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PubMed1985

Trimethoprim sulphamoxole in the treatment of chancroid. Comparison of two single dose treatment regimens with a five day regimen.

In a prospective blinded study, 135 men with genital ulcers culture positive for Haemophilus ducreyi, were randomized to one of three regimens. Two single dose regimens, either the combination of sulphamoxole 3200 mg/trimethoprim 640 mg or trimethoprim 700 mg alone were compared to a five day regimen of sulphamoxole 800 mg/trimethoprim 160 mg twice daily. All 31 treated with a five day regimen of trimethoprim sulphamoxole healed without further treatment. Of 27 patients treated with the single dose sulphamoxole/trimethoprim regimen, only 21 were cured and of 34 treated with trimethoprim alone, 25 responded. Antibacterial susceptibilities were performed on 31 H. ducreyi isolates. The laboratory susceptibility of these strains to trimethoprim correlated with the clinical response to the single agent. Trimethoprim alone in a dose of 700 mg or the combination of sulphamoxole (3200 mg) and trimethoprim (640 mg) is not satisfactory for the single dose treatment of genital ulcer disease. However, when prescribed for five days, sulphamoxole/trimethoprim is effective and compares favourably with other treatment regimens.

Adult↗

PubMed2001

Effect of a conjugate pneumococcal vaccine on the occurrence of respiratory infections and antibiotic use in day-care center attendees.

BACKGROUND: Incidence and severity of respiratory infections are increased in day-care center attendees. Streptococcus pneumoniae is an important contributor to these infections. OBJECTIVE: To examine whether the use of a pneumococcal conjugate vaccine could reduce the occurrence of respiratory infections and the ensuing antibiotic drug use in the day care. METHOD: In this double blind, randomized, controlled study performed in 8 day-care centers located in Beer-Sheva, Israel, 264 toddlers ages 12 to 35 months at enrollment were randomized to receive either a 9-valent conjugate pneumococcal vaccine (conjugated to CRM197) or a control vaccine [conjugate meningococcus C vaccine (conjugated to CRM197)] and were followed for an average of 22 months. The main outcome measures were respiratory morbidity and antibiotic use. RESULTS: An overall reduction of 7% in child months with > or = 1 reported illness episodes was observed among vaccinees (P = 0.008), and 85% of all episodes were related to the respiratory tract. Reductions of 15, 16 and 17% were observed in upper respiratory infections, lower respiratory problems and otitis media, respectively. An overall reduction of 17% in antibiotic days was observed [10% for upper respiratory infections, 20% for otitis and 47% for lower respiratory problems (P < or = 0.005 for each entity)]. The reduction in episodes and antibiotic use was greater for those <36 months of age than for the older children. CONCLUSION: The reduction of respiratory problems, including those not traditionally considered of pneumococcal origin and the ensuing lowered antibiotic use in day-care center attendees by pneumococcal conjugate vaccination suggest a broader benefit from the vaccine than preventing invasive disease only.

Acidosis, Respiratory↗

PubMed1978

Oral cimetidine in reflux esophagitis: a double blind controlled trial.

The efficacy of cimetidine (1.6 g per day) was evaluated using a double blind placebo-controlled trial in 24 patients with moderate or severe peptic reflux esophagitis. The results show that cimetidine is superior to placebo when using endoscopic and histological criteria. Improved patient symptomatology and lower antacid comsumption failed to reach statistical significance. No change in the abnormally low lower esophageal sphincter pressure was observed at the end of the trial. No clinical side effects or significant biochemical changes were noted during the trial.

Administration, Oral↗

PubMed1978

Beta-blockers: once or three times a day?

In a double-blind, crossover trial 16 hypertensive patients were treated, in random order, with placebo, metoprolol 300 mg in a single daily dose, or metoprolol 300 mg/day in three doses. Both therapeutic regimens produced detectable plasma metoprolol concentrations and appreciable beta-blockade, estimated from exercise tachycardia, throughout the day. Fluctuations throughout the day in plasma drug concentrations and degree of beta-blockade were insignificant on the thrice-daily regimen, but they varied considerably on the single-dose regimen. Both therapeutic regimens also significantly lowered blood pressure throughout the day. Although the thrice-daily regimen again tended to produce a stronger and less fluctuating hypotensive action, the differences in hypotensive effect between the two regimens were not statistically significant. A single-dose of 300 mg of metoprolol can therefore be recommended if the only aim is to reduce blood pressure but not if a steady degree of beta-blockade is needed.

Adult↗

PubMed1984

Comparison of diazepam and oxazepam: preference, liking and extent of abuse.

