Effects of fluoxetine and melatonin on mood, sleep quality and body mass index in postmenopausal women.

Frequent mood and sleep disorders and increased appetite leading to obesity are observed in postmenopausal women. Due to the limitations of hormone replacement therapy the researchers look for other treatment regimes. The aim of the study was to evaluate the efficacy of fluoxetine and melatonin in the treatment of these disorders. The study included 64 overweight postmenopausal women, aged 54 - 65 years, with increased appetite. They were randomly assigned in 2 groups. In group I (n = 30) fluoxetine (20 mg in the morning) and placebo (in the evening) were administered for 24 weeks. Group II (n = 34) received fluoxetine (20 mg in the morning) and melatonin (5 mg in the evening) in the same period of time. Hamilton anxiety rating scale (HARS), Beck depression scale (BDI), the insomnia severity index (ISI) and body mass index (BMI) were used to assess the health status and the treatment efficacy. After 24 weeks, comparable and statistically significant reduction in the level of anxiety and depression was obtained in both groups. In group I, the ISI decreased from 14.9 ± 2.5 points to 10.9 ± 1.9 points (P < 0.05) and in group II from 15.8 ± 2.4 points to 7.7 ± 1.5 points (P < 0.001). In group I no reduction in BMI was achieved whereas in group II this index decreased from 30.9 ± 3.1 to 26.3 ± 3.2 (P < 0.05). We conclude that combined administration of fluoxetine and melatonin was useful option to treat mood, sleep and appetite disorders in postmenopausal women.

Influence of tianeptine on melatonin homeostasis and psychosomatic symptoms in patients with irritable bowel syndrome.

UNLABELLED: Selective serotonin reuptake inhibitors (SSRIs) exert beneficial effect on gastrointestinal tract (GIT), but its mechanism has not been recognized. One of the hypothesis assumes, that fluoxetine increases indirectly melatonin production. For this reason it can be hypothesized, that administration of drugs of opposite effect, for example tianepine (selective serotonin reuptake enhancer (SSRE), can reduce melatonin production resulting in harmful effects as regards GIT. The aim of the study was to confirm or reject this hypothesis. The study included 100 patients, aged 21-58 years, with irritable bowel syndrome (IBS). Basing on the Rome III Criteria patients with constipation-predominant (IBS-C, n=50) and with diarrhoea-predominant (IBS-D, n=50) and 25 health volunteers (control group C) were distinguished. Visual Analog Scale (VAS) and Hamilton Depression Rating Scale (HDRS) were used to determine the severity of somatic and psychic symptoms. The concentration of 6-sultatoxymelatonin (6-HMS) in the urine was measured by ELISA method. In both groups the patients were administrated tianeptine 12.5 mg three times daily or placebo for 8 weeks. After 8 weeks of tianeptine therapy no significant changes were found in urinary 6-HMS excretion both in IBS-C group (9.9±3.2 versus 11.5±3.5 µg/24 h) and in IBS-D group (11.8±3.3 versus 12.2±3.5 µg/24 h). Eight-week tianeptine therapy resulted in significant decrease of somatic and psychic symptoms in both investigated groups. The improvement in the quality of life indices was obtained in 76.5% of IBS-C and in 63.3% of IBS-D patients. CONCLUSIONS: tianeptine does not impair melatonin homeostasis in patients with IB, diminishes IBS symptoms and improves the patients' quality of life.

Evaluation of melatonin effectiveness in the adjuvant treatment of ulcerative colitis.

Ulcerative colitis (UC) is a chronic disease characterized by the variable clinical picture with the inflammatory changes which can involve the whole colon or its distal part. The current treatments for UC are mostly nonspecific, not always effective, and often accompanied by serious side effects. Therefore, there is a considerable interest in finding alternative and more tolerable treatments for this serious disease. Several lines of experimental studies have shown that melatonin (MEL) regulates the extensive gut immune system and exerts antiinflammatory and immunomodulatory effects suggesting its beneficial action in UC by reducing and controlling inflammation. The study aimed at evaluating the effect of MEL on the activity of inflammatory process and sustaining the remission in patients with UC. It comprised 60 patients with left-sided UC, divided in two equal groups of 30 patients each (38 women and 22 men, aged 26-49 years), similar in both groups, who were in clinical remission for the last 12 months. Patients, during a next period of 12 months, were given mesalazine in daily doses 2 x 1.0 g and melatonin 5 mg daily at bedtime (group I) or placebo (group II). All the patients on MEL adjuvant treatment remained in remission during 12 months of observation with The Mayo Clinic Disease Activity Index (MCDAI) values 1.50±0.51 at the beginning and 2.75±1.86 points after 12 months. In the placebo group significantly higher MCDAI values were observed than in patients on MEL after 6, 9 and 12 months. At the inclusion MCDAI was 1.61±0.68 points and at the end of observation it reached the value of 5.10±2.22 points. In MEL group CRP level remained within the normal range during the course of the study (from 3.49±1.40 to 4.17±2.10 mg/dl). Whereas in the placebo group from the end of the third month the steady rise in CRP blood concentration was noted from 3.85±1.29 to 13.13±6.08 mg/dl. Parallelly to CRP rise a significant decrease in hemoglobin concentration in blood from 12.05±0.69 to 10.93±0.81 g/dl was observed in patients receiving placebo and the values significantly differed between the groups after 3 (p<0.05), 6, 9 and 12 months (p<0.01). The level of anxiety and the intensity of depression in patients on adjuvant MEL decreased during the study but there were no statistical differences noted between the groups. The results of the study allowed drawing the conclusion that adjuvant melatonin therapy may help in sustaining remission in patients with UC.

