viprox effect on hiv/aids patients

VIPROX EFFECT

ON HIV/AIDS

PATIENTS

CONTENTS

African nutrition study report by David L. Weston ……………... 1

Letter from Dr. Deberry ……………………………………………… 6

1- Survey Report …………………………………………………………. 7

(a) Abbreviations and Acronyms ………………………………………. 8

(b) List of tables and graphs ……………………………………………. 9

(c) List of participants in the Survey…………………………………… 10

1.1 Introduction …………………………………………………………….. 11

2- Context and Justifications …………………………………………… 11-12

3- Research Hypothesis…… …………………………………………… 12

4- Objectives ………………………………………………………………. 13

4.1 General Objective ……………………………………… 14

4.2 Specific Objectives ……………………………………… 13

4.3 Strategy ………………………………………………….. 13

4.4 Nutraceutical products Management ………………….. 13

5- Framework of the Survey…………………………………………… 14

5.1 Overview of Togo …….…………………………… 14

5.2 Presentation on the Health Sector.. ………………… 14

5.2.1 Organization of the Health Delivery System ……… 14

5.2.2 Health Delivery Infrastructures ……………………… 15

5.2.3 Human Resources …………………………………… 15

6- Methodology ………………………………………………………… 16

6.1 Type of Survey ……………………………………… 16

6.2 Definition and Measurement of variables …………… 16

6.3 Patient Selection Criteria……….. …………………….. 17

6.4 Survey Population and Sampling…………..… ………. 17

6.5 Intervention ………………..…………………………….. 17-18

6.6 Duration of the Survey……..… ……………………….. 18

6.7 Data Collection…………. ………………………………. 18

6.8 Data Management………….……………………………. 18

6.9 Ethical Issues…………….……………………………… 18

7- Difficulties Encountered …………………………………………….. 18-19

8- Findings ………………………………………………………………… 19

8.1 The Kodjoviakopé Site ………………………….………… 19-20

8.2 The Agou Site ……………………………………………… 20-21

8.3 The Kouvé Site …………………………………………….. 21-22

9- General Conclusion ………………………………………………….. 23

10- Annexes ………………………………………………………………… 24-61

11- Bio Impedance Analysis……………………………………………… 62

10.1 BIA background ……………………………………………... 64-68

10.2 BIA data collected in course of survey ……………………. 69

AFRICAN NUTRITION STUDY REPORT—SUMMARY OF A NUTRITIONAL

APPROACH DESIGNED TO FORTIFY, MAINTAIN FUNCTION AND

REVERSAL OF WASTING IN HIV2 PATIENTS LIVING IN WEST AFRICA

“INCREASE IN WEIGHT AND PHASE ANGLE IN TOGO HIV-2 PATIENTS

USING VIPROX. OCTOBER 2007.

Principal Investigators: B. Deberry, K Anthony, R Gauthier, R Bender, R

Alexander, L Lorenzen, Z Wang. Representing University of California Irvine

Medical School, Togo Ministry of Health, Nutraxis Group, the New Jersey Institute

of Technology and the All Around the World Foundation.”

BACKGROUND

This is a background report and independent review written by a former US FDA-

California Department of Health Investigator (Retired) on the recent clinical validation of

trials on West African HIV2-AIDS patients using Viprox Nutritional Complex (VNC).

This study was designed, administered and evaluated under World Health Organization

HIV Therapy guidelines. The therapy is designed as a nutritional life extension

intervention program, appropriate for resource-poor communities with little or no local

institutional medical support for HIV2-AIDS populations. The study population had no

exposure to anti viral therapies before or during the Viprox trial.

The study objective is, “To evaluate the effect of Viprox on HIV-2 patients in Togo

West Africa for three months. Viprox is a peptide-enzyme delivered with a

functional cluster water delivery system complex designed to be a low-cost, non-

toxic, nutritional approach to fortify, extend and maintain function and quality of

life for HIV-2 patients.” The summary of clinical data is contained on a power point

presentation, while the full review text of the clinical data contributors is available on

separate format and awaits journal publication.

It is the opinion of this investigator that VNC has immediate application for

reconstructive remedial nutritional therapy protocols designed for severely mal-nourished

HIV2-AIDS patients. The therapy seems to be most appropriate for resource-poor

communities with little or no local institutional medical support. Safety and efficacy of

the West African Study has been shown in the study summary and is being validated by

World Health Organization and a number of third party scientists, MD’s and public

health experts.

THE CURRENT NEED IN TOGO, WEST AFRICA

The current focus is upon the great and immediate need in Africa as outlined in the

President’s Emergency Plan for AIDS Relief and recently manifested in US funding

appropriations for effective containment of the epidemic. The Prime Minister, Health

Secretary and the IDH Microfinace Minister of Togo, West Africa, who have seen and

evaluated the results of this initial trial, have made a formal written request that Viprox

Nutritional Complex be made widely and immediately available to as many HIV-AIDS

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patients as possible. The HIV-AIDS infected population of Togo alone is conservatively

estimated at 180,000.

In his letter of request for assistance dated January 20, 2008, Prime Minister Kwasse

Klutse advised all involved parties that the VNC nutrition program is seen to be a cost-

effective approach to returning previously non-functioning HIV-2 patients to work,

family and society after less than three months of daily administration of the Viprox

Nutritional Complex. The letter on behalf of IDH Micro Finance and Human

Development Program, the Secretary of Health and other parties of interest states, in

part, that:

1—All parties are “anxious to move the use of Viprox to a much larger scale” and on

“a very broad use” in West Africa;

2—All parties wish to incorporate “broad availability” of Viprox because it restores

HIV-2 patients to fully functional status enabling positive economic and social benefits

for families, governments and the local economy. “Once the individual is physically

capable, he/she will re-enter the work force in their former vocation or be trained

by the IDH Human Development Program in new skills, accompanied by

microlending to initiate their new business.” (this is of particular interest to the West

African IDH Microfinance Program);

3—“The Viprox Program is the most successful, low cost approach (to restoring

HIV-2 patients to functionality) we have seen” and most importantly;

4—“We desperately need more Viprox to expand our (HIV-AIDS) health rebuilding

program”.

THE ROLE OF FAITH BASED ORGANIZATIONS IN EXPANSION OF THE

VIPROX STUDY

Because the need for the VNC program in Africa is immediate, the All Around the World

Foundation (AATWF.ORG) and Associates propose to begin work with Churches to

enable the humanitarian intervention that is required. We believe that eventually, the

global body of the church (as described in Pastor Warren’s visionary PEACE Plan) is

uniquely positioned to enable the church to lead the way for this compassionate life

enhancing intervention ministry for HIV-AIDS patients around the world.

We believe this nutritional program can be expanded to meet the Prime Minister’s

request as soon as funding becomes available. Unlike antiviral protocols, this approach

can be administratively integrated with local churches, medical clinics, schools,

communal kitchens, hospitals and humanitarian organizations wherever the Church and

its local leaders have ministerial influence and enabling resources. Also, this program

may be incorporated with other trials involving anti-viral administration if the hosting

study protocol administrator requires a life enhancing-extension component and

conditions allow for appropriate cross-waivers of liability.

Clinical studies prove that tangible physiological results (see below) are reported by HIV-

2 patients within several weeks and continue with the maintenance of the nutritional

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program. In addition, clinical studies show the Viprox Nutritional Complex is safe, non-

toxic and inexpensive when compared with pharmaceutical trials (the estimated cost per

person per day of Viprox appears, in this study, to be on the order of a typical morning

beverage at Starbucks), requires no special medical devices or clinical apparatus and is

easily administered orally (twice a day) with no reported side effects.

Many patients fortunate to be selected into pharmaceutical trials are not able to withstand

the rigors of these trials due to extreme malnutrition, compounding the wasting of the

immune system. This is an important ethical consideration expressed by the National

Institutes of Health and investigators concerning anti-viral pharmaceutical testing

protocols in Africa. Many HIV2-AIDS patients die due to poor nutritional status and the

toxicity of the medications before anti-viral studies can be fully evaluated. The tragedy

in these situations is that neither the patient nor the clinical study is well served. In

contrast, VNC nutritional program deals primarily with the issue of reversing of

physiological, wasting restoration of function and quality of life issues, including return

to work and family.

TREND ANALYSIS SUMMARY

The study summary (available on power point) shows rapid restoration (beginning within

30 days) of these physiological metrics:

1—Bio-phase angle (90 % increase). This is the most reliable indicator / predictor of

survival in HIV-AIDS patients and has been used for many years in conjunction with

highly-active retroviral treatments in HIV epidemiology studies.

2—Total Body weight (trend line slopes upward for the 111 surviving patients in the

study, an average body weight increase of 6.9 pounds in 3 months).

3—Total Body Water (67% increase)

4—CD-4 Count (trend line slopes upward for the 115 patients in the study).

This investigator is not aware of another study that shows the above evidence for rapid

improvement of health and well-being parameters for HIV2-AIDS patients. For this

reason, we are advocating that all possible means be explored to expand this nutritional

protocol to Togo, West Africa and to other locations as resources become available.

EXPANSION FUNDING FOR THE EXPANSION OF VIPROX IN WEST AFRICA:

Currently, no funding exists to expand the program.

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DELIVERY SYSTEM FOR VIPROX:

The primary functional / delivery component for this nutritional therapy (“the Viprox

Complex”) is a patented “clustered water solution” whose molecular geometry, energy

resonance, dynamic hydration capability and other properties is protected by two US

patents and whose efficacy has found application in a number of other clinically-tested,

peer reviewed, trials for a variety of physiological disorders. Similar highly-hydrating

functional waters have been sold commercially under the VIVO label with pre-market

approval from US FDA for over four years. The food-grade nutritional wafer (peptide–

enzyme complex) is delivered to the patients orally with the clustered water twice daily.

L. H. Lorenzen is the patent holder and a principal investigator in the Viprox study,

performed his undergraduate studies at the University of California Berkeley and

graduate studies at Cal State Fullerton and foreign Institutes while a researcher at the

University of California Irvine School of Medicine. At about the same time, the study

evaluator, David Weston was pursuing an MPH at Berkeley and working for California

Department of Health Services and the US Food and Drug Administration working with

Pharmaceutical NDA and efficacy reviews near the Berkeley campus. Lorenzen was in

process of receiving two US patents on his invention of functional or clustered water. He

spent the next 20 years in water research and clinical studies and has been involved in

development of a number of applications that promise to have efficacy in delivery of

substances at the cellular and molecular level.

