bluuebunny/crossref_metadata_2025 huggingface dataset:
The Critical Oestrogen Content of Combined Oral Contraceptives
Authors: Mumford J P
Published: January 2017

A review of the evidence concerning efficacy, safety and side-effects of oral contraceptives indicates clear differences related to the lowering of oestrogen dosage. It is suggested that 50 μ g of ethinyloestradiol or its equivalent is a critical dose, for below that level the efficacy in combination with current progestogens falls almost twenty-fold without evidence of a similar reduction in unwanted side-effects.

In fact there is a marked increase of irregular bleeding patterns in early cycles associated with diminished patient acceptance.
Mefenamic Acid Compared with Ibuprofen in the Treatment of Rheumatoid Arthritis
Authors: Leslie R D G
Published: January 2017

A randomized double-blind within-patient study of mefenamic acid compared with ibuprofen was performed on forty patients with rheumatoid arthritis. It was concluded that mefenamic acid and ibuprofen had an analgesic and anti-inflammatory effect which was not significantly different in the dosages employed. Apart from six complaints of drowsiness on ibuprofen with two complaints on mefenamic acid, the side-effects were similar.
A Comparison of Lomotil and Imodium in Acute Non-Specific Diarrhoea
Authors: Jaffé Gabriel
Published: January 2017

A multicentre trial was conducted to compare Lomotil and Imodium in the treatment of acute non-specific diarrhoea in general practice. A total of eighty-three patients contributed to the study and were randomly allocated to one of the two treatments. No statistically significant differences were found between the drugs in their efficacy and speed of action in alleviating diarrhoea or in their palliative effect on nausea/vomiting and abdominal pain when present.
Practolol and Dextro-Propranolol in Prophylaxis of Post Infarction Arrhythmias
Authors: Kubik M Michael , Joshi Marion
Published: January 2017

In a double blind trial, 279 patients who had a myocardial infarction less than eighteen hours previously were divided into three groups and given tablets of Practolol, 50 mg 6- hourly, D-Propranolol, 50 mg 6- hourly and Placebo respectively for 5 days during which period their ECG was continuously monitored. No definite protection from dysrhythmia was observed.
An Evaluation of Andursil – A New Antacid
Authors: Beaumont G , Rigby G I J , Seldrup J
Published: January 2017

A number of characteristics of an ideal antacid are proposed. A new antacid formulation, Andursil, has been assessed both by in vitro and in vivo methods.

Andursil has been found to compare favourably in its properties, with the profile of the ideal antacid.

In a multicentre general practitioner trial it was found to be effective in relieving the symptoms of dyspepsia, to have a rapid onset of action and a satisfactory duration of effect, to be palatable and to be relatively free from undesirable effects.
Different Efficacy of Anti-Inflammatory Drugs in Inhibiting the Reactions to Intradermal Phospholipase A and PGE2
Authors: Arrigoni-Martelli E , Selva D , Schiatti P
Published: January 2017

The increase in local vascular permeability caused by intradermal injection of Phospholipase A is antagonized by both steroidal and non-steroidal antiinflammatory drugs at dose levels roughly equieffective in carrageenin oedema test. In the same range of doses these drugs are scantly effective against PGE2— induced increase of vascular permeability. Since it is generally accepted that Phospholipase A stimulates prostaglandin formation and alters cell membranes function the effect of non-steroidal drugs is interpreted as an inhibition of prostaglandin biosynthesis and the effect of steroidal drugs as a membrane stabilization. In addition the results indicate that both steroidal and non-steroidal drugs are devoid of a direct antagonistic effect towards the increase of vascular permeability induced by PGE2.
Netilmicin: Clinical Evaluation of Efficacy and Toxicity of a New Aminoglycoside
Authors: Nordstrom Lisbeth , Christensson Per , Hæger Knut , Juhlin Ingmar , Tjernström Örjan , Walltnark Ewa
Published: January 2017

The efficacy and toxicity of netilmicin, a new semisynthetic aminoglycoside, was clinically evaluated in fifty-two patients with moderate to severe infections with Gram-negative rods or Staph, aureus. Average duration of treatment was 14 days and mean total dose 2, 960 mg. One-hour mean value of netilmicin serum concentration was 6·4 μg/ml and mean trough value 1·2 μg/ml. Forty-four patients were cured or improved. In twenty-one of them the effect could be attributed to netilmicin alone; the other twenty-three had a combined therapy. No improvement took place in five, but four of them could not be regarded as netilmicin failure. One patient with Pseudomonas aeruginosa infection was a possible failure. The sensitivity of the causative bacteria to netilmicin was studied and compared with amikacin, gentamicin, sisomicin and tobramycin. Vestibular function and hearing acuity was thoroughly examined by electronystagmography and audiography. Drug-related VIIIth nerve damage could not be confirmed in any of our patients. Five patients showed a rise of serum creatinine of 30 μmol/l. This shows that netilmicin, similar to other aminoglycosides, is a potential nephrotoxic drug.

