Vitamin D supplementation for primary dysmenorrhea: a double-blind, randomized, placebo-controlled trial

Objective@#Recent studies have shown a possible association between vitamin D deficiency and the severity of primary dysmenorrhea. The present study aimed to investigate the effect of vitamin D supplementation on pain and systemic symptoms in patients with primary dysmenorrhea. @*Methods@#This double-blind, randomized, placebo-controlled trial was conducted on female students aged 18 to 32 years with primary dysmenorrhea and vitamin D deficiency (25 [OH]D <30 ng/mL). The participants (n=116) received either 50,000 IU of vitamin D3 (cholecalciferol) or placebo capsules on a weekly basis for eight consecutive weeks. The outcomes were pain intensity (scored 0 to 10), number of days with pain, number of consumed pain-relief medications (per day), and severity of systemic symptoms (fatigue, headache, nausea/vomiting, and diarrhea; total score of 0 to 12). @*Results@#Compared with baseline, our participants who received vitamin D experienced significant reductions in pain intensity (-1.0 and -1.5 score at weeks 4 and 8, P<0.001), the number of days with pain (-1.0 day at weeks 4 and 8, P<0.001), the number of consumed pain-relief medications (-1.0 at weeks 4 and 8, P<0.001), and systemic symptoms severity (-1.0 score at weeks 4 and 8, P<0.001). No significant improvements were observed in the placebo group in terms of these outcomes. @*Conclusion@#Vitamin D supplementation in women with primary dysmenorrhea and vitamin D deficiency could improve systemic symptoms and reduce pain intensity, the number of days with pain, and the need for consuming pain-relief medications.

Vitamin D supplementation for primary dysmenorrhea: a double-blind, randomized, placebo-controlled trial

Objective@#Recent studies have shown a possible association between vitamin D deficiency and the severity of primary dysmenorrhea. The present study aimed to investigate the effect of vitamin D supplementation on pain and systemic symptoms in patients with primary dysmenorrhea. @*Methods@#This double-blind, randomized, placebo-controlled trial was conducted on female students aged 18 to 32 years with primary dysmenorrhea and vitamin D deficiency (25 [OH]D <30 ng/mL). The participants (n=116) received either 50,000 IU of vitamin D3 (cholecalciferol) or placebo capsules on a weekly basis for eight consecutive weeks. The outcomes were pain intensity (scored 0 to 10), number of days with pain, number of consumed pain-relief medications (per day), and severity of systemic symptoms (fatigue, headache, nausea/vomiting, and diarrhea; total score of 0 to 12). @*Results@#Compared with baseline, our participants who received vitamin D experienced significant reductions in pain intensity (-1.0 and -1.5 score at weeks 4 and 8, P<0.001), the number of days with pain (-1.0 day at weeks 4 and 8, P<0.001), the number of consumed pain-relief medications (-1.0 at weeks 4 and 8, P<0.001), and systemic symptoms severity (-1.0 score at weeks 4 and 8, P<0.001). No significant improvements were observed in the placebo group in terms of these outcomes. @*Conclusion@#Vitamin D supplementation in women with primary dysmenorrhea and vitamin D deficiency could improve systemic symptoms and reduce pain intensity, the number of days with pain, and the need for consuming pain-relief medications.

Synbiotic containing Bacillus coagulans and fructo-oligosaccharides for functional abdominal pain in children

We evaluated the effectiveness of a synbiotic in the treatment of childhood functional abdominal pain [FAP]. Probiotics are effective in the treatment of functional gastrointestinal disorders in adult patients, but there is lack of information in children. Children with FAP, based on the Rome III criteria [n= 115, aged 6-18 years], were randomized to receive either synbiotic [Bacillus coagulans, Unique IS-2, 150 million spore plus FOS, 100 mg] twice daily or placebo for four weeks. Treatment response was defined as >/= 2-point reduction in the 6-point self-rated pain scale or "no pain". Physician-rated global severity and improvement were also evaluated. Patients were followed for a total of 12 weeks. Eighty-eight patients completed the trial [45 with synbiotic]. Response rate was higher with synbiotic than placebo after medication [60% vs. 39.5%, P = 0.044], but was not different between the two groups at week 12 [64.4% vs. 53.4%, P = 0.204]. Difference between the two groups regarding the physician-rated global severity over the study period was not statistically significant [z = -1.87, P = 0.062]. There was no significant difference between the two groups in physician-rated global improvement [week 4, P = 0.437; week 12, P = 0.111]. Receiving synbiotic [OR 2.608, 95% CI: 1.01-6.68] and baseline pain score [OR 2.21, 95% CI: 1.19-4.10] were predictors of treatment response after medication. The synbiotic containing Bacillus coagulans and FOS seems to be effective in the treatment of childhood FAP. Further trials are recommended in this regard

Sleep quality in patients on maintenance hemodialysis and peritoneal dialysis

Sleep disturbances are common among uremic patients; however, limited data are available on predictors of sleep quality in this population. We assessed sleep quality in patients on hemodialysis [HD] and peritoneal dialysis [PD] and investigated predictors related to sleep quality. Patients on maintenance HD and PD were consecutively included from two medical centers in Isfahan city [Iran]. They completed the Pittsburgh sleep quality index [PSQI] and hospital anxiety and depression scale. Laboratory tests were done for iron state, kidney function, and electrolytes. Univariate and multivariate analyses were performed to find predictors of sleep quality. About 90 patients were evaluated [53 males, age = 54.2 +/- 15.2 years, disease duration = 5.3 +/- 4.5 years]. Poor sleep quality was frequent in 86.6% of the cases in each group of HD and PD patients. Patients on HD had poorer sleep quality in terms of total PSQI scores and two dimensions of sleep latency and sleep efficiency [P < 0.05]. Anxiety [beta = 0.232, P = 0.027], depression [beta = 0.317, P = 0.004], and being on HD [beta = 2.095, P = 0.009] were independent predictors of overall poor sleep quality. Poor sleep quality is highly frequent in patients on maintenance dialysis and mood disorders and being on HD are predictive factors. Further studies are required for better understanding of risk factors associated with poor sleep quality and thus possible treatments in these patients

Vitamin B[12] deficiency and multiple sclerosis; is there any association?

