A clinical trial of glycosaminoglycan-peptide complex (‘Rumalon’) in patients with osteoarthritis of the knee

Summary

A clinical trial was undertaken in 50 patients with osteoarthritis of the knee to assess the therapeutic value of glycosaminoglycan-peptide complex in treatment. The first year consisted of a randomized, double-blind, placebo-controlled, parallel-group trial (25 patients in each group), after which all patients received active treatment for a further 2 years. Treatment consisted of three 8-week courses in the first year and 2 such courses per year in subsequent years, each consisting of 2 ml intramuscular injections given 3 times per week. Patients were permitted to continue taking anti-inflammatory drugs and to receive physiotherapy during the trial period. At the end of the first year of the trial (double-blind phase), there were no significant differences between the two treatment groups. However, after the second year, those patients who had received glycosaminoglycan-peptide complex for 2 years had significantly greater improvements in night pain andrestpain than did those who had received active treatment for only 1 year. At the end of 3 years (when half the patients had received active treatment for 2 years and half for 3 years), there were significant overall improvements in relation to rest pain, pain on walking and morning stiffness, but not in respect to night pain, pain on standing or climbing stairs. At the same time, improvements were seen in radiological severity of disease (assessed double-blind) in 16% of patients, with ‘no change’ in 74% and deterioration in lo%, these figures being considerably better than might be expected with conventional therapy. Glycosaminoglycan-peptide complex was extremely well tolerated.     

A double-blind trial of ‘ Nethaprin’ Expectorant syrup in patients with bronchospastic disease

Summary

In a double-blind comparative trial of'Nethaprin¹ Expectorant syrup versus placebo in 36 patients with bronchospastic disease, 20 patients received placebo for 1 week and 16 patients ‘Nethaprin’' for 1 week. Assessments of response to treatment were based on symptomatic improvement and on increases in objective measures of ventilatory capacity, namely forced expiratory volume over 1 second (FEV,) and vital capacity (VC). Following ‘Nethaprin’, there was a 79% overall improvement in symptoms compared to 21% with placebo. FEV₁ and VC were significantly increased in the 'Nethapriri group compared to the placebo group.     

A double-blind controlled trial of ‘Gaviscon’ in patients with symptomatic gastro-oesophageal reflux

Summary

In a double-blind trial in 26 patients with symptomatic gastro-oesophageal reflux, the alginate I effervescent I antacid compound ‘Gaviscon’ was compared with antacid containing placebo similarly formulated. Retrosternal pain after meals and at night was significantly reduced whilst patients were taking ‘Gaviscon’ and the beneficial effects lasted for many weeks after discontinuation of the active preparation.     

A comparison of ‘Integrin’ and ‘Tacitin’ in the treatment of anxiety neurosis in general practice

Summary

A double-blind trial was carried out in general practice over a 4-week period on 76 patients with anxiety neurosis to compare the efficacy of ‘Integrin’ (oxypertine) with that of ‘Tacitin’ (benzoctamine hydrochloride). A standard daily dose of 30?mg. of either drug was used. Patients were assessed on a modified Hamilton Anxiety Scale. Changes in total score and in specific scores for anxious and for depressed mood were examined. Both agents produced a highly significant improvement and were equally effective. Side-effects were acceptably low in both.     

Two-years' study with a combination of pindolol and clopamide (‘Viskaldix’) in patients with moderate hypertension

Summary

A study was carried out to evaluate the long-term effects and side-effects of a combination product containing the beta-blocker pindolol (10?mg) and the diuretic clopamide (5?mg) in 15 patients with moderate hypertension. AN patients completed the 2-years' study. The dose of the combination was increased until blood pressure normalized or a maximum dose of 3 tablets (equivalent to 30?mg pindolol and 15?mg clopamide) daily was reached. Blood pressure and heart rate were recorded monthly and detailed medical examinations were done regularly throughout the study. A mean dose of 2 tablets of the combination product (20?mg pindolol and 10?mg clopamide) produced a significant reduction in blood pressure. In all but 1 patient, blood pressure control was achieved and maintained. No toleratice developed. Heart volume showed a marked decrease. No side-effects of clinical importance were noted.     