Netilmicin appears to be an efficacious aminoglycoside and the oto- and nephrotoxicity is low, if careful attention is paid to the renal function and the serum concentrations of the drug.
Domperidone in the Treatment of Dyspepsia: A Double-Blind Placebo-Controlled Study
Authors: Arts E , Anthoni H , de Roy G , D'Hollander J , Verhaegen H
Published: January 2017

Domperidone, at a dosage of 20 mg t.d.s. before meals, in a double-blind, crossover, placebo-controlled trial reduced the level of the symptoms of dyspepsia by 76% compared to a 16% reduction with placebo. This difference was statistically significant (p <0·001). Thirteen of the fourteen patients in the study preferred domperidone to placebo. Four patients in the active treatment period and one in the placebo complained of mild side-effects.
Antihypertensive Effect of Oxprenolol and Chlorthalidone in Fixed Combination, Given Once Daily
Authors: Buoninconti R , Motolese M , Rubegni M
Published: January 2017

In a multicentre, single-blind, within-patient study, the effectiveness and tolerability of the fixed combination oxprenolol 80 mg + chlorthalidone 10 mg per tablet given once daily, compared to the well established b.i.d. schedule, has been investigated in forty out-patients with mild to moderate hypertension. After a two-weeks placebo wash-out, twenty patients were given 1 tablet b.i.d. of the fixed combination for 4 weeks and thereafter 2 tablets once-daily for a further 4 weeks; the remaining twenty patients were given the fixed combination in the reverse order. There was no significant difference in clinical response between the two treatment regimes, which were equally effective and well tolerated. However, patient compliance might be considerably improved with the once-daily dosage schedule of the fixed combination.
Clinical Evaluation of Amoxycillin in the Treatment of Syphilis
Authors: Onoda Yoichi
Published: January 2017

Following demonstration of in vitro activity of amoxycillin against Treponema pallidum, a clinical research group was set up to study the effects of amoxycillin against various stages of syphilitic infection in men.

A total of eighty-nine cases, fifteen primary, twenty-nine secondary, thirty late and fifteen adult congenital patients have been investigated. One hundred per cent effectiveness was recorded for primary and secondary syphilis; 66.7% for late syphilis and 60% success for adult congenital syphilis. In 10.4% of cases there was a transient elevation of SGOT and SGPT although it is not certain whether this was a reaction to the drug itself. There were three incidences of drug-related rash and two other minor side-effects. Amoxycillin is thus a safe and effective oral agent for the treatment of all stages of syphilis in man.
The Symptomatic Treatment of Heartburn and Dyspepsia with Liquid Gaviscon®: A Multicentre General Practitioner Study
Authors: Williams D L , Haigh G G , Redfern J N
Published: January 2017

In a multicentre open study. Liquid Gaviscon was shown to give effective relief of heartburn and dyspepsia in over 82% of patients.

Symptomatic relief was obtained during the day and at night-time and the treatment was as effective whether the patients had a short (0–4 weeks) or long (more than 1 year) history of problems.
Inhibition of Platelet Aggregation in Man by Indobufen (K 3920)
Authors: Vittoria A , Pasini F Laghi , Messa G L , Di Perri T , Corvi G , Fuccella LM
Published: January 2017

A complete crossover trial was undertaken in six healthy volunteers to gain information on dose-effect responses to indobufen by assessing the intensity and duration of the effect of 3 single oral doses of the drug on platelet aggregation induced by threshold concentration of ADP and by 3 added doses of collagen.

The results of the study confirm that the activity is dose-related and is reversible since 24 hours after administration it has practically disappeared. The effect of the same dose of indobufen differed significantly according to the amount of collagen added to plasma, whereas increasing doses of indobufen provoked a significantly more marked effect when the amount of inducer employed was the same.
Mathematical Models of Diuresis after Oral Administration of Tizolemide, Furosemide and Placebo to Healthy Adults
Authors: Reyes A J , Cardiol CE , Biomat CP , Leary W P , Venter C P
Published: January 2017

Urine volumes and flows as functions of time after oral administration of placebo, furosemide 80 mg and tizolemide 100 mg to sixteen healthy male adults at 08.00 a.m. are described through mathematical models.

Accumulated urine volumes after dosing, V, as functions of time, t, are accounted for by sigmoid functions and urine flows are described as dV/dt.

No significant differences were found between the 24-hour urine volume mean values after furosemide (2457 ml) and tizolemide (2283 ml) and both were significantly higher than the corresponding mean value after placebo (1369 ml) (p < 0.001).

Peak diuresis after dosing occurs about 1.5 hours for furosemide, 4 hours for tizolemide and 6 hours for placebo.

Fourteen hours after dosing, urine volume amounts to 90% of the 24-hour urine volume after furosemide and to 76% after tizolemide, so that both substances may be regarded as diurnal diuretics.
Ticarcillin Therapy of Risk Patients with Infections Due to Pseudomonas Aeruginosa
Authors: Welter Jürgen , Wittman Dietmar H , Freitag Volker
Published: January 2017

The implication of nosocomial infection due to Pseudomonas aeruginosa is demonstrated by comparing the bacteriological findings with the clinical picture often patients in a surgical intensive care unit. The occurrence of this organism and its resistance to beta-lactam-antibiotics and aminoglycosides is demonstrated. Ticarcillin was administered to ten patients following bacteriological and clinical evidence of infections due to P. aeruginosa. The pathogenicity of P. aeruginosa as an organism complicating the course of severely injured patients is discussed. Therapeutic consequences in regard to possible combination with other antibiotics are suggested.
Safety and Efficacy of Netilmicin in Neonates with Serious Systemic Infections
Authors: Trujillo Hugo , Manotas Rafael , Loaiza Jorge
Published: January 2017

Twenty-five hospitalized neonates, each with two or more serious symptomatic infections, were given netilmicin by intramuscular injection. The antibiotic was administered usually at 1.5 or 3.0 mg/kg twice a day (q 12 hr) for 7 to 13 days. At the end of therapy the signs and symptoms of infection were completely resolved in twenty-four of the twenty-five patients and markedly improved in the remaining one. Thirty-five causative organisms were isolated from 30 of the 59 infection sites; after netilmicin therapy 31 causative organisms were completely eliminated and 4 were markedly reduced in number. One of the babies had a slight increase in serum creatinine level, possibly related to therapy, and a mild transient rash which was doubtfully related to netilmicin. None of the other neonates had adverse reactions.
A Comparison of a 3-Day Course of Mictral with a 7-Day Course of Ampicillin in the Treatment of Urinary Tract Infection
Authors: Winwick J G , Savage S J
Published: January 2017

This general practice study compared a 3-day course of a new preparation, Mictral, with a standard 7-day course of ampicillin in the treatment of uncomplicated urinary tract infection.