In a residential hospital research ward setting, the effects of and preference for placebo, oxazepam (480 mg) and diazepam (40, 80 and 160 mg) were studied in human volunteers with histories of sedative drug abuse. Doses p.o. were administered every 3rd day under double-blind conditions. After an initial exposure to the letter-coded test drugs, a series of choice days was scheduled on which subjects chose between two available drug alternatives. Compared with oxazepam, diazepam produced greater liking (area under the time-action curve), peak liking and euphoria and was judged to be of greater monetary street value. Diazepam was categorized as producing barbiturate-like subjective effects more frequently than was oxazepam (54 vs. 21%), whereas oxazepam was identified as placebo more often than diazepam (32 vs. 4%). Diazepam was associated with a more rapid onset of effect than was oxazepam, and this rapid onset was repeatedly cited by subjects in poststudy written comments as being a desirable feature of the drug effect. In choice tests, 80 and 160 mg of diazepam were preferred to 480 mg of oxazepam on 62.5 and 91.7% of the choice tests, respectively. In choice tests between placebo and drug, placebo was never preferred to diazepam; however, placebo was preferred to oxazepam on 21.4% of choice tests. Overall, these results extend previous experimental observations suggesting that diazepam has a higher abuse liability than oxazepam. The results are also compatible with an analysis of epidemiological data showing that diazepam abuse uniformly exceeds oxazepam abuse on seven epidemiological measures of drug abuse.

Adult↗

PubMed2006

Comparing 10-day and 4-month doxycycline courses for treatment of Chlamydia trachomatis-reactive arthritis: a prospective, double-blind trial.

OBJECTIVE: To compare the efficacy of a 10-day and a 4-month doxycylcine course for the treatment of Chlamydia trachomatis-reactive arthritis (Ct-ReA). METHODS: Patients with active Ct-ReA were enrolled in a prospective, multicentre, double-blind, controlled clinical trial and randomised to receive doxycycline 100 mg twice daily for 10 days followed either by placebo or by continued doxycycline 100 mg twice daily over 4 months. Various clinical and laboratory parameters referring to disease activity were recorded in the beginning and at the end of treatment. RESULTS: 32 of 37 patients included (15 men and 17 women; mean (standard deviation) disease duration 17 (13) months completed the study; 17 were randomised to short-term doxycycline and placebo (placebo group) and 15 to prolonged treatment with doxycycline (doxycycline group) over the 4-month study period. After this time, only two patients from each group went into remission. There were no drop-outs owing to adverse events or treatment failures. CONCLUSIONS: The results of this study suggest that prolonged treatment with a 4-month course of doxycycline is not superior to short-term treatment over 10 days in patients with Ct-ReA.

Adult↗

PubMed1983

Clotrimazole and econazole in the treatment of vaginal candidosis. A single-blind comparison.

Clotrimazole and econazole used as treatment for vaginal candidosis are both effective when given for three days. In a single-blind controlled study of 110 women followed for 14 days the efficacy of treatment with clotrimazole and econazole for three days was equal. Eighty-six per cent of the group treated with clotrimazole were mycologically clear at 14 days compared with 90% of those treated with econazole. Both treatment regimens were equally acceptable to the patients and no side effects were reported.

Candidiasis, Vulvovaginal↗

PubMed2000

Double-blind randomized study of tramadol vs. paracetamol in analgesia after day-case tonsillectomy in children.

Fifty children (2-9 years) scheduled for tonsillectomy were enrolled in a double-blind randomized prospective study to compare postoperative analgesia provided with propacetamol/paracetamol (acetaminophen) or tramadol. A standard anaesthetic technique was used; each patient received sufentanil 0.25 microg kg(-1) intravenously followed with either i.v. propacetamol 30 mg kg(-1) or tramadol 3 mg kg(-1) before surgical incision. For postoperative analgesia, each child received either tramadol drops (2.5 mg kg(-1)) or paracetamol (acetaminophen) suppositories (15 mg kg(-1)), 6 and 12 h after surgery the first day and three times a day during postoperative days 2 and 3. This dosage of paracetamol is lower than the current recommended dosage, which is 40 mg kg(-1) loading dose followed by 20 mg kg(-1) 8 h(-1). Rescue medication consisted of i.v. diclofenac (1 mg kg(-1)) during the first six postoperative hours and oral ibuprofen (6-9 mg kg(-1)) afterwards. Postoperative pain scores (Children's Hospital of Eastern Ontario Pain Scale) in recovery, numerical pain scale in the ward and at home, and rescue analgesic use were significantly lower in the tramadol group. No serious adverse effects were observed.

Acetaminophen↗

PubMed1988

Two-day cefamandole versus five-day cephazolin prophylaxis in 965 total hip replacements. Report of a multicentre double blind randomised trial.

