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Objectives Postoperative nausea and vomiting (PONV) are common symptoms after cesarean delivery (CD) that affect patients outcomes and satisfaction. The treatment of choice is still evolving, therefore, we aimed to evaluate PONV of combined paracetamol-dexamethasone vs. paracetamol alone. Methods This study is a double-blind randomized controlled trial on 100 patients undergoing cesarean delivery. Participants were randomly assigned into two groups of paracetamol or combined paracetamol-dexamethasone. Nausea and vomiting score, VAS score of pain, and chill were compared between the two groups. Results The result of this study found that mild nausea 2nd h after surgery in the combined group was lesser than paracetamol group (0.03). However, there was no statistically significant difference in nausea and vomiting score in other periods of time between the two groups. VAS score of pain decreased 12th and 6th h after the surgery in the combined and paracetamol group, respectively. Chilling occurred in two patients of combined group and four patients of paracetamol group (p=0.432). Conclusions Dexamethasone added to paracetamol might not improve pain and vomiting after cesarean delivery comparison with just paracetamol. But it can be effective for reducing the score of nausea after the surgery.

Context The relationship between metabolic syndrome (MetS) and the risk of fracture is a matter of debate. Objective This work aimed to determine the impact of MetS and its components on the risk of hospitalized fractures, during a median follow-up of 15.9 years. Methods A total of 7,520 participants (4,068 women) 30 years or older entered the study. Multivariable Cox proportional hazards regression were applied for data analysis. Results The prevalence of MetS was 40.0% and 40.4% in men and women, respectively. During the follow-up, hospitalized fracture was observed in 305 cases (men = 152). The multivariable hazard ratio (HR) and 95% confidence interval (CI) of MetS for incident fracture for men and women was 0.72 (0.49-1.05, P = .08) and 1.38 (0.96-1.98, P = .08), respectively. In the fully adjusted model, high fasting plasma glucose (FPG) among men tended to be associated with a lower risk of fracture [0.67 (0.44-1.02, P = .06)]; among women, high waist circumference (WC) was associated with a greater risk [2.40 (1.55-3.73)]. Among the population 50 years and older in the pooled sample, MetS was not accompanied by the risk of fracture, but high WC was associated with a higher risk [1.58 (1.07-2.33)]. For incident hip/pelvic fracture, abdominal obesity—but not MetS per se—was also a strong and independent risk factor. Conclusion A significant sex difference in the association between MetS and its components with incident fracture was observed. Women with central adiposity were at increased risk of hospitalized fracture, whereas men with high FPG were at decreased risk.

Treatment of persistent or recurrent equinus after repeated surgical releases can be challenging in patients with clubfoot. Anterior distal tibial epiphysiodesis has recently been used in patients with recurrent progressive equinus deformity, with inconsistent outcomes. Herein, we used this technique in a carefully selected subgroup (8 children, 9 feet) of patients with a severe equinus deformity and a flat-top talus. The patients were followed up with radiological and clinical measures for 12 to 18 months. The mean angle of the ankle improved significantly (25.5°, p < .0001). The mean anterior distal tibial angle decreased from 86.3° to 69° (p < .0001). Plantigrade foot was obtained in all patients, except 1 with arthrogryposis. When applied to carefully selected patients, anterior distal hemiepiphysiodesis of the tibia is an effective method for management of recurrent equinus deformity.

Background: The aim of this study was to develop a prognostic model to identify a subgroup of high-risk patients for non-healing after femoral neck fracture fixation among young adults. The model was implemented by presenting graphically as a nomogram that could be easily used in every day clinical cases. Methods: Data on a total of 129 patients were included in the current study. The mean [standard deviation (SD)] age of the participants was 42 (13) years and 28% of the patients were women. Harrell’s C statistic was used as a measure of discrimination predictive power. We calculated the Nam-D’Agostino χ 2 to examine calibration for prediction models. Results: Approximately, 83% of fractures united uneventfully, with avascular necrosis (AVN), fixation nonhealing, non-union, infection, arthroplasty, and death being observed. Body mass index (BMI) and head acetabular trabecular angle (HATA) were inversely associated with the risk of all-cause nonhealing. The final model showed excellent discriminatory power [Harrell’s C statistic: 0.820, 95% confidence interval (CI) (0.680-0.960)] and it was well-calibrated [Nam-D’Agostino χ 2 : 10.1, (P = 0.3456)]. A nomogram developed by incorporating significant predictors modelled without discretizing continuous variables. Conclusion: Using readily available clinical and radiological data, we developed a parsimonious, simple, accurate yardstick to measure the 5-year risk of nonhealing after femoral neck fractures among young adults. In order to add ease-of-use and to promote its integration into clinical practice, the prognostic model was demonstrated visually as a statistic nomogram.

Objectives The aim of this study was to identify risk factors of in-hospital mortality among diabetic patients infected with COVID-19. Study design Retrospective cohort study. Methods Using logistic regression analysis, the independent association of potential prognostic factors and COVID-19 in-hospital mortality was investigated in three models. Model 1 included demographic data and patient history; model 2 consisted of model 1, plus vital signs and pulse oximetry measurements at hospital admission; and model 3 included model 2, laboratory test results at hospital admission. The odds ratios (ORs) and 95% confidence intervals (95% CIs) were reported for each predictor in the different models. Moreover, to examine the discriminatory powers of the models, a corrected area under the receiver-operating characteristic curve (AUC) was calculated. Results Among 560 patients with diabetes (men = 291) who were hospitalised for COVID-19, the mean age of the study population was 61.8 (standard deviation [SD] 13.4) years. During a median length of hospitalisation of 6 days, 165 deaths (men = 93) were recorded. In model 1, age and a history of cognitive impairment were associated with higher mortality; however, taking statins, oral anti-diabetes drugs and beta-blockers were associated with a lower risk of mortality (AUC = 0.76). In model 2, adding the data for respiratory rate (OR 1.07 [95% CI 1.00–1.14]) and oxygen saturation (OR 0.95 [95% CI 0.92–0.98]) slightly increased the AUC to 0.80. In model 3, the data for platelet count (OR 0.99 [95% CI 0.99–1.00]), lactate dehydrogenase (OR 1.002 [1.001–1.003]), potassium (OR 2.02 (95% CI 1.33–3.08]) and fasting plasma glucose (OR 1.04 [1.02–1.07]) significantly improved the discriminatory power of the model to AUC 0.86 (95% CI 0.83–0.90). Conclusions Among patients with type 2 diabetes, a combination of past history and pulse oximetry data, with four non-expensive laboratory measures, was significantly associated with in-hospital COVID-19 mortality.

