Microsoft word - fleishman 15jun04.doc

Adjunctive steroids for reducing residual pleural effusion in patients

CITATION
Fleishman SI, Coetzee AM, Mindel S, Berjak J, Lichter AI. Antituberculous therapy combined with
adrenal steroids in the treatment of pleural effusions: a controlled therapeutic trial. Lancet. 1960 Jan
23;1:199-201
RESEARCH QUESTION
Compared to standard therapy, how effective is adjunctive steroid therapy for treating patients with
pleural effusion of unknown cause?
THE STUDY
Controlled therapeutic trial.
STUDY SETTING
Central hospital within the mining area of Witwatersrand, Johannesburg.
PARTICIPANTS
Included:
Mineworkers with pleural effusion of unknown cause, presumably all men. Patients with Pulmonary Tuberculosis (TB), other TB, adenopathy, abdominal masses, vitamin deficiency, bilateral effusions.
INTERVENTIONS
1. Treatment V: Ascorbic Acid 500mg IM daily for 14 days 2. Treatment P: Procaine Penicillin 300,000 units IM twice daily for 14 days 3. Treatment T: ATT (see below) 4. Treatment TS: ATT plus corticosteroids (see below) ATT Plus
Description
Frequency
3 times daily, then 3 times daily for rest of 8 weeks Duration
for 2 days at higher dose, rest of 8 weeks at lower dose
Co-interventions:
OUTCOMES
Primary:
Reduction in the extent of pleural effusion Are scurvy and pneumonia involved in the pathogenesis of pleurisy?
RISK OF BIAS

SELECTION BIAS: moderate to high
Previously prepared sealed instructions of treatment. As each case was admitted to the trial,
hospital clerical staff drew one so that the treatment was allocated at random. Table 1: Appears to
be balanced for Initial weights and Initial ESR. However no other parameters (e.g. demographics)
are reported on. The ESR appears to be low for TB for which you would normally expect readings
of around 40+ mm/hr.
PERFORMANCE BIAS: low
(ie: What else happened that may have affected the result?)
Patients not blinded - Not a problem since outcome is not affected by patient’s performance.
Patients were confined to hospital – good compliance to therapy
Period of bed rest varied according to “patient’s condition” – article did not clarify who made this
judgement.
Initial aspiration of 20 ml of pleural fluid may affect first four weeks’ score.

DETECTION BIAS: low
Pleural effusions were scored by a panel of 5 doctors who, according to the authors, were blinded
to the patient's treatment. No indication that the laboratory staff was blinded.
However, it appears as if the panel were aware of the treatment given at the beginning of the trial
since on page 200, column 2 – "this result became known only at the completion of his course of
treatment" almost indicating that they would have changed the treatment had they known?


ATTRITION BIAS:
No intention to treat analysis performed.
Total

STUDY FINDINGS
Significant reduction in the extent of the effusion in TS at 4 weeks
No significant reduction seen from 4 weeks to 8 weeks

PRESENCE OF RESIDUAL FLUID (95% CI)
Treatment


ADVERSE EVENTS
Four patients deteriorated: Treatment change from V, P to T, TS
COMMENTS
Adjunctive steroid therapy appears to be an effective treatment for reducing residual pleural fluid in
patients with pleural effusion of unknown cause.
Prepared by: MARK ENGEL
E-mail:

Source: http://www.mrc.ac.za/cochrane/fleishman.pdf