Results of biofeedback in constipated patients

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Results of biofeedback in constipated patients
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  Results of iofeedback in Constipated Patients Prospective Study Urban Karlbom, M.D., Marianne H~tllden, R.N., Karin E. Eeg-Olofsson, M.D., Ph.D.,t Lars Pfihlman, M.D., Ph.D., Wilhelm Graf, M.D., Ph.D. From the Departments of Surgery and tNeurophysiology, University Hospital, Uppsala, Sweden PURPOSE The aims of this study were to assess the results of biofeedback treatment in constipated patients and to identify variables that might be used to predict the out- come. METHOD: Twenty-eight patients (5 men; median age, 46 (range, 22-72) years) with any degree of paradoxi- cal activation measured with thin hook needle electromyo- graphy in the external sphincter or puborectalis muscle were included. The symptom duration varied between 1 and 30 (median, 9) years. The patients had eight outpatient training sessions with electromyography-based audiovisual feedback. M1 patients were followed up prospectively with a validated bowel function questionnaire from which a symptom index was created. RESULTS: At three months, nine patients had no improvement and underwent other treatments. The remaining 19 patients were followed up for a median of 14 (range, 12-34) months. Twelve patients (43 percent) stated they had improved rectal emptying. A good result was associated with increased stool frequency (P < 0.05), improved symptom index (P < 0.01), and reduction of laxative use (P < 0.05). A long symptom duration, a high pretreatment symptom index, and laxative use were related to a poor result (P < 0.01-0.05). The improved group had less perineal descent (P < 0.05), and a prominent puborec- tails impression on defecography tended to be more com- mon (P = 0.06). CONCLUSION: With the use of wide inclusion criteria, biofeedback was successful in 43 percent of patients, with a treatment effect lasting at least one year. The results suggest that biofeedback should be used as the initial treatment of constipated patients with a paradoxical puborectalis contraction. [Key words: Biofeedback; Consti- pation; Outlet obstruction; Paradoxical puborectalls con- traction; Anismus] Karlbom U, Hfillden M, Eeg-Olofsson KE, Pfihlman L, Graf W. Results of biofeedback in constipated patients: a pro- spective study. Dis Colon Rectum 1997;40:1149-1155. atients with constipation can usually be catego- rized into slow-transit or outlet obstruction con- stipation based on results of radiologic and physio- logic investigations in combination with the patient s history of infrequent or obstructed defecation. A rectocele and a paradoxical puborectalis contrac- tion might be considered as causes of outlet ob- struction, because both have been related to im- Address reprint requests to Dr. Karlbom: Department of Surgery, Akademiska sjukhuset, S-751 85 Uppsala, Sweden. paired rectal emptying on defecography. ~ The etiologic importance of a paradoxical puborectalis contraction in constipated patients has been ques- tioned because it also has been found in other anorectal conditions 2 and in healthy control sub- jects. 3 Wasserman 4 described the inappropriate contraction of the puborectalis muscle as a syn- drome with constipation, rectal evacuation difficul- ties, and pain. The proposed treatment was division of the puborectalis muscle. Posterior division or resection of the puborectalis muscle has been used,5, 6 but the surgical treatments have not gen- erally been successful, and there is a definite risk of incontinence postoperatively. < 7 Local injections of botulinum A toxin have also been attempted. 8 Biofeedback has been used for a long time to strengthen the pelvic floor muscles in patients with fecal incontinence. In recent years, the biofeedback concept has been used for retraining of the pelvic floor in patients with a paradoxical sphincter contrac- tion. The reported results are varying, with success rates ranging from 0 to more than 90 percent 9-17 (Table 1). Differences in diagnostic methods, patient selection for treatment, and type of treatment (num- ber of sessions and dietary, laxative, and psychologic counseling) may explain the various results. Although there are great differences in the results of biofeed- back treatment, the data suggest that a paradoxical puborectalis contraction has a clinical significance for some patients, but how to properly find these patients is unclear. The aim of this study was to prospectively assess the results of biofeedback treatment in constipated patients with paradoxical puborectalis contraction. Another aim was to evaluate data from the patient s history and investigational results in relation to out- come to find factors that might be helpful in selecting patients for this treatment. 