Effect of sofosbuvir and daclatasvir on lipid profile, glycemic control and quality of life index in chronic hepatitis C, genotype 3 patients.

OBJECTIVES: The management of hepatitis C has progressed from interferon-based therapy to oral direct acting antiviral therapy. Deranged lipid levels (total cholesterol, triglyceride) after treatment with interferon-based therapy are well known. There is a paucity of data on changes in lipid profile, glycemic parameters and alteration in quality of life with the newer regimen. This study was designed to assess the changes in lipid profile, glycemic parameters, quality of life in chronic hepatitis C patients with genotype 3 after treatment with sofosbuvir and daclatasvir. METHODS: The study was a single-centre, prospective study, conducted at tertiary care hospital from January 2017 to December 2017. Fifty patients, who received sofosbuvir (400 mg) and daclatasvir (60 mg) orally once daily for a period of 12 weeks for chronic hepatitis C and genotype 3, were recruited. RESULTS: Total cholesterol levels (166.9 ± 23.8 to 192.4 ± 34.5 mg/dL, p-value < 0.0001) and low-density cholesterol (LDL) levels (100.9 ± 22.8 to 121.6 ± 37.2, p-value < 0.0001) were elevated after the treatment. A significant decrease in median levels of glycated hemoglobin (HbA1c) was observed (5.57% to 5.41%, p-value < 0.002). Quality of life markedly improved in all domains, i.e. physical, physiological, environmental, and social relationships according to an abbreviated form of World Health Organization quality of life assessment named WHOQOL-BREF questionnaire. Treatment was found to be effective with sustained virological response (SVR) achieved in 94% patients. CONCLUSIONS: Our study reports a substantial increment in total cholesterol, and low-density lipoprotein with sofosbuvir and daclatasvir treatment though it achieved SVR in 94% of patients and improved their quality of life.

Neamine and 2-deoxystreptamine neomycin derivatives exhibit antinociceptive activity in rat models of phasic, incision and neuropathic pain.

OBJECTIVES: To assess the antinociceptive activity of the neomycin derivatives neamine and 2-deoxystreptamine following intraspinal administration in rats. METHODS: We used the tail-flick test and measured the threshold to mechanical stimulation in models of incisional and neuropathic pain. KEY FINDINGS: The derivatives produced antinociception in the tail-flick test and reduced mechanical allodynia in models of incisional and neuropathic pain. The approximate ED50 in milligrams (confidence limits in parenthesis) in these tests were 1.35 mg (0.61; 2.95), 0.20 mg (0.14; 0.27) and 0.28 mg (0.12; 0.63) for neamine, and 1.05 mg (0.68; 1.60), 0.78 mg (0.776; 0.783) and 0.79 mg (0.46; 1.34) for 2-deoxystreptamine, respectively. Neamine was more potent than 2-deoxystreptamine in the incisional and neuropathic pain models, but they had similar potency in the tail-flick test. Tetra-azidoneamine, a neamine derivative in which free amino groups are replaced with azido groups, did not change the incisional mechanical allodynia. The reduction of incisional allodynia by neamine and 2-deoxystreptamine was transitorily antagonized by intrathecal administration of calcium chloride. CONCLUSIONS: The intraspinal administration of neamine and 2-deoxystreptamine is antinociceptive in rats. The presence of amino groups in the structure of these derivatives is fundamental to their antinociceptive effect, which may be due to a calcium antagonist activity.

Pharmacokinetics of neamine in rats and anti-cervical cancer activity in vitro and in vivo.

