Table 2

Trials testing passionflower

Reference

Study Design

Sample Population

Intervention

Control

Length of Treatment

Outcomes

Direction of Evidence

Reported Adverse Events


Bourin (1997) [34]

Randomized;

Double-blind;

Parallel Group

182 outpatients with adjustment disorder with anxious mood

Euphytose1; 2 tablets, 3 times a day

Placebo tablets

28 days

Significant reduction in HAMA scores (from D7 to D28) in favour of Euphytose treatment

+

No serious AEs.

Dry mouth

Headache

Constipation

Drowsiness


Akhondzadeh (2001) [32]

Randomized;

Double-blind; Parallel group

36 outpatients with DSM-IV for GAD for at least 6 months

45 drops/day of Passiflora extract plus placebo tablet

Oxazepam 30 mg/day plus placebo drops

4 weeks

Decrease in HAMA for both treatments2; overall no

significant difference in efficacy between treatments

+

Higher impairment of job performance in oxazepam group; overall no significant difference in total side effects3


Movafegh (2008) [33]

Randomized;

Double-blind; Parallel Group

60 patients undergoing inguinal herniorrhaphy

Oral Passiflora incarnata (500 mg, Passipy™ IranDarouk)

Placebo

Given as pre-medication 90 minutes before surgery

NRS anxiety scores were significantly

lower in the passiflora group

+

Not reported


AEs: Adverse events; HAMA: Hamilton Anxiety Scale; DMS-IV: Diagnostic and Statistical Manual of Mental Disorders, fourth edition; GAD: generalized anxiety disorder; NRS: numerical rating scale.

1. Combination of Crataegus oxyacantha (10 mg), Ballota foetida (10 mg), Passiflora incarnata (40 mg), Valeriana officinalis (50 mg), Cola nitida (15 mg) and Paullinia cupana (15 mg).

2. D4 oxazepam; D7 passiflora.

3. Passiflora, mild/moderate: Dizziness, Drowsiness, Confusion, Ataxia, Allergic reaction, Impairment of job performance.

Lakhan and Vieira Nutrition Journal 2010 9:42   doi:10.1186/1475-2891-9-42

Open Data