Fontaine Zink

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  • <number>
    The success of the Diarrhoeal Diseases Control Strategies that were developed in the 1980s is clearly illustrated in this slide. In twenty years, childhood mortality due to diarrhoea was reduced from 4.6 million deaths per year in 1980 to 1.8 million deaths per year in 2003. This is certainly the greatest success ever recorded for a public health intervention.
    However, we should not consider this as a true success. 1.8 million deaths due to diarrhoea per year is still a very high number. It represents still the 1st or 2nd cause of death in many countries. And to be more concrete, it still represents the death of 4 children every minute; the equivalent of a 747 crashing every 2 hours.
  • This pie chart using data from 2003, clearly shows that globally diarrhoea is still the number 2 cause of death in under 5 children.
  • If mortality has been dramatically decreased over the last 20 years, the same is not true for morbidity. On this slide we can see that the incidence of diarrhoea has not changed between 1980 and 2000 (black and grey bars).
    We can also see that diarrhoea essentially affects children below 2 years of age and that also has not changed over the years.
  • Finally, a last background epidemiological information.
    Within a given country, diarrhoea does not affect all the children equally. It is clear from this slide presenting data from a few developing countries (but the same data could be obtained in many developed countries) that diarrhoea is essentially affecting the children belonging to the poorest section of the population. The prevalence of diarrhoea being about double in the 20% poorest families when compared to the 20% richest families.
  • The impressive reduction in mortality due to diarrhoea is due to the adoption of a simple diarrhoea treatment strategy, composed of four elements.
  • <number>
    Here are the four key elements of the Global Diarrhoea Management Policy:
    Rehydration with ORS or IV (if needed in case of severe dehydration) to prevent or correct dehydration
    Feeding to prevent malnutrition
    Proper and limited use of antimicrobials
    Advice to mothers on home treatment of diarrhoea and on signs justifying return to the health centre..
  • <number>
    Recently, this Treatment Policy was enriched with a fifth element:
    The provision of 20 mg of elemental zinc for 10 – 14 days to all the children with diarrhoea (10 mg for infants below 6 months of age).
    In addition, the formulation of ORS recommended by WHO and UNICEF, following 20 years of research, was changed.
  • <number>
    So, in the rest of my presentation I will focus on these two new developments:
    The new ORS solution, and
    The provision of zinc as an adjunct treatment to ORS.
  • Now let's talk about zinc in the treatment of diarrhoea.
  • <number>
    Zinc is an essential micronutrient and is a critical element for proper immune function. It has also been shown that zinc is lost from the gut at greater rates during an episode of diarrhoea.
    Research trials investigating zinc supplementation for the treatment of diarrhoea have been on-going since the 1990s.
    Countries for acute diarrhoea studies: India (6), Bangladesh (4), Brazil, Indonesia, Nepal
    Countries for persistent diarrhoea studies: Peru, Bangladesh, India and Pakistan for Persistent diarrhoea studies.
    Acute diarrhoea is typically defined as less than 3 days, in these trials some defined it as less than 7 days.
    Persistent diarrhoea is defined as 14 days or more. These trials were in conjunction with this definition.
  • <number>
    All patients included in these studies received ORS. And Zinc supplementation was ALWAYS recommended in addition to ORS or home fluids.
    Zinc supplementation has been shown to decrease the duration of diarrhoea by at least 15% in acute diarrhoea and 24% in persistent diarrhoea.
    Zinc supplementation has also been shown to decrease treatment failure or death by 42%.
    Treatment failure was defined as an increase in diarrhoea severity, the occurrence of dehydration, or diarrhoea continuing for 7 or more days (or 14 or more days).
  • <number>
    The presentation of this graph is similar to the presentation of the graphs for ORS.
    This one shows 12 studies that compared the effect of zinc supplementation plus ORS, with ORS alone, on the duration of acute diarrhoea. The red line represents no effect. Small black bars to the left of the red line represent a positive effect of zinc on the duration of diarrhoea. The blue bar represents the statistical significance of the effect. Blue bars that do not cross the red line represent a statistically significant effect.
