[2 oral contraceptives with the same gestagen and different estrogen. A controlled clinical trial]. / To perorale antikonceptiva med samme gestagen og forskelligt østrogen. En kontrolleret klinisk undersøgelse

PIP: The results of a double-blind study of 237 women are presented comparing the effects of 2 oral contraceptives COCs containing the same gestagen but different estrogens. 116 women used contraceptive A (Planmite), a preparation of 1 mg norethisterone and 50 mcg mestranol, while contraceptive B, a preparation of 1 mg norethisterone and 50 mcg ethinyl estradiol, was used by 121 women. 787 women continued use of their respective contraceptive through 3 months and 116 through 9 months. The material was divided according to the type of contraceptive taken and according to whether OCs had been used in the 3 months preceding the survey. Both pills were equally effective, with no pregnancies occurring during the course of the study. Bleeding was insignificantly more frequent with contraceptive B, and where bleeding occurred, it had a strong tendency to decrease after the first 3 months of contraceptive use. Bleeding was greater among those taking OCs for the 1st time. There was less nausea among patients using contraceptive A. There was no significant variation in weight change with respect to the type of contraceptive taken or the time period within which it was used, but there was a greater weight gain in those using OCs for the 1st time. Systolic blood pressure fell a median of 10.2 mm Hg, irregardless of the type of contraceptive, length of present use, or previous use. Diastolic blood pressure fell a median of 7.0 mm Hg in those who had used OCs previously, and rose .4 mm Hg in those who had not used contraceptives previously. This study indicates that mestranol and ethinyl estradiol, in opposition to previous findings, are equally effective in preventing pregnancy with no significant difference in aftereffects.^ieng

[Hormonal treatment of climacteric complaints. A controlled, double-blind comparative study between 2 different types of sequential estrogen-gestagen preparations]. / Hormonbehandling af klimakterielle gener. En kontrolleret, dobbeltblind sammenligning mellem to forskellige typer østrogen-gestagen sekvenspraeparater.

PIP: 156 women, 31-55 years of age, were treated for menopausal difficulties with 2 hormonal preparations. Menonorm and Medovan were administered in a Double-blind, double dummy study during 3 cycles to determine if there were a difference in the effectiveness of the 2 preparations. A statistical analysis was made on the results from 107 of the women who took part in the study; no significant difference was found between the effectiveness of the 2 preparations or the patients's subjective evaluation of them. Improvement in the incidence of heat flashes was recorded in 76%-86% of the material. Psychological problems improved in 47%-56% of those observed. The median cycle length was 28.2 days for both preparations. 1 woman developed a reversible hypertension during Medovan use. Women using Menonorm showed a tendency toward weight gain, while those using Medovan showed a tendency toward weight loss. Discontinuation rate during the first 2 months of use were significantly higher among women who had hormone treatments before (P .05).^ieng

[Continuous graduated sequential therapy with estrogen-gestagen in the climacteric. A double-blind study]. / Kontinuerlig gradueret sekvensterapi med østrogen-gestagen i klimakteriet. En dobbelt-blind undersøgelse

PIP: 70 women, aged 37-59, were treated with Menonorm and Gotistron (3 cycles with each preparation) in a double-blind survey to determine which medication was more effective in treating menopausal symptoms. Menonorm was preferred to Gotistron for the relief of hot flashes and nervous symptoms. Menonorm brought improvement in hot flashes in 88% of the cases, Gotistron in 73%; these medications brought improvement in nervous symptoms in about 55% of the patients. 27% of the women who took part discontinued the experiment due to side effects, which were mild in 21% of these patients. 80% of the patients experienced some type of side effect. This double-blind study was not considered the best method for indicating which drug was more effective, due to the subjective nature of the patients' symptoms: 40% of the patients had to be excluded from the statistical analysis because of side effects or forgetting to take the medication.^ieng

Emotional contagion for pain is intact in autism spectrum disorders.

Perceiving others in pain generally leads to empathic concern, consisting of both emotional and cognitive processes. Empathy deficits have been considered as an element contributing to social difficulties in individuals with autism spectrum disorders (ASD). Here, we used functional magnetic resonance imaging and short video clips of facial expressions of people experiencing pain to examine the neural substrates underlying the spontaneous empathic response to pain in autism. Thirty-eight adolescents and adults of normal intelligence diagnosed with ASD and 35 matched controls participated in the study. In contrast to general assumptions, we found no significant differences in brain activation between ASD individuals and controls during the perception of pain experienced by others. Both groups showed similar levels of activation in areas associated with pain sharing, evidencing the presence of emotional empathy and emotional contagion in participants with autism as well as in controls. Differences between groups could be observed at a more liberal statistical threshold, and revealed increased activations in areas involved in cognitive reappraisal in ASD participants compared with controls. Scores of emotional empathy were positively correlated with brain activation in areas involved in embodiment of pain in ASD group only. Our findings show that simulation mechanisms involved in emotional empathy are preserved in high-functioning individuals with autism, and suggest that increased reappraisal may have a role in their apparent lack of caring behavior.