1149  1150 KARLBOM ET L Table 1 Results of Biofeedback in Different Studies Dis Colon Rectum, October 1997 Sex Diagnostics Type of No. of Follow-Up Percent Author n Age yr) M/F Anorectal) Feedback Sessions mo) Improved Dahl etaL 9 14 6-60 4/10 EMG EMG 5 6 93 Manometry Wexner et aL ~ 18 10-84 5/13 Defecography EMG 9 9 89 EMG Fleshman et aL 11 9 35- 62 1/8 Defecography EMG 8-9 6 89 Balloonexpulsion Turnbull and Ritvo 12 7 28-42 0/7 * Manometry 4-5 36 71 Bleijenberg and Kuijpers 13 7 19-48 * Defecography EMG 10 6.5 70 EMG Lestar t aL ~4 16 42 + 3.5 6/10 Defecography Manometry 1 12 44 Manometry Loening_Baucke ~5 38 6-15 28/10 EMG EMG 6 7 39 Manometry Keck et aL ~6 12 17-82 2/10 Manometry EMG 3 8 33 EMG Defecography Weber et aL ~r 26 8-47 17/9 Manometry Manometry 4 12 77 16 24-55 0/16 Manometry Manometry 4 * 0 EMG = electromyography; M = male; F = female * Not clearly stated PATIENTS AND METHODS Patients During 1992 to 1994, 29 patients with constipation and any degree of paradoxical sphincter contraction measured with electromyography (EMG) were of- fered biofeedback as a first-line treatment, irrespec- tive of other findings at the work-up. One patient died from cardiovascular disease two months after treat- ment (before follow-up) and was excluded from the study. Four patients had neurologic disease as a cause or a contributing reason for the constipation, and in the remaining patients, the srcin was idiopathic. All patients had tried bulking agents and a dietary fiber supplement without satisfactory results. Median age was 46 (range, 20-72) years, and there were 5 men and 23 women. Duration of symptoms varied be- tween 1 and 30 (median, 9) years. Most patients (n = 22) were reliant on laxatives; 14 patients used com- binations of bulking agents, motor-stimulants, and/or enemas. Six patients managed with manually assisted defecation. In 17 patients, the predominant symptom was emptying difficulties, and in the remaining 11 patients, there was a mixed symptomatology of infre- quent defecation (--<2 stools per week) and emptying difficulties. One patient underwent rectocele repair six years before treatment, and two patients had been operated on because of rectal prolapse (rectopexy and Delorme s procedure) 5 and 1.5 years before treatment. Otherwise, there had been no surgical in- terventions directed toward constipation. Eight pa- tients had anorectal surgery previously because of other reasons (hemorrhoids, 7; subcutaneous lateral sphincterotomy, 1; anal fistula, 1). nvestigations Organic bowel pathology and megacolon were ex- cluded by proctoscopy and a barium enema in each patient. Colonic transit time was measured with a single x-ray technique, is Anal pressures during rest and squeeze, the rectoanal inhibitory reflex, rectal sensibility, and compliance were assessed by anorec- tal manovolumetry. 19 Defecography was performed to identify morphologic abnormalities such as recto- cele, intussusception, and a paradoxical impression of the puborectalis muscle. An analysis of rectal empty- ing was done by a computer-based area calculation method expressing rectal evacuation as percent evac- uated contrast per second. 1 Integrated EMG was mea- sured with hook electrodes in the external anal sphincter and the puborectalis muscle in the left lat- eral and sitting positions and during an attempt to expel a balloon (Norta| catheter 18 Ch, Beijers- dorf AG, Hamburg, Germany) filled with 40 ml of water at body temperature. The increase in electrical  Vol. 40, No. 10 BIOFEEDBACK IN CONSTIPATION 1151 activity during straining was measured in millivolts (mV), and the increase was related to activity during a maximum squeeze effort: strain amplitude/squeeze amplitude • 100 = strain - squeeze index. A mean value of the indexes in the muscles in the different positions (= EMG index) was used as an overall indicator of paradoxical muscle activation. An EMG index of >0 constituted the main inclusion criterion in the study. iofeedback The biofeedback training consisted of eight outpa- tient sessions. Initially, the patients were taught anat- omy and physiology of the colon, rectum, and pelvic floor and received some general contraction-relax- ation training for back, abdominal, and gluteal mus- culature. The biofeedback was performed with an EMG device (EMG 200 combined with LB 200 light bar, Biofeedback systems, Biodata Ltd, Manchester, United Kingdom). The device provided both audio and visual feedback. The anal plug (Medicon, Trond- helm, Norway), with a circumferential electrode thus reflecting activity in the external