Mictral achieved bacteriological cure in all infected patients by Day 4 while only 69% of infected patients in the ampicillin group were abacteriuric by Day 8. Symptomatic relief and the incidence of side-effects were similar for both groups. It is concluded that Mictral appears to be a useful addition to currently available therapy for urinary tract infection and merits further investigation.
Ketazolam (Solatran) an Open Study of Once-a-Day Treatment in Ambulatory Patients with Anxiety
Authors: Deberdt R
Published: January 2017

The efficacy of ketazolam (Solatran®)* in alleviating the symptoms of short-term reactive or neurotic anxiety in thirty-three patients was examined using a single 30 mg night-time dose in an open study. Patients were to receive treatment for up to 1 month and thereafter as necessary for several months. At the follow-up visits, at the end of the first, second and fourth weeks and then at the end of therapy if continued, the clinical condition was assessed by the Hamilton Anxiety Rating Scale and physician's and patients' subjective global assessments. A highly significant improvement was observed after a week's treatment in both somatic and psychic aspects of anxiety. A favourable response as measured by the two subjective assessments was observed in more than 80% of the patients by the third visit. There were two reports of morning tiredness, both dose-related, but no other adverse effects. Only four patients derived no benefit from the treatment.
Pivmecillinam plus Pivampicillin in Complicated Urinary Tract Infection. Double-Blind Comparison of the Combination Pivmecillinam/Pivampicillin and Pivmecillinam Alone in Patients with Urinary Tract Infection
Authors: Frimodt-Møller C , Vejlsgaard R
Published: January 2017

Twenty-six surgical-urological patients with severe underlying diseases of the urinary tract and an acute urinary tract infection received a 10-day treatment with either pivmecillinam, 400 mg three tmes daily (twelve patients), or the fixed dose combination of pivmecillinam/pivampicillin (pivmecillinam 200 mg plus pivampicillin 250 mg) three times daily (fourteen patients). Eleven of the fourteen patients given combined therapy were cured bacteriologically, compared to only four out of twelve patients taking pivmecillinam alone. Clinical success was achieved in eleven out of fourteen patients who received combination therapy and in seven out of twelve subjects given pivmecillinam. Mild gastro-intestinal discomfort was recorded in a few patients in both treatment groups. The results suggest that the combination of pivmecillinam and pivampicillin is a promising alternative in patients with complicated urinary tract infections.
A Comparison of Slow Trasicor (Oxprenolol 160 mg) and Trasidrex (Oxprenolol 160 mg and Cyclopenthiazide 0.25 mg) in the Treatment of Hypertension in General Practice
Authors: Elsdon-Dew R W , Holden E
Published: January 2017

A crossover study was carried out in general practice to compare Slow Trasicor and Trasidrex (a fixed combination of Slow Trasicor 160 mg and Navidrex 0.25 mg) in the treatment of newly diagnosed hypertensive patients. Trasidrex produced a significantly lower systolic and diastolic pressure, but there were no obvious differences in the incidence of side-effects between the two treatments.
An Evaluation of Pyrisuccideanol Maleate (Nadex) in the Treatment of Mild to Moderate Depression in Patients Aged 55 Years and Over, Presenting in General Practice
Authors: Murphy J Eric
Published: January 2017

A randomized double-blind study was undertaken comparing the therapeutic efficacy of pyrisuccideanol maleate (Nadex) and placebo in sixteen general practices, involving a total of 100 patients presenting with mild to moderate depression. The trial duration period was 6 weeks with assessments being made initially, and at 4 and 6 weeks. A consistently higher proportion of those treated with Nadex demonstrated an improvement in their symptoms as compared to those treated with placebo and some of the differences proved to be statistically significant. Nadex was also observed to be well tolerated.
Double-Blind Crossover Study of Nabumetone versus Naproxen in the Treatment of Osteoarthritis of the Knee and Hip
Authors: Ginsberg Fr , Famaey J P
Published: January 2017

Twenty-five patients suffering from osteoarthritis (O.A.) of the hip or knee were treated with nabumetone (1 g at night) or naproxen (250 mg b.i.d.) during 4 weeks starting either with nabumetone (twelve patients) or with naproxen (thirteen patients). The results of the study were subjected to a statistical analysis which showed good efficacy for both drugs. Tolerance was better with nabumetone than with naproxen. Nabumetone (1 g at night) appeared, thus, to be a good and very well tolerated anti-inflammatory drug in the treatment of osteoarthritis.
Meptazinol: A Side-Effect Profile Compared to Placebo in General Practice
Authors: Price R K J , Latham A N
Published: January 2017

The side-effect profile of oral meptazinol (200 mg) has been described in comparison to placebo in a multicentre general practice setting. Complaints were concerned primarily with the gastro-intestinal tract (64% and 59% of all reported adverse reactions in the placebo and meptazinol groups, respectively). There was no evidence of any deleterious interaction between meptazinol and other medications taken during the course of the trial.
The Use of Meptazinol as a Premedication for Surgical Patients
Authors: Broadley J , Wilson T , Robson P
Published: January 2017

The acceptability of a mixture of meptazinol and hyoscine as a surgical premedication was compared with that of an Omnopon-hyoscine combination in a randomized, double-blind trial involving 101 surgical patients.