Controlled trial of a back support (‘Lumbotrain’) in patients with non-specific low back pain

Summary

A randomized, controlled, parallel-group clinical trial was carried out in general practice to assess the clinical efficacy of a new back support (‘Lumbotrain’) compared with ‘standard therapy’ of advice on rest and lifestyle in the treatment of patients with non-specific low back pain. A total of 216 patients entered this study (111 ‘Lumbotrain’ group, 105 control group). All patients were allowed to take 1?g paracetamol up to 4-times daily if necessary for control of pain. Self-assessments were made daily by patients, over a period of 21 days, of pain levels at rest, on activity, at night, and limitation of activity using visual analogue scales. Details were also recorded of their ability to work or not, and the number of doses of paracetamol taken. At the end of the study period, patients assessed their overall response to treatment and those in the ‘Lumbotrain’ group were questioned on the comfort and ease of use of the back support. A clinical examination was carried out by the doctor at the start and end of the study period and an assessment made of the total range of active and passive back movement. Analysis of the daily diary records showed there were progressive, significant reductions in mean scores for all the pain and activity criteria in both groups and these were significantly greater in the ‘Lumbotrain’ group from Day 7 onwards. The times taken for reduction of symptom scores to 10% of initial values were significantly less in the Lumbotrain' group, such a degree of recovery occurring 2 to 4 days more rapidly than in the control group. A significantly higher proportion of patients in the ‘Lumbotrain’ group became able to work normally. After 3 weeks, 85% of patients in the ‘Lumbotrain’ group could work normally. as compared with 67% in the control group (p<0.02). Total analgesic consumption during the trial was significantly lower (p<0.0001) in the ‘Lumbowain’ group (median 24.5 doses) than in the control group (median 51 doses). Overall clinical assessment scores were significantly superior in the ‘Lumbotrain’ group (p<0.002). Improvement was seen in 106 (95%) of 111 patients in the ‘Lumbotrain’ group, as compared with 79 (77%) of 103 of those in the control group (p<0.0002). At the end of the trial, 92 (89%) of 103 patients in the ‘Lumbotrain’ group were considered to have returned to normal, whilst the same was true of 63 (68%) of 92 in the control group (p<0.002). Of those patients who wore ‘Lumbotrain’, 103 (94%) of 109 commented positively on it. The remaining 6 patients reported minor discomfort or skin irritation, not severe enough to require discontinuing the use of the support. It is suggested, therefore, that because of its patient acceptability and the significantly greater and more rapid alleviation of symptoms than with conventional measures, the use of ‘Lumbotrain’ should be considered as a possible valuable aid in the management of patients with non-specific low back pain.     

Effect of a combination of orphenadrine/paracetamol tablets (‘Norgesic’) on myalgia: A double-blind comparison with placebo in general practice

Summary

The clinical efficacy and tolerability of a combination preparation (‘Norgesic’) of 35?mg orphenadrine plus 450?mg paracetamol was compared with that of placebo in a controlled double-blind, parallel group, 7-day study comprising 44 patients suffering from pain due to tension of the cervical and upper thoracic musculature. The patients were allocated at random into two homogenous groups, stratified by sex and initial pain intensity. One group received the combination, the other placebo. The dosage used was 1 tablet 3-times daily. The effect of treatment of pain was assessed daily using a visual analogue scale. Despite the low dosage used, orphenadrine/paracetamol produced statistically significant pain relief from initial levels by and from the second day of the study. Comparison between the groups showed that the analgesic efficacy of the combination was significantly superior to that of placebo from the third day of treatment. These results confirm the efficacy of a combination of orphenadrine/paracetamol in patients suffering from myalgia nuchae.     