    All but one study in this meta analysis showed a positive effect of zinc. The pooled analysis shows an overall reduction in duration of diarrhoea by 25%. This effect was statistically significant.
    The most important message in this slide is the very strong evidence for benefit of adding zinc supplementation to ORS in the management of diarrhoea.
  • <number>
    Severity is measured by 2 indicators:
    1. The frequency of stools, i.e. the number of stools per day
    2. The output of stools, i.e. the volume of stools per day
    Zinc decreased the severity of the episode in all 5 studies.
    These indicators are not included in studies as often as duration. Cholera beds are needed to accurately measure the volume of stool which limits studies to clinics.
    These trials are a subset of the larger group of trials and show important clinical benefit in the reduction in severity.
  • <number>
    The preventive aspects of zinc supplementation are very important reasons to encourage and support widespread use of zinc supplementation for the treatment of diarrhoea.
    In short-course trials where supplementation was given for 10-14 days and children were followed for 2-3 months following assessing the incidence and prevalence of illnesses, there was a significant decrease in the prevalence of diarrhoea (34%) and the incidence of pneumonia (26%).
  • <number>
    This figure illustrates the statistics from the previous slide. Zinc supplementation reduces the incidence of diarrhoea in the 2-3 months following a 10-14 day zinc treatment. We interpret this figure the same as the one on the previous slide – the red line represents no effect. The black lines to the left of the red line illustrate a positive effect of zinc on the incidence of diarrhoea. The blue lines show the statistical significance of each study and the pooled effect.
    The overall pooled effect is about a 25% reduction in diarrhoea incidence.
  • <number>
    This was the first community-based trial. Previous trials were all efficacy trials. This trial is very important because it shows that putting zinc in the community – in this case with local community health workers – is an effective intervention.
    The results of this study were similar to efficacy studies showing a 23% reduction in duration of diarrhoea. This reduction was seen among all diarrhoea cases in the zinc clusters assessed by an intention-to-treat analysis. The analysis included all children living in the zinc areas, regardless of whether or not they were actually given zinc treatment.
  • <number>
    Children in the clusters were followed-up with bi-monthly interviews assessing recent episodes of diarrhoea, pneumonia, and hospitalizations. Recall was limited to one week to ascertain the most accurate information regarding the length of the illness and severity.
    The children in the zinc clusters had fewer days of illness with diarrhoea and ALRI and were hospitalized less.
  • <number>
    During the 2 years of the trial, all childhood deaths were recorded in the trial areas. Non-injury deaths were 51% lower in the zinc-supplemented clusters than the control clusters. This statistically significant difference likely reflects the decrease in the number of episodes which progressed to persistent diarrhoea, the improved ORS use rates, the decrease in overall hospitalization, and an improvement in overall health of the child.
    Zinc supplemented clusters also showed a decrease in the use of unnecessary antibiotics AND improvement in the ORS use rate. Zinc supplements can and should be promoted as the better alternative to unnecessary antibiotics.
    Parents often like to be giving their child some ‘drug’ other than ORS. With zinc, their immediate desire for treatment other than ORS is satisfied. Because children recover faster, parents are less likely to seek additional treatments for the episode.
    Zinc supplementation is never meant to take the place of ORS. When promoted, the 2 should always go hand in hand. In some studies zinc has been shown to increase ORS use rates. This is likely attributable to the overall satisfaction with the efficacy of the duo – children are not becoming dehydrated and are recovering faster. This is beneficial to the promotion of zinc and a testament to the positive effect of well-trained health care personnel in the complete diarrhoea management protocol.
  • <number>
    Thousands of children have been studied and the only reported adverse effect is vomiting. Vomiting is rare with the current zinc formulation which has been developed to successfully mask the metallic taste of zinc. Zinc is acceptable to children of all ages. Few have reported any negative effects. Zinc has been shown to be safe in infants as young as 28 days.