OBJECTIVE: To study the pharmacokinetics of neamine in rats and to evaluate its anti-cervical cancer activity. METHODS: The plasma level of neamine was determined by HPLC-ELSD. Pharmacokinetic parameters were calculated using DAS 2.0 software. Tissue microarray analysis was conducted to examine angiogenin (ANG) expression in normal and cancerous cervical tissues and to determine its correlation with clinical and pathologic presentations of cervical cancers. The anti-cervical cancer activity of neamine was assessed both in vitro and in vivo. RESULTS: After intravenous (i.v.) administration of 15, 30, and 60 mg kg(-1) neamine, the pharmacokinetic parameters were as follows: AUC(0-t), 9,398.0 ± 653.4, 19,235.2 ± 2,939.0, and 35,437.7 ± 3,772.2 mg L(-1) min; C max, 170.8 ± 13.1, 353.3 ± 15.8, and 464.0 ± 33.1 mg L(-1); T 1/2, 34.9 ± 4.1, 46.8 ± 5.1, and 58.0 ± 12.5 min, respectively. The bioavailability of neamine administered through intramuscular, subcutaneous, intraperitoneal and intragastric route was 14.0 ± 3.0, 8.4 ± 0.6, 6.5 ± 3.3, and 3.1 ± 0.2 %, respectively. Up-regulated ANG expression and increased nuclear translocation were observed in cervical cancers as compared to normal cervical tissues. Moreover, upregulation of ANG was positively correlated with primary tumor invasion. Neamine inhibited ANG-induced HUVEC and HeLa cell proliferation as well as nuclear translocation of ANG. Consistently, neamine inhibited both the establishment and progression of xenograft human cervical cancers in athymic mice. CONCLUSIONS: The bioavailability of neamine administered through extravascular routes was low. The half-life of neamine through i.v. administration was short. This suggests that a higher dosing frequency in order to maintain a therapeutic effect. Neamine holds potential against cervical cancer. The mechanisms of neamine inhibition are through blocking nuclear translocation of ANG thereby inhibiting both angiogenesis and cancer cell proliferation.

[The comparative effectiveness of framycetin included in combined therapy of adenoiditis in the children].

The objective of the present study was to evaluate the effectiveness of framycetin included in combined therapy of adenoiditis in the children. The study involved 67 children at the mean age of 6.9±2.7 years. Group 1 was comprised of 35 children given framycetin as topical therapy, the patients of group 2 were treated by the endonasal administration of a 2% silver proteinate solution. It was shown that the use of framycetin as a component of combined therapy of adenoiditis enhances the effectiveness of the treatment and compliance to therapy in comparison with the same parameters in the case of the application of traditional topical antibacterial preparations.

Kaposi's sarcoma-associated herpesvirus-positive primary effusion lymphoma tumor formation in NOD/SCID mice is inhibited by neomycin and neamine blocking angiogenin's nuclear translocation.

Angiogenin (ANG) is a 14-kDa multifunctional proangiogenic secreted protein whose expression level correlates with the aggressiveness of several tumors. We observed increased ANG expression and secretion in endothelial cells during de novo infection with Kaposi's sarcoma-associated herpesvirus (KSHV), in cells expressing only latency-associated nuclear antigen 1 (LANA-1) protein, and in KSHV latently infected primary effusion lymphoma (PEL) BCBL-1 and BC-3 cells. Inhibition of phospholipase Cγ (PLCγ) mediated ANG's nuclear translocation by neomycin, an aminoglycoside antibiotic (not G418-neomicin), resulted in reduced KSHV latent gene expression, increased lytic gene expression, and increased cell death of KSHV(+) PEL and endothelial cells. ANG detection in significant levels in KS and PEL lesions highlights its importance in KSHV pathogenesis. To assess the in vivo antitumor activity of neomycin and neamine (a nontoxic derivative of neomycin), BCBL-1 cells were injected intraperitoneally into NOD/SCID mice. We observed significant extended survival of mice treated with neomycin or neamine. Markers of lymphoma establishment, such as increases in animal body weight, spleen size, tumor cell spleen infiltration, and ascites volume, were observed in nontreated animals and were significantly diminished by neomycin or neamine treatments. A significant decrease in LANA-1 expression, an increase in lytic gene expression, and an increase in cleaved caspase-3 were also observed in neomycin- or neamine-treated animal ascitic cells. These studies demonstrated that ANG played an essential role in KSHV latency maintenance and BCBL-1 cell survival in vivo, and targeting ANG function by neomycin/neamine to induce the apoptosis of cells latently infected with KSHV is an attractive therapeutic strategy against KSHV-associated malignancies.

