were on a waiting list to join the study and were updated weekly about their status during the 6-week intervention. They were given the option of relaxation therapy at the end of the study. Both treatment and control subjects were tested before and immediately after the study as well as 6 weeks later. Outcomes measured included self-reports, using the subject's own words, of the pain; intensity, duration, and frequency of pain episodes; pain relief; use of pain medication; and distress. The relaxation group was significantly better than the control group on six out of seven outcome measures both immediately after treatment and at 6 weeks. The results were not different when the subjects took pain medication, but only a few were actually taking it. The Jadad score is 1.

Blanchard, Greene, Scharff et al. (1993) studied irritable bowel syndrome in 14 patients (22 to 64 years old, 78 percent female), treating one group with relaxation therapy and simply monitoring a control group for the duration of the study. All patients had received an IBS diagnosis from a physician. Prior to the study, all patients received a psychiatric interview and completed an anxiety disorders interview schedule. The treatment involved abbreviated progressive muscle relaxation, which focused first on 16 muscle groups and then on 8 and finally on 4. Training was done individually at two sessions during the first 2 weeks and then once per week for 6 weeks. Regular home practice with an audiotape was also prescribed. The study examined the daily GI symptom diary that subjects kept for 4 weeks before and after the treatment and during the 8-week treatment period. The symptom diaries recorded abdominal pain, abdominal tenderness, diarrhea, constipation, bloating, flatulence, and nausea. The control group was monitored through the diaries for 16 weeks. Using a measure of multiple symptoms (the Composite Primary Symptom Reduction scores, CPSR), the authors reported that the relaxation group showed significantly more improvement than the control group. Fifty percent of the relaxation group reached a conventional level of clinically significant improvement while only 13 percent of the control group did so. The Jadad score is 1.

Hentschel, Bauer, Loew et al. (1994) conducted a randomized study of irritable bowel syndrome comparing physical relaxation with a placebo treatment. No information was given on the age or gender of the 57 subjects. The relaxation therapy combined body perception with physiotherapy on the skeletal joints carried out for 10 hours over 5 weeks. The placebo treatment consisted of tablets taken three times daily for 12 weeks. Outcomes measured were abdominal complaints and symptoms based on patient diaries. At the end of the treatment period, the relaxation group was significantly better than the placebo group in terms of reduced physical and mental stress in coping with their disease, general well being, satisfaction with activities of daily living, and global life satisfaction. The two groups, however, were not significantly different in vegetative dysfunction. The Jadad score is 1.

Arakawa (1995) reported the results of a randomized study of progressive muscle relaxation therapy to reduce nausea, vomiting, and anxiety for patients receiving chemotherapy (n = 60, ages 22 to 74 years, 40 percent female). The treatment group (n = 30) was given muscle relaxation instruction and an explanatory booklet. The initial training session took 45 to 60 minutes, and the patients met with the researcher once a day for additional sessions (number unknown). They were also given a 25-minute audiotape and instructed to use it to practice the relaxation technique at home twice daily. The treatment group was assessed on nausea, vomiting, and anxiety every 12 hours for 72 hours after the initiation of chemotherapy. The control group (n = 30) received routine nursing care, antiemetics, and met with the researcher once a day. They too were assessed on nausea, vomiting, and anxiety every 12 hours for 72 hours after the initiation of chemotherapy. The author reported that progressive muscle relaxation reduced the total scores for nausea, vomiting, and retching in the treatment group compared to the control group and reduced anxiety scores as well for the treatment group. The Jadad score is 2.

Relaxation studies reporting no effect

There are two controlled studies reporting no effect from relaxation therapy, one on children with abdominal pain and constipation and the other on vomiting in adult chemotherapy patients.

Edwards, Finney, Bonner et al. (1991) used relaxation therapy to treat abdominal pain and constipation in boys (n = 4) and girls (n = 7), ages 6 to 12 years (64 percent female). The relaxation therapy was a progressive muscle relaxation procedure taught through weekly sessions and daily home practice with audiotapes. The study lasted from 10 to 18 weeks, depending on the type of intervention. Subjects were treated with either a simple fiber regime, a fiber regime followed by a period of relaxation therapy, a period of relaxation therapy followed by a fiber regime, or a fiber regime followed by a combination period of fiber plus relaxation therapy. Outcomes measured included pain and disruption of social functioning. The researchers reported that, although the children improved at greater than 6 months, in only one instance could improvement be attributed to the relaxation therapy. The Jadad score is 0.