    When given in high doses for long periods of time, zinc has shown to decrease copper status in adults. 20mg for 10-14 days has had no effect on copper status in 4 of the 4 trials which assessed copper status
  • <number>
    Zinc supplements are in-expensive and easy to administer. Zinc decreases the duration and severity of the episode thus decreasing the need for hospitalizations and more advanced medical care. Zinc has also been shown to displace unnecessary antibiotics and other drugs such as antidiarrhoeals.
    Preliminary cost studies have shown zinc to be cost-effective because of the small incremental cost of adding zinc compared to the savings as just indicated.
  • <number>
    ORS has prevented the unnecessary deaths of millions of children for more than 20 years.
    Preliminary data suggest that the introduction of low osmolarity ORS could save an additional 80,000 to 200, 000 lives very year, and that introduction of zinc in the treatment of diarrhoea could save an additional 400,000 lives every year.
    So if these two recent discoveries can be implemented and are made accessible/available to every children throughout the world, we will certainly be able to make a big difference and reduce deaths due to diarrhoea to such a low level that it will not appear anymore on our pie chart.
    Thank you.
  • Fontaine Zink

    1. 1. Update on Diarrhoea Management What is New? O. Fontaine, WHO – Geneva On behalf of the Zinc task Force A Workshop to Support the Introduction of Zinc as part of Diarrhoea Management in Indonesia Jakarta, Indonesia 26-28 September 2006
    2. 2. Epidemiology
    3. 3. Diarrhoea Mortality • 1980: 4.6 million child deaths from diarrhoea • 2003: 1.8 million child deaths from diarrhoea Black, Morris, Bryce. Lancet 2003. Jones, Steketee, Black et al. Lancet 2003.
    4. 4. Diarrhoea prevalence in under-five children by socioeconomic status in selected countries 0 5 10 15 20 25 30 Bangladesh Viet Nam Benin Tanzania Country Diarrhoeaprevalence Poorest 20% Richest 20%
    5. 5. Diarrhoea Treatment Policy
    6. 6. Global Diarrhoea Treatment Policy • Treatment of dehydration with ORS solution (or with an intravenous electrolyte solution in cases of severe dehydration) • Continue feeding or increase breastfeeding during , and increase feeding after the diarrhoeal episode • Use antibiotics only when appropriate (i.e. bloody diarrhoea) and abstain from administering anti-diarrhoeal drugs • Advise mothers of the need to increase fluids and continue feeding during future episodes • Provide children with 20mg per day of zinc for 10-14 days WHO/UNICEF. Joint statement on the clinical management of acute diarrhoea. 2004.
    7. 7. Global Diarrhoea Treatment Policy • Treatment of dehydration with ORS solution (or with an intravenous electrolyte solution in cases of severe dehydration) • Continue feeding or increase breastfeeding during , and increase feeding after the diarrhoeal episode • Use antibiotics only when appropriate (i.e. bloody diarrhoea) and abstain from administering anti-diarrhoeal drugs • Advise mothers of the need to increase fluids and continue feeding during future episodes • Provide children with 20mg per day of zinc for 10-14 days WHO/UNICEF. Joint statement on the clinical management of acute diarrhoea. 2004.
    8. 8. Global Diarrhoea Treatment Policy • Treatment of dehydration with ORS solution (or with an intravenous electrolyte solution in cases of severe dehydration) • Continue feeding or increase breastfeeding during , and increase feeding after the diarrhoeal episode • Use antibiotics only when appropriate (i.e. bloody diarrhoea) and abstain from administering anti-diarrhoeal drugs • Advise mothers of the need to increase fluids and continue feeding during future episodes • Provide children with 20mg per day of zinc for 10-14 days WHO/UNICEF. Joint statement on the clinical management of acute diarrhoea. 2004.