Background: Limited information is available on how to properly manage to implant nonsterile devices in the medical literature. To the best of our knowledge, there is no guideline for managing nonsterile medical devices implanted inadvertently. Case Presentation: A 3.5-year-old boy was operated on because of femur fracture malunion. After the completion of the operation and discharging the patient, we were informed that the nail has not been sterilized. The parents were immediately informed about the complication and the patient was re-admitted to the hospital. The situation and its complication were thoroughly discussed with the family. By active involvement of the parents, infectious specialist, and the orthopedic surgeon, a shared decision was made to treat the complication. The patient was closely observed. In a radiograph obtained at the 4th week after the index surgery, the sign of callus formation was observed. At this time, we decided to remove the Titanium Elastic Nail (TEN) and continue casting for another two weeks. Conclusion: The primary “take-away” lesson of this case report is that honest disclosure of our mistake facilitated the additional necessary treatment. One single case is not enough for making a recommendation or offer a guideline for this kind of error during or after an orthopedic procedure; however, this case presents a successful method. Although the consequences of infection could be dire, it is prudent to take “not-to-harm” as the first step in benefiting.

Study Design Retrospective study. Purpose Lumbar intervertebral disc degeneration is an important cause of low back pain. Overview of Literature Spinal fusion is often reported to have a good course for adolescent idiopathic scoliosis (AIS). However, many studies have reported that adjacent segment degeneration is accelerated after lumbar spinal fusion. Radiography is a simple method used to evaluate the orientation of the vertebral column. magnetic resonance imaging (MRI) is the method most often used to specifically evaluate intervertebral disc degeneration. The Pfirrmann classification is a well-known method used to evaluate degenerative lumbar disease. After spinal fusion, an increase in stress, excess mobility, increased intra-disc pressure, and posterior displacement of the axis of motion have been observed in the adjacent segments. Methods we retrospectively secured and analyzed the data of 15 patients (four boys and 11 girls) with AIS who underwent a spinal fusion surgery. We studied the full-length view of the spine (anterior-posterior and lateral) from the X-ray and MRI obtained from all patients before surgery. Postoperatively, another full-length spine X-ray and lumbosacral MRI were obtained from all participants. Then, pelvic tilt, sacral slope, curve correction, and fused and free segments before and after surgery were calculated based on X-ray studies. MRI images were used to estimate the degree to which intervertebral discs were degenerated using Pfirrmann grading system. Pfirrmann grade before and after surgery were compared with Wilcoxon signed rank test. While analyzing the contribution of potential risk factors for the post-spinal fusion Pfirrmann grade of disc degeneration, we used generalized linear models with robust standard error estimates to account for intraclass correlation that may have been present between discs of the same patient. Results The mean age of the participant was 14 years, and the mean curvature before and after surgery were 67.8 and 23.8, respectively (p

There is no agreement on the best surgical strategy to manage multicolumnar tibial plateau fracture. The combined approach used by many investigators has been found to be an effective method. However, combined approaches call for repositioning the patient which lengthens the operation time. The sterility of the field of surgery might be jeopardized by repositioning. Intraoperative fluoroscopic imaging is hard to adjust to both parts of the combined positions. To tackle these problems without sacrificing the concept of three-column tibial plateau, we have started to use a combined medial and lateral approach without repositioning the patients using a modified semi-lithotomy position.

To examine the population-based incidence of any-fracture and its potential risk factors in a sex-split cohort of the Iranian population.A total of 3477 men and 4085 women with a mean (SD) age of 47.92(13.1) and 45.88(11.47) years, respectively were entered into the study. The age-standardized incidence rates per 100,000 person-years were reported for the whole population and each sex separately. Cox proportional hazard models were used to estimate hazard ratios (HR) for potential risk factors. Only fractures requiring inpatients' care were considered as the outcome. We also defined major osteoporotic fractures (MOF) as the composite of the fractures that occurred in the vertebral, wrist, hip and pelvic sites among population aged ≥50 years.During the median (IQR) follow-up of 15.9 years, 4.34%men and 3.75% women experienced at least one incident any-fracture. The annual age-standardized incidence rates (95% CI) among men and women were 330.9 (279.6-388.9) and 319.4(268.1-377.3) per 100,000 person-years, respectively; the corresponding values for incidence of MOF was 202.2(142.3-278.6) in men and 342.1(260.4-441.0) per 100,000 person-years for women. In the multivariable model, among the whole population, age groups ≥50 years, central obesity [HR: 95% CI 1.77(1.32-2.39)], current smoking [1.59(1.15-2.20)] and using steroid medications [2.20(1.04-4.67)] significantly increased the risk of incident fracture (all P 0.05); however the impact of the first two risk factors were more prominent among women (P for interaction ≤0.01). Moreover, being obese was associated with a lower risk of incident first fracture in the total population [HR: 95% CI: 0.61(0.40-0.92)]. Being men [HR: 95% CI: 0.54(0.30-0.99)] and prediabetes status [HR: 95% CI: 0.53(0.30-0.95)] were also associated with lower risk for MOF.This is the first report of long-term incidence rate of any-fracture and MOF conducted in the metropolitan city of Tehran. Among modifiable risk factors of fracture, in the whole population smoking habit and using steroid medications and particularly for women central obesity should be considered as main risk factors for preventive strategies. Prediabetes status was associated with lower risk of MOF.

Background: This study was conducted to develop a modified, parsimonious, faster to produce, easier to implement, and patient-specific drill guide template and also to examine if such a modification might affect the accuracy. Methods: On two cadaveric spines, using reverse engineering, the orientation of pedicles and safe corridors for pedicle screw were determined. A drill template was designed with a surface that was the inverse of the posterior vertebral surface. The drill template was manufactured using rapid prototyping technique. To decrease the costs, the cervical spine corresponding prototypes were not manufactured. In contrary to previous studies, to preserve the stability from posterior element, the templates were designed in such a way that removing interspinous and supraspinous ligaments was not necessary. The accuracy was evaluated by computed tomography (CT) images and classified into three grades of 0: correct placement, 1: malposition by less than a half screw diameter, and 2: malposition by more than a half screw diameter. Results: Of 20 positions available, we inserted 19 screws, because the trajectory of one of the patient-specific drill guide templates was misdirected. The overall accuracy rate for cervical pedicle screw (CPS) placement was 84.2% (16 of 19). Safely inserted screws, combining the grades 0 and 1 categories, were as high as 100%. We observed no “unsafe screw placement”. Conclusions: The total cost and the latency period before the operation was reduced and the interspinous and supraspinous ligaments were preserved. A good applicability and high accuracy was obtained for subaxial CPS (SCPS) insertion.