Nocturnal secretion of melatonin in patients with upper digestive tract disorders.

Recently, the results of many experimental investigations have shown that melatonin possesses gastroprotective properties. On the other hand its role in pathogenesis of upper digestive tract diseases in man still remains unclear. The aim of the study was to investigate nocturnal secretion of melatonin in patients with functional and organic diseases of the upper part of digestive tract. The investigations were carried out in 149 persons, aged 21-51 years, including healthy subjects (group I, n=30), and patients with non-erosive gastroduodenal reflux (NERD, group II, n=24), with gastroesophageal reflux disease (GERD, group III, n=25), with functional dyspepsia (FD, according to the Rome III Criteria, group IV, n=36) and with recurrent duodenal ulcer (DUD, group V, n=34). Diagnoses were established on the basis of endoscopic imaging and histological examination, 24-hour pH-metry and laboratory tests. Melatonin serum concentration was measured with ELISA method. Blood samples were taken for examination in red-lighted room at 10 p.m. and on the following day at 2 and 6 a.m. The highest concentration of melatonin in all examined groups was determined at 2 a.m. The average melatonin concentration in healthy subjects was 34,7 +/- 4,8 pg/ml. In patients with GERD and DUD melatonin concentration was lower than in healthy subjects - 27,2 +/- 8,5 pg/ml and 25,5 +/- 6,2 pg/ml respectively (p < 0,05; p < 0,01). The highest concentration of melatonin was found in patients with NERD and FD - 43,2 +/- 10,8 pg/ml and 42,4 +/- 10,1 pg/ml (p < 0,01; p < 0,05). The findings of this study support the notion that melatonin exerts beneficial influences on the upper digestive tract. It is likely that high or relatively correct secretion of melatonin is sufficient to prevent peptic changes in esophageal and duodenal mucosa.

Effect of cisapride and cimetidine on 24-hour intraesophageal pH monitoring in patients with gastroesophageal reflux disease.

In 16 patients with symptomatic gastroesophageal reflux disease (GERD) 24-h intraesophageal pH monitoring (Medilog 1010, Oxford) was carried out after placebo, cisapride (4 x 5 mg) and cimetidine (3 x 200 mg plus 400 mg at bedtime). The per cent time at which intraesophageal pH < 4.0 (refluxive time) was analysed. Cisapride shortened daytime and postprandial refluxive time from 16.1 +/- 14.5% and 12.6 +/- 9.2% to 5.1 +/- 4.4% and 7.5 +/- 6.5%, respectively (p < 0.01, p < 0.05). Whereas, cimetidine shortened particularly night refluxive time from 24.7 +/- 14.1% to 8.8 +/- 6.9% (p < 0.01) and total time from 20.4 +/- 12.8% to 12.0 +/- 6.4% (p < 0.05).

[Effect of cimetidine on the heart conduction system]. / Wplyw cymetydyny na uklad bodzcowo--przewodzacy serca.

An effect of cimetidine on ECG records has been investigated in a group of 40 patients with gastric or duodenal ulcers and coexisting circulatory disorders. For this purpose ECG has been recorded with Holter's technique (Medilog 2000) together with ECG-recording using high amplifying technique. An intravenous injection of 200 mg of cimetidine produced in some of patients inhibition of the sinus rhythm atrio-ventricular conduction disturbances as well as changes in the end phase of ECG ventricular image. The authors suggest, that intravenous administration of cimetidine to patients with cardiac diseases should be monitored with ECG recording.

[Cimetidine and stilbestrol treatment of peptic ulcer in menopausal women]. / Leczenie cymetydyna i stylbestrolem wrzodów zoladka u kobiet w okresie przekwitania.

Cimetidine in the daily dose of 1,000 mg was administered orally to menopausal women (group I) with peptic ulcer. The group II (n = 25) was given cimetidine (1,000 mg/24 hours) with stilboestrol in the daily dose of 1 mg. Healing of the ulcers was seen in 16 women of group I (72.7%) and in 23 women of group II (92.0%; p less than 0.05) following a 6-week treatment.

[Effectiveness of sucralfate in the treatment of gastric ulcer in women during menopause--comparison with cimetidine]. / Skutecznosc sukralfatu w leczeniu wrzodów zoladka u kobiet w okresie przekwitania--porównanie z cymetydyna.

The reported study was done in 60 women aged 44 to 60 years during menopause. In group I (n = 30) sucralfate was used (Venter, Krka) in doses of 1.0 g daily. The rate of symptom disappearance and ulcer healing and the frequency of recurrences were assessed. It was observed that the rate of ulcer healing after sucralfat was higher and recurrences were leas frequent.

[Morphological and functional condition of the stomach in multiple sclerosis patients treated with prednisone]. / Stan morfologiczny i czynnosciowy zoladka u chorych na stwardnienie rozsiane leczonych prednisonem.

In 30 patients with multiple sclerosis treated with prednisone the morphological status of the gastric mucosa was assessed endoscopically and microscopically, and the secretory function of the stomach was studied determining hydrophloric acid, sialic acid and total glycoproteins in gastric juice before and after 6 weeks of prednisone treatment. After the treatment in 9 cases the symptoms and signs of gastritis were exacerbated, in 7 cases they were alleviated, and in gastric juice secretion of sialic acid was reduced in most cases.