Table 4.
Overview of clinical studies with dequalinium chloride (DQC)
| Publication and design | Subjects and indications | Medication | Efficacy | Safety |
|---|---|---|---|---|
| Monopreparation | ||||
| Weissenbacher, 2012 [32] Controlled, comparative |
321: BV—321 | Fluomizin® vaginal tablets vs. clindamycin 2 % cream vaginal 6 days |
At week 1, cure rates were 81.5 % with 10 mg DQC and 78.4 % in clindamycin group. 10 mg DQC vaginal tablets had equal efficacy as a clindamycin vaginal cream. At week 4, cure rates were 79.5 % with 10 mg DQC and 77.6 % with clindamycin, demonstrating that the efficacy of DQC was not inferior to that of clindamycin (significant). | Only ADRs - discharge followed by vulvovaginal pruritus |
| Radzinsky et al., 2011 [107] Comparative, two-stage therapy |
622: BV—409; ‘nonspecific vaginitis’—213 | Fluomizin® vaginal tablets 6 days vs. standard anti-infective treatment (afterwards Gynoflor® restoration) |
Fluomizin® group – cure 77.8 % (best dynamics observed for disappearance of the ‘clue cells’); standard antiinfective treatment – cure 77.1 % (average). | Not assessed |
| Dankovich and Gopchuk, 2006 [102] Open, pre-operative prophylaxis |
45: Abnormal vaginal flora—45 | Fluomizin® vaginal tablets 6 days | Disturbed vaginal flora in 44 women became healthy, only 1/45 patient had complication after surgery. | None |
| Grishchenko et al., 2006 [104] Open |
66 (pregnant): BV—66 | Fluomizin® (34) vs. povidone-iodide vaginal | Sanitation of vagina, demonstrated favourable pregnancy conditions and perinatal outcomes. | None |
| Grishchenko et al. 2006 [105] | 76: Mixed infection—76 | Fluomizin® (45) vs. chlorhexidine bigluconate vaginal | Cure rate after the treatment with Fluomizin®—96.7 %, with chlorhexidine bigluconate—66.0 %. | Local ADRs—5 patients; discontinued therapy—2 |
| Demina et al., 2005 [103] Open |
60 (pregnant): BV and ‘opportunistic flora vaginitis’—60 | Fluomizin® (32) vs. povidone iodine vaginal | Vaginal ecosystem recovery—in all pregnant women of group I after one treatment, and vaginal clearance of degrees I and II was seen in 91.7 %. No Candida albicans after Fluomizin®. | None |
| Petersen, 2002 [26] Controlled |
121: BV—48; VVC—23; TV—5; other—45 | Fluomizin® vaginal tablets vs. povidone iodine vaginal | Symptoms decreased in the Fluomycin® group from 5.13 to 1.33. BV: 96 % and 82 % of women were diagnosed BV-negative after therapy at short- and long-term follow-up, respectively. VVC: symptoms decreased from 6.5 at to 1.1. Flour vaginalis: symptoms decreased from 5.0 to 1.3. | 5.8 % reported a local ADRs |
| Schmidt, 2000 (unpublished) Open, drug utilisation trial |
446 (60 pregnant) BV—126; TV—10; VVC—97; flour vaginalis—213 |
Fluomycin® N (10 mg DQC) vaginal tablets, daily 6 days | 303 patients (67.9 %) at entry showed 3 to 4 symptoms, whereas at control only 42 patients (9.4 %). A distinct improvement in all documented clinical symptoms. | None |
| Strecker, 1993 [28] Open |
388 (mixed group is included twice) BV—375; VVC—113 |
Gyken® ovula twice (3 or 4 days interval) | Negative microscopy (cure): BV—115 (31 %); VVC—86 (76 %) | 1 case of enhanced sleepiness |
| Warnecke, 1976 [101] Open |
