The quality of essential antimicrobial and antimalarial drugs marketed in Rwanda and Tanzania: influence of tropical storage conditions on in vitro dissolution.

OBJECTIVE: The quality of 33 formulations of essential antimicrobial and antimalarial drugs (amoxicillin capsules, metronidazole tablets, sulfamethoxazole/trimethoprim tablets, quinine tablets and sulphadoxine/pyrimethamine tablets) marketed in Rwanda and Tanzania was assessed and the influence of tropical storage conditions on potency and in vitro dissolution investigated. METHODS: Drug content and in vitro dissolution were determined immediately after purchase and during 6-month storage under simulated tropical conditions (75% relative humidity, 40 degrees C) using the methods described in the USP 24 monographs on the drugs concerned. RESULTS AND DISCUSSION: At the time of purchase, the drug content of all the formulations was within the limits recommended by the USP 24, but after 6-month storage, the drug content of one sulfamethoxazole/trimethoprim and one quinine formulation were found to be substandard. Immediately after purchase, four formulations (three sulfamethoxazole/trimethoprim and one sulphadoxine/pyrimethamine combination) failed the USP 24 dissolution test. Except for three metronidazole and one quinine formulations, dissolution tests performed after 6 months of storage under simulated tropical conditions showed that drug release remained within the USP 24 recommended values. CONCLUSION: In both countries, essential drug formulations met pharmacopoeial potency requirements, but some had a poor in vitro drug release profiles. Some of the formulations tested were not stable upon storage under simulated tropical conditions.

Stroke mortality in urban and rural Tanzania. Adult Morbidity and Mortality Project.

BACKGROUND: Most data for stroke mortality in sub-Saharan Africa are hospital based. We aimed to establish the contribution of cerebrovascular disease to all-cause mortality and cerebrovascular disease mortality rates in adults aged 15 years or more in one urban and two rural areas of Tanzania. METHODS: Regular censuses of the three surveillance populations consisting of 307,820 people (125,932 aged below 15 years and 181,888 aged 15 or more) were undertaken with prospective monitoring of all deaths arising in these populations between June 1, 1992 and May 31, 1995. Verbal autopsies were completed with relatives or carers of the deceased to assess, when possible, the cause of death. FINDINGS: During the 3-year observation period 11,975 deaths were recorded in the three surveillance areas, of which 7629 (64%) were in adults aged 15 years or more (4088 [54%] of these in men and 3541 [46%] in women). In the adults, 421 (5.5%) of the deaths were attributed to cerebrovascular disease, 225 (53%) of these in men and 196 (47%) in women. The yearly age-adjusted rates per 100,000 in the 15-64 year age group for the three project areas (urban, fairly prosperous rural, and poor rural, respectively) were 65 (95% CI 39-90), 44 (31-56), and 35 (22-48) for men, and 88 (48-128), 33 (22-43), and 27 (16-38) for women, as compared with the England and Wales (1993) rates of 10.8 (10.0-11.6) for men and 8.6 (7.9-9.3) for women. INTERPRETATION: We postulate that the high rates in Tanzania were due to untreated hypertension. Our study assessed mortality over a single time period and therefore it is not possible to comment on trends with time. However, ageing of the population is likely to lead to a very large increase in mortality from stroke in the future.

Application of the new ADA criteria for the diagnosis of diabetes to population studies in sub-Saharan Africa. American diabetes association.

AIMS: To examine the implications for epidemiological studies of the American Diabetes Association (ADA) recommendation that the fasting blood glucose at a lowered level becomes the main diagnostic test for diabetes on cross-sectional-based data from sub-Saharan Africa. METHODS: Data from 11 surveys conducted in rural, peri-urban and urban Cameroon (n = 1804), South Africa (n = 3799) and Tanzania (n = 10013) which measured fasting (ADA criteria) and 2-h blood glucose concentrations during a standard 75 g OGTT (old WHO criteria) were analysed. RESULTS: The prevalence of diabetes was higher in eight of the 11 surveys when applying the new ADA compared to the old WHO criteria. With the exception of one population (Mara, Tanzania) the absolute difference in prevalence between the two classifications tended to be small (< 2%). There was considerable variation in the categorization of individuals using the ADA and old WHO criteria. The level of agreement between the two ranged from fair to good (Kappa statistic 0.17-0.86). The prevalence of impaired fasting glycaemia (IFG) was lower than that of impaired glucose tolerance (IGT) in 10 of the surveys and the agreement between the two was fair, < or = 0.26 in all the surveys. CONCLUSIONS: Although the use of the new ADA fasting criteria for prevalence surveys is an attractive and practical option, particularly in Africa, further information is required on the characteristics and prognosis of individuals classified as IFG or diabetic by the fasting criteria, prior to wide adoption of the ADA criteria. Ideally measurement of both fasting and two low glucose concentrations should remain the standard for epidemiological studies.

Age specific prevalence of impairment and disability relating to hemiplegic stroke in the Hai District of northern Tanzania. Adult Morbidity and Mortality Project.

OBJECTIVES: To determine the age specific prevalence of impairment and disability relating to hemiplegic stroke in one rural area of Tanzania. METHODS: During the yearly house to house census of the study population of 148 135 (85 152 aged 15 and over) in August 1994, specific questions were asked to identify those who might be disabled from stroke. People thus identified were subsequently interviewed and examined by one investigator. In those in whom the clinical diagnosis of stroke was confirmed a more detailed interview and examination relating to risk factors and recovery was carried out. RESULTS: One hundred and eight patients, 61 men and 47 women, were identified with a median age of 70 (range 18-100). Median age at first stroke was 65 years. The age specific rates in this study were lower than previous studies in developed countries. All were cared for at home although 23 (21%) were bedbound. CONCLUSIONS: Although prevalence of impairment and disability related to stroke in this population as a whole was low this is mainly explained by the age structure, with less than 6% being aged 65 and over. Age standardised rates for stroke with residual disability were about half those found in previous studies in developed countries. Death from stroke in Africa may be higher but data are limited. With the demographic transition stroke is likely to become a more important cause of disability in sub-Saharan Africa.

Outlook for survivors of childhood in sub-Saharan Africa: adult mortality in Tanzania. Adult Morbidity and Mortality Project.

OBJECTIVE: To measure age and sex specific mortality in adults (15-59 years) in one urban and two rural areas of Tanzania. DESIGN: Reporting of all deaths occurring between 1 June 1992 and 31 May 1995. SETTING: Eight branches in Dar es Salaam (Tanzania's largest city), 59 villages in Morogoro rural district (a poor rural area), and 47 villages in Hai district (a more prosperous rural area). SUBJECTS: 40,304 adults in Dar es Salaam, 69,964 in Hai, 50,465 in Morogoro rural. MAIN OUTCOME MEASURES: Mortality and probability of death between 15 and 59 years of age (45Q15). RESULTS: During the three year observation period a total of 4929 deaths were recorded in adults aged 15-59 years in all areas. Crude mortalities ranged from 6.1/1000/year for women in Hai to 15.9/1000/year for men in Morogoro rural. Age specific mortalities were up to 43 times higher than rates in England and Wales. Rates were higher in men at all ages in the two rural areas except in the age group 25 to 29 years in Hai and 20 to 34 years in Morogoro rural. In Dar es Salaam rates in men were higher only in the 40 to 59 year age group. The probability of death before age 60 of a 15 year old man (45Q15) was 47% in Dar es Salaam, 37% in Hai, and 58% in Morogoro; for women these figures were 45%, 26%, and 48%, respectively. (The average 45Q15s for men and women in established market economies are 15% and 7%, respectively.) CONCLUSION: Survivors of childhood in Tanzania continue to show high rates of mortality throughout adult life. As the health of adults is essential for the wellbeing of young and old there is an urgent need to develop policies that deal with the causes of adult mortality.

Perinatal mortality in rural Tanzania.

In 1987, as part of the World Health Organization's Inter-Health Programme, we carried out a noncommunicable diseases survey in six rural villages in Tanzania. Each women completed a questionnaire, part of which was concerned with obstetric history, and underwent a physical examination. Our findings of unacceptably high perinatal mortality and abortion rates are described below.

PIP: Within the framework of the World Health Organization's [WHO] Inter- Health Program, a noncommunicable diseases survey was carried out in 6 villages located in 2 regions of Tanzania in 1987. A total of 3565 women were queried about their viable pregnancies, still-births, perinatal deaths (death within the first week of life), and abortions (loss of conceptus within 28 weeks of gestation). The overall abortion rate was 119/1000 pregnancies (range of 89/1000-170/1000 pregnancies). In the Kilimanjaro region, the abortion rate was 97/1000 compared to 145/1000 in the Morogoro region. The overall perinatal mortality rate was 73/1000 births (range of 49/1000-124/1000 births). In the Kilimanjaro region, the perinatal mortality rate was 58/1000 births vs. 91/1000 in the Morogoro region. The overall abortion rate for the 6 villages was 12% of pregnancies, while the range culled from the literature was 10-25%. The rate of miscarriage before 20 weeks of gestation has been estimated at 36-43%. In the Morogoro region, miscarriage rates were highest in the older age groups, which is indicative of improved health care. The difference in perinatal mortality rates between the 2 regions may be attributable to the relatively higher level of development of the Kilimanjaro region. This difference in socioeconomic development was also reflected in the infant mortality rate: 70/1000 births in the Kilimanjaro compared to 140/1000 in the Morogoro region. Other studies in east Africa showed perinatal mortality rates of 46/1000 births in Kenya's Machakos region during 1975-78, and a rate of 124/1000 births in Tanzania near the Morogoro region during 1984-85. Community-based studies focusing on women's health and care during pregnancy and childbirth are needed to investigate the causes of perinatal deaths, because hospital-based studies give a disjointed picture of both rates and the causes.

Coronary heart disease risk factors in sub-Saharan Africa: studies in Tanzanian adolescents.

STUDY OBJECTIVE: To assess the level of cardiovascular risk factors in young people in sub-Saharan Africa living in rural and urban settings. DESIGN: Cross sectional survey of the population aged 15 to 19 years. SETTING: Eight rural Tanzanian villages in three regions, and two districts in Dar es Salaam. PARTICIPANTS: 664 males and 803 females in rural villages and 85 males and 121 females in the city. Response rates for total population were 74% to 94% in the rural areas and 60% in the city. MEASUREMENTS AND RESULTS: Measurements included blood pressure, body mass index, serum lipids, and blood glucose concentrations (fasting and two hours after 75 g glucose). Blood pressure was slightly but significantly higher in young women than in young men (115/67 mmHg versus 113/65 mmHg) and increased significantly with age. Only 0.4% subjects had blood pressure greater than 140 and/or 90 mmHg. There were no urban-rural differences. Body mass index was higher in females (mean (SD) 20.3 (2.8) kg/m2) than males (18.5 (2.1)). Overweight was found in only 0.6% at age 15 years but 5.4% at age 19 years. Serum cholesterol concentrations were low at 3.5 mmol/l in males and 3.7 mmol/l in females. Only 7% had values above 5.2 mmol/l. The highest concentrations were found in the city and in Kilimanjaro, the most prosperous rural region. Serum triglycerides were 1.0 (0.5) mmol/l in males and 1.1 (0.5) mmol/l in females, and were highest in the city dwellers. Diabetes was rare (0.28% males, 0.12% females) but impaired glucose tolerance was present in 4.7% and 4.1% respectively. Drinking alcohol was equally prevalent in males and females, reaching 30% at age 19 years. Only 0.4% of females smoked compared with 7.3% of males. Smoking was commoner in rural areas that in the city. CONCLUSIONS: Several risk factors for cardiovascular disease were found in Tanzanian adolescents, but levels were much lower than in studies reported from developed nations. The challenge is to maintain these low levels as the population becomes more urbanised and more affluent.

Is diabetes mellitus related to undernutrition in rural Tanzania?

OBJECTIVE: To investigate the relation between undernutrition and diabetes. DESIGN: Survey of glucose tolerance in rural Tanzania. SETTING: Eight villages in three widely separated regions of Tanzania. SUBJECTS: 8581 people aged 15 and above: 3705 men and 4876 women. MAIN OUTCOME MEASURES: Oral glucose tolerance, body mass index, height, and low haemoglobin and cholesterol concentrations. RESULTS: In the eight villages 42.7-56.9% of all men and 30.0-45.2% of all women had a body mass index below 20 kg/m2; the lowest quintile was 18.2 kg/m2 in men and 18.6 kg/m2 in women. The prevalence of diabetes did not change significantly from the lowest to the highest fifths of body mass index in men (lowest 1.6% (95% confidence interval 0.8% to 2.9%) v highest 1.3% (0.7% to 2.5%)) or women (1.1% (0.6% to 2.1%) v 0.5% (0.2% to 1.2%)). In men and in women prevalence of impaired glucose tolerance was greater in the lowest fifths of height (8.2% (6.3% to 10.6%), and 11.1% (9.2% to 13.3%)) respectively and body mass index (9.6% (7.5% to 12.1%), and 8.4% (6.7% to 10.5%)) than in the highest fifths (impaired glucose tolerance 4.7% (3.4% to 6.5%); and 5.1% (3.9% to 6.7%); body mass index 5.1% (3.7% to 7.0%), and 7.7% (6.2% to 9.6%). CONCLUSION: Rates of diabetes were not significantly associated with low body mass index or height, but overall rates were much lower than those in well nourished Western populations. Increased impaired glucose tolerance in the most malnourished people may reflect the larger glucose load per kilogram weight. The role of undernutrition in the aetiology of diabetes must be questioned.

No deterioration of oral glucose tolerance during pregnancy in rural Tanzania.

There is still controversy concerning the reference ranges for glucose tolerance tests in pregnancy. The WHO has recommended the universal use of the 75 g oral glucose load with 2-h post-load values of greater than 6.7 mmol l-1 to be considered impaired glucose tolerance (IGT) in the non-pregnant, and equivalent to gestational diabetes in the pregnant. Some data are available for pregnant Caucasians but little information is available for other ethnic groups. Oral glucose tolerance tests (75 g) have therefore been performed in 189 pregnant women in rural Tanzania. Mean fasting blood glucose values were 4.0 mmol l-1 in non-pregnant women, and 3.7, 3.5, and 3.3 mmol l-1 in pregnant women in the first, second, and third trimesters, respectively. Two-hour OGTT values were 4.7 mmol l-1, and 4.6, 4.5, and 4.2 mmol l-1 while the upper limit of normal values (mean + 2SD) were 7.1 mmol l-1, and 6.8, 6.8, and 6.1 mmol l-1. The 2-h glucose levels are therefore close to WHO recommendations but lower than those reported for Caucasians. By contrast with reports for Caucasians, glucose tolerance did not deteriorate during pregnancy. The prevalence of diabetes and IGT was zero in the pregnant group.

Study in Tanzania of impaired glucose tolerance. Methodological myth?

During a study of diabetes prevalence in six rural Tanzanian communities, a repeat oral glucose tolerance test (OGTT) was carried out in 514 subjects greater than or equal to 15 yr of age within 1 wk of an initial 75-g OGTT. In 498 subjects, blood glucose was measured 2 h after the glucose load on both occasions, and in 175 subjects, fasting blood glucose measurement was also repeated. Of the 498 subjects, 245 had normal glucose tolerance in the first test and were selected at random for further testing; 223 subjects had impaired glucose tolerance (IGT), and 30 had diabetic values. Diabetes and IGT were diagnosed on the basis of the 2-h blood glucose values. In the second test, 241 (98.4%) of the 245 subjects with normal tolerance continued in this category and 4 (1.6%) showed IGT. Of the 223 with IGT in the first test, 171 (76.2%) reverted to normal on the second test, 7 (3.1%) had diabetic values, and 45 (20.2%) persisted with IGT. Of the 30 subjects diagnosed as diabetic in the first test, 8 (26.7%) remained with diabetic values, 11 (36.7%) had IGT, and 11 (36.7%) were normal. Based on the second test, the population-prevalence rates of diabetes and IGT would have been 0.5 and 3.3% vs. 1 and 7.6% based on the first test. There was a significant downward trend in the mean 2-h blood glucose values in all three diagnostic groups. Regression toward the mean could not account for the downward shift in blood glucose values observed on retesting.(ABSTRACT TRUNCATED AT 250 WORDS)

Prevalence of diabetes and impaired glucose tolerance in rural Tanzania.

The prevalence of diabetes mellitus and impaired glucose tolerance (IGT) was assessed by use of WHO diagnostic criteria in 6299 Africans aged 15 years and above living in six villages in Tanzania. 0.87% (1.1% male, 0.68% female) had diabetes and 7.8% (6.9% male, 7.7% female) had IGT. Prevalence rates were 1.1% and 8.4%, respectively, when age-adjusted to the USA population. Only 7 (13.5%) of the 53 individuals with diabetes had been known to have the disorder; 34 (74%) of the other 46 were symptom-free. Mean age was 54 (SD 20) for diabetic subjects and 37 (17) years for the whole population. Diabetes and IGT rates did not differ significantly between villages despite geographical, socioeconomic, and dietary differences. Diabetes rates increased modestly with age and body mass index (BMI). Fasting blood glucose (FBG) levels did not rise significantly with age but correlated positively with systolic blood pressure (BP) and negatively with haemoglobin concentration (Hb) and BMI. The 2 hour post-glucose load blood glucose values correlated positively with age, sex, and systolic BP and negatively with Hb. Diabetes is less prevalent in rural Africa than in developed countries, even when age has been corrected for. This difference is probably related to body weight, diet, and exercise.