Blood pressure and respiratory rate were significantly reduced to a similar extent by both premedicant combinations, and this may be interpreted as evidence of a satisfactory alleviation of anxiety by both test mixtures. The two mixtures produced a similar degree of sedation, and both were associated with a useful inhibition of salivary secretion. Side-effects were reported in 25% patients in the meptazinol group, and in 28% of those receiving Omnopon, although a number of these effects may be attributable to hyoscine. There was no difference in the pattern of post-operative analgesic requirements between the two groups, and no unfavourable interaction was noted with any of the anaesthetic agents used.
Comparative Bioavailability of a Microsize and Ultramicrosize Griseofulvin Formulation in Man
Authors: Lin C , Lim J , DiGiore C , Gural R , Symchowicz bS
Published: January 2017

The bioavailability of 500 mg of a microsize formulation of griseofulvin has been compared to two new ultramicrosize griseofulvin formulations, two 165 mg tablets and a 330 mg tablet, in sixteen healthy, male, volunteers in a randomized crossover study design. Based on the griseofulvin plasma levels measured at specified times over a 48-hour period, the major bioavailability parameters (i.e., area under plasma concentration-time curve, maximum plasma concentration, and time to reach maximum plasma concentration) were determined and statistically evaluated. The results showed that one 330 mg ultramicrosize tablet is bioequivalent to two 165 mg ultramicrosize griseofulvin tablets and that either ultramicrosize griseofulvin dosage regimen is bioequivalent to 500 mg of the microsize griseofulvin formulation.
Comparison of Two Dosage Schedules in the Treatment of Streptococcal Pharyngitis
Authors: McLinn Samuel E
Published: January 2017

The results of this comparative study in 210 patients offer substantial evidence of the safety and efficacy of cephalexin as therapy for acute bacterial pharyngitis and tonsillitis due to group A streptococci. In addition, administration twice a day appears to be as effective as four times a day, provided the total daily dosages are equivalent and are taken for 10 days.
Evaluation of the Short-Term Treatment of Insomnia in Out-Patients with 15 Milligrams of Quazepam
Authors: Mendels Joseph , Stern S
Published: January 2017

The short-term safety and hypnotic efficacy of 15 mg of quazepam was compared with that of placebo in a double-blind study in sixty out-patients with insomnia. All patients received placebo for 3 consecutive nights to establish a baseline; for the next 5 nights thirty patients received quazepam and thirty received placebo. The results indicated that quazepam was significantly more effective than placebo in terms of quantity and quality of sleep and that quazepam was effective on the first night. Despite having a marked hypnotic effect, quazepam was not different from placebo in terms of hang-over effects (i.e., ease in awakening and alertness) the following morning. Treatment-related adverse experiences were reported by ten patients who received quazepam and by five who received only placebo. The most frequently reported adverse experience was daytime somnolence. This study demonstrates that quazepam, in a 15 mg dose, is an effective, rapidly acting, oral hypnotic agent with a low incidence of adverse effects.
The Prophylactic Treatment of Bronchial Asthma in Children with Ketotifen: A Double-Blind Comparison with Placebo
Authors: Spičak V
Published: January 2017

Report on a double-blind parallel group comparison of ketotifen and placebo in two groups of twenty-five children with extrinsic bronchial asthma.

Duration of treatment: 12 weeks, dosage adapted to body-weight, 0·5–1 mg b.i.d.

Main parameters: Overall assessment of efficacy by the treating physician, total duration and frequency of asthmatic episodes per observation period.

In all parameters ketotifen was far superior to placebo in spite of decreased concomitant bronchodilator therapy. The tolerance and acceptability of the compound was good.
The Antihypertensive Effect of Verapamil in Twice and Thrice Daily Dose Regimens. A Randomized, Double-Blind, Crossover Trial
Authors: Hedbäck B , Parment K
Published: January 2017

The antihypertensive effect of verapamil 200 mg b.i.d. was compared with that of verapamil 120 mg t.i.d. in a double-blind crossover study in eight out-patients with essential hypertension. The mean supine blood pressure measured before the morning dose was 150/87 mm Hg in patients treated with verapamil 200 mg b.i.d. and 151/87 mm Hg in those treated with verapamil 120 mg t.i.d. The recently reported prolonged half-life and accumulation of verapamil during steady-state conditions explains the lasting antihypertensive effect with the twice-daily dose regimen. Such a twice daily dose regimen is presumed to be more convenient to the patients and thus improve their compliance.
A Comparison of the Efficacy and Tolerability of Clobazam and Chlordiazepoxide in the Treatment of Acute Withdrawal from Alcohol in Patients with Primary Alcoholism
Authors: Mukherjee P K
Published: January 2017

Forty patients with primary chronic alcoholism took part in a randomized, double-blind, comparative group study of clobazam and chlordiazepoxide in the treatment of acute alcohol withdrawal. Assessments were carried out during an initial in-patient week followed by a week of out-patient assessments.

Both benzodiazepines were shown to be highly effective when compared with baseline measurements. However, the Hamilton Anxiety Rating Scale showed clobazam to be more effective than chlordiazepoxide at both 7 days (p = 0·03) and 14 days (p<0·05). The clobazam group showed significant improvements compared with baseline for all four factors of the Leeds Sleep Evaluation Questionnaire, whereas the chlordiazepoxide group showed a significant improvement in only one factor. At the end of the in-patient week, clobazam showed a significant improvement (p < 0·01) compared to chlordiazepoxide for the Linear Analogue Rating Scale of anxiety/tension.