Paromomycin and neomycin B derived cationic lipids: synthesis and transfection studies.

Cationic lipid-based nonviral gene delivery is an attractive approach for therapeutic gene transfer. Basically, gene transfection can be achieved by using synthetic vectors that compact DNA, forming cationic lipoplexes which can interact with the cell plasma membrane by electrostatic interactions. Among the basic components of any cationic lipid, the type of cationic headgroup has been shown to have a major role in transfection efficiency. We have previously reported the DNA transfection potential of vectors characterized by a kanamycin A headgroup. The encouraging transfection results obtained with these compounds prompted us to evaluate the potential of cationic lipids bearing headgroups based on other aminoglycosides. Thus, we herein report the synthesis and gene transfection properties of novel cationic lipids consisting of cholesteryl or dioleyl moieties linked, via various spacers, to paromomycin or neomycin B headgroups. Our results confirm that these new aminoglycoside-based cationic lipids are efficient for gene transfection both in vitro and into the mouse airways in vivo. We also investigated physico-chemical properties of the DNA complexes formed by this particular type of synthetic vectors in order to better understand their structure-activity relationships.

Risk factors associated with bacteriological cure, new infection, and incidence of clinical mastitis after dry cow therapy with three different antibiotics.

Factors affecting bacteriological cure rates (BCR) and new intramammary infections (IMI) during the dry period as well as clinical mastitis (CM) during early lactation were investigated in 414 German Holstein dairy cows receiving dry cow therapy. Cows were treated with either benethamine benzylpenicillin (300,000 IU), penethamate hydriodide (100,000 IU), and framycetin sulphate (100 mg, n = 136), or cefquinome (150 mg, n = 135), or benzathine cloxacillin (1,280 mg, n = 143). Overall BCR, IMI, and CM at parturition were 86.4%, 20.7%, and 4.3%, respectively. The three antibiotic treatments differed only in BCR, with cloxacillin yielding better results than the others. Udder quarters from cows with > 4 lactations had a higher risk of IMI and CM at calving. Chronic changes in udder tissues were linked to a lower BCR and were associated with a higher risk of CM during early lactation. The risk of CM at calving was higher in udder quarters with unspecific or subclinical mastitis before drying off. In conclusion, with antibiotic dry cow therapy, age and health status of the udder appear to be major determinants of IMI and CM during the dry period and early lactation, while BCR was associated with the antibiotic type and udder tissue status.

The effect of dry cow therapy and internal teat-sealant on intra-mammary infections during subsequent lactation.

Dry cow therapy (DCT), an infusion of antibiotics into the mammary gland at the end of lactation, is widely used for the control of intra-mammary infections (IMI) in the dairy cow. However, increased public health concerns about the use of antibiotics, has led to the search for alternatives to the routine use of antibiotics during drying off. In the present study the effects of three dry cow treatments, two types of DCT and a teat-sealant, on the development of new IMI and clinical mastitis were investigated in 240 cows belonging to two herds (Herd A and Herd B). In Herd A, 60 cows were given one type of DCT (Cloxacillin) and the other 60 cows were given another type of DCT (Framycetin). In Herd B, 60 cows were given teat-sealant and the other herd were not given any treatment. There were significantly more new IMI at calving in control cattle compared to those given teat-sealants (p<0.001) and there were more cases of clinical cases of mastitis in the control group. The number of clinical cases detected in cows given teat-sealant in Herd B were not significantly different from those detected in cows in Herd A given Cloxacillin or Framycetin.

