Epidemiology of substance and opium use among adult residents of Tehran; a comprehensive report from Tehran cohort study (TeCS).

BACKGROUND: The prevalence and burden of substance and opium use have increased worldwide over the past decades. In light of rapid population changes in Tehran, we aimed to evaluate the prevalence of opium and other substance use among adult residents in Tehran, Iran. METHOD: From March 2016 to March 2019, we utilized data from 8 296 participants in the Tehran Cohort Study recruitment phase (TeCS). We calculated the age-sex-weighted prevalence of substance use and the geographic distribution of substance use in Tehran. We also used logistic regression analysis to determine possible determinants of opium use. RESULT: We analyzed data from 8 259 eligible participants with complete substance use data and the average age of participants was 53.7 ± 12.75 years. The prevalence of substance use was 5.6% (95% confidence interval [CI]: 4.6- 7.1%). Substance use was more common in males than females (Prevalence: 10.5% [95% CI: 8.6- 12.6%] vs. 0.5% [95% CI: 0.2- 1.2%], respectively). The age-sex weighted prevalence of substance use was 5.4% (95% CI: 4.6-7.1%). Moreover, opium was the most frequently used substance by 95.8% of substance users. Additionally, we found that male gender (Odds ratio [OR]: 12.1, P < 0.001), alcohol intake (OR: 1.3, P = 0.016), and smoking (OR: 8.5, P < 0.001) were independently associated with opium use. CONCLUSIONS: We found that the prevalence of substance use in Tehran was 5.6%, and opium was the most frequently used substance. In addition, male gender, lower levels of education, alcohol, and tobacco consumption are the main risk factors for substance use in Tehran. Healthcare providers and policymakers can utilize our results to implement preventive strategies to minimize substance use in Tehran.

Association Between Incident Type 2 Diabetes and Opium Use: Mediation by Body Mass and Adiposity.

Opiates can affect glucose metabolism and obesity, but no large prospective study (to our knowledge) has investigated the association between long-term opium use, body mass index (BMI; weight (kg)/height (m)2), and incident type 2 diabetes mellitus (T2DM). We analyzed prospective data from 50,045 Golestan Cohort Study participants in Iran (enrollment: 2004-2008). After excluding participants with preexisting diseases, including diabetes, we used adjusted Poisson regression models to estimate incidence rate ratios (IRRs) and 95% confidence intervals (CIs) for T2DM in opium users compared with nonusers, using mediation analysis to assess the BMI-mediated association of opium use with incident T2DM. Of 40,083 included participants (mean age = 51.4 (standard deviation, 8.8) years; 56% female), 16% were opium users (median duration of use, 10 (interquartile range), 4-20) years). During follow-up (until January 2020), 5,342 incident T2DM cases were recorded, including 8.5% of opium users and 14.2% of nonusers. Opium use was associated with an overall decrease in incident T2DM (IRR = 0.83, 95% CI: 0.75, 0.92), with a significant dose-response association. Most (84.3%) of this association was mediated by low BMI or waist circumference, and opium use did not have a direct association with incident T2DM (IRR = 0.97, 95% CI: 0.87, 1.08). Long-term opium use was associated with lower incidence of T2DM, which was mediated by low body mass and adiposity.

Epidemiology and prevalence of tobacco use in Tehran; a report from the recruitment phase of Tehran cohort study.

INTRODUCTION: Tobacco use is a major health concern worldwide, especially in low/middle-income countries. We aimed to assess the prevalence of cigarette smoking, waterpipe, and pipe use in Tehran, Iran. METHODS: We used data from 8272 participants of the Tehran Cohort Study recruitment phase. Tobacco use was defined as a positive answer to using cigarettes, waterpipes, or pipes. Participants who did not report tobacco use during the interview but had a previous smoking history were categorized as former users. Age- and sex-weighted prevalence rates were calculated based on the national census data, and characteristics of current and former tobacco users were analyzed. RESULTS: Age- and sex-weighted prevalence of current tobacco users, cigarette smokers, waterpipe, and pipe users in Tehran was 19.8%, 14.9%, 6.1%, and 0.5%, respectively. Current tobacco use was higher in younger individuals (35-45 years: 23.4% vs. ≥ 75 years: 10.4%, P < 0.001) and men compared to women (32.9% vs. 7.7% P < 0.001). The prevalence of tobacco use increased with more years of education (> 12 years: 19.3% vs. illiterate: 9.7%, P < 0.001), lower body mass index (< 20 kg/m2: 31.3% vs. ≥ 35 kg/m2: 13.8%, P < 0.001), higher physical activity (high: 23.0% vs. low: 16.4%, P < 0.001), opium (user: 66.6% vs. non-user: 16.5%, P < 0.001), and alcohol use (drinker: 57.5% vs. non-drinker: 15.4%, P < 0.001). Waterpipe users were younger (46.1 vs. 53.2 years) and had a narrower gender gap in prevalence than cigarette smokers (male/female ratio in waterpipe users: 2.39 vs. cigarette smokers: 5.47). Opium (OR = 5.557, P < 0.001) and alcohol consumption (OR = 4.737, P < 0.001) were strongly associated with tobacco use. Hypertension was negatively associated with tobacco use (OR = 0.774, P = 0.005). CONCLUSION: The concerning prevalence of tobacco use in Tehran and its large gender gap for cigarette and waterpipe use warrant tailored preventive policies.

