bluuebunny/crossref_metadata_2025 huggingface dataset:
Clinical Effects of Trithiozine, a Newer Gastric Anti-Secretory Agent
Authors: Pellegrini R
Published: January 2017

Trithiozine is a new product which in animal studies proved to have a marked anti-secretory and anti-ulcer effect, along with a very low acute and chronic toxicity and no ganglioplegic, anticholinergic and anti-H2 activity.

Clinical trials with trithiozine have been performed in some European countries. The results of these trials, most of which were conducted on a double-blind basis, and including already several hundreds of patients, have shown that oral trithiozine:

exerts a very significant action on both basal and stimulated gastric acid secretion, without a rebound hypersecretion; promotes, in most patients, a complete endoscopic healing of peptic ulcer, in addition to an early symptomatic relief; has a mild sedative action; does not affect the pancreatic secretion; is well tolerated even for long-term (up to 10 months) treatments.
Loxapine versus Thioridazine in the Treatment of Organic Psychosis
Authors: Versiani Marcio , da Silva J A R , Mundim F D
Published: January 2017

Two double-blind trials comparing loxapine and thioridazine were conducted in hospitalized adult males diagnosed as having symptoms of chronic psychosis associated with organic brain syndrome or mental retardation. The drugs were administered orally in the ranges of loxapine 10–150 mg/day and thioridazine 150–750 mg/day for 13 weeks.

In the first trial loxapine was found to be generally superior to thioridazine on the Brief Psychiatric Rating Scale, Nurses Observation Scale for Inpatient Evaluation and Clinical Global Impression.

The second trial failed to confirm this superiority. The heterogeneity of diagnostic categories included may explain the discrepancy. Extra-pyramidal symptoms and sedative effects were common to both groups and consistent with the pharmacologic profiles of the study drugs.
Comparison of Action of β-Methyldigoxin and Digoxin Utilizing Systolic Time Intervals
Authors: Katdare A D , Namjoshi S A , Nair K G
Published: January 2017

The temporal course of orally and parenterally administered β-methyl-digoxin and orally administered digoxin was studied in a series of twenty patients who suffered from congestive heart failure due to a variety of causes. The parameters studied mainly were systolic time intervals. The incontrovertible conclusion was that β-methyldigoxin acts almost immediately when administered intravenously and after 20 minutes when given by mouth. The peak action, however, by either route of administration was evident at the end of 45 minutes. Viewed in comparison, digoxin after oral administration acted after 2 hours, reaching its peak action after 8 hours. It must be admitted, however, that the magnitude of the response to both drugs, as measured by significant reduction in PEP/L VET ratio and increase in ejection fraction, was the same.

Our study suggests that β-methyldigoxin is as effective an inotropic agent as digoxin, with an additional characteristic of total and rapid gastrointestinal absorption, predictable and rapid onset and much shorter time interval for its peak action.
Pentoxifylline in Strokes: A Clinical Study
Authors: Janaki S
Published: January 2017

The results of a comparative clinical study with pentoxifylline – a new vasoactive compound – and xanthinol nicotinate in fifty-eight patients suffering from cerebral thrombosis with hemiplegia or monoplegia, are presented. Pentoxifylline appeared to be more effective in reducing motor deficit and was significantly better in improving the patients' intelligence and memory score. Recovery from speech deficit was equally well seen with both drugs.
Experiences with the New Oral Contraceptive Ovysmen
Authors: James A , Karoussos K
Published: January 2017

The contraceptive effect of the new pill Ovysmen has been tested in two groups in a total of thirty-six patients. The preparation was well tolerated and the results failed to reveal fundamental differences in comparison with other trials performed by other investigators. No pregnancies occurred in either group.
Comparison of the Therapeutic Effect, Tolerance and Safety of Ketazolam and Diazepam Administered for Six Months to Out-Patients with Chronic Anxiety Neurosis
Authors: Fabre Louis F , McLendon David M , Stephens Allison G
Published: January 2017

Recently, it has been argued that benzodiazepines may not be safe or efficacious beyond 3 months continuous dosage. This study was designed to provide data regarding efficacy, safety, possible tolerance development, and possible withdrawal effects of administering ketazolam and diazepam for a 6-month period. Chronic anxiety patients were screened for participation according to specific inclusion and exclusion criteria. Of 139 patients, forty-four terminated prematurely for non-drug related reasons and are not included in the analysis. Of the ninety-five patients remaining, sixty-three were on ketazolam, and thirty-two on diazepam. Efficacy parameters included the Hamilton Anxiety Rating Scale, Physician's Global Impressions, Target Symptoms, Self-Rating Symptom Scale, and Patient's Global Impressions. Patients were evaluated weekly for the first month except for Week 3, and then seen bi-weekly and rated monthly. The results of the study showed that ketazolam was as efficacious as diazepam in treating anxiety and resulted in fewer side-effects. No adverse effects were noted in either group. Both benzodiazepines were safe and well-tolerated. No tolerance or withdrawal effects were noted. The average doses were ketazolam Week 4 (50.0 mg), Week 24 (66.14 mg) and diazepam Week 4 (26.33 mg) and Week 24 (33.0 mg). An increase in anxiety occurred in a significant number of patients after termination of either drug. By 2 weeks after the last dose many patients were free of anxiety and did not require further treatment. These results demonstrate that benzodiazepines are safe and efficacious for at least 6 months of continuous dosage.
Evaluation of Guanabenz Added to Hydrochlorothiazide Therapy in Hypertension
Authors: Walker Barry R , Deitch Marc W , Gold Jerome A , Levey Barbara A
Published: January 2017