Risk factors associated with bacteriological cure, new infection, and incidence of clinical mastitis after dry cow therapy with three different antibiotics

Factors affecting bacteriological cure rates (BCR) and new intramammary infections (IMI) during the dry period as well as clinical mastitis (CM) during early lactation were investigated in 414 German Holstein dairy cows receiving dry cow therapy. Cows were treated with either benethamine benzylpenicillin (300,000 IU), penethamate hydriodide (100,000 IU), and framycetin sulphate (100 mg, n = 136), or cefquinome (150 mg, n = 135), or benzathine cloxacillin (1,280 mg, n = 143). Overall BCR, IMI, and CM at parturition were 86.4%, 20.7%, and 4.3%, respectively. The three antibiotic treatments differed only in BCR, with cloxacillin yielding better results than the others. Udder quarters from cows with > 4 lactations had a higher risk of IMI and CM at calving. Chronic changes in udder tissues were linked to a lower BCR and were associated with a higher risk of CM during early lactation. The risk of CM at calving was higher in udder quarters with unspecific or subclinical mastitis before drying off. In conclusion, with antibiotic dry cow therapy, age and health status of the udder appear to be major determinants of IMI and CM during the dry period and early lactation, while BCR was associated with the antibiotic type and udder tissue status.

Influence of an intramammary infusion at drying-off of combined penethamate hydriodide, benethamine penicillin, and framycetin sulfate on intramammary infections and somatic cell counts in dairy sheep.

The dynamics of intramammary infection (IMI) during the dry period were studied in 435 half-udders of 229 Assaf ewes, belonging to 2 flocks with high and medium IMI prevalences. Ewes were randomly assigned to 2 lots: 1) treated lot (TL) with 223 half-udders (118 ewes), which received complete dry therapy (1 syringe/teat) of an antibiotic combination containing 100 mg of penethamate hydriodide, 280 mg of benethamine penicillin, and 100 mg of framycetin sulfate, and 2) control lot (CL) with 212 nontreated half-udders (111 ewes). Two samplings per half-udder were carried out on 2 different days in the 5 d preceding drying-off, and 2 other samplings were again carried out in the 5 first d of the postpartum period. The length of the dry period averaged 109.0 d. Cure, persistent infections, reinfection, and new infection rates were 81.7, 12.8, 5.5, and 7.9%, respectively, for TL and 13.3, 70.4, 16.3, and 22.8%, respectively, for the CL. The prevalence of IMI decreased significantly from 48.9% at drying-off to 13.0% at lambing for the TL, but it did not vary for the CL (46.2 and 52.4%, respectively). Within the TL, IMI prevalence significantly diminished for Staphylococcus (41.3 to 9.9%) and Streptococcus (5.8 to 1.8%) genera, and more specifically this decrease was most evident for Staphylococcus epidermidis and Streptococcus agalactiae species. Log somatic cell count (SCC) diminished significantly between drying-off (5.68) and lambing (5.33) in the TL, whereas log SCC did not vary in the CL (5.61 vs. 5.66). This SCC reduction was very significant in the flock with the greater IMI prevalence. As a conclusion, the antibiotic formulation used as dry therapy drastically diminished IMI prevalence and SCC during the dry period in dairy ewes as a result of greater IMI cure rates and lower reinfection and new infection rates in the TL compared with the CL.

Topical ciprofloxin versus topical framycetin-gramicidin-dexamethasone in Australian aboriginal children with recently treated chronic suppurative otitis media: a randomized controlled trial.

BACKGROUND: Chronic suppurative otitis media (CSOM) affects many children in disadvantaged populations. The most appropriate topical antibiotic treatment in children with persistent disease is unclear. METHODS: Children with CSOM despite standard topical treatment were randomized to 6-8 weeks of topical ciprofloxacin (CIP) versus topical framycetin-gramicidin-dexamethasone (FGD). Otoscopic, audiologic, and microbiologic outcomes were measured using standardized assessments and blinding. RESULTS: Ninety-seven children were randomized. Ear discharge failed to resolve at the end of therapy in 70% children regardless of allocation [risk difference = -2%; (95% CI: -20 to 16)]. Healing of the tympanic membrane occurred in one of 50 children in the CIP group and none of 47 children in the FGD group. Severity of discharge failed to improve in more than 50% children in each group, and mean hearing threshold (38 dB and 35 dB) and proportion of children with greater than 25 dB hearing loss (98% and 88%) were not significantly different between the CIP and FGD groups. Side effects were rare. CONCLUSIONS: This study showed a similarly low rate of improvement or cure in children with persistent CSOM for both CIP and FGD topical therapies. Complications and side effects were insufficient to cease therapy or inform prescribing of either therapy.

