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PubMed2003

Randomized, double-blind study of the clinical efficacy of 3 days of azithromycin compared with co-amoxiclav for the treatment of acute otitis media.

BACKGROUND: Compared with 5 days of dosing, a 3 day dosing regimen of azithromycin for treatment of acute otitis media (AOM) may improve compliance, will simplify therapy for the caregiver and, by giving the same total dose as the 5 day regimen, provide more drug when the bacterial burden is highest. METHODS: Children of 6 months-12 years were enrolled if they had had symptoms and signs of AOM for <4 weeks and tympanic membrane effusion by acoustic reflectometry. Eligible children were randomized to azithromycin 10 mg/kg/day x 3 days or co-amoxiclav 45 mg/kg/day x 10 days. The primary endpoint was clinical response at day 28. RESULTS: One hundred and eighty-eight children (mean age 3.5 years) were randomized to azithromycin and 185 to co-amoxiclav. At day 10, the clinical success rate was 153/185 (83%) in children treated with azithromycin and 159/181 (88%) in children treated with co-amoxiclav. At day 28, 134/182 (74%) of the children were cured on azithromycin compared with 124/180 (69%) on co-amoxiclav. Also at day 28, signs of AOM, such as abnormal reflectometry (45% versus 59%; P = 0.017), bulging of the eardrum (10% versus 16%; P = 0.059) and loss of tympanic membrane landmarks (11% versus 22%; P = 0.010) were seen less frequently in azithromycin- than co-amoxiclav-treated children, respectively. Adverse events related to therapy were seen in 11% of azithromycin patients compared with 20% on co-amoxiclav (P = 0.014). CONCLUSIONS: Azithromycin given over 3 days is as effective as co-amoxiclav for treatment of AOM, may result in more complete resolution of tympanic membrane disease, and is better tolerated.

Acute Disease↗

PubMed1975

Maternal influences on ontogeny of suckling and feeding rhythms in the rat.

To assess the effects of both maternal and endogenous factors on the ontogeny of nocturnal feeding in the rat, day and night weight gain was determined in the sighted or blind litters of sighted or blind litters of sighted or blind dams and in young weaned at 15 days of age. Sighted dams impose a diurnal milk-intake pattern on their young. The nocturnal pattern of solid-food intake begins at 19 days of age. Blind litters also display nocturnal feeding when kept with sighted dams, but only until 35 days of age.

Age Factors↗

PubMed2002

[Vision 2020: 100 years of river blindness research].

BACKGROUND: The early investigators of onchocerciasis from 1874 - 1930 in Africa made no mention at all of concomitant severe eye disease. Publications of the observations in Central America in 1917/1919 prompted some specialists in tropical medicine to look for eye disease associated with African onchocerciasis. However, there did not seem to be any eye disease leading to blindness. It was not until 1930/1931 that Hissette reported that 20 % of patients with onchocerciasis were blind in an onchocerciasis focus on the Sankuru river in the Belgian Congo, and that 50 % of the villagers suffered from eye troubles. Two years later, he found a second focus with the same pathology on the Uéle river. WORKING HYPOTHESIS: We wished to establish why African river blindness manifested itself so unusually late and what criteria must be fulfilled for it to be brought under control quickly. The following questions are examined: (1) Had the early tropical doctors overlooked river blindness? (2) Could the still low distribution and density of microfilariae in the body of the affected patients have determined whether or not eye disease is likely to occur? (3) Had the microfilariae mutated into a more aggressive variety? RESULTS: There are indications confirming all three points in the working hypothesis. Before 1930, cases of African onchocerciasis with ocular complications were demonstrably very localized on the Uéle river. The reason for this is likely to have been that the severity of the disease still varied from focus to focus at that time and/or because the individuals concerned still had a relatively mild microfilarial infection. CONCLUSION: In principle, onchocerciasis has reverted to the situation before occurrence of ocular complications in consequence of the ongoing control measures even though the insect destruction and mass therapy are sometimes incomplete. This appears to be sufficient to prevent blindness even if onchocerciasis is not cured. Only a few of the present-day patients with river blindness will still be left by 2030. By then, the problem of river blindness is likely to have become a thing of the past.

Africa↗

PubMed2003

A randomized, double-blind trial of pre-emptive local anesthesia in day-case knee arthroscopy.

