Major and minor criteria for gastric dystemperaments in Persian Medicine: Sari gastric dystemperament criteria-I (SGDC-I).

Background: Gastric disorders are one of the most common human ailments, which impose a huge economic burden on countries. In Persian Medicine (PM), it is possible to predict the susceptibility to gastric diseases with diagnosis of gastric Mizajes (temperaments) and dystemperaments. The semiology of gastric dystemperaments has been investigated in PM textbooks, although the value of each sign and symptom is not mentioned. Consequently, this research is designed to determine the major and minor criteria for classifying gastric dystemperaments on the basis of valid manuscripts and with the help of PM specialists in the present era. Methods: This was a consensus-based study consisting of four phases. In the first phase, reference PM textbooks were studied. Symptoms and signs of gastric dystemperaments were collected and listed in four groups. In the second phase, semi-structured interviews with a sample of PM experts were carried out. Phase three included a focused group discussion with experts. Eventually, findings were integrated from the three study phases in a two-day meeting in Sari City. Results: Selected criteria included eight major and eight minor criteria for hot-cold dystemperament, as well as six major and eight minor criteria for wet-dry gastric dystemperament. Conclusion: Modern lifestyles and the interfering factors are responsible for some changes in diagnostic signs and symptoms according to PM. This was the first step to coordinate PM diagnostic criteria for gastric dystemperaments. Further studies are recommended to reach a unique protocol in the field of PM diagnostics. The next step includes design and validation of national diagnostic tools.

Aloe vera for Prevention of Acute Radiation Proctitis in Colorectal Cancer a Preliminary Randomized, Placebo-Controlled Clinical Trial.

OBJECTIVE: To examine the preventive effects of Aloe vera in colorectal cancer patients undergoing radiotherapy. MATERIAL AND METHOD: Twenty colorectal cancer patients, who received radiation, were randomized to receive Aloe vera 3% or placebo ointment, 1 g twice daily for 6 weeks. At weekly visits, acute radiation proctitis (ARP) was evaluated by Radiation Therapy Oncology Group and clinical presentation criteria as the primary endpoint. We also evaluated secondary endpoints of quality of life, psychosocial status, by applying Hospital Anxiety-Depression (HAD) Scale and laboratory measures of quantitative measurement of C-reactive protein (CRP) as a marker for systemic inflammation. RESULTS: There was a significant improvement in the symptom index (before treatment vs. after treatment with Aloe vera) for diarrhea (p = 0.029, median score: 0.5 vs. 0.001). The overall primary and secondary outcomes favored Aloe group, while the measures of toxicity did not achieve a statistical significant difference. The lifestyle score improved significantly with A. vera (p = 004), and they also had a lower depression score in HAD scale (p = 0.008). Furthermore, quantitative CRP decreased significantly during the course of treatment with Aloe vera. CONCLUSION: The use of topical formulation of Aloe vera 3% diminishes the severity of ARP in colorectal cancer patients.

Can Use of Silymarin Improve Inflammatory Status in Patients with ß-Thalassemia Major? A Crossover, Randomized Controlled Trial.

BACKGROUND: In ß-thalassemia major (ß-TM) patients, iron overload is one of the main causes of inflammation. This study investigated whether use of silymarin could improve inflammatory status in patients with ß-TM and iron overload, through a placebo-controlled, crossover study. METHODS: Silymarin (140 mg, 3 times a day) or placebo were prescribed to all patients (n = 82) for 12 weeks, and after a 2-week washout period, patients were crossed over to the other group. The efficacy of silymarin was assessed by measuring serum C-reactive protein (CRP) (mg/dL), interleukin (IL)-6 (pg/mL), and IL-10 (pg/mL). RESULTS: Sixty-nine patients completed the study. Data analysis showed that compared to the placebo, silymarin could decrease CRP, IL-6, and raise IL-10 significantly (the p values for all variables were <0.001). Cohen's d for CRP adjusted according to the baseline CRP value was -1.72, the 95% confidence interval (CI) -2.12 to -1.33. The adjusted Cohen's d equal to -1.12, 95% CI -1.48 to -0.76, and 0.78, 95% CI 0.43-1.12, were also estimated for IL-6 and IL-10, respectively. CONCLUSION: The results of the current study demonstrate that the combination of iron chelation therapy with silymarin can improve inflammatory status in patients with ß-TM in the clinical setting.