Expansile properties of otowicks: an in vitro study.

OBJECTIVE: To determine the expansile and absorptive properties of the expandable ear wick when tested with commonly prescribed ear drop preparations. DESIGN: This in vitro study assessed wick expansion and absorption of drops when different ear drop preparations were applied. Nine commonly used ear drop preparations were tested (Gentisone HC, Sofradex, Otomize, Betnesol, Exocin, Canesten, Locorten-Vioform, EarCalm and ichthammol glycerin) with a standard expandable ear wick. MAIN OUTCOME MEASURES: Weight, length and width of otowick following exposure to ear drops. RESULTS: There was a marked difference in the absorption and expansion of the otowick when different drops were used. This corresponded to the aqueous or oil base of each preparation. All aqueous ear drop preparations (i.e. Gentisone HC, Sofradex, Otomize, Betnesol, Exocin and EarCalm) produced similar rates of absorption into, and expansion of, the otowick. The oil-based ear drop preparations (i.e. Canesten, Locorten-Vioform and ichthammol glycerin) failed to expand the wick and showed poor rates of absorption into the wick. CONCLUSION: Expandable ear wicks should only be used in conjunction with aqueous ear drops. When using expandable otowicks as an adjunct to treating fungal otitis externa, acetic acid ear drops should be prescribed, as all other anti-fungal drops are oil-based.

A blinded in-vitro study to compare the efficacy of five topical ear drops in clearing grommets blocked with thick middle ear effusion fluid.

OBJECTIVE: To compare the efficacy of 5% NaHCO3, 3% H2O2, Sofradex (dexamethasone sodium metasulphobenzoate 0.05%, framycetin sulphate 0.5%, gramicidin 0.005%), 0.33% acetic acid and 0.9% NaCl eardrops in clearing grommets blocked with harvested thick middle ear effusion fluid. STUDY DESIGN: A blinded in-vitro study. SETTING: District general hospital. PARTICIPANTS: A total of 473 grommets were blocked with freshly harvested unpooled thick middle ear effusion fluid obtained from 68 patients. MAIN OUTCOME MEASURES: Patency of the grommets before and 7 days after intervention was ascertained by tympanometry and close visual inspection. RESULTS: Instillation of eardrops leads to a statistically significant increase in the clearance of grommets as compared with not using any drops (chi2 = 14.3, d.f. = 5, P = 0.006). The numbers needed to treat were 2.8 for NaHCO3, 3.2 for 0.9% NaCl, 3.9 for 0.33% acetic Acid, 4.4 for Sofradex and 9.5 for H2O2 eardrops. Pair-wise comparison was only significant for comparison between 5% NaHCO3 and 3% H2O2 eardrops (Bonferroni corrected P = 0.01, odds ratio = 4.3, CI = 1.9-9.9). CONCLUSIONS: Use of eardrops leads to a clinically and statistically significant increase in the clearance of blocked grommets. Of the five drops used, 5% NaHCO3 was the most efficacious and 3% H2O2 the least efficacious. Limitations of this in-vitro study are recognized and a prospective in-vivo double blind randomized controlled trial is planned.

[The effectiveness of some methods in eliminating bacteria from the root canal of a tooth with chronic apical periodontitis]. / Skutecznosc wybranych metod leczenia przewleklych zapalen tkanek okolowierzcholkowych w eliminacji bakterii z kanalu korzeniowego zeba.

