Article type
Year
Abstract
Background: Nutritional status, specifically maintenance of protein stores impacts on the individuals ability to survive with HIV infection (Steenkamp & Danabauser, 2001). Nutritional therapy is an important adjunct in the clinical care of patients infected with HIV. It is believed that achieving and maintaining optimal nutritional therapy will improve the individuals immune function; reduce the incidence of complications associated with HIV infection; attenuate the progression of HIV infection, improve the quality of life and ultimately reduce mortality associated to HIV infections (Donald & Kotle, 2002). These effects should also lead to a reduction in the overall cost of health care. There is an urgent need to systematically review the existing research on the effectiveness of macronutrients for improving outcomes in persons with HIV infection especially those living in developing countries.
Objectives: The objective of this review was to evaluate the effectiveness of various nutritional interventions with macronutrients such a balanced diet, proteins, carbohydrates, and lipids given orally in reducing morbidity and mortality in adults and children living with HIV infection world wide.
Included studies: Randomised controlled trials (RCTs) that evaluate the effectiveness of various nutritional interventions, Nutrition aimed at either treatment or prevention were considered. Studies were included regardless of the setting in which they were done. Studies in pregnant women were not included and those that assessed the effects of micronutrient supplementation and parenteral nutrients on outcomes in HIV/AIDS.
Types of participants: Children or adults living with HIV/AIDS worldwide, regardless of the stage of the disease.
Types of interventions: Experimental 1. Nutritional therapy given orally in the form of a balanced diet or macronutrients such as carbohydrates, proteins, fats, vitamins and mineral salts given in the form of food or snacks to meet the nutritional requirement of a person living with HIV infection. 2. High energy diet including lipids and sugars given to compensate for the specific individuals energy demands. 3. High protein diet specifically designed to address or cater for the individuals protein demands.
Only studies offering the above interventions for at least 4 weeks were considered.
Control: No nutritional therapy.
Types of outcome measures:
Primary outcomes 1. All cause mortality. 2. Mortality related to HIV infection and other HIV related conditions. 3. Morbidity (frequency, types and duration of episodes of opportunistic infections, incidence of HIV/AIDS as defined by each trial, hospital admissions and other types of illnesses related to HIV infection as reported in each study).
Secondary outcomes 1. Disease progression according to WHO or CDC staging system as recorded in each study. 2. Indices of viral load. 3. Markers of immune response (absolute CD4+ T-lymphocyte count and CD4+ percent of total lymphocytes). 4. Nutritional status measurements such as body weight, body mass index (BMI), energy expenditure, biochemical markers such as serum albumin. 5. Dietary intake and appetite.
Search strategy for identification of studies
A comprehensive, unbiased search strategy has been developed.
Methods: See: Collaborative Review Group Guidelines We (SM and MV) will screen all citations and abstracts. We are independently applying the pre-specified selection criteria to identify the relevant studies. If there is uncertainty concerning eligibility of a particular study, we obtain the full article. We are resolving our differences by discussing them with the third reviewer (JV). Where disagreements cannot be resolved, we will seek clarification from the study authors before reaching a decision. We are excluding all studies that do not meet the criteria and stating the reasons for exclusion.
Assessment of the methodological quality: We (SM and MV) are independently assessing the methodological quality of the included trails using the following criteria; (1) Generation of allocation sequence is considered adequate if methods such as tables of random numbers, computer generated random or coin tossing was used. We are using a classification derived from the Jadad scale, viz. A = truly random, B = quasi random, C = alternate, D = unclear (Jadad, 1996). (2) Concealment of allocation is considered adequate if methods such as central randomisation, sequentially numbered, sealed opaque envelopes were used classifying into the following categories - A = adequate, B = inadequate. C = unclear. (3) Blinding. Studies are assessed for blinding of investigators and/ or outcome assessors. A = yes, B = no, C = Unclear. (4) Completeness of follow-up: We are recording the adequacy of follow-up. A >80% B< =80%, C =
unclear.