A number of peer reviewed studies show the patented clustered waters are delivered or

channeled to the cellular level at a rate many times that of distilled water or drinking

water. Many of these studies, although well researched, remained relatively obscure and

many were not widely published. The science of clustered water as a delivery system for

molecular cellular therapies is not yet well known in medical journals.

However, the theory and functionality of Lorenzen’s patents received wide attention in

2003 with the Nobel research by McKinnon and Agree in the chemistry and physics of

Water Channeling. The practical applications for enhancement of nutritional and

pharmaceutical delivery at the sub-cellular level (as described in their ground breaking

research) appear to be very effective and innovative. It is of more than passing interest

that Lorenzen was patenting and designing clinical research with his “designed” cluster

waters long before the concept of water channeling was introduced or accepted as an

explanation of the mechanism of hydration.

Lorenzen recently invited David Weston and Associates to join his team in developing

further commercial applications for cluster water solutions and implementing commercial

manufacture of solutions premised upon these clustered water patents. Weston has been

given access to a number of research papers and clinical research studies on functional

water that Lorenzen & Associates have conducted. The efficacy shown in many of the

studies under review is most helpful in evaluating role of “functional” or “clustered”

water in the subject African HIV2-AIDS study. The range of functional application of

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these solutions in nutrition, human performance, reversal of bodily wasting and select

symptom reversal, appears to be very far-reaching.

SUMMARY AND FOLLOW UP

1--We advocate that the Viprox Nutritional Program be made available at the request of

the Prime Minister and Secretary of Health of Togo, West Africa as funds and resources

become available. It is remarkable that the reversing of the average weight gain in

severely-immune compromised, nutritionally deprived HIV2-AIDS patients is 6.9 pounds

in 90 days for 115 participants. The nutritional factor alone is worthy of expanding the

Viprox program to a much larger level (perhaps as a stand-alone African Nutrition Plan

to enhance existing programs sponsored by, for example, the World Food Programme) as

enabling resources allow. As the Viprox African Nutrition Plan is designed, funded and

implemented, the following steps may be included in the Plan, specific to HIV, Malaria

and related interventions.

2--Considering the demonstrated weight gains and reversal of wasting in the latter-stage

HIV patients, it would be of extreme interest to study the effects of administration of

Viprox to patients with a less-advanced stage of HIV compared to the more-advanced

results demonstrated in the initial trial. Establishing the optimal time during the

progression of the disease to begin the Viprox Nutritional Program would be of great

value as a more comprehensive intervention program is designed and expanded.

3--As the nutritional factors evaluated above become more well understood, it is

recommended that the Viprox Nutritional Program be incorporated into a recognized

anti-viral trial for the purpose of reversing the bodily wasting trends (demonstrated

above) in the trial group, with the hope of increasing / maximizing the amount of time for

the anti-viral course and viral load trend to be fully evaluated for efficacy.

4—Should the findings from the above studies show meaningful results, an independent

anti-viral protocol using clustered water as a delivery system (with the appropriate double

blind distilled water for control) should be considered for design and implementation.

David L. Weston, Senior Investigator Ret.

1288 C Street

Arcata, CA 95521

Voice & Fax: (707) 822-8227

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SURVEY REPORT

ASSESSMENT OF VIPROX EFFECT

ON HIV/AIDS PATIENTS

OCTOBER 2007

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ABBREVIATIONS AND ACRONYMS

ARV Anti- Retro Viral

CAMEG General Centre for the Purchase of Essential Generic Medicines

CDVA Centre for Counselling, Anonymous and Voluntary Testing

CHR Regional Hospital Centre

DRS Regional Health Delivery Directorate

IDH Investing in Human

INH National Institute of Hygiene

NFS Blood Formula Numeracy

ONG Non-Governmental Organisation

PVVIH Person Living with HIV

PTME Prevention of Mother-Child Transmission

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LIST OF TABLES AND GRAPHS

Table 1 : Distribution of patients according to sites and age

Table 2 : Distribution of patients according to sites and sex

Table 3 : Distribution of patients according to sites and occupations

Table 4 : : Distribution of patients according to sites an matrimonial status

Table 5 : Distribution of patients according to sites of and educational standards

Table 6 : Distribution of patients according to sites and temperature

Table 7 : Distribution of patients according to sites and weights

Table 8 : Distribution of patients according to sites and transaminases

Table 9 : Distribution of patients according to sites and lymphocytes (%)

Table 10 : Distribution of patients according to sites and white corpuscles

Table 11 : Distribution of patients according to sites and glycaemia

Table 12 : Distribution of patients according to sites and cholesterol (g/l)

Table 13 : Distribution of patients according to sites and red corpuscles

Table 14 : Distribution of patients according to sites and creatinine (mg/l)

Table 15 : Distribution of patients according to the sites and triglycerides (g/l)

Table 16 : Recapitulation of variables at Kodjoviakopé

Table 17 : Recapitulation of variables at Agou

Table 18 : General health status of patients

Table 19 : Changes in the patient’s defence system according the duration of treatment

Table 20 : Changes in the patient’s hepatic system according the duration of treatment.

Table 21 : Changes in the patient’s kidney system according the duration of treatment

Table 22 : Change in the patient’s general status according to the duration of treatment.

Table 23 : Recapitulation of data analysis after :

Fig N°1 : The changes in the blood pressure according to the duration of treatment (Lome-

Commune)

Fig N°2 :The changes in weight according to the duration of treatment (Lome- Commune)

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LIST OF PARTICIPANTS IN THE SURVEY Names Occupations Dr Kodzo ANTHONY MD MPH Project Coordination

Officer Dr DJOBO Chief Medical Officer in charge of

Kodjoviakope Health Delivery Centre Dr ADOSSI Chief Medical Officer in charge of

Care and Support of Patients on the Agou-Nyogbo

Mme GOUNA Akuavi Chief Nurse in charge of site supervision

Mrs Essinu Akoua ANTHONY Chief Nurse in charge of site supervision

Mr DJOKE Agbeviade Population Statistician Sister DORES In-charge of Care and Support on

Kouve site Mr AHIADJITSE Joel K. Associate Laboratory Technician in

charge of care and support on Kodjoviakope site

Mrs. CODJIE Yvette Secretary /Computer operator Mr Pascal Chief Nurse at Kouve Health Delivery

Centre 6 Health workers (2 workers per site)

Auxiliaries for the preparation and distribution of products

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I - INTRODUCTION For many decades, the Togolese state, highly concerned with the welfare of her citizens and acknowledging the importance of health as a factor of productivity, has made Health one of her priorities: “Health For All and All For Health”. HIV/AIDS is one of the deadly diseases plaguing the nation calling for the mobilization of efforts to fight it and to provide care and support for people living with the HIV/AIDS disease. The average HIV prevalent infection rate among the adult population rose from 5% in 1995 to over 6% in 1998 (according to PNLS source) but dropped below 4% in 2006. The disease affects all the regions in Togo; however, the urban areas are relatively more vulnerable. In 82.8% cases the transmission of the disease is heterosexual. The mother-to-child transmission accounts for 6.5% of the cases. II - CONTEXT AND JUSTIFICATIONS HIV/AIDS infection is rising in exponential proportion in spite of the noticeable efforts being deployed to prevent the transmission of the virus and to provide care and support for persons infected by HIV virus.

Africa pays the heaviest toll for this pandemic; over a total of 40 million people infected by the HIV in December 2001 throughout the world, 28.1 million, representing 70% of the total number live in the sub-Saharan region of Africa. Developing countries account for over 95% of the 14,000 new cases occurring everyday. HIV/AIDS in TOGO: In Togo, the HIV epidemic is of the mature type and generalized; the prevalence among the general population is 4.2% in 2006 with a high rate of AIDS-orphaned children. Women constitute the most vulnerable target of HIV. From 4.2% in 1985, the sex ratio dropped to 1.1 in 2000. This female vulnerability to HIV infection has many reasons: women’s biological constitution and their socio-cultural and economic conditions. According to the data collected by the National HIV/AIDS PREVENTION PROGRAM from sentinel sites for the surveillance of the epidemic at the regression period show that the prevalence rate was 4.7% in 2003, 4.5% in 2004 and 4.2% in 2006. The HIV epidemic is getting stabilised in Togo thereby concealing major differences in the regions as well as within the populations. . On the basis of the analysis of the data collected from the sentinel sites among the target populations such as sex workers and their customers, blood donors, the UN experts on the surveillance of HIV/AIDS and STI reckoned HIV prevalence in Togo to be 3.2% in 2005 among the sexually active population of the 15- 49- year- olds. These data range from 1.9 to 4.7 representing the gap mark. The study carried out in 2005 by AIDS3 with the help of the Canadian cooperation among sex workers in Lome revealed a prevalence of 44.5%.

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On the basis of the present prevalence of 3.2% it was noted that 110,000 adults and children lived with HIV; 9,700 children from 0 to14 years old lived with HIV; 9,100 adults and children died of AIDS; the epidemic rendered orphan 88,000 children from 0 to 17 years.(period). In September 2006 ending the number of people living with HIV who benefited from the total care and support including the ARV was 5,300 out of a target population of 15,000 persons from now to year 2010. In this respect the national strategy was in line with the universal access to prevention, treatment, care and support services. It emphasized prevention of new infections, treatment of people living with HIV by ARV and medicines for opportunistic infections, care and support to infected and affected persons. The coverage rate of mother-child prevention and transmission (MCPT) was 11.1% in 2006 in the 34 sites spreading over the 14 districts that were covered. This low rate is the result of difficulties of access to mother-child prevention and transmission services. Up to 2006, out of 65,455 pregnant women admitted to CPN (Pre-natal Consultation), 58,693 benefited from free tests, counseling; 35,130 were tested for HIV; 1,794 HIV-positive women received Nevirapine treatment and 1,038 delivered after taking the Nevirapine; 159 received ARV treatment; 1,144 children were born of HIV-positive mothers; 1,077 children received Nevirapine syrup treatment; after testing104 children aged 18 months, 81 were found negative, i.e.78%; 1,021 children were treated with Cotrimoxazol; pregnant women partners accepted to be tested and 24.4% were found HIV-positive. In spite of efforts made to combat the disease, the virus on account of its multiple mutations remains out of control. This calls for new researches and mechanisms of treatment to enable the immune system to combat or control this aggressive disease. In 1994 J.A. Levy one of the first researchers involved in the studies to isolate the AIDS virus and member of the Department of Medicine and Cancer Research Institute of the University of California, San Francisco, expressing his personal view said, “The secret of controlling HIV/AIDS resides not in the medicines which directly attack the virus, but in the body’s own defence mechanism. By strengthening the body’s immune system the HIV-positive can avoid the attacks of the disease for some decades and probably until their natural death. The aim of our survey is to assess the effects of VIPROX on the health of people infected with HIV/AIDS. III- Research Hypothesis The health condition of HIV/AIDS patients was considerably improved by taking VIPXOX TM: the combination of (GSH COMPLEX ®), STRUCTURED WATER (VIVO TM) and TRIOSYME TM. GSH COMPLEX®: substrate which helps in Glutathione intracellular production. VIVO TM : structured water which helps in intracellular conductivity.

