Table 2.
Clinical complications and side effects related to saffron
| Duration of exposure | Dose | Adverse effects | P | N | Ref. | ||||
|---|---|---|---|---|---|---|---|---|---|
| Saffron | Drug | Saffron (N) | Drug (N) | Placebo (N) | |||||
| 6 weeks | capsule /30 mg/day (BD) | - | Anxiety | 3 | - | 1 | 0.60 | 40 | (41) |
| Decreased appetite | 2 | 2 | 1.39 | ||||||
| Increased appetite | 5 | 1 | 0.18 | ||||||
| Sedation | 1 | 2 | 1.00 | ||||||
| Nausea | 2 | 1 | 1.00 | ||||||
| Headache | 3 | 2 | 1.00 | ||||||
| Hypomania | 2 | 1 | 1.00 | ||||||
| 22 weeks | capsule/30 mg/day | Donepezil capsule 10 mg/day | Vomiting | 1 | 7 | - | 0.05 | 44 | (42) |
| Dizziness | 2 | 5 | 0.42 | ||||||
| Dry mouth | 5 | 3 | 0.70 | ||||||
| Fatigue | 1 | 4 | 0.35 | ||||||
| Hypomania | 1 | 0 | 1.00 | ||||||
| Nausea | 2 | 6 | 0.25 | ||||||
| 16 weeks | capsule /30 mg/ day | - | Dizziness | 2 | - | 3 | 1.00 | 46 | (43) |
| Dry mouth | 3 | 1 | 0.60 | ||||||
| Fatigue | 1 | 2 | 1.00 | ||||||
| Hypomania | 2 | 0 | 0.48 | ||||||
| Nausea | 2 | 1 | 0.25 | ||||||
| 4 weeks | capsule /15 mg (twice daily) | - | Dry mouth | 3 | - | 2 | NS | 20 | (44) |
| Restlessness | 2 | 0 | NS | ||||||
| Anxiety | 2 | 0 | NS | ||||||
| Tachycardia | 0 | 1 | NS | ||||||
| Constipation | 1 | 1 | NS | ||||||
| Nausea | 0 | 1 | NS | ||||||
| Reflux | 0 | 1 | NS | ||||||
| Abdominal pain | 0 | 1 | NS | ||||||
| Headache | 0 | 1 | NS | ||||||
| Dizziness | 0 | 1 | NS | ||||||
| Daily drowsiness | 1 | 1 | NS | ||||||
| Morning drowsiness | 1 | 0 | NS | ||||||
| six weeks | capsule /30 mg/ day | Fluoexetine /40mg/day | Daytime drowsiness | 0 | 1 | - | 1.00 | 40 | (45) |
| Morning drowsiness | 1 | 1 | 1.00 | ||||||
| Constipation | 1 | 3 | 0.60 | ||||||
| Nervousness | 0 | 1 | 1.00 | ||||||
| Decreased appetite | 4 | 2 | 0.66 | ||||||
| Dry mouth | 1 | 4 | 0.34 | ||||||
| 8 weeks | capsule / 15 mg bid | capsule fluoxetine /10 mg bid | Anxiety | 4 | 7 | - | 0.48 | 40 | (46) |
| Decreased appetite | 5 | 4 | 1.00 | ||||||
| Increased appetite | 1 | 3 | 0.60 | ||||||
| Sexual dysfunction | 3 | 5 | 0.69 | ||||||
| Tremor | 2 | 5 | 0.40 | ||||||
| Nausea | 3 | 4 | 1.00 | ||||||
| Headache | 2 | 5 | 0.40 | ||||||
| Sweating | 2 | 3 | 1.00 | ||||||
| Heart Pounding | 3 | 2 | 1.00 | ||||||
| Insomnia | 3 | 3 | 1.00 | ||||||
| 6 weeks | capsule /30 mg/day (BD) | - | Anxiety | 4 | - | 2 | 0.66 | 40 | (47) |
| Decreased appetite | 4 | 2 | 0.66 | ||||||
| Stomach pain | 4 | 2 | 0.66 | ||||||
| Tremor | 3 | 1 | 0.60 | ||||||
| Nausea | 5 | 2 | 0.40 | ||||||
| Headache | 3 | 1 | 0.60 | ||||||
| Sweating | 2 | 1 | 1.00 | ||||||
| Heart pounding | 4 | 2 | 0.66 | ||||||
| 6 weeks | Capsule/30 mg/day (BD) | Fluoxetine/20 mg/day (BD) | Anxiety | 3 | 6 | - | 0.45 | 40 | (48) |
| Decreased appetite | 2 | 5 | 0.45 | ||||||
| Increased appetite | 5 | 2 | 0.40 | ||||||
| Sedation | 1 | 0 | 1.00 | ||||||
| Nausea | 2 | 4 | 0.66 | ||||||
| Headache | 3 | 6 | 0.45 | ||||||
| Sexual dysfunction | 0 | 4 | 0.10 | ||||||
| Tremor | 0 | 4 | 0.10 | ||||||
| Sweating | 0 | 3 | 0.23 | ||||||
| 6 weeks | capsule/ 30 mg/day (TDS) | capsule of imipramine 100 mg/day (TDS) | Anxiety | 4 | 1 | 0.32 | 30 | (49) | |
| Decreased Appetite | 2 | 0 | 0.48 | ||||||
| Increased Appetite | 1 | 5 | 0.16 | ||||||
| Sedation | 0 | 6 | 0.01 | ||||||
| Nausea | 2 | 1 | 1.00 | ||||||
| Headache | 3 | 2 | 1.00 | ||||||
| Dry Mouth | 1 | 5 | 0.03 | ||||||
| Hypomania | 2 | 1 | 1.00 | ||||||
| Constipation | 2 | 5 | 0.38 | ||||||
| Urinary Retention | 1 | 5 | 0.16 | ||||||