Fenticonazole nitrate for treatment of vulvovaginitis: efficacy, safety, and tolerability of 1-gram ovules, administered as ultra-short 2-day regimen.

Because of its potential as a low cost first-line monotherapy for the most common vulvovaginal infections, we evaluated fenticonazole nitrate in a prospective, open-label, multicenter pilot study with 101 sexually active women (per-protocol; 16 to 61 years of age) with vulvovaginitis involving single or mixed infections with Candida albicans, Trichomonas vaginalis, and/or Gardnerella vaginalis. Fenticonazole nitrate (1 g) was administered as vaginal ovules, once daily on days 1 and 3. Eradication (direct phase-contrast microscopy of vaginal swabs and/or microbiological culture) on day 8 was 90% (C. albicans, 26/29, p < 0.001), 70% (T. vaginalis, 7/10, p = 0.161), 67% (G. vaginalis, 22/33, p < 0.009), and 45% (mixed infection, 13/29, p = 0.001). After 28 days, relapse was 0% for candidiasis and trichomoniasis, 27% (6/22) for G. vaginalis, and 23% (3/13) for mixed infection. Overall, eradication of all offending pathogens was achieved in 67% of the total per-protocol population, with a relapse rate of only 16%. Score sums for symptoms improved from 7.0 (baseline) to 1.7 (day 8), and 0.71 (day 28), (p < 0.001). Treatment was safe and well tolerated. The results of our pilot study suggest that application of fenticonazole nitrate 1 g intravaginal ovules on 2 alternate days is a suitable first-line treatment of vulvovaginitis with acceptable broad-spectrum efficacy against the most commonly involved pathogens and with a low rate of early relapse, reserving antibiotics for patients with treatment failure or relapse of infection. Our results should encourage further examination of this approach in larger and well controlled clinical trials.

Comparison of Three 7-Day Pantoprazole-Based Helicobacter pylori Eradication Regimens in a Mexican Population with High Metronidazole Resistance.

OBJECTIVE: To compare the efficacy and tolerability of three 7-day pantoprazole-based regimens to eradicate Helicobacter pylori in Mexican patients with peptic ulcer (PU) or non-ulcer dyspepsia (NUD). BACKGROUND: Short-term therapeutic regimens based on a proton pump inhibitor (PPI) and two antibiotics have been recommended for the eradication of H. pylori. Resistance of H. pylori to metronidazole may adversely affect the efficacy of such regimens. PATIENTS AND METHODS: This was a single-centre, randomised, open-label, parallel-group study in which three groups of H. pylori-positive patients with PU or NUD were compared (n = 159; intention-to-treat population). Patients were randomised to receive a 7-day pantoprazole-based triple therapy for eradication of H. pylori. Patients received pantoprazole (P) 40mg twice daily in combination with either i) amoxicillin (A) 1000mg twice daily and clarithromycin (C) 500mg three times daily (PAC regimen, n = 51 patients), or ii) clarithromycin 500mg three times daily and metronidazole (M) 500mg three times daily (PCM regimen, n = 55 patients), or iii) amoxicillin 1000mg twice daily and metronidazole 500mg three times daily (PAM regimen, n = 53 patients). After completing eradication therapy, all PU patients were further treated with once-daily pantoprazole 40mg, either for another 3 weeks (patients with duodenal ulcer) or for another 7 weeks (patients with gastric ulcer), to ensure complete ulcer healing. At baseline examination, all patients underwent the (14)C-urea breath test and endoscopy; biopsy specimens were taken for histology, CLO-test, H. pylori culture and antibiotic susceptibility testing (agar dilution E-test). Eradication of H. pylori was assessed after all treatment with pantoprazole had been discontinued for at least 4 weeks, using the (14)C-urea breath test. RESULTS: In the per-protocol population (n = 153), eradication was achieved in 81.3% (39/48) of patients receiving PAC, 66.0% (35/53) of PCM recipients, and 48.1 % (25/52) of those receiving PAM (p = 0.13 for PAC vs PCM and 0.001 for PAC vs PAM). In the intention-to-treat population, respective eradication rates were 76.5 (39/51), 63.6 (35/55) and 47.2% (25/53) [p = 0.22 for PAC vs PCM and 0.004 for PAC vs PAM]. Patient compliance was very good in all treatment groups. The main adverse event affecting 40% of all patients was a metallic taste, assessed as likely related to the antibiotics. Susceptibility to the three study antibiotics was determined for H. pylori isolates using the pretreatment biopsies from 103 patients. Resistance to metronidazole was present in 68.2% of patients and to clarithromycin in 24.3%. In 16.8% of patients, H. pylori isolates were resistant to both metronidazole and clarithromycin. In patient populations with H. pylori strains resistant to one or both of the antibiotics used in the respective treatment regimen, eradication rates were consistently lower than in those with susceptible H. pylori strains. However, these differences were not statistically significant, probably due to the small sample size. CONCLUSIONS: The 7-day H. pylori eradication regimen with PAC was superior to PCM and PAM. This is probably due to the high resistance rate to metronidazole in the Mexican population. Thus, H. pylori eradication regimens that involve metronidazole cannot be recommended for Mexican patients. RESULTS from this study highlight the regional differences in efficacy of some well established H. pylori eradication regimens, and suggest that culture and susceptibility testing to define H. pylori resistance patterns in specific geographical areas may be indicated before recommending any particular eradication schedule.

