Angola Electrotherapy Study - 9 March 2006

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Investigation of the effect of a multi wave oscillator in the treatment of adult HIV/AIDS patients: Authors: Campbell N R, Paspaliaris V, Ballard R Enquiries: Prof. N. Campbell, P O Box 137, Parkville. Vic. 3052 Australia Email: noelc@smile.org.au Abstract In this study 26 patients infected with the HIV-1 virus were treated daily for two months with an electrotherapy device and their results compared with 27 non-treated patients matched for sex and age who were not participating in any anti-HIV
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   1 Investigation of the effect of a multi wave oscillator in the treatment of adult HIV/AIDS patients: Authors: Campbell N R, Paspaliaris V, Ballard R  Enquiries: Prof. N. Campbell, P O Box 137, Parkville. Vic. 3052 AustraliaEmail:noelc@smile.org.au  Abstract In this study 26 patients infected with the HIV-1 virus were treated daily fortwo months with an electrotherapy device and their results compared with27 non-treated patients matched for sex and age who were not participatingin any anti-HIV treatment.Over the 2 months of the trial, CD4 cell numbers reduced by 12% in thenon-treated patients.The treated group showed a 5% increase in CD4 cell numbers.CD8 cell numbers dropped by 17% in the non-treated patients, andincreased by 18% in the treated patients, over the same 2 months.In addition HIV viral loads increased by 109% in the untreated patients, anddecreased by 6% in treated patients.In many parts of the world where HIV infection is particularly rife, there areinsufficient financial resources to pay for treatment with anti-viral drugs.This electrotherapy technique appears to be a low cost method for treatingHIV infected patients who cannot afford conventional anti-viral treatment,and so are currently receiving no treatment at all.Further investigation of this electrotherapy methodology in large-scalemulti-centre trials is warranted. Introduction It is well known that human immunodeficiency virus (HIV) infection leads todepressed cellular immunity, which can result in serious opportunistic infectionsin acquired immune deficiency syndrome (AIDS) patients (Gottlieb et al. 1981;Gallo et al. 1984). At present, combination anti-retroviral drug regimens includingprotease inhibitors are used as a standard therapy for HIV-1 infection.Access to antiretroviral drugs for HIV-infected patients in developing countries is   2 a global public health priority. With the support of multilateral and bilateralprogrammes, non-governmental organisations, and national authorities, WHOhas the ambitious objective to treat 3 million people with highly activeantiretroviral therapy (HAART) by 2005 (WHO, UNAIDS 2003). WHO currentlyrecommends first-line therapy with two nucleoside reverse transcriptaseinhibitors (NRTIs) and one non-NRTI (NNRTI), a combination with good efficacy,tolerability and simplicity, low cost, and good adherence to treatment (WHO2003).Generic fixed-dose combinations of such regimens are widely regarded ascrucial for scaling-up AIDS treatment in developing countries. These treatmentsimprove adherence owing to the fewer daily doses relative to individualformulations. Supply, storage, and distribution are also easier because the rangeof products is smaller. Generic drugs are generally much cheaper than brand-name formulations. Several generic fixed-dose combinations have been pre-qualified by WHO (WHO 2004) after assessment of manufacturers’ product data(including data for purity of all ingredients, stability of the finished products, andresults of in-vivo bioequivalence tests), actual pharmacological composition,and manufacturing practices. However, these formulations are not yetrecommended by some of the major donor agencies, such as the USgovernment's multi-billion dollar PEPFAR (President's emergency plan for AIDSrelief funding) programme for developing countries (USAID 2004). In addition topolitical considerations, particularly on the legitimacy and consequences of usinggeneric instead of brand-name drugs, this situation is partly explained by theabsence of clinical studies showing the efficacy and tolerability of generic fixed-dose combinations. Quality control of different drug batches is also a difficulty inmost developing countries.The generic fixed-dose combination of