lysine-clonixinate and Dysmenorrhea

We studied 125 patients with primary dysmenorrhea in a prospective randomized double-blind crossover study. After an admission pretreatment period without medication, the patients completed three consecutive randomized treatment phases with lysine clonixinate 125 mg plus propinox 10 mg or paracetamol 500 mg plus hyoscine N-butylbromide 10 mg or placebo, according to a fixed-dose schedule of 1 tablet every 6 h, 3 days before onset of menses and for 5 days thereafter. Changes in menstrual pain intensity and duration, amount of bleeding measured according to the number of daily pads used and concomitant symptoms were assessed on the fifth day of each cycle. Every night, the patients recorded the average intensity of menstrual pain during the first 4 days of menstruation in a diary The follow-up visit carried out at day 5 showed significant reduction in pain intensity with both active treatments vs. the other two phases: baseline: 2.72 +/- 0.61; placebo: 1.85 +/- 0.87; lysine clonixinate plus propinox 1.36 +/- 0.81, and paracetamol plus hyosine N-butylbromide: 1.45 +/- 0.87. The patients' diaries showed increasingly lower pain intensities starting from day 1 with the three treatments. Active treatments revealed significantly higher analgesic efficacy from the outset compared with baseline and placebo; however, only the lysine clonixinate plus propinox combination reached a statistically significant difference by days 3 and 4. No changes in duration or intensity of menstrual bleeding or in the incidence of adverse effects were observed during the four study periods.

Topics: Acetaminophen; Adult; Analgesics, Non-Narcotic; Butylscopolammonium Bromide; Clonixin; Cross-Over Studies; Double-Blind Method; Drug Combinations; Dysmenorrhea; Female; Follow-Up Studies; Humans; Lysine; Mandelic Acids; Pain; Parasympatholytics; Parity

The analgesic efficacy and tolerance of lysine clonixinate (LC) as well as LC-induced changes in menstrual prostaglandin levels were studied according to a prospective double-blind randomized crossover design, controlled with ibuprofen (I) and placebo (P). Treatment consisted in 4 consecutive phases: in the first phase, patients refrained from taking medication and during the remaining three phases, they received double-blind fixed doses of 1 tablet of lysine clonixinate 125 mg, I 400 mg or P, q.6 h. at random, three days before onset of menses and during 8 days thereafter. Controls were carried out at each menstrual cycle, assessing pain according to a scale from 0 to 4, onset of premenstrual and intramenstrual symptoms, relief of pain and occurrence of side-effects. During menstruation, patients recorded their assessments of pain in a diary and collected the whole menstrual bleeding during the first three days. The intensity of menstrual pain remained unchanged in controls upon admission (3.16) and during the phase with no treatment (3.04), but was significantly reduced with P (2.4), LC (1.79) and I (1.54). Significantly lower pain intensities compared with placebo were seen with active treatment phases. Forty-two percent of patients treated with P reported premenstrual pain which was significantly reduced to 17% with LC and to 12.5% with I. Active treatment phases revealed 21% of asymptomatic patients during premenstrual and menstrual periods and 71% (LC) and 75% (I) of cases with partial relief of pain. Patients' diaries showed significant pain reductions with LC and I, during the 1st and 2nd days compared with P; such differences were gradually reduced to nil by the 4th day. Levels of menstrual PGs changed according to pain intensity reductions from baseline (P: 29%, (NS); LC: 58% and I: 61%; both were statistically significant, p < 0.01).

Topics: Adolescent; Adult; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Clonixin; Double-Blind Method; Dysmenorrhea; Female; Humans; Ibuprofen; Lysine; Menstrual Cycle; Prospective Studies; Prostaglandins; Statistics, Nonparametric

The purpose of this longitudinal open but not comparative study was to confirm the safety and efficacy of Lysine clonixinate (125 mg) and hyoscinbutylbromide (10 mg) capsules, during a period of observation of there menstrual cycles on 30 women with uterine dysfunction due to primary or secondary dysmenorrhea. The time of evolution for primary dysmenorrhea was of 4.46 years, and for secondary was of 1.77 years. Some associated manifestations of dysmenorrhea were: nausea (92%), vomit (92%), general pain (82.1%), abdominal pain (85.7%) and headache (46.4%). Regarding to the menstrual pain intensity, at first was highly severe in 10.7% severe in 42.9%, and moderate in 46.4%. At the end of the study, only 1 of 28 patients showed menstrual pain of moderate intensity. Only three adverse effects of light intensity were found without needing treatment, related to the manifestations of gastralgia and sleepiness. The association of a spasmolytic analgesic (Lysine clonixinate and hyoscinbutylbromide bromide) on the treatment for primary or secondary dysmenorrhea, reduces and prevents the menstrual pain (colic) as well as the associated manifestations with few spasmolytic association is efficacy and safety.

Topics: Administration, Oral; Adolescent; Adult; Analgesics; Butylscopolammonium Bromide; Clonixin; Cyclooxygenase Inhibitors; Dysmenorrhea; Female; Humans; Longitudinal Studies; Lysine; Menstrual Cycle; Muscarinic Antagonists; Parasympatholytics