The prevalence and associated factors of overweight/obesity and abdominal obesity in South-eastern of Iran: a cross-sectional study based on Rafsanjan cohort study.

BACKGROUND: Obesity has become a major health issue in both high and middle-income countries, increasing the risk of cardiovascular diseases and all-cause mortality. Risk of obesity is related to both unchangeable factors such as genetics and gender, and modifiable lifestyle factors. Most importantly, finding the major modifiable lifestyle factors which contribute to obesity may provide valuable benefits to every society. This study aimed to determine the association of demographic and lifestyle parameters with overweight/obesity and abdominal obesity in a population of Iranian adults. METHODS: In this cross-sectional study, adult participants of Rafsanjan Cohort Study (RCS) (as one of the district areas of the PERSIAN cohort (Prospective Epidemiological Research Studies in IrAN) included the study population. RCS is a population-based prospective cohort of men and women aged 35-70 years, launched in August 2015. Individuals were recruited from four urban and suburban areas of Rafsanjan, south-eastern of Iran. Trained experts interviewed each participant and completed the related questionnaires about his/her socioeconomic status, demography, anthropometric features, personal habits, physical activity and medical history. Multinomial logistic regression models were used to examine the relationships between overweight/obesity/abdominal obesity and associated factors. RESULTS: From 9980 participants, 1974 (42.42%) males and 2115 (39.70%) females were overweight, 784 (16.85%) males, 2223 (41.73%) females were obese and 1895 (40.73%) males and 989 (18.57%) females were normal weight. Also, 832 (17.9%) males and 4548 (85.4%) females had abdominal obesity and 3819 (82.1%) males and 778 (14.6%) females didn't have abdominal obesity. Based on the adjusted multiple logistic regression, overweight/obesity (BMI > 25) was associated with age > 45, female gender, education ≥ 13 years, heavy physical activity, wealth status index (WSI), alcohol consumption, current cigarette smoking and opium consumption compared to reference group. Also, odds of abdominal obesity displayed a significant association with age > 45, female gender, education > 5 years, physical activity, WSI, current cigarette smoking, alcohol and opium consumption compared to reference group. CONCLUSIONS: Our results recommend local public health strategies that promote training the society on the health benefits of avoiding alcohol, getting more physical exercise and gaining more personal education on the health-threatening lifestyle.

Oral candidiasis and cigarette, tobacco, alcohol, and opium consumption in Rafsanjan, a region in the southeast of Iran.

BACKGROUND: We investigated the association between oral candidiasis prevalence and cigarette, tobacco, alcohol, and opium consumption in Rafsanjan, a region in the southeast of Iran. METHODS: This cross-sectional study was conducted using the data of Oral Health Branch of Rafsanjan Cohort Study (OHBRCS) as a part of the Rafsanjan Cohort Study (RCS). RCS included in Prospective Epidemiological Research Studies in IrAN (PERSIAN) was begun in 2015 in the Rafsanjan. A full-mouth examination was done by trained dental specialists. Oral candidiasis was diagnosed based on clinical examination. Information about cigarette, tobacco, and opium smoking and alcohol consumption were collected based on data from self-reported questionaries. Univariate and multivariate dichotomous logistics regression were used to assess the association between oral candidiasis and cigarette, tobacco, alcohol, and opium consumption. RESULTS: Among 8682 participants with mean age of 49.94 years, the prevalence of oral candidiasis was 7.94%. There was a direct association between cigarette smoking in current and former cigarette smokers with an increased odds of oral candidiasis (OR: 3.26, 95% CI: 2.46-4.33 and OR: 1.63, 95% CI: 1.18-2.25 respectively) in fully adjusted models. There was a dose-response relationship between the odds of oral candidiasis and dose (OR: 3.31, 95% CI: 2.38-4.60), duration (OR: 2.48, 95% CI: 2.04-3.95) and number (OR: 3.01, 95% CI: 2.02-4.50) of cigarette smoking in the 4th quartile compared to reference group. CONCLUSIONS: A dose-response relationship was shown between cigarette smoking and increased odds of oral candidiasis.

Dydrogesterone and 20α-dihydrodydrogesterone plasma levels on day of embryo transfer and clinical outcome in an anovulatory programmed frozen-thawed embryo transfer cycle: a prospective cohort study.