Guanabenz, a centrally acting a-adrenergic antihypertensive agent, produces neither the sodium retention seen with other centrally acting agents nor the metabolic abnormalities characteristic of diuretics. In this study, which involved 204 hypertensive out-patients, the additive effects of guanabenz and hydrochlorothiazide were compared with the effects of hydrochlorothiazide therapy alone. Before randomization to the 6-month blinded addition of either guanabenz or placebo, hydrochlorothiazide (50 or 100 mg/day; mean, 70 mg/day) was administered as sole therapy for 6 weeks. During this time, mean supine diastolic blood pressure (SDBP) decreased from 102 to 94 mm Hg (p < 0·01), with a satisfactory clinical response rate of 62% and a mean weight loss of 2 lbs (p < 0·01). No further change in mean SDBP occurred during the next 6 months of diuretic therapy, whereas the addition of guanabenz (mean dose, 24 mg/day) caused a further decrease in mean SDBP to 88 mm Hg (p < 0·01), an increase in the response rate to 86%, and no weight change. Pulse rates in both groups were unchanged. The principal side-effects in both groups were dry mouth, drowsiness, weakness, and dizziness, with a greater incidence of each during the combination therapy. The usual laboratory abnormalities were associated with hydrochlorothiazide. Guanabenz was found to enhance the antihypertensive efficacy of hydrochlorothiazide without compromising its natriuretic properties or producing additional metabolic abnormalities.
The Subacute Effect of Bromazepam on Psychomotor Activity and Subjective Mood
Authors: Hobi V , Dubach U C , Skreta M , Forgo I , Riggenbach H
Published: January 2017

In a double-blind study, fifty-five healthy, male medical students received a tranquillizer (bromazepam, ‘Lexotanil') or placebo according to dosage group (placebo, 1·5 mg and 3 mg bromazepam). The subjects were randomly allocated to three groups (placebo: n = 19; 1·5 mg: n = 19; and 3 mg: n = 17). Dependent variables tested were the subjective assessment of performance and the level of activation (self-rating), and aspects of psychomotor function were assessed using the standard testing devices.

The medication was administered for a total of 14 days. The testing times reported here were: before start, and after 7 and 14 days of administration of verum or placebo. The subjective evaluation (self-rating) such as performance assessment and level of activation demonstrated no changes related to either the medication or the length of time elapsed. The objective measures of performance revealed two main effects: lengthening of time of reaction to optical stimuli during the course of the study, especially in the higher bromazepam dosage group (sedative effect). This sedative effect was, however, relatively weak since, despite this observation, there was a significant training effect in the 3 mg group with regard to attentiveness and alertness testing.

The results were also evaluated for a possible effect on driving ability. In the group studied here and at the relatively low dosage administered, any possible negative influence can be disregarded.
Treatment of Acute Alcohol Withdrawal Syndrome with Carbamazepine: A Double-Blind Comparison with Tiapride
Authors: Agricola R , Mazzarino M , Urani R , Gallo V , Grossi E
Published: January 2017

A double-blind, randomized trial is described which was designed to compare the clinical effect of 600 mg daily of carbamazepine (Tegretol®) and of tiapride (Sereprile®) in hospitalized patients with pre-delirium tremens. Physicians' assessment of patients' progress was made following 2, 4 and 7 days of treatment. Of the sixty patients admitted to the study, five dropped out for various reasons, leaving fifty-five patients who completed the study. Both drugs were effective in the treatment of alcohol withdrawal symptoms; no significant difference was found between the two treatments with respect to total symptoms' score and visual analogue scale assessment. Carbamazepine gave faster relief of symptoms and demonstrated a preferential action on symptoms like fear and hallucinations. No case of delirium tremens was observed in those patients who completed the trial.
Lormetazepam (Lorámet®): A Multicentre Assessment of its Efficacy and Acceptability as a Hypnotic in Out-Patients with Sleep Disturbances
Authors: Hill R C , Harry T V A
Published: January 2017

In an open, multicentre study, the short-acting benzodiazepine hypnotic lormetazepam (Loramet®) was administered nightly (1–2 mg p.o.) for a period of 7 nights to 665 out-patients with various types of sleep disturbances. The patients assessed the efficacy and acceptability of lormetazepam with the aid of a simple diary card and a set of visual analogue scales. The results showed that about 75% of the patients reported a significant improvement in their sleep pattern. The time to onset of sleep was decreased, the number of nocturnal wakings was reduced and the patients reported waking in the morning more refreshed and co-ordinated. The effects were significant after the first night and there were further significant improvements by the seventh night on the drug. In patients who had prior experience of other hypnotics, twice as many preferred lormetazepam to temazepam and three times as many preferred lormetazepam to nitrazepam. Nine patients withdrew from the study due to lack of efficacy and only fifteen patients dropped out following the occurrence of side-effects, mainly drowsiness and lightheadedness. It was concluded that lormetazepam is an effective and highly acceptable hypnotic in patients with sleep disturbances.
Flunitrazepam: Acute Benefit-Risk Assessment in General Practice
Authors: Hallett C , Dean B C
Published: January 2017

A methodology is described which is practical in assessing the benefit-risk ratio of a single new drug prior to marketing. Flunitrazepam at doses of 0·5 mg, 1·0 mg (and 2 mg) node in 2,435 patients is shown to be effective in 78% of patients and the acute risk, predictable and low, irrespective of age or dose. One may conclude that the acute benefit-risk ratio is acceptable with respect to the class of drug and indication for which flunitrazepam is prescribed.
Foetal Safety of Nitrofurantoin Macrocrystals Therapy during Pregnancy: A Retrospective Analysis
Authors: Hailey Francis J , Fort Heather , Williams J Collins , Hammers Betty
Published: January 2017

