Summary of findings 3. Mood stabilisers compared with placebo for people with borderline personality disorder.
| Mood stabilisers compared with placebo for people with borderline personality disorder | ||||||
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Patient or population: people with borderline personality disorder Settings: inpatient, outpatient, inpatient and outpatient Intervention: mood stabilisers Comparison: placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo | Mood stabilisers | |||||
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BPD symptom severity Timing of outcome assessment: end of treatment (6 to 52 weeks treatment duration) |
‐ | The mean score in the intervention groups was 0.07 SD lower than in the placebo group (0.43 lower to 0.57 higher, I2 = 55%) | ‐ | 265 (4 trials) | ⊕⊝⊝⊝ Very lowa,b,c | A SMD of 0.07 represents a marginal effect. |
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Self‐harm Timing of outcome assessment: end of treatment (52 weeks treatment duration) |
345 per 1000 |
373 per 1000 (72 less to 166 more self‐harm incidents than in the placebo group) |
RR 1.08 (95% CI 0.79 to 1.48) | 276 (1 trial) | ⊕⊝⊝⊝ Very lowd,e | ‐ |
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Suicide‐related outcomes Timing of outcome assessment: end of treatment (6 to 10 weeks treatment duration) |
‐ | The mean score in the intervention group was 0.36 SD lower than in the placebo group (1.96 lower to 1.25 higher, I2 = 81%) | ‐ | 44 (2 trials) | ⊕⊝⊝⊝ Very lowd,e,f | ‐ |
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Psychosocial functioning Timing of outcome assessment: end of treatment (32 days to 6 weeks treatment duration) |
‐ | The mean score in the intervention groups was 0.01 SD lower than in the placebo group (‐0.28 lower to 0.26 higher, I2 = 0%) | ‐ | 214 (2 trials) | ⊕⊝⊝⊝ Verylowd,e,g | A SMD of 0.01 represents a marginal effect. RR 0.64 (95% CI 0.37 to 1.11; 1 trial, 16 participants).Very low‐certainty evidence |
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Interpersonal problems Timing of outcome assessment: end of treatment (32 days to 24 weeks) |
‐ | The mean score in the intervention groups was 0.58 SD lower than in the placebo group (1.14 lower to 0.02 lower, I2 = 73%) | ‐ | 300 (4 trials) | ⊕⊕⊝⊝ Lowg,h | A SMD of 0.58 represents a moderate effect. |
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Attrition Timing of outcome assessment: end of treatment (32 days to 24 weeks treatment duration) |
260 per 1000 | 208 per 1000 (6 less to 154 more than in the placebo group dropped out ) | RR 0.89 (95% CI 0.69 to 1.15; I2 = 0%) | 530 (9 trials) | ⊕⊕⊝⊝ Lowa,i | TSA‐adjusted CI is 0.37 to 2.23 TSA DARIS = 1300 |
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Non‐serious adverse events Timing of outcome assessment: end of treatment (6 weeks treatment duration) |
670 per 1000 |
563 per 1000 (201 less to 7 more than in the placebo group dropped out ) |
RR 0.84 (95% CI 0.70 to 1.01; I2 = 0%) | 276 (1 trial) | ⊕⊝⊝⊝ Very lowa,e | ‐ |
| *The basis for the assumed risk (e.g. the median control group risk across trials) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk Ratio; BPD: Borderline Personality Disorder; NA: not applicable; OAS‐M: Modified Overt Agression Scale; CGI‐I: Clinical Global Impression scale ‐ Improvement SD: standard deviation; SMD: Standardised mean difference; TSA Trial Sequential Analysis, DARIS: Diversity adjusted required information size | ||||||
| GRADE Working Group grades of evidence High certainty: Further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: We are very uncertain about the estimate. | ||||||
a We downgraded the evidence one level due to risk of bias in the included studies (indication of incomplete outcome data in the included studies) (rated by HEC and OJS) b We downgraded the evidence one level due to imprecision (wide CI around the pooled effect estimate suggest both an appreciable effect and no effect) (rated by HEC and OJS)
cWe downgraded the evidence one level due to inconsistency (a high I2 score of 55%) (rated by HEC and OJS)
dWe downgraded the evidence one level due to risk of bias (indication of selective outcome reporting in the included study) (rated by HEC and OJS) eWe downgraded the evidence two levels due to imprecision (wide CI around the pooled effect estimate suggest both an appreciable effect and no effects; results based on 1 study or few participants) (rated by HEC and OJS)
fWe downgraded the evidence one level due to inconsistency (a high I2 score of 81%) (rated by HEC and OJS)
gWe downgraded the evidence one level due to inconsistency (a high I2 score of 73%) (rated by HEC and OJS)
hWe downgraded the evidence one level due to risk of bias (indication of incomplete outcome data and vested interests)
iWe downgraded the evidence one level due to imprecision (wide CI around the pooled effect estimate suggest both an appreciable effect and no effects; TSA not reaching required information size (RIS)) (rated by HEC and OJS)