AC Health|FamilyDoc

Department of Family and Community Medicine

Evidence Based Medicine

Jeanne Mae L. Afalla, MD

First Year Resident

Training Officer: Nenacia Ranali Nirena R. Palma-Mendoza, MD

Department Chair: Ma. Eufemia Collao, MD
EVIDENCE BASED MEDICINE
PIOM

POPULATION Patients with Bacterial Vaginosis

INTERVENTION Probiotics + Metronidazole versus Placebo +
Metronidazole
OUTCOME Reduce the recurrence rates of bacterial
vaginosis
METHOD Randomized controlled Trial
 Are the results Valid
Was the assignment of patients to treatments randomized?
YES
This multicentre, randomised, double-blind, placebo controlled, parallelgroup study was conducted
between March 2009 and February 2012. p2

All eligible women were given at I visit a standard treatment (500 mg oral metronidazole twice daily for
7 days) and were randomly assigned to one of two study arms (1:1) (using block randomisation with a block
size of 12 and equal group ratios) to receive probiotic or placebo twice daily for 10 days. p3
 Are the results Valid
Were all patients who entered the trial properly accounted for
and attributed at its conclusion?
YES
The safety analysis included 578 participants in the intent-to-treat population, 241 (prOVag group, n = 118;
placebo group, n = 123) of whom complied with the recommended regimen and completed treatment
(i.e.used 20 capsules). No participant was excluded from the study due to an adverse event, and no serious
adverse event related to the use of the probiotic product occurred. In total, there were 431 adverse events in
160 participants, which accounts for 28 % of the population for which the safety analysis was carried out (ITT);
prOVag was used by 77 of these participants. There were no significant differences between the total numbers
of adverse events reported in either of the study groups.. p4
 Are the results Valid
Were patients, health workers and study personnel blind to
treatment?
YES In the main study the methodology mentioned that study was double
blind placebo controlled
 Are the results Valid
Were the groups similar
at the start of
treatment?
YES. Table 2 of the results
section showed no major
difference in the baseline
characteristics between the
two groups.
 Are the results Valid
Aside from experimental intervention, were the groups treated
equally?
YES. There were no planned co-intervention for the two groups
 What are the Results
How large was the treatment effect?

Primary Outcome:
Clinical Recurrence:
Average times to relapse were:
47.3 [standard deviation (SD) = 26.98] days in the placebo group
71.4 (SD = 37.51) days in the prOVag group.
This interval, which was up to 51 % longer in the prOVag group, differed significantly
between placebo-treated
and control patients (t = 2.606, p = 0.0125; Fig. 2). p4
 What are the Results
How large was the treatment effect?
Primary outcome: Microbiological recurrence
I. Risk in control (Rc) = 38/81= 0. 47 (47%)
II. Risk in treatment (Rt)= 33/73= 0.45 (45 %)
III. Absolute Risk Reduction: 47-45%= 2%, therefore proVag
reduces the risk of relapse by 2%
IV. Relative Risk= 0.45/ 0.47 = 0.95
V. Relative Risk Reduction= .05 (5%)
VI. Numbers Needed to treat= 100/2%= 50
 What are the Results
How precise was the estimate of the treatment effect?

The average times to relapse were 47.3 [standard deviation (SD) = 26.98] days in the
placebo group and 71.4 (SD = 37.51) days in the prOVag group. This interval, which
was up to 51 % longer in the prOVag group, differed significantly between placebo-
treated and control patients (t = 2.606, p = 0.0125; Fig. 2)

Relative Risk of relapse from provag compared to placebo is 0.95, This difference
approached statistical significance (2 = 4.883, p = 0.0870).