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International Journal of Phytomedicine and Phytotherapy

Table 2 Effects of VAC preparations in placebo controlled clinical studies on PMS, PMDD, and premenstrual mastodynia

From: The premenstrual syndrome, premenstrual mastodynia, fibrocystic mastopathy and infertility have often common roots: effects of extracts of chasteberry (Vitex agnus castus) as a solution

Ref. (only placebo controlled) Design Patient Characteristics and Age Treatment, Dose, and Duration Outcome Measures Finding and Comments Effects in short No = Ø Signif. pos = + Signif. neg = −
Milewicz et al., 1993 [22] Randomized, placebo controlled trial 11 VAC extract. 11placebo treated women with PMS and latent hyperprolactinemia, mean age 30 y 20 mg of an extract of VAC dried fruits (Strotan) for 3 months PMS. Basal and TRHstimulated prolactin, lutael phase progesterone Reduction of PMS in 9 verum but only in 2 placebo treated women +
Turner et al., 1993 [21] Randomized, double blind placebocontrolled trial 600 verum, 217 soy based placebo. age 18–46 y 3×600 mg/day of a not defined VAC extract, 3 months Moos Menstrual Distress Questionnaire No significant effects on all but one item placebo effects better than verum, note however, the extremely high dose Ø
Lauritzen et al., 1997 [23] Randomized, double blind. comparatorsudy 46 VAC. 57 pyridoxine treated women with PMS, 18–45 y 3.5–4.2 mg dried VAC extract (Agnolyt) vs pyridoxine, 3 cycles PMS was measured by VAS premenstrual Tension Scale Significant “excellent” reduction of PMS superior to pyridoxine +
Schellenberg et al., 2001 [26] Randomized, double-blind, placebocontrolled 170 women with PMS Mean age 36 y 86 VAC, 84 placebo treated women with PMS, 3 cycles 20 mg of a VAC extract Ze 440, Significant reduction of all symptoms in comparison to placebo (except bloating) +
Wuttke et al. 1997 [24] Randomized, double-blind, placebocontrolled 104 patients with premenstrual mastodynia determined by VAS 66 patients treated with 40 mg dried fruit VAC, 38 placebo, 3 cycles Visual analogue score of mastodynia Significantly better improvement of mastodynia under both VAC peparations +
Halaska et al. 1999 [25] Randomized, double-blind, placebo controlled 97 patients with premenstrual mastodynia determined by VAS 48 patients with dried VAC fruit, 49 with placebo, 3 cycles Visual analogue score of mastodynia Significantly better reduction of mastodynia under VAC +
He at al., 2009 [29] Randomized, double-blind, placebocontrolled trial 101 women verum vs 101 placebo for 3 cycles 40 mg dried fruit powder (equivalent to 4 mg dried extract vs placebo Moderate to severe forms of PMS assessed by DSM IV and PMTS score greater than 18 Significantly greater improvement under VAC (80%) than under placebo (50%) +
Ma et al., 2010 [31] Randomized, double blind, placebo controlled trial 31 women with verum vs 33 women under placebo, 3 cycles 40 mg dried fruit powder vs placebo given during luteal phase PMSD score greater 16 points Significantly greater improvement under VAC (85%) vs placebo (56%) +
Kilicdag et al., 2004 [27] Randomized, double blind comparator controlled trial 40 women with mastodynia and 40 women with latent hyperprolactinemia 2×40 mg dried fruit vs 2×2.5 bromocriptine daily for 3 months Breast discomfort by VAS Both treatments were similarly effective Fewer side effects under VAC +
Gumenyuk (2010) [45] Randomized oprn 3 months 31 with PMS 19 of them PMDy 40 mg VAC(Mastodynon) PMS, mastodynia, prolactin Significant reduction of all parameters +
Pakgohar et al., 2009 [30] Randomized, double-blind, placebocontrolled, 39 women with verum, 50 with placebo 4.3–4.8 mg dried VAC extract vs placebo PMS diagnosed by general practitioner Improvement significantly better under VAC (61%) vs placebo (29%) +
Ciotta et al., 2011 [33] Randomized, double blind, comparator controlled 31 women under verum vs 26 under fluoxetine, 2 months 20 mg dried fruit powder vs 20–40 mg fluoxetine DSM IV criteria for severe PMS Both treatments improved symptoms significantly with better outcome for fluoxetine +
Zamani et al., 2012 [34] Randomized, double-blind, placebocontrolled trial 62 verum vs 66 women under placebo for 6 days prior to expected menstrual bleeding for 6 cycles 40 drops of an undefined VAC extract vs placebo Selection by DSM IV criteria i Significantly better effects for all items under VAC in comparison to placebo +
Schellenberg et al. 2012 [35] Randomized, double-blind, placebo controlled, 4 groups of women (3 verum. Vs placebo) with PMS, 18–45 y 8, 20 and 30 mg drie VAC fruit vs plavebo40 mg VAC dried fruit (Mastodynon) vs placebo Premensrual mastodynia i Dose dependent significant reduction of mastodynia +
Malykhina 2006 [28] Randomized single-blind, comparator controlled 120 women with mastalgia and latent hyper-prolactinemia divided in 3 groups 2.5 mg bromocriptine, 0.25 mg Dostinex, 40 mg dried fruit VAC (Agnucaston) all given for 3 months Mastalgia and latent hyperprolactinemia Breast pain absent within 2 weeks in all 3 groups. Normalization of prolactin at the end of the study in all 3 groups +
Suturina and Popova, 2010 [32] Randomized, single-blind, comparator controlled 2 goups of women (24 in each group) after intensive gynecologic check up 40 mg of dried VAC fruit (Cyclodynon) vs 2.5 mg bromocripitine, twice daily for 3 months Questionnaire and serum prolactin Significant reduction of mastalgia in both groups, Cyclodynon improved symptoms in all bromocriptine only in 16 patients, +
Tuganbekov and Oralbay 2012 [46] Non randomized, prospective study, 2 monnths 30 women with fibrocystic mastopathy with mastodynia 40 mg VAC dried fruit (Mastodynon) Changes in fibrocystic appearance, serum prolactin, TSH and estradiol Significant (90%) reduction of fibrocystic appearance, mastodynia and prolactin +
Ledina and Prelipskaya 2011 [36] Randomized. 2 months 50 women with mastalgia 1 group (n = 30) with VAC, the other with an COC (n = ` 20) Visual analogue scale Significant effects of both treatments VAC > than COC +
v Kubista et al. 1986 Randomized, double-blind trial vs placebo and a progestin 38 verum vs 28 progestin vs 55 placebo VAC 1095 (Mastodynon) vs a progestin vs placebo Mastodynia, often in combination with fibrocystic mastopathy Reduction under progestin 89%, under VAC 74% and under placebo 37% +