The aim of this trial was to compare a 5-day course of cephazolin with a regimen of 2 days of cefamandole in 965 total hip replacements (488 in the cefamandole group and 477 in the cephazolin group). The effect of the prophylactic antibiotic on the bacterial colonization of drains (mean duration of drainage: 3.2 +/- 0.3 days) and on the susceptibility of colonizing organisms was assessed. No significant difference was observed in the percentage of infected drains between the two groups. The cefamandole group had a lower rate of Gram-negative organisms (23% versus 44%, p less than 0.01). The rate of deep infections within one year after operation was 0.7% in the cefamandole group versus 0.5% in the cephazolin group, and the difference is not significant. Cefamandole given for two days appears to be an effective prophylaxis against sepsis in total hip replacements.

Aged↗

PubMed1993

Effects of acute buprenorphine on responses to intranasal cocaine: a pilot study.

Five inpatients dependent on both intravenous cocaine and heroin were detoxified from opiates. They were then given 5 days of double-blind treatment with active or placebo buprenorphine 2 mg/d sublingually, followed by a crossover to the converse for 5 days (buprenorphine or placebo). Intranasal cocaine challenges (2 mg/kg) were performed on Days 3 and 5 of each treatment. Buprenorphine significantly enhanced patients' ratings of cocaine-induced pleasurable effects, and augmented cocaine-induced pulse increases. The buprenorphine enhancement of subjective cocaine effects appeared to be more prominent on Day 3 than on Day 5. This reduction from Day 3 to Day 5 suggests that cocaine may interact differently with buprenorphine as treatment is more prolonged.

Adult↗

PubMed2004

Increased positive versus negative affective perception and memory in healthy volunteers following selective serotonin and norepinephrine reuptake inhibition.

OBJECTIVE: Antidepressants that inhibit the reuptake of serotonin (SSRIs) or norepinephrine (SNRIs) are effective in the treatment of disorders such as depression and anxiety. Cognitive psychological theories emphasize the importance of correcting negative biases of information processing in the nonpharmacological treatment of these disorders, but it is not known whether antidepressant drugs can directly modulate the neural processing of affective information. The present study therefore assessed the actions of repeated antidepressant administration on perception and memory for positive and negative emotional information in healthy volunteers. METHOD: Forty-two male and female volunteers were randomly assigned to 7 days of double-blind intervention with the SSRI citalopram (20 mg/day), the SNRI reboxetine (8 mg/day), or placebo. On the final day, facial expression recognition, emotion-potentiated startle response, and memory for affect-laden words were assessed. Questionnaires monitoring mood, hostility, and anxiety were given before and after treatment. RESULTS: In the facial expression recognition task, citalopram and reboxetine reduced the identification of the negative facial expressions of anger and fear. Citalopram also abolished the increased startle response found in the context of negative affective images. Both antidepressants increased the relative recall of positive (versus negative) emotional material. These changes in emotional processing occurred in the absence of significant differences in ratings of mood and anxiety. However, reboxetine decreased subjective ratings of hostility and elevated energy. CONCLUSIONS: Short-term administration of two different antidepressant types had similar effects on emotion-related tasks in healthy volunteers, reducing the processing of negative relative to positive emotional material. Such effects of antidepressants may ameliorate the negative biases in information processing that characterize mood and anxiety disorders. They also suggest a mechanism of action potentially compatible with cognitive theories of anxiety and depression.

Adrenergic Uptake Inhibitors↗

PubMed2002

Effects of nursing mothers on rPer1 and rPer2 circadian expressions in the neonatal rat suprachiasmatic nuclei vary with developmental stage.

The ability of nursing mothers to entrain the circadian pacemaker of rat pups was examined by measuring the rat Per1 (rPer1) and rPer2 expression levels in the suprachiasmatic nuclei (SCN). Newborn rats from mothers under a light-dark cycle (LD) were blinded immediately after birth and reared by foster mothers under either LD (LD blind pups) or reversed light-dark cycle (DL; DL blind pups). At postnatal day (P)6, small but significant phase differences were observed in the circadian gene expression rhythms of the SCN not only between the blind and sighted pups, but also between the two groups of blind pups, indicating the involvement of both free-running and maternal influence in phase-resetting the circadian rhythms of blind pups. However, from P6 to P13 the circadian rhythms of both LD and DL blind pups showed phase delays of similar extent, which suggests that the influence of nursing mothers was lost. From P13 to P20 (the day of weaning), the rPer1 and rPer2 rhythms phase-shifted in a different manner, the rPer2 rhythm being related more closely to the behavioural rhythm than was the rPer1. This finding suggests a differential influence of mothers on the rPer1 and rPer2 rhythms in the third week of life. It is concluded that the ability of nursing mothers to entrain pup circadian oscillation depends on the developmental stage.