sphincter, was in- serted in the anal canal with the patient in the left lateral position. Training was performed in the lying position and sitting on a toilet and consisted of learn- ing to strain while relaxing the anal sphincter and puborectalis muscle. The ability and time to expel a balloon (Norta| catheter Ch 18 filled with 40 ml of water at body temperature) was tested in 22 pa- tients at the first and last visit. There was no interven- tion concerning diet and laxative use during the train- ing period, and there was no psychologic counseling. The therapist (MH) was constant throughout the study period. Follow-Up Before training and at follow-up, all patients an- swered a validated questionnaire consisting of 45 questions about laxatives, stool frequency, and gas- trointestinal symptoms. 2~ All patients attended an out- patient visit three months after treatment. Patients with no improvement and other pathologic findings were considered for other treatments. An index of symptom load was derived from the questionnaire using 11 of the questions (use of enemas, digitation, hard straining, abdominal and rectal pain before and after defecation, excessive flatus, rectal bleeding, ef- fect on general well-being and social life). These 11 questions and the status of stool frequency and strain- ing time discriminate between constipated patients and controls and have good reproducibility with kappa values of ->0.40. 2~ The index (1 point for each symptom) could thus reach a maximum of 11. Twen- ty-one patients answered the questionnaire twice in the pretreatment period, with an interval median of four (range, 2-14) months. Three men and 13 women (median age, 40 (range, 18-54) years) without consti- pation and who were otherwise healthy answered the questionnaire once (reproducibility in controls is ex- cellent 2~ to serve as a control group. At a minimum of one year after biofeedback, the patients were sent the questionnaire and some extra questions about the treatment. The patients opinion on whether rectal emptying was improved was used to distinguish a successful treatment effect from an unsuccessful one. Statistical Methods Nonparametric statistical methods were used. Wil- coxon s signed-rank test was used to compare numer- ical values before and after treatment. Changes in proportions were analyzed with McNemar s test. Mann-Whitney Utest and Fisher s exact test were used for comparison between groups. RESULTS Results of iofeedback Treatment All patients fulfilled the training program, and no side effects were noticed. At the initial follow-up three months after biofeedback, nine patients with no pos- itive treatment effect proceeded to surgical treatment (rectocele repair, 5; stomas, 3; colonic resection, 1). For all 28 patients, median stool frequency was 3.5 (range, 0-28) before and 3.5 (0.5-21) after treatment. Mean values were 5.4 and 6.1, respectively (P < 0.05). There was a 32 percent decrease in straining time from a median of 5.7 (0-30) to 3.9 (0.2-30) minutes, but this reduction did not reach statistical significance. The level of the symptom index was stable in the pretreatment period (first measurement, 7 (2-11) vs second, 7 (3-11); P = 0.67, Wilcoxon s signed- rank test; Fig. 1). Twenty of 21 patients had a variation of _+ 1 symptom or less. At initial follow- up, the symptom index was reduced from a median of 6.5 (3-11) to 6 (1-11; P = 0.02). There was a reduction of the number of patients using combi- nations of laxatives from 14 to 7 (P = 0.01) and an increase of the number of patients managing with- out laxatives from 6 to 12 (P = 0.02).  1152 KARLBOM ETAL Dis Colon Rectum, October 1997 The remaining 19 patients were followed up for a median of 14 (range, 12-34) months after treatment. At this time, 12 patients (43 percent; 95 percent con- fidence limits, 23-62 percent) stated improved rectal emptying, whereas the other seven patients reported unchanged emptying. This statement was in agree- ment with the patients general opinion of the treat- ment as excellent or good in nine cases and fair in three cases. Five patients wanted a repeat treatment. Three patients would not have undergone the training if they had known what the result would be. Overall at 14 months (n = 19), the stool frequency was un- changed compared with the pretreatment frequency. Median straining time was 5 (0.5-27.6) minutes, not clearly different from before training. A reduction of laxative use was seen (combinations of laxatives, 7/19 vs 2/19 (P = 0.04); no laxatives, 4/19 vs 9/19 (P = 0.06)). Also, a reduction in the symptom index was observed (median, 6.5 (3-11) compared with 4 (0-9); P = 0.01; Fig. 1). The improved group reported increased stool fre- quency