MATERIAL AND METHODS: [corrected] The study material consisted of 45 teeth with chronic apical periodontitis treated in 37 patients (22 females and 15 males). The aim of the study was to determine the effectiveness of one-visit (group 1, 26 teeth) and two-visit endodontic treatment with iodoform and pulpomixine between visits (group II, 19 teeth) in eliminating bacteria from the root canal. RESULTS: Microbiological samples were cultured and microorganisms were identified before and after treatment. A rich and varied bacterial flora was found in all samples before treatment. Following treatment, there were 17 (65.4%) bacteria-free root canals and 9 (34.6%) canals with sparse bacterial flora in group I and 15 (78.9%) bacteria-free and 4 (21.1%) bacteria-containing root canals in group II. CONCLUSION: We conclude that both methods performed similarly and neither method was fully effective in eliminating bacteria from the root canals.

The use of perioperative Sofradex eardrops in preventing tympanostomy tube blockage: a prospective double-blinded randomized-controlled trial.

Around 11-12% of tympanostomy tubes are reported to become blocked by middle ear secretions or blood immediately following surgery, and so no longer function. Many otologists routinely instil an antibiotic and steroid-containing solution at the time of surgery in the belief that this may reduce this complication. The aim of the study was to investigate the efficacy of instilling the antibiotic and steroid-containing solution Sofradex at the time of grommet insertion in preventing grommet blockage. Double-blind randomized-controlled trial, comparing rates of grommet blockage in ears treated with Sofradex drops against control (no drops) in patients undergoing bilateral grommet insertion. Sixty-one pairs of results were obtained. There was a significant difference between the rates of grommet blockage in the two groups. Grommets with Sofradex drops instilled perioperatively were nine times less likely to be blocked than controls [1.6%versus 13.1%, odds ratio (Sofradex/control) = 9.06, 95% confidence interval (CI): 1.04-78.82, P = 0.05]. There was no association between grommet blockage and perioperative bleeding or the nature and presence of middle ear secretions. Sofradex eardrops are effective in reducing the rate of grommet blockage when instilled perioperatively.

Efficacy and safety of topical ciprofloxacin/dexamethasone versus neomycin/polymyxin B/hydrocortisone for otitis externa.

OBJECTIVES: To compare the efficacy and safety of ciprofloxacin 0.3%/dexamethasone 0.1% (CIP/DEX) otic suspension with that of neomycin 0.35%/polymyxin B 10,000 IU/mL/hydrocortisone 1.0% (N/P/H) otic suspension in patients with acute otitis externa (AOE). STUDY DESIGN: Randomized, observer-masked, parallel-group, multicenter study. Patients were randomized to 7 days treatment with either CIP/DEX 3-4 drops twice daily or N/P/H 3-4 drops three times daily. POPULATION: Patients of either sex and older than 1 year, with a clinical diagnosis of mild, moderate, or severe AOE and intact tympanic membranes were recruited to participate. OUTCOMES MEASURED: Signs and symptoms of AOE, including ear inflammation, tenderness, edema and discharge (assessed on Days 3, 8 [End-of-Therapy] and 18 [Test-of-Cure]); microbiologic eradication (presumed or documented); and frequency of adverse events. RESULTS: Patients enrolled numbered 468. In culture-positive patients who met the inclusion criteria (N = 396), clinical cure rates at Day 18 were significantly higher with CIP/DEX than with N/P/H (90.9% vs. 83.9%; p = 0.0375), as were microbiologic eradication rates (94.7% vs. 86.0%; p = 0.0057). In addition, the clinical response was significantly better with CIP/DEX than with N/P/H at Days 3 and 18 (p = 0.0279 and p = 0.0321, respectively), as was the reduction in ear inflammation at Day 18 (p = 0.0268). Both preparations were well tolerated in pediatric and adult patients. CONCLUSIONS: 7 days treatment with CIP/DEX otic suspension administered twice daily is clinically and microbiologically superior to N/P/H otic suspension administered 3 times daily in the treatment of mild to severe AOE, and is equally well tolerated.

Randomized, double-blind trial comparing topical nitroglycerine with xylocaine and Proctosedyl in idiopathic chronic anal fissure.