The 1,5 benzodiazepine clobazam has been shown to be a valuable addition to currently available regimens when used alone in the treatment of acute alcohol withdrawal, especially during the initial period where anxiety and insomnia related symptoms are at their peak.
Effects of Intravenous High Doses of Ketoprofen on Blood Clotting, Bleeding Time and Platelet Aggregation in Man
Authors: Gandini R , Cunietti E , Pappalepore V , Ferrari M , Deleo B , Locatelli E , Fasoli A , Liverta C
Published: January 2017

The effect of ketoprofen (Orudis, Farmitalia) on ADP, epinephrine (EPI) and collagen (COLL) induced platelet aggregation (PIA), simplate bleeding time (SBT), partial thromboplastin time (PTT) and per cent prothrombin activity (PrA) was studied in eleven patients, four males and seven females (median age 59 years) with rheumatoid arthritis (six cases), cancer (four cases) and osteoarthrosis (one case). Tests were performed before and 1, 8 and 24 hours after a single intravenous dose (600 mg) of ketoprofen and on Days 4 and 8 during a 7-day treatment (200 mg i.v. every 8 hours) and 1 day after withdrawal of the drug.

PTT and PrA were not affected by the drug. Bleeding time was not significantly modified by the acute treatment, but was prolonged during the subacute course, though it was not different from baseline values at the end of the trial. Significant reduction of platelet aggregation was seen in both acute and subacute conditions with complete or almost complete recovery 36 hours after the last dose.

It is concluded that ketoprofen affects platelets with readily reversible inhibition of in vitro aggregation and a slight increase of bleeding time.
A Double-Blind Multicentre Study of Piretanide and Hydrochlorothiazide in Patients with Essential Hypertension
Authors: Buckert C , Muhlhausler W , Fratzer U , Verho M
Published: January 2017

In a randomized double-blind parallel group study conducted in three centres the hypotensive activity of piretanide 6 mg b.i.d. was compared with that of hydrochlorothiazide (HCT) 25 mg b.i.d. and HCT 50 mg b.i.d. Ninety-three patients entered the study and sixty-one completed a 16–week trial period. All three treatments produced a significant reduction in supine diastolic and systolic blood pressure after only 2 weeks of active treatment and this was maintained for the duration of the study. The mean maximal reduction in supine diastolic blood pressure was 18% in the piretanide group, 18·8% in the HCT 25 mg b.i.d. group, and 20% in the HCT 50 mg b.i.d. group. The corresponding figures for the percentage of patients attaining a supine diastolic pressure below 95 mm Hg were 83%, 62% and 89%. There were no significant differences between the three groups.

Side-effects were generally mild and transient, except for polyuria which was noted in all three groups but more commonly in the piretanide group. Two patients were withdrawn because of side-effects: one patient in the high dose HCT group developed severe postural symptoms; and one patient in the low dose HCT group was withdrawn because of restlessness, nausea, weakness, dizziness and somnolence.

All three treatments caused a significant increase in serum uric acid concentrations. Four patients in each of the HCT groups developed hypokalemia, but no patients in the piretanide group did so.
Nimesulide in the Treatment of Fever: A Double-Blind, Crossover Clinical Trial
Authors: Reiner Michele , Massera Edy , Magni Enrico
Published: January 2017

A double-blind, crossover clinical trial was carried out in subjects with fever, to assess the activity of three antipyretic drugs. Eighteen in-patients with body temperature (axillary) above 38°C were given a single dose of nimesulide 100 mg, acetylsalicylic acid 500 mg, and dipyrone 500 mg, orally according to an incomplete balanced block design. Significant improvement was recorded with nimesulide and dipyrone, which gave similar results. Acetylsalicylic acid normalized body temperature in a few patients.

Safety was very satisfactory. No local or systemic side-effects were noted.
A Randomized, Double-Blind Study to Compare Tenoxicam with Sustained Release Indomethacin in Osteoarthritic Patients Treated in General Practice
Authors: Hooper P. A. , O'Brien K. , Spence S.
Published: January 2017

A total of 144 patients were recruited for this randomized, double-blind study to compare the efficacy and tolerance of tenoxicam and sustained release indomethacin in patients with osteoarthritis. The results show that 20 mg/day tenoxicam is equal in efficacy to, and significantly better tolerated than, 75 mg/day sustained release indomethacin. Patients receiving tenoxicam recorded significantly better global tolerance ratings ( P=0.042) and fewer adverse events than those receiving indomethacin.
Ticlopidine—Pentoxifylline Combination in the Treatment of Atherosclerosis and the Prevention of Cerebrovascular Accidents
Authors: Apollonio A. , Castignani P. , Magrini L. , Angeletti R.
Published: January 2017

