Summary of Treatment and Outcomes for Included Studies
| Study | Buspirone dose | Duration of treatment | Between group comparisons (mean ± SD, P-value for between-group differences) | Effect on psychiatric outcomes | Adverse effects reported |
|---|---|---|---|---|---|
| Aggarwal, 2018 | 10 mg TDS | 2 weeks | Compared to placebo, buspirone did not improve dysphagia severity score (2.9 ± 0.99 vs 2.6 ± 0.7, P = 0.28); Dysphagia frequency score (3.9 ± 1.9 vs 3.9 ± 1.1, P = 0.72) or GERD-HRQL score (26.4 ± 22.2 vs 20.3 ± 16.6, P = 0.30) | NR | Mild nausea that resolved after 3 days (n = 1) |
| Alianova, 2019 | 10 mg TDS | 14 days | Buspirone produced 85.2% reduction of post-prandial heaviness vs 34.5% in controls (no P-value). Rate of symptom recurrence at 30 days was 13.8% in buspirone group vs 80% in controls (P < 0.001). | 82.3% decrease in anxiety level in buspirone group vs 20.6% in controls (P < 0.001) | NR |
| Ambros, 2023 | 10 mg TDS | 63 days but given only 5 times in study before wine challenges | Borderline significant improvement in mean pain score after wine challenges in buspirone group vs controls (2.2 [0.6-3.7] vs 4.8 [2.1-7.4], P = 0.051); no difference between prucalopride and placebo (P = 0.091) | NR | Nausea, diarrhoea, drowsiness on 1st administration but no significant association when compared to placebo |
| Caviglia, 2017 | 10 mg BD | 3 months | Compared to placebo, lower number of patients reporting severe early satiation (50% pre-treatment to 6.3% after treatment, P < 0.001) but no difference in post-prandial fullness (P = 0.16), epigastric pain (P = 0.41) or epigastric burning (P = 0.21) | NR | Dizziness (6.3%) |
| Parkman, 2023 | 10mg TDS | 4 weeks | Compared to placebo, no difference in GCSI ES/PPF subscore (–1.03 ± 1.19 vs –1.16 ± 1.25, P = 0.69) (primary outcome); Compared to placebo, buspirone improved ANMS Gastroparesis Cardinal Symptom Index Daily Diary improvement in feeling excessively full after meals (–0.82 ± 1.03 vs –0.31 ± 0.84, P = 0.01) but no difference in early satiation/postprandial fullness (–0.71 ± 1.03 vs –0.39 ± 0.71, P =0.10) or feeling unable to finish a normal-sized meal (–0.62 ± 1.10 vs –0.46 ± 0.76, P = 0.43), nor in PAGI-SYM items of stomach fulness (P = 0.76), excessive fullness after a meal (P = 0.64), inability to finish meal (P = 0.66) or loss of appetite (P = 0.70) |
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| Radetic, 2019 | 10 mg TDS | 1 week | Subjective complete resolution of nausea, vomiting, early satiation and diarrhoea | NR | NR |
| Sadiku, 2020 | 10 mg TDS | 3 days | Improvement in vomiting, nausea and epigastric after 3 days of buspirone but not quantified | NR | NR |
| Singh, 2021 | 10 mg OD | 2-5 years | Subjective improvement in pain, nausea or bloating in 3/5 patients | Not quantified though 1 reported improvement in anxiety | NR |
| Taghvaei, 2021 | 5 mg TDS 1 month, 10 mg TDS 2nd month | 2 months | SF-LDQ score 5.72 ± 5.16 buspirone vs 5.33 ± 7.30 placebo (P = 0.86) | HADS depression score 6.05 ± 4.59 vs 7.16 ± 5.13 (P = 0.54); HADS anxiety score 7.72 ± 4.87 vs 9.58 ± 3.70 (P = 0.27) | In buspirone group, increased appetite (15%), drowsiness (20%), and fatigue (5%). In placebo group, increased appetite (10%) and dry mouth (10%) |
| Tack, 2012 | 10 mg TDS | 4 weeks (crossover study) | Compared to placebo, buspirone improved DSS score (7.5 ± 5.4 vs 9.5 ± 4.5, P = 0.05), post-prandial fullness (1.3 ± 1.2 vs 1.9 ± 0.8, P < 0.05), total meal-related symptom score (67 ± 17 vs 97 ± 15, ) P < 0.01); meal-related postprandial fullness (23 ± 20.6 vs 14 ± 20.6, P < 0.05) and upper abdominal bloating (22 ± 20.6 vs 14 ± 16.5, P < 0.05) | NR – study excluded patients with depression or anxiety or psychiatric background by doing SCL-90R scores at baseline, these scores not repeated post-buspirone treatment | No significant adverse effect compared to placebo - comparable, specific adverse effects not mentioned |
TDS, 3 times daily; BD, twice daily; OD, once daily; GERD-HRQL score, Gastroesophageal Reflux Disease–Health-related Quality of Life score; GCSI, Gastroparesis Cardinal Symptom Index; ES/PPF subscore, early satiety/postprandial fullness subscore; SF-LDQ score, Short-Form Leeds Dyspepsia Questionnaire score; DSS score, Dyspepsia Symptom Severity score; NR, not reported; HADS, Hospital Anxiety and Depression Scale; SCL-90R score, Symptom Checklist 90 score (questionnaire to screen for range of psychological symptoms).