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Medical Forum / Diseases and Disorders / AIDS / December 2006

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Death - 09 Dec 2006 22:53 GMT
TEXAS: Herpes Study Authors Deny Claims that Subjects Were at Risk
Dallas Morning News (12.02.06) - Wednesday, December 08, 2006
Paul Meyer

The public interest advocacy group Public Citizen recently criticized as unnecessarily risky a
Dallas-based, placebo- controlled study of a drug therapy to prevent genital herpes outbreaks
in women during childbirth.
The GlaxoSmithKline-funded study enrolled 170 pregnant women who were given Valtrex
(valacyclovir) and 168 pregnant women given placebos. Researchers wanted to determine whether
Valtrex reduced the need for women to have C-sections to avoid transmitting the virus to their
newborns. Published this year in the journal Obstetrics & Gynecology, the study by University
of Texas Southwestern Medical Center researchers found just 4 percent of women taking Valtrex
needed a C- section, compared with 13 percent of women taking placebos.

Public Citizen said giving women a placebo put them needlessly at risk, given that researchers
could have used as a control acyclovir, a drug doctors "should consider" for women experiencing
their first genital herpes outbreak while pregnant, the American College of Obstetrics and
Gynecologists said in 1999. A few such women were in the Dallas study.

In 2003, Valtrex study senior author George Wendell and colleagues published a review of
studies and concluded giving acyclovir at 36 weeks gestation reduced the risk of outbreaks at
delivery and need for C-sections. "I, simply as a doctor myself, cannot imagine how you would
have just such a patient come to you having concluded a drug worked and then give them a dummy
pill," said Peter Lurie of Public Citizen.

In response, Wendell said the 2003 paper found evidence acyclovir might work but further
investigation was needed. "The safety of the drug in pregnancy for both the mother and baby had
not been established," he said. An Institutional Review Board approved the Valtrex study,
Wendell said.

"I think it comes down to did the women know the nature of the research and what was being
done" when they gave their consent for the study, said William Bondeson, a University of
Missouri-Columbia professor of medical ethics.
061208
AD062371
GMCarter - 10 Dec 2006 10:03 GMT
>TEXAS: Herpes Study Authors Deny Claims that Subjects Were at Risk
>Dallas Morning News (12.02.06) - Wednesday, December 08, 2006
[quoted text clipped - 3 lines]
>Dallas-based, placebo- controlled study of a drug therapy to prevent genital herpes outbreaks
>in women during childbirth.

I see. The intervention they used was peanut butter?

That's your reading of the report?
Death - 10 Dec 2006 23:22 GMT
"GMCarter" <fiar@verizon.net> wrote in message

> >TEXAS: Herpes Study Authors Deny Claims that Subjects Were at Risk
> >Dallas Morning News (12.02.06) - Wednesday, December 08, 2006
[quoted text clipped - 7 lines]
>
> That's your reading of the report?

It's as good a placebo as anything else. It has no side effects
and it is healthy food.
GMCarter - 10 Dec 2006 23:52 GMT
>"GMCarter" <fiar@verizon.net> wrote in message
>
[quoted text clipped - 14 lines]
>It's as good a placebo as anything else. It has no side effects
>and it is healthy food.

LOL...there's a cheap and rather stupid dodge from you.

Peanut butter is a lousy placebo. A placebo is meant to look and, if
need be, taste and smell and have the same appearance as the active
agent being studied.

The drug therapy to manage herpes outbreaks I seriously doubt looks,
smells nor tastes like peanut butter.

        George M. Carter
Death - 11 Dec 2006 00:10 GMT
"GMCarter" <fiar@verizon.net> wrote in message > >

> " Death" <Death@yourdoor.net>
> >>
> >It's as good a placebo as anything else. It has no side effects
> >and it is healthy food.
>
> LOL...there's a cheap and rather stupid dodge from you.

Nothing stupid about giving someone peanut butter.
It has no side effects and it is a healthy food.

Zimbabwe - Living Standards
Plummet 150% In 10 Years
From Cathy Buckle
cbuckle@mango.zw
12-9-6

Dear Family and Friends,

A shameful and very distressing report has just been released in Zimbabwe. This time it does
not come from the UN or any other international body, but from Zimbabwe's own Ministry of
Public Service and Social Welfare. Research was undertaken and statistics gathered right across
the country and included 58 rural districts and 27 urban areas.