This randomized, double-blind study on 79 patients reported the efficacy of ticlopidine–pentoxifylline combination in the treatment of atherosclerosis and the prevention of cerebrovascular accidents. Comparisons were made with aspirin–dipyridamole–buflomedil and buflomedil–placebo combinations as controls. Global symptoms, sensorimotor disorders and vertigo were improved in all treatment groups, although improvement tended to be more pronounced with ticlopidine–pentoxifylline. None of the groups showed any change in stenosis or vessel wall rigidity although ticlopidine–pentoxifylline reduced flow irregularity. This combination therapy also normalized the direction of flow in the ophthalmic artery in 46.2% of patients with retrograde flow prior to treatment, compared with 30.0% following aspirin–dipyridamole–buflomedil and 28.6% following buflomedil–placebo administration. Significantly fewer cerebrovascular accidents occurred after treatment with ticlopidine–pentoxifylline. In conclusion, ticlopidine–pentoxifylline showed good therapeutic efficacy against atherosclerosis and a preventative effect against new cerebrovascular accidents. This therapy was well tolerated.
Pirprofen in the Treatment of Migraine and Episodic Headache Attacks: A Placebo-Controlled Crossover Clinical Trial
Authors: Guidotti M. , Zanasi S. , Garagiola U.
Published: January 2017

A double-blind, within patient, randomized study to compare the efficacy and tolerability of acute rectal administration of 600 mg pirprofen capsules with matched placebo was carried out in 40 out-patients. They were divided into two groups of 20 patients each according to diagnosis of episodic headache or common or classic migraine. Treatment was given once during each of two consecutive attacks according to a crossover design. None of the patients was withdrawn after randomization. There was a statistically significant difference in favour of pirprofen as regards the preferences expressed by patients at the end of the trial: 34 patients preferred pirprofen, two preferred placebo and four patients had no preference. Pirprofen significantly reduced the duration of headache attack and associated symptoms, but not the peak of pain intensity. Tolerability of the drug was good.
Ranitidine plus Bromazepam in the Treatment of Duodenal Ulcer: Effect on Gastric Acid Secretion
Authors: García-Oyola E. , Curioso W. I.
Published: January 2017

The effect of adding bromazepam to treatment of duodenal ulcer with ranitidine was investigated in 30 out-patients. Under double-blind conditions one group of 15 patients received, for 14 days, 300 mg ranitidine and 6 mg bromazepam in the evening as a single dose. The other group received the same dose of ranitidine together with placebo, also for 14 days. In addition to measurements of gastric acid secretion after fasting and following histamine provocation, psychological ratings (Hamilton Anxiety Rating Scale and Zung Self-Assessment Scale for Anxiety) were carried out. Basal acid secretion was the same in both groups. During treatment, maximal acid output was significantly lower in the group of patients taking bromazepam than in those taking placebo. Similarly, significant differences were seen in favour of bromazepam in the psychological tests. It is concluded that these results confirm that bromazepam exerts a significant influence on acidity, over and above the effect of ranitidine. This effect, in all probability, is modulated by the emotional environment of individuals.
Oral Bioavailability of Nizatidine and Ranitidine Concurrently Administered with Antacid
Authors: Desager J. P. , Harvengt C.
Published: January 2017

This four-way crossover open-label study on eight healthy subjects was designed to investigate the effect on bioavailability of orally administered nizatidine given concurrently with an antacid (magnesium hydroxide–aluminium hydroxide mixture). Ranitidine was used as a comparison. Subjects were hospitalized overnight for each drug application which was given as a single dose [nizatidine or ranitidine (300 mg) or antacid (20 ml) of a neutralizing capacity of 50 mmol hydrochloric acid]. Plasma nizatidine or ranitidine concentrations were measured by high performance liquid chromatography. No statistically significant difference occurred in the kinetic profile of nizatidine after antacid administration although it took longer to reach maximum concentration in plasma. The area under the concentration–time curve was also reduced (by ≤10%) and there was a longer lag between administration and absorption. Bioequivalence (Westlake test) for ranitidine in the presence or absence of antacid was confirmed (difference ≤12%). For nizatidine, with or without antacid, the value of the Westlake test was just above the limit for bioequivalence (21.4%), whereas the Student's t-test for related means (one-tailed distribution) gave P = 0.045. There was no clinically relevant nizatidine–antacid interaction at the doses used in this study.
Thiamine and Zinc in Prevention or Therapy of Lead Intoxication
Authors: Flora S. J. S. , Singh S. , Tandon S. K.
Published: January 2017

Thiamine, zinc or their combination given through gastric gavage were investigated for their ability to prevent or treat experimental lead toxicity in rats. Simultaneous dietary supplementation with thiamine plus zinc was found to be the most effective way of reducing the lead-induced inhibition of δ-aminolevulinic acid dehydratase activity in blood, urinary excretion of δ-aminolevulinic acid and accumulation of lead in blood, liver and kidney. Prevention was more effective than post-lead exposure treatment which may be due mainly to the decrease in the absorption of lead in the gastro-intestinal tract in the presence of thiamine and/or zinc.
The Use of 2.5% Natamycin, as Orally Administered Drops, in the Treatment of Fungal Infections of the Oral Cavity in Children with Chronic Blood Diseases
Authors: Rokicka-Milewska R. , Derulska D. , Lipnicki D. , Skrobowska-Woźniak A. , Moszczeńska A.
Published: January 2017

A total of 34 children with oral candidiasis were treated with 2.5% natamycin in the form of orally administered drops; 6–20 drops applied to oral lesions four times daily for up to 8 weeks. A total cure was achieved in 28 (82.3%) cases. No side-effects were observed. This preparation was an effective treatment for Candida albicans infections in children with blood diseases, and was well tolerated.
Intravenous Chlormethiazole in the Management of Primary Trigeminal Neuralgia Resistant to Conventional Therapy
Authors: Zurak N. , Randic B. , Poljaković Z. , Vöglein S.
Published: January 2017

