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PubMed1983

Controlled study of psychotherapy in irritable bowel syndrome.

101 outpatients with irritable bowel syndrome were randomly allocated to two treatment groups. Both groups received the same medical treatment, but patients in one group also received dynamically oriented individual psychotherapy in ten hour-long sessions spread over 3 months. After 3 months there was a significantly greater improvement in somatic symptoms in the psychotherapy group. The difference became more pronounced a year later, with the patients given psychotherapy showing further improvement, and the patients who received medical treatment showing some deterioration. The combination of medical treatment with psychotherapy improves outcome, not only in the short term but also in the long run.

Adolescent↗

PubMed1981

Internal fixation versus hemiarthroplasty for the displaced subcapital fracture of the femur. A prospective randomised study.

A prospective randomised trial of surgical treatment for the displaced subcapital femoral fracture in patients of 70 years or more is presented. Two hundred and eighteen patients were randomly allocated into one of three treatment groups: manipulative reduction and internal fixation using Garden screws; Thompson hemiarthroplasty through a posterior (Moore) approach; and Thompson hemiarthroplasty through an anterolateral (McKee) approach. There is no significant difference in the mortality of the internal fixation and posterior arthroplasty groups. Both groups showed a significantly higher mortality than patients operated on through the anterior approach. The technical results of operation were worse in the internally fixed group, with only 40 per cent being satisfactory. Mobilisation was best achieved after the posterior approach. It is concluded that Thompson hemiarthroplasty, using an anterolateral approach, is the safest operation in this group of patients.

Aged↗

PubMed1988

Dosage and duration of tamoxifen treatment for mastalgia: a controlled trial.

A controlled trial has been conducted in which 60 women with mastalgia were randomly allocated to receive tamoxifen at a dosage of either 10 mg or 20 mg daily for either 3 or 6 months. All eligible patients had self-rated moderate or severe mastalgia present for at least 6 months, for which no specific therapy had been given for the previous 3 months. End points of the study were pain control, measured by linear analogue scales, relapse rate and side-effects. Pain relief was achieved in 90 per cent of those receiving 10 mg daily and 86 per cent of those given 20 mg daily. The relapse rate was also similar for both dosages, being 48 per cent and 39 per cent respectively and usually occurred within 2-3 months of discontinuing treatment. However, side-effects were reported less frequently among those receiving 10 mg daily (21 per cent versus 64 per cent; chi 2 = 11.1, P less than 0.001). Prolongation of treatment from 3 months to 6 months did not materially improve the response rate (85 per cent versus 90 per cent). Side-effects were similar, as was the relapse rate among the patients receiving the two durations of treatment. The agent proved to be significantly more effective in the relief of cyclical rather than non-cyclical pain (94 per cent versus 56 per cent). Use of tamoxifen for the treatment of mastalgia is still experimental. Nevertheless, for the majority of women with mastalgia, pain relief can be achieved using tamoxifen 10 mg daily, given for a 3-month course. As almost half these patients will develop relapse of breast pain it may be necessary to give longer courses of therapy, although the safety of this more protracted treatment has yet to be determined.

Adult↗

PubMed1987

Postoperative complications in colorectal surgery in relation to preoperative clinical and nutritional state and postoperative nutritional treatment.

The impact of the pre-operative nutritional and clinical state on post-operative morbidity and mortality is not fully known and the effect of total parenteral nutrition (TPN) on the postoperative complication rate has not been established. We have investigated the effects of postoperative TPN on the complication rate in 92 patients after major colorectal surgery for carcinoma of the large bowel or inflammatory bowel disease in a controlled, randomised study. The complication rate was analysed against seven commonly used nutritional (biochemical and anthropometric) variables and against the diagnosis, clinical inflammatory activity and presence of pre-operative septic complication. Patients were randomly allocated to postoperative TPN or conventional fluid and electrolyte support. The results show no correlation between the complication rate and the nutritional and clinical state of the patients as assessed pre-operatively. The complication rate was not significantly reduced by postoperative TPN. This study indicates that biochemical and anthropometric nutritional variables do not identify patients at risk to develop postoperative complications. The presence of pre-operative complications showed a marginal correlation with postoperative morbidity, in agreement with previous experience. The result of this study obviates the use of TPN in routine postoperative care.

Adult↗

PubMed1984

Randomized trial of intracervical prostaglandin E2 gel and intraamniotic prostaglandin F2 alpha for induction of second trimester abortion.