STUDY QUESTION: What are the plasma concentrations of dydrogesterone (DYD) and its metabolite, 20α-dihydrodydrogesterone (DHD), measured on day of embryo transfer (ET) in programmed anovulatory frozen embryo transfer (FET) cycles using 10 mg per os ter-in-die (tid) oral DYD, and what is the association of DYD and DHD levels with ongoing pregnancy rate? SUMMARY ANSWER: DYD and DHD plasma levels reach steady state by Day 3 of intake, are strongly correlated and vary considerably between and within individual subjects, women in the lowest quarter of DYD or DHD levels on day of FET have a reduced chance of an ongoing pregnancy. WHAT IS KNOWN ALREADY: DYD is an oral, systemic alternative to vaginal progesterone for luteal phase support. The DYD and DHD level necessary to sustain implantation, when no endogenous progesterone is present, remains unknown. While DYD is widely used in fresh IVF cycles, circulating concentrations of DYD and DHD and inter- and intraindividual variation of plasma levels versus successful treatment have never been explored as measurement of DYD and DHD is currently only feasible by high-sensitivity chromatographic techniques such as liquid chromatography/tandem mass spectroscopy (LC-MS/MS). STUDY DESIGN, SIZE, DURATION: Prospective, clinical cohort study (May 2018-November 2020) (NCT03507673); university IVF-center; women (n = 217) undergoing a programmed FET cycle with 2 mg oral estradiol (tid) and, for luteal support, 10 mg oral DYD (tid); main inclusion criteria: absence of ovulatory follicle and low serum progesterone on Days 12-15 of estradiol intake; serum and plasma samples were taken on day of FET and stored at -80°C for later analysis by LC-MS/MS; in 56 patients, two or more FET cycles in the same protocol were performed. PARTICIPANTS/MATERIALS, SETTING, METHODS: Women undergoing FET on Day 2 or Day 3 (D2, D3, cleavage) or Day 5 (D5, blastocyst) of embryonic development had blood sampling on the 3rd, 4th or 6th day of 10 mg (tid) DYD oral intake, respectively. The patient population was stratified by DYD and DHD plasma levels by percentiles (≤25th versus >25th) separately by day of ET. Ongoing pregnancy rates (a viable pregnancy at >10th gestational week) were compared between ≤25th percentile versus >25th percentile for DYD and DHD levels (adjusted for day of ET). Known predictors of outcome were screened for their effects in addition to DYD, while DYD was considered as log-concentration or dichotomized at the lower quartile. Repeated cycles were analyzed assuming some correlation between them for a given individual, namely by generalized estimating equations for prediction and generalized mixed models for an estimate of the variance component. MAIN RESULTS AND THE ROLE OF CHANCE: After exclusion of patients with 'escape ovulation' (n = 14, 6%), detected by the presence of progesterone in serum on day of ET, and patients with no results from LC-MS/MS analysis (n = 5), n = 41 observations for cleavage stage ETs and n = 157 for blastocyst transfers were analyzed. Median (quartiles) of plasma levels of DYD and DHD were 1.36 ng/ml (0.738 to 2.17 ng/ml) and 34.0 ng/ml (19.85 to 51.65 ng/ml) on Day 2 or 3 and 1.04 ng/ml (0.707 to 1.62 ng/ml) and 30.0 ng/ml (20.8 to 43.3 ng/ml) on Day 5, respectively, suggesting that steady-state is reached already on Day 3 of intake. DHD plasma levels very weakly associated with body weight and BMI (R2 < 0.05), DYD levels with body weight, but not BMI. Levels of DYD and DHD were strongly correlated (correlation coefficients 0.936 for D2/3 and 0.892 for D5, respectively). The 25th percentile of DYD and DHD levels were 0.71 ng/ml and 20.675 ng/ml on day of ET. The ongoing pregnancy rate was significantly reduced in patients in the lower quarter of DYD or DHD levels: ≤25th percentile DYD or DHD 3/49 (6%) and 4/49 (8%) versus >25th percentile DYD or DHD 42/149 (28%) and 41/149 (27%) (unadjusted difference -22% (CI: -31% to -10%) and -19% (CI: -29% to -7%), adjusted difference -22%, 95% CI: -32 to -12, P < 0.0001). LIMITATIONS, REASONS FOR CAUTION: Some inter- and intraindividual variations in DYD levels could be attributed to differences in time between last 10 mg DYD intake and blood sampling, as well as concomitant food intake, neither of which were registered in this study. Ninety percent of subjects were European-Caucasian and DYD/DHD blood concentrations should be replicated in other and larger populations. WIDER IMPLICATIONS OF THE FINDINGS: Daily 10 mg DYD (tid) in an artificial FET cycle is potentially a suboptimal dose for a proportion of the population. Measurement of DYD or DHD levels could be used interchangeably for future studies. The pharmacokinetics of oral DYD and associated reproductive pharmacodynamics need further study. STUDY FUNDING/COMPETING INTEREST(S): The trial was financed by university funds, except for the cost for plasma and serum sample handling, storage and shipment, as well as the liquid chromatography-mass spectrometry (LC-MS/MS) analysis of DYD, DHD and progesterone, which was financially supported by Abbott Products Operations AG (Allschwil, Switzerland). Abbott Products Operations AG had no influence on the study protocol, study conduct, data analysis or data interpretation. K.N. has received honoraria and/or non-financial support (e.g. travel cost compensation) from Ferring, Gedeon-Richter, Merck and MSD. A.M. has no competing interests. R.V. has no competing interests. M.D. has received honoraria and/or non-financial support from Ferring and Merck. A.S.-M. has no competing interests. T.K.E. has received honoraria and/or non-financial support from Roche, Novartis, Pfizer, Aristo Pharma, Merck. G.G. has received honoraria and/or non-financial support (e.g. travel cost compensation) from Abbott, Ferring, Gedeon Richter, Guerbet, Merck, Organon, MSD, ObsEva, PregLem, ReprodWissen GmbH, Vifor and Cooper. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT03507673.