Urinary tract infection during pregnancy poses increased risk to mother and foetus and warrants prompt detection and treatment. Currently, there are no antibacterials approved for use in pregnant women. A retrospective analysis was undertaken to evaluate the safety to the human foetus of nitrofurantoin macrocrystals (Macrodantin®) when administered during pregnancy. The records of ninety-one pregnancies in eighty-one obstetric patients who were treated with nitrofurantoin macrocrystals for urinary tract infection were reviewed. Safety was assessed according to incidence of foetal death, neonatal death, malformation, prematurity, low birth weight, low Apgar score and jaundice. The incidence of abnormal events in the pregnancies evaluated was not significantly different from that in the United States population. No abnormal event was considered to be drug-related. This study yielded no evidence that would implicate nitrofurantoin macrocrystals as toxic to the foetus or unsafe for treatment of maternal urinary tract infection during pregnancy.
A Multicentre General Practice Study Comparing Pivampicillin (Pondocillin) and Amoxycillin (Amoxil) in Respiratory Tract Infections
Authors: Moran D G
Published: January 2017

Seven-day courses of either pivampicillin (Pondocillin) 500 mg twice daily or amoxycillin (Amoxil) 250 mg three times daily were compared in a multicentre general practice study in 463 patients with symptoms of upper or lower respiratory tract infections. Patients were stratified into four diagnostic groups: sinusitis, otitis media, throat infections, and acute bronchitis, and randomly allocated to treatment within these groups. There was an over-all response of 93% in the 227 patients receiving 12-hourly pivampicillin compared with 90% for the 236 patients receiving 8-hourly amoxycillin. Patients suffering from acute bronchitis responded significantly better to pivampicillin (Pondocillin) than to amoxycillin. Side-effects were reported by 15·6% of patients in the amoxycillin group and 14·0% in the pivampicillin group.
Sulphinpyrazone in Cardiovascular Elderly Azotemic Patients: A Proposal of a ‘Guided’ Incremental Dose Schedule
Authors: Palummeri E , Borghi C , Di Ruvo R , Dacco‘ L , Passeri M
Published: January 2017

Renal tolerability of a guided incremental dose schedule of sulphinpyrazone was evaluated in an open study of 2-month duration, performed in twenty-one cardiovascular elderly azotemic patients (thirteen males, eight females; mean age: 79 years, S.D.: 7·3 years). Starting dosage was 200 mg per day; daily dosage was then increased, every 4 days, by 200 mg or kept constant for another 4 days, according to each patient's basal renal function, up to the maintenance dose: 800 mg/day. Eighty-one per cent of the patients followed a successful incremental pathway, 9% kept a constant daily dosage of 200 mg for 8 days, reaching then the maintenance daily dose without any problems. Nine per cent withdrew at 200 mg/day because renal function deteriorated at two consecutive visits. Renal function of the patients who completed the study significantly improved (two-way ANOVA, p < 0·01). General tolerability was good. The proposed incremental dose schedule of sulphinpyrazone can be successfully used in the treatment of cardiovascular elderly azotemic patients.
Effects of Long-Term Ticlopidine Treatment on Platelet Function and its Tolerability in Cerebrovascular Disease
Authors: Carrieri P , Orefice G , Fioretti A , Indaco A , Carfagna S
Published: January 2017

A trial was performed on thirty-two patients with cerebrovascular disease (transient ischaemic attack and stroke) to assess the effect of ticlopidine, a new inhibitor of platelet aggregation, on some platelet functions and coagulation, and its safety in long-term use (6 months). The results show that ticlopidine was highly effective in inhibiting ADP-induced platelet aggregation, platelet adhesiveness and circulating platelet aggregates, but it had no effect on fibrinogen levels. No serious side-effects were observed. Ticlopidine may therefore prove to be a useful antiplatelet drug in the management of patients with cerebrovascular disease.
Comparative Evaluation of Antipyretic Activity of Ibuprofen and Aspirin in Children with Pyrexia of Varied Aetiology
Authors: Kandoth P W , Joshi M K , Joshi V R , Satoskar R S
Published: January 2017

The antipyretic activity of Ibuprofen and aspirin was compared in sixteen children with pyrexia due to upper respiratory tract infection and in twelve with fever due to other causes. All 28 children received ibuprofen (7 mg/kg of body-weight) and aspirin (15 mg/kg of body-weight) in a single dose on 2 consecutive days in a crossover manner. Rectal temperature was recorded prior to and at regular intervals up to 8 hours after drug administration.

Analysis of the results indicate that ibuprofen and aspirin effectively lower temperature and the two drugs are comparable in their antipyretic activity. In conclusion, significant antipyretic activity, good tolerance profile and availability in syrup form make ibuprofen a useful substitute for aspirin in children with fever.
The Effect of Trimipramine (Surmontil) on the Gastric Secretion of Acid and Pepsin in Patients with Duodenal Ulceration
Authors: Mackay H P , Mitchell K G , Pickard W R , Hearns J , Crean G P
Published: January 2017

Twenty-three patients with endoscopically proven, symptomatic duodenal ulceration were randomized to receive trimipramine 50 mg daily or placebo. Maximal acid output studies and estimations of pepsin levels were performed before treatment, for 4 weeks while on drug or placebo and for 4 weeks after cessation of treatment. Gastric acid secretion was significantly reduced after 3 weeks treatment with trimipramine and this reduction was maintained for the duration of the study. Gastric pepsin levels were unaffected by the administration of the drug.
Halomethasone (C 48.401-Ba) for the Topical Treatment of Common Dermatoses
Authors: de la Brassine M , Kint A , Lachapelle J M , Tennstedt D
Published: January 2017

C48.401-Ba cream, containing 0·05% halomethasone* was compared in a double-blind between-patients trial with a cream containing 0·1% betamethasone valerate** in forty-eight patients suffering from atopic dermatitis and in thirty-nine patients suffering from seborrhoeic dermatitis.