The therapeutic efficacy of 0.8% chlormethiazole, administered as 3–10 intravenous infusions each lasting 5–6 h on alternate days, was assessed in an uncontrolled study of 16 patients, aged 44–82 years, with primary trigeminal neuralgia. Prior to entry into the study, patients showed a high frequency of neuralgic paroxysms (20–70 attacks/day) which were refractory to high dosages (1600–2000 mg/day) of carbamazepine. After treatment with chlormethiazole neuralgic paroxysms no longer occurred in five patients, were considerably reduced in intensity and frequency (≤5 attacks/day) in six patients, moderately improved in two patients, slightly improved in one patient and showed no change in two patients. The relatively small number of cases and short post-treatment follow-up period limit the conclusions which can be drawn. These results indicate, however, that infusion with chlormethiazole is effective in the treatment of primary trigeminal neuralgia in patients for whom conventional therapy has been unsuccessful.
The Pupillary Light Reflex in Borderline Diabetics
Authors: Kuroda N. , Taniguchi H. , Baba S. , Yamamoto M.
Published: January 2017

Computerized IR videopupillography, using an open-loop photic stimulator, was used to compare the reflexes of borderline diabetics with overt non-insulin-dependent diabetics and with age- and sex-matched non-diabetic healthy controls. The patients were all male, aged 41–59 years. Overt non-insulin-dependent diabetics in their 40s had a smaller pupillary area and pupillary diameter prior to photic stimulus compared with borderline diabetics and healthy controls. Overt non-insulin-dependent diabetics in their 50s had a lower pupillary area and pupillary diameter prior to photic stimulus, maximum velocity and acceleration of constriction and maximum velocity of dilation than did borderline diabetics or controls. The only abnormality observed among borderline diabetics compared to controls was a smaller amplitude of constriction in response to light in patients in their 50s. Amplitude of constriction in response to light and velocity of constriction measurements of borderline diabetics, however, were considerably more frequently abnormal than were those of controls. The frequency of abnormal pupillary diameter prior to photic stimulus, maximum velocity of dilation and acceleration of constriction was higher in overt non-insulin-dependent diabetics than in borderline diabetics. The results indicate that borderline diabetics have autonomic neuropathy before the disease becomes overt. The importance of the pupillary light reflex examination is discussed.
Changes in the Plasma Pattern of Sex Steroids in Patients with Liver Cirrhosis Treated with Mepartricin
Authors: Tavanti A. , Monache M. Delle , Ulissi A. , Vecchio S. Del , Rapocci M.A. , Ruozi P. , De Bernardi M. , Ricci G.L.
Published: January 2017

Mepartricin was given to cirrhotic patients in order to evaluate its effect on the imbalance of sex steroids which is typical of this disorder. Patients were divided into two groups: one group received placebo ( n=19) and the other received 150000 IU/day mepartricin for 30 days ( n=19). The patients were evaluated by separate medical staff who were unaware of the treatment. Mepartricin significantly decreased the plasma concentration of testosterone, oestradiol and prolactin as compared with the values at the start of the trial, while no significant changes were seen in the occurrence of gynaecomastia. No relevant changes were seen in patients receiving the control, except for a slight increase in the peripheral concentration of androstenedione, aldosterone and follicle stimulating hormone.
Acceleration of Fructose Mediated Collagen Glycation
Authors: Oimomi M. , Sakai M. , Ohara T. , Igaki N. , Nakamichi T. , Hata F. , Baba S.
Published: January 2017

The effect of fructose on the formation of advanced Maillard reaction products which show fluorescence and have crosslinking was investigated. Type I collagen was added to various concentrations of glucose and fructose which were then incubated at 37°C for 4 weeks. The level of furosine and the fluorescence intensity both increased in direct proportion to glucose and fructose levels and to the duration of incubation. Incubation with fructose produced less furosine but more intense fluorescence than incubation with glucose. Furthermore, collagen was significantly less soluble after incubation with fructose than after incubation with glucose. These results suggest that fructose in the polyol pathway plays an important role in the formation of advanced Maillard products.
Sustained-Release Verapamil as a First-Step Drug in the Treatment of Mild to Moderate Hypertension
Authors: Karcier S.M. , Orbay B. , Özder A.B. , Gürses N. , Aytekin S. , Satar S. , Öztürk M. , Demiroğlu C.
Published: January 2017

The efficacy of sustained-release verapamil as a first-stage treatment for mild to moderate, uncomplicated essential hypertension was studied. Nineteen patients aged 36 – 70 years (mean±SD 55±10 years) entered the study. Treatment with 240 mg sustained-release verapamil, once daily for 8 weeks, caused systolic and diastolic blood pressures to decline significantly during the first 2 weeks and this lower level was maintained until week 8. Heart rate decreased gradually during the treatment period reaching significance at week 8. After 2 weeks maximum systolic and diastolic blood pressures during isometric exercise were significantly reduced compared with pre-treatment values; there was no difference in the percentage increase occurring pre- and post-treatment. These measures for heart rate did not change significantly. Except for a significant reduction in cardiac index after 8 weeks left ventricular function and left ventricular mass were unchanged. The 24-h urinary Na+ excretion increased significantly after 2 and 8 weeks' treatment. Plasma renin activity, serum lipid concentrations and routine blood chemistries were not affected. Side-effects were transient and did not require discontinuation of therapy. In conclusion, sustained-release verapamil is an efficacious and well tolerated first-stage drug in the treatment of essential hypertension.
Comparison of Two Oral Forms of Erythromycin in the Treatment of Acute Respiratory Tract Infections. A Multicentre General Practice Study
Authors: MacKlin J. , Barden R. , Coles S.
Published: January 2017