[Comparison of 2 schedules based on pantoprazole for eradication of Helicobacter pylori in patients with active duodenal ulcer]. / Comparación de dos esquemas basados en pantoprazol para erradicación de Helicobacter pylori en pacientes con úlcera duodenal activa.

OBJECTIVE: To compare the efficacy and tolerability of a triple vs dual pantoprazole based therapy to eradicate Helicobacter pylori (H. pylori) in mexican patients with florid duodenal ulcer. BACKGROUND: The treatment of peptic ulcer disease was revolutionized by the fact that H. pylori generally induces chronic gastritis and peptic ulcer disease and that the cure of the infection prevents ulcer relapses. MATERIAL AND METHODS: 74 H. pylori positive patients with florid duodenal ulcer were randomized to receive either pantoprazole 40 mg bid in combination with clarithromycin 500 mg tid and amoxicillin 1 g bid (triple regimen PAC) or pantoprazole in combination with clarithromycin and placebo (dual regimen PC) during 14 days. To ensure complete ulcer healing all patients received an additional 2 weeks treatment with pantoprazole 40 mg od. 14C Urea Breath test (UBT) was the main criteria used to determine eradication rate with < 150 disintegrations per minute (DPM) to consider a patient eradicated. In all patients culture, antibiotic susceptibility (E-test) and histology were performed. RESULTS: In the per protocol analysis (n = 66) the eradication rate was: PAC 93.5% vs PC 54.3% (p < 0.001). 76% of H. pylori strains were resistant to metronidazole. Tolerance and compliance were excellent in both groups. CONCLUSIONS: Triple therapy (PAC) was shown to be superior to dual therapy (PC) for H. pylori eradication in mexican patients with florid duodenal ulcer.

[Clinical superiority of pantoprazole over ranitidine in the treatment of reflux esophagitis grade II and III. A prospective, double-blind, double-placebo study. Mexican clinical experience. Mexican Pantoprazole Study Group]. / Superioridad clínica del pantoprazol sobre la ranitidina en la curación de la esofagitis por reflujo grado II y III. Estudio prospectivo, doble ciego, doble placebo. Experiencia clínica mexicana Grupo Mexicano de Estudio del Pantoprazol.

OBJECTIVE: To compare and contrast the efficacy and tolerability of a proton pump inhibitor, pantoprazole, to that of an H2 antagonist, ranitidine, in the treatment of patients with mild to severe reflux esophagitis. BACKGROUND: Reflux esophagitis is a common illness affecting 5-10% of the world's population. Acid reflux plays a major role in the disease's genesis, as do esophageal and gastric motility disturbances. METHODS: 315 patients (intent to treat) with endoscopically confirmed reflux esophagitis (Savary-Miller (SM) stages II and III) were recruited to the study by 46 mexican investigators in nine centers. Patients received either pantoprazole 40 mg once daily or ranitidine 150 mg twice daily in this double blind, randomized, parallel group study. Patients not achieving complete endoscopic healing after four weeks of therapy received an additional four weeks of treatment. Drug tolerability was assessed by adverse event reporting during the study. RESULTS: After four weeks pantoprazole therapy, 81% of patients with SM II and 67% of the patients with SM III were healed; in contrast ranitidine healed only 67 and 30% of the patients respectively, all results expressed on an per-protocol basis. After eight weeks therapy the healing rates for pantoprazole group increased to 94% and the ranitidine group to 74% (p = 0.001). The incidence of adverse events was less than 2% in both treatment groups, thus both therapies were found to be well tolerated. CONCLUSIONS: Pantoprazole is superior to ranitidine in the treatment of mild to severe reflux esophagitis and is equally well tolerated.