A similar comparison was made with ointments containing the same concentration of active ingredient in forty-six patients suffering from atopic dermatitis. Both ointments were also compared in a within-patient double-blind trial in thirty patients suffering from psoriasis.

The analysis of the results showed that for the treatment of the above-mentioned dermatoses, both drugs, the cream as well as the ointment, are equally effective and well tolerated.
Pharmacokinetics and Bioavailability of Pinacidil Capsules in Human Volunteers
Authors: Laher Mark S , Hickey Michael P
Published: January 2017

Pinacidil is a new and potent vasodilator, which has recently been used in the treatment of various forms of hypertension. In this study pharmacokinetic parameters were determined following administration of intravenous (0·2 mg/kg) and capsule (12·5 mg) formulations of pinacidil to twelve healthy volunteers.

The serum half life (t½ and volume of distribution (Vd) of pinacidil were 204 ± 0·40 h and 1·4 ± 0·4 l/kg respectively, while the elimination rate constant (k el) was 0·34 ± 0·07 h1

The mean bioavailability of pinacidil (capsule formulation) was 57% ± 16 S.D.

Mild side-effects such as dizziness, headache and fatigue were noted in two volunteers following intravenous administration of pinacidil, while no side effects were reported with the oral formulation.
Efficacy and Tolerability of Sustained-Release Clomipramine (Anafranil SR®) in the Treatment of Phobias: A Comparison with the Conventional Formulation of Clomipramine (Anafranil®)
Authors: Allsopp Lynette F , Huitson A , Deering R B , Brodie N H
Published: January 2017

This multicentre double-blind trial in general practice compared the efficacy and tolerability of the sustained-release formulation of clomipramine (Anafranil SR®) with its conventional formulation (Anafranil®) in the treatment of phobias. Patients were allocated at random to receive clomipramine 75 mg once daily as either the sustained-release or conventional formulation for 11 weeks following a 1-week dosage build-up period. Analysis of results from forty-six patients showed that the sustained-release formulation of clomipramine 75 mg was as effective as the conventional formulation of clomipramine 75 mg in improving symptoms of phobia as assessed by a phobia inventory and global evaluation. Unwanted effects attributable to therapy were similar in both treatment groups but there were fewer withdrawals due to unwanted effects of the sustained-release formulation of clomipramine 75 mg. It was concluded that the sustained-release formulation of clomipramine does offer advantages for patients requiring 75 mg clomipramine daily.
Lormetazepam (Loramet®) in the Elderly: An Acceptability Study
Authors: Joseph D N , Hossain M
Published: January 2017

In an open, single centre, general practice study, the short acting benzodiazepine lormetazepam (Loramet®) was administered nightly for a period of 7 nights to fifty-eight geriatric insomniacs. All patients took 0–5 mg on the first night but were allowed to increase their dosage to 1·0 mg and 1·5 mg as required. The patients assessed the efficacy and acceptability of lormetazepam with the aid of a diary card completed on each morning of the study. The results showed that 65·5% of the patients reported an improvement in their sleep pattern and 76·9% were taking the 0·5 mg dosage by the last night of the study. Throughout the study there was a progressive increase in the mean duration of sleep and a similar increase in the number of patients awaking refreshed. The effects were significant after the second and third nights, respectively. Three patients withdrew from the study, two due to lack of efficacy and one dropped out following the occurrence of side-effects. It was concluded that the results confirm the efficacy and acceptability of lormetazepam and may suggest 0·5 mg to be a more suitable dosage than 1·0 and 1·5 mg in elderly patients.
The Use of Cimetropii Bromidum as Premedication for Endoscopy of the Upper Gastro-Intestinal Tract: A Double-Blind Controlled Clinical Trial
Authors: Parente F , Lazzaroni M , Imbimbo B P , Panza E , Ardizzone S , Porro G Bianchi
Published: January 2017

The effectiveness of cimetropii bromidum (10 or 20 mg i.v.) as premedication for upper gastro-intestinal tract endoscopy was examined and compared with that of placebo in a double-blind crossover study involving 160 patients. The drug effects were assessed from the degree of opening of the pyloric sphincter and the endoscopist's rating of drug performance. The study showed that the effects of cimetropii bromidum differed highly significantly (p < 0·0001) from those of placebo, on either count. No adverse effects were noted.
Effect of the Standardized Ginseng Extract G115® on the Metabolism and Electrical Activity of the Rabbit's Brain
Authors: Samira M M Hassan , Attia M Attia , Allam M , Elwan Osamah
Published: January 2017

The objective of this original investigation was to study the effect of the standardized Ginseng Extract G115* on the metabolic activity and ECoG of the rabbit's brain. The results showed significant increase of the glucose uptake with simultaneous significant reduction of the lactate, pyruvate and lactate/pyruvate ratio. These findings indicate shift of glucose utilization by the drug from anaerobic to the more economical pathway. G115 was also shown to produce a desynchronizing effect on the electrocorticogram (ECoG) which correlated well with the biochemical findings.
Effect of Fenticonazole in Vaginal Candidiasis: A Double-Blind Clinical Trial versus Clotrimazole
Authors: Brewster Earl , Preti Piero Monici , Ruffmann Ralf , Studd John
Published: January 2017