PURPOSE: The study goal was to assess the efficacy of pre-emptive analgesia in a clinical setting. TYPE OF STUDY: A block randomized, double-blind design was used. METHODS: Subjects were 40 patients undergoing day-case arthroscopy of the knee. The trial group received a prophylactic injection of bupivacaine with adrenaline. After surgery, a placebo injection was given. The postsurgical injection group received identical injections in reverse order. There was no difference in the mean dose of propofol used to maintain general anesthesia between groups: 15 mg/kg/h (standard deviation [SD] = 2.85) trial versus 14.6 mg/kg/h (SD = 1.96) postsurgical injection (95% confidence interval [CI] = -1.14 to 1.94). RESULTS: Although no statistically significant difference was observed in postoperative pain scores at 15, 30, or 60 minutes, there was a trend for the trial group to require less analgesia in recovery (chi2 = 9.74; P =.1). CONCLUSIONS: Prophylactic local anesthesia confers no statistically significant reduction in pain scores or perioperative general anesthetic requirements as compared with postoperative administration. The pre-emptive effect in clinical practice may be less dramatic than that observed in more controlled animal models. Further studies are required to investigate the magnitude of the pre-emptive effect in clinical practice.

Adult↗

PubMed1993

Double-blind, comparative study of rufloxacin once daily versus amoxicillin three times a day in treatment of outpatients with exacerbations of chronic bronchitis.

In a double-blind, randomized, multicenter study, the efficacy and safety of two dosage schedules of rufloxacin once daily were compared with those of amoxicillin three times a day in the treatment of 192 outpatients with exacerbations of chronic bronchitis. Rufloxacin was given as a single oral dose of 400 mg on day 1 and single daily doses of 200 mg on the subsequent 9 days (n = 64) or as 300 mg on day 1 and then 150 mg daily for 9 days (n = 63); amoxicillin was given as 500 mg orally three times a day for 10 days (n = 65). Clinical and bacteriological assessments were carried out before treatment, between study days 3 and 5, and at days 1 and 8 after treatment. Pretreatment cultures were positive for 139 patients, the most frequently isolated pathogens being Streptococcus pneumoniae, Moraxella catarrhalis, and Haemophilus influenzae. Clinical success rates were comparable in the three groups (94, 95, and 98%, respectively), as were bacteriological success rates at the end of treatment (93, 95, and 91%, respectively) and at follow-up (88, 95, and 98%, respectively). The power to detect a significant 15% difference in cure rates was 74.9%. Follow-up bacteriological failures from pneumococcal infection were 18% in both rufloxacin groups combined and 5% in the amoxicillin group. The 200-mg dose regimen achieved average steady-state concentrations in plasma higher than did the 150-mg dose regimen (3.75 versus 2.72 micrograms/ml). Adverse events occurred in 11 and 13 patients, respectively, on rufloxacin and 8 on amoxicillin. This study shows that rufloxacin once daily ay be a possible option for the treatment of acute exacerbations of chronic bronchitis. The 200-mg daily oral dose preceeded by a loading dose of 400 mg displays a better pharmacokinetic profile than the lower dose.

Adolescent↗

PubMed2002

A randomized, double-blind study of the efficacy of a 10- or 20-day course of sodium stibogluconate for treatment of cutaneous leishmaniasis in United States military personnel.

The recommended treatment for cutaneous leishmaniasis is pentavalent antimony at a dosage of 20 mg/kg/day for 20 days. Some studies conducted in locales in which Leishmania is endemic have suggested that shorter courses of treatment may be as efficacious. We conducted a randomized, double-blind, placebo-controlled study of 10 versus 20 days of sodium stibogluconate (SSG) in United States military personnel who contracted cutaneous leishmaniasis while serving overseas; 19 patients received SSG for 10 days (and placebo for 10 days), and 19 patients received SSG for 20 days. Cure rates were 100% (19 of 19 patients) in the 10-day group and 95% (18 of 19 patients) in the 20-day group. Side effects were more common among patients who received 20 days of therapy. In this group of otherwise healthy young adults, SSG at a dosage of 20 mg/kg/day for 10 days appears to have been therapeutically equivalent and less toxic than the standard 20-day course.

