Author, year, country (setting) |
Design |
n (age) |
Population |
Intervention |
Control/Comparator |
Primary outcome measure |
Results |
Berens et al,52 2018, Germany (University Hospital) |
Pilot RCT |
34 (18–65) |
IBS refractory to basic primary care treatment. Rome III with somatoform autonomic dysfunction symptom pattern57 |
IG: GDH, education, psychodynamic therapy and CBT |
Waitlist group receiving enhanced medical care, plus completion of online daily diary |
IBS-SSS. Measure of clinical improvement was not defined |
No significant improvements compared with control. IG scores improved from mean (SD) 271.18 (104.93) to 181.5 (79.09) producing a large within-group effect size d = 0.956 Control group also improved from mean (SD) 263.43 (106.05) to 231.69 (107.00) (effect size d = 0.298) ITT analysis with repeated-measures mixed ANOVA reported the main effect for the group was not significant (P = 0.370) nor was the time × group (P = 0.267). The effect size for between-group difference was moderate post-treatment (d = 0.539) |
Flik et al,49 2019, the Netherlands (11 hospitals) |
Multicentre, parallel group, long-term follow-up RCT |
354 (18–65) |
Rome III,58 referred by primary and secondary care clinicians |
GGDH |
Educational supportive therapy (EST) & IH |
ARQ "Did you have adequate relief of IBS related abdominal pain or discomfort in the past week?" Treatment response is defined as an answer of "Yes" 3 or 4 times over 4 consecutive weeks |
Hypnotherapy significantly more effective than EST at 3 months P = 0.024 and 12 months P = 0.0185. ITT analysis at 3 months 40.8% of IH, 33.2% of GGDH and 16.7% of EST reported adequate relief. At 12 months 40.8% of IH, 49.5% of GGDH and 22.6% of EST reported adequate relief. Per-protocol analysis at 3 months 49.9% of IH and 42.7% of GGDH reported adequate relief. At 12 months 55.5% of IH and 51.7% of GGDH reported adequate relief. Therefore, GGDH non-inferior compared to IH at 3 months P = 0.34 and 12 months P = 0.17 |
Forbes et al,53 2000, UK (St Mark's Hospital—specialist bowel hospital and home-based) |
Equivalence RCT |
52 (19–71) |
IBS diagnosis with 3 or more Manning et al59 criteria and satisfying Rome 160 Symptomatic presentation for ≥6 months and refractory to fibre, antispasmodics and diet changes |
HHT: Home-based autohypnosis, education and reassurance using audio recordings |
IH |
Daily symptom diary recording severity and frequency of pain, abdominal distension or bloating, excessive gas or wind, bowels open, stools/motions, performance at work/normal daily tasks, fatigue and tiredness. Measure of clinical improvement was not defined |
Using ITT, symptom scores were reduced in 76% of IH and 59% of HHT participants with median post treatment scores of 11 and 13 respectively. The median differences of −3 (IH) and −1 (HHT) proved not to be significant. In the 45 participants who completed the symptom diary, IH median scores reduced from 14 to 8.5 and HHT median scores remained unchanged at 13 showing advantage to IH (P < 0.05). Semi-objective assessment by the assessor reported 52% improvement in both groups |
Gerson et al,48 2013, United States (University Hospital) |
Long-term follow-up, one group, pre-test, post-test |
89 (20+) |
Moderate to severe IBS refractory to prior medical treatment. Rome II61 |
GGDH |
|
IBS-SSS. Clinical improvement is defined as ≥50 point reduction in IBS-SSS scores |
ITT mean scores of IBS-SSS improved significantly from 259 to 196 (P < 0.05) Mean IBS-SSS scores of treatment completers improved significantly from 258 to 183 after 1 year (P < 0.001) Scores lower post treatment at every interval P < 0.001 45 of the 75 treatment completers (60%) achieved clinically significant improvement |
Gulewitsch & Schlarb,55 2017, Germany (Home-based, contact via short telephone calls and emails) |
RCT |
45 (6–17) |
Paediatric Rome III62 |