Fenticonazole is an imidazole derivative which possesses a broad spectrum antimycotic activity, including activity against Candida albicans. Its therapeutic activity and tolerability have been evaluated, in a double-blind clinical trial versus clotrimazole, in 54 patients affected by mycologically confirmed symptomatic vaginal candidiasis. Both drugs were administered intravaginally as a cream once a day for 7 days. Assessment was by laboratory mycological investigations and symptomatic evaluation. Patients ‘cured’ at the end of the trial were re-evaluated after 4–6 weeks for possible relapses. Both treatments resulted in a progressive, statistically significant reduction in vaginal symptoms (itching and discharge) and in elimination of Candida in more than 95% of patients. When ‘cured’ patients were reassessed 4–6 weeks after therapy, relapses occurred in four patients after fenticonazole treatment, but in none following clotrimazole treatment. This apparent difference between treatments is far from being statistically significant and, therefore, may have been a chance occurrence. It should also be noted that patients from the fenticonazole group had a previous history of significantly more frequent episodes of candidiasis suggesting that they may have been at greater risk of re-infection than patients from the control group. The tolerance of both treatments was excellent since no local or systemic signs or symptoms of toxicity were reported. An equally high efficacy and safety for both drugs in the elimination of symptoms and objective evidence of vaginal candidiasis is indicated.
Rubella Vaccine – How ‘Reactogenic’ is it?
Authors: Griffin G V , Bryett K A
Published: January 2017

Girls (231) aged 11—13 years were allocated at random to receive one of two RA27/3 rubella vaccines. A high incidence of minor and self-limiting side-effects were found by intensive follow-up. No difference in reactogenicity could be found between vaccines from the Institut Merieux and Wellcome. This study confirms the highly acceptable risk/benefit ratio of vaccination against rubella in the U.K.
Platelet Deposition on Human Atherosclerotic Lesions is Decreased by Low-Dose Aspirin in Combination with Dipyridamole
Authors: Sinzinger H. , O'Grady J. , Fitscha P.
Published: January 2017

Eighteen patients with ischaemic peripheral vascular disease were treated for a 5-week period with either 20 mg aspirin daily, 75 mg dipyridamole three times daily or a combination of these two treatments. Before and after 4 weeks' treatment autologous platelet labelling with 111In was carried out and sites of active vascular platelet uptake monitored, and platelet half-life measured. Neither aspirin nor dipyridamole alone had any effect on platelet uptake or on platelet half-life. The combination of aspirin and dipyridamole resulted in a significant decrease in platelet uptake and a nonsignificant trend towards prolongation of platelet half-life. These findings suggest that this combined therapy may be of benefit in the treatment of atherosclerosis in man.
An Evaluation of Topical Mupirocin in Moderately Severe Primary and Secondary Skin Infections
Authors: Buchvald J.
Published: January 2017

Five days' treatment with topical mupirocin, applied twice daily, in 36 patients with moderately severe primary and secondary skin infections, resulted in resolution/much improvement of skin lesions in 75.0% of patients and bacterial eradication in 83.9% of cases. Penicillin-resistant and penicillin-sensitive staphylococci were most commonly implicated. No adverse effects were reported in any of the patients treated. Physicians' assessment of cure/improvement was recorded in 91.7% of patients.
A Multicentre Placebo-Controlled Study in General Practice to Evaluate the Efficacy and Safety of Tizanidine in Acute Low-Back Pain
Authors: Berry H. , Hutchinson D. R.
Published: January 2017

Patients (112) with acute low-back pain of recent onset were recruited to this double-blind, randomized, placebo-controlled parallel group study in general practice to evaluate the efficacy and tolerability of the muscle relaxant, tizanidine. They were treated for 7 days with tizanidine (4 mg three times daily) or matching placebo. Aspirin tablets (300 mg) were taken as required as ‘rescue’ medication. Symptoms were assessed by the patient and doctor before treatment, and after 3 and 7 days. Patients recorded pain and aspirin consumption in a daily diary. Both treatments were effective. In patients who had taken no medication prior to entry, aspirin consumption was almost halved in the first 3 days of taking tizanidine compared with placebo ( P = 0.037). Results for pain at rest, pain at night, restriction of movement and pain on movement suggest that tizanidine may give greater improvement, earlier. No serious drug-related adverse events or abnormal biochemistry or haematology were observed in either group. Drowsiness occurred in 22% of patients taking tizanidine although, in patients with severe acute low-back pain, sedation, analgesia and bed rest might be beneficial and desired. Considerably more patients given aspirin/placebo had gastro-intestinal side-effects ( P = 0.018). In conclusion, tizanidine may reduce the need for analgesics and be useful in the treatment of acute low-back pain.
Tizanidine and Ibuprofen in Acute Low-Back Pain: Results of a Double-Blind Multicentre Study in General Practice
Authors: Berry H. , Hutchinson D. R.
Published: January 2017