For the purpose of reducing the side effects and complication rate when inducing second trimester abortion, intracervically administered PGE2 gel was tested for the first time and compared with a single intraamniotic instillation of PGF2 alpha by a randomized allocation of 41 consecutive patients in the 13th to 24th week of gestation. In both groups the treatment was supplemented with oxytocin 5 - 6 hours after starting the induction. The methods proved of equal value as regards the abortion success rate and the induction-abortion interval, whereas the incidence of gastrointestinal side effects on intracervical application of PGE2 gel was only half as high and the occurrence of diarrhea significantly lower (p less than 0.05) with this non-invasive method than with intraamniotic PGF2 alpha. Intracervical PGE2 gel also possessed other advantages, being int. al. more acceptable by the patients and technically easier to administer.

Abortion, Induced↗

PubMed1988

Olsalazine in the treatment of active ulcerative colitis: a placebo controlled clinical trial and assessment of drug disposition.

The efficacy, safety and disposition of olsalazine was assessed in patients with left-sided ulcerative colitis or proctitis in a double-blind placebo controlled trial. Thirty patients with a mild-to-moderate attack of ulcerative colitis were randomly allocated to olsalazine capsules, 1 g b.d., or placebo for 6 weeks. Good clinical response was found in six patients receiving olsalazine and in two receiving placebo. Improvement in sigmoidoscopic findings and histological appearance of rectal biopsies was also seen more often in olsalazine-treated patients. Plasma concentrations of olsalazine were significantly higher in patients who improved. Olsalazine showed an advantage over placebo which needs to be confirmed by further studies; it was safe in sulphasalazine-sensitive patients but appeared to cause watery diarrhoea in two patients.

Aminosalicylic Acids↗

PubMed1981

Podophyllin 10% and 25% in the treatment of ano-genital warts. A comparative double-blind study.

One hundred and forty male patients with ano-genital warts were randomly allocated to a double-blind study of 10% and 25% podophyllin in tincture of benzoin compound. One hundred and nine patients attended for a three-month period of surveillance. Only 24 (22%) patients were free of warts after having podophyllin treatment alone, 12 each after treatment with 10% and 25% podophyllin. There was no significant difference in the number of applications needed with each treatment. Neither hypersensitivity nor chemical ulceration occurred.

Anus Diseases↗

PubMed1989

Adverse effects of three different forms of heparin therapy: thrombocytopenia, increased transaminases, and hyperkalaemia.

A prospective study has been made of the incidence of changes in transaminase levels, hyperkalaemia and thrombocytopenia in three groups of patients: 89 consecutive patients with venous thrombosis receiving therapeutic heparinization, 49 patients admitted because of hip fracture and receiving prophylactic low-dose conventional heparin, and 43 patients admitted because of hip fracture and randomly allocated to receive low molecular weight heparin. Laboratory measurements were made on admission and 8 days after commencing heparin. Only two patients on high-dose heparin developed thrombocytopenia. Increased transaminases were frequent with conventional heparin (18% and 32% of patients on high-dose heparin developed abnormal AsT and AlT values, respectively compared with 14% and 17% patients on low dose therapy). In contrast, only one patient on low molecular weight heparin developed abnormal AlT activity. Hyperkalaemia was uncommon in patients on any form of heparin therapy, and severe hyperkalaemia occurred in only one patient.

Adult↗

PubMed1987

Prognostic evaluation of planned follow-up in patients with colorectal adenomas. An interim report.

Between 1978 and 1986 colorectal adenomas without invasion were removed in 552 patients under 76 years of age. Patients were randomly allocated to different follow-up groups with intervals of colorectal examination varying from 6 to 48 months after the initial polypectomy. A large bowel carcinoma developed in three patients and new adenomas in 87 patients. Based on the morphology of the initial adenomas possible relationships between prognostic factors and the risk of new adenoma formation were assessed using life-table analysis. The advantage of a possible decrease in the risk of developing carcinoma was offset by the disadvantage of eight severe complications occurring in 1818 colonoscopies, one of which proved fatal. The occurrence of one of the three carcinomas was considered a failure of the follow-up programme.

Actuarial Analysis↗

PubMed1988

Interim report of the Medical Research Council/Royal College of Obstetricians and Gynaecologists multicentre randomized trial of cervical cerclage. MRC/RCOG Working Party on Cervical Cerclage.