Adult↗

PubMed1999

Randomised, placebo-controlled study of vigabatrin as first-line treatment of infantile spasms.

PURPOSE: Vigabatrin (VGB) has been shown to be an effective drug in the treatment of infantile spasms (West syndrome) in predominantly retrospective and open but also in prospective studies. This prospective, randomised, and placebo-controlled trial of VGB in infantile spasms was considered to be justified and feasible to confirm or refute these previous findings. METHODS: Forty children with newly diagnosed infantile spasms received either VGB or placebo for 5 days in a double blind, placebo-controlled, parallel-group study, after which all the infants continuing in the study were treated openly with VGB for a minimum of 24 weeks. RESULTS: Compared with baseline, at the end of the double-blind phase, the patients treated with VGB had a 78% (95% confidence interval, 55-89%) reduction in spasms compared with 26% (-56-65%) in the group treated with placebo (p = 0.020). Seven VGB-treated patients and two placebo-treated patients were spasm free on the final day of the double-blind period (p = 0.063). At the end of the study, 15 children (38% of the original 40 patients or 42% of the 36 patients who entered the open phase) were spasm free with VGB monotherapy. No patient withdrew from the study because of an adverse event. CONCLUSIONS: This unique randomized, placebo-controlled study is the first to demonstrate the efficacy of a specific drug in the treatment of West syndrome and supports the results of previously published open and prospective trials. It further confirms that VGB could be considered as the drug of first choice in treating infantile spasms.

Adolescent↗

PubMed2001

Oral midazolam premedication for day case breast surgery, a randomised prospective double-blind placebo-controlled study.

We conducted a randomised prospective double-blind placebo-controlled study to assess the efficacy of oral midazolam premedication in 50 ASA I and II female patients scheduled to undergo day case breast surgery. Anxiety was assessed using 100-mm visual analogue scales (VAS) and The State-Trait Anxiety Inventory (STAI) psychometric questionnaire. Midazolam premedication did not significantly reduce either VAS or STAI score, although heart rate and systolic arterial pressure immediately before induction of anaesthesia were significantly lower in patients who received midazolam (p = 0.006 and 0.039, respectively). Induction of anaesthesia was achieved with a lower dose of propofol (p = 0.0009) and excellent (Grade I) conditions for insertion of a laryngeal mask airway were achieved more often after midazolam premedication (p = 0.038). Arterial desaturation during induction of anaesthesia and insertion of a laryngeal mask airway occurred more often in patients who received placebo (p = 0.022). There was a good correlation between VAS and STAI used to assess the anxiolytic effects of premedication. (Spearman coefficient 0.58, p < 0.0001).

Adolescent↗

PubMed1989

"Food allergy in children: an attempt to improve the effects of the elimination diet with an immunomodulating agent (thymomodulin). A double-blind clinical trial".

During 90 days of elimination diet nineteen children with food allergy manifesting atopic dermatitis were treated with either 120 mg/day of thymomodulin (10 subjects) or placebo (9 subjects) in a double blind design. After this period an improvement in skin lesions was observed in both groups. Subsequently a food challenge was performed for two weeks: in the group treated with thymomodulin skin lesions did not modify while they worsened in the placebo group and the comparison was statistically significant (p less than 0.01). Before the beginning of the trial laboratory assessments evidenced an increase in total and specific IgE serum levels, which decreased by the end of the study only in the group receiving the thymic derivative (p less than 0.05).

Adjuvants, Immunologic↗

PubMed1980

A new inhalation technique for freon aerosols. Terbutaline aerosol with a tube extension in a 2-day cross-over comparison with salbutamol aerosol.

In a double-blind, cross-over, 2-day study 32 adult asthmatic patients compared the bronchodilating effect of 0.5 mg terbutaline sulphate aerosol, administered via a 10 cm tube extension attached to the actuator of a pressurized aerosol, with that of 0.2 mg salbutamol sulphate, administered by a conventional pressurized aerosol. New instructions for the inhalation technique were given for the terbutaline aerosol, dividing the actuation of the aerosol and the slow inhalation into two steps. The salbutamol aerosol was to be taken according to the instructions enclosed, i.e. coordinating the actuation of the aerosol and the inhalation. The improvement in peak expiratory flow rate (PEFR) values was similar for the two treatments. Subjective assessments by the patients showed no differences between the two regimens. As the effect seems to be equal, an aerosol actuator furnished with a tube extension, with no strict demands of synchronizing the actuation of the aerosol and the inhalation, could be a suitable alternative treatment in patients who find self-administration with conventional asthma aerosols difficult.

