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PubMed1984

The recovery of gases insufflated at laparoscopy.

The recovery of gases used for insufflation at gynaecological laparoscopy was investigated in 163 women who were randomly allocated to receive insufflation with nitrous oxide or carbon dioxide, the two most commonly used gases. No difference was detected and since nitrous oxide has dangerous side effects, the use of carbon dioxide is recommended. Methods of enhancing the recovery of gas were then investigated in a further 207 women, treatment being allocated in a random fashion. No merit was found in the use of these techniques and they have been abandoned.

Carbon Dioxide↗

PubMed1985

A 10-year assessment of controlled trials of inpatient and outpatient treatment and of plaster-of-Paris jackets for tuberculosis of the spine in children on standard chemotherapy. Studies in Masan and Pusan, Korea. Ninth report of the Medical Research Council Working Party on Tuberculosis of the Spine.

Two hundred and eighty-three patients with tuberculosis of the thoracic and/or lumbar spine have been followed for 10 years from the start of treatment. All patients received PAS plus isoniazid daily for 18 months, either with streptomycin for the first three months (SPH) or no streptomycin (PH), by random allocation. There was also a second random allocation for all patients: in Masan to inpatient rest in bed (IP) for six months followed by outpatient treatment or to ambulatory outpatient treatment from the start (OP), and in Pusan to outpatient treatment with a plaster-of-Paris jacket (J) for nine months or to ambulatory treatment without any support (No J). A favourable status was achieved on their allocated regimen by 88% of patients at 10 years. Some of the remaining patients also attained a favourable status after additional chemotherapy and/or operation, and if these are included the proportion achieving such a status increases to 96%. There were five patients whose deaths were attributed to their spinal disease. A sinus or clinically evident abscess was present on at least one occasion in the 10-year period in 42% of the patients. Residual sinuses persisted at 10 years in two patients, at death at seven years in a third and at default in the seventh year in a fourth. Thirty-five patients had paraparesis at some time during the 10-year period, including two who died with paraplegia before five years. Complete resolution occurred in 26 patients (in six after additional chemotherapy and/or surgery). At 10 years two patients had severe paraplegia and one a moderate paraparesis.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

PubMed1987

Randomization and efficiency in Zelen's single-consent design.

The "single-consent design" was devised by Zelen to circumvent the reluctance of some patients and physicians to participate in certain types of randomized clinical trials. Crucial to the validity of Zelen's design is randomized allocation of patients. Randomization theory is therefore the key theoretical base of the approach taken in this paper to an examination of the efficiency of this design.

Analysis of Variance↗

PubMed2026

Durvalumab and tremelimumab, with or without lenvatinib, combined with transarterial chemoembolisation in participants with embolisation-eligible hepatocellular carcinoma (EMERALD-3): a global, randomised, open-label, sponsor-blinded, phase 3 study.