Prevention of acute radiation-induced Proctitis by Aloe vera: a prospective randomized, double-blind, placebo controlled clinical trial in Pelvic Cancer patients.

BACKGROUND: Acute radiation-induced proctitis (ARP) is the most common side effect following radiotherapy for malignant pelvic disease. This study evaluated the efficacy of Aloe vera ointment in prevention of ARP. METHODS: Forty-two patients receiving external-beam radiotherapy (RT) for pelvic malignancies were randomized to receive either Aloe vera 3% or placebo topical ointment during radiotherapy for 6 weeks. These patients were evaluated based on the severity (grade 0-4) of the following symptoms weekly: rectal bleeding, abdominal/rectal pain, diarrhea, or fecal urgency. RTOG acute toxicity criteria and psychosocial status of the patients were also recorded weekly. Lifestyle impact of the symptoms, and quantitative measurement of C-reactive protein (CRP), an indicator of systemic inflammation, were also measured. RESULTS: The results of present study demonstrated a significant preventive effect for Aloe vera in occurrence of symptom index for diarrhea (p < 0.001), rectal bleeding (p < 0.001), and fecal urgency (p = 0.001). The median lifestyle score improved significantly with Aloe vera during RT (p < 0.001). Intervention patients had a significant lower burden of systemic inflammation as the values for quantitative CRP decreased significantly over 6 weeks of follow-up (p = 0.009). CONCLUSION: This study showed that Aloe vera topical ointment was effective in prevention of symptoms of ARP in patients undergoing RT for pelvic cancers. TRIAL REGISTRATION: IRCT201606042027N6. Registration date: 2016-09-04.

Iron-chelating effect of silymarin in patients with ß-thalassemia major: A crossover randomised control trial.

This study aimed to determine the potential iron-chelating effects of silymarin in patients with ß-thalassemia major receiving standard iron-chelation therapy. We evaluated whether addition of silymarin to standard iron-chelation therapy could improve iron burden markers and liver and cardiac function in these patients, via a placebo-controlled, crossover clinical study. Silymarin (140 mg) or placebo were administered thrice daily to all patients (n = 82) for 12 weeks, and after a 2-week washout period, patients were crossed over to the other groups. Silymarin efficacy was assessed by measuring serum iron level, ferritin level, total iron-binding capacity and liver and cardiac function on magnetic resonance imaging. Silymarin treatment resulted in a negative change in the serum iron and ferritin levels and a positive change in the total iron-binding capacity levels (treatment effect, p < .001, p = .06, and p = .05, respectively). Silymarin treatment led to positive changes in cardiac and liver function in both treatment sequences of study; however, this was not statistically significant. There was a negative change in liver iron concentration in both treatment sequences (treatment effect, p = .02). In conclusion, combined iron-chelation and silymarin therapy was effective for improving the iron-burden status in patients with ß-thalassemia major.

The Effect of Zinc Supplementation on Sleep Quality of ICU Nurses: A Double Blinded Randomized Controlled Trial.

This study examined the effect of zinc supplementation on the sleep quality (SQ) of intensive care unit (ICU) nurses. In a double-blind, randomized controlled trial, 54 ICU nurses were randomly assigned to the intervention group ( n = 27) that received 220 mg zinc sulfate capsules every 72 hours for 1 month and the control group ( n = 26) that received placebo. Sleep quality of ICU nurses was measured by calculating the total quality sleep score using the Pittsburgh Sleep Quality Index (PSQI). The serum zinc level was a secondary outcome. All measurements were calculated at both baseline and 1 month after intervention. The total PSQI, subjective SQ, and sleep latency scores for the intervention group were significantly lower than the control group, which means that the SQ of ICU nurses in the intervention group improved from baseline. The serum zinc level of the intervention group at the end of the study was significantly higher than the control group, which means that zinc supplementation improved participants' serum zinc level. Based on these findings, the researcher suggested that zinc supplementation could be associated with better SQ, subjective SQ, and sleep latency in this group of workers.