Adult↗

PubMed2000

Carbamezapine for pain management in Guillain-Barré syndrome patients in the intensive care unit.

OBJECTIVE: To evaluate carbamezapine (CBZ) for neuritic pain relief in Guillain-Barré syndrome (GBS) patients in the intensive care unit (ICU). DESIGN: Prospective, double-blind, randomly allocated cross-over study days. SETTING: ICU in a tertiary care university hospital. PARTICIPANTS: Twelve consecutive, conscious adult (22-54 yrs) patients with GBS during recovery from the muscular weakness and receiving pressure-support ventilation in the ICU. All patients complained of severe backache and/or leg cramps and tenderness in muscles, and they required opioids for pain relief. INTERVENTIONS: CBZ (100 mg every 8 hrs) or equivalent placebo was given to nursing staff in coded powder form. Medication was given to patients through a nasogastric feeding tube. The same coded medicine was given for 3 days, and after a 1-day omission, a second set of coded powder was given for the next 3 days in a randomized, double-blind, crossover fashion. Pethidine (1 mg x kg(-1)) was given intravenously in between, if the pain score was >2. Group 1 (n = 6) patients were given a placebo on the first 3 days, followed by CBZ. Group 2 (n = 6) patients were given CBZ on the first 3 days, followed by a placebo. MEASUREMENTS AND MAIN RESULTS: In these two study periods of different medications, we observed and scored pain (1, no pain; 5, severe pain), sedation (1, alert; 6, asleep, does not respond to verbal command), and total pethidine requirement per day. In group 1 patients, a significant (p < .001) improvement in the sedation score and a low requirement for pethidine was observed 3 days later, when CBZ was started. However, in group 2 patients, a gradual increase in the pethidine requirement and a high sedation score were noteworthy in the later days of placebo medication. Observations were also analyzed for CBZ days vs. placebo days. Overall, the pain score (1.7 +/- 0.8) during the CBZ period of both regimens was significantly (p < .001) lower than during the placebo days (3.1 +/- 0.9). Significantly higher doses of pethidine (3.7 +/- 0.9 mg/kg/day) were used on the placebo days than on the CBZ days (1.7 +/- 1.0 mg/kg/day). CONCLUSION: The pain in GBS has a dual origin, and we recommend CBZ as an adjuvant to treat pain in GBS patients, during the recovery phase in the ICU, to reduce the narcotic requirement.

Adult↗

PubMedDate not supplied

[Utility of prolonged incubation and terminal subcultures of blood cultures from immunocompromised patients].

The value of blind terminal subcultures (7 and 30 days) and prolonged incubation (30 days) of blood cultures from immunosuppressed patients was analyzed in the Fundación Favaloro, the Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia and the Hospital de Niños Ricardo Gutiérrez. A total of 2707 blood cultures and 369 patients were included (transplantation of solid organs 154, oncohematologic disorders 106 and solid tumors 109). Bact-Alert bottles were incubated at 35 degrees C for 30 days in the Bact-Alert System. Bottles with positive signals were routinely removed, and aliquots of the broth were Gram stained and subcultured aerobically in chocolate agar and Sabouraud agar. A total of 136 bacteremic episodes were obtained. The positivization time of blood cultures was 81.6% at 24 h, 93.3% at 48 h, 94.5% at 72 h and 97.7% within 7 days. Only 3 (2.2%) episodes were positive by blind terminal subcultures and 1 (0.75%) by prolonged incubation (14 days). The median time and range of positivization in hours were 13.8 and 2.2-168, respectively. The microorganisms isolated were coagulase negative staphylococci (n = 24), Klebsiella pneumoniae (n = 22), Staphylococcus aureus (n = 21), Escherichia coli (n = 18), Acinetobacter spp (n = 9), Candida spp (n = 8), Pseudomonas aeruginosa (n = 6), Enterobacter cloacae (n = 5), Stenotrophomonas maltophilia (n = 5), Enterococcus faecalis, Salmonella spp and Capnocytophaga sputigena (n = 2), Enterobacter aerogenes, Enterococcus faecium, Citrobacter diversus, Candida albicans, Klebsiella oxytoca, Chryseomonas luteola, Serratia marcescens, Abiotrophia spp, Campylobacter jejuni, Moraxella catarrhalis, Moraxella urethralis, Neisseria sicca, beta hemolytic group G streptococci, Rhodococcus equi, Micrococcus spp, Cryptococcus neoformans and Streptococcus mitis (n = 1). In our experience, blind terminal subcultures and prolonged incubation of blood cultures from immunosuppressed patients are unnecessary and cost expensive.