In a study of chemotherapy-induced vomiting, Holli (1993) randomized 43 subjects (ages 19 to 84 years, gender not given) to an intervention of relaxation therapy and 24 subjects to a control group. Both groups received the normal antiemetics before chemotherapy. The control group received no other active intervention beyond completion of the evaluation. The relaxation group received progressive deep-muscle relaxation training before and after chemotherapy. The outcome evaluation, made by both the subjects and by an observer, looked at onset, quantity, and duration of vomiting. The study found no significant differences between the two groups. The Jadad score is 1.

In summary, we identified eight studies assessing the efficacy of relaxation therapy for a variety of gastrointestinal disorders. The single study characterized as “good” quality reported a benefit for relaxation therapy in reducing nausea and anxiety associated with chemotherapy.

Behavioral therapy study with a no-behavioral therapy control

Cox, Sutphen, Borowitz et al. (1998) investigated the use of biofeedback and enhanced toilet training (ETT, a behavioral therapy) in a study of encopresis in children (n = 29) from 6 to 15 years old. The children were randomly assigned to three groups: one received intense medical care (usual and customary care for this clinic); the second received behavioral therapy (ETT with incentives) plus intense medical care; and the third received behavioral therapy, biofeedback (surface EMG shown on a video display), and intense medical care. Baseline measures involved 14 days of recording toilet behavior by parents in a voice-mail diary. The subjects underwent psychological, physical, and manometric tests. However, because the researchers also wished to determine cost effectiveness, the number of treatments was open-ended, with sessions scheduled every 1 or 2 weeks as needed. The sessions were terminated based on the child's performance and by a therapist/parent decision. During the 2 weeks of treatment and 3 months after the initial treatment, the parents repeated the 14-day voice-mail diary. Although both interventions that included behavioral therapy (ETT) produced similar reductions in fecal incontinence and were superior to intensive medical care alone, children in the group that combined behavioral therapy with intense medical care used fewer laxatives, required fewer treatments, had fewer relapses at 3 months, and had lower treatment costs at 3 months. The Jadad score for this study is 2.

Zeltzer, LeBaron, and Zeltzer (1984) compared a group receiving behavioral therapy (supportive counseling) with a control group and with a group receiving hypnosis in a study of 19 children (ages 6 to 17 years, gender not specified) receiving chemotherapy. The control group received only antiemetic treatment for nausea and vomiting. The supportive counseling consisted of distracting the children's attention during chemotherapy administration by helping them focus on other objects, using breathing exercises, and playing guessing games. The intent was to avoid the use of imagery, fantasy, or other hypnotic techniques. The parents were instructed to keep the children as active as possible at home to avoid having them focus on symptoms. In the hypnosis intervention, the child was helped to become involved in imagery and fantasy, with the fantasy taking on a sense of reality. The children were also given posthypnotic suggestions to help them use imagery at home. Ratings of nausea and vomiting as well as the bothersomeness of the chemotherapy were obtained from the parents and the children. Ratings were taken before, during, and after the intervention (the time interval was not given). Both supportive counseling and hypnosis were equally effective and were associated with a significant reduction in nausea, in vomiting, and in the extent to which these symptoms bothered the patient. These results remained after termination of the intervention. The Jadad score is 3.

Morrow and Morrell (1982) studied the use of behavioral therapy to control nausea and vomiting in adults receiving chemotherapy (60 patients, ages 19 to 76, 70 percent female). Patients were randomized to one of three groups: systematic desensitization, counseling, or no treatment. All patients received antiemetics. The systematic desensitization group received two 1-hour training sessions between the fourth and fifth chemotherapy treatments. During training they were individually taught a progressive deep-muscle relaxation technique for 20 minutes and then asked to create a hierarchy of increasingly intense anticipatory side effects. Once deeply relaxed, the patients revisited the hierarchy and were desensitized to it. The objective was for the patients to remain relaxed while visualizing the distressing situations. The second group received counseling to control for placebo effects. The patients met individually with the experimenter for two 1-hour sessions between the fourth and fifth chemotherapy treatments. Nausea and vomiting (frequency, severity, and duration) were assessed through patient reports. Two followup evaluations were conducted (no time interval was given). Significantly more patients receiving desensitization reported no anticipatory nausea before their fifth and sixth chemotherapy treatments than those receiving counseling or no treatment. Desensitized patients also reported significantly less severe anticipatory nausea and vomiting and a shorter duration of anticipatory nausea than patients in the other two groups. The Jadad score is 3.