from a median of 3.5 to 4.3 per week at 3 months (P = 0.01) and maintained the increase at 14 months (5/week; P -- 0.02; Table 2). The symptom index was improved in a similar way (Fig. 1), but the index in the improved group never reached the level 11 10 9 8 7 6 E 5 ~ ~ I ~ ~ I ~ i i j i ~ i .0 Pretreatment (n=21) Nonimproved Patients (overall) - ,,O- Improved [] Controls ~ (n=~6) I I I I I I consultation 4 months Start 3 months 1 year treatment Figure 1, Median symptom index before and after biofeedback treatment in relation to outcome and compared with 16 healthy control subjects. Table 2, Changes in Bowel Function in Relation to Outcome After Biofeedback Treatment Improved Not Improved Before 3 Months ->1 Year Before 3 Months _>1 Year (n = 12) (n = 12) (n = 12) (n = 16) (n = 16) (n = 7) Stools/week 3.5 (0.5-14) 4.3 (2-18)* 5.0 (2-17)* 3,3 (0-28) 2.8 (0.5-21) 2.0 (0.5-14) Straining time (min) 5.4 (0-16.7) 3.4 (0.3-12.6) 4.2 (0.5-15.6) 10 (0.2-30) 7.2 (0.3-30) 8.1 (2.4-27,6) Laxatives None 3 81 81 3 4 1 Bulking agents 7 3 3 7 5 3 Motor-stimulants 3 0 1 9 8 4 Enemas 2 2 1 10 41 2 Combinations 2 1 1 12 61 11 Symptom index 5 (3-10) 4 (1-8)* 3 (0-7)** 8.5 (4-11) 8 (4-11) 8 (6-9) Figures are median and (range) or no. of patients. * P < 0.05; ** P < 0.01, Wilcoxon's signed-rank test. 1- P < 0.05 McNemar's test,  Vol. 40, No. 10 BIOFEEDBACK IN CONSTIPATION 1153 of the control subjects median index at i year, 3 0-7) compared with 1 0-1); P = 0.01). The use of laxatives was reduced on both follow-up occasions, with an increased proportion of patients with no need for laxatives. The nonimproved group also reduced their laxative use, but otherwise there were no significant changes Table 2). ssociations to Outcome A short duration of symptoms, few associated symptoms, and less use of laxatives were related to a good outcome of treatment Table 3). At defecogra- phy, the improved group had less perineal descent compared with the nonimproved group P = 0.03), and a prominent impression of the puborectalis mus- cle during straining was more common 7/12 vs 4/16; P = 0.06). The presence of a circular intussusception of more than 0.6 cm did not influence outcome. Im- proved patients had a tendency toward shorter co- ionic transit time Table 3); otherwise there were no clear differences between the groups. Degree of par- adoxical sphincter contraction, measured with an EMG index or absolute amplitudes, was not related to outcome. There were no differences in anal pres- sures, rectal sensibility, and compliance between groups Table 3). The rectoanal inhibitory reflex could be elicited in all patients. There was no difference in outcome between pa- tients with isolated rectal emptying difficulties and patients with both infrequent defecation and empty- ing difficulties. Three of four patients with a possible neurologic cause improved. Balloon Expulsion Test of the 22 patients who underwent the balloon expulsion test, 11 managed to expel the balloon be- fore treatment and 13 after treatment. Balloon expul- sion was faster after treatment 55 range, 5-150) seconds vs 24 range, 2-120) seconds; P = 0.02). Eleven patients improved their results after treatment 2 managed to expel the balloon and 9 managed to expel it faster). In the improved group, five of nine 56 percent) improved in balloon expulsion com- pared with 6 of 13 46 percent) in the nonimproved group. There was no relation between results of the balloon expulsion test before treatment and outcome. DISCUSSION The concept of biofeedback is based on the premise that paradoxical puborectalis contraction is a functional disturbance in an otherwise normal mus- cle. 21 Although neurologic causes have been de- scribed, 22 the paradoxical puborectalis contraction is Table 3 Clinical Data and Investigational Findings in Relation to Outcome After Biofeedback Improved Not Improved (n = 12) (n = 16) Age 46 (24-70) 46 (22-72) Male/female 4/8 1/15 Symptom duration (yr) 3 (1-24) 11 (2-30)* Symptom index 5 (3-10) 8.5 (4-11)** EMG amplitude (mV) 0.8 (0.1-3.7) 0.4 (0.1-3.4) EMG index 40 (5-142) 30 (2-304) Defecography PIP 7 4 Rectocele (cm) 2.3 (0-3.5) 2.1 (0.4-3.7) Perineal descent (cm) 1.6 (0.4-4.8) 3.1 (1.2-4,4)* Intussuception >0.6 cm 8 9 Rectal evacuation (%/sec) 2.0 (0-16.6) 4.6 (0-12.5) Colonic transit time (days) 1.9 (0.9-6.5) 3.5 (1-6.3) Prolonged transit1- 3 6 Manometry Resting pressure (cm H20) 53 (35-115) 57 (35-110) Squeeze pressure (cm H20 186 (86-414) 152 (94-261) EMG = electromyographic; PIP --- prominent impression of puborectalis muscle. Values are median (range) or no. of patients * P < 0.05; ** P < 0.01, Mann-Whitney U test 1 Exceeding 95th percentile of controls.
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