HHT: GDH using audio recordings (GDH) |
HHT: Unspecified hypnotherapy using audio recordings (UHT) |
Daily symptom diary scoring number of days with pain, mean duration and intensity of pain. >80% improvement represented clinical remission. 30%-80% represented significant improvement. <30% considered unsuccessful |
Reduction in number of days with pain: UHT P = 0.001, GDH P < 0.001 Reduction in pain intensity: UHT P < 0.001, GDH P = 0.171 (not significant) Reduction in pain episodes: UHT P = 0.001, GDH P < 0.005 Using ITT, significant reduction in symptoms over time for both groups [F(1,43) = 20.97–43.90, Ps < 0.001] Clinical remission (34%): UHT (n = 9), GDH (n = 2) Significant improvement (41%): UHT (n = 6), GDH (n = 7) Unsuccessful (25%): UHT (n = 3), GDH (n = 5) |
Harvey et al,47 1989, UK (Hospital) |
3 month follow up RCT |
36 (19–62) |
Refractory IBS is defined as abdominal pain, disordered bowel habit and abdominal distention |
GGDH |
IH |
Daily symptom diary. Maximum weekly score of 63. Weekly score of ≤5 considered symptom free. Severe symptoms are defined as ≥35 |
No significant differences were reported between GGDH and IH Symptom-free (n = 11): IH (n = 5), GGDH (n = 6) Less symptoms (n = 9): IH (n = 3), GGDH (n = 6) No improvement (n = 13): IH (n = 8), GGDH (n = 5) |
Moser et al,51 2013, Austria (University Hospital) |
Long-term follow-up RCT |
100 (18–70) |
Severe or incapacitating refractory IBS, Rome III22 |
IG: GDH with supportive talks and medical treatment |
Supportive talks and medical treatment (SMT) |
IBS-IS. Mean score of ≤4 was defined as severe IBS. Clinical improvement is defined as an increase in an overall score of ≥1 |
IG was found to be superior to SMT. Significant improvements were reported within 12 weeks for IG: 28 out of 46 (60.8%) and SMT: 18 out of 44 (40.9%) [absolute difference 20%; 95% confidence interval (CI):0%-40.2%; P = 0.046] At the 12-month follow-up post-treatment, significant improvements were reported for 54.3% of IG and 25% of SMT participants (absolute difference 29.4%; 95% CI: 10.1%-48.6%; P = 0.004) |
Palsson et al,54 2006, United States (Home-based, contact via e-mail, internet, mail) |
Non-randomised comparative follow-up pilot study |
25 (mean 43) |
Clinical diagnosis satisfying Rome II63 in an active phase of IBS |
HHT: GDH treatment using audio recordings |
Usual medical care |
IBS-SSS. Clinical improvement is defined as >50% reduction in symptom severity |
10 out of 19 participants (53%) HHT participants reported statistically significant improvements of ≥50% reduction in symptom severity in comparison to 15 out of 57 control group participants (26%) (P < 0.05). |
Rutten et al,56 2017, Netherlands (Secondary and tertiary care centres, & home-based. Contact via visit from research nurse and two follow-up telephone calls) |
Non-inferiority RCT with 1 year follow-up |
260 (8–18) |
Rome III62 |
HHT: Home-based GDH treatment using audio recordings |
IH |
Daily symptom diary scoring pain frequency and intensity during 7 consecutive days. Treatment success is defined as ≥50% reduction in scores |
HHT was reported to be significantly non-inferior to IH with 90% CI, P = 0.002 Immediately post treatment 46 (36.8%) HHT and 62 (50.1%) IH participants achieved treatment success. 12 months post treatment, 78 (62.1%) HHT and 88 (71.0%) IH participants achieved treatment success |
Taylor et al,50 2004, England and Ireland (Hospital or community settings) |
Feasibility study, one group, pre-test, post-test |
190 (18–80) |
Clinical diagnosis of IBS with compatible symptomatic presentation |
IG: GDH with CBT |
|
GSRS. Measure of clinical improvement was not defined |
16 of 23 groups reported statistically significant improvements in gastrointestinal symptoms. When adjusted for clusters, scores significantly improved pre and post treatment from mean (SD) 40.2 (11.8) to 29.2 (9.4) (P < 0.001) |