Sanders, Rebgetz, Morrison et al. (1989) reported on a cognitive-behavioral intervention for nonspecific abdominal pain in 16 children (6 to 12 years of age, gender not given). After medical screening, the children were randomly assigned to one of two groups with eight in each: one group received a cognitive-behavioral intervention, and the other was a wait list control group. The treatment arm of the study received 8 weeks of therapy sessions. The treatment sessions (length not given) involved both the child and the child's mother, and they had both a behavioral component and a cognitive coping skills component. The behavioral component involved self-monitoring of pain; a differential reinforcement of other behavior; a schedule for increasing pain-free periods and prompting distraction; and competing activities. The cognitive component consisted of a cognitive self-control procedure that included self-monitoring, self-instruction, self-efficacy statements, self-administration of rewards, self-induced relaxation, and an imaginal strategy to reduce pain. Self-reports of pain were used, as were parent and teacher observation reports. Members of the research team also observed the child and parent at home for 30 minutes. In the pretest assessment, children and parents kept observational records. Parents and teachers also completed a questionnaire. The children and parents in both the treatment and control groups completed pain diaries, and parents kept pain observation records during the 8 weeks of treatment. At the 3-month followup, all pretest measures were repeated for both groups. The results reported show that although both the control group and the cognitive-behavioral group had reduced their level of pain, the latter group improved more quickly, the effects generalized to the school setting (the children were rated better by the teachers for pain scores), and a larger proportion of the subjects (87.5 percent vs. 37.5 percent for the control group) were completely pain free by the 3-month followup. The Jadad score is 1.

Shaw, Srivastava, Swann et al. (1991) randomized 35 patients (ages 22 to 72 years, 45 percent female) to a conventional therapy group (n = 17) or to a stress management group (n = 18) for treatment of irritable bowel syndrome. The conventional care included antispasmodic medication taken three times daily. The stress management involved a 40-minute, individual weekly session with a physiotherapist. The number of sessions varied (a median of six sessions). During training, the patients identified areas of stress and were taught breathing exercises that were used to both identify and control tension. Patients were tested before and after treatment and 6 weeks later. The trial lasted 6 months with at least one review of the intervention. Patients were again interviewed at the end of the trial. The outcome measured was the change in symptoms. A followup was done at 12 months after the start of the trial. Sixty-seven percent of the stress management group (compared with 18 percent of the control group receiving conventional care) rated the program effective for relieving symptoms; they also experienced fewer and less severe attacks. This benefit was maintained for 12 months. The two groups differed significantly on these three variables. The Jadad score is 1.

In a study of irritable bowel syndrome using cognitive therapy, Greene and Blanchard (1994) reported that the cognitive therapy group had significantly greater symptom reduction than a control group. The 20 patients (18 to 70 years old, 75 percent female) were randomly assigned to a symptom-monitoring control group or to cognitive therapy group. The patients were assessed at baseline for physical symptoms, psychosocial functioning, and psychiatric symptoms. At the first visit all patients began a daily GI symptom diary that recorded severity of abdominal pain, abdominal tenderness, constipation, diarrhea, flatulence, belching, and bloating. The diaries were checked after 1 week and then kept during the 2-week pretreatment period, throughout the 8-week treatment, and for a 2-week post-treatment period. Subjects in the cognitive therapy group also completed the diaries for 2 weeks before the 3-month followup. The cognitive therapy involved ten 1-hour individual sessions: two sessions per week for the first 2 weeks and then one session per week for 6 additional weeks. Therapy focused on increasing patient awareness of the association between stressors, thought, and IBS symptom s as well as id entifying and modifying threatening stimuli. The therapy used verbal and behavioral techniques to modify psychological mechanisms, beliefs, and assumptions. Self-recording of thoughts was encouraged, and the patients were provided with monitoring sheets, which identified cognitive responses of the patient that the therapist could focus on. Patients in the control group continued to monitor their GI symptoms for 10 weeks (8 weeks to match the treatment group and 2 more weeks for the post-treatment period.). They were also seen at the mid-point for collection of the diaries and for assessment. At the conclusion, this group crossed over into the cognitive therapy group and then had treatment for 8 weeks. The primary outcome measured was IBS symptoms, but the researchers also measured cognitive changes. Symptom reduction was significantly greater for subjects in the treatment group than for those in the control group. At post-treatment, 80 percent of the cognitive therapy group showed clinically significant improvement while only 10 percent of the control group did. The results also held up at the 3-month followup. Within the cognitive therapy group, the reduction in symptoms correlated well with an increase in positive thoughts and with a reduction in negative ones. The Jadad score is 2.