[Breath tests as a noninvasive diagnostic method in Helicobacter pylori infection]. / La prueba de aliento como método diagnóstico no invasivo en la infección por Helicobacter pylori.

There are several diagnostic methods for Helicobacter pylori infection, some of them need an endoscopic procedure and biopsy to be performed (invasive) like the rapid urease test, culture and histology. Recently non invasive, specific, sensible, easy to perform and patient's well accepted methods had been developed known as breath test, based on the hydrolysis of labelled urea by Helicobacter pylori urease enzyme, to release ammonia and bicarbonate. Labelled CO2 reaches the bloodstream and the lungs, from where can be collected into the breath for quantification. Labelled urea has to options: 13C stable, non-radioactive and 14C unstable, radioactive. Breath test with 13C is based on the atomic mass difference between 12C and 13C and it is necessary a mass spectrometer and 40 minutes to perform it. Breath test with 14C has 1 uCi (one micro-curie) of radioactivity (1/300 of total radiation received in one year from the environment); the test takes 10 minutes and the samples are read in a beta counter. Both non-invasive tests had demonstrated sensitivity and specificity comparable to established "gold standards" for Helicobacter pylori infection diagnosis.

Reduction of post-prandial motility by pinaverium bromide a calcium channel blocker acting selectively on the gastrointestinal tract in patients with irritable bowel syndrome.

BACKGROUND: Growing evidence points to irritable bowel syndrome physiologically as a disease of the enteric nervous system characterised by hypermotility. The aim of this study was to investigate the action of pinaverium bromide a calcium channel blocker acting selectively on the gastrointestinal tract on basal and post-prandial recto-anal motility of 40 irritable bowel syndrome patients in a random, double blind and placebo controlled trial. METHODS: Pinaverium bromide (50 mg) or placebo was taken orally t.i.d. with food. Myoelectrical and mechanical activities of the rectum and the internal anal sphincter were recorded before treatment for 2 h in the fasting state and for an additional 2 h post-prandial. RESULTS: Post-prandial rectal spike amplitude and frequency as well as the spontaneous recto-anal inhibitory reflex frequency decreased after pinaverium bromide (P < 0.01) but not after placebo. CONCLUSIONS: These results suggest that the calcium channel blockers acting selectively on the gastrointestinal tract may have a therapeutic role in patients with irritable bowel syndrome.

Reduction of post-prandial motility by pinaverium bromide a calcium channel blocker acting selectively on the gastrointestinal tract in patients with irritable bowel syndrome

Background: Growing evidence points to irritable bowel syndrome physiologically as a disease of the enteric nervous system characterised by hypermotility. The aim of this study was to investigate the action of pinaverium bromide a calcium channel blocker acting selectively on the gastrointestinal tract on basal and post-prandial recto-anal motility of 40 irritable bowel syndrome patients in a random, double blind and placebo controlled trial. Methods: Pinaverium bromide (50 mg) or placebo was taken orally t.i.d with food. Myoelectrical and mechanical activities of the rectum and the internal anal sphincter were recorded before treatment for 2 h in the fasting state and for an additional 2 h post-prandial. Results: Post-prandial rectal spike amplitude and frequency as well as the spontaneous recto-anal inhibitory reflex frequency decreased after pinaverium bromide (P < 0.01) but not after placebo. Conclusions: These results suggest that the calcium channel blockers acting selectively on the gastrointestinal tract may have a therapeutic role in patients with irritable bowel syndrome.

