Premenstrual syndrome
Cyclical physical and emotional symptoms in the luteal phase of the menstrual cycle, resolving with menses. Standard therapy includes lifestyle change, oral contraceptives, and luteal-phase SSRIs. Additional approaches – magnesium, calcium, B6 – have limited evidence.
ICD-10 N94.34 drugs
Also known as: PMS
Drugs used for this condition
- CL-tryptophanThird line · Essential amino acid, precursor of serotonin, melatonin and niacin. In the UK registered by MHRA as Optimax for resistant depressionL-tryptophan has been studied in premenstrual syndrome and premenstrual dysphoric disorder as a serotonin precursor. In a double-blind, placebo-controlled trial (71 women, 6 g daily during the luteal phase across three cycles) it reduced irritability, mood swings and tension more than placebo, with a 34.5% drop in peak luteal mood scores versus 10.4% on placebo. The evidence is limited to this one small, older trial with no larger replication. Guidelines (RCOG, SEGO) place SSRIs, lifestyle measures and combined oral contraceptives first and do not list L-tryptophan among recommended options. High doses can cause serotonergic effects and are risky alongside SSRIs, so any use is an individual decision made with a clinician.
- CVitex agnus-castus (chasteberry, monk's pepper)Add-on therapy · Herbal preparation for PMS, supplement. In EU – traditional herbal medicinal product (EMA HMPC). AEMPS does not register as medicineVitex is one of the few herbal preparations with relatively convincing evidence in premenstrual syndrome (PMS). Csokay 2013 (Planta Med) systematic review of 7 RCTs in 1100 patients: vitex 4–40 mg extract per day × 3 cycles improved PMS questionnaire scores (irritability, mastodynia, headache, mood swings) vs placebo. EMA HMPC 2018 recognises vitex as a traditional herbal medicinal product for mild PMS symptoms. ACOG 2014 lists SSRIs (fluoxetine, sertraline), drospirenone-containing combined oral contraceptives and CBT first-line for PMS; for marked mastodynia – topical NSAIDs, spironolactone. Vitex is an additional option for mild PMS symptoms in patients preferring herbal preparation.
Marketing claims without evidence base
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
- DPyridoxine (vitamin B6)Not recommended · Vitamins. CoenzymeAn old Cochrane review (1999) showed a weak effect of pyridoxine 50–100 mg daily on PMS symptoms. Newer systematic reviews have not confirmed clinically meaningful effects. ACOG does not include pyridoxine in first-line PMS therapy. Standard therapy: oral contraceptives, luteal-phase SSRIs, lifestyle change. High-dose pyridoxine for PMS carries neuropathy risk with prolonged use.
- FFabomotizoleNot recommended · Other anxiolytics (local classification)For PMS, ACOG 2023 and RCOG international guidelines recommend CBT, selective serotonin reuptake inhibitors (sertraline, fluoxetine, citalopram) for marked symptoms, and combined oral contraceptives. Afobazole is not included.
How to read tiers A–F
Evidence tiers belong to the drug-indication pair, not to the drug as a whole: the same substance can be A for one condition and F for another.
- AStrong evidence – first or second line in international guidelines
- BRecommended in selected cases
- CStudy data contradict each other
- DBenefit not proven, no documented harm
- FDocumented harm, or risk without benefit