#21 Does Lubricant reduce the adequacy of the PAP test?

CLINICAL QUESTION

QUESTION CLINIQUE

Does the use of small amount of water soluble lubricant on the speculum reduce the adequacy of the PAP test?

BOTTOM LINE

RÉSULTAT FINAL

A small amount of water-soluble lubricant on a speculum does not reduce the quality of the PAP test and probably does not affect microbiologic results. Adequacy of liquid-based PAP tests may be minimally affected or not at all.

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EVIDENCE

DONNÉES PROBANTES

The largest randomized controlled trial (RCT)¹: 2,906 patients.

Water soluble lubricant on speculum versus tap water.
No difference in quality of cytology.

Four smaller RCTs:

70 to 400 patients: No difference in PAP test adequacy.^2-5
Two investigated and found pain scores significantly lower in the lubricant group^4,5 (example, mean score on visual analogue scale 1.4 in the lubricant group and 2.2 in the water group, p<0.01).⁴

Quasi-randomized, 3,460 PAP tests.⁶

No difference in PAP test adequacy.

Conventional cervical cytology smears (glass slide) were used in most studies.^1-3,5,6 A meta-analysis of these trials plus another quasi-RCT found no difference on PAP test adequacy or pain scores.⁷ Context:

One study found “more than the usual amount of gel” could affect PAP test adequacy by applying an additional 1-1.5 cm ‘ribbon’ of gel directly to the cervical os before sampling.⁸
- Clinicians don’t do this, and it is not applicable to regular practice.
One RCT assessed lubricant influence on liquid-based PAP tests and found no effect, although it may have been underpowered.⁵
Two retrospective cohorts using liquid-based cytology found:
- More unsatisfactory smears when lubricant was used (4.3% versus 1.8%, p=0.01).⁹
- Obscuring material causing misinterpretation of PAP results on 0.4%: ~half may have been related to lubricant use.¹⁰
Two studies applied lubricant directly into liquid-based cervical cytology samples:^11,12
- One reported reduced cell counts, but impact on adequacy was not assessed/reported.¹¹
- The second demonstrated no impact on liquid-based PAP test outcomes.¹²
One RCT also examined if lubricant affected testing for Chlamydia and found no effect after 5,535 samples.⁶ (Gonorrhea too uncommon to assess.)
- A laboratory study demonstrated that gel mixed with Chlamydia and Gonnorrhea cultures did not impact plating or diagnosis.¹³

reviewed dec 6 2017 by ricky