This study reports on 105 patients with acute low-back pain given tizanidine (4 mg three times daily) plus ibuprofen (400 mg three times daily) or placebo plus ibuprofen (400 mg three times daily). Patients assessed their pain using visual analogue scales in a daily diary and the doctor assessed their condition at baseline and on days 3 and 7. Both groups were treated effectively, but earlier improvement occurred in patients given tizanidine/ibuprofen, particularly regarding pain at night and at rest. Doctors assessed the helpfulness of treatment: tizanidine/ibuprofen was significantly better than placebo/ibuprofen at day 3 ( P = 0.05). Significant differences between treatments in favour of tizanidine/ibuprofen occurred in patients with moderate and severe pain at night ( P<0.05), at rest ( P<0.05) and those with moderate or severe sciatica ( P<0.05). Significantly more patients given placebo/ibuprofen had gastro-intestinal side-effects compared with tizanidine/ibuprofen ( P = 0.002). This supports previous work in animals showing that tizanidine mediates gastric mucosal protection against anti-inflammatory drugs. More patients given tizanidine/ibuprofen suffered drowsiness and other central nervous system effects ( P = 0.025). In patients with severe acute low-back pain, however, some sedation and bed rest is advantageous. This study shows that tizanidine/ibuprofen is more effective in the treatment of moderate or severe acute low-back pain than placebo and ibuprofen alone.
Atenolol and Amiodarone: A Comparative Study of Their Anti-Ischaemic Effect
Authors: Ferraro S. , Liguori V. , Fazio S. , Iacono C. , Somma S. Di , Petitto M. , Galderisi M. , Cianfrani M. , de Divitiis O.
Published: January 2017

A total of 10 patients with mixed angina were entered into a study to compare the anti-ischaemic efficacy of atenolol and amiodarone. The study was divided into three parts: (a) placebo for 2 weeks; (b) 100 mg atenolol given for 8 weeks; and (c) amiodarone given for 8 weeks, divided into week 1, 200 mg three times daily; week 2, 200 mg twice daily; weeks 3 and 4, 200 mg once daily; weeks 5–8, 200 mg once daily for 5 days a week. Clinical examination, basal and multi-stage effort electrocardiograms were performed at the end of each treatment. The number of anginal attacks and the amount of trinitrin taken by the patients were significantly reduced by both drugs with no significant difference between them. Compared with placebo, both drugs induced a significant increase in work capacity and in the time to decrease the ST-segment by 1 mm. At rest, atenolol reduced systolic blood pressure, heart rate and the systolic blood pressure–heart rate product compared with placebo. Systolic blood pressure was also reduced significantly compared with patients given amiodarone. Amiodarone did not influence these parameters. At maximum effort, amiodarone reduced heart rate and the systolic blood pressure–heart rate product compared with placebo. This reduction was greater for atenolol. The ST-segment depression was comparable between patients given either test drug. Amiodarone, therefore, exerts an anti-ischaemic effect similar to that shown by atenolol with different haemodynamics: atenolol reducing myocardial oxygen demand, amiodarone having an additive increase of coronary flow. Such an effect was obtained with a lower dose of amiodarone than is commonly used.
Animal Pharmacological Effects of 24R,25-Dihydroxyvitamin D3 One of the Endogenous Substances Regulating Calcium Metabolism
Authors: Maeda Y. , Hirai T. , Yamato H. , Kobori N. , Matsunaga K.-I. , Oguchi Y. , Yoshimura M. , Fujii T. , Kobayashi Y. , Saitoh K.-I. , Inoguchi E. , Hakozaki M. , Iijima H. , Kodaira T. , Konai Y. , Katoh T. , Yoshikumi C. , Kawai Y. , Nomoto K.
Published: January 2017

Lewis lung carcinoma was found to cause hypercalcaemia in tumour-bearing mice. 24 R,25-Dihydroxyvitamin D3, a naturally occurring steric epimer, significantly prolonged the survival time of mice with Lewis lung carcinoma. It also had an analgesic effect in mice with Lewis lung carcinoma and increased the strength of bone weakened by the carcinoma which causes abnormal calcium metabolism and results in hypercalcaemia.
Oxaprozin versus Diclofenac Sodium in the Treatment of Ankylosing Spondylitis
Authors: Santo J. E. , Queiroz M. V.
Published: January 2017

The efficacy and tolerance of 1200 mg/day oxaprozin and 100 mg/day diclofenac sodium were compared in 40 patients with ankylosing spondylitis in a 6-week open study. Overall improvement was seen in the patients in both treatment groups. Oxaprozin-treated patients showed significant improvement in spontaneous pain of the vertebral spine and in morning stiffness after 6 weeks' treatment. There were no statistically significant differences between the treatment groups. Therapy was discontinued in 10 patients; five treated with oxaprozin (three because of intolerance and two because of worsening of symptoms) and five taking diclofenac sodium (four because of intolerance and one because of worsening of symptoms). Five (25%) oxaprozin-treated patients and six (30%) diclofenac sodium-treated patients had side-effects, with gastro-intestinal disturbances and dizziness reported most frequently. There were no statistically significant differences between the groups in the frequency of side-effects. These results indicate that oxaprozin is a promising therapeutic agent for ankylosing spondylitis.
Effect of Doxycycline on Pre-Menstrual Syndrome: A Double-Blind Randomized Clinical Trial
Authors: Toth A. , Lesser M. L. , Naus G. , Brooks C. , Adams D.
Published: January 2017

Thirty patients with well-defined symptoms of pre-menstrual syndrome were randomly treated with the antibiotic doxycycline or placebo. The antibiotic-treated group showed a highly significant reduction of symptoms. Subsequent antibiotic treatment of the original placebo group similarly diminished the symptoms in this group. A 6-month follow-up demonstrated that the improvement in symptom scores was permanent and independent from the presence of the antibiotic. Luteal phase endometrial biopsies showed a high incidence of out-of-phase endometrium. An unexpectedly high percentage of endometrial biopsy cultures yielded positive findings for mycoplasma, Chlamydia trachomatis and anaerobic bacteria. There were no characteristic hormonal changes in this study group. An infectious aetiology, possibly a sub-clinical endometrial or ovarian infection, behind certain cases of pre-menstrual syndrome is postulated.
Effect of 24R,25-Dihydroxyvitamin D3 in Experimental Diabetic Rats
Authors: Katoh T. , Maeda Y. , Yamato H. , Hirai T. , Fujii T. , Yoshino F. , Kodaira T. , Konai Y.
Published: January 2017