A comparison of etodolac (Ultradol®) with acetaminophen plus codeine (Tylenol #3) in controlling post-surgical pain in vasectomy patients

Summary

The efficacy and safety of etodolac (Ultradol®) and acetaminophen plus codeine [A + C (Tylenol #3)] in controlling post-surgical pain were compared in an open-label, randomized, parallel-group outpatient study. Patients who were voluntarily having a vasectomy performed for sterilization were assigned to receive either etodolac 200?mg (20 patients) or A + C (20 patients). All medication was taken as required for up to 7 days. Efficacy assessments were made at 1, 6 and 24 hours after surgery and included pain measurement (Likert Visual Analogue scale), patient and physician global assessments and time to analgesic relief. Safety assessments were made throughout the study and included vital signs and adverse event monitoring. Results of the study indicated that patients taking etodolac were more likely to say they could return to work 24 hours after their vasectomy (p = 0.04). There were no other statistically significant differences between the two groups of patients. The results from this study indicate that etodolac and A + C are equally efficacious and well-tolerated for the control of post-vasectomy pain and that patients may observe an increased benefit with etodolac by being able to return to work sooner.     

A double-blind comparison between meptazinol (Wy 22811) and ‘Buscopan’ Compositum in renal colic

Summary

The analgesic effect of a single intravenous injection of 60?mg. meptazinol or of a spasmolytic-analgesic combination (‘Buscopan’ Compositum: 20?mg. hyoscine-N-butylbromide plus 2.5 g. nor-amidopyrine)was studied in a double-blind trial in 40 patients with acute renal colic. The results showed that meptazinol provided greater pain relief and was faster acting. Pain relief after meptazinol persisted for at least 1 hour in all but 1 of the 20 patients treated. Dizziness was a frequent but well tolerated side-effect of meptazinol, and nausea and vomiting were reported almost equally after both treatments.     

A multi-centre trial of mazindol (‘Teronac’) in general practice in Ireland

Summary

In a multi-centre trial of mazindol (‘Teronac’), a new anorectic agent unrelated to amphetamine, 274 male and female patients were treated by 53 investigators in Eire. All patients were overweight according to the Metropolitan Life Assurance Company Tables, and 166 patients completed the treatment regime of one 2?mg. tablet daily and a 1000 calorie diet for 12 weeks. The average weight loss was 18.8 lbs. (8.5 kg.); 85% of patients reported good appetite supression and good ability to adhere to their diet, and the attending physicians rated mazindol as being of considerable help in 92 % of the patients. Mazindol was well tolerated, only 29 patients dropped out of the trial because of side-effects.     

A general practice study to compare the efficacy and tolerability of a spray (‘Otomize’) versus a standard drop formulation(‘Sofradex’) in the treatment of patients with Otitis externa

Summary

In an open, multi-centre study in general practice, a comparison was made of the efficacy, tolerability and acceptability of a neomycin/ dexamethasone preparation administered by metered-dose spray (‘Otomize’) and a framycetin/gramicidin/ dexamethasone preparation (‘Sofradex’) administered as drops in 60patients with otitis externa. Patients were allocated at random to receive one or other preparations 3-times daily for 10 days and were followed-up again 14 days after cessation of therapy. Clinical assessments were carried out under observer blind conditions on entry (Day 0) and on Days 10 and 24 of the severity of erythema, swelling and debris in the affected ear(s). A global assessment of clinical outcome was made by the doctor on Day 10. There were no significant differences in the two groups at the start of treatment. Significant improvement occurred in both groups from Day 0 to Day 10 and from Day 10 to Day 24 in all symptoms, with the proportion symptom-free in the ‘Otomize’ group significantly greater than in the ‘Sofradex’ group at 24 days, and approaching significance at 10 days. Significantly more patients in the ‘Otomize’ group were rated as having a good clinical outcome by the physician, and fewer patients experienced discomfort on application. Few side-effects were reported by either treatment group, none necessitating discontinuation of therapy.     