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TRIOSYME TM: enzyme complex which helps in the assimilation of vitamins and minerals. IV – OBJECTIVES 4.1 General Objective To assess the effect of VIPROX on the health of people infected with HIV/AIDS over a period of 3 months. 4.2 Specific Objectives

1. To describe the profile of the sample of study To assess the initial and monthly anthropometric measurements of patientsTo assess the initial and monthly biological constants of patientsTo analyze the resultsTo draw conclusionsto make suggestions and recommendations to various partners

4.3 STRATEGY The strategy used, is an experimental study, a randomized double-blind clinical test with a controlled placebo on half of the sample for a period of one month. This strategy involved active practicing partners on the field in providing psychosocial and clinical care for persons living with HIV. This implies involving those partners in taking care of persons living with HIV through the introduction of VIPROX for a period of three months. The total cost of the biological tests was borne by the project budget. A particular incentive was given to the patients selected to make good transport expenses so that these products could be taken under the supervision of the care providers.

4.4 Care and Support and nutraceutical product Management:

Patients’ Care and Support: The care and support for patients organized on a global basis involved their follow up in their homes. The procedures used tallied with the general procedures proposed by the Kpalime National Workshop on the Care and Support for Persons Living with HIV, viz. a prior diagnostic confirmation by a laboratory test. . An initial general medical check up comprising as a rule, blood formula numeracy, CD4, and the other laboratory tests if possible.

Nutraceutical product Management Each of the selected field partners received a take-off stock of VIPROX and a subsequent stock is supplied by IDH NGO.

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V. FRAMEWORK OF THE SURVEY

MAP OF THE ADMINISTRATIVE SET UP OF TOGO

5.1 OVERVIEW OF TOGO Togo is a narrow strip of land situated in West Africa in the Gulf of Guinea. It stretches over 600 km lengthwise and its width varies between 50 and 150 km. It is limited on the north by Burkina Faso, on the south by the Atlantic Ocean, on the east by Benin and on the west by Ghana. 5.2 Presentation of the Togolese Health Sector 5.2.1 Organization of the Togolese Health System The health sector is organized on a three-tier-pyramidal system.

The Central Tier. The administrative structure of this tier comprises the Ministry, a general directorate, 5 central directorates, 5 divisions and 39 central services and various programs. Regarding health service delivery, there are 300 University Teaching Hospitals as well as national institutions such as the National Institute of Hygiene, the National Blood Transfusion Center constituting the major national health delivery system.

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The Intermediate or Regional Tier This is made up of 6 regional directorates:

The Lome Commune, the Maritime Region, the Plateau Region, the Central Region, the Kara Region, the Savannah Region and 6 regional central hospitals which constitute the second major health delivery system;

The Peripheral or District Health Delivery Centre This tier comprises 35 district health delivery centres including public hospitals, mission hospitals, health centres and private clinics and offices As a matter of the district and mission hospitals represent the first reference centres but often they are the first contact centres for the beneficiaries of the delivery service 5.2.2 Health Delivery Infrastructures

There are 618 public and mission health delivery services of all kinds including 3 University Teaching Hospitals, 6 Regional Hospitals, 2 specialized hospitals, 25 district hospitals, 9 private/mission hospitals and about 573 peripheral heath delivery units composed of polyclinic, health delivery centres, infirmaries and mother-child protection centres. There are about 236 private clinics and offices 90% of which are found in the Lome Commune. In spite of all these health delivery infrastructures, the health coverage rate still remains low as a result of the population growth and development of settlement areas.

Access to peripheral health delivery units within a range of 5km is reckoned at 88% according to AS/SR 2003.

5.2.3 Human Resources In 2004 the public health sector comprised 7,459 staff of all categories working in the administration and health delivery centres including military hospitals. Now in 2005 ending it comprised only 6,953.

From a medical viewpoint, the ARV was accessible to 5,400 persons living with HIV through state funding and by the agency of the World Fund as well as the Essential Generic Purchase Centre i.e.30% of the overall needs involving18, 000 persons. Twenty (20) health delivery structures and NGO/Associations were regularly supplied with medicines for opportunistic diseases.

5.2.4 PTME (Prevention of Mother-Child Transmission)

The number and of tested pregnant women and their follow up as well as the care and follow up of

children has improved thanks to integrated plans put in place in 10 districts, the regular supply of

ARV and medicines to combat opportunistic infectious diseases and laboratory equipment, the

increase in the number of sites (Prevention of Mother-Child Transmission) from 16 to 34 by their

rehabilitation and the supervision of the activities.

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6. METHODOLOGY

6.1 Type of Survey

A randomized double-blind clinical test with placebo was carried out for a one-month period using half of the sample. Target Population: HIV/AIDS patients selected and followed up according to precise criteria in one urban area and 2 rural areas. 6.2 Definition and Measurement of Variables The Patient’s general health condition. This is measured with respect to the following variables: temperature, weight and blood pressure The function of the defence system of the body This is measured with respect to the following variables: the number of red corpuscles, the haemoglobin rate, the number of white corpuscles and the lymphocyte rate. The Hepatic Function This is measured with respect to the following variables: transaminases, glycaemia, triglycerides and cholesterol. The Kidney Function This measured with respect to the following variable: Creatinine TABLE OF THE VARIABLES

VARIABLES NORMS MESURE UNITS

T° : Temperature 36°.6 – 37° Degree centigrade

Weights 45kg plus Kilogramme

B.P (Blood Pressure) 13/8 Hg (mm of mercury)

Red Corpuscles 4500 000 – 5500 000 N° Corpuscles /mm3 of blood

Haemoglobine Rate 12.5 – 15 g/mml

White Corpuscles 5000 – 10 000 N° Corpuscles /mm3 of

blood

Lymphocytes Rate 20 – 40 %

Transaminase

SGOT

SGPT

12 -20

12 - 25

mUl/ml

mUl/ml

Glycemia 0.8 - 1 g/liter of blood

Triglycerides 0.4 – 1.4 g/liter of blood

Cholesterol 1.3 – 3 g/liter of blood

Creatinine 6 – 12 Mg/l of blood

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6.3 Patient Selection Criteria

We selected in one urban area and one rural a group of HIV infected persons (aged 18 – 45) whose

CD4 rate was above 150 and who weighed between 55 and 75kg. These patients were consulted

and selected according to the following exclusion criteria:

- Patients with liver disorders.

- Alcoholic patients

- Medically dependent patients

- Patients undergoing anti-AIDS treatment (ARV)

- Milk protein-allergic persons

- Person undergoing immuno-depressant treatment

6.4 Target Population and Sampling

The target population which was selected in three sites (Kodjoviakope, Kouve and Agou)

comprised HIV-positive persons of either sex according to the above mentioned criteria.

The sampling which was done at random was based on exclusion criteria.

On account of the variation of rate of HIV-prevalence from one region to another we opted for the

selection of the maximum number representing 5% (p)

After making good the number of withdrawals during the survey period, we found thereby, on the

basis of our calculations, 82 patients. This figure was raised to 115 to further minimize sampling

errors.

In all our study involved 115 HIV persons.

In recruiting the HIV persons for the survey we took into account the gender approach, thus 58

women and 57 men were selected.(see table above).

6.5 Intervention

First Month:

Group N° 1:

The selected HIV persons received placebos having similar physical properties as the other

products except that they were not active.

Group N° 2:

Members of this group received active products:

- Active proteins (GSH Complex) 20g x 2 a day for one month.

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- 500 ml of structured water for the preparation of active protein.

- 2g of enzyme complex twice a day during meals.

These two groups were formed by a random selection by lot.

2nd and 3rd Months

At this time all the patients were subjected to active products.

6.6 Duration (3months):

The first phase of the survey consisted in writing the protocol, designing the data collection cards,

training the interviewers.

The second phase consisted in data gathering and patient follow up.

The third phase consisted in data analysis.

6.7 Data Gathering

The data were collected by means of questionnaire coupled with an observation grid.

The data to be collected concerned clinical and para-clinical information items on the individual

files of the patients namely the above-mentioned variables.

6.8 Data Management

The keying of the data was done by means of Epi Data and their analysis with SPSS 11 software.

6.9 Ethical Issues

A prior written permit was obtained from the ministries concerned.

Similarly a prior consent was obtained from each patient involved in the survey after the whole

thing was explained to them.

These patients were assured that they would have a free supply of VIPROX during and after the

survey.

The total cost of transport expenses and daily allowance was guaranteed for the patients selected

for the survey.

The publishing of the findings of the survey was subject to the approval of the Medical Ethics

Committee.

7. Difficulties Encountered:

Difficulties related to:

- sampling

The number of patients in each site raised many problems. As a matter of fact, in recruiting

patients with CD4 above 150, it was necessary to test more than 100 patients per site, which the

18

initial budget did not provide for. And as a result the survey could not take off according

schedule and the beginning of the intake of the products was in three stages.

- duration of the survey

The duration of the survey was extended on account of the different periods when the patients

started taking the products.

The failure of patient to turn up for the laboratory tests.

8. FINDINDS

Kodjoviakope Site

a) General Health Status of Patient:

This was assessed with respect to the following variables (weight, temperature and blood

pressure).

We observed a net increase in the average weight of the patients as they took the products

(66.8kg to 67.5kg).

The average temperature of the patients was within the norms (37.3 ° to 37.6°).

The average blood pressure of the patients was within the norms (85% of the patients regained

their normal blood pressure after three months’ treatment).

From these we could conclude that the general health status of the patients was normal.

b) Function of the Body Defence System

After the patients had taking the product for 3 months, a net increase was observed in the

average CD4 (ranging from 347 to 359).