The prevalence and predictors of cardiovascular diseases in Kherameh cohort study: a population-based study on 10,663 people in southern Iran.

BACKGROUND: The prevalence of cardiovascular disease (CVD) is rapidly increasing in the world. The present study aimed to assess the prevalence and Predictors factors of CVD based on the data of Kherameh cohort study. METHODS: The present cross-sectional, analytical study was done based on the data of Kherameh cohort study, as a branch of the Prospective Epidemiological Studies in Iran (PERSIAN). The participants consisted of 10,663 people aged 40-70 years. CVD was defined as suffering from ischemic heart diseases including heart failure, angina, and myocardial infarction. Logistic regression was used to model and predict the factors related to CVD. Additionally, the age-standardized prevalence rate (ASPR) of CVD was determined using the standard Asian population. RESULTS: The ASPR of CVD was 10.39% in males (95% CI 10.2-10.6%) and 10.21% in females (95% CI 9.9-10.4%). The prevalence of CVD was higher among the individuals with high blood pressure (58.3%, p < 0.001) as well as among those who smoked (28.3%, p = 0.018), used opium (18.2%, p = 0.039), had high triglyceride levels (31.6%, p = 0.011), were overweight and obese (66.2%, p < 0.001), were unmarried (83.9%, p < 0.001), were illiterate (64.2%, p < 0.001), were unemployed (60.9%, p < 0.001), and suffered from diabetes mellitus (28.1%, p < 0.001). The results of multivariable logistic regression analysis showed that the odds of having CVD was 2.25 times higher among the individuals aged 50-60 years compared to those aged 40-50 years, 1.66 folds higher in opium users than in non-opium users, 1.37 times higher in smokers compared to non-smokers, 2.03 folds higher in regular users of sleeping pills than in non-consumers, and 4.02 times higher in hypertensive individuals than in normotensive ones. CONCLUSION: The prevalence of CVD was found to be relatively higher in Kherameh (southern Iran) compared to other places. Moreover, old age, obesity, taking sleeping pills, hypertension, drug use, and chronic obstructive pulmonary disease had the highest odds ratios of CVD.

Incidence, early case fatality and determinants of stroke in Iran: Golestan Cohort Study.

OBJECTIVES: While few studies investigated the incidence of stroke in Iran, no Iranian cohort has estimated the standardized-incidence rate and early fatality of first-ever-stroke subtypes along with associated factors. METHODS: Golestan Cohort Study is a prospective study launched in northeastern Iran in 2004, including 50,045 individuals aged 40-75 at baseline. Age-standardized incidence rate of first-ever-stroke was calculated per 100,000 person-years, according to World Standard Population. The 28-day case fatality was calculated by dividing the number of fatal first-ever-stroke during the first 28 days by total events. Cox proportional hazard models were conducted to assess incidence and fatality risk factors. We used Population Attributable Fractions to estimate the incidence and early fatality proportions reduced by ideal risk factor control. RESULTS: 1,135 first-ever-strokes were observed during 8.6 (median) years follow-up. First-ever-stroke standardized incidence rate was estimated 185.2 (95% CI: 173.2-197.2) per 100,000 person-years. The 28-day case fatality was 44.1% (95% CI: 40.4-48.2). Hypertension and pre-stroke physical activity were the strongest risk factors associated with first-ever-stroke incidence (Hazard ratio: 2.83; 2.47-3.23) and 28-day case fatality (Hazard ratio: 0.59; 0.44-0.78), respectively. Remarkably, opium consumption was strongly associated with hemorrhagic stroke incidence (Hazard ratio: 1.52; 1.04-2.23) and ischemic stroke fatality (Hazard ratio: 1.44; 1.01-2.09). Overall, modifiable risk factors contributed to 83% and 61% of first-ever-stroke incidence and early fatality, respectively. CONCLUSION: Efficient risk factor control can considerably reduce stroke occurrence and fatality in our study. Establishing awareness campaigns and 24-hour stroke units seem necessary for improving the stroke management in this area.

Effectiveness of Arsenicum album 30C in Prevention of COVID-19 in Individuals Residing in Containment Zones of Delhi-A Prospective, Community-based, Parallel Cohort Study.