Bacteremia↗

PubMed2002

[Double blind randomized multicentre study of a seven-day eradication regime of Helicobacter pylori by omeprazole, clarithromycin and ornidazole vs. omeprazole, clarithromycin and metronidazole].

Effective eradication regimes of Helicobacter pylori infections are nowadays based on administration of a substance with a strong suppressive effect on production of gastric HCl combined with two antibiotics. As suppressor of gastric HCl production unequivocally some drug from the group of proton pump blockers is used. As to antibiotics, in first line therapy the following are recommended: clarithromycin, amoxicillin, metronidazole. A problem in the eradication therapy of Helicobacter pylori infection in recent years is the increasing resistance to clarithromycin and apparently also metronidazole. In the Czech Republic the resistance to clarithromycin in relation to Helicobacter pylori is stabilized at a level lower than 3.0 %. Resistance to metronidazole was reported in 1992 within the range of 24 % - 26 %, however in 2001 it was already 36.0 %. Therefore the question arises whether it is possible under our conditions to check the increasing metronidazole resistance by a drug which by its spectrum of action resembles metronidazole while it differs from it as to its chemical structure. This is the reason why the authors implemented a trial where metronidazole was replaced by tinodazole (Avrazor, Léciva Co.). The results revealed that in the group treated with tinidazole eradication was achieved after 7-day administration of ornidazole in 93.0 %, in the group where part of the eradication regime was metronidazole eradication was 82.6 %. The tolerance of both drugs was very good. The authors recommend to include the pattern omeprazole 2 x 20 mg, clarithromycin 2 x 500 mg and tinidazole 2 x 500 mg among first line therapeutic regimes.

Adolescent↗

PubMed1980

Evaluation of neoalleviase (NA-1700) in heroin detoxification: preliminary report on toxicity and efficacy including prophylactic measure in mice and clinical study.

Neoalleviase (NA-1700) is a specially formulated unique combination of 14 well-identified species of higher plants whose extracts were obtained through an enzymatic process with macerozymes prior to clinical study. Toxicity and efficacy tests were satisfactorily performed by bioassay with 120 mice under double-blind conditions for 82 days. Straub tests facilitated efficacy proof in mice. Neoalleviase (530 mg capsules q.i.d.) was administered to 268 active heroin addicts under double-blind conditions. The established dosage schedule was utilized over a 35 day drug administration period (maximum) with a follow-up observation at 10 months. Himmelsback's techniques were used to determine withdrawal scores. The results of this study indicated that Neoalleviase (NA-1700) effectively suppressed withdrawal signs and symptoms without undesirable major side effects at the given therapeutic dose level. It appears to be potentially the most promising heroin detoxification agent.

Adult↗

PubMed1989

[Daytime sedation measured after intake of nitrazepam and lorazepam, respectively, as hypnotics for 10 days].

A prospective double-blind cross-over investigation was undertaken among 46 geriatric patients (62-92 years) in which either 5 mg nitrazepam or 1 mg lorazepam were administered as hypnotics for two periods of ten days. No significant differences were observed in the quality of sleep but the objective psychomotor tests and the patients' subjective experience of hang-overs showed that there were significant differences in the frequencies of side effects in favour of lorazepam. It is concluded that daytime sedation after repetitive administration of a benzodiazepine preparation depends upon the half-life and that side effects are revealed better by psychomotor tests than by intellectual, cognitive tests and that lorazepam should be given preference to nitrazepam as a hypnotic for elderly patients.

Aged↗

PubMed2000

Optimal asthma control, starting with high doses of inhaled budesonide.