However, there was a slight fall in the number of red corpuscles resulting in a slight anaemia

with an average rate of haemoglobin ranging from 11. 6% to 11.1%.

A further slight increase was found at the leucocytes side ranging from 4,770 to 4,855 with an

average lymphocyte percentage rise ranging from 55.4% to 57%.

It was found that an improvement of the patients’ body defence system was under way.

c) Function of the Hepatic System

The average transaminases and SGOT and average SGPT decreased in number indicating an

improvement of this variable ( 50.4 IU/L to 40.8 IU/L).

The median glycaemia was falling showing an improvement from 0.9g/l to 0.87 g/l.

The triglycerides also were falling from 0.9g/l to 0.7g/l.

19

There was also a fall in the blood cholesterol level from 1.6g/l to 1.5g/l.

It was found that the hepatic system was getting normal.

d) Function of the Kidney System

The average creatinine dropped from 9.7mg/l to 9.1mg/l.

The kidney system reached normal values (7mg/l – 12mg/l).

CONCLUSION

One could conclude that the patients’ general health status had improved as there was an

improvement in their hepatic, kidney and defence systems.

The Agou Site

a) General Health Status of the Patients:

As a net increase in the patients’ average weight was observed in the case of the Kodjoviakope

site, there was a net increase in the patients’ average weight (54 kg to 56.9 kg) as they took the

products.

The patients’ average temperatures reached normal values (36.7° to 36.8°).

The average blood pressure also reached normal values.

After three months’ treatment the patients’ weight increased considerably.

As a matter of fact, after three months’ treatment the initial average weight which was 55kg,

reached nearly 57kg.

It was found that the patients’ general health status was normal.


After the patients had taken the products for three months, there was a change in the average

CD4 (from 420 to 458 then to 374).

There was a slight fall in the number of red corpuscles resulting in a slight anaemia with an average

rate of haemoglobin ranging from 11.8% to 11.1%.

A further slight increase was found at the leucocytes side ranging 4,582 to 4,247 with an

average lymphocyte percentage rise ranging from 49.9% to 51.9%.


20


The average transaminases and SGOT and average SGPT decreased in number signalling an

improvement of this variable (30.4 IU/L to 24.1 IU/L).

The median glycaemia was falling showing an improvement from 0.9g/l to 0.87 g/l.

The triglycerides also reached normal values 0.6g/l to 0.7g/l.

There was also a fall in the blood cholesterol level from 1g/l to 09.0g/l.

It was found that the hepatic system was getting normal.

e) Function of the Kidney System

The average creatinine dropped from 9.4mg/l to 8.4mg/l.


CONCLUSION

One could conclude that the patients’ general health status had improved.

There was an improvement in the patients’ hepatic, kidney and defence systems

The Kouve Site

a) General Health Status of the Patients:

This assessed with respect to the following variables: (weight, temperature, blood pressure).

There was an increase in the patients’ average weight as they took the products (54.42 kg to

58.26 kg).





After the patients had taken the products for three months, the average CD4 increased

considerably (from 312 to 370).

However, there was a slight fall in the number of red corpuscles resulting in a slight anaemia with

an average haemoglobin rate ranging from 11.7% to 2.145%.

21

A further slight increase was observed at the leucocytes side ranging 5,853 to 5,932 with an




The average transaminases and SGOT and average SGPT increased in number indicating a

change in this system( 34 IU/L to 40 IU/L).

The median glycaemia got stabilized.

The average triglycerides also dropped from1.5g/l to 0.82g/l.

There also a slight rise in the blood cholesterol level (from 0.95g/l to 1.38g/l.)

It was found that the hepatic system was getting slightly bad. It must be noted that that area is

known for the consumption of locally distilled alcohol.

d)Function of the Kidney System

The average creatinine went up slightly from 8.52mg/l to 9.09mg/l.


CONCLUSION

In the case of Kouve site one could conclude that the patients’ general health status had

undergone a slight improvement; however, it is to be noted that the hepatic and kidney systems

had gone slightly bad. This may be due to regular consumption of locally distilled alcohol,

which characterizes the drinking habit of the local people.

22

9. GENERAL CONCLUSION

The comparative analysis of the data collected was made by the Levene and T-test to ensure

average equality.

The Levene variance equality test and the average equality T-test ensured the strength of the

comparisons of the biological constants levels during the three months’ treatment with active

product.

The analysis showed that the average constant variations of the functions of the patients’

general health status (Weight, T°, BP) representing a threshold of 99% was statistically

significant.

As regards the other functions of the kidney and body defence systems, it was further noticed

that there was a statistically significant difference between the months of treatment (M0 to M3)

according to the average equality T-test. Thus one can conclude without great risk (1%) that the

improvement is due to the treatments received by the patients.

Lome, 11th October 2007

Dr Kodjo Akpenyo ANTHONY M D; M P H

In-charge of the Survey

23

The findings of the survey are as follows:

I- Description of initial sample 2- Analysis of the findings per site and variables after three months’ treatment.

I- Initial Information Table 1 : Distribution of patients according to sites and age The patients used in survey are generally aged between 20 and 49 years (94.8% at Kodjoviakopé and 84.2% at Agou). This age group is the most sexually active.

LOMÉ COMMUNE

(Kodjoviakopé) PLATEAUX RÉGION (AGOU)ÄGE OF

PATIENTS

n % n %

18-19 years 1 2.6 0 0.0

20-29 years 7 17.9 7 18.4

30-39 years 24 61.5 15 39.5

40-49 years 6 15.4 10 26.3

50 years + 1 2.6 6 15.8

Total 39 100.0 38 100.0

Table 2 : Distribution of patients according to site and sex

25

At Agou 50% of the patients were men and women and at Kodjoviakope the per ratio of men to women was 18: 82.

SEX LOMÉ COMMUNE

(Kodjoviakope) PLATEAUX RÉGION (AGOU)

n % n %

MASCULINE 7 17.9 19 50.0

FÉMININE 32 82.1 19 50.0

Total 39 100.0 38 100.0

Tableau 3 : Distribution of patients according sites and occupations The majority of patients on both sites were traders.

OCCUPATION LOMÉ

COMMUNE (Kodjoviakope)

PLATEAUX RÉGION (AGOU)

OCCUPATION n % n %

TRADER 19 48.7 10 26.3

HAIR DRESSER /SEAMSTRESS 5 12.8 4 10.5

HOUSEWIFE 3 7.7 3 7.9

FARMER 0 0 4 10.5

DRIVER 0 0 4 10.5

LIBERAL PROFESSION 2 5.1 2 5.3

SALARIED MAN/WOMAN 5 12.8 3 7.9

THE UNEMPLOYED 4 10.3 8 21.1

Total 39 100.0 38 100.0

Table 4 : Distribution of patients according to site and matrimonial status The majority of the patients on either site were married (48.7% à Kodjoviakope and 65.8% at Agou).

LOMÉ COMMUNE (Kodjoviakope)

PLATEAU RÉGION (AGOU) MATRIMONIAL STATUS

n % n %

MARRIÉD 19 48.7 25 65.8

SINGLE 13 33.3 11 28.9

WIDOW/WIDOWER 7 17.9 2 5.3

Total 39 100.0 38 100.0

26

Table 5 : Distribution of patients according to site and educational standard The primary and secondary school educational standards of the patients were acceptable, 82% at Kodjoviakope and 94.7 at Agou.


PLATEAU RÉGION ( AGOU)EDUCATIONAL STANDARD

n % n %

NONE 7 17.9 1 2.6

PRIMARY 16 41.0 17 44.7

SECONDARY 16 41.0 19 50.0

TERTIARY 0 0.0 1 2.6

Total 39 100.0 38 100.0

Table 6 : Distribution of patients according to site and temperature Patients with temperatures ranging from 37° et 37.4°: 28.2% at Kodjoviakope and 86.9% at Agou


RÉGION PLATEAU ( AGOU) TEMPÉRATURE

n % n %

< 37°C 4 10.3 24 63.2

37°C-37.4°C 7 17.9 9 23.7

37.5°C+ 28 71.8 5 13.2

Total 39 100.0 38 100.0

27

Table 7: Distribution of patients according to site and weight The weights of the majority of the patients varied between 50kg et 79kg.


PLATEAU RÉGION ( AGOU) WEIGHT

n % n %

< 50 KG 7 17.9 8 21.1

50-59 KG 8 20.5 16 42.1

60-69 KG 9 23.1 5 13.2

70-79 KG 5 12.8 7 18.4

80-89 KG 6 15.4 1 2.6

90 KG+ 4 10.3 1 2.6

Total 39 100.0 38 100.0

BIOLOGICAL CONSTANTS Table 8 : Distribution of patients according to transaminases The transaminases of the patients: SGOT : were within the norms, 65.8% at Agou and only 46.2% at Kodjoviakope ; SGPT : were normal, 65.8% at Agou and 12.8% at Kodjoviakope. SGPT1 TRANSAMINASES SGOT


PLATEAU RÉGION (AGOU) TRANSAMINASES SGOT

n % n %

≤ 30 IU/L 18 46.2 25 65.8

>30 IU/L 21 53.8 13 34.2

Total 39 100.0 38 100.0

28

SGPT1 TRANSAMINASES SGPT


PLATEAU RÉGION (AGOU) TRANSAMINASES SGPT

n % n %

≤30 IU/L 5 12.8 9 65.8

>30 IU/L 34 87.2 29 34.2

Total 39 100.0 38 100.0

Table 9 : Distribution of patients according to lymphocytes (%) Hyper lymphocytosis was noticed with 92.3% of the patients at Kodjoviakope and 78.9% at Agou.


RÉGION PLATEAU ( AGOU) LYMPHOCYTE RATE

n % n %

20-40% 3 7.7 6 15.8

Over 40% 36 92.3 30 78.9

≤19% 0 0.0 2 5.3

Total 39 100.0 38 100.0

Table 10 : Distribution of patients according to site white corpuscles The leucocytosis was within the norms, 76.9% at Kodjoviakope and 60.5% at Agou.


PLATEAU RÉGION ( AGOU)NUMBER OF WHITE CORPUSCLES

n % n %

4000-10000 30 76.9 23 60.5

≤3900 9 23.1 15 39.5

Total 39 100.0 38 100.0

29

Table 11 : Distribution of patients according to site and glycaemia The glycaemia rates were within the norms (0.7 g/l – 1g /l), 82.1% at Kodjoviakope and 97.4% at Agou.