The impact of silymarin on antioxidant and oxidative status in patients with ß-thalassemia major: A crossover, randomized controlled trial.

BACKGROUND & AIMS: Blood transfusion therapy is lifesaving for individuals with ß-thalassemia major (ß-TM). Iron burden following blood transfusion is the main cause of oxidative stress (OS) and organ dysfunction in these patients. The aim of this study was to evaluate the effects of silymarin on serum antioxidant and oxidative status in patients with ß-TM. METHODS: A crossover, randomized controlled trial was performed on 82 thalassemia patients. In two periods of 12 weeks, patients received 420mg silymarin (divided into three equal 140-mg daily doses) and placebo. The washout period between the two phases was two weeks. Serum malondialdehyde (MDA), protein carbonyl (CO), total antioxidant capacity (TAC), and reduced glutathione (GSH) were measured before and after both periods. RESULTS: Sixty-nine patients completed the study. Mean serum MDA and protein CO significantly decreased in all patients with ß-TM after three months of treatment with silymarin. At the end of the study, serum MDA decreased from 20.36±20.11 to 4.79±4.71µmol/l (compared to 17.81±16.05µmol/l after administration of placebo), and protein CO dropped from 0.31±0.28 to 0.11±0.09mM/l (compared to 0.24±0.17mM/l with placebo). Additional laboratory parameters (such as serum TAC and plasma GSH) were also significantly elevated after therapy with silymarin. At the end of the study, serum TAC increased in all patients from 620.7±202.64 to 971.83±328.16µmol FeSO4/l (compared to 672.22±206.88µmol FeSO4/l with placebo), and GSH increased from 46.16±41.68 to 195.35±210.98nM/l (compared to 58.52±48.95nM/l with placebo). The treatment effect of silymarin was measured using a mixed-effects model of variance analysis for changes in MDA, protein CO, TAC, and GSH, with significant effects being demonstrated for each laboratory parameter (P<0.001, P=0.002, P<0.001, and P<0.001, respectively). CONCLUSIONS: Silymarin was effective in decreasing serum OS and enhancing serum antioxidant capability in patients with ß-thalassemia major. Silymarin given as an adjuvant therapy to standard iron chelators may provide an improvement in the OS measurements obtained in these patients, with accompanying benefit.

Use of ginger versus stretching exercises for the treatment of primary dysmenorrhea: a randomized controlled trial.

BACKGROUND: Dysmenorrhea is a common gynecologic problem. In some cases, non-medical treatments are considered to be more effective, with fewer side effects. Ginger and exercise are alternative treatments for dysmenorrhea, but in the present study they were not combined. OBJECTIVE: In this study, the effects of ginger and exercise on primary dysmenorrhea were compared. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: This randomized controlled trial was performed in Mazandaran University of Medical Sciences, Iran. Two groups of female students were recruited by simple random allocation. In each group, 61 students with moderate to severe primary dysmenorrhea with regular menstrual cycles and without a history of regular exercise were assessed. The ginger group received 250 mg ginger capsules from the onset of menstruation. In the exercise group, belly and pelvic stretching exercises were performed for 10 min, 3 times per week. MAIN OUTCOME MEASURES: Intensity of pain was assessed according to a visual analogue scale after the first and the second month. RESULTS: Exercise was significantly more effective than ginger for pain relief (31.57 ± 16.03 vs 38.19 ± 20.47, P = 0.02), severity of dysmenorrhea (63.9% vs 44.3% mild dysmenorrhea, P = 0.02) and decrease in menstrual duration (6.08 ± 1.22 vs 6.67 ± 1.24, P = 0.006), in the second cycle. CONCLUSION: Stretching exercises, as a safe and low-cost treatment, are more effective than ginger for pain relief in primary dysmenorrhea. TRIAL REGISTRATION: The trial was registered in www.IRCT.ir with No. 201203118822N2.