In summary, we identified six studies that assessed the efficacy of behavioral therapy, all of which reported a statistically significant benefit. The two studies whose quality scores characterized them as “good” quality reported in children and adults receiving chemotherapy that behavioral therapy significantly decreased nausea and/or vomiting.

Behavioral therapy studies without a no-behavioral therapy control

Nolan, Debelle, Oberklaid et al. (1991) reported on a randomized trial of children that compared the use of laxatives and behavior modification (n = 83) to the use of behavior modification alone (n = 86) for encopresis. The ages of the children ranged from 3 to 16 years, and 27 percent were female. The primary outcome measured was remission from encopresis (at least one continuous 4-week period with no soiling episodes). Relapse was defined as soiling that reoccurred more than twice a month after a period of full remission. Treatment failure was defined as having made no substantial progress toward remission by at least 6 weeks from study entry. Both groups received a standard pediatric behavior modification intervention. This consisted of clarification of encopresis during a joint parent-child interview. The bowel training program used positive reinforcement for successful defecation in the toilet and reinforcement for every 24 hours without soiling. Reinforcement included parental praise and the use of a star-chart diary to indicate soiling-free days. A regular 5- to 10-minute toilet-sitting time within 30 minutes of eating was used. Dietary advice, general counseling, and support were provided. In addition to behavior modification, the second group also received laxatives. Constipation was assessed by stool retention based on a radiograph at baseline and at 2 weeks after randomization. A child behavior checklist (CBCL) was done at baseline and at 12 months. Clinic followup was done at 2, 6, 14, 30, and 52 weeks and thereafter as required. Followup varied depending on the child's clinical progress. By the 12-month followup, 51 percent of the combined therapy group compared with 36 percent of the behavioral therapy alone group had achieved remission, a significant difference. Partial remission was 63 percent and 43 percent, respectively. The combined therapy group achieved remission significantly faster than the behavioral therapy alone group. The authors report that the combination of laxatives and behavioral therapy offers a considerable benefit over behavioral therapy alone for children who are able to maintain regular toileting. The Jadad score is 1.

Fernandez, Perez, Amigo et al. (1998) compared two behavioral interventions to study irritable bowel syndrome -- stress management and contingency management -- in 90 patients (mean age of 44 years, 66 percent female). The patients were randomly assigned to one of four study arms: a control group that received conventional medical care; a placebo group using visualization; a stress management group using progressive muscular relaxation, self-instruction, problem solving, and coping; and a contingency management group that involved both the patient and relevant others (family etc.) practicing behaviors more adaptive to IBS symptoms. These patients identified which situations made them worse and learned to stop inappropriate reactions using a contingency contract, self observation, shaping, stimulus control, restructuring of time, and training in social skills. The stress management and the contingency management interventions consisted of 12 individual training sessions. Patients were assessed at the end of treatment (10 weeks) and at 1 year through diaries in which they rated the presence and severity of symptoms. The symptom diaries were kept at baseline for 2 weeks and then throughout the 10-week treatment period. The contingency management group showed significant reductions in all the digestive symptoms (abdominal pain, diarrhea, constipation, dyspepsia). At the end of treatment, 50 percent of these patients remained asymptomatic, and 37.5 percent had reduced their symptoms by at least 50 percent. Thirty-three percent of the patients in the stress management group got rid of all their symptoms, and this group showed significant reductions in abdominal pain, diarrhea, and dyspepsia. No significant changes were observed in the conventional care control group. These results were maintained 1 year after the intervention. The changes noted in the placebo group, however, were determined not representative because of the high dropout rate for these patients. Nevertheless, the authors concluded that behavior modification can eliminate or lessen chronic-illness behavior symptoms. The Jadad score for this study is 4.