nevirapine, stavudine, and lamivudine(Cipla, Mumbai Central, Mumbai, India) is one of the most frequently prescribedtreatments in African countries. In Angola, a south west African country withmore than 15 million inhabitants, the prevalence of HIV infection is increasingrapidly, with up to 8% of town-dwelling pregnant women infected (UNAIDS 2002).HIV-1 predominates, and HIV-1 groups M, N, and O and many subtypes andcirculating recombinant forms co-circulate (Vergne at al 2003). A nationalantiretroviral access programme has started, most usually based on the genericcombination of nevirapine, stavudine, and lamivudine owing to its low price.However the sad fact remains that many AIDS-infected patients in Angola gowithout any anti-viral treatment.Use of these combination therapies has dramatically decreased morbidity andmortality rates in HIV-1 infected individuals (Hogg et al. 1997; Cameron et al.1998; Palella et al. 1998). However, such intensive combination therapies havevarious drawbacks, such as drug side-effects, the complexity of the therapeuticregime, and the appearance of resistant HIV strains (Carr et al. 1998; Colgroveet al. 1998; Sarmati et al. 2002). So far, it appears that these combination anti-   3 retroviral drug regimens must remain in use until a radical curative treatment andHIV-1 vaccine are established. Therefore, therapies based on new principlesother than drug treatment would appear to be highly desirable.Electrical stimulation effects on living cells have been extensively studied sincethe 1970s (Zimmerman et al. 1974). It has been reported that use of high d.c.voltage pulse application not only induces changes in cellular membranestructure and permeability, but also results in its breakdown (Berg et al. 1984;Powell et al. 1986). Moreover, cells suspended in solution were found to beeasily fused by pulses of high d.c. voltage (Zimmerman 1982). On the otherhand, pulses of low d.c. voltage are known to regulate cellular proliferation andprotein production together with induction of differentiation of various cell types(Kojima et al. 1992; Mie et al. 1996; Aizawa et al. 1999).Furthermore, the effects of electrical stimulation on HeLa cells chronicallyinfected with HIV-1 LAI and on uninfected P6 HeLa cells (Tominaga et al. 2003)has been reported, and the possible causes for the significant damage thatoccurs to infected P6 HeLa/HIV-1 LAI cells compared with uninfected control cellshas been considered.In this study we tested the effectiveness of an electrotherapy apparatus (The Bio-Lyfe machine), that delivered an oscillating electrical signal via hand-held probes,on the immunological parameters and viral load in HIV infected patients.   Methods All participants in the trial were periodically monitored with respect to their clinicalfeatures; any side effects were noted. Blood was withdrawn and placed intotubes with ethylenediaminetetraacetic acid (EDTA) as anticoagulant; the plasmawas used in tests and some was also stored at -70C. Laboratory tests,including routine blood tests, and CD4 and CD8 counts, were performed at theMilitary Hospital. The HIV viral load was determined in the HIV Laboratory,Laboratory Services Branch, of the Military Hospital which used the sensitivitycut-off value of 10 000 HIV copies of RNA per millilitre) (Chiron Diagnostics1997). All data and clinical records were kept confidential.In this study, 37 patients with HIV infection were treated with The Bio-Lyfemachine. The treatment period was at least 2 months. Patients were exposed tohand held electrode probes daily for 20 minutes at the highest tolerable current.There were no obvious side effects reported throughout the two months.Compliance was difficult to maintain as it involved patients coming to a medicalcentre daily. Seven patients were discontinued from the trial due to poorcompliance. Thirty HIV infected patients who were not participating in any anti-HIV treatment were randomly chosen from the hospital database and matchedwith trial patients who were observed for two months.   4  The CD4 and CD8 counts and HIV viral loads of patients were measured beforethe trial, at 1 month and at 2 months of treatment with the Bio-Lyfe machine(Tables 1 and 2). These results were compared to test results for the untreatedpatients. All patients gave their written informed consent.
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