Aging↗

PubMed1990

Efficacy of octreotide acetate in treatment of severe postgastrectomy dumping syndrome.

The present study evaluates the acute and chronic use of a long-acting somatostatin analog, octreotide acetate, in the treatment of patients with severe postgastrectomy dumping syndrome. In the acute phase, 10 patients with severe dumping were studied over 2 consecutive days before and for 3 hours after the ingestion of a 'dumping breakfast' in a randomized double-blind fashion. On one day octreotide (100 micrograms) was given subcutaneously 30 minutes before the test meal and on the other day an equal volume of vehicle was injected. An additional group of six postgastrectomy patients without dumping were studied in a similar fashion and these acted as controls. During placebo treatment the test meal resulted in an immediate increase (p less than 0.01) in the pulse rate and in plasma levels of glucose, glucagon, pancreatic polypeptide, neurotensin, and insulin. Similar changes were seen in the control group with respect to placebo; however glucagon and neurotensin (p less than 0.05) did not show the same magnitude of increase as seen with placebo. Treatment with octreotide acetate prevented the development of both vasomotor and gastrointestinal symptoms and completely ablated all of the above responses in plasma peptides. These changes were associated with complete ablation of diarrhea (p less than 0.001). Pretreatment with octreotide acetate completely suppressed the rise in plasma insulin response to the meal and this ablated the late hypoglycemia of dumping. Treatment with octreotide acetate resulted in delayed gastric emptying and transit time (578 +/- 244 minutes) versus 76 +/- 23 minutes with placebo and 125 +/- 36 minutes in controls (p less than 0.05). Chronic daily treatment with octreotide acetate resulted in minimal side effects. These patients demonstrated a stable fasting plasma glucose, normal liver function tests, and an average weight gain of 11% during a 12-month period. In addition most patients were able to resume employment. The long-acting somatostatin analog, octreotide acetate, is highly effective in preventing the development of symptoms of severe dumping syndrome, both vasomotor and gastrointestinal.

Adult↗

PubMed2002

Efficacy and tolerability in migraine prophylaxis of flunarizine in reduced doses: a comparison with propranolol 160 mg daily.

This was a phase-IV double-blind equivalence trial designed to assess the efficacy and tolerability of two doses of flunarizine (10 mg o.d.=FLU 10 mg and 5 mg o.d.=FLU 5 mg) in the prophylaxis of migraine, in comparison with slow-release propranolol (160 mg o.d.). A total of 808 subjects were treated in a treatment period of 16 weeks. 142 subjects discontinued the trial prematurely, mainly because of adverse events (n=58). The mean attack frequency in the double-blind period was 2.0 for the FLU 5 mg group, 1.9 for the FLU 10 mg group, and 1.9 for the propranolol group. The mean attack frequency in the last 28 days of the double-blind period was 1.8 for FLU 5 mg, 1.6 for FLU 10 mg, and 1.7 for propranolol. Both flunarizine groups were at least as effective as propranolol (P<0.001 in one-sided test). The percentage of responders (defined as subjects for whom attack frequency decreased by at least 50% compared to run-in) in the last 28 days of the double-blind period was 46% (118/259) for FLU 5 mg, 53% (141/264) for FLU 10 mg, and 48% (125/258) for propranolol. Statistical analysis showed that FLU 10 mg is at least as effective as propranolol (P<0.001) and showed a trend for noninferiority of FLU5 and propranolol (P=0.053). No statistically significant differences between the treatment groups were found for any of the secondary parameters. Overall, 190 subjects reported one or more adverse events during the run-in phase: 54 (20.5%) in the FLU 5 mg group, 76 (27.7%) in the FLU 10 mg group and 60 (22.3%) in the propranolol group. The results of this equivalence trial show that 10 mg flunarizine daily with a drug-free weekend is at least as effective as 160 mg propranolol in the prophylaxis of migraine for all evaluated parameters (one-sided equivalence tests) after 16 weeks of treatment. In addition, 5 mg flunarizine proves to be at least as effective as 160 mg propranolol when looking at the mean attack frequency for both the whole double-blind period and the last 28 days of treatment. However, in the analysis of responders, 160 mg propranolol seems to be slightly better than 5 mg flunarizine. In addition, no significant differences between the three treatments were found with regard to safety: all three treatments were generally well-tolerated and safe.

Adolescent↗

PubMed2005

Surgical reversal of prolonged blindness from a metastatic neuroblastoma.