OBJECTIVE: To compare symptomatic relief, healing, and changes in maximal anal resting pressure with the use of topical formulations in patients with chronic anal fissure. METHODS: Sixty-four consecutive patients with chronic anal fissure were randomized into 4 groups that received, in a double-blind manner, a topical ointment that contained 0.2% nitroglycerine (GTN), 5% xylocaine, Proctosedyl (hydrocortisone acetate, heparin, framycetin sulfate, esculoside, ethoform, butoform) or petroleum jelly (Vaseline), to be applied twice daily. Patients were reviewed at 2-week intervals for 6 weeks. Anal manometry was done before, and 20 minutes after, the first application of the ointment. RESULTS: There was significant (p < 0.0001) reduction in mean anal resting pressure after application of GTN, but not any other ointment. Of 16 patients receiving GTN, complete pain relief occurred in 6 and 15 patients after 2 and 4 weeks of treatment, respectively; this was more frequent than in the other 3 groups. At 6 weeks also, complete pain relief occurred more often with GTN than with Vaseline or xylocaine. After 4 weeks of treatment, 3 patients on GTN had complete healing of fissure as compared to one each in the xylocaine and Proctosedyl groups and none in the Vaseline group. At 6 weeks, healing of fissure had occurred in 15 of 16 patients receiving GTN as compared to 4 receiving Vaseline, 11 receiving xylocaine, and 12 on Proctosedyl. CONCLUSIONS: Topical nitroglycerine produces 'chemical sphincterotomy' with reduction in mean anal resting pressure. Pain relief and healing of fissure occurred earlier with GTN than with other treatments. GTN should be considered as the treatment of choice for the non-surgical management of patients with chronic anal fissure.

Effectiveness of ototopical antibiotics for chronic suppurative otitis media in Aboriginal children: a community-based, multicentre, double-blind randomised controlled trial.

OBJECTIVES: To compare the effectiveness of ototopical ciprofloxacin (0.3%; CIP) with framycetin (0.5%), gramicidin, dexamethasone (FGD) eardrops (5 drops twice daily for 9 days) together with povidone-iodine (0.5%) ear cleaning as treatments for chronic suppurative otitis media (CSOM) in Aboriginal children. DESIGN AND PARTICIPANTS: Aboriginal community-controlled, community-based, multicentre, double-blind, randomised controlled trial in eight Aboriginal Community Controlled Health Services across northern Australia, involving 147 Aboriginal children with CSOM. MAIN OUTCOME MEASURES: Resolution of otorrhoea (clinical cure), proportion of children with healed perforated tympanic membrane (TM) and improved hearing, 10-21 days after starting treatment. RESULTS: 111 children aged 1-14 years (CIP, 55; FGD, 56) completed treatment. CSOM cures occurred in 64% (CIP, 76.4%; FGD, 51.8%), with a significantly higher rate in the ciprofloxacin group (P = 0.009, absolute difference of 24.6% [95% CI, 15.8%-33.4%]). TM perforation size and the level of hearing impairment did not change. Pseudomonas aeruginosa was the most common bacterial pathogen (in 47.6%), while respiratory pathogens were rare (in 5.7%). CONCLUSIONS: Twice-daily ear cleaning and topical ciprofloxacin is effective at community-level in achieving cure for CSOM. Healthcare providers to Aboriginal children with CSOM should be given special access to provide ototopical ciprofloxacin as first-line treatment.

Comparison of compliance between topical aural medications.

Patients receiving Gentisone HC, Sofradex and Otomize for chronic suppurative otitis media and otitis externa were investigated for compliance of medication. Drops were accurately weighed before and after use so that both the amount used and the expected amount patients should have used could be calculated. The amount used differed statistically from the amount expected for Sofradex (P = 0.0008) but not for Gentisone HC (P = 0.1049) or Otomize (P = 0.7553) when analysed by a Mann-Whitney U-test. There was a trend to overdose with both Sofradex & Gentisone HC. The reason for the differences, we believe, is due to a combination of both differing delivery systems and drop viscosities. Manufacturers need to improve delivery systems so that patients can deliver a reproducible volume of medication each time with ease.