The aim of this study was to determine whether outcomes in poorly controlled asthma can be further improved with a starting dose of inhaled budesonide higher than that recommended in international guidelines. The study had a parallel-group design and included 61 subjects with poorly controlled asthma, randomized to receive 3,200 microg or 1,600 microg budesonide daily by Turbuhaler for 8 weeks (double-blind), then 1,600 microg x day(-1) for 8 weeks (single-blind), followed by 14 months of open-label budesonide dose down-titration using a novel algorithm, with a written asthma crisis plan based on electronic peak expiratory flow monitoring. The primary outcome variable for weeks 1-16 was change in airway hyperresponsiveness (AHR), and, for the open-label phase, mean daily budesonide dose. By week 16, there were large changes from baseline in all outcomes, with no significant differences between the 3,200- and 1,600-microg x day(-1) starting dose groups (AHR increased by 3.2 versus 3.0 doubling doses, p=0.7; morning peak flow increased by 134 versus 127 L x min(-1), p=0.8). Subjects starting with 3,200 microg x day(-1) were 3.8 times more likely to achieve AHR within the normal range, as defined by a provocative dose of histamine causing a 20% fall in forced expiratory volume in one second (PD20) of > or = 3.92 micromol by week 16 (p=0.03) [corrected]. During dose titration, there was no significant difference in mean budesonide dose (1,327 versus 1,325 microg x day(-1), p>0.3). Optimal asthma control was achieved in the majority of subjects (at completion/withdrawal: median symptoms 0.0 days x week(-1), beta2-agonist use 0.2 occasions x day(-1), and PD20 2.4 micromol). In subjects with poorly controlled asthma, a starting dose of 1,600 microg x day(-1) budesonide was sufficient to lead to optimal control in most subjects. The high degree of control achieved, compared with previous studies, warrants further investigation.

Administration, Inhalation↗

PubMed1986

Alfentanil supplemented anaesthesia for short procedures. A double-blind study of alfentanil used with etomidate and enflurane for day cases.

Thirty-nine unpremedicated patients who presented for cystoscopy were given either alfentanil or saline in a random double-blind fashion immediately before anaesthesia with etomidate, nitrous oxide and enflurane. Alfentanil significantly reduced myoclonus associated with etomidate. During anaesthesia, patients who received alfentanil had smaller minute volumes, lower respiratory frequencies, and smaller increases in heart rate. The incidence of apnoea was not significantly increased. After operation, patients who received alfentanil were prescribed significantly more analgesia, possibly because of their reduced uptake of volatile anaesthetic agent. It is concluded that supplementation with alfentanil improves the quality of anaesthesia induced with etomidate.

Adjuvants, Anesthesia↗

PubMed1981

Lack of requirement for blind subcultures of BACTEC blood culture media.

To determine the need for blind subculturing of BACTEC (Johnston Laboratories, Cockeysville, Md.) blood culture media, we compared results of radiometric readings, visual inspection, and blind subculturing for nearly 7,500 blood specimens. Visual inspection and radiometric testing were performed on day 1 through 7, and blind subcultures were made on day 3. In the first phase of the study, 402 of 3,896 aerobic bottles were positive by radiometric testing (growth index, greater than 25), visual inspection, or subculturing. Only six bottles were radiometrically negative but subculture positive on day 3. The second phase of the study was designed to determine if aerobic bottles eventually became radiometrically positive in those cases in which they were radiometrically negative but subculture positive on day 3. Two bottles were subculture positive but never gave a growth index of greater than or equal to 25 by day 7. One yielded Staphylococcus epidermidis, and one yielded viridans, Streptococcus sp. A total of 35 anaerobic organisms were isolated from 3,896 blood specimens. All of these anaerobes were detected by both radiometric testing and subculturing. We examined a total of 14,972 blood culture bottles. Twenty-nine bottles considered negative by visual inspection or radiometric readings were found to be positive by subculturing. Fifteen of these were shown, by chart review, to contain contaminants. Organisms in the other negative bottles would not have gone undetected because companion bottles from the same patients were radiometrically or visually positive. We concluded that it is necessary to perform blind subcultures of BACTEC 7B and 8B blood culture bottles.

Aerobiosis↗