OBJECTIVE: This work was undertaken to evaluate the protective effect of Arsenicum album 30C against COVID-19. DESIGN: The work was designed as a prospective parallel cluster cohort study. INTERVENTION: Participants were enrolled in a homeopathy intervention (HI) cohort (who received Arsenicum album) or in a non-intervention (NI) cohort (who received no systematic intervention) from COVID-19 containment areas of Delhi. Individuals of age 5 years or above were given four medicated pills of Arsenicum album 30C, while those from 1 to 5 years old were given two medicated pills in each dose. RESULTS: The analysis included 10,180 individuals residing in 11 COVID-19 containment areas in Delhi, out of which 6,590 individuals were in the HI cohort and 3,590 individuals were in the NI cohort. The overall protective effect of Arsenicum album 30C was 83.43% (95% confidence interval [CI], 76.77 to 88.17): 45 cases per 6,590 (8.34 per 10,000 person-weeks) in the Arsenicum album 30C group versus 143 cases per 3,590 (45.01 per 10,000 person-weeks) in the NI cohort. The protective effect of Arsenicum album 30C against laboratory confirmed COVID-19 was 74.40% (95% CI, 55.08 to 85.41): 18 cases per 6,590 (3.32 per 10,000 person-weeks) in the Arsenicum album 30C group versus 38 cases per 3,590 (11.85 per 10,000 person-weeks) in the NI cohort. CONCLUSION: The use of Arsenicum album 30C was associated with some protection against probable and laboratory-confirmed COVID-19 in a containment-zone setting. Randomized controlled trials are needed to confirm or refute these results.

Clinical Characteristics and Remedy Profiles of Patients with COVID-19: A Retrospective Cohort Study.

OBJECTIVE: The aim of the study was to identify indicated homeopathic remedies based on the clinical characteristics of coronavirus disease 2019 (COVID-19) patients in India. METHODS: In this retrospective, cohort study, confirmed COVID-19 patients admitted at a COVID Health Centre in New Delhi between April 29 and June 17, 2020 were given conventional and homeopathic treatment. Patients were grouped into mild, moderate or severe categories of disease. Their symptomatologic profiles were analyzed to identify indicated homeopathic medicines. RESULTS: A total of 196 COVID-19 patients were admitted. One hundred and seventy-eight patients had mild symptoms; eighteen patients had moderate symptoms; no patients with severe symptoms were included as they were referred to tertiary care centers with ventilatory support. The mean age of patients with mild symptoms was significantly lower (38.6 years; standard deviation or SD ± 15.8) compared with patients in the moderate category (66.0 years; SD ± 9.09). The most important symptoms identified were fever (43.4%), cough (47.4%), sore throat (29.6%), headache (18.4%), myalgia (17.9%), fatigue (16.8%), chest discomfort (13.8%), chills (12.6%), shortness of breath (11.2%) and loss of taste (10.2%). Twenty-eight homeopathic medicines were prescribed, the most frequently indicated being Bryonia alba (33.3%), Arsenicum album (18.1%), Pulsatilla nigricans (13.8%), Nux vomica (8%), Rhus toxicodendron (7.2%) and Gelsemium sempervirens (5.8%), in 30C potency. CONCLUSION: Data from the current study reveal that Arsenicum album, Bryonia alba, Pulsatilla nigricans, Nux vomica, Rhus toxicodendron and Gelsemium sempervirens are the most frequently indicated homeopathic medicines. A randomized controlled clinical trial based on this finding is the next step.

The prevalence of denture stomatitis in cigarette and hookah smokers and opium addicts: findings from Rafsanjan Cohort Study.

BACKGROUND: The aim of this study was to investigate the association of denture stomatitis prevalence with cigarette, hookah and opium consumption and also dose-response relationship between the cigarette smoking duration and odds of denture stomatitis in population of Rafsanjan cohort center. METHODS: This cross-sectional study based on data of Rafsanjan Cohort Study (RCS) with 10,000 participants. After applying inclusion and exclusion criteria, 1619 participants were included in the analysis. Data were collected by oral examination and completion of pre-designed questionnaires to assess denture hygiene, smoking behavior, opium use and some other exposure variables. Multivariable logistic regression models were fitted to investigate possible association of cigarette, hookah and opium consumption and denture stomatitis. RESULTS: Prevalence of denture stomatitis among all 1619 denture wearers was 21.6%. Cigarette smoking was associated with a higher odds of denture stomatitis, with the adjusted odds ratio (95% CI) of 2.29 (1.53-3.41). Also, dose-response increases were observed with the highest odds ratio in the 4th quartile for denture stomatitis (p-value < 0.001). Opium consumption was associated with a decreased odds of denture stomatitis (adjusted OR; 0.81, 95% CI 0.58-1.13) which was not statistically significant. Also interaction between opium consumption and cigarette smoking was not associated with higher odds of denture stomatitis (adjusted OR: 1.65, 95% CI 0.85-3.22). CONCLUSIONS: Based on the findings of the present study, while cigarette smoking had a dose-response relationship with the increased odds of denture stomatitis; this association was not found with opium consumption.

Rethinking ADHD intervention trials: feasibility testing of two treatments and a methodology.