Vitamin B[12] [Cobalamin] deficiency can result in some clinical and paraclinical characteristics similar to what is seen in multiple sclerosis [MS] patients. This study aimed to evaluate the controversial association between B[12] deficiency and MS. We measured serum vitamin B[12] in 60 patients with MS and 38 healthy controls. Clinical disability was evaluated according to the Extended Disability Status Scale [EDSS]. Serum B[12] concentration was measured with Radioimmunoassay Dual Isotope method. The cutoff value for low serum vitamin B[12] concentration was 75 pg/mL. Patients were in remission at the time of blood draw. There were 13 [21.6%] MS patients and 10 [26.3%] controls with low serum B[12] concentration with no significant difference between the groups; P>0.05. The mean serum vitamin B[12] concentration in MS patients [108.9 +/- 45.3 pg/mL] was not significantly different compared with controls [98.9 +/- 44.4 pg/mL]; P=0.284. Likewise, there was no correlation between the concentration of serum vitamin B[12] and disease' age of onset, duration, subtypes, or disability status. In contrast to some previous reports, our findings did not support any association between B[12] deficiency and MS

Linguistic validation of the irritable bowel syndrome-quality of life questionnaire for Iranian patients

There is a growing interest of clinical and epidemiological researches in the field of functional gastrointestinal disorders in our society. Accordingly, validated and culturally adapted instruments are required for appropriate measurement of variables specially the quality of life. The aim of our study was the linguistic validation of the Irritable Bowel Syndrome-Quality of Life questionnaire [IBS-QOL] for Iranian IBS patients with Persian language. Following the standard forward-backward translation method, the IBSQOL was translated into the Persian language and completed by 141 IBS patients. Patients also completed the IBS Symptom Severity Scale [IBS-SSS] and Hospital Anxiety and Depression Scale [HADS]. One-week retest was performed on 30 randomly selected patients. Internal consistency and test-retest reliability were assessed using Cronbach's alpha and intraclass correlation coefficient [ICC], respectively. To analyze the discriminant validity, the IBS-QOL scores was correlated to the IBS-SSS and HADS scores. According to the results, reliability analyses were acceptable for all of the IBS-QOL domains [Cronbach's alpha=0.68 to 0.90 and ICCs=0.77 to 0.91]. Discriminant validity was supported by the presence of correlations of the IBS-QOL scores with disease severity [r=-0.628], depression [r=-0.692], and anxiety [r=-0.711] scores; P<0.001. These results indicate that the Persian version of the IBS-QOL is a reliable instrument with sufficient psychometric requirements to assess quality of life in Iranian IBS patients with Persian language

Serum sodium changes in fluoxetine users at different age groups

Fluoxetine, a widely used antidepressant, can affect the serum sodium level. The aim of this study was to evaluate and compare changes in the serum sodium level of depressive patients taking fluoxetine according to age. This quasi-experimental study was conducted on 126 patients with depression, dividing the patients into two age groups of 15 to 35 years, and above 55 years, who referred to psychiatric clinics of the Isfahan University of Medical Sciences. Serum sodium level was measured prior to fluoxetine therapy and at the first and third week after; adverse symptoms were recorded. Serum sodium level, hyponatremia, and other adverse effects were compared between the two age groups. There was a significant decrease in serum sodium levels in the older patients at the first and third week after the therapy; but the serum sodium levels decreased only after the third week of therapy in the younger patients [p < 0.05]. Serum sodium level was significantly lower in older than in younger patients at the third week of the therapy [140.8 +/- 2.26 vs. 135.2 +/- 2.06; p < 0.05], and hyponatremia was detected only in the older patients after the first and third week of therapy, 4.7% and 15.8%, respectively. Using fluoxetine can decrease serum sodium level, which is more frequent, more severe, and more clinically manifested in older than younger patients. Monitoring serum sodium level is recommended in early weeks of fluoxetine therapy especially for patients older than 55 years of age

Effect of trazodone on sleep bruxism in children and adolescents 6-18 years of age, a pilot study

Sleep bruxism is a common sleep disorder with unclear etiology and no definitive treatment. Recent suggested medications are not often practically used due to their numerous limitations. Based on the fact that sleep bruxism occurs most often in the second stage of non-REM sleep, this study aimed to assess the effect of trazodone on sleep bruxism. This pilot study was conducted as a before-after design on 28 children and adolescents with 6-18 years of age suffering from sleep bruxism referring by children and adolescents mental health clinic, children dental specialists and pediatricians. The treatment started with 0.5mg/kg/day. In non-responders, it was weekly added by 0.5 mg/kg/day [with optimum of 2 mg/kg/day]. Frequency of bruxism and related morning face/jaw pain were assessed daily from two weeks before [baseline] to four weeks after starting the intervention by the parents/roommate. Findings showed a significant reduction in the frequency of both bruxism and related morning pain from baseline to the 2nd and the 4th weeks of the intervention [P<0.001]. Minor side effects such as drowsiness, nausea and dry mouth were seen among approximately one-third of the patients. These side effects were self-limited and tolerable. Trazodone could be effective in reducing the frequency of sleep bruxism and its related morning face/jaw pain. Well-designed placebo-controlled trials are needed to confirm the results