PLATEAU RÉGION ( AGOU) GLYCAÉMIA

n % n %

0.7-1 g/L.5 29 74.4 15 39.5

Over 1 g/l 7 17.9 1 2.6

< 0.7 g/l 3 7.7 22 57.9

Total 39 100.0 38 100.0

Table 12 : Distribution of patients according to site and cholesterol (g /l) The cholesterol was within the norms (1.5 g/l- 2.5g/l) ; 97.4% at Kodjoviakope and at Agou.


PLATEAU RÉGION D ( AGOU) CHOLESTÉROL

n % n %

1.5 g/l- 2.5g/l 22 56.4 15 39.5

Over 2.5g/l 1 2.6 1 2.6

< 1.5g/l 16 41.0 22 57.9

Total 39 100.0 38 100.0

30

Table 13 : Distribution of patients according to site and red corpuscles The red corpuscles were within the norms (4-5 millions), 53.1% at Kodjoviakopé and 21.1% at Agou.


PLATEAU RÉGION ( AGOU) NUMBER OF WOMEN’S RED

CORPUSCLES n % n %

4-5 millions 17 53.1 4 21.1

Over 5 millions 4 12.5 1 5.3

< 4 millions 11 34.4 14 73.7

Total 32 100.0 19 100.0


PLATEAU RÉGION ( AGOU) NUMBER OF MEN’S RED

CORPUSCLES n % n %

4,5-5,5 millions 2 28.6 11 57.9

Over 5,5 millions 2 28.6 8 42.1

< 4,5 millions 3 42.9 0 0

Total 7 100.0 19 100.0

31

Table 14 : Distribution of patients according to site and creatinine (mg/l) The creatinine was within the norms (5 mg/l – 14 mg/l), 93.8% at Kodjoviakopé and 84.2% at Agou.


PLATEAU RÉGION ( AGOU) WOMEN’S CRÉATININE

n % n %

5-12 30 93.8 16 84.2

Over 12 1 3.1 2 10.5

≤4 1 3.1 1 5.3

Total 32 100.0 19 100.0


PLATEAU RÉGION ( AGOU) MEN’S CRÉATININE

n % n %

≤6 1 14.3 1 5.3

7-14 6 85.7 17 89.5

Over 14 0 0.0 1 5.3

Total 7 100.0 19 100.0

32

Table 15 : Distribution of patients according to site and triglycerides (g/l) The triglycerides were within the norms (0.3g/l – 1.4g/l), 81.3% at Kodjoviakope and 84.2% at Agou.


PLATEAU RÉGION (AGOU) WOMEN’S TRIGLYCERIDES

n % n %

0.3g/l -1.4g/l 26 81.3 16 84.2

Over 1.4g/l

6 18.8 3 15.8

Total 32 100.0 19 100.0


PLATEAU RÉGION (AGOU) MEN’S TRIGLYCERIDES

n % n %

0.40g/l - 1.50g/l 6 85.7 17 89.5

Over 1.5g/l 1 14.3 2 10.5

Total 7 100.0 19 100.0

33

RECAPILATION TABLES LOMÉ COMMUNE Table 16 Recapitulation of variables at Kodjoviakope

Average Median Mode Mark Gap Minimum Maximum Total Age 34.72 34 33(a) 6.794 18 52 1354Weight 66.5256 64 48.00(a) 16.68081 38 100.5 2594.5INITIAL TEMPERATURE 12.264 12.8 12.8 1.1913 10.5 14.9 478.3NUMBER OF CD4 373.23 345 151(a) 147.797 151 822 14556 Number of red corpuscles 4282820.51 4200000 3930000(a) 784326.559 2940000 6680000 167030000TRANSAMINASES SGOT 50.31 46 44 25.487 22 173 1962TRANSAMINASES SGPT 32.8205 33 19 14.20502 12 73 1280 Haemoglobin rate 11.3897 11.3 10.80(a) 2.00405 7.8 18.6 444.2 Number of white corpuscles 4956.41 4700 3800(a) 1366.862 2400 8900 193300Lymphocytes % 53.8205 55 60 9.22774 31 76 2099Creatinine 9.3308 9 9.00(a) 2.07962 0.9 13 363.9Glycaemia 0.9021 0.9 0.97 0.14311 0.61 1.21 35.18Triglycérides 1.0323 0.94 0.94 0.68902 0.34 4.48 40.26Cholesterol 1.5838 1.51 1.50(a) 0.49686 0.93 3.95 61.77

34

35

PLATEAU RÉGION Table 17 Recapitulation of variables at Agou

Average Median Mode Mark Gap Minimum Maximum

Age 38.0 35.5 41 10.89 22 68 Weight 59.5 55.5 55 13.31274 40 97 INITIAL TEMPERATURE 12.6 12.6 11.6 1.8242 9.5 18.8 NUMBER OF CD4 475.6 358 263 290.047 153 1185 Number of red corpuscles

3 877 289 3 965 000

2 900 000 847 694

2 095 000 5 200 000

TRANSAMINASES SGOT 42.9 41.5 24 14.644 16 78 TRANSAMINASES SGPT 29.1 23 13 16.65378 11 81 Haemoglobin rate 12.3 12.3 11.5 2.61628 8 17.1 Number of white corpuscles 4 773.7 4150 4100 2073.342 2000 9700 Lymphocytes % 47.6 48.5 42 14.70241 6.4 71 Creatinine 10.2 8.95 7.7 7.33099 0.65 51 Glycaemia 0.7 0.65 0.7 0.17209 0.2 1.47 Triglycerides 2.8 0.78 1.1 11.69846 0.44 73 Cholesterol 1.0 0.89 0.89 0.29821 0.47 1.87

THE FINDINGS FROM THE FIRST MONTH TO THE THIRD MONTH LOME COMMUNE (Kodjoviakope) General health status of the patients : This was assessed with respect to the following variables (Weight, T°, and B/P) A net improvement was noticed in the average weight of the patients as they took the products (66.8kg to 67.5kg). The patients’ average temperature was within the norms (37.3° to 37.6°) It may be concluded that the general health conditions are normal.

MOIS DE TRAITEMENT BIOLOGICAL CONSTANTS

STATISTICS MONTH 0 MONTH 1 MONTH 2 MOINTH 3AVERAGE 66.8 68.3 69.5025 70.4 MEDIAN 65 66 66.5 67.5

WEIGHT (kg) MARK GAP 18.5 17.3 18.3 18.2 AVERAGE 37.37 37.185 37.38 37.65 MEDIAN 37.5 37 37.5 38

TEMPERATURE MARK GAP 0.4 0.2 0.3 0.5 Changes in the blood pressure during the treatment period (Lome- Commune)

20

510

5

45

65 65

85

3530

25

10

0

10

20

30

40

50

60

70

80

90

MOIS 0 MOIS 1 MOIS 2 MOIS 3

MONTH OF TREATMENT

nu

mb

er

of

pa

tie

nts

(%)

> 12/8 12/8-10/8 < 12/8

The blood pressure showed a net improvement after 3 months’ treatment; patients with blood pressure ranging from 12/8 – 10/8 accounted for only 45% at the beginning of the treatment.

xxxvi

After 3 months’ treatment more than 85% of the patients regained their normal blood pressure. According to Levene Test, this change at the threshold of 99% was significant from statistical point of view. Defence function of the body After the patients had taken the products for 3 months, there was a net improvement in the average CD4 (from 347 to 359). However, there was a slight drop in the number of red corpuscles resulting in the patients having a slight anaemia with an average haemoglobin rate of 11.6% to 11.1%. A slight increase was also noticed in the number of leucocytes from (4770 to 4855 with an average percentage rise in the lymphocytes also, 55.4% to 57%. It may be concluded that an improvement in the patients’ body defence systems was under way. MONTH 0 MONTH 1 MONTH 2 MONTH 3

AVERAGE 347.15 327.5 327.55 359.25 MEDIAN 313.5 286.5 279 290.5

CD4 MARK GAP 154.4 177.3 160.1 180.0 AVERAGE 4434500 4380500 4398000 4409500 MEDIAN 4375000 4275000 4370000 4370000 Number of red

corpuscles MARK GAP 934 009.3 852 102.5 933 632.4 927 217.0 AVERAGE 11.61 11.33 11.17 11.11 MEDIAN 11.25 11.05 11.3 11.4

Haemoglobin rate MARK GAP 2.1 1.9 1.8 1.4 AVERAGE 4770 4620 4975 4855 MEDIAN 4550 4250 4350 4400 Number of white

corpuscles MARK GAP 1 249.0 1 346.2 2 108.1 1 621.4 AVERAGE 55.45 56.55 49.9 57 MEDIAN 57 56.5 52.5 57.5

Lymphocytes % MARK GAP 9.4 9.0 8.3 10.7 Function of the hepatic system The average transaminases SGOT and SGPT decreased showing an improvement of this variable, 50.4 IU /L to 40.8 IU/L.

xxxvii

The patients’ median glycaemia dropped showing an improvement of this constant, from 0.9g/l to 0.87g/l). The average triglycerides also dropped, from 0.9g/l 0.7g/. The blood cholesterol level also dropped, from1g/l to 09.0g/l) It may be concluded that the hepatic system was getting normal. ********************************************************************************************* MONTH 0 MONTH 1 MONTH 2 MONTH 3

AVERAGE 50.4 44.75 44.45 40.8 MEDIAN 45 41.5 41 37.5 SGOT

TRANSAMINASES MARK GAP 32.2 25.4 20.4 13.4 AVERAGE 31.15 28.9 37.5 30.8 MEDIAN 29.5 24.5 26.5 29 SGPT

TRANSAMINASES MARK GAP 13.3 18.0 28.9 16.4 AVERAGE 0.959 0.952 0.8905 1.31 MEDIAN 0.92 0.975 0.89 0.875

GLYCAEMIA MARK GAP 0.3 0.1 0.1 1.8 AVERAGE 0.97 0.9065 0.8475 0.77 MEDIAN 0.725 0.8 0.765 0.725

TRIGLYCERIDES MARK GAP 0.9 0.5 0.4 0.3 AVERAGE 1.6175 1.5965 1.554 1.5115 MEDIAN 1.505 1.5 1.595 1.555

CHOLESTEROL MARK GAP 0.6 0.6 0.3 0.3 Function of the kidney system The average creatinine dropped from 9.7mg/l to 9.1mg/l The kidney system is within the norms (7mg/l – 12mg/l) MONTH 0 MONTH 1 MONTH 2 MONTH 3

AVERAGE 9.7 9.9 9.25 9.1 MEDIAN 10 9.5 8.5 9

CREATININE MARK GAP 1.2 2.4 2.5 1.3 CONCLUSION On the whole, it may be concluded that the patients general health conditions were getting improved. The patients’ hepatic, kidney and body defence system had improved.

xxxviii

AGOU General health status of the patients : This was assessed with respect to the following variables (Weight, T°, and B/P) A net improvement was noticed in the average weight of the patients as they took the products (66.8kg to 67.5kg). The patients’ average temperature was within the norms (37.3° to 37.6°) The average blood pressure was also within the norms. It may be concluded that the general health conditions were normal.

