The following are critiques of the Kusum study:
- No placebo control. Kusum et al. discuss the difficulty in finding
a suitable control, given the pungent smell and taste of the Chinese herb
preparation.
- Small size.
- This study used laboratory markers of disease progression as its
endpoints--not decreased mortality, decreased morbidity, decreased incidence
of opportunistic infections...etc. In other words, not any of the
outcomes that hold the highest importance to AIDS patients. To measure
the impact that a decreased viral load would have on any of these outcomes,
a longer study would need to be designed. Kusum et al essential say
this at the end of their discussion.
- No T cell response observed, and since absolute T cell count may be the
best predictor of clinical outcomes in PLWA, actual clinical benefit is
questionable.10
- There were no P-levels reported to aid in the reader's evaluation of the
significance of the decrease in viral load. Instead, the decreases
were reported as significant based on whether they were greater that 0.5 log
units, if mRNA versus time was plotted on a log-rhythmic scale. This
0.5 log number comes from previous studies that evaluated the anti-HIV
activity of other drugs, and seems to be a convention between different
investigators. However, Kusum does a poor job explaining this to the
reader, and it is not clear whether this seemly-arbitrary number correlates
to any actual clinical benefit in the patient.
|
