Characteristics of randomised controlled trials of psychotropic drugs versus placebo in functional dyspepsia
| Study name and year | Country | Setting | Diagnostic criteria used for FD | Criteria used to define symptom improvement following therapy | Sample size (% female) | Psychotropic drug used and duration of therapy | Screened for mood disorder prior to entry? | Methodology |
|---|---|---|---|---|---|---|---|---|
| Hui et al, 198640 | Hong Kong, China | Tertiary care | Clinical diagnosis and negative investigations | Patient-reported improvement in, or resolution of, dyspeptic symptoms | 100 (58.0) | Sulpiride 100 mg four times daily for 1 week, then 50 mg four times daily for 3 weeks | Yes, but not excluded | Method of randomisation and concealment of allocation not stated. Double-blind. Antacids only allowed. |
| Arienti et al, 199427 | Italy | Tertiary care | Clinical diagnosis and negative investigations | Patient-reported improvement in dyspeptic symptoms using a visual analogue scale | 30 (63.3) | Levosulpiride 25 mg thrice daily for 20 days | No | Method of randomisation and concealment of allocation not stated. Double-blind. No other FD medications allowed. |
| Song et al, 199841 | South Korea | Tertiary care | Clinical diagnosis and negative investigations, delayed gastric empting present in all patients | Patient-reported global efficacy of treatment rated as excellent or good | 42 (78.6) | Levosulpiride 25 mg thrice daily for 3 weeks | No | Method of randomisation and concealment of allocation not stated. Double-blind. No other FD medications allowed. |
| Hashash et al, 200842 | Lebanon | Tertiary care | Rome III criteria and negative investigations | Patient-reported subjective feeling of global symptom relief | 25 (56.0) | Flupenthixol 0.5 mg and melitracen 10 mg twice daily for 2 weeks | Yes, no patients with anxiety recruited | Method of randomisation and concealment of allocation stated. Double-blind. Unclear if other FD medications allowed. |
| van Kerkhoven et al, 200833 | The Netherlands | Secondary care | Clinical diagnosis and negative investigations | Patient-reported absence of symptoms on a 7-point Likert scale | 160 (59.4) | Venlafaxine 75 mg once daily for 2 weeks, then 150 mg once daily for 4 weeks, then 75 mg once daily for 2 weeks | Yes, but not excluded | Method of randomisation and concealment of allocation stated. Double-blind. No other FD medications allowed. |
| Tack et al, 200944 | Belgium, Germany and The Netherlands | Tertiary care | Rome II criteria and negative investigations | 30% improvement in patient assessment of upper GI symptom severity¶ | 53 (66.0) | R-137696 2 mg thrice daily for 4 weeks | Yes, and excluded | Method of randomisation and concealment of allocation stated. Double-blind. No other FD medications allowed. |
| Miwa et al, 200943 | Japan | Secondary and tertiary care | Rome II criteria and negative investigations | Patient-reported total abdominal symptom score of 0 or 1 on a modified GI symptom rating scale | 150 (73.3) | Tandospirone 10 mg thrice daily for 4 weeks | Yes, but not excluded | Method of randomisation and concealment of allocation stated. Double-blind. No other FD medications allowed. |
| Braak et al, 201145 | The Netherlands | Tertiary care | Rome III criteria and negative investigations | 30% improvement in patient assessment of upper GI symptom severity¶ | 38 (60.5) | Amitriptyline 25 mg once daily for 8 weeks | Yes, and excluded | Method of randomisation and concealment of allocation stated. Double-blind. No other FD medications allowed. |
| Wu et al, 201146 | Hong Kong, China | Tertiary care | Rome II criteria and negative investigations | Patient-reported relief of global symptoms | 107 (80.4) | Imipramine 25 mg once daily for 2 weeks, then 50 mg once daily for 10 weeks | Yes, but not excluded | Method of randomisation and concealment of allocation stated. Double-blind. Other FD medications allowed. |
| Tack et al, 201225 | Belgium | Tertiary care | Rome II criteria and negative investigations | 30% improvement in patient-reported dyspepsia symptom severity¶ | 17 (76.5) | Buspirone 10 mg thrice daily for 4 weeks | Yes, and excluded | Method of randomisation and concealment of allocation stated. Double-blind. No other FD medications allowed. |
| Tan et al, 201232 | Hong Kong, China | Tertiary care | Rome II criteria and negative investigations | Patient-reported relief of global symptoms | 193 (72.0) | Sertraline 50 mg once daily for 8 weeks | Yes, but not excluded | Method of randomisation and concealment of allocation stated. Double-blind. Other FD medications allowed. |
| Tack et al, 201548 | Belgium | Tertiary care | Rome III criteria and negative investigations, weight loss present in all patients | 30% improvement in patient-reported dyspepsia symptom severity¶ | 34 (85.3) | Mirtazepine 15 mg once daily for 8 weeks | Yes, and excluded | Method of randomisation and concealment of allocation stated. Double-blind. No other FD medications allowed. |
| Talley et al, 201547 | USA and Canada | Tertiary care | Rome II criteria and negative investigations | Patient-reported adequate relief of global symptoms for 50% of weeks during weeks 3–12 | 292 (75.0) | Amitriptyline 25 mg once daily for 2 weeks, then 50 mg once daily for 10 weeks, or escitalopram 10 mg once daily for 12 weeks | Yes, and excluded | Method of randomisation and concealment of allocation stated. Double-blind. Other FD medications allowed. |
¶Dichotomous data obtained from original investigators.
FD, functional dyspepsia.