Data analysis: We are in the process of analysing data. Results should be ready by October for presentation in the Colloquium.
Acknowledgements: This protocol was developed with the guidance and mentorship program organized by the HIV/AIDS Group in November, 2001 and financial assistance received from the Cochrane Health promotion and Public Health Field.
Objectives: The objective of this review was to evaluate the effectiveness of various nutritional interventions with macronutrients such a balanced diet, proteins, carbohydrates, and lipids given orally in reducing morbidity and mortality in adults and children living with HIV infection world wide.
Included studies: Randomised controlled trials (RCTs) that evaluate the effectiveness of various nutritional interventions, Nutrition aimed at either treatment or prevention were considered. Studies were included regardless of the setting in which they were done. Studies in pregnant women were not included and those that assessed the effects of micronutrient supplementation and parenteral nutrients on outcomes in HIV/AIDS.
Types of participants: Children or adults living with HIV/AIDS worldwide, regardless of the stage of the disease.
Types of interventions: Experimental 1. Nutritional therapy given orally in the form of a balanced diet or macronutrients such as carbohydrates, proteins, fats, vitamins and mineral salts given in the form of food or snacks to meet the nutritional requirement of a person living with HIV infection. 2. High energy diet including lipids and sugars given to compensate for the specific individuals energy demands. 3. High protein diet specifically designed to address or cater for the individuals protein demands.
Only studies offering the above interventions for at least 4 weeks were considered.
Control: No nutritional therapy.
Types of outcome measures:
Primary outcomes 1. All cause mortality. 2. Mortality related to HIV infection and other HIV related conditions. 3. Morbidity (frequency, types and duration of episodes of opportunistic infections, incidence of HIV/AIDS as defined by each trial, hospital admissions and other types of illnesses related to HIV infection as reported in each study).
Secondary outcomes 1. Disease progression according to WHO or CDC staging system as recorded in each study. 2. Indices of viral load. 3. Markers of immune response (absolute CD4+ T-lymphocyte count and CD4+ percent of total lymphocytes). 4. Nutritional status measurements such as body weight, body mass index (BMI), energy expenditure, biochemical markers such as serum albumin. 5. Dietary intake and appetite.
Search strategy for identification of studies
A comprehensive, unbiased search strategy has been developed.
Methods: See: Collaborative Review Group Guidelines We (SM and MV) will screen all citations and abstracts. We are independently applying the pre-specified selection criteria to identify the relevant studies. If there is uncertainty concerning eligibility of a particular study, we obtain the full article. We are resolving our differences by discussing them with the third reviewer (JV). Where disagreements cannot be resolved, we will seek clarification from the study authors before reaching a decision. We are excluding all studies that do not meet the criteria and stating the reasons for exclusion.
Assessment of the methodological quality: We (SM and MV) are independently assessing the methodological quality of the included trails using the following criteria; (1) Generation of allocation sequence is considered adequate if methods such as tables of random numbers, computer generated random or coin tossing was used. We are using a classification derived from the Jadad scale, viz. A = truly random, B = quasi random, C = alternate, D = unclear (Jadad, 1996). (2) Concealment of allocation is considered adequate if methods such as central randomisation, sequentially numbered, sealed opaque envelopes were used classifying into the following categories - A = adequate, B = inadequate. C = unclear. (3) Blinding. Studies are assessed for blinding of investigators and/ or outcome assessors. A = yes, B = no, C = Unclear. (4) Completeness of follow-up: We are recording the adequacy of follow-up. A >80% B< =80%, C =
unclear.
Data analysis: We are in the process of analysing data. Results should be ready by October for presentation in the Colloquium.
Acknowledgements: This protocol was developed with the guidance and mentorship program organized by the HIV/AIDS Group in November, 2001 and financial assistance received from the Cochrane Health promotion and Public Health Field.