Study DesignMethodological study.PurposeTo our knowledge, this is the first study to introduce a new modified method for inserting iliosacral screws and to compare its results with those of a conventional method.Overview of LiteraturePrevious techniques, such as open reduction and internal fixation, are associated with perioperative hemorrhage, postoperative infection, and neurological deficits. Although percutaneous iliosacral screw insertion confers the advantage of being minimally invasive, leading to less blood loss and a low postoperative infection rate, it harbors the risk of screw malpositioning due to narrow sacral proportions and a high interindividual variability.MethodsNine cadaveric pelvises were included in this study, with one hemipelvis of each being assigned to the new modified method and the other to the conventional iliosacral screw insertion method. In the new modified method, the guidewire entry point was determined using a lateral sacral X-ray. To do so, we first identified the anterosuperior quadrant of the S1 body on one hemipelvis. The anterosuperior quadrant was further divided into four imaginary quadrants, and the guidewire was inserted into the posteroinferior quadrant. The guidewire trajectory was perpendicular to the sagittal plane so that the guidewire resembled a single point in the lateral sacral view. Guidewires were inserted into corresponding hemipelves using the conventional method as described in the literature. Subsequently, an axial computed tomography scan with 1-mm fine cuts was obtained, and sagittal and coronal views were reconstructed. The distance of the guidewire from the sacral canal, anterior sacral cortex, and first sacral foramen was measured in axial, sagittal, and coronal views. The minimum measurement among different views was defined as the safety index of the insertion methods. The conventional and new modified methods were then compared in terms of safety and duration of the procedure.ResultsThe minimum distance of the guidewire from the S1 foramen and anterior sacral cortex was not significantly different between the two methods. However, the minimum distance between the guidewire and sacral canal was significantly greater in the new modified method than in the conventional method. The duration of guidewire insertion was significantly shorter in the new modified method than in the conventional method.ConclusionsThis new modified method of iliosacral screw insertion could be safely and simply implemented while taking less surgical time than the conventional methods.

Objectives A body shape index (ABSI) based on waist circumference (WC) adjusted for height and weight has been shown to be a risk factor for premature mortality. The aim of this study was to demonstrate that ABSI predicts mortality hazard better than other anthropometric measures in an Iranian population. Methods The study population included 9242 Iranian participants in Tehran, aged ≥30 y, followed for a median 10 y. The risk for mortality was estimated by incorporating ABSI, body mass index (BMI), WC, waist-to-hip ratio (WHpR), and waist-to-height ratio (WHtR), one at a time, into multivariate models as well as in terms of the effect size, calibration, discrimination, and added predictive ability. Results We documented 487 deaths with the annual incidence rate of mortality per 1000 persons being 3.9 for women and 8.2 for men. ABSI was associated with all-cause mortality in a curvilinear fashion. ABSI was more strongly associated with all-cause mortality than were BMI, WC, and WHtR. Among women, however, WHpR was observed to be a stronger predictor of all-cause mortality than ABSI. Among both men and women, ABSI improved the risk classification based on other anthropometric measures, the only exception being WHpR. None of the anthropometric measures studied could add any value to the predictive ability of the Framingham's general cardiovascular disease algorithm. Conclusion ABSI was the strongest predictor of all-cause mortality among the anthropometric measurements, except WHpR in women. When ABSI was added to the Framingham general cardiovascular disease algorithm, it failed to improve the predictive ability.

CONTEXT: We summarized findings from Tehran lipid and glucose study (TLGS) about different aspects of type 2 diabetes (T2D) over the span of nearly 2 decades. EVIDENCE ACQUISITION: A review was undertaken to retrieve papers related to all aspects of T2D from the earliest date available up to January 30, 2018. RESULTS: An annual crude incidence rate of 10 per 1000 person-years of follow-up was found for T2D in adult participants. Overall incidence rate of pre-diabetes/T2D was 36.3 per 1000 person-years or about 1% each year among youth. Diabetes was associated with increased risk of CVD [hazard ratio (HR): 1.86, 95% confidence interval (95% CI): 1.57 - 2.27] and mortality [HR: 2.56; 95% CI: 2.08 - 3.16] in the total population. Compared with non-diabetic men and women, their diabetic counterparts survived 1.4 and 0.7 years shorter, respectively, during 15 years of follow-up. Wrist circumference, hyperinsulinaemia, 25-hydroxy vitamin D and increase in alanin aminotranferase provided incremental prognostic information beyond the traditional risk factors for incident T2D in adults. Using decision tree algorithms, a number of high risk groups were found for incident T2D. A probability of 84% was found for incidence of T2D among a group of men with fasting plasma glucose (FPG) > 5.3 mmol/L and waist to height ratio (WHtR) > 0.56, and women with FPG > 5.2 mmol/L and WHtR > 0.56. CONCLUSIONS: Original TLGS studies have contributed greatly to clarify important evidence regarding the epidemiology and risk factors for T2D among Iranian population.

To examine whether a body shape index (ABSI) calculated by using waist circumference (WC) adjusted for height and weight could improve the predictive performances for cardiovascular disease (CVD) of the Framingham’s general CVD algorithm and to compare its predictive performances with other anthropometric measures. We analyzed data on a 10-year population-based follow-up of 8,248 (4,471 women) individuals aged ≥30 years, free of CVD at baseline. CVD risk was estimated for a 1 SD increment in ABSI, body mass index (BMI), waist-to-hip ratio (WHpR) and waist-to-height ratio (WHtR), by incorporating them, one at a time, into multivariate accelerated failure time models. ABSI was associated with multivariate-adjusted increased risk of incident CVD among both men (1.26, 95 % CI 1.09–1.46) and women (1.17, 1.03–1.32). Among men, for a one-SD increment, ABSI conferred a greater increase in the hazard of CVD [1.26 (1.09–1.46)] than did BMI [1.06 (0.94–1.20)], WC [1.15(1.03–1.28)], WHpR [1.02 (1.01–1.03)] and WHtR [1.16 (1.02–1.31)], and the corresponding figures among women were 1.17 (1.03–1.32), 1.02 (0.90–1.16), 1.11 (0.98–1.27), 1.03 (1.01–1.05) and 1.14 (0.99–1.03), respectively. ABSI as well as other anthropometric measures failed to add to the predictive ability of the Framingham general CVD algorithm either. Although ABSI could not improve the predictability of the Framingham algorithm, it provides more information than other traditional anthropometric measures in settings where information on traditional CVD risk factors are not available, and it can be used as a practical criterion to predict adiposity-related health risks in clinical assessments.