Overall 905 pregnant women whose obstetricians were 'uncertain' whether to recommend cervical cerclage, chiefly because of a history of early delivery or cervical surgery, were randomly allocated to cerclage or no surgery; 92% were treated as allocated. The overall preterm delivery rate was 30%. The results for those allocated cerclage were marginally statistically significant, more favourable in terms of fewer deliveries before 33 weeks [59 (13%) compared with 82 (18%), P = 0.03] and correspondingly for birthweight under 1500 g [48 (11%) compared with 73 (16%), P = 0.01] and for miscarriage, stillbirth or neonatal death [37 (8%) compared with 54 (12%), P = 0.06]. There were similar numbers of deliveries between 33 and 36 weeks [65 (14%) compared with 64 (14%)]. These results suggest that the operation had an important beneficial effect in one in 20 to 25 cases in the trial. But because the observed differences are not strongly statistically significant and because no such benefit has been seen in other randomized trials, there remains uncertainty about how much (if any) of this apparent benefit is real. So, the trial still remains open for randomization of more women whose obstetricians are uncertain about the advisability of cerclage.

Birth Weight↗

PubMed1988

The analgesic effect of indomethacin in the early post-operative period following abdominal surgery. A double-blind controlled study.

Patients undergoing major intra-abdominal operations were randomly allocated to receive either 100 mg indomethacin (n = 26) or placebo (n = 20), both given as suppositories, 3 times a day for 3 days. The analgesic effect of indomethacin was measured during the first 5 post-operative days by grading the experience of pain on a closed visual analogue pain scale and further by registration of the amount of narcotics requested. Patients receiving indomethacin had significantly lower pain scores and received significantly fewer doses of narcotics (p less than 0.01). There were only minor side effects which were equally frequent in the 2 groups. These results indicate that indomethacin is an effective analgesic drug in the early post-operative period.

Abdomen↗

PubMed1981

Protected environment - prophylactic antibiotic program for malignant sarcomas: randomized trial during remission induction chemotherapy.

Fifty-one valuable patients with malignant sarcomas were randomly allocated to receive three courses of remission induction chemotherapy with cyclophosphamide, vincristine, Adriamycin, and dimethyl triazeno imidazole carboxamide (CYVADIC) on the protected environment-prophylactic antibiotic for the control group (P = 0.22). The response rates (complete plus partial) were 71% and 67%, respectively. The durations of response were similar for both groups of patients, but the PEPA patients survived substantially longer (median, 84 weeks vs. 58 weeks). The frequency of infection was significantly lower among the PEPA patients, and the doses of CYVADIC could be escalated more often among these patients. Dosage escalation was associated with a higher complete remission rate and lower fatality rate.

Adolescent↗

PubMed1986

Colloidal bismuth subcitrate and two different dosages of cimetidine in the treatment of resistant duodenal ulcer. Preliminary results.

The use of colloidal bismuth subcitrate (CBS) has been recently suggested for cimetidine-resistant duodenal ulcers. We have therefore compared the activity of CBS with that of two different doses of cimetidine in patients whose duodenal ulcers had not healed after 8 weeks of therapy with cimetidine, 1.2 g, or ranitidine, 300 mg/day. Forty-three patients (35 men and 8 women) were randomly allocated to one of the following oral regimens: CBS, 120 mg 4 times a day, or cimetidine (C), 400 mg 3 times a day, or cimetidine, 400 mg at meals plus 800 mg at bedtime, for 4-8 weeks. The interim analysis after 4 weeks of treatment showed similar percentages of healing in the two cimetidine schedules (46.7% with C, 1.2 g, and 42.9% with C, 2 g, respectively); conversely, CBS treatment resulted in a significantly higher healing rate as compared with both C, 1.2 g, and C, 2 g (P less than 0.05). These findings suggest that resistant duodenal ulcers are more responsive to cytoprotective agents than to antisecretory compounds.

Adult↗

PubMed1990

Enhanced thromboxane synthesis with extradural anaesthesia.

