Are a Speculum Examination and Wet Mount Always Necessary for Patients With Vaginal Symptoms? A Pilot Randomized Controlled Trial

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Figure 1.
Flow chart of participant enrollment, randomization, follow-up and analysis (based on the CONSORT Flow Diagram: http://www.consort-statement.org/consort-statement/flow-diagram/).

Table 1.

Management Algorithm and Treatments for Vaginal Symptoms

Control Group	Intervention Group	Treatments
Patient meets 3 or 4 Amsel criteria and is diagnosed with bacterial vaginosis	Patients whose chief complaint is odor are diagnosed with presumptive bacterial vaginosis	Metronidazole 500 mg bid for 7 days Alternative: Clindamycin 2% cream intravaginal bid for 7 days or Metrogel intravaginal qhs for 5 days
Yeast forms are seen and patient is diagnosed with candidiasis	Patients whose chief complaint is itching or irritation are diagnosed with presumptive candidiasis	Fluconazole 150 mg po once at the time of visit Alternative: Terconazole vaginal cream or suppositories
Trichomonads are seen on microscopy or Trichomonas vaginalis culture is positive	Patients treated if culture is positive	Metronidazole 2 g po at the time of visit; partner referred for treatment Alternative: Metronidazole 500 mg po bid for 5 days
If none of the above, provider may either treat as per the intervention arm or not treat	All other patients are treated for both presumptive candidiasis and presumptive bacterial vaginosis

Table 2.

Characteristics of the Study Population of Forty-six Women with Vaginal Symptoms

* The woman in the intervention group used oral contraceptive pills. Two women in the control group used oral contraceptive pills and 2 used Depo-Provera.
† Some women took more than one therapy. Specific types of self-therapy shown as n.
STD, sexually transmitted disease; FHC, family health center.

Table 3.

Initial Management of Forty-six Women with Vaginal Symptoms

	Intervention Group (n = 24)	Control Group (n = 22)
Bacterial vaginosis
Empiric	9	1
Confirmed	0	9
Candidal vaginitis
Empiric	14	3
Confirmed	0	8
Both bacterial vaginosis and candida	1	0
No treatment given	0	1

Table 4.

Relationship Between Symptom Resolution, Diagnosis, and Clinical Management*

	No Better	Somewhat Better	Completely Better
All women	3	13	28
Control group
No diagnosis	1	0	0
Confirmed Candida	2	2	4
Confirmed bacterial vaginosis	0	2	6
Empiric Candida	0	3	0
Empiric bacterial vaginosis	0	1	0
Intervention group^†
Empiric bacterial vaginosis	0	2	7
Empiric Candida	0	3	10
Both empiric bacterial vaginosis and empiric Candida	0	0	1
Women with STD
Trichomonas	0	1	0
GC and Chlamydia	0	0	1

All data provided as n.
* Two women were lost to follow-up. One of these had trichomonas.
† Women in the ntervention group showed superior resolution of symptoms (P = .046; Fischer's exact test).
STD, sexually transmitted disease; GC, Gonorrhea.