To examine the association between the different definitions of metabolic syndrome (MetS) and the prediction of incident cardiovascular disease (CVD) and mortality events and to determine whether the concept of MetS adds to traditional risk factors among elderly Iranians.The association between MetS and outcomes was examined in 922 adults aged ⩾65 years, free of CVD at baseline, using multivariate Cox proportional hazards models. To examine whether MetS could enhance prediction of outcomes beyond that achieved by risk factors; the net reclassification improvement index was used.During a median follow-up of 9.9 years, 207 CVD events and 193 deaths (82 CVD deaths) occurred. World health organization (WHO) and the joint interim statement (JIS) definitions were shown to be the strongest predictors of CVD events. The WHO definition predicted CVD and all-cause mortality events (hazard ratio (HR)=1.55 (95% confidence interval (CI)=1.15-2.09) and 2.08 (95% CI=1.23-3.51), respectively) and the JIS definition showed a risk for CVD mortality (HR=1.65 (95% CI=1.03-2.65)). Different definitions of MetS did not add to traditional risk factors in the prediction of different outcomes.The WHO definition was the strongest predictor of CVD and mortality outcomes; however, none of the MetS definitions provided added value to traditional risk factors.

Background We investigated non-linear contribution of fasting plasma glucose (FPG) and 2-hour post-challenge plasma glucose (2h-PCPG) to the risk of CVD and mortality. We hypothesized that glucose measures improve risk-stratification made by the Framingham's general CVD risk algorithm. Methods Among participants aged ≥30 (n=8071), not taking glucose-lowering agents, 6169 (3477 women) remained eligible. Non-linear contribution of FPG and 2h-PCPG to incident CVD and mortality were assessed using Cox models incorporating restricted cubic splines functions. Risk reclassification improvement conferred by FPG and 2h-PCPG was examined using an extended version of net reclassification index (NRI) that takes into account the censoring nature of survival data. Results We documented 465 incident CVD events (402 CHD), 212 deaths from any cause (94 CVD deaths). Excluding the contribution of the 2h-PCGP to mortality (that was linear) dose–response relationships between glucose measures and CVD and mortality were curvilinear with nadirs below which decreasing levels of glucose were unlikely to offer any benefit. These nadirs were assigned to FPG of 4.9–5.3 and 2h-PCPG of 6.0mmol.l −1 . Glucose measures added to the predictive ability of the Framingham's general CVD risk algorithm with cutpoint-free NRIs ranging from 19 to 54%. Conclusion Glucose measures contributed to the risk of CVD and mortality in a curvilinear fashion, we observed increased risk below glucose thresholds currently used to define diabetes, supporting criteria for the diagnosis of impaired fasting glycemia and impaired glucose tolerance. Glucose measures were observed to add to predictive ability of the predictive model which included established cardiovascular risk factors.

To determine the extent to which burden of cardiovascular disease (CVD) outcomes among diabetic population is attributable to hypertension. Nine-year follow-up data were secured for 7068 participants aged ≥ 20 years old, free from CVD at baseline. Cox proportional hazards regression was implemented to estimate hazard ratios (HRs) of hypertension. Population-attributable hazard fraction (PAHF) was used to assess proportion of diabetic population hazard of CVD events and mortality attributable to hypertension. In the whole population, irrespective of diabetes or hypertension status, incidence rate (95% CI) of CVD, coronary heart disease (CHD), as well as CVD and all-cause mortality per 1000 person-year were 8.3 (7.6-9.0), 7.1 (6.5-7.8), 1.8 (1.5-2.1) and 3.9 (3.5-4.5), respectively. Among diabetes participants, hypertension was a risk factor for CHD (HR = 1.63, 95% CI 1.15-2.03), CVD (HR = 1.74, 95% CI 1.50-2.41), CVD mortality (HR = 1.65, 95% CI 0.87-3.12) and all-cause mortality (HR = 1.53, 95% CI 0.97-2.42). HRs, however, were not statistically significant for all-cause or CVD mortality. PAHFs (%) of hypertension was 27.5 (95% CI 8.3-42.6) for CHD, 29.6 (95% CI 10.6-44.4) for CVD, 27.9 (95% CI - 17.2 to 55.7) for CVD mortality and 22.6 (95% CI - 5.9 to 43.4) for all-cause mortality. Our study shows that there is an excess risk of CVD in hypertensive patients with diabetes related to inadequate control of blood pressure.

Pharmacological treatments of polycystic ovary syndrome (PCOS) have side effects. We compared the efficacy and safety of the aerial parts of wood botany (AWB) with those of Medroxyprogesterone acetate (MPA) in the management of abnormal uterine bleeding (AUB) due to PCOS. We conducted a randomized clinical trial of 66 women aged 15–45 years, with AUB. Participants were randomly assigned to either cyclical 10-mg BD MPA for three cycles or 5 g ABW TDS for three months. Clinical symptoms and paraclinical parameters were recorded before and 3 months after initiation of the treatment. Comparisons were made using generalized linear models. Age-adjusted prevalence rate of different patterns of AUB, decreased from 2.7 (95%CIs: 0.6–48.0) to 1.1 (95%CIs: 0.1–18.3) for patients taking MPA, and from 2.5 (95% CIs: 0.2–40.2) to 0.7 (95%CIs: 0.0–12.1). Decrease in prevalence rate was similar across two arms of the study (P value = 0.248). Adverse effects were observed less frequently (24.2%) among participants on MPA than among those on AWB (45.5%). The multivariate-adjusted odds for developing adverse reaction of MPA was 0.40 (95%CIs: 0.14–1.19, P value = 0.099) time odds of AWB. In conclusion, AWB may be used as an alternative for MPA in the treatment of AUB caused by PCOS. Copyright © 2013 John Wiley & Sons, Ltd.