The results are presented of a controlled study in male Wistar rats into the effects of 24 R,25-dihydroxyvitamin D3 on blood glucose levels, bone calcium content and ADP-induced platelet aggregation in streptozocin-induced diabetes mellitus. Blood glucose levels were shown to be decreased by 10 μg/kg 24 R,25-dihydroxyvitamin D3. The reduced bone calcium content associated with diabetes mellitus was returned to normal levels with both 1 and 10 μg/kg 24 R,25-dihydroxyvitamin D3. It was also shown to exhibit dose-dependent anti-platelet activity. The data suggest that 24 R,25-dihydroxyvitamin D3 might have potential as a mild therapeutic agent in the treatment of osteoporosis and platelet hyperactivity associated with diabetes mellitus.
Effect of Dopamine on Plasma Growth Hormone and Prolactin Concentrations under Anaesthesia
Authors: Mikawa K. , Kusunoki M. , Obara H. , Iwai S.
Published: January 2017

Five patients with acromegaly and five patients with prolactinoma undergoing general anaesthesia were studied. Concentrations of plasma growth hormone in patients with acromegaly and concentrations of plasma prolactin in patients with prolactinoma were measured before anaesthesia, when 250 mg levodopa was administered orally, and after anaesthesia when dopamine was infused intravenously at a rate of 5 μg/kg-min. There was no difference in hormonal (growth hormone or prolactin) response to either treatment in the anaesthetized and the awake states. These findings indicate that the functioning of dopamine receptors in the anterior pituitary is not affected by anaesthesia.
Lymphocyte Function Tests in Cirrhotic Patients under Treatment with Spironolactone and Potassium Canrenoate
Authors: Cuppone R. , Vecchio S. Del , Zanninelli G. , Monache M. Delle , Ulissi A. , Tavanti A. , Angeloni A. , Ricci G. L.
Published: January 2017

This controlled study in cirrhotic patients investigated whether two antialdosteronic steroids, spironolactone (100–200 mg/day; n=12 patient pairs) and potassium canrenoate (50–100 mg/day, n=32 patient pairs) which are reported to bind to intracellular membranes and modify cytochrome P-450, could also produce nuclear changes. The model used was the response of peripheral lymphocytes to blastogenic agents by studying lymphocyte sub-populations. No changes occurred in the B- and T-lymphocyte sub-populations or in the helper and suppressor sub-types. The response to the blastogenic agents, phytohaemagglutinin and purified protein derived from mycobacteria, did not change significantly from before entry into the study to the follow-up (18.1 ± 2.9 months). All control patients ( n=44 patient pairs) had slightly greater mitogenic activity compared with patients treated with spironolactone; no difference was found when control patients were compared with patients given potassium canrenoate. The difference between spironolactone and potassium canrenoate might be due to toxicity caused by the thio group of spironolactone. Overall, however, both drugs may be regarded as safe, in terms of effects on lymphatic tissue, occurring during the course of cirrhosis.
Non-Prostanoid Endothelium-Derived Vasoactive Factors
Authors: Xuan A.T. Dinh , Higenbottam T.W.
Published: January 2017

Endothelium-derived relaxing factor (EDRF) and endothelium-de-rived contracting factor (EDCF) are released by endothelial cells following stimulation by a wide range of chemical agonists acting on specific endothelial membrane receptors and by physical factors such as shear stress on the vascular wall. It has now been firmly established that EDRF is nitric oxide, whereas EDCF has been recently identified as a 21-residue peptide, endothelin. Circumstantial evidence, however, suggests that there may be more than one EDRF and/or EDCF. EDRF induces relaxation of the underlying vascular smooth muscle by enhancing intracellular cyclic GMP levels. This action is comparable to that of nitrovasodilators, and nitric oxide can, therefore, be regarded as an endogenous nitrovasodilator. The mechanism of action of endothelin is uncertain, but depends on influx of extracellular calcium. The respective roles of EDRF and EDCF in disease are still hypothetical. It is preferable to think in terms of balance (or imbalance) between these two factors which, probably, have a fundamental role, and very likely interact with each other in maintaining and regulating vascular tone in man.
Scavenger Effect of Elastase on Calcifications in Liver, Kidney and Central Nervous System Tissues of Rabbits with Atherosclerosis Induced by Cholesterol-Rich Diet
Authors: Yasui M. , Yano I. , Ota K. , Oshima A.
Published: January 2017

The inhibitory effect of elastase on calcification in liver, kidney and the central nervous system (CNS) was studied in rabbits with atherosclerosis induced by a cholesterol-rich diet. A total of 25 male rabbits were divided into six groups. In the first three groups, rabbits received a standard diet, a 1.5% cholesterol-rich diet or a 1.5% cholesterol-rich diet with intraperitoneal elastase (450 IU/kg·day) for 3 months. In the second three groups, rabbits received a standard diet, a 0.67% cholesterol-rich diet or a 0.67% cholesterol-rich diet with intraperitoneal elastase (450 IU/kg day) for 6 months. Tissue calcium levels were then determined by neutron activation analysis. Tissue lipid levels were also measured. Dietary cholesterol increased serum lipid levels, atherosclerotic lesions and calcium levels in the CNS, but not in the liver or kidney. Calcium levels in the cerebellum and spinal cord of rabbits receiving the 0.67% cholesterol-rich diet plus elastase were significantly lower than those of rabbits receiving the 0.67% cholesterol diet alone. Elastase had a gradual inhibitory effect on the increase in calcium levels in CNS of cholesterol-induced atherosclerotic rabbits, reduced the increase in serum lipids and decreased the incidence of atherosclerotic lesions.
Ceftriaxone in the Treatment of Acute and Subacute Human Brucellosis
Authors: Al-Idrissi H. Y. , Uwaydah A. K. , Danso K. T. , Qutub H. , Al-Mousa M. S.
Published: January 2017

