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Obat Herbal: Antara Reputasi

dan Bukti

Laetrile: Reputasi VS Bukti Pada


Kanker Lanjut

Laetrile (singkong beracun) termasyhur


sebagai obat kanker. US Nationa Cancer
Institute (1978) memperkirakan 70 000 pasien
telah diobati dengan laetrile; hanya 93 orang
yang terdokumentasi, responsenya dapat
dinilai, 6 orang dinyatakan ada response.
Moertel dkk (1982) lakukan uji klinik tak
terkontrol pada 178 penderita kanker lanjut.
Median survival time 4.8 bulan, bebrapa orang
cepat mati karena intoksikasi sianida.

Vitamin C Dosis Tinggi: Reputasi


VS Bukti Pada Kanker Lanjut

Ascorbate-treated terminal cancer patients vs


matched controls: the ascorbate-treated patients
were found to have a mean survival time about 300
days greater than that of the control
(Cameron&Pauling, 1978)
In a double-blind study 100 patients with advancenave colorectal cancer were randomly assigned to
either high-dose vit.C (10 gr daily) or placebo. Vit C
therapy showed no advantage over placebo therapy
with regard to either interval between the beginning
of treatment and disease progression or patient
survival (Moertel et al, 1982).

Improved and Unimproved BPH


Treated with Saw Palmetto

3139 men from 21 randomized trials lasting 4-48


weeks were assessed. 18 trials were double-blinded
and treatment allocation concealment was adequate
in 11 studies. Compared with placebo, saw palmetto
improved urinary symptoms score, symptoms and
flow measure (Wilt et al, 2006).
225 men over 49 years who had a moderate to severe
symptoms of BPH were randomly assigned to one
year of treatment with saw palmetto (2X160 mg
daily) or placebo. Saw palmetto did not improve
symptoms or objective measures of BPH (Bent et al,
2006).
This studies raise questions about the variability of
botanical products and indicate additional studies are
needed to reach firm conclusion (Peola et al, 2006)

Bias in Systematic Review of Herbal


Medicinal Products

Reporting bias: publication bias, language


bias, citation bias, multiplr publication bias.
True heterogeneity: size effect differs
according to study size, intensity of
intervention, different in underlying risk.
Data irregularities: poor methodological
design of small studies, inadequate
analysis, fraud.
Chance factor

Concern in Herbal Medicinal


Products

Trials of herbal medicinal products have been too few,


too small, and too short.
The clinician is caught between encouraging results of
RCTs and the relative lack of controlled long-term
data.
Systematic reviews have limitations in area of herbal
medicine. They are limited by the quality and quantity
of the primary studies.
Because herbal medicinal products cannot be
patented, the incentives for research investments are
lower.
Lack quality control and standardization of herbal
medicinal products is of concern of many experts.

Various Expectation Effects Behind


the Placebo Response

Hawthorne effect : Subjects respond to knowledge of being


evaluated and observed.
Jastrow effect
: Subjects respond to explicit expectation
about outcome.
Pygmalion effect : Evaluator expect therapeutic benefit, so
they see it.
John Henry effect : Control subject attempt to emulate
expected outcomes.
Halo effect
: Subjects respond to treatment novelty.
Experimenter effect: Evaluators interpreted outcome
differently.
Socialization effect : Other reporting apparent effect
influence the outcome.
Value effect
: Costs influence expected outcome.

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