MONTHS OF TREATMENT BIOLOGICAL CONSTANTS

STATISTICS MONTH 0 MONTH 1 MONTH 2 MOINTH 3AVERAGE 54.8 55.2 56.1 56.9 MEDIAN 55.0 55.0 56.0 57.0

WEIGHT (kg) MARK GAP 10.8 10.6 10.9 10.6 AVERAGE 36.7 37.0 36.9 36.8 MEDIAN 36.8 37.0 37.0 37.0

TEMPERATURE MARK GAP 0.5 0.6 0.7 0.5 BLOOD PRESURE AVERAGE 12.7 12.0 12.2 12.5 MEDIAN 12.6 11.5 11.5 12.6 MARK GAP 2.1 2.3 2.7 2.1

xxxix

Changes in the patients’ weights during the treatment period

54,8

55,2

56,1

56,9

54

54

55

55

56

56

57

57

58

MOIS 0 MOIS 2 MOIS 2 MOIS 3

AVERAGE WEIGHT OF PATIENTS

MONTH OF TREATMENT

After 3 months’ treatment there was a net increase in the patients’ weights from an initial average weight of 55kg to nearly 57kg. Defence function of the body After the patients had taken the products for 3 months, there was a net improvement in the average CD4 (from 420 to 458 then to 374). However, there was a slight drop in the number of red corpuscles resulting in the patients having a slight anaemia with an average haemoglobin rate of 11.8% to 11.1%. A slight increase was also noticed in the number of leucocytes from (4582 to 4247 with an average percentage rise in the lymphocytes also, 49.9% to 51.9%.

xl

It may be concluded that an improvement in the patients’ body defence systems was under way. MONTH 0 MONTH 1 MONTH 2 MONTH 3

AVERAGE 420 345 458 374 MEDIAN 42.0 32.0 36.0 34.0

CD4 MARK GAP 13.7 10.6 31.9 15.3

AVERAGE 3695 588.2 3465823.5 3173294.1

3533 823.5

MEDIAN 3700 000.0 3461000.0 3346000.0

3585 000.0 Number of red

corpuscles MARK GAP 903223.0 553629.2 1028878.7 723631.1 AVERAGE 1.8 11.0 9.8 11.2 MEDIAN 11.5 11.3 10.2 11.5

Haemoglobin rate MARK GAP 2.6 1.8 3.4 2.5 AVERAGE 4582.4 4758.8 4158.8 4247.1 MEDIAN 4200.0 4600.0 4100.0 4300.0 Number of white

corpuscles MARK GAP 1933.7 1749.7 1741.4 649.2 AVERAGE 49.5 42.9 45.6 51.9 MEDIAN 48.0 40.0 48.0 52.0

Lymphocytes % MARK GAP 13.4 12.4 17.8 10.6

xli

Function of the hepatic system The average transaminases SGOT and SGPT decreased showing an improvement of this variable, 30.4 IU /L to 24.1 IU/L. The patients’ median glycaemia dropped showing an improvement of this constant, from 0.9g/l to 0.87g/l). The average triglycerides were within the norms 0.6g/l 0.7g/l. The blood cholesterol level also dropped, from1g/l to 09.0g/l) It may be concluded that the hepatic system was getting normal. MONTH 0 MONTH 1 MONTH 2 MONTH 3

AVERAGE 30.4 24.4 32.4 24.1 MEDIAN 20.0 24.0 22.5 23.0 SGOT

TRANSAMINASES MARK GAP 17.9 8.8 23.2 7.8 AVERAGE 436.2 337.6 389.0 378.1 MEDIAN 345.0 267.0 292.0 306.0 SGPT


GLYCAEMIA MARK GAP 0.1 0.1 0.1 0.1 AVERAGE 1.0 1.0 0.6 0.8 MEDIAN 0.7 0.8 0.6 0.7

TRIGLYCERIDES MARK GAP 0.5 0.3 0.3 0.4 AVERAGE 1.0 0.8 1.1 0.9 MEDIAN 0.9 0.8 1.1 0.8

CHOLESTEROL MARK GAP 0.3 0.3 0.3 0.3 Function of the kidney system The average creatinine dropped from 9.4mg/l to 8.4mg/l The kidney system was within the norms (7mg/l – 12mg/l) MONTH 0 MONTH 1 MONTH 2 MONTH 3

AVERAGE 9.4 11.3 9.2 8.4 MEDIAN 8.7 8.2 8.2 7.9

CREATININE MARK GAP 2.2 8.9 2.5 2.1

xlii

CONCLUSION On the whole, it may be concluded that the patients’ general health conditions were getting improved. The patients’ hepatic, kidney and body defence systems had improved. RECAPITULATION OF DATA ANALYSIS AFTER THE TREATMENT

AGOU MONTH 0 MONTH 1 MONTH 2 MONTH 3 WEIGHT N % N % N % N % < 50 KG 6 35.3 6 35 6 35 6 35.3 50-59 KG 8 47.1 7 41 5 29 6 35.3 60-69 KG 1 5.88 1 5.9 3 18 2 11.8 70-79 KG 2 11.8 2 12 2 12 2 11.8 80-89 KG 0 0 1 5.9 1 5.9 1 5.9 TEMPERATURE < 37°C 10 58.8 5 29 8 47 8 47.1 37°C-37.4°C 5 29.4 6 35 4 24 7 41.2 37.5°C+ 2 11.8 6 35 5 29 2 11.8 MONTH 0 MONTH 1 MONTH 2 MONTH 3 SGOT TRANSAMINASES ≤ 30 IU/L 5 29.4 8 47 6 35 6 35.3 >30 UI/L 12 70.6 9 53 11 65 11 64.7 SGPT TRANSAMINASES ≤ 30 IU/L 10 58.8 13 76 9 56 15 88.2 >30 IU/L 7 41.2 4 24 7 44 2 11.8 CHOLESTEROL 1.5 g/l -2.5g/l 1 5.88 0 0 1 5.9 1 5.9 < 1.5g/l 16 94.1 17 100 16 94 16 94.1 GLYCAEMIA < 1.5g/l 17 100 17 100 17 100 17 100.0 LYMPHOCYTES 20-40% 2 11.8 9 53 4 24 3 17.6 OVER 40% 15 88.2 8 47 12 71 14 82.4 ≤ 19% 0 0 0 0 1 5.9 0 - LEUCOCYTES 4000-10000 11 64.7 12 71 10 59 11 64.7 ≤ 3900 6 35.3 5 29 7 41 6 35.3

xliii

0 1 2 3 N % N % N % N % RED CORPUSCLES (WOMEN) 4-5 millions 0 0 0 0 1 9.1 2 18.2 OVER 5 millions 1 9.09 0 0 0 0 0 - < 4 millions 10 90.9 11 100 10 91 9 81.8

TRIGLYRERIDES (WOMEN)

0.3g/l-1.4g/l 8 72.7 9 82 11 100 10 90.9 OVER 1.4 3 27.3 2 18 0 0 1 9.1 CREATININE (WOMEN) 5mg/l -12mg/l 10 90.9 10 91 9 82 9 81.8 OVER 12mg/l 1 9.09 1 9.1 1 9.1 0 - ≤ 4mg/l 0 0 0 0 1 9.1 0 -

4.2 0 0 0 0 0 0 1 9.1 4.8 0 0 0 0 0 0 1 9.1

MONTH 0 MONTH 1 MONTH 2 MONTH 3

N % N % N % N % RED CORPUSCLES (MEN) 4,5 - 5,5 millions 4 66.7 0 0 1 17 0 - < 4,5 millions 2 33.3 6 100 5 83 6 100.0 TRIGLYRERIDES (MEN)

0.40g/l -1.50g/l 6 100 5 83 6 100 4 66.7 ove 1.5g/l 0 0 1 17 0 0 0 - < 0.40g/l 0 0 0 0 0 0 2 33.3 CREATININE (MEN) 7-13mg/l 6 100 6 100 6 100 6 100.0

xliv

LOME COMMUNE Patients’ general health conditions MONTH 0 MONTH 1 MONTH 2 MONTH 3 WEIGHT N % N % N % N % < 50 KG 5 25 3 15 4 20 3 15 50-59 KG 3 15 4 20 3 15 3 15 60-69 KG 3 15 5 25 4 20 4 20 70-79 KG 3 15 2 10 1 5 2 10 80-89 KG 4 20 3 15 4 20 4 20 90 KG+ 2 10 3 15 4 20 4 20 TEMPERATURE < 37°C 2 10 0 0 0 0 0 0 37°C-37.4°C 6 30 14 70 9 45 7 35 37.5°C+ 12 60 6 30 11 55 13 65 Function of the hepatic system MONTH 0 MONTH 1 MONTH 2 MONTH 3 SGOT TRANSAMINASES ≤ 30 IU/L 4 20 4 20 6 30 5 25 >30 IU/L 16 80 16 80 14 70 15 75 SGPT TRANSAMINASES ≤30 IU/L 10 50 11 55 11 55 12 60 >30 IU/L 10 50 9 45 9 45 8 40 CHOLESTEROL 1.5g/l - 2.5g/l 11 55 8 40 13 65 11 55 OVER 2.5g/l 1 5 2 10 0 0 0 0 < 1.5g/l 8 40 10 50 7 35 9 45 GLYCAEMIA 1.5g/l - 2.5g/l 1 5 0 0 0 0 0 0 OVER 2.5 0 0 0 0 0 0 1 5 < 1.5g/l 19 95 20 100 20 100 19 95 The body’s defence system LYMPHOCYTES 20-40% 1 5 2 10 3 15 0 0 OVER 40% 19 95 18 90 17 85 20 100 LEUCOCYTES 4000-10000 16 80 12 60 12 60 14 70 OVER 10000 0 0 0 0 1 5 0 0 ≤ 3900 4 20 8 40 7 35 6 30 MONTH 0 MONTH 1 MONTH 2 MONTH 3 RED CORPUSCLES (WOMEN) N % N % N % N % 4-5 millions 9 56.25 7 43.8 8 50 6 37.5 OVER 5 millions 2 12.5 2 12.5 2 13 3 18.8

xlv

5 31.25 7 43.8 6 38 7 43.8 TRIGLYRERIDES (WOMEN) 0.3g/l - 1.4g/L 14 87.5 13 81.3 14 88 16 100 PLUS DE 1.4g/L 2 12.5 3 18.8 2 13 0 0 CREATININE(WOMEN) 5mg/l – 12mg/L 16 100 14 87.5 15 94 16 100 OVER 12mg/l 0 0 2 12.5 1 6.3 0 0