The report says that living standards in Zimbabwe have dropped by 150% in the last ten years.
Malnutrition in children under 5 has increased by 35% and the number of people without access
to health care has increased by 48%.

Seeing the percentages in black and white is bad enough but when you see for yourself the
evidence of this dramatic decline, it is truly terrifying. In the last month the basic cost of
living in Zimbabwe went up by 47% percent. When you go shopping in a supermarket, everywhere
you look people are carrying almost nothing. Finding sources of affordable protein is almost
impossible. Meat is a luxury now - out of reach for almost all Zimbabweans.

Long, long gone are the days when we would buy strips of biltong to snack on as we walked or
when butchers would break off pieces of beer sticks to quieten niggling kids. Now people are
buying scraps, bones and something called "shavings" which are the white crumbs which
accumulate under the blade of the saws and butchery knives. Cheese is off the menu permanently;
eggs and milk are very close behind. This week one single egg is selling for 200 dollars and
half a litre of milk for 600 dollars (add 3 zeroes for the real cost). A cup of milk or an egg
for breakfast is now the height of luxury and when you understand that, then you understand why
malnutrition has increased by 35% in young children.

It hardly bears thinking how bad nutrition levels must be in the vast majority of our adult
population. Adults who, when you ask them if they have had breakfast say they are not hungry
because they have had a "very big drink of water" to fill their stomachs - it will see them
through till lunch time.

Outside the supermarkets these days there are the usual swarm of street children but if you
look a bit harder, in between the hordes, you see the really desperate ones. Old men, skin and
bone, bare feet, shaking hands, sunken eyes and it makes you just weep to see the depths we
have dropped to. So very many people need help now but so few are able to help anymore.

I end on a positive note with congratulations for our rugby team. Its always very dangerous for
me to write about sports because I know so little about it - and understand even less, however
this is a story as much about patriotism as of sports. A friend wrote to say he had just
watched the Zimbabwean rugby team do a lap of honour in the pouring rain at the end of a
tournament being played outside the country. He said the team had lost in the end but they had
done Zimbabwe proud. They were fine, upstanding men who had given their all and were so very
obviously proud to be Zimbabweans. The Zimbabweans in the crowd were equally proud to stand and
cheer the sportsmen from the country that is in such a mess, but that we all love so much. The
rugby pitch might be a million miles away from the "shavings" in the butchery but all tell the
story of the people in this wonderful country. As hard as it is, we all try to carry on as
normal because we know that bad times don't ever last.

Until next week, with love, cathy Copyright cathy buckle 9 December 2006.

<http:/africantears>http:/africantears,netfirms.com

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GMCarter - 11 Dec 2006 01:00 GMT
>"GMCarter" <fiar@verizon.net> wrote in message > >
>
[quoted text clipped - 6 lines]
>
>Nothing stupid about giving someone peanut butter.

Yes, there is something stupid about giving someone peanut butter if
they have a peanut allergy.

>It has no side effects and it is a healthy food.

An allergy could be fatal.
Death - 11 Dec 2006 01:24 GMT
"GMCarter" <fiar@verizon.net> wrote in message

> >> " Death" <Death@yourdoor.net>
> >
> >Nothing stupid about giving someone peanut butter.
>
> Yes, there is something stupid about giving someone peanut butter if
> they have a peanut allergy.

No doubt the sniffles out-weigh herpes, you're correct.
Once again you dove into the cess-pool and came up
with the lowest common denominator between your teeth,
the ole what (if).

Perhaps I should have used boxwood extract instead of peanut butter
as my placebo example.

Like the song said, nothing from nothing, leaves nothing.
GMCarter - 11 Dec 2006 12:37 GMT
snip
>Perhaps I should have used boxwood extract instead of peanut butter
>as my placebo example.

You're very confused.
Death - 11 Dec 2006 13:45 GMT
"GMCarter" <fiar@verizon.net> wrote in message

>  " Death" <Death@yourdoor.net>

> snip
> >Perhaps I should have used boxwood extract instead of peanut butter
> >as my placebo example.
>
> You're very confused.

Complementary AIDs therapies

Clinical bottom line: Acupuncture, herbal remedies, massage, stress management and
vitamins/other supplements do not appear to have any beneficial effect on immune function or
behavioural factors in patients with HIV/AIDs.

Alternative therapies are widely used by HIV/AIDs patients, even in the advanced stages of
illness, to help boost immunity, to prevent weight loss, nausea and diarrhoea and to relieve
stress or depression. Herbal therapies, vitamins, massage, acupuncture and imagery are the most
commonly used treatments.