Successful Treatment of Acute Radiation Proctitis with Aloe Vera: A Preliminary Randomized Controlled Clinical Trial.

BACKGROUND: Acute radiation proctitis (ARP) is a common side-effect that affects up to 50% of patients receiving radiotherapy. The aim of this study was to evaluate the role of a topical preparation of Aloe vera in the treatment of ARP induced by radiotherapy of pelvic area. SUBJECTS AND INTERVENTIONS: In this double-blind placebo-controlled trial, 20 consecutive patients with ARP after external-beam radiation therapy (46-72 Gy) of pelvic malignancies were randomized to receive either Aloe vera 3% or placebo ointment, 1 g twice daily for 4 weeks. These patients presented with at least two of the following symptoms: rectal bleeding, abdominal/rectal pain, diarrhea, or fecal urgency. These symptoms were rated by the patients in terms of their severity (grade 0-4) for each of the symptoms mentioned earlier at baseline and then weekly for 4 weeks. A symptom index was calculated by the addition of the scores (16 most symptomatic). Radiation Therapy Oncology Group (RTOG) acute toxicity criteria and psychosocial status of the patients were also recorded weekly. The lifestyle impact of the symptoms was assessed by questionnaire grading from 0 (no effect on daily activity) to 4 (afraid to leave home). RESULTS: There was a significant (p < 0.05) improvement in the symptom index (before treatment vs. after treatment with Aloe vera) for diarrhea (median score: 0.67 vs. 0.11), fecal urgency (median score: 0.89 vs. 0.11), clinical presentation total (median score: 4.33 vs. 1.22), RTOG total (median score: 2.89 vs. 0.89), and lifestyle (median score: 1.1 vs. 0.33). Hemorrhage and abdominal/rectal pain did not improve significantly. The odds ratios for advantage of Aloe vera over placebo for "clinical presentation total" and "RTOG total" were 3.97 (1.3-11.9) and 5.9 (1.6-21.6), respectively. CONCLUSION: A substantial number of patients with radiation proctitis seem to benefit from therapy with Aloe vera 3% ointment.

Zinc Supplementation in Adult Mechanically Ventilated Trauma Patients is Associated with Decreased Occurrence of Ventilator-associated Pneumonia: A Secondary Analysis of a Prospective, Observational Study.

BACKGROUND: Ventilator-associated pneumonia (VAP) is a type of lung infection that typically affects critically ill patients undergoing mechanical ventilation (MV) in the Intensive Care Unit (ICU). The aim of this analysis is to determine potential association between zinc supplementation with the occurrence of VAP in adult mechanically ventilated trauma patients. SUBJECTS AND METHODS: This secondary analysis of a prospective observational study was carried out over a period of 1 year in ICUs of one teaching hospital in Iran. A total of 186 adults mechanically ventilated trauma patients, who required at least 48 h of MV and received zinc sulfate supplement (n = 82) or not (n = 104) during their ICU stay, were monitored for the occurrence of VAP until their discharge from the ICU or death. RESULTS: Forty-one of 186 patients developed VAP, 29.09 days after admission (95% confidence interval [CI]: 26.27-31.9). The overall incidence of VAP was 18.82 cases per 1000 days of intubation (95% CI: 13.86-25.57). Patients who received zinc sulfate supplement have smaller hazard of progression to VAP than others (hazard ratio: 0.318 [95% CI: 0.138-0.732]; P < 0.0001). CONCLUSION: The findings show that zinc supplementation may be associated with a significant reduction in the occurrence of VAP in adult mechanically ventilated trauma patients. Further well-designed randomized clinical trials to confirm the efficacy of this potential preventive modality are warranted.

Massage as adjuvant therapy in the management of post-cesarean pain and anxiety: A randomized clinical trial.

