Dysmenorrhea Clinical Pharmacology: Dose Finding of Physiological Modulators in Foods or Capsules

Background: Dysmenorrhea is a disease, which occurs in about 45% of women in childbearing age. Objective: Dose finding study to evaluate the activity of specific physiological modulators (PMs) aimed at protecting GABAA receptors and CaSRs (calcium sensing receptors) against oxidative stress (OS) and at reducing the discomfort caused by dysmenorrhea. Methods: The discomfort was measured using a score of from 0 to 5 and plasma antioxidant capacity was determined using a plasma antioxidant test (PAT). The PMs were combined and administered at low doses in the form of specific foods (SFs) and capsules. Twenty women with a score of ≥ 3 took part in the study during 5 sessions of 4 hours. In session 1, the women were treated with placebo, whereas in sessions from 2 to 5 they alternated between capsules and SFs containing the same amount of PMs. In sessions 4 and 5, the PM doses were double those taken in sessions 2 and 3. At the end of each sessions, women were asked about the need of pain relief as an indirect measurement of treatment efficacy. Results: The SFs and capsules reduced the discomfort in 60% and 75% of cases respectively. However, the effect with capsules was more rapid and lasted longer than with SFs. The need for pain relief was lower after treatment with capsules than it was with SFs. The increase in PAT was similar for both treatments. Conclusions: PMs taken as SFs or capsules showed similar activity, but capsules had a significantly more rapid and longer lasting effect.