Systematic review:
Özsoy M, Ernst E. How effective are complementary AIDs therapies for HIV and AIDS? A systematic
review. International Journal of STD and AIDS 1999;10:629-635.

Date review completed: 1997

Number of trials included: 14

Number of patients: (see below)

Control groups: placebo, sham acupuncture therapy, or no treatment.

Main outcomes: viral count; CD4+ count; effect on mood (e.g. anxiety); pain.

Inclusion criteria were: randomised trial; assessment of alternative therapies for HIV
infection or AIDs; treatment groups which included placebo, sham therapy, standard treatment or
no treatment. Medline, Embase, CISCOM, the Cochrane Library and the authors' database were
searched (all years to December 1997) for reports of studies which assessed the effectiveness
of alternative therapies for HIV infection or AIDs. Reference lists of retrieved reports were
checked for additional citations and experts were contacted. No language restrictions were
made. Data were extracted in a standardised, predefined manner. A descriptive analysis was
conducted.

Findings:

Fourteen randomised trials of variable modality, sample size and methodological rigour were
included. Various alternative therapies were assessed. The reviewers' commented on the
methodological flaws of the studies, particularly their small sample size. The presence or
absence of blinding was not mentioned; unblinded studies are open to observer bias.
Additionally, some studies where of short duration or follow-up. Numbers of patients improved
with the different treatments were not provided.

Herbal remedies:

Two randomised trials were assessed. One showed a beneficial effect of boxwood extract 990
mg/day compared with placebo on CD4 count, but was aborted due to ethical reasons.

The number of patients was not provided. The other trial showed no difference between a mixture
of 31 Chinese herbal treatments (650 mg/day for 12 weeks) and placebo on CD4 count and mood,
but was reported to have reduced neurological, gastrointestinal and respiratory symptoms and
disruption to sleep. The reviewers stated that this study was methodologically flawed: small
sample size (30 patients), short duration etc.

Vitamins and other supplements:

Five studies assessed either vitamins (A, B6, C, E), beta-carotene, selenium or other
nutritional supplements in 217 HIV-infected patients. Three studies used a placebo control. No
significant difference in CD4 count or viral load was shown between treatment and control with
any of these vitamins/supplements.

Stress management:

Five studies (178 patients) assessed stress management compared with no treatment on behaviour
and/or immune functioning in mainly HIV-positive men. One study (10 patients) showed
significantly lower stress scores and T-cell count with treatment after one month. Two studies
(104 patients) showed no difference in immune function, one (45 patients) showed a decline in
HIV-related intrusive thinking, and one (19 patients) showed significantly better scores for
anger in the group which received relaxation training than in the groups which received
psychotherapy or no treatment.

Acupuncture:

One randomised trial assessed a standardised acupuncture regimen versus sham acupuncture (239
patients), and amitriptyline versus placebo (136 patients) over 14 weeks for the relief of pain
due to HIV-related peripheral neuropathy. After 14 weeks there was no significant difference
between acupuncture and sham acupuncture. Amitriptyline was more effective than placebo after
six weeks, but no different after 14 weeks.

Massage:

One randomised trial assessed the effect of 3-15 minutes of massage therapy daily for 10 days
in 28 newborns who had been exposed to HIV. The control group received no treatment. The trial
reported improved performance and weight gain in the massage group. It was not stated if this
difference was significant.

Adverse effects

The reviewers' stated that the common belief that complementary therapies do more good than
harm is not upheld by randomised controlled trials. No further details were provided.

Comment

Many different treatments are assessed in this review; all were based on few data from studies
which were small and of variable quality. Different outcomes were used in each of the trials
which assessed stress management. This meant that studies could not be compared and the
effectiveness of this intervention on HIV/AIDs is unknown. None of these treatments worked
except, perhaps, massage, but it was not stated whether significant improvements occurred with
massage treatment for weight gain.

Further reading

1. Ernst E. Complementary AIDS therapies: the good, the bad and the ugly (editorial review).
Int J STD AIDs 1997; 8: 271-285.

2. Ernst E, White AR. Acupuncture may be associated with serious adverse events (letter). BMJ
2000;320;513.
GMCarter - 11 Dec 2006 17:01 GMT
>"GMCarter" <fiar@verizon.net> wrote in message
>
[quoted text clipped - 5 lines]
>>
>> You're very confused.

Well, this review is extremely limited, a bit out-of-date and
inaccurate.