BACKGROUND: Transarterial chemoembolisation (TACE), a standard treatment for embolisation-eligible hepatocellular carcinoma (HCC), induces tumour immune responses. Single tremelimumab regular interval durvalumab (STRIDE) is a standard treatment in advanced HCC. In this phase 3 trial, we assessed the efficacy and safety of STRIDE, with or without lenvatinib, plus TACE, in participants with embolisation-eligible HCC. METHODS: EMERALD-3 is a phase 3, randomised, open-label, sponsor-blinded study, conducted at 177 medical sites in 21 countries. Eligible participants were 18 years or older (aged ≥21 years in Egypt or Singapore) at screening and had confirmed HCC (by imaging or histopathologically from biopsy specimen, surgery, or both) not amenable to curative surgery, curative ablation, or transplantation but amenable to TACE. Participants had Child-Pugh class A liver function, an Eastern Cooperative Oncology Group performance status of 0-1, and at least one measurable target intrahepatic lesion per modified Response Evaluation Criteria in Solid Tumours. Participants were randomly allocated in a 1:1:1 ratio to receive STRIDE plus lenvatinib plus TACE, STRIDE plus TACE, or TACE until each group reached its preplanned enrolment target of 175 participants. After the STRIDE plus TACE group reached its enrolment target, randomisation was adjusted to continue in a 1:1 ratio between the STRIDE plus lenvatinib plus TACE group and TACE group until approximately 275 participants were enrolled in each of these two groups. Randomisation used a centrally assigned interactive response technology system, stratified by region, baseline tumour burden, and previous palliative embolisation. In the STRIDE plus lenvatinib plus TACE group, on the first day, participants were given 300 mg tremelimumab intravenously, followed by 1500 mg durvalumab plus oral lenvatinib (8 mg for <60 kg bodyweight or 12 mg for ≥60 kg bodyweight); participants then received 1500 mg durvalumab every 4 weeks plus once-daily lenvatinib for up to 36 cycles. In the STRIDE plus TACE group, participants were given 300 mg tremelimumab and 1500 mg durvalumab intravenously on the first day, followed by 1500 mg durvalumab every 4 weeks. The technique and number of TACE procedures were at the investigators' discretion, with the first procedure administered at least 7 days after the first dose of durvalumab in the two investigation treatment groups and within 7 days of random allocation in the TACE group. The primary endpoint was progression-free survival for STRIDE plus lenvatinib plus TACE versus TACE. Key secondary endpoints were overall survival for STRIDE plus lenvatinib plus TACE versus TACE and progression-free survival and overall survival for STRIDE plus TACE versus TACE. This study was registered with ClinicalTrials.gov (NCT05301842), with enrolment completed. FINDINGS: From March 28, 2022, to Nov 20, 2024, 1124 participants were screened. The full analysis set comprised 760 participants, who were randomly allocated to STRIDE plus lenvatinib plus TACE (n=293), STRIDE plus TACE (n=175), or TACE (n=292). 633 (83%) participants were male and 127 (17%) were female; 548 (72%) were Asian. At the first data cutoff (Sept 2, 2025); the overall median follow-up for progression-free survival was 10·0 months (IQR 4·6-17·2); median follow-up for progression-free survival was 11·0 months (IQR 4·8-18·4) for STRIDE plus lenvatinib plus TACE and 8·3 months (4·1-15·5) for TACE. Median progression-free survival was 13·0 months (95% CI 12·2-16·7) for STRIDE plus lenvatinib plus TACE versus 9·8 months (8·0-11·4) for TACE (HR 0·70 [95% CI 0·57-0·86]; p=0·0007). At the second data cutoff (Feb 23, 2026) and a median follow-up for overall survival of 24·6 months (IQR 16·5-31·5) for STRIDE plus lenvatinib plus TACE and 22·9 months (14·9-30·2) for TACE, median overall survival was 39·5 months (95% CI 34·1-not reached) for STRIDE plus lenvatinib plus TACE and 34·7 months (28·8-not reached) for TACE (HR 0·84 [95% CI 0·65-1·09]; p=0·18). At this data cutoff, median progression-free survival was 12·9 months (95% CI 10·2-15·9) for STRIDE plus TACE and 8·1 months (6·5-10·2) for the first 175 participants randomised to TACE (HR 0·71 [95% CI 0·56-0·91]), with median follow-up of 10·3 months (IQR 4·6-23·7) for STRIDE plus TACE and 7·7 months (3·0-18·5) for the first 175 participants randomly allocated to TACE. The most common adverse events of maximum grade 3 or 4 were hypertension (34 [12%] of 287) for STRIDE plus lenvatinib plus TACE, post-embolisation syndrome and anaemia (ten [6%] of 175 each) for STRIDE plus TACE, and post-embolisation (17 [6%] of 290) for TACE. 184 (64%) participants receiving STRIDE plus lenvatinib plus TACE, 89 (51%) receiving STRIDE plus TACE, and 68 (23%) receiving TACE had serious adverse events. Treatment-related adverse events with an outcome of death during the treatment-emergent period occurred in seven (2%) of 287 participants who received STRIDE plus lenvatinib plus TACE (two for myocarditis; and one each for hepatic failure, haemophagocytic lymphohistiocytosis, septic shock, cardiac failure, and unknown cause), none of 175 participants who received STRIDE plus TACE, and two (1%) of 290 participants who received TACE (one each for acute myocardial infarction and unknown cause). INTERPRETATION: STRIDE plus lenvatinib plus TACE showed a statistically significant progression-free survival improvement versus TACE. These findings support a STRIDE-based regimen as a potential new treatment option for people with embolisation-eligible HCC; additional follow-up is being conducted for final analysis of overall survival across treatment groups. FUNDING: AstraZeneca.

Adult↗

PubMed2026

Once-weekly IcoSema versus once-daily insulin glargine U100 in type 2 diabetes management (COMBINE 4): an open-label, multicentre, treat-to-target, randomised, phase 3b trial.

BACKGROUND: Stepwise treatment intensification is recommended for managing type 2 diabetes, including insulin initiation when non-insulin glucose-lowering medications are insufficient. Guidelines recommend combining a GLP-1 receptor agonist with basal insulin to improve glycaemic efficacy while reducing weight gain and hypoglycaemia risk. COMBINE 4 evaluated the efficacy and safety of IcoSema, a once-weekly combination therapy of basal insulin icodec and semaglutide (a GLP-1-receptor agonist) versus insulin glargine U100 (glargine U100) in people with type 2 diabetes on oral glucose-lowering medications. METHODS: COMBINE 4 was a 40-week, randomised, open-label, treat-to-target, phase 3b trial conducted across 97 sites in nine countries. Adults (aged ≥18 years) with type 2 diabetes (HbA1c ≥8·0%) receiving oral glucose-lowering medications were randomly allocated in a 1:1 ratio without stratification to IcoSema or once-daily glargine U100. The titration target was 3·9-5·0 mmol/L (70-90 mg/dL). The primary endpoint was change in HbA1c and the secondary confirmatory endpoint was change in bodyweight, both from baseline to week 40, evaluated in all randomly allocated participants. Adverse events were recorded during weeks 0-45. This trial is registