Controlled Trial In India Research Articles

Leaf concentrate as an alternative to iron and folic acid supplements for anaemic adolescent girls: a randomised controlled trial in India

Despite public health campaigns based on Fe and folic acid supplements, Fe-deficiency anaemia remains highly prevalent among women in India. We investigated leaf concentrate as an alternative to Fe and folic acid supplements for treating anaemia in adolescent girls. Randomised controlled two-arm trial over 3 months: one group received daily Fe and folic acid (IFA; 60 mg Fe, 500 microg folic acid); the other daily leaf concentrate (LC; 5 mg Fe, 13 microg folic acid). Hb concentration, mean cell volume, serum Fe, serum ferritin and total Fe-binding capacity were measured pre- and post-intervention. Jaipur, India. One hundred and two adolescent girls aged 14-18 years. Of the 102 girls randomized to the two arms of the trial, four (3.9 %) were severely anaemic (Hb < 7 g/dl), twenty-eight (27.5 %) were moderately anaemic (Hb > or = 7 g/dl, <10 g/dl) and seventy (68.6 %) were mildly anaemic (Hb > or = 10 g/dl, <12 g/dl). In the IFA group, eleven girls (20.4 %) withdrew due to side-effects, compared with one girl (2.1 %) in the LC group (P = 0.005). Total losses to follow-up were 14/54 in the IFA group and 2/48 in the LC group. At the end of the trial, none of the eighty-six remaining girls were severely anaemic, nine (10.5 %) were moderately anaemic and twenty-six (30.2 %) were mildly anaemic; fifty-one (59.3 %) had normal Hb levels (> or = 12 g/dl). After adjustment for baseline values, LC was as effective as IFA in improving serum Fe parameters and treating anaemia. Leaf concentrate is an effective, and more palatable, alternative to Fe and folic acid supplements for treating anaemia in adolescent girls.

Cost-effectiveness of oral cancer screening: results from a cluster randomized controlled trial in India.

To evaluate oral cancer screening by visual inspection. A cluster randomized controlled trial was initiated in Trivandrum district, Kerala, India. Of 13 population clusters, seven were randomly allocated to three rounds of screening between 1996 and 2004, while standard care was provided in six (control arm). An activity-based approach was employed to calculate costs associated with various components of the screening trial. Information on the resources used and on clinical events in each trial arm was derived from trial databases. Total costs for each cluster were estimated in 2004 United States dollars (US$). The incremental cost per life-year saved was calculated for all eligible individuals and for high-risk individuals (i.e. tobacco or alcohol users). The proportion of oral cancers detected at an early stage (i.e. stage I or II) was higher in the intervention arm than the control arm (42% versus 24%, respectively). The incremental cost per life-year saved was US$ 835 for all individuals eligible for screening and US$ 156 for high-risk individuals. Oral cancer screening by visual inspection was performed for under US$ 6 per person. The most cost-effective approach to oral cancer screening by visual inspection is to offer it to the high-risk population. Targeted screening of this group will ensure that screening can be offered at a reasonable cost in a limited-resource setting.

A cluster randomized controlled trial of visual, cytology and human papillomavirus screening for cancer of the cervix in rural India

The impact of screening by visual inspection with acetic acid (VIA), cytology or HPV testing on cervical cancer incidence and mortality is investigated in a cluster randomized controlled trial in India. We report findings after the screening phase, when 52 clusters, with a total of 142,701 women aged 30-59 years in Osmanabad District, India, were randomized into 4 arms for a single round of screening by trained midwives with either VIA, cytology or HPV testing as well as a control group. All laboratory tests were done locally. Test-positive women underwent investigations (colposcopy/biopsy) and treatment in the base hospital. Data on participation, test positivity, positive predictive value and detection rates of cervical neoplasia were analyzed using cluster design methodology. Of the eligible women, 72-74% were screened. Test positivity rates were 14.0% for VIA, 7.0% for cytology and 10.3% for HPV. The detection rate of high-grade lesions was similar in all intervention arms (0.7% for VIA, 1.0% for cytology and 0.9% for HPV testing) (p = 0.06, Mann-Whitney test). While the detection rate for VIA dropped to 0.5% with declining test positivity during the course of the study, it remained constant for cytology and HPV testing. Over 85% of women with high-grade lesions received treatment. Our results show that a high level of participation and good-quality cytology can be achieved in low-resource settings. VIA is a useful alternative but requires careful monitoring. Detection rates obtained by HPV testing were similar to cytology, despite higher investments.