[Oral contraception].

PIP: Information is presented about the effects and side effects of the use of combination preparation oral contraceptives. Combination preparations consist of 2 components: an estrogen and a gestagen. The estrogen is either ethinyl estradiol or mestranol, and the gestagen comes from 1 of 2 groups, either 19-nortestosterone or 17alpha-hydroxyprogesterone. Tables indicating the chemical configurations of the estrogens and gestagens and the chemical composition of contraceptives marketed in Denmark are presented. combination preparations hinder ovulation, the development of the endometrium, and production of the cervical secreations. The estrogen-gestagen combination affects the hypothalamus-pituitary gland system, which decreases the production of follicle stimulating hormone and luteinizing hormone and impedes ovulation. The gestagen accelerates yet curbs the development of the endometrium, which reduces menstrual bleeding. The gestagen also causes the vaginal secretions to thicken, making them impenetrable to sperm. Nausea, weight gain, and tenderness of the breasts are less serious side effects of oral contraceptive use. Blood pressure, lactation, and liver functions can be affected by oral contraceptive use. Use of contraceptives can increase incidence of cancer, diabetes, and thromboembolic disorders. Sequential preparations and semisequential preparations also consist of estrogens and gestagens. Minipills consist only of a gestagen. ''1-a-month-pills,'' ''day-after-pills,'' and male oral contraceptives are also being tested.^ieng

Systematic within-person variation in the bioavailability of various drugs in healthy volunteers.

The relative bioavailability of 22 registered pharmaceutical specialities compared to one or more generic equivalents was investigated in 50 human volunteers using randomized cross-over trials. The data were reassessed with regard to individual behaviour in different experiments and with different drugs. The pharmacokinetic behaviour (Cmax, Tmax, and AUCo-t) of the volunteers exhibited consistent patterns, which were not attributable to chance. It is concluded that the cross-over design is necessary in conducting relative bioavailability studies.

Carbamazepine: a clinical biopharmaceutical study.

In a biopharmaceutical study of carbamazepine, the F-CBZ, DAK preparation, which contained small particles with minor variation in size, had a more rapid dissolution rate than Tegretol, which contained larger particles of more variable size. Accordingly, carbamazepine had a more rapid absorption rate from F-CBZ, DAK than from Tegretol in a comparative absorption test involving single-dose administration of 200 mg to 8 healthy volunteers. The clinical significance of the difference in absorption rates for the steady state levels of carbamazepine and carbamazepine-10,11-epoxide, and the frequency of side-effects in relation to tablet intake, were evaluated in a double-blind, randomized, double-dummy cross-over trial of 35 days' duration, in 21 well-adjusted epileptic patients. 9 patients were treated with Tegretol alone and 12 with Tegretol combined with other antiepileptic drugs. A lower steady state plasma level of carbamazepine was found at 08.00 h during treatment with F-CBZ, DAK in comparison with Tegretol. The difference was small. There was no difference in the type and frequency of side-effects or seizures between the 2 preparations. The frequency of epileptic fits was not correlated with the plasma level of carbamazepine or the epoxide. Side-effects, however, had a tendency to be correlated with the concentration of the epoxide. Thus, the particle size influenced the absorption rate of carbamazepine, without having a significant correlation wih the frequency of side-effects. The difference in the minimum plasma level of carbamazepine between treatments with the two preparations was modest, and appeared to be without clinical significance.

Oral supplementation of myoinositol: effects on peripheral nerve function in human diabetics and on the concentration in plasma, erythrocytes, urine and muscle tissue in human diabetics and normals.

28 young diabetics with short disease duration participated in a double-blind study by taking 6 g of myoinositol or placebo daily for 2 months. The aim was to demonstrate a possible beneficial effect of this compound on subclinical diabetic neuropathy. Measurement of vibratory perception threshold, motor and sensory conduction velocity and amplitude of nerve potential did not disclose any effect of the myoinositol given. In accordance with this, no indication for a lack of myoinositol in human diabetic blood or tissue could be found. The concentration of myoinositol in the plasma and erythrocyte of 4 human diabetics was normal or high, even though the loss of urinary myoinositol was greater than in the case of 4 normals. Further, an analysis of the content of free and lipid-bound myoinositol in muscle biopsies taken from the 4 diabetics did not give any indication of deficiency. The content of myoinositol in their muscle tissue remained uninfluenced by oral supplementation of myoinositol.