BACKGROUND: Reports of tumor-related anterior visual pathway blindness that have resolved after surgical decompression are rare. The longest reported duration of tumor-related blindness completely reversed by optic nerve decompression is 3 days. We describe a pediatric patient with 7 days of no light perception who experienced reversal of blindness following tumor resection and optic nerve decompression. CASE DESCRIPTION: A 33-month-old boy presented with a 4-day history of no light perception. Magnetic resonance imaging revealed a mass involving the sphenoid sinus, sella turcica, and clivus with significant optic nerve involvement. Loss of light perception and complete absence of a pupillary light reflex were documented for the next 72 h. A sluggish pupillary light reflex was regained 24 h after instituting intravenous steroids. An urgent bi-frontal craniotomy and optic nerve decompression were performed 7 days after the onset of blindness. Surgical pathology revealed metastatic neuroblastoma. Eleven days after optic nerve decompression, the child was able to count fingers and recognize faces and printed book characters. CONCLUSION: Prolonged blindness secondary to tumor-related optic nerve compression may be reversible up to 1 week from onset in children presenting with no light perception.

Blindness↗

PubMed1994

Addition of morphine to intra-articular bupivacaine does not improve analgesia after day-case arthroscopy.

We conducted a randomized, double-blind, controlled study in patients undergoing day-case knee arthroscopy to evaluate the analgesic effect, for 36 h after operation, of the addition of either 2 mg or 5 mg of morphine to intra-articular bupivacaine. Patients in group BM5 (n = 20) received 0.25% bupivacaine 40 ml with morphine 5 mg; patients in group BM2 (n = 20) received 0.25% bupivacaine 40 ml with morphine 2 mg and patients in group B0 (n = 18) received 0.25% bupivacaine 40 ml only. The drugs were given by intra-articular injection by the surgeon at the end of the operation and the tourniquet released 10 min later. Preoperative and postoperative pain was assessed over the ensuing 36 h, at rest and with movement, using a 100-mm visual analogue scale. There were no significant differences in pain scores, consumption of additional analgesia, or time to first request for analgesia between any of the groups. We conclude that, after day-case knee arthroscopy, no additional analgesic effect was afforded by the addition of morphine to intra-articular bupivacaine.

Adolescent↗

PubMed1996

A randomized, double-blind, double-dummy, crossover trial comparing the safety and efficacy of oral sustained-release hydromorphone with immediate-release hydromorphone in patients with cancer pain. Canadian Palliative Care Clinical Trials Group.

PURPOSE: To evaluate the safety and efficacy of a new slow-release preparation of hydromorphone (SRH) in the treatment of cancer pain. PATIENTS AND METHODS: Ninety-five adult patients from three Canadian Palliative Care Centers with no evidence of mental impairment received treatment for cancer pain with an oral opioid analgesic. After informed consent was obtained, patients underwent titration to a stable dose of immediate-release hydromorphone (IRH) for 48 hours, and were then randomized to receive IRH or SRH for 5 days in a double-blind basis. During day 6, a crossover took place, and patients received the alternate drug for 5 days. Pain intensity was assessed using a visual analog scale (VAS) and ordinal scale (OS). Side effects were assessed using VAS. Patients and investigators made a blinded global rating of efficacy a blinded final choice between SRH and IRH. RESULTS: In 75 assessable patients, pain intensity of the VAS and OS were (mean +/- SD) 27 +/- 21 and 1.3 +/- 0.6 on IRH, versus 29 +/- 21 (P = .13) and 1.3 +/- 0.6 (P = .19) on SRH, respectively. The total number of extra doses of opioids, global rating, and final blinded choice by both patients and investigators were not significantly different between IRH and SRH. Differences in side effects were not significant. CONCLUSION: Our findings suggest that SRH is as safe and effective as IRH in the treatment of cancer pain.

Adult↗

PubMed1975

Six-day clotrimazole therapy in vaginal candidosis.

Two hundred and two patients with symptoms, signs and mycological evidence of Candida vaginitis were entered in a single-blind trial comparing 6-day clotrimazole therapy with a control group receiving 6 days' nystatin therapy. Adequate data was collected on 69 clotrimazole and 72 nystatin treated patients for analysis. Judged by both the severity of symptoms and signs and the number of patients with negative mycological findings, 6-day clotrimazole therapy produced statistically significantly better results than obtained in the control group. When reviewed 4 weeks after starting therapy, 93% of the clotrimazole treated patinets had culturally negative results for Candida compared with 74% of the patients treated with nystatin. It is concluded that 6-day clotrimazole therapy is effective in the treatment of Candida vaginitis.

Candida albicans↗