Attention deficit hyperactivity disorder (ADHD) is a lifelong condition associated with considerable costs. The long-term effectiveness and acceptability of treatments to improve outcomes remains in doubt. Long-term trials are needed comparing interventions with standard care and each other. The Sheffield Treatments for ADHD Research (STAR) project used the Trials within Cohorts (TwiCs) approach. A cohort of children with ADHD was recruited and outcomes collected from carers and teachers. A random selection was offered treatment by homoeopaths (hom) or nutritional therapists (NT). Their outcomes (Conners Global ADHD Index) were compared with those not offered interventions. The feasibility of the methods and interventions was assessed. The TwiCs approach was feasible with modifications. 144 participants were recruited to the cohort, 83 offered treatment, 72 accepted, and 50 attended 1+ appointments. Results according to carers assessments at 6 months were as follows: t = 1.08, p = .28 (- 1.48, 4.81) SMD .425 (hom); t = 1.71, p = .09 (- .347, 5.89), SMD = .388 (NT). Teachers' responses were too few and unstable. No serious treatment adverse events occurred.Conclusion: the STAR project demonstrated the feasibility of the TwiCs approach for testing interventions for children with ADHD. What is Known: • Attention deficit hyperactivity disorder (ADHD) is a lifelong condition associated with considerable costs to ADHD stakeholders. Children are at risk of negative outcomes and in need of pre-emptive strategies • The long-term effectiveness and acceptability of recommended treatments to improve outcomes remains in doubt What is New: • A small-scale test of the design demonstrated that the Trials within Cohorts (TwiCs) approach is feasible and can make a useful contribution regarding testing the effectiveness of interventions for children with ADHD to improve long-term negative outcomes • Treatment by homoeopaths and nutritional therapists may offer novel opportunities to improve outcomes.

Effect of Adjuvant Homeopathy with Usual Care in Management of Thrombocytopenia Due to Dengue: A Comparative Cohort Study.

BACKGROUND: Dengue is an emerging threat to public health. At present, no clear modalities are available for the prevention and management of thrombocytopenia due to dengue. This article reports the clinical outcomes of integrative homeopathic care in a hospital setting during a severe outbreak of dengue in New Delhi, India, during the period September to December 2015. METHODS: Based on preference, 138 patients received a homeopathic medicine along with usual care (H+UC), and 145 patients received usual care (UC) alone. Assessment of thrombocytopenia (platelet count < 100,000/mm3) was the main outcome measure. Kaplan-Meier analysis enabled comparison of the time taken to reach a platelet count of 100,000/mm3. RESULTS: There was a statistically significantly greater rise in platelet count on day 1 of follow-up in the H+UC group compared with UC alone (mean difference = 12,337; 95% confidence interval [CI], 5,421 to 19,252; p = 0.001). This trend persisted until day 5 (mean difference = 14,809; 95% CI, 1,615 to 28,004; p = 0.02). The time taken to reach a platelet count of 100,000/mm3 was nearly 2 days earlier in the H+UC group compared with UC alone (H+UC: 3.44 days ± standard error of the mean [SEM] 0.18; 95% CI, 3.08 to 3.80; UC: 5.28 days ± SEM 0.29; 95% CI, 4.71 to 5.86; p < 0.001). CONCLUSION: These results suggest a positive role of adjuvant homeopathy in thrombocytopenia due to dengue. Randomized controlled trials may be conducted to obtain more insight into the comparative effectiveness of this integrative approach.

Electronic Registration in Complementary/Homeopathic Medical Practice with Identification of 'Best Homeopathic Cases': A Pilot Study.

BACKGROUND: Practice-based registration could identify 'general' and 'homeopathic' prognostic factors for therapeutic success in patients who seek complementary and alternative medicine (CAM)/homeopathic treatment. Identification of 'best homeopathic cases' within a database could inform clinical research and improve homeopathic practice. OBJECTIVE: To investigate the feasibility of registration in daily CAM/homeopathic practice, evaluate patient-reported outcome measures and tools for identifying 'best homeopathic cases' and to make recommendations for an electronic database. METHODS: In 2015 and 2016, 25 homeopathic doctors registered details of a maximum of 20 patients each, with 6 months of follow-up (extended follow-up for 'best homeopathic cases'), in Excel or in the Homeopathic Administration and Registration Program (HARP) database. Informed consent was obtained from each patient. Patient-perceived change of main complaint was measured by a 7-point Likert scale. Best homeopathic cases were defined by treatment with one homeopathic medicine, ≥ 2 months of follow-up, result score +2 to +4 on a 9-point Likert scale by the doctor, and by changes that could be attributed to the homeopathic medicine. Association between scores for change of main complaint and scores for 'best homeopathic case' was analysed by the Kruskal gamma test. RESULTS: Three-hundred and ninety-nine patients were included. In 49.1%, the main complaint was present for ≥ 2 years. The most common diagnosis was 'fatigue' (N = 56; 14%). Major improvement in the main complaint (score +3) was reported by 22 to 26% at consecutive follow-up visits. One-hundred and ninety-six patients were treated with a single homeopathic medicine, among whom 66 'best homeopathic cases' were identified. The correlation between patient-reported changes of main complaint and assessment by the doctor was significant (gamma = 0.832; p < 0.001). CONCLUSIONS: Registration of (co-)diagnoses, chronicity, treatments and outcomes in homeopathic practice with identification of 'best homeopathic cases' is feasible, using the tools provided. A user-friendly electronic database for efficient recording is recommended.