MONTH 0 MONTH 1 MONTH 2 MONTH 3 N % N % N % N % RED CORPUSCLES (MEN) 4,5 - 5,5 millions 1 25 1 25 2 50 0 0 OVER 5,5 millions 2 50 0 0 0 0 0 0

< 4,5 millions 1 25 1 25 1 25 2 50 TRIGLYRERIDES (MEN) 0.40g/l - 1.50g/l 4 100 3 75 4 100 4 100 OVER 1.5g/l 0 0 1 25 0 0 0 0 Function of the kidney systeml MONTH 0 MONTH 1 MONTH 2 MONTH 3 CREATININE (MEN) 7mg/l- 13mg/l 4 100 3 75 2 50 4 100 OVER 13mg/l 0 0 1 25 1 25 0 0 ≤ 6mg/l 0 0 0 0 1 25 0 0

KOUVE

General Health Status of the Patients:

This was assessed with respect to the following variables: (weight, temperature, blood

pressure).

There was an increase in the patients’ average weight as they took the products (54.42 kg to

58.26 kg).




xlvi

MONTHS OF TREATMENT BIOLOGICALCONSTANTS

STATISTICS MONTH 0 MONTH 1 MONTH 2 MONTH 3 AVERAGE 54.42 56.77 58.08 58.26 MEDIAN 56.00 56.00 58.00 58.50

WEIGHT (kg) MARK GAP 7.50 8.72 8.36 9.04 AVERAGE 36.98 37.25 37.01 37.02 MEDIAN 36.90 37.20 36.90 37.00

TEMPERATURE MARK GAP .40 .40 .37 .41

Function of the Body Defence System

After the patients had taken the products for three months, the average CD4 increased

considerably (from 312 to 370).

However, there was a slight fall in the number of red corpuscles resulting in a slight anaemia with

an average haemoglobin rate ranging from 11.7% to 2.145%.

A further slight increase was observed at the leucocytes side ranging 5,853 to 5,932 with an



xlvii


AVERAGE 312 301 331 370 MEDIAN 312 267 302 363

CD4 MARK GAP 78 141 150 153 AVERAGE 4543684 4493158 4740526 4286842 MEDIAN 4460000 4300000 4750000 3930000

Number of red corpuscles MARK GAP 597143 721881 802132 664505

AVERAGE 11.71 11.66 11.77 12.45 MEDIAN 11.50 11.40 11.50 12.20 Haemoglobin rate

MARK GAP 1.97 1.81 1.91 1.97 AVERAGE 5853 6042 6426 5932 MEDIAN 5400 6100 6100 6200 Number of white

corpuscles MARK GAP 1799 1763 2397 2405 AVERAGE 35.34 44.57 49.13 44.70 MEDIAN 33.80 44.20 48.40 45.60

Lymphocytes % MARK GAP 12.37 6.54 9.00 13.04

xlviii

Function of the Hepatic System

The average transaminases and SGOT and average SGPT increased in number indicating a

change in this system( 34 IU/L to 40 IU/L).

The median glycaemia got stabilized.

The average triglycerides also dropped from1.5g/l to 0.82g/l.

There also a slight rise in the blood cholesterol level (from 0.95g/l to 1.38g/l.)

It was found that the hepatic system was getting slightly bad.

It must be noted that that area is known for the consumption of locally distilled alcohol.


AVERAGE 36.42 44.53 47.37 42.42 MEDIAN 34.00 39.00 46.00 40.00 SGOT


SGPT TRANSAMINASES MARK GAP 8.98 10.01 7.76 11.68

AVERAGE .75 .75 .75 .73 MEDIAN .74 .71 .72 .80 GLYCAEMIA

MARK GAP .12 .10 .11 .12 AVERAGE 1.50 .65 .74 .82 MEDIAN 1.36 .58 .72 .80 TRIGLYCERIDES

MARK GAP .98 .25 .25 .27 AVERAGE .95 1.28 1.41 1.38 MEDIAN 1.01 1.32 1.47 1.50

CHOLESTEROL MARK GAP .36 .49 .44 .41

xlix

Function of the kidney system The average creatinine slightly rose from 8.52mg/l to 9.09mg/l The kidney system was within the norms (7mg/l – 12mg/l) MONTH 0 MONTH 1 MONTH 2 MONTH 3

AVERAGE 8.52 8.57 8.56 9.09 MEDIAN 8.50 8.20 8.70 9.30

CREATININE AVERAGE 1.69 1.68 2.58 1.65 RECAPITULATION OF DATA ANALYSIS AFTER TREATMENT

MONTH 0 MONTH 1 MONTH 2 MONTH 3 OVER ALL N % N % N % N % N %

WEIGHT < 50 KG 4 21.1 4 21.1 4 21.1 4 21.1 16 21.1 50-59 KG 11 57.9 7 36.8 7 36.8 6 31.6 31 40.8 60-69 KG 4 21.1 7 36.8 8 42.1 7 36.8 26 34.2 70-79 KG 0 - 1 5.3 0 - 2 10.5 3 3.9 TEMPERATURE < 37°C 10 52.6 3 15.8 10 52.6 3 15.8 26 34.2 37°C-37.4°C 6 31.6 10 52.6 6 31.6 14 73.7 36 47.4 37.5°C+ 3 15.8 6 31.6 3 15.8 2 10.5 14 18.4 TOTAL 19 100.0 19 100.0 19 100.0 19 100.0 76 100.0 Function of the hepatic system

MONTHS OF TREATMENT OVER ALL MONTH 0 MONTH 1 MONTH 2 MONTH 3

N % N % N % N % N %

<=30 IU/L

7 36.8 3 15.8 5 26.3 5 26.3 20 26.3SGOT TRANSAMINASES

>30 IU/L

12 63.2 16 84.2 14 73.7 14 73.7 56 73.7

<=30 IU/L

12 63.2 10 52.6 11 57.9 14 73.7 47 61.8SGPT TRANSAMINASES

>30 IU/L

7 36.8 9 47.4 8 42.1 5 26.3 29 38.2

1.5-2.5

0 .0 5 26.3 9 47.4 10 52.6 24 31.6CHOLESTEROL

< 1.5 19 100.0 14 73.7 10 52.6 9 47.4 52 68.4GLYCAEMIA < 1.5 19 100.0 19 100.0 19 100.0 19 100.0 76 100.0TOTAL 19 100.0% 19 100.0 19 100.0 19 100.0 76 100.0 Body defence system

l

MONTHS OF TREATMENT OVER ALL 0 1 2 3 N %

N % N % N % N %

20-40% 12 63.2 3 15.8 3 15.8 3 15.8 21 27.6OVER 40%

6 31.6 16 84.2 16 84.2 15 78.9 53 69.7

LYMPHOCYTES

<=19% 1 5.3 0 .0 0 .0 1 5.3 2 2.6 4000-10000

16 84.2 16 84.2 16 84.2 13 68.4 61 80.3

OVER 10000

1 5.3 1 5.3 1 5.3 1 5.3 4 5.3

LEUCOCYTES

<=3900 2 10.5 2 10.5 2 10.5 5 26.3 11 14.5TOTAL 19 100.0 19 100.0 19 100.0 19 100.0 76 100.0

li

Function of the kidney system

MONTHS OF TREATMENT OVER ALL MONTH 0 MONTH 1 MONTH 2 MONTH 3 N % N % N % N % N %

4-5 millions

13 68.4 10 52.6 11 57.9 7 36.8 41 53.9 RED CORPUSCLES (WOMEN)

OVER 5 millions

4 21.1 5 26.3 5 26.3 2 10.5 16 21.1

< 4 millions

2 10.5 4 21.1 3 15.8 10 52.6 19 25.0

0.3-1.4 10 52.6 18 94.7 19 100.0 19 100.0 66 86.8 OVER 1.4 8 42.1 0 .0 0 .0 0 .0 8 10.5

TRIGLYRERIDES WOMEN)

< 0.3 1 5.3 1 5.3 0 .0 0 .0 2 2.6 5-12 19 100.0 19 100.0 16 84.2 18 94.7 72 94.7 OVER 12 0 .0 0 .0 2 10.5 1 5.3 3 3.9

CREATININE (WOMEN)

<=4 0 .0 0 .0 1 5.3 0 .0 1 1.3

TOTAL 19 100.0 19 100.0 19 100.0 19 100.0 76 100.0

MONTHS OF TREATMENT OVER ALL MONTH 0 MONTH 1 MONTH 2 MONTH 3 N %

N % N % N % N %

0.40-1.50 10 52.6 17 89.5 19 100.0 18 94.7 64 84.2 OVER 1.5 7 36.8 0 .0 0 .0 0 .0 7 9.2

TRIGLYRERIDES (MEN)

< 0.40 2 10.5 2 10.5 0 .0 1 5.3 5 6.6

4,5-5,5 millions

6 31.6 5 26.3 7 36.8 7 36.8 25 32.9

OVER 5,5 millions

1 5.3 2 10.5 4 21.1 1 5.3 8 10.5

RED CORPUSCLES (MEN) < 4,5 millions 12 63.2 12 63.2 8 42.1 11 57.9 43 56.6

<=6 4 21.1 3 15.8 3 15.8 3 15.8 13 17.1 CREATININE (MEN)