A doubie-blind,between-patient comparison of alclofenac (‘Prinalgin’) and indomethacin in the treatment of low back pain and sciatica

Summary

A double-blind, between-patient comparison of alclofenac and indomethacin was carried out in 60 patients with low back pain and sciatica. Pain, functional disability and signs of dural irritation (Laségue's sign) were rated by the clinician before and at the end of each 7-day treatment period, and an overall assessment of treatment effectiveness was made by both clinician and patients.

Response to treatment in terms of patient improvement was considered satisfactory with both drugs, but more erratic in those patients with an acute condition. Analysis of pain scores showed a significant tendency for patients with acute or chronic low back pain to improve more with alclofenac than with indomethacin treatment. Overall assessments by the clinician and patients also indicated signiJcantly greater improvement with alclofenac.     

Section 2 ‘Brufen’ in the treatment of rheumatoid disease in patients with gastric intolerance

Summary

Ibuprofen was administered to 64 patients with known peptic ulceration and to 42 patients with gastric intolerance of other antirheumatic drugs for periods up to 5 years. Twenty-six patients are continuing therapy and in a further 23, treatment was maintained long enough for remission to occur, either medically or surgically induced. Only 13 (12.3 %) of this specially selected, difficult group of patients withdrew because of gastric side-effects. This compares favourably with the reported incidence of similar side-effects produced by other non-steroidal anti-inflammatory agents.     

Use of midazolam (‘Dormicum’) and flumazenil (‘Anexate’) in paediatric bronchology

Summary

One hundred and seven bronchological examinations using midazolam narcosis in association with flumazenil were carried out in 100 children (mean age 3.5 years, range 4 months to 1 4 years) suffering from chronic non-specific lung disease. Rigid bronchoscopy was followed in 49 cases by bronchography. All patients were premedicated with atropine followed by midazolam (0.2?mg/kg intravenously). Ventilation was carried out with nitrous oxide and oxygen in 47 children and with oxygen only in 60 patients. After 3 mins, suxamethonium (2?mg/kg intravenously) was given for muscle relaxation and intubation carried out. Fifty-one of the children ventilated with oxygen only also received fentanyl (0.002?mg/kg intramuscularly), at the same time as atropine, to provide analgesia. After extubation, all patients were given flumazenil (0.1 to 0.2?mg intravenously) to reverse the effects of midazolam. The results showed that midazolam provided effective sedation and comfortable sleep (mean examination time 12?min 50 sec) and it was considered that the method using fentanyl rather than nitrous oxide for analgesia was the most satisfactory one. Patients awakened promptly (1?min) after flumazenil and quick and effective expectoration was noted, particularly important in those who had undergone bronchography. No complications were observed. Since this investigation, a further 500 bronchoscopics have been carried out using this method with the same results. Even though no narcosis equipment is required, it is recommended that, as with other procedures involving narcosis with muscle relaxation, bronchoscopy with these drugs should not be used in out-patients.     

Comparison of nystatin (‘Nystan’) and hydrargaphen (‘Penotrane’) in the treatment of vaginal candidosis in pregnancy

Summary

A double-blind comparison of nystatin (‘Nystan’) pessaries and hydrargaphen (‘Strong Penotrane’) pessaries for the treatment of vaginal candidosis showed that the former is more effective on clinical and mycological assessment. Relief from symptoms was obtained in 95.9% and 84.6% of the patients treated with nystatin and hydrargaphen respectively. On stopping treatment, yeasts could no longer be isolated from 75.0% of the cases receiving 'Nystan' and from 23.1% receiving 'Strong Penotrane'. There was no evidence of resistance to either drug before, during or after therapy.     