Mortality from respiratory diseases associated with opium use: a population-based cohort study.

BACKGROUND: Recent studies have suggested that opium use may increase mortality from cancer and cardiovascular diseases. However, no comprehensive study of opium use and mortality from respiratory diseases has been published. We aimed to study the association between opium use and mortality from respiratory disease using prospectively collected data. METHODS: We used data from the Golestan Cohort Study, a prospective cohort study in northeastern Iran, with detailed, validated data on opium use and several other exposures. A total of 50 045 adults were enrolled from 2004 to 2008, and followed annually until June 2015, with a follow-up success rate of 99%. We used Cox proportional hazard regression models to evaluate the association between opium use and outcomes of interest. RESULTS: During the follow-up period, 331 deaths from respiratory disease were reported (85 due to respiratory malignancies and 246 due to non-malignant aetiologies). Opium use was associated with an increased risk of death from any respiratory disease (adjusted HR 95% CI 3.13 (2.42 to 4.04)). The association was dose-dependent with a HR of 3.84 (2.61 to 5.67) for the highest quintile of cumulative opium use versus never use (Ptrend<0.001). The HRs (95% CI) for the associations between opium use and malignant and non-malignant causes of respiratory mortality were 1.96 (1.18 to 3.25) and 3.71 (2.76 to 4.96), respectively. CONCLUSIONS: Long-term opium use is associated with increased mortality from both malignant and non-malignant respiratory diseases.

Individualized homeopathic treatment in addition to conventional treatment in type II diabetic patients in Hong Kong - a retrospective cohort study.

OBJECTIVE: Glycaemic goals are not achieved in most patients with type II diabetes mellitus (T2DM), especially in those with long disease duration and taking multiple oral antidiabetic drugs (OAD). We aimed to investigate the effectiveness of individualized homeopathic treatment in glycaemic control. DESIGN: Retrospective cohort study. SETTING: At least 6 months of individualized homeopathic treatment at a private homeopathic centre in Hong Kong. PARTICIPANTS: Twenty-seven adults aged 37-84 years were treated with individualized homeopathic remedies between 2012 and 2015. Published data on 40 T2DM patients under standard conventional treatment in Hong Kong were used as a control. MAIN OUTCOME MEASURE: Change in fasting plasma glucose (FPG) and glycated haemoglobin (HbA1c) at 12-month or the last follow-up, whichever is earlier. RESULTS: Compared with the conventional treatment only group, the homeopathy group had higher baseline FPG (p = 0.044), and more patients had a long (>20 years) duration of diabetes (p = 0.006), and a history of cardiac events (p = 0.022). The mean difference in FPG in the homeopathy group was significantly greater than in the control after 12 months: -2.24 mmol/L (95% confidence interval [CI]: -3.47 to -1.01) vs 0.16 mmol/L (95% CI: -1.72 to 2.04), p = 0.001. The mean difference in glycated haemoglobin (HbA1c) was also significantly greater, -1.11% (95% CI: -2.17 to -0.05) vs 0.08% (95% CI: -1.37 to 1.53), p = 0.046. Poorer baseline glycaemic control was associated with better outcome (r = -0.750, p < 0.001), but not the duration of diabetes (r = 0.058, p = 0.772). The improvement was robust to sensitivity analyses. CONCLUSION: Individualized homeopathic treatment was associated with better glycaemic control compared with standard conventional treatment alone.

[Effectiveness of preventive treatment by Influenzinum in the winter period against the onset of influenza-like illnesses]. / Efficacité d'un traitement préventif par Influenzinum en période hivernale contre la survenue d'un syndrome grippal.

AIM: In vitro Influenzinum induce a cellular change. We present the results of the first study examining the effectiveness of Influenzinum against influenza-like illnesses. METHOD: Retrospective cohort study during winter 2014-2015. After influenza epidemic, a self-assessment questionnaire was offered to patients presenting for a consultation. The primary endpoint was the declaration of an influenza-like illness. The exposed patients (treated by Influenzinum) were matched to two non-exposed patients (untreated) with a propensity score. A conditional logistic model expressed influenza-like illness risk reduction provided by the Influenzinum. RESULTS: The cohort included 3514 patients recruited from 46 general practitioners. After matching, the treated group (n=2041) and the untreated group (n=482) did not differ on variables collected. Influenzinum preventive therapy does not significantly alter the likelihood of influenza-like illness (adjusted odds ratio=0,91 [0,62 to 1,35], p=0,64). CONCLUSION: Influenzinum preventive therapy did not appear effective in preventing influenza-like illness.

A longitudinal comparison of drug use among 10-year-old children and 15-year-old adolescents from the German GINIplus and LISAplus birth cohorts.