Reperfusion of a limb following tourniquet ischaemia increases plasma concentrations of thromboxane (TxB2). The study examined TxB2 production during the ischaemia and reperfusion of femoral-popliteal bypass surgery and the effect of anaesthetic technique. Patients (n = 19) were randomly allocated to receive either general (GA) or extradural (EA) anaesthesia. TxB2 concentrations were similar both before and after anaesthesia in the two groups. Clamping the femoral artery in patients given GA resulted in a small but insignificant increase in TxB2 concentration. However, in the EA group clamping resulted in a 10-fold increase in TxB2 concentration (P less than 0.05). To demonstrate that anaesthesia itself was not the stimulus to TxB2 synthesis, patients undergoing inguinal herniorrhaphy (n = 13) received either GA or EA. There were no subsequent changes in TxB2 concentrations in each group. The results indicate that EA but not GA maintains collateral flow during femoral arterial clamping and provides the oxygen needed for generation of TxB2 during ischaemia.

Anesthesia, Epidural↗

PubMed1986

A prospective five-year comparison of treatment which included penicillamine with that excluding penicillamine in early rheumatoid arthritis. The Multicentre Trial Group.

Seventy-three patients with early, active rheumatoid arthritis (RA) were randomly allocated either to a group that received penicillamine or to a control group from which penicillamine was barred, any other second-line drug being permitted. Most (87%) of the controls received chrysotherapy at some stage. Clinical, serological and radiographic progress was observed for at least 5 years. Outcome after 5 years for the 27 remaining in the penicillamine group was compared with that for the 23 surviving controls. Both groups had improved clinically but deteriorated radiographically, with much individual variation. A subset of patients, mostly seronegative, who were radiographically normal at the outset remained so, regardless of treatment. Penicillamine was as effective as the control group treatments in relieving synovitis and as ineffective in arresting radiographic deterioration.

Adolescent↗

PubMed1987

A double-blind study of Grenz ray therapy in chronic eczema of the hands.

The effect of Grenz ray therapy as an adjunct to topical therapy in chronic symmetrical eczema of the hands was assessed in 24 patients by randomly allocating active treatment to one hand while the other, which received simulated therapy, served as a control. Three Gy of Grenz rays were applied on six occasions at intervals of 1 week. There was a significantly better response to active treatment 5 and 10 weeks after the start of treatment compared with the untreated control.

Chronic Disease↗

PubMed2003

Changes in tissue factor and activated factor XII following an acute myocardial infarction were uninfluenced by high doses of n-3 polyunsaturated fatty acids.

Few data exist on the effects of n-3 polyunsaturated fatty acids (PUFAs) on the initiators and endstage products of coagulation following an acute myocardial infarction (MI). We assessed the long-term effects of n-3 PUFAs on postinfarct variations of tissue factor (TF), activated factor XII (FXIIa) and fibrin monomer (FM), and expected additional statin treatment to modify thrombogenicity. Acute MI patients (n = 300) were randomly allocated to a high dose of n-3 PUFAs or corn oil for at least one year. Plasma concentrations of TF, FXIIa and FM were unaffected by n-3 PUFAs as compared to corn oil, and were uninfluenced by additional statin treatment in subgroup analyses. TF decreased (p = 0.0001), while FXIIa increased during the first 6 weeks (p = 0.001). FM remained essentially unchanged during the entire observation period. In conclusion, TF, FXIIa and FM were unaffected by long-term treatment with high- dosed n-3 PUFAs and by additional statin treatment.

Acute Disease↗

PubMed1983

Naloxone does not antagonize the antihypertensive effect of clonidine in essential hypertension.

Reports on spontaneously hypertensive rats suggested that naloxone blocked the antihypertensive effects of clonidine. We compared the effects of an 8-hr intravenous naloxone infusion (6 micrograms/kg/hr) or 5% dextrose in water (D5/W) begun 2 hr before single oral doses of clonidine (0.3 mg) in six men with mild to moderate essential hypertension (EHT). Supine and standing (after 5 min) blood pressure (BP) and heart rate (HR) were measured every 20 min. Initial treatment with naloxone or placebo (D5/W) infusion was randomly allocated, with the alternate treatment given 1 wk later. Naloxone did not modify either supine or standing BP or HR. Clonidine induced a gradual, sustained reduction in both supine and standing systolic and diastolic BP and in supine HR, and there was an increase in standing HR. Naloxone did not modify the onset, maximal effect, or recovery of the hypotensive and HR effects of clonidine in both the supine and standing positions. Our data indicate that hypotensive and bradycardiac effects of clonidine in EHT are not mediated by naloxone-sensitive opioid receptors. They also suggest that opioid receptors play no role in the maintenance of hypertension nor in the BP and HR adjustments induced by postural changes in EHT.

Adult↗