Table 2. Clinical, Bacteriologic, Therapeutic, and Standard Amsel Criteria Cure Ratesa.
| Outcome | No. of cured patients/total No. with nonmissing data (%) | Treatment difference (95% CI) | P value | |
|---|---|---|---|---|
| Dequalinium chloride | Metronidazole | |||
| Primary outcome | ||||
| Clinical cure rate at visit 1 | ||||
| Intention-to-treat population | 64/69 (92.8) | 69/74 (93.2) | −0.5 (−10.8 to 9.8) | .002 |
| Per-protocol population | 54/58 (93.1) | 48/53 (90.6) | 2.5 (−9.4 to 14.4) | .001 |
| Secondary outcomes (intention to treat) | ||||
| Clinical cure rate | ||||
| Visit 2 | 55/69 (79.7) | 62/71 (87.3) | −7.6 (−20.1 to 4.8) | .12 |
| Bacteriologic cure rate | ||||
| Visit 1 | 35/69 (50.7) | 51/74 (68.9) | −18.2 (−34.1 to −2.3) | .65 |
| Visit 2 | 28/69 (40.6) | 38/71 (53.5) | −12.9 (−29.3 to 3.4) | .40 |
| Therapeutic cure rate | ||||
| Visit 1 | 34/69 (49.3) | 48/74 (64.9) | −15.6 (−31.6 to 0.5) | .53 |
| Visit 2 | 26/69 (37.7) | 33/71 (46.5) | −8.8 (−25 to 7.4) | .23 |
| Standard Amsel criteria cure rate | ||||
| Visit 1 | 68/69 (98.6) | 73/74 (98.6) | −0.1 (−8.9 to 8.7) | <.001 |
| Visit 2 | 61/69 (88.4) | 67/71 (94.4) | −6.0 (−16.2 to 4.3) | .04 |
a
Findings of the noninferiority analyses for the primary and secondary outcomes are given. The primary outcome was analyzed using the intention-to-treat and per-protocol populations. The secondary outcomes were analyzed using the intention-to-treat population. Visit 1 was 7 to 11 days after treatment start; visit 2 was 20 to 40 days after treatment start. The 95% CIs and P values are based on the Farrington-Manning test with a 1-sided significance level of α = .025 and a noninferiority margin of 15 percentage points.