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Is the placebo powerless? An analysis of clinical trials comparing placebo

with no treatment.

Hrobjartsson A, Gotzsche PC.

Department of Medical Philosophy and Clinical Theory, University of

Copenhagen, Panum

Institute, and the Nordic Cochrane Centre, Rigshospitalet, Denmark.

a.hrobjartsson@...

BACKGROUND: Placebo treatments have been reported to help patients with many

diseases,

but the quality of the evidence supporting this finding has not been

rigorously evaluated.

METHODS: We conducted a systematic review of clinical trials in which

patients were randomly

assigned to either placebo or no treatment. A placebo could be pharmacologic

(e.g., a tablet),

physical (e.g., a manipulation), or psychological (e.g., a conversation).

RESULTS: We identified

130 trials that met our inclusion criteria. After the exclusion of 16 trials

without relevant data on

outcomes, there were 32 with binary outcomes (involving 3795 patients, with

a median of 51

patients per trial) and 82 with continuous outcomes (involving 4730

patients, with a median of

27 patients per trial). As compared with no treatment, placebo had no

significant effect on binary

outcomes (pooled relative risk of an unwanted outcome with placebo, 0.95; 95

percent confidence

interval, 0.88 to 1.02), regardless of whether these outcomes were

subjective or objective. For

the trials with continuous outcomes, placebo had a beneficial effect (pooled

standardized mean

difference in the value for an unwanted outcome between the placebo and

untreated groups, -0.28;

95 percent confidence interval, -0.38 to -0.19), but the effect decreased

with increasing sample

size, indicating a possible bias related to the effects of small trials. The

pooled standardized mean

difference was significant for the trials with subjective outcomes (-0.36;

95 percent confidence

interval, -0.47 to -0.25) but not for those with objective outcomes. In 27

trials involving the

treatment of pain, placebo had a beneficial effect (-0.27; 95 percent

confidence interval, -0.40

to -0.15). This corresponded to a reduction in the intensity of pain of 6.5

mm on a 100-mm

visual-analogue scale.

CONCLUSIONS: We found little evidence in general that placebos had

powerful clinical effects. Although placebos had no significant effects on

objective or binary

outcomes, they had possible small benefits in studies with continuous

subjective outcomes and

for the treatment of pain. Outside the setting of clinical trials, there is

no justification for the use

of placebos.

-----------------------------------

This is an abstract of the article cited in quackwatch. I know these people

mean well, but

spare me! For about 8 *years* I said " but there really is something wrong

with me. I have

numbness in two fingers that never goes away. Occasionally I limp for no

reason. I have

been seeing double. "

I was dismissed as a hypochondriac. Those people would have had a lot less

to put up

with had I been correctly diagnosed. Now I am hearing that folks who have

had a prolonged

remission from progressive MS are just imagining things. In your dreams!

If somebody tells

you they're sick, they probably are, even if *you* can't diagnose it. If

somebody with progressive

MS tells you they're feeling better, you had better listen! It is a

violation of the Hippocratic

oath to deliberately ignore a valid treatment, just as surely as it is to

administer poison. It

is a sin of omission that can cause great harm.

Use of placebo outside of the conditions stated in the conclusions above is

misleading to the

scientific and general public, where objective measures are available (MRI,

EDSS, etc.). It

leads them not to believe empirical evidence unless it is compared

statistically to placebo. If

most people could cure MS by mental force they would. If someone tells you

they are in remission

for the first time in years, look for a reason and don't tell them they did

it by pseudo-magic

jiggery pokery. Measure it!

The other thing about the placebo effect is it does not last. It cannot

last for a year.

So what's the use of controlling with it in a two year trial? Forget it,

man, it can't happen.

Unless you happen to *like* making people poke themselves with needles and

inject saline.

So don't bother calculating statistical validity as compared to placebo when

it is exactly

the same (except for sadistic thrills) as no treatment.

-Sullivan

" He's not pining, he's passed on... this is an ex-parrot! "

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