Reduction of post-prandial motility by pinaverium bromide a calcium channel blocker acting selectively on the gastrointestinal tract in patients with irritable bowel syndrome

Background: Growing evidence points to irritable bowel syndrome physiologically as a disease of the enteric nervous system characterised by hypermotility. The aim of this study was to investigate the action of pinaverium bromide a calcium channel blocker acting selectively on the gastrointestinal tract on basal and post-prandial recto-anal motility of 40 irritable bowel syndrome patients in a random, double blind and placebo controlled trial. Methods: Pinaverium bromide (50 mg) or placebo was taken orally t.i.d with food. Myoelectrical and mechanical activities of the rectum and the internal anal sphincter were recorded before treatment for 2 h in the fasting state and for an additional 2 h post-prandial. Results: Post-prandial rectal spike amplitude and frequency as well as the spontaneous recto-anal inhibitory reflex frequency decreased after pinaverium bromide (P < 0.01) but not after placebo. Conclusions: These results suggest that the calcium channel blockers acting selectively on the gastrointestinal tract may have a therapeutic role in patients with irritable bowel syndrome. (AU)

[Superiority of pantoprazole over ranitidine in the treatment of duodenal ulcer. Mexican clinical experience. Mexican Study Group of Pantoprazole++ in Duodenal Ulcer]. / Superioridad del pantoprazol sobre la ranitidina en el tratamiento de la úlcera duodenal. Experiencia clínica Mexicana. Grupo Mexicano de Estudio del Pantoprazol en Ulcera Duodenal.

BACKGROUND: Pantoprazole is a new Proton Pump Inhibitor that has demonstrated to be superior to ranitidine in the healing of the acid related diseases. AIMS: To compare efficacy and tolerability of oral treatment with pantoprazole vs. ranitidine in outpatients with endoscopically confirmed florid duodenal ulcers in Mexican patients. METHODS: Prospective, multicentric, balanced, randomized, double blind, parallel group comparison clinical trial. Each patient received 40 mg pantoprazole plus placebo or 300 mg ranitidine plus placebo once daily for 2 weeks; if patients had not healed endoscopically by then, treatment was continued for two more weeks, with a final endoscopy. RESULTS: 163 protocol-correct patients were analyzed: 82 for pantoprazole group and 81 for ranitidine group. Healing rates at week 2 were 72% for pantoprazole and 51% for ranitidine (p < 0.01) and correspondingly 95 and 86% at week 4. The percentage of patients suffering from pain declined faster in the pantoprazole group. Both products were well tolerated and safe. CONCLUSIONS: Pantoprazole is well tolerated and significantly superior to ranitidine in florid duodenal ulcers healing.

Irritable bowel syndrome treatment using pinaverium bromide as a calcium channel blocker. A randomized double-blind placebo-controlled trial.

BACKGROUND: Irritable bowel syndrome is one of the principal causes of days lost from work. As there has been no effective treatment up to now, sufferers turn to various doctors and try all sorts of medicines over extended periods that last for years. Thus irritable bowel syndrome has become a serious socio-economic problem that affects the family and the workplace. METHODS: We conducted a randomized, double-blind, placebo-controlled trial among 40 consecutive irritable bowel syndrome patients (mean age: 31.4 +/- 1.8, range 17-52 year; females). Pinaverium bromide (50 mg) or placebo was taken orally t.i.d with food. RESULTS: Pinaverium bromide diminished pain duration from several hours to a few minutes (P Text:nav2]Conclusions. Pinaverium bromide is safe, and produce a significant benefit in the quality of the patients life, hence may be a valuable drug for the treatment of irritable bowel syndrome patients.

Irritable bowel syndrome treatment using pinaverium bromide as a calcium channel blocker: a randomized double-blind placebo; controlled trial

ANTECEDENTES: El síndrome de intestino irritable es una de las principales causas de días perdidos en el trabajo. Como no se conoce hasta ahora ningún tratamiento realmente efectivo, los pacientes acuden con muchos médicos probando todo tipo de medicinas, durante largos períodos de tiempo que duran años. Así, el síndrome de intestino irritable se ha convertido en un serio problema socio-económico que afecta a la familia y al trabajo. METODOS: Se efectuó un estudio aleatorio, doble ciego, controlado con placebo en 40 pacientes consecutivos con síndrome de intestino irritable (edad media: 31.4 +/- 1.8, rango 17-52 años; mujeres). Se administró oralmente bromuro de pinaverio (50 mg) o placebo, tres veces al día con las comidas. RESULTADOS: El bromuro de pinaverio disminuyó la duración del dolor de varias horas a pocos minutos (p<0.05) y mejoró los síntomas recto-anales. No hubieron efectos secundarios. CONCLUSIONES: El bromuro de pinaverio es inocuo y produce beneficio significativo en la calidad de vida del paciente, por lo que puede ser un medicamento valioso en el tratamiento de pacientes con síndrome de intestino irritable.