Background: A fundamental part of prevention is prediction. Potential predictors are the sine qua non of prediction models. How- ever, whether incorporating novel predictors to prediction models could be directly translated to added predictive value remains an area of dispute. The dierence between the predictive power of a predictive model with (enhanced model) and without (base- line model) a certain predictor is generally regarded as an indicator of the predictive value added by that predictor. Indices such as discrimination and calibration have long been used in this regard. Recently, the use of added predictive value has been suggested while comparing the predictive performances of the predictive models with and without novel biomarkers. Objectives: User-friendly statistical software capable of implementing novel statistical procedures is conspicuously lacking. This shortcoming has restricted implementation of such novel model assessment methods. We aimed to construct Stata commands to help researchers obtain the aforementioned statistical indices. Materials and Methods: We have written Stata commands that are intended to help researchers obtain the following. 1, Nam- D'Agostino X 2 goodness of fit test; 2, Cut point-free and cut point-based net reclassification improvement index (NRI), relative abso- lute integrated discriminatory improvement index (IDI), and survival-based regression analyses. We applied the commands to real data on women participating in the Tehran lipid and glucose study (TLGS) to examine if information relating to a family history of premature cardiovascular disease (CVD), waist circumference, and fasting plasma glucose can improve predictive performance of Framingham's general CVD risk algorithm. Results: The command is adpredsurv for survival models. Conclusions: Herein we have described the Stata package "adpredsurv" for calculation of the Nam-D'Agostino X 2 goodness of fit test as well as cut point-free and cut point-based NRI, relative and absolute IDI, and survival-based regression analyses. We hope this work encourages the use of novel methods in examining predictive capacity of the emerging plethora of novel biomarkers.

The utility of a risk function in clinical practice is an important concept that has received insufficient attention. The authors evaluated the clinical usefulness of the Framingham risk function (FRF) for cardiovascular disease in a Middle Eastern population (2,640 men and 3,584 women aged 30–74 years) free of cardiovascular disease at baseline in 1999. They calculated the net benefit fraction for treatment of subjects with an estimated 10-year risk of ≥10% and also ≥20%, where the net benefit fraction is a weighted sum of true-positive and false-positive rates divided by incidence, as estimated by Kaplan-Meier analysis. The authors drew a decision curve by plotting the net benefit fraction against a wide range of risk thresholds for treatment. The cumulative incidence of cardiovascular disease was 7.6% and 12.3% in women and men, respectively. The FRF had a C index of 0.832 in women and 0.785 in men with a reasonable calibration. On the basis of the net benefit fraction, about 50% of the incidence in men and women could be appropriately treated by using the 10% threshold; however, the FRF was not useful at the 20% threshold, especially in women. In both genders, usefulness of the FRF was as good as the function derived directly from Tehrani data with the same variables; however, it could be useful in low thresholds for treatment. cardiovascular diseases; decision support techniques; epidemiologic methods; forecasting; Kaplan-Meier estimate; proportional hazards models; risk

Diabet. Med. 28, 1330–1336 (2011) Abstract Aim To investigate the effects of height and hip circumference, individually and in combination with waist circumference, on incident diabetes. Methods A total of 1589 men and 2132 women, free of diabetes at baseline aged ≥ 20 years participated in a 6-year follow-up examination. The standard 2-h post-challenge plasma glucose test was performed at baseline and during follow-up. The Cox model was used to regress the hazard of diabetes on height and hip circumference individually and in combination with waist circumference. Results Median follow-up was 6 years, with a total of 9433 and 12 607 person-years follow-up among men and women, respectively. The incidence rate of diabetes (95% CIs) was 9.0 (7.6–11.5) and 11.0 (9.6–−13.4) per 1000 persons per year in men and women, respectively. Among men, after multiple adjustments, the anthropometric measures were no longer associated with incident diabetes. Among women, the age-adjusted hazard ratio (95% CIs) of diabetes was 0.80 (0.61–1.04) for height, 1.39 (1.21–1.60) for hip circumference and 1.86 (1.59–2.17) for waist circumference. After further adjustment for waist circumference, the hazard ratios were 0.69 (0.53–0.90) for height and 0.76 (0.61–0.96) for hip circumference. These inverse associations resisted multiple adjustments. The hazard ratio for waist circumference increased by 7 and 54% when height and hip circumference were included in the models. Conclusion We observed that height and hip circumference were inversely associated with incident diabetes among women and that these associations could be explored by considering the effect of waist circumference. The risk of diabetes attributable to waist circumference might be underestimated were the effects of height and hip circumference not considered.

Summary Aims: To examine the performance of ‘the Framingham’s general CVD algorithm’ in estimating 5-year risk of cardiovascular disease (CVD) and coronary heart disease (CHD) in an adult Middle Eastern community. Methods: In a population-based prospective cohort, the Tehran Lipid and Glucose Study (TLGS), CVD risk estimates were calculated for 3838 individuals (2183 women) free of CVD at baseline. Results: Over 8.6 years, there were 119 CVD (106 CHD) events among women, and 164 (137) among men aged ≥ 30 years. Standard risk factors [age, systolic blood pressure (SBP), antihypertensive treatment, total and high-density lipoprotein cholesterol, smoking and diabetes mellitus], measured at baseline, were significantly related to the incidence of CVD. The only exception, lack of significance for coefficients of SBP among women, was attributable to collinearity between age and SBP. For most risk factors, hazard ratios (HRs) for CVD were similar for the TLGS and the Framingham cohorts’ participants. Few exceptions were lower HR for SBP among TLGS’ women and lower HR for age among TLGS’ men. The Framingham equations quite correctly discriminated participants [C statistic: CVD, 0.818 (women) and 0.774 (men); CHD: 0.822 (women) and 0.751 (men)] with good calibration (all calibration χ2 values 0.1). Discussion and Conclusions: The Framingham’s CVD algorithm was effective at ranking individuals and could be used to quantify risk and to guide preventive care in Iranian adults. For regions without established cohort, recalibration using risk factors and CVD (CHD) rates may be an effective method to develop CVD (CHD) risk prediction algorithms for local practice.

Background: Although several strategies to predict the development of diabetes have been developed the question is whether better scores can be developed without sacrificing simplicity. Methods: Data on 3242 participants of Tehran Lipid and Glucose Study aged ≥20 years, without diabetes at the baseline that completed a ~6-year follow-up were used to develop prediction models by running a series of logistic regression model. A simple score system was then developed based on the most important variables selected with forward stepwise approach. Results: During follow-up, 231 individuals developed diabetes. The area under the receiver operating characteristic curve for the score system based on the model including systolic blood pressure (SBP), family history of diabetes, waist-to-height ratio (WHtR), triglyceride-to-high-density lipoprotein cholesterol ratio (TG/HDL-C) ≥3.5 and fasting plasma glucose (FPG) levels ≥5mmol l−1 was 0.83 (95% CI 0.80–0.86); the model discriminated subjects with substantial risk for diabetes, appreciably better than 2-h post-challenge plasma glucose (2h-PCPG) alone (0.78; 95% CI 0.75–0.82) ( P < 0.001). Scoring ≥25 yielded a positive likelihood ratio of 3.27. FPG levels even in the presence of 2h -PCPG predicted incident diabetes. Conclusion: We presented a simple model based on SBP, family history of diabetes, WHtR, TG/HDL-C and FPG; concluding that this approach is superior to relying exclusively on the 2h-PCPG for identifying individuals at high risk for developing diabetes in a Middle Eastern adult population.