A total of 14 adults were diagnosed as having brucellosis by clinical means, serology and blood culture. The first patient to be treated failed to respond to 2 g/day intravenous ceftriaxone, therefore, subsequent patients were treated intravenously, twice daily with 2 g ceftriaxone. Immediate clinical response was seen in nine (69.2%) of the patients. Therapy was changed to tetracycline plus streptomycin in the remaining four (30.8%) patients because of lack of response after 5 days. It is concluded that ceftriaxone may be considered a second-line therapy for brucellosis in patients who cannot be given conventional therapy. Further evaluation of ceftriaxone, either alone or preferably in combination with streptomycin or rifampicin on a larger scale, is indicated.
Controlled Release Salbutamol Tablets versus Aminophylline in the Control of Reversible Airways Obstruction
Authors: Higenbottam T. W. , Khan M. A. Ali , Williams D. O. , Mikhail J. R. , Peake M. D. , Hughes J.
Published: January 2017

A crossover study was carried out to compare the acceptability and efficacy of 8 mg twice daily controlled release salbutamol with 525 or 700 mg twice daily aminophylline in patients with reversible obstructive airways disease. Patients were randomly allocated into two groups to determine the treatment order. A 2-week run-in period was used to titrate the aminophylline dosage, followed by a crossover phase of two 4-week treatments. A total of 68 patients, aged 20 − 75 years, entered the study and 39 (57%) completed it. The two drugs differed in the pattern and severity of their side-effects. Of the 15 patients withdrawn because of severe adverse events, 12 were unable to tolerate treatment with aminophylline. There were no statistically significant differences between the treatments for lung function tests measured at the clinic, peak expiratory flow rate recorded by the patients, frequency (or severity) of asthma symptoms or the use of relief medication. Patients completing the study expressed a preference for controlled release salbutamol in 17/25 (68%) cases.
Effects of Glipizide on β-Endorphin Concentration in the Brain of Genetically Diabetic (db/db) Mice
Authors: Belon J.P. , Orosco M. , Henry J.C. , Jacquot C.
Published: January 2017

Sulphonylurea drugs have been shown to augment glucose metabolism by both pancreatic and extrapancreatic actions. The regulation of glucose involves a modification of β-endorphin secretions via central and peripheral mechanisms. β-Endorphin participates in the regulation of feeding and is implicated both in obesity and diabetes mellitus. This study shows that glipizide could exert its pharmacological action in genetically diabetic ( db/db) mice via β-endorphin secretions by a central mechanism.
Pirprofen in the Treatment of Sports Injuries
Authors: Ventura A. , Volpi P. , Braconaro F. , Porretti E. , Azzolini V. , Giani E. , Garagiola U. , Maresca V.
Published: January 2017

Patients with sports injuries were treated with pirprofen, a non-steroidal anti-inflammatory drug, in two separate studies. In the single centre study, 39 athletes were treated with 1000 mg/day pirprofen for 2 weeks. In the multicentre study, a further 80 athletes were treated with a variable dosage (600 − 1200 mg/day) until the disappearance of symptoms, but for no longer than 2 weeks. Efficacy was considered excellent or good in 99/119 (83%) of the patients treated. The clinical variables of pain and mobility significantly ( P<0.05) improved after 1 week of treatment. Tolerability was satisfactory, the main side-effects involving the gastro-intestinal tract.
Autoradiographic Localization and Computerized Quantification of α1- and α2-Adrenoceptors in Spontaneously Hypertensive Rat Kidney: [3H]Bunazosin and [3H]Yohimbine Binding Studies
Authors: Takatori K. , Ogura T. , Katayama E. , Ota Z. , Mizukawa K. , Ogawa N.
Published: January 2017

The autoradiographic localization of α1- and α2-adrenoceptors was identified in 22-week-old Wistar – Kyoto rat kidney, using α1-selective ([3H]bunazosin) and α2-selective ([3H]yohimbine) antagonists. [3H]Bunazosin binding was distributed predominantly over the cortex, less over the outer medulla and was absent from the inner medulla. [3H]Yohimbine binding was distributed predominantly over the medulla, less over the renal cortex and was absent from the inner medulla. In addition, the distribution of renal α-adrenoceptors was investigated in 3-, 7- and 22-week-old spontaneously hypertensive rats (SHRs) using a computerized image analysis system. Renal α-adrenoceptors were both found to be increased in SHRs at all ages tested compared with their respective controls and were increased in both the cortex and the outer medulla. The increase in renal α-adrenoceptors was already present in 3-week-old SHRs whose systolic blood pressures did not differ significantly from those of the controls. The results strongly suggest that these abnormalities of renal α-adrenoceptors may play a critical role in the development of hypertension in SHRs.
Symptomatic Cervical Oesophageal Ectopic (Heterotopic) Gastric Mucosa Treated with Omeprazole
Authors: Payne-James J.J. , Loft D.E. , Mears T. , Lovell D.
Published: January 2017

A 60-year-old female patient with a 3-year history of nausea underwent oesophagogastroduodenoscopy. Red lesions were found in the cervical oesophagus: one of 2 cm and the other < 1 cm. These lesions were biopsied and the larger lesion showed typical gastric mucosa. Following 40 mg/day omeprazole for 3 days all symptoms disappeared. Treatment was stopped after the patient remained symptom-free for 4 weeks.