PURPOSE: The purpose of this study was to compare longitudinal data on drug utilization between 10-year-old children and 15-year-old adolescents and to analyse the association of drug use at the age of 15 years with drug use at the age of 10 years. METHODS: Based on the German GINIplus (German infant study on the Influence of Nutrition Intervention plus environmental and genetic influences on allergy development) and LISAplus (Influence of lifestyle factors on the immune system and allergies in East and West Germany plus the influence of traffic emissions and genetics) birth cohorts, data on drug utilization (past 4 weeks) were collected using a self-administered questionnaire for 3642 children (10-year follow-up) and 4677 adolescents (15-year follow-up). The drugs were classified by therapeutic categories (conventional drugs, homeopathic drugs, etc.) and by codes according to the anatomical therapeutic chemical (ATC) classification system. Associations of adolescents' drug use with gender, study area, maternal education, parental income, presence of chronic conditions, and prior drug use at the age of 10 years were analysed using a logistic regression model. RESULTS: The 4-week prevalence rates of overall drug use were similar for adolescents (41.1%) and children (42.3%). However, adolescents used noticeably more anti-inflammatory drugs, analgesics, and systemic antihistamines. Exactly 3194 children/adolescents participated in both follow-ups. Adolescents' use of anti-inflammatory drugs was predicted (OR = 3.37) by use of anti-inflammatory drugs as a child. In summary, the strongest predictor of adolescents' use of specific therapeutic categories or ATC groups was the previous use of the same therapeutic drug category or ATC group as a 10-year-old child. CONCLUSIONS: Despite similar prevalence rates of overall drug utilization among both age groups, there is a noticeable difference concerning the use of drugs from specific ATC groups. Drug use as a child may partly determine what they use as an adolescent.

Maternal use of probiotics during pregnancy and effects on their offspring's health in an unselected population.

Probiotics are used by women in the perinatal period and may improve balance of microbiota, with possible health benefits for both mother and baby. Characteristics and (health) behaviour patterns of mothers using probiotics during pregnancy, and health effects on their offspring, were investigated. Differences between mothers using probiotics during pregnancy and those who did not, were assessed. In total, 341 out of 2491 (13.7%) mothers reported use of probiotics during pregnancy. There were no significant differences in maternal features (gestation, age, ethnicity, education) between users and non-users. Logistic regression analyses showed that consumption of probiotics was significantly associated with use of homeopathic products [odds ratio (OR) 1.65, 95% confidence interval (CI) 1.17-2.33, p = 0.005], maternal history of smoking (OR 1.72, 95% CI 1.25-2.37, p = 0.001) and paternal history of smoking (OR 1.39, 95% CI 1.01-1.89, p = 0.05). Common disease symptoms during the first year of life in the offspring did not differ between both groups. CONCLUSION: The use of probiotics or other health-related products without doctor's prescription during pregnancy might point to compensation for types of less favourable behaviour. Probiotic use during pregnancy does not seem to induce positive health effects in the offspring in an unselected population. WHAT IS KNOWN: Aberrant microbiota compositions have been detected during critical periods when early programming occurs including pregnancy and early neonatal life. Probiotics modulate intestinal microbiota composition and are associated with positive health effects. WHAT IS NEW: The use of probiotics or other health-related products without doctor's prescription during pregnancy is associated with and might point to compensation for types of less favourable behaviour. Probiotic use during pregnancy does not induce positive health effects in the offspring in this unselected population.

Homeopathic medical practice for anxiety and depression in primary care: the EPI3 cohort study.

BACKGROUND: The purpose of the study was to compare utilization of conventional psychotropic drugs among patients seeking care for anxiety and depression disorders (ADDs) from general practitioners (GPs) who strictly prescribe conventional medicines (GP-CM), regularly prescribe homeopathy in a mixed practice (GP-Mx), or are certified homeopathic GPs (GP-Ho). METHODS: This was one of three epidemiological cohort studies (EPI3) on general practice in France, which included GPs and their patients consulting for ADDs (scoring 9 or more in the Hospital Anxiety and Depression Scale, HADS). Information on all medication utilization was obtained by a standardised telephone interview at inclusion, 1, 3 and 12 months. RESULTS: Of 1562 eligible patients consulting for ADDs, 710 (45.5 %) agreed to participate. Adjusted multivariate analyses showed that GP-Ho and GP-Mx patients were less likely to use psychotropic drugs over 12 months, with Odds ratio (OR) = 0.29; 95 % confidence interval (CI): 0.19 to 0.44, and OR = 0.62; 95 % CI: 0.41 to 0.94 respectively, compared to GP-CM patients. The rate of clinical improvement (HADS <9) was marginally superior for the GP-Ho group as compared to the GP-CM group (OR = 1.70; 95 % CI: 1.00 to 2.87), but not for the GP-Mx group (OR = 1.49; 95 % CI: 0.89 to 2.50). CONCLUSIONS: Patients with ADD, who chose to consult GPs prescribing homeopathy reported less use of psychotropic drugs, and were marginally more likely to experience clinical improvement, than patients managed with conventional care. Results may reflect differences in physicians' management and patients' preferences as well as statistical regression to the mean.