To assess the validity of the San Antonio heart study (SAHS) diabetes prediction model in a large representative Iranian population.A risk function derived from data in the SAHS to predict the 7.5-year risk of diabetes, was tested for its ability to predict incident diabetes in 3,242 individuals agedor=20 years. The performance or ability to accurately predict diabetes risk, of the SAHS function compared with the performance of risk functions developed specifically from the Tehran lipid and glucose study. Comparisons included goodness of fit, discrimination, and calibration.The participants were followed for 6.3 years. The area under the receiver operating characteristic curve (AROC) for diabetes of SAHS model was 0.83 (95% CI 0.80-0.86). The model overestimated the risk of diabetes in TLGS population with the overall bias of 111%. After the recalibration, the model-predicted probability agreed well with the actual observed 6-year risk of diabetes.The American SAHS was a prediction model for diabetes with good discrimination in an Iranian target population after calibration.

Data on the association between serum nitrate/nitrite and cardiovascular disease (CVD) is controversial; the aim of this study was to examine the potential utility of serum nitrate/nitrite in prediction of CVD. A total of 2443 adult participants, free from CVD at baseline were included. The probability of developing CVD was estimated by incorporating traditional CVD risk factors into a logistic regression model in the presence of serum nitrate/nitrite. The probability of CVD was calculated using Ln-transformed CVD risk factors as a covariate in the presence of Ln-transformed nitrate/nitrite in the final model. The added value of nitrate/nitrite was estimated using receiver operating characteristic curves and the net reclassification index (NRI). During follow-up, 169 events occurred. The multivariate odds ratio (95% confidence interval) for each 1 unit of increase in the Ln-transformed traditional risk factors and Ln-transformed nitrate/nitrite, were 3.20 (2.67-3.84) and 1.35 (1.01-1.80) for incident CVD, respectively. The areas under the curves of discrimination for models with and without nitrate/nitrite were not significantly different; however, incorporating nitrate/nitrite to the traditional CVD risk model can help appropriately reclassify over 6% of individuals at risk. In conclusion, serum nitrate/nitrite levels were independently associated with incident CVD. Measurement of serum nitrate/nitrite provided information beyond individual data on risk factors and improved prediction of CVD.

Background Prediction is a fundamental part of prevention of cardiovascular diseases (CVD). The development of prediction algorithms based on the multivariate regression models loomed several decades ago. Parallel with predictive models development, biomarker researches emerged in an impressively great scale. The key question is how best to assess and quantify the improvement in risk prediction offered by new biomarkers or more basically how to assess the performance of a risk prediction model. Discrimination, calibration, and added predictive value have been recently suggested to be used while comparing the predictive performances of the predictive models’ with and without novel biomarkers. Objectives Lack of user-friendly statistical software has restricted implementation of novel model assessment methods while examining novel biomarkers. We intended, thus, to develop a user-friendly software that could be used by researchers with few programming skills. Materials and Methods We have written a Stata command that is intended to help researchers obtain cut point-free and cut point-based net reclassification improvement index and (NRI) and relative and absolute Integrated discriminatory improvement index (IDI) for logistic-based regression analyses.We applied the commands to a real data on women participating the Tehran lipid and glucose study (TLGS) to examine if information of a family history of premature CVD, waist circumference, and fasting plasma glucose can improve predictive performance of the Framingham’s “general CVD risk” algorithm. Results The command is addpred for logistic regression models. Conclusions The Stata package provided herein can encourage the use of novel methods in examining predictive capacity of ever-emerging plethora of novel biomarkers.

16.35 expected cases) published by the Committee on Medical Aspects of Radiation in the Environment (COMARE) differ from those used by Korblein. Of note, COMARE reported a combined SIR of 1.07 (95% CI 0.92–1.26) from a random-effects metaanalysis of 37 estimates from five countries. Korblein rightly points out that the 95% CI of the rate ratio estimate from the main analysis of childhood leukaemia in 0to 4-year olds just includes the point estimate (2.19) of the German KiKK study. However, there is in fact considerable disagreement between the two studies. Assuming that the true IRR for leukaemia in 0to 4-year olds comparing the 0to 5-km zone with the 415-km zone around NPPs is indeed 2.2 (as estimated in the KIKK study), the probability of observing an IRR of 1.2 (as in our study) is 0.03 (Figure 1) and the power of rejecting the null hypothesis of no association at the 5% significance level is 76%. Chirga argues that estimates of mean annual radiation doses originating from nuclear power plants (NPPs) are uncertain and that actual doses might fluctuate over time. He suggests that short spikes in emissions could increase the incidence of childhood cancer. Whereas we cannot exclude this possibility, we reiterate that our study provides little evidence that the rate of childhood cancer is higher in the proximity of NPPs. The few cases of cancer occurring in excess of the expected number of cases among children living in the 5-km zone around Swiss NPPs are well within statistical uncertainty, and so is the deficit of cases a few kilometres further afield. We agree with Chirga that our main exposure measure, Euclidean distance of place of residence to nearest NPP, was crude and can only serve as a proxy for true radiation exposure.