A comparison of the application of STOPP/START to patients’ drug lists with and without clinical information

Background A European screening tool (STOPP/START) has been formulated to identify the prescribing of potentially inappropriate medicines (PIMs) and potential prescribing omissions (PPOs). Pharmacists working in community pharmacies could use STOPP/START as a guide to conducting medication use reviews; however, community pharmacists do not routinely have access to patients’ clinical records. Objective To compare the PIM and PPO detection rates from application of the STOPP/START criteria to patients’ medication details alone with the detection rates from application of STOPP/START to information on patients’ medications combined with clinical information. Setting Community Pharmacy. Method Three pharmacists applied STOPP/START to 250 patient medication lists, containing information regarding dose, frequency and duration of treatment. The PIMs and PPOs identified by each pharmacist were compared with those identified by consensus agreement of two other pharmacists, who applied STOPP/START criteria using patients’ full clinical records. Main outcome measure The main outcome measures were: (1) PIM and PPO detection rates among pharmacists with access to patients’ clinical information compared to PIM and PPO detection rates among pharmacists using patients’ medication information only, and (2) the levels of agreement (calculated using Cohen’s kappa statistic (k)) for the three most commonly identified PIMs and PPOs. Results Pharmacists with access to patients’ clinical records identified significantly fewer PIMs than pharmacists without (p = 0.002). The three most commonly identified PIMs were benzodiazepines, proton pump inhibitors and duplicate drug classes, with kappa (k) statistic agreement ranges of 0.87–0.97, 0.60–0.68 and 0.39–0.85 respectively. PPOs were identified more often (p < 0.001) when clinical information was considered. The three most commonly identified PPOs were: bisphosphonates, β₂-agonists and anti-platelets, with kappa (k) statistic agreement ranges of 0.89–1.0, 0.50–0.80 and 0.5–1.0 respectively. Conclusions PIM detection is likely to be overestimated using STOPP and PPO detection underestimated using START when STOPP/START is used in isolation of clinical information. Agreement for a selected number of criteria for which clinical information is not required is good, suggesting that some criteria may be reliably deployed without clinical information during a medicines use review. However, for STOPP/START criteria to be deployed more effectively by pharmacists, access to the full clinical record is recommended.     

The use of long-acting propranolol (‘Inderal’ LA) in the management of elderly hypertensive patients

Summary Fifteen elderly patients whose hypertension was controlled by conventional propranolol 80 mg twice a day had their medication changed to one capsule of Inderal LA¹ (160 mg) daily. The blood pressure, heart rate and propranolol concentrations were measured at various time points when the patients were receiving the conventional preparation and these assessments were repeated when the long-acting preparation was administered. Although the heart rate was lower with conventional propranolol than with Inderal LA there was no significant difference in the blood pressure levels. The mean peak blood level of propranolol was, however, significantly lower with Inderal LA compared with conventional propranolol and occurred later. At 12 h the plasma propranolol levels were higher after Inderal LA than following the intake of conventional propranolol (p<0.01); there was no difference in the plasma levels at 24 h. The area under the concentration time curve was significantly higher on conventional propranolol. Compared with published data, the plasma levels were higher than those in younger patients. Inderal LA was well tolerated and side effects were minimal.     

A controlled study of benzydamine oral rinse (‘Difflam’) in general practice

Summary

Fifty-two patients suffering from presumed viral pharyngeal infection or tonsillitis were treated with either benzydamine or placebo oral rinse as a gargle at 3-hourly intervals in a randomized double-blind study. Patients on the active preparation experienced faster resolution of pain and dysphagia and at 7 days 88% were symptom-free compared with 38% on placebo.     

A double-blind comparison of 0.1% dithranol in a 17% urea base (‘Psoradrate’) and base alone in the treatment of active chronic psoriasis

Summary

A preliminary double-blind controlled trial was carried out in 8 patients with active chronic psoriasis, whose lesions were more or less bilaterally symmetrical, to assess the efficacy of topical treatment with 0.1% dithranol in a specialized carbamide (17% urea) base. The trial preparation was applied twice daily to one side only over a period of 3 weeks, and lesions on the other side of the body were treated in a similar manner with the base alone. Assessments of clinical improvement, based on severity rating scores, were carried out at weekly intervals. The results showed that, although use of the base alone led to some improvement, the preparation including dithranol was twice as effective, and this finding was supported by the patients'” preference. It was easy to apply and remove and was well tolerated, the only side-effects reported being stinging and/or smarting.