Kashani 2017.
| Study characteristics | ||
| Methods |
Study design: RCT, double‐blind Location: Iran Setting: outpatient clinics No. of centres: 3 (Yas Women General Hospital, Arash Hospital, Baharloo Hospital) Dates of study: September‐December 2015 Total duration of study: 6 weeks Recruitment: outpatient clinic Randomisation method: permuted randomisation block (blocks of 4, allocation ratio 1:1) Analysis by ITT: no Power calculation: yes |
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| Participants |
Inclusion criteria: women 18–45 years of age; diagnosis of postpartum depression based on DSM‐IV; 4–12 weeks after childbirth; mild to moderate depression with HDRS score ≥10 and ≤18 Exclusion criteria: women with psychotic depression, history of suicidal or infanticidal thoughts, a history of bipolar disorder, substance or alcohol dependence (with the exception of nicotine dependence), lactation, hypothyroidism, acute medical illness, patients suffering from any DSM‐IV diagnosis other than postpartum depression Number recruited: 68 Number dropped out: fluoxetine: N = 2; saffron: N = 2 Number analysed: 64; fluoxetine N = 32; saffron N = 32 Age, mean (SD) years: fluoxetine: 32.09 (4.99); saffron: 29.21 (7.69) Severity of PND, mean (SD) HDRS score: fluoxetine 16.65 (1.12); saffron 16.53 (1.48) Duration of PND, mean (SD): not reported Physical health co‐morbidities: not reported Mental health co‐morbidities: history of depression: fluoxetine N = 9; saffron N = 7 Ethnicity: no data Socioeconomic status: education fluoxetine group: primary school 2/32, high school diploma 24/32, university degree 4/32; saffron group: primary school: 4/32, high school diploma 26/32, university degree 2/32 |
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| Interventions | Women were randomly assigned to 1 of 2 groups
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| Outcomes |
Primary outcome: improvement of depressive symptoms using HDRS Secondary outcomes: improvement in HDRS score at each time point, partial responders (25%‐50% reduction in HDRS score), responders (≥ 50% reduction in HDRS score), remitters (HDRS score ≤ 7), time needed to respond to treatment, response rate (≥ 50% reduction in HDRS score) and remission rate (HDRS score ≤ 7) compared between groups Adverse events: 25‐item checklist Time points: week 1, 3 and 6 |
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| Notes | Funded through a grant from Tehran University of Medical Sciences (Grant no: 23222). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "An independent party, who was not involved elsewhere in the trial, randomized codes by permuted randomization block (blocks of 4, allocation ratio 1:1)." |
| Allocation concealment (selection bias) | Low risk | "Concealment of allocation was performed using sequentially numbered, sealed opaque envelopes. An aluminium foil inside the envelopes kept them impermeable to intense light." |
| Blinding of participants (performance bias) | Low risk | Study participant, research investigator and the rater were all blind to the treatment allocation. Saffron and fluoxetine capsules were indistinguishable in their shape, size, texture, colour and odour." |
| Blinding of personnel (performance bias) | Low risk | Study participant, research investigator and the rater were all blind to the treatment allocation. Saffron and fluoxetine capsules were indistinguishable in their shape, size, texture, colour and odour." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Study participant, research investigator and the rater were all blind to the treatment allocation. Saffron and fluoxetine capsules were indistinguishable in their shape, size, texture, colour and odour." |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 34 randomised to each group but data presented for only 32. Not ITT. 2 excluded from each group due to shift from moderate to severe depression |
| Selective reporting (reporting bias) | High risk | Remission, response and adverse events are not specified as outcomes in protocol (and therefore protocol does not define remission or response). Protocol states HDRS will be measured at weeks 2, 4 and 6, not weeks 1, 3 and 6 |
| Other bias | Unclear risk | No adherence data reported. No other bias identified, including financial conflicts or other COIs. Limited detail on recruitment of the small sample of women ‐ possible risk of sampling bias |