    9. 9. Recent Scientific Advances about Zinc in the Treatment of Diarrhoea
    10. 10. Zinc for the Treatment of Diarrhoea History of Research • Ongoing research from the 1990s until today • 13 trials in acute diarrhoea • 5 trials in persistent diarrhoea • Age groups: 3-60 mo • Dose of zinc: ≈ 20 mg/d (range 5-45 mg/d)
    11. 11. Zinc for the Treatment of Diarrhoea Research Findings • 15% reduction in duration of acute diarrhoea • 24% reduction in duration of persistent diarrhoea • 42% reduction in treatment failure or death in persistent diarrhoea Zinc Investigators’ Collaborative Group. AJCN 2000.
    12. 12. Effect of Zinc Supplementation on Duration of Acute Diarrhoea/Time to Recovery *Bangladesh, 1999 Pooled 1 *Difference in mean and 95% CI Relative Hazards and 95% CI *India, 1988 *India, 2000 *Brazil, 2000 *India, 2001 Indonesia, 1998 India, 1995 Bangladesh, 1997 India, 2001 India, 2001 Nepal, 2001 Bangladesh, 2001
    13. 13. Therapeutic Effects of Zinc on Diarrhoea Severity Country Diarrhoea Outcome Percent Reduction India Frequency 18 India Frequency 39 Bangladesh Output 28 India Output 38 Brazil Frequency 59
    14. 14. Additional Preventive Aspects of Zinc Treatment • Zinc supplementation for 10-14 days has longer term effects on childhood illnesses in the 2-3 months after treatment • 34% reduction in prevalence of diarrhoea • 26% reduction in incidence of pneumonia Zinc Investigators’ Collaborative Group. Pediatrics. 1999.
    15. 15. Preventive Effect of Zinc Supplementation on Diarrhoea Incidence in Short - Course Supplementation Trials Bangladesh (I) Bangladesh (II) Pakistan Bangladesh (III) Pooled 0 0.25 0.5 0.75 1 1.25 1.5 1.75 2 2.25 2.5 Odds Ratio and 95% CI
    16. 16. Community-based Trial Demonstrates Zinc Effectiveness in Treating Diarrhoea • 30 health worker areas in rural Bangladesh randomized to ORS alone or ORS + zinc (20mg/d for 14 days) for diarrhoea treatment • 11,880 child-years of observation during the 2 year study • 23% decrease in duration of all diarrhoea episodes in zinc treatment clusters compared to control clusters (RH 0.77, 95% CI 0.69-0.86)
    17. 17. Community-based Trial Demonstrates Longer-term Benefits of Zinc • Zinc supplementation decreased: • Overall diarrhoea prevalence by 15% (RR 0.85, 95% CI: 0.76, 0.96) • Hospitalization from diarrhoea by 19% (RR 0.81, 95% CI: 0.65, 1.00) • ALRI prevalence by 7% (RR 0.93, 95% CI: 0.78, 1.10) • Hospitalization from ALRI by 19% (RR 0.81, 95% CI: 0.53, 1.23)
    18. 18. Community-based Trial Demonstrates Longer-term Benefits of Zinc • Decreased overall mortality by 51% (RR 0.49 95% CI: 0.25, 0.94), non-injury deaths • Decreased antibiotic use rate from 34% in control clusters to 13% in zinc clusters (p<0.01) • Increased ORS use from 50% in control clusters to 75% in zinc clusters (p<0.01)
    19. 19. Safety of Zinc Supplementation • 9,100 children less than 5 years of age studied in 18 published clinical trials • 11,880 child yrs of observation in 1 large community trial • Vomiting is the only reported adverse effect – 5/7 trials report no differences between zinc and placebo – 2 trials report slightly higher vomiting rates in zinc supplemented children • 4 trials show no difference in copper status after 2 weeks of zinc supplementation
    20. 20. Cost Effectiveness of ORS and Zinc Supplementation • Decreases the duration and severity of the episode • Decreases the need for expensive hospitalization • Decreases the use of unnecessary antibiotics and other drugs • Further cost-benefit analyses are underway • Robberstad, Strand, Sommerfelt, and Black. Bull WHO 2004. Baqui, Black, Arifeen. J Health Pop Nutr. 2004.
    21. 21. ORS and Zinc Treatment is now more effective This is the chance to make a difference

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