7-14 15 78.9 16 84.2 16 84.2 16 84.2 63 82.9

TOTAL 19 100.0 19 100.0 19 100.0 19 100.0 76 100.0 LÉGEND: Color ash = variables within the norms Red color = pathological

lii

Progression of Weight according to the center and the period

Progression of CD4 according to the centre and the period

Evolution du CD4 selon les sites et la période

347,15

420

312327,5

345

301327,5

458

331359,25

374 370

0

50

100

150

200

250

300

350

400

450

500

KODJOVIAKOPE BETHESDA KOUVE

Sites

CD4 moyen

M0 M1 M2 M3

Evolution du poids selon les sites et la période

68,8

54,8 54,4

68,3

55,2 56,7

69,5

56,1 58

70,4

56,9 58,26

0

10

20

30

40

50

60

70

80


Sites

Po

ids m

oyen

M0 M1 M2 M3

liii

Progression of Transaminases according to the centre and the period

Progression of Cholesterol according to the centre and the period

Evolution du taux de cholestérole selon les sites et la période

1,62

10,95

1,59

0,8

1,28

1,55

1,1

1,411,51

0,9

1,38

0

0,2

0,4

0,6

0,8

1

1,2

1,4

1,6

1,8


Sites

Taux moyen de

cholesterole

M0 M1 M2 M3

Evolution de la transaminase (SGOT) selon les sites et la période

50,4

30,4

36,42

44,75

24,4

44,5344,45

32,4

47,37

40,8

24,1

42,42

0

10

20

30

40

50

60


Sites

Taux moyen de transa

(SGOT)

M0 M1 M2 M3

liv

Progression of Creatinine according to the centre and the period

Evolution du taux de créatinine selon les sites et la période

9,7 9,4

8,52

9,9

11,3

8,579,25 9,2

8,569,1

8,49

0

2

4

6

8

10

12


Sites

Taux moyen de créatinine

M0 M1 M2 M3

lv

Background: Bioelectric Impedance Analysis, A New Index

for Modern Health Evaluation

62

American Journal of Clinical Nutrition, Vol 64, 524S-532S, 1996

BBiiooeelleeccttrriiccaall iimmppeeddaannccee aannaallyyssiiss iinn bbooddyy ccoommppoossiittiioonn mmeeaassuurreemmeenntt::

National Institutes of Health Technology Assessment Conference

Statement

The objective of this conference was to provide physicians with a responsible assessment of bioelectrical impedance analysis (BIA) technology for body composition measurements.

The panel concluded that BIA provides a reliable estimate of total body water under most conditions. It can be a useful technique for body composition analysis in healthy individuals and in those with a number of chronic conditions such as mild-to-moderate obesity, diabetes mellitus, and other medical conditions in which major disturbances of water distribution are not prominent.

Therefore, the panel recommends that a committee of appropriate scientific experts and instrument manufacturers be formed with the goal of setting instrument standards and procedural methods.

64

American Journal of Clinical Nutrition, 77: 331-340, 2003

DDeevveellooppmmeenntt ooff bbiiooeelleeccttrriiccaall iimmppeeddaannccee aannaallyyssiiss pprreeddiiccttiioonn eeqquuaattiioonn ffoorr bbooddyy ccoommppoossiittiioonn wwiitthh tthhee uussee ooff aa mmuullttiiccoommppoonneenntt mmooddeell ffoorr uussee iinn eeppiiddeemmiioollooggiicc ssuurrvveeyyss 11,,33,,44 Shumei S Sun, W Cameron Chumlea, Steven B Heymsfield, Henry C Lukaski, Dale Schoeller, Karl Friedl, Robert J Kuczmarski,

Katherine M Flegal, Clifford L Johnson and Van S Hubbard 1 From the Department of Community Health, Wright State University School of Medicine, Dayton, OH (SSS and WCC); the Obesity Research Center, St Lukes–Roosevelt Hospital, Columbia University, New York (SBH); the US Department of Agriculture, Agricultural Research Service, Grand Forks Human Nutrition Research Center, Grand Forks, ND (HCL); Nutritional Sciences, University of Wisconsin, Madison (DS); the Military Operational Medicine Program, Military Medical Research and Materiel Command, Frederick, MD (KF); the National Institutes of Health, Division of Digestive Diseases and Nutrition (RJK) and the Division of Nutrition Research (VSH), National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD; and the Centers for Disease Control and Prevention, National Center for Health Statistics, Division of Health Examination Statistics, Hyattsville, MD (KMF and CLJ). Background: Previous studies to develop and validate bioelectrical impedance analysis (BIA) equations to predict body composition were limited by small sample sizes, sex specificity, and reliance on reference methods that use a 2-component model. Conclusion: These equations have excellent precision and are recommended for use in epidemiological studies to describe normal levels of body composition.

65

J Acquir Immune Defic Syndr Hum Retrovirol. 1995 May 1;9(1):20-5. Bioelectrical impedance analysis as a predictor of survival in patients with human immunodeficiency virus infection. Ott M, Fischer H, Polat H, Helm EB, Frenz M, Caspary WF, Lembcke B Division of Gastroenterology, University Hospital, Johann Wolfgang Goethe University, Frankfurt, Germany. In patients with AIDS, short-term survival has been related to body weight, body composition, and serum nutritional parameters, but their prognostic impact at earlier stages of the HIV infection is not known. With an individual follow-up period of 1,000 days, we investigated the prognostic relevance of electrical tissue conductivity [resistance R, reactance Xc, phase angle alpha, extracellular mass (ECM), body cell mass (BCM)] measured by bioelectrical impedance analysis, of the CD4+ cell count, and of serum parameters indicating malnutrition in 75 HIV-infected male patients at Walter Reed stages 3-5. After initial recording, 29 patients (38.7%) died from AIDS during this period. Among 12 parameters estimated with a semiparametric Cox regression model adjusted for therapy (pentamidine, azidothymidine), the phase angle alpha (parameter estimate: -1.043, 95% confidence interval of -0.61 to -1.47; p < or = 0.0001), the ECM/BCM ratio, Xc, BCM, serum cholesterol, number of CD4+ cells, and serum albumin had significant prognostic influence on survival, whereas age, body weight, body mass index, resistance, serum protein, and serum triglycerides did not. In a model with four covariates (CD4+ cells, phase angle, pentamidine, azidothymidine), the prognostic impact of the CD4+ cell count (parameter estimate: -0.549) was lower compared with the phase angle alpha (parameter estimate: -0.799; p < or = 0.0001) and did not gain statistical significance (p = 0.0626). The phase angle alpha was the best single predictive factor for survival among all 12 parameters (comparison of the respective Cox models with the likelihood ratio test).

66

Am J Clin Nutr. 2000 Aug;72(2):496-501. PPhhaassee aannggllee ffrroomm bbiiooeelleeccttrriiccaall iimmppeeddaannccee aannaallyyssiiss rreemmaaiinnss aann iinnddeeppeennddeenntt pprreeddiiccttiivvee mmaarrkkeerr iinn HHIIVV--iinnffeecctteedd ppaattiieennttss iinn tthhee eerraa ooff hhiigghhllyy aaccttiivvee aannttiirreettrroovviirraall ttrreeaattmmeenntt.. Schwenk A, Beisenherz A, Römer K, Kremer G, Salzberger B, Elia M. Klinik I für Innere Medizin der Universität zu Köln, Cologne, Germany. BACKGROUND: Highly active antiretroviral treatment (HAART) reduces the risk of wasting in HIV infection and may alter the prognostic weight of wasting. The phase angle from bioelectrical impedance analysis (BIA) can be interpreted as a surrogate marker for the catabolic reaction to chronic HIV infection and opportunistic disease. OBJECTIVE: Our objective was to assess the prognostic ability of the phase angle in HIV-infected patients in the era of HAART. DESIGN: Two cross-sectional observation studies were conducted in 1996 and 1997 at a German university outpatient HIV clinic. In the 1996 and 1997 cohorts, HAART was prescribed to 17 of 212 and 168 of 257 patients at baseline and to 179 of 212 and 234 of 257 patients during observation, respectively. Whole-body BIA was assessed at 50 KHz. Time to clinical progression and survival were calculated by using Cox proportional hazard models with time-dependent covariates. Median observation times were 1000 and 515 d for the 1996 and 1997 cohorts, respectively. RESULTS: Higher phase angle was associated with a lower relative mortality risk, adjusted for viral load and CD4(+) cell count, of 0.49 (95% CI: 0.30, 0.81) per degree in 1996 and of 0.33 (95% CI: 0.18, 0.61) in 1997. The influence of phase angle on time to clinical progression, adjusted for viral load and CD4(+) cell count, was not significant in 1996 but the relative risk was 0.58 (0.36, 0.83) in 1997. CONCLUSION: Despite the favorable effects of HAART on the nutritional status of HIV-infected persons, low phase angle remains an independent adverse prognostic marker of clinical progression and survival.

67

68

J Nutr. 2001 Nov;131(11):2843-7. Severity of human immunodeficiency virus infection is associated with decreased phase angle, fat mass and body cell mass in adults with pulmonary tuberculosis infection in Uganda. Shah S., Whalen C., , Kotler DP., , Mayanja H., Namale A., Melikian G,, Mugerwa R, Semba RD. The Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA, USA. Although coinfection with tuberculosis and human immunodeficiency virus (HIV) is emerging as a major problem in many developing countries, nutritional status has not been well characterized in adults with tuberculosis and HIV infection. We compared nutritional status between 261 HIV-positive and 278 HIV-negative adults with pulmonary tuberculosis in Kampala, Uganda, using anthropometry and bioelectrical impedance analysis. Among 163 HIV-positive and 199 HIV-negative men, intracellular water-to-extracellular water (ICW:ECW) ratio was 1.48 +/- 0.26 and 1.59 +/- 0.48 (P = 0.006) and phase angle was 5.42 +/- 1.05 and 5.76 +/- 1.30 (P = 0.009), respectively. Among 98 HIV-positive and 79 HIV-negative women, ICW:ECW was 1.19 +/- 0.16 and 1.23 +/- 0.15 (P = 0.11) and phase angle was 5.35 +/- 1.27 and 5.43 +/- 0.93 (P = 0.61), respectively. There were no significant differences in BMI, body cell mass, fat mass or fat-free mass between HIV-positive and HIV-negative adults. Among HIV-positive subjects, BMI, ICW:ECW, body cell mass, fat mass and phase angle were significantly lower among those with CD4(+) lymphocytes < or = 200 cells/microL compared with those who had > 200 cells/microL. In sub-Saharan Africa, coinfection with pulmonary tuberculosis and HIV is associated with smaller body cell mass and intracellular water, but not fat-free mass, and by large differences in ICW:ECW and phase angle alpha.

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viprox effect on hiv/aids patients

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