>Complementary AIDs therapies
>
>Clinical bottom line: Acupuncture, herbal remedies, massage, stress management and
>vitamins/other supplements do not appear to have any beneficial effect on immune function or
>behavioural factors in patients with HIV/AIDs.

An unsupported conclusion.

>Alternative therapies are widely used by HIV/AIDs patients, even in the advanced stages of
>illness, to help boost immunity, to prevent weight loss, nausea and diarrhoea and to relieve
[quoted text clipped - 7 lines]
>Date review completed: 1997
>Number of trials included: 14

There are more than 14 studies of CAM--but if you randomly picked 14
pharmaceutical studies, you might conclude drugs don't work either
(like the denialists and Frod Show do). This would be erroneous.

>Number of patients: (see below)
>
[quoted text clipped - 24 lines]
>Two randomised trials were assessed. One showed a beneficial effect of boxwood extract 990
>mg/day compared with placebo on CD4 count, but was aborted due to ethical reasons.

Boxwood can have some benefit. It is hardly the only intervention for
HIV.

>The number of patients was not provided. The other trial showed no difference between a mixture
>of 31 Chinese herbal treatments (650 mg/day for 12 weeks) and placebo on CD4 count and mood,
>but was reported to have reduced neurological, gastrointestinal and respiratory symptoms and
>disruption to sleep. The reviewers stated that this study was methodologically flawed: small
>sample size (30 patients), short duration etc.

I can't comment without seeing the whole study but if it is the one I
think it is, they did see a good impact on hemoglobin levels. But that
particular blend was not effective for managing HIV disease.

>Vitamins and other supplements:
>
>Five studies assessed either vitamins (A, B6, C, E), beta-carotene, selenium or other
>nutritional supplements in 217 HIV-infected patients. Three studies used a placebo control. No
>significant difference in CD4 count or viral load was shown between treatment and control with
>any of these vitamins/supplements.

There have been more since then. Most single-nutrient studies fail to
show benefit. However, two large clinical studies of mutivitamins vs.
placebo showed in one case a 30% reduction in the rate of progression
and in the case of people with more advanced disease, no effect on
viral load or CD4 count but a significant impact on mortality and
morbidity. An inexpensive intervention that could give many additional
time as antiretroviral therapy becomes more broadly available.

The Kaiser study did see a statistically increased level of CD4 counts
when antioxidants were included with the multivitamin.

>Stress management:
snip
>Comment
>Many different treatments are assessed in this review; all were based on few data from studies
[quoted text clipped - 3 lines]
>except, perhaps, massage, but it was not stated whether significant improvements occurred with
>massage treatment for weight gain.

This comment is based on inadequate review of the literature, older
data and a distorted view of what works in HIV. There have been
studies showing benefits for acetylcarnitine in managing neuropathy
and glutamine in protease-inhibitor-related diarrhea.

There is more to health than ARV. But so far, ARV are the best drug
options for increasing lifespan and improving outcomes. They are not
mutually exclusive ideas.

        George M. Carter
Death - 11 Dec 2006 17:24 GMT
"GMCarter" <fiar@verizon.net> wrote in message

>  " Death" <Death@yourdoor.net>

> International Journal of STD and AIDS 1999;10:629-635.
> >
[quoted text clipped - 5 lines]
> Boxwood can have some benefit. It is hardly the only intervention for
> HIV.

It seems you still cling to a trial that was ended due to ethical reasons.
GMCarter - 11 Dec 2006 21:47 GMT
>"GMCarter" <fiar@verizon.net> wrote in message
>
[quoted text clipped - 11 lines]
>
>It seems you still cling to a trial that was ended due to ethical reasons.

The "ethical reasons" I believe were that more effective mult-drug
therapy were becoming routinely part of clinical practice while the
trial was underway, rendering it "unethical" to treat people with a
single botanical agent when more effective therapies were becoming
available.

It is evidence for a principle that botanical agents can have an
impact, albeit in that case, only a modest one.

For many people who either are not yet ready for ARV or who do not
have access, a safer and somewhat effective approach is better than
just waiting for the CD4 count to plummet.

        George M. Carter
Death - 11 Dec 2006 22:14 GMT
> >"GMCarter" <fiar@verizon.net> wrote in message
> >
[quoted text clipped - 4 lines]
> It is evidence for a principle that botanical agents can have an
> impact, albeit in that case, only a modest one.

http://www.vitacost.com/science/hn/Concern/HIV_Support.htm
 
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