OBJECTIVE: The present study was conducted to determine the effect of massage on post-cesarean pain and anxiety. METHODS: The present single-blind clinical trial was conducted on 156 primiparous women undergone elective cesarean section. The participants were randomly divided into three groups, including a hand and foot massage group, a foot massage group and a control group (n = 52 per group). The patients' intensity of pain, vital signs and anxiety level were measured before, immediately after and 90 min after the massage. RESULTS: A significant reduction was observed in the intensity of pain immediately and 90 min after massage (P < 0.001). Moreover, changes in some of the physiological parameters, including blood pressure and respiration rate, were significant after massage (P < 0.001); however, this change was not significant for pulse rate. A significant reduction was also observed in the level of anxiety (P < 0.001) and a significant increase in the frequency of breastfeeding (P < 0.001) after massage. CONCLUSION: As an effective nursing intervention presenting no side-effects, hand and foot massage can be helpful in the management of postoperative pain and stress.

The effect of mefenamic acid and ginger on pain relief in primary dysmenorrhea: a randomized clinical trial.

PURPOSE: The aim of the study was to compare the effect of mefenamic acid and ginger on pain management in primary dysmenorrhea. METHODS: One hundred and twenty-two female students with moderate to severe primary dysmenorrhea were randomly allocated to the ginger and mefenamic groups in a randomized clinical trial. The mefenamic group received 250 mg capsules every 8 h, and the ginger group received 250 mg capsules (zintoma) every 6 h from the onset of menstruation until pain relief lasted 2 cycles. The intensity of pain was assessed by the visual analog scale. Data were analyzed by descriptive statistics, t test, Chi-square, Fisher exact test and repeated measurement. RESULTS: The pain intensity in the mefenamic and ginger group was 39.01 ± 17.77 and 43.49 ± 19.99, respectively, in the first month, and 33.75 ± 17.71 and 38.19 ± 20.47, respectively, in the second month (p > 0.05). The severity of dysmenorrhea, pain duration, cycle duration and bleeding volume was not significantly different between groups during the study. The menstrual days were more in the ginger group in the first (p = 0.01) and second cycle (p = 0.04). Repeated measurement showed a significant difference in pain intensity within the groups by time, but not between groups. CONCLUSION: Ginger is as effective as mefenamic acid on pain relief in primary dysmenorrhea. Ginger does not have adverse effects and is an alternative treatment for primary dysmenorrhea.

Can Valeriana officinalis root extract prevent early postoperative cognitive dysfunction after CABG surgery? A randomized, double-blind, placebo-controlled trial.

RATIONALE: We hypothesized that valerian root might prevent cognitive dysfunction in coronary artery bypass graft (CABG) surgery patients through stimulating serotonin receptors and anti-inflammatory activity. OBJECTIVES: The aim of this study was to evaluate the effect of Valeriana officinalis root extract on prevention of early postoperative cognitive dysfunction after on-pump CABG surgery. METHODS: In a randomized, double-blind, placebo-controlled trial, 61 patients, aged between 30 and 70 years, scheduled for elective CABG surgery using cardiopulmonary bypass (CPB), were recruited into the study. Patients were randomly divided into two groups who received either one valerian capsule containing 530 mg of valerian root extract (1,060 mg/daily) or placebo capsule each 12 h for 8 weeks, respectively. For all patients, cognitive brain function was evaluated before the surgery and at 10-day and 2-month follow-up by Mini Mental State Examination (MMSE) test. RESULTS: Mean MMSE score decreased from 27.03 ± 2.02 in the preoperative period to 26.52 ± 1.82 at the 10th day and then increased to 27.45 ± 1.36 at the 60th day in the valerian group. Conversely, its variation was reduced significantly after 60 days in the placebo group, 27.37 ± 1.87 at the baseline to 24 ± 1.91 at the 10th day, and consequently slightly increased to 24.83 ± 1.66 at the 60th day. Valerian prophylaxis reduced odds of cognitive dysfunction compared to placebo group (OR = 0.108, 95 % CI 0.022-0.545). CONCLUSION: We concluded that, based on this study, the cognitive state of patients in the valerian group was better than that in the placebo group after CABG; therefore, it seems that the use of V. officinalis root extract may prevent early postoperative cognitive dysfunction after on-pump CABG surgery.