Background: Coronary heart disease (CHD) is the leading cause of death worldwide. Research indicates that coronary atheroscle- rosis is the most frequent cause of CHD. Evidence is scarce concerning the clinical ecacy of fibrinogen or neutrophil-lymphocyte ratio (NLR) measurement in risk-stratifying patients with chronic stable angina. Objectives: To examine the independent and incremental prognostic value of fibrinogen and neutrophil-lymphocyte ratio (NLR) for angiographically-detected coronary artery disease (CAD). Patients and Methods: In this cross-sectional study, angiography was performed for 183 Iranian patients with chronic stable angina with exercise ECG-determined intermediate risk. Generalized estimated equations were used to obtain the odd ratio (OR) of CAD for a 1-unit increase in log-NLR and a 1-SD increase in plasma fibrinogen. Models were adjusted for established CAD risk factors. Integrated discriminatory improvement index (IDI) and net reclassification improvement index (NRI) were used as measures of predictive ability for CAD, combined with traditional risk factors by NLR and fibrinogen. Results: The mean age of the participants was 57.5, with 51.9% being male. Only 12% of participants had angiographically- determined patent coronary arteries. The number of participants with one, two, and three-vessel stenosis were 76, 31, 31, respectively, while 45 did not have stenosed vessels. NLR and fibrinogen levels were significantly higher in patients with stenosis in two (2.4 and 512 mg.dL -1 ) or three (2.6 and 517 mg.dL -1 ) coronary arteries, as compared to the group of patients with no significant involvement (2 and 430 mg.dL -1 ) (all P < 0.01). Patients with a higher NLR and a higher fibrinogen levels were more likely to have higher grades of CAD. OR log-NLR = 1.36 (95% CI: 1.05 - 1.94) and OR Z-Fibrinogen = 1.61 (95% CI: 1.18 - 2.22). When NLR and fibrinogen were added to the traditional risk factors separately, the NRIs were 0.170 (0.023 - 0.324) and 0.380 (0.214 - 0.543), respectively. The NRI was 0.460 (0.303 - 0.620) when both NLR and fibrinogen added to traditional risk factors simultaneously. Conclusions: NLR and fibrinogen predicted CAD, independent of traditional CAD risk factors. Both measures (whether separately or together) substantially enhanced the predictive performance of traditional risk factors for identifying patients with CAD.

Background. To reconcile “the obesity paradox,” we tested if (1) the contribution of anthropometric measures to mortality was nonlinear and (2) the confounding of hip circumference contributed to the obesity paradox recently observed among diabetic patients.Methods. We analyzed data of diabetic patients attending a community-based prospective, “Tehran lipid and glucose study.” In the mortality analysis, anthropometric measures—body mass index (BMI), waist, and hip circumference—were assessed using Cox models incorporating cubic spline functions.Results. During 12 990 person-years follow-up, BMI levels below 27 and those above 40 kg·m−2were associated with increased mortality. When we added waist circumference to the BMI in the multivariate-adjusted model, the steepness of BMI-mortality association curve slope for values below 27 kg·m−2increased, whereas the steepness of BMI-mortality association curve slope for values above this threshold decreased. Further adjusting the model for hip circumference, the steepness of the slopes of the association curve moved towards null on both extremes and no associations between BMI and all-cause mortality remained.Conclusion. BMI harbors intermixed positive and negative confounding effects on mortality of waist and hip circumference. Failing to control for the confounding effect of hip circumference may stymie unbiased hazard estimation and render conclusions paradoxical.

Background To examine the association between potentially modifiable risk factors with cardiovascular disease (CVD) and all-cause mortality and to quantify their population attributable fractions (PAFs) among a sample of Tehran residents. Methods Overall, 8108 participants (3686 men) aged≥30 years, were investigated. To examine the association between risk factors and outcomes, multivariate sex-adjusted Cox proportional hazard regression analysis were conducted, using age as time-scale in two models including general/central adiposity: 1)adjusted for different independent variables including smoking, education, family history of CVD and sex for both outcomes and additionally adjusted for prevalent CVD for all-cause mortality 2)further adjusted for obesity mediators (hypertension, diabetes, lipid profile and chronic kidney disease). Separate models were used including either general or central adiposity. Results During median follow-up of >10 years, 827 first CVD events and 551 deaths occurred. Both being overweight (hazard ratio (HR), 95%CI: 1.41, 1.18–1.66, PAF 13.66) and obese (1.51, 1.24–1.84, PAF 9.79) played significant roles for incident CVD in the absence of obesity mediators. Predicting CVD, in the presence of general adiposity and its mediators, significant positive associations were found for hypercholesterolemia (1.59, 1.36–1.85, PAF 16.69), low HDL-C (1.21, 1.03–1.41, PAF 12.32), diabetes (1.86, 1.57–2.27, PAF 13.87), hypertension (1.79, 1.46–2.19, PAF 21.62) and current smoking (1.61, 1.34–1.94, PAF 7.57). Central adiposity remained a significant positive predictor, even after controlling for mediators (1.17, 1.01–1.35, PAF 7.55). For all-cause mortality, general/central obesity did not have any risk even in the absence of obesity mediators. Predictors including diabetes (2.56, 2.08–3.16, PAF 24.37), hypertension (1.43, 1.11–1.84, PAF 17.13), current smoking (1.75, 1.38–2.22, PAF 7.71), and low education level (1.59, 1.01–2.51, PAF 27.08) were associated with higher risk, however, hypertriglyceridemia (0.83, 0.68–1.01) and being overweight (0.71, 0.58–0.87) were associated with lower risk. Conclusions Modifiable risk factors account for more than 70% risk for both CVD and mortality events.

Aims To examine the nature of the association between 25-hydroxyvitamin D [25(OH)D] and newly diagnosed type 2 diabetes. Methods Serum 25(OH)D concentrations were measured for 761 participants (aged 20–83 years) in the Tehran Lipid and Glucose Study, selected for a 1-to-3 nested case–control study. Cases were 191 cases of Type 2 diabetes diagnosed during a median follow-up of 3.6 years. A total of 570 participants were matched with these cases with regard to age, sex, BMI, and month of entering the study. Diabetes was defined according to the American Diabetes Association criteria, 2003. Serum 25(OH)D was measured using the enzyme immunoassay method. Odds ratios for Type 2 diabetes were obtained from conditional logistic regression models for tertiles of serum 25(OH)D concentrations [tertile-1: 2.82–11.02 (reference), tertile-2: 11.03–21.80, and tertile-3: ≥ 21.82 ng/ml]. The multivariate model was adjusted for age, sex, family history of diabetes, systolic blood pressure, triglyceride-to- HDL cholesterol ratio, waist-to-height ratio, lifestyle modification intervention, leisure time physical activity, and fasting plasma glucose at baseline. Non-linearity in the associations between baseline 25(OH)D and Type 2 diabetes, was examined by using restricted cubic splines. Results Unadjusted odds ratios (95% confidence intervals) of diabetes were 0.73 (0.74–1.13), 0.54 (0.34–0.85) for the second and third tertiles, respectively. Multivariate adjusted odds ratios were 0.47 (0.25–0.90) and 0.43 (0.23–0.82), respectively. Below the cutoff of ~ 10 ng/ml the risk of newly diagnosed Type 2 diabetes increased dramatically. Discussion It was found that 25(OH)D concentrations contributed to the Type 2 diabetes incidence rate in a non-linear fashion, with the risk beginning to increase sharply for values