100 fluor vaginalis—7; ‘non-infective colpitis’—80; other—13 |
Eriosept® 0.1 % vaginal spray once daily 3 days (84), 6 days (11) |
Negative microscopy (cure): Fluor vaginalis—4 (57 %); ‘non-infective colpitis’—67 (84 %); other—10 (77 %) | None |
| Fauner, 1974 [91] Open |
55 (pregnant) VVC: 55 |
Dequavagyn® depot once, eventual repetition after 1 week | Negative microscopy (cure): VVC first therapy—46 (84 %), second therapy—8 (14 %) | None |
| Kucera, 1973 [93] Active-controlled |
150: Bacterial fluor vaginalis—116; VVC—15; TV—14; mixed infection—5 | Dequavagyn® depot alone or with 0.0015 % estriol, or with 0.02 % estriol (Oestro-Dequavagyn®) twice, repetition after 1 week | Negative microscopy (cure, Dequavagyn® depot alone): flour vaginalis—30 (79 %), VVC—3 (75 %), TV—4 (67 %), mixed infection—0 (0 %) | Not assessed |
| Kolbe, 1972 [92] Open |
124: Bacterial fluor vaginalis—42; VVC—50; TV—27; TV + VVC—5 | Dequavagyn® depot once, eventual repetition after 10 days | Cure (examination not specified): Bacterial fluor vaginalis—42(100 %), VVC—47 (94 %). TV—26(96 %), TV +VVC—3 (60 %) | 1 case of generalised pruritus |
| Mühlbauer, 1972 [97] Open |
134: Bacterial fluor vaginalis—44; VVC—78; TV—12 | Dequavagyn® depot once (continuous DQC release over 8-10 days) | Negative microscopy (cure): Bacterial fluor vaginalis—33 (76 %), VVC 56 (72 %), TV—2 (24 %) | None |
| Tatra, 1972 [100] Open |
311: Bacterial fluor vaginalis—180; VVC—69; TV—48; TV + VVC—13 | Dequavagyn® depot once, eventual repetition after 10 days | Negative microscopy (cure): Bacterial fluor vaginalis—147 (82 %), VVC—53 (77 %), TV—8 (30 %), TV + VVC 0 (0 %) | 1 case of generalised pruritus |
| Lange, 1971 [94] Open |
82: Bacterial fluor vaginalis—8; VVC—38; TV—36 | Dequavagyn® depot once, eventual repetition after 10 days | Negative microscopy (cure): Bacterial fluor vaginalis—8 (73 %), VVC—38 (76 %), TV - 36 (92 %) | 1 case of purulent discharge |
| Martin & Martin, 1971; Martin, 1971 [34, 96] Open |
200 (several indications possible): Bacterial fluor vaginalis—44; VVC—173; TV—4; ‘super-infection’—21 | Dequavagyn® depot once, eventual repetition after 10 days | Negative microscopy (cure): Bacterial fluor vaginalis—9 (66 %), VVC—117 (68 %), TV—2 (50 %), ‘super-infection’—19 (90 %) | 1 case of pruritus (allergy) |
| Atlante, 1959 [88] Open |
60 (4 mixed): VVC—2; TV—60 | Dequadin® pessary twice daily 5–6 days, repeated after menstruation | Negative microscopy (cure): VVC—4 (67 %), TV—54 (90 %) | None |
| Levinson, 1959 [95] Open |
43: TV—43 | Dequadin® pessary twice daily 4 weeks | Negative microscopy (cure after 10 days): TV—17 (40 %) | Not assessed |
| Roddie, 1958 [99] Open |
70: Bacterial fluor vaginalis—30; VVC—4; TV—36 | Dequadin® pessary twice daily 2 weeks | Symptoms after 2 weeks (absent/improved): bacterial fluor vaginalis—16 (59 %)/4 (15 %), VVC—2 (67 %)/1 (33 %), TV—1 (3 %)/5 (14 %) | None |
| Combination(s) | ||||
| Rippmann, 1974 [98] Open |
106: VVC—26; TV—31; mixed infection—49 | Oestro-Dequavagyn® (DQC + 0.02 % estriol) twice, repetition after 1 week (continuous DQC release over 8–10 days) | Negative microscopy (cure): VVC—18 (69 %), TV—11 (35 %), mixed infection—39 (80 %) | none |