Irritable bowel syndrome treatment using pinaverium bromide as a calcium channel blocker: a randomized double-blind placebo; controlled trial

ANTECEDENTES: El síndrome de intestino irritable es una de las principales causas de días perdidos en el trabajo. Como no se conoce hasta ahora ningún tratamiento realmente efectivo, los pacientes acuden con muchos médicos probando todo tipo de medicinas, durante largos períodos de tiempo que duran años. Así, el síndrome de intestino irritable se ha convertido en un serio problema socio-económico que afecta a la familia y al trabajo. METODOS: Se efectuó un estudio aleatorio, doble ciego, controlado con placebo en 40 pacientes consecutivos con síndrome de intestino irritable (edad media: 31.4 +/- 1.8, rango 17-52 años; mujeres). Se administró oralmente bromuro de pinaverio (50 mg) o placebo, tres veces al día con las comidas. RESULTADOS: El bromuro de pinaverio disminuyó la duración del dolor de varias horas a pocos minutos (p<0.05) y mejoró los síntomas recto-anales. No hubieron efectos secundarios. CONCLUSIONES: El bromuro de pinaverio es inocuo y produce beneficio significativo en la calidad de vida del paciente, por lo que puede ser un medicamento valioso en el tratamiento de pacientes con síndrome de intestino irritable. (AU)

Irritable bowel syndrome treatment using pinaverium bromide as a calcium channel blocker. A randomized double-blind placebo-controlled trial.

BACKGROUND. Irritable bowel syndrome is one of the principal causes of days lost from work. As there has been no effective treatment up to now, sufferers turn to various doctors and try all sorts of medicines over extended periods that last for years. Thus irritable bowel syndrome has become a serious socio-economic problem that affects the family and the workplace. METHODS. We conducted a randomized, double-blind, placebo-controlled trial among 40 consecutive irritable bowel syndrome patients (mean age: 31.4 +/- 1.8, range 17-52 year; females). Pinaverium bromide (50 mg) or placebo was taken orally t.i.d with food. RESULTS. Pinaverium bromide diminished pain duration from several hours to a few minutes (P Text:nav2]Conclusions. Pinaverium bromide is safe, and produce a significant benefit in the quality of the patients life, hence may be a valuable drug for the treatment of irritable bowel syndrome patients.

Beneficial effect of vegetable protein diet supplemented with psyllium plantago in patients with hepatic encephalopathy and diabetes mellitus.

A controlled crossover study was performed in 8 diabetic patients with chronic portal-systemic encephalopathy. After a basal period the patients were treated during periods A and B. During period A, a meat protein diet (0.8 g/kg body wt, approximately 1800 kcal/day) was consumed and neomycin plus laxatives were given. During period B patients received vegetable protein (0.8 g/kg body wt, 1800 kcal/day). This diet was supplemented with psyllium fiber to reach 35 g of fiber per day. Four patients were randomly assigned to receive the treatments in the order A-B and the other 4 patients in the order B-A. At the end of the first experimental period, fasting glucose levels were 204 +/- 86 mg% in the meat protein diet group and 127 +/- 8 mg% in the vegetable protein diet group (p less than 0.014). The patients were receiving 2.5 +/- 0.2 g/day and 2.1 +/- 0.5 g/day of tolbutamide at the end of the meat protein diet and vegetable protein diet, respectively. In all cases, fasting glucose levels decreased at the end of the vegetable diet period regardless of the previous treatment. An improvement of greater than or equal to 25 mg% of fasting glucose levels was observed in 7 of the 8 patients after the vegetable protein diet and in no case after the meat protein diet (p less than 0.0078). The parameters of encephalopathy were comparable at the end of both the meat protein diet and the vegetable protein diet. A significant increase in the number of bowel movements was noticed after the vegetable diet plus fiber (p less than 0.01). We propose the use of vegetable diet plus fiber to facilitate the treatment of patients with both diabetes and hepatic encephalopathy.