Pentraxins are a superfamily of multifunctional conserved proteins, some of which are components of the humoral arm of innate immunity and behave as functional ancestors of antibodies. They are divided into short (C reactive protein) and long pentraxins (pentraxin 3; PTX3). We investigated the diagnostic values of systematic arterial and coronary sinus (PTX3) in developing prediction models for estimating pretest probability of coronary artery disease (CAD) among an intermediate-risk population of patients with chronic stable angina.Cross-sectional analysis.Referral cardiology hospital.Patients with chronic stable angina, without evidence of previous CAD if they were referred for angiography.All participants underwent diagnostic angiography. Prevalence rate ratio (PRR) of angiographically-determined coronary artery stenosis was separately examined in association with coronary sinus and femoral artery PTX3 concentrations using a general linear model. Duke treadmill score (DTS) was derived from the results of treadmill exercise cardiac stress testing. PTX3 data were collected in 100 patients with DTS-determined intermediate-risk chronic stable angina (aged 56.1 (1.1) years, 51 female).Both coronary sinus (PRR: 2.33, 95% CIs 1.64 to 3.31) and femoral artery PTX3 (PRR: 2.09, 95% CIs 1.46 to 2.97) independently predicted the prevalence rate of coronary artery involved with stenosis independent of the established CAD risk factors. Femoral artery PTX3 was highly correlated with coronary sinus PTX3 (β=0.8, 95% CIs 0.66 to 0.94; p value0.001). When we added femoral artery PTX3 to the predictive models incorporating traditional CAD risk factors, net reclassification improvement indices were 40% (cutpoint-free) and 15% (cutpoint-based). In the presence of PTX3, high-density lipoprotein cholesterol (HDL-C) was no longer protective against CAD.Gathering information on systemic arterial PTX3 may help more accurately reclassify DTS-determined patients with intermediate-risk chronic stable angina into more appropriate risk categories. PTX3 possibly, at least in part, mediates the protective effect on CAD of HDL-C.

BACKGROUND AND OBJECTIVES We investigated if a combination of plasma or salivary interleukin-2 (IL-2), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), transforming growth factor-beta (TGF-β), and troponin can improve estimation of the pretest probability of the left ventricular systolic dysfunction (LVSD). SUBJECTS AND METHODS Eighty patients with newly-diagnosed myocardial infarction (MI) were echocardiographically examined for LVSD (ejection fraction ≤40%). Measurements included traditional MI risk factors, plasma and salivary concentrations of troponin, IL-2, IL-6, TNF-α, and TGF-β. With the LVSD as the outcome variable, we developed logistic regression models, starting with a basic model incorporating traditional risk factors and consecutively adding salivary and plasma biomarkers. Models were compared using several criteria, including (but not limited to) C statistic (discrimination) and net reclassification improvement index (NRI). RESULTS APART FROM TROPONIN, PLASMA, AND SALIVARY VALUES OF THE BIOMARKERS WERE CORRELATED: spearman's ρ was 0.19 (p=0.088) for troponin, 0.36 (p=0.001) for IL-2, 0.74 (p

Aims. To provide a yardstick for physicians/patients to efficiently communicate/measure incident diabetes risk. Methods. We included data on 5,960 (3,438 women) diabetes-free adults, aged ≥20 years at baseline who either developed diabetes during two consecutive examinations or completed the followup. Age, systolic blood pressure, family history of diabetes, waist-to-height ratio (WHtR), triglyceride-to-high-density lipoprotein cholesterol ratio (TG/HDLD-C), and fasting plasma glucose (FPG) were introduced into an accelerated failure time regression model. Results. Annual diabetes incidence rate was 0.85/1000-person (95% CIs 0.77–0.94). Point-score-system incorporated age (1 point for >65 years), family history of diabetes (4 points), systolic blood pressure (−1 to 3 points), WHtR (−4 to 6 points), TG/HDL-C (1 point for ≥1.5), and FPG (0 to 27 points). Harrell’s C statistic = 0.830 (95% CIs 0.808–0.852) and Hosmer-Lemeshow χ2=9.7 (P for lack of fitness = 0.462) indicated good discrimination and calibration. We defined beta-cell age as chronological age of a person with the same predicted risk but all risk factors at the normal levels (i.e., WHtR 0.50, no family history of diabetes, Ln (TG/HDL-C) = 0.531, and FPG = 4.9 (mmol·L−1)). Conclusion. Hereby, we have made it also possible to estimate wide ranges of “beta-cell age” for most chronological ages to assist clinician with risk communication.

Objective: To assess the impact of short-term changes in body mass index (BMI), waist circumference (WC), hip circumference (HC), and waist-to-hip ratio on the risk of future coronary heart disease (CHD) among women. Participants and Methods: The study sample consisted of 2468 women aged 30 years or older without cardiovascular disease at baseline who underwent 2 consecutive examinations, the first between January 31, 1999, and August 21, 2001, and second between October 20, 2001, and September 22, 2005, and were followed up until March 31, 2010. Cox proportional hazard regression was performed to estimate the hazard ratios (HRs) of the anthropometric measures for CHD events. Results: During a mean follow-up of 6.6 years, CHD occurred in 127 of the study participants (5.1%). There were significant interactions between a BMI of 30 kg/m 2 or greater and anthropometric changes in prediction of CHD events (all P

Pharmacological treatments of polycystic ovary syndrome (PCOS) have side effects. We compared the efficacy and safety of the aerial parts of wood botany (AWB) with those of Medroxyprogesterone acetate (MPA) in the management of abnormal uterine bleeding (AUB) due to PCOS. We conducted a randomized clinical trial of 66 women aged 15-45 years, with AUB. Participants were randomly assigned to either cyclical 10-mg BD MPA for three cycles or 5 g ABW TDS for three months. Clinical symptoms and paraclinical parameters were recorded before and 3 months after initiation of the treatment. Comparisons were made using generalized linear models. Age-adjusted prevalence rate of different patterns of AUB, decreased from 2.7 (95%CIs: 0.6-48.0) to 1.1 (95%CIs: 0.1-18.3) for patients taking MPA, and from 2.5 (95% CIs: 0.2-40.2) to 0.7 (95%CIs: 0.0-12.1). Decrease in prevalence rate was similar across two arms of the study (P value = 0.248). Adverse effects were observed less frequently (24.2%) among participants on MPA than among those on AWB (45.5%). The multivariate-adjusted odds for developing adverse reaction of MPA was 0.40 (95%CIs: 0.14-1.19, P value = 0.099) time odds of AWB. In conclusion, AWB may be used as an alternative for MPA in the treatment of AUB caused by PCOS.