A total of 1244 patients with acute upper or lower respiratory tract infection were randomized to receive, twice daily for 7 days, either capsules of enteric-coated pellets of erythromycin base at a dose of 1 g/day or erythromycin ethylsuccinate tablets at a dose of 2 g/day in a single-blind, multicentre study. The efficacy of each formulation was similar, with about 90% of patients who had completed at least 5 days of treatment being reported as either cured or improved. Gastro-intestinal symptoms were the most commonly reported side-effects, being significantly more frequent in patients receiving erythromycin base. Gastro-intestinal intolerance was also the main reason for discontinuing either treatment, although it was a significantly more frequent reason in patients given erythromycin base. This study indicates that both formulations of erythromycin are highly effective for routine, empirical treatment of acute respiratory tract infections. Erythromycin base, however, appears to be less well tolerated than erythromycin ethylsuccinate.
Efficacy and Tolerability of Nimesulide in Elderly Patients with Osteoarthritis: Double-Blind Trial versus Naproxen
Authors: Fossaluzza V. , Montagnani G.
Published: January 2017

A double-blind trial was carried out to assess the therapeutic efficacy and tolerability of nimesulide versus naproxen in the treatment of elderly patients with osteoarthritis. A total of 40 elderly female patients with osteoarthritis of the hip and/or knee were entered into the study and treated with either 200 mg/day nimesulide or 500 mg/day naproxen for 28 days. Both treatments were very effective in alleviating spontaneous pain, pain on movement, morning stiffness and joint mobility. Nimesulide was better tolerated than naproxen with fewer and less serious side-effects being reported. The results of this study show nimesulide to be effective and well tolerated in the treatment of elderly patients with osteoarthritis.
Inhaled Terbutaline Administered via a Spacer Fully Prevents Exercise-Induced Asthma in Young Asthmatic Subjects: A Double-Blind, Randomized, Placebo-Controlled Study
Authors: Xuan A.T. Dinh , Lebeau C. , Roche R. , Ferriere A. , Chaussain M.
Published: January 2017

The effects of inhaled terbutaline, a β2-adrenergic agonist, administered via a 750-ml spacer device were studied in young asthmatic subjects with exercise-induced asthma. A double-blind, randomized, placebo-controlled study of the effects of inhaled 0.5 mg terbutaline and placebo was conducted in 10 asthmatic children (age range 6–16 years) with documented exercise-induced asthma. Forced expiratory volume in 1 s (FEV1) was measured at baseline, 15 min after inhaling terbutaline or placebo, and at intervals up to 60 min after exercising. Subjects exercised using a cycle ergometer for 5 min at a submaximal, constant work-load while breathing dry air at room temperature. Terbutaline induced bronchodilation at rest in all subject and fully prevented exercise-induced asthma in nine out of the 10 subjects; the exercise-induced fall in FEV1 was markedly reduced in the remaining subject. It is concluded that exercise-induced asthma can be inhibited by pretreatment with inhaled terbutaline, administered via a spacer, in a majority of young asthmatics.
Clinofibrate Therapy Raises High-Density Lipoprotein Levels and Lowers Atherogenic Index in Diabetes Mellitus Patients
Authors: Okada S. , Miyai Y. , Ichiki K. , Sato K. , Masaki Y. , Higuchi T. , Ogino Y. , Ota Z.
Published: January 2017

The effects of clinofibrate on serum lipoprotein concentrations, lecithin cholesterol acyl transferase activity and atherogenic index were studied in 10 diabetes mellitus patients. The patients comprised five with well-controlled non-insulin-dependent diabetes, and five with poorly controlled insulin-dependent diabetes; six non-insulin-dependent diabetics acted as placebo controls. No adverse side-effects were reported and there were no significant changes in total cholesterol, triglyceride or high-density lipoprotein 3-cholesterol concentrations following 600 mg/kg clinofibrate treatment for 4 weeks in either insulin-dependent or non-insulin-dependent diabetics. High-density lipoprotein-cholesterol concentrations and lecithin cholesterol acyl transferase activity were significantly ( P<0.05) increased by clinofibrate treatment in insulin-dependent and non-insulin-dependent diabetics and high-density lipoprotein 2-cholesterol concentrations were significantly ( P<0.05) increased by clinofibrate in insulin-dependent diabetics. The atherogenic index was significantly ( P<0.01) reduced in non-insulin-dependent diabetics. It is suggested that the enhanced plasma lecithin cholesterol acyl transferase activity following clinofibrate therapy is the result of increased high-density lipoprotein-cholesterol and high-density lipoprotein 2-cholesterol concentrations and may play a central role in the efficacy of clinofibrate.
Oral Bioavailability of Ampicillin and Amoxycillin Alone and Bound in Fixed Proportions to Sulbactam and Clavulanic Acid
Authors: Desager J.P. , Costermans J. , Van Nieuwenhuyze Y. , Harvengt C.
Published: January 2017

Oral bioavailability of ampicillin when bound to sulbactam (sultamicillin) compared with ampicillin alone and that of amoxycillin with a ligand of clavulanic acid versus amoxycillin alone were assessed in 16 healthy subjects using an open label, multiple crossover study. After a single administration of the drugs, the bioavailability of ampicillin released from sultamicillin was more than twice (2.17) that of ampicillin administered alone, whereas that of amoxycillin was increased by a factor of 1.64 by the presence of clavulanic acid. Higher peak concentrations and areas under the curves, along with shorter lag times, were observed in both cases. The increased oral bioavailability of these aminopenicillins when associated with a β-lactamase inhibitor was well demonstrated in this study, the bioavailability of ampicillin being more enhanced by sulbactam than that of amoxycillin by clavulanic acid.