Table 6.
Reference | Study Design | Sample Population | Intervention | Control | Length of Treatment | Outcomes | Direction of Evidence | Reported Adverse Events |
---|---|---|---|---|---|---|---|---|
Carroll (2000) [75] | Randomized; Double-blind; Parallel Group | 80 healthy males | Berocca: oral multivitamin1 | Placebo | 28 days | Multivitamin treatment significantly reduced anxiety as measured by GHQ-28, HADS and PSS. | + | Not reported |
De Souza (2000) [76] | Randomized; Double-blind; Crossover (4) | 44 women with adverse premenstrual symptoms but otherwise in good health | (1) 200 mg Mg, (2) 50 mg vitamin B6, (3) 200 mg Mg + 50 mg vitamin B6 per day | Placebo | One menstrual cycle | 200 mg/day Mg + 50 mg/day vitamin B6 significantly reduced anxiety-related premenstrual symptoms | + | Participants were not specifically asked, but none were reported spontaneously |
Hanus (2004) [77] | Randomized; Double-blind; Parallel Group |
264 patients with generalized anxiety (DSM-III-R) of mild-to-moderate intensity2 | Sympathyl: extracts of crataegus oxyacantha and eschscholtzia californica plus magnesium | Placebo | 3 months | Significant clinical improvement in anxiety3 in favour of the combination treatment | + | No serious AEs related to treatment4 |
GHQ-28: General Health Questionnaire; HADS: Hospital Anxiety and Depression Scale; PSS: Perceived Stress Scale; DMS-II-R: Diagnostic and Statistical Manual of Mental Disorders, third edition revised; HAMA: Hamilton Anxiety Scale; HAMA-SOM: Hamilton Anxiety Scale, subscore somatic anxiety; HAMA-T: Hamilton Anxiety Scale, total score (HAMA-T
1. Multivitamin containing vitamin B1 (15 mg), B2 (15 mg), niacin (50 mg), pantothenic acid (23 mg), B6 (10 mg), biotin (150 mcg), folic acid (400 mcg), B12 (10 mcg), C (500 mg), calcium (100 mg), magnesium (100 mg), zinc (10 mg).
2. Total HAMA score between 16 and 28.
3. Measured by HAMA-T and HAMA-SOM and subjective patient-rated anxiety.
Headache, muscular stiffness, insomnia, drowsiness, indifference, anxiety, palpitations, nausea (4), gastralgia, diarrhea, gastric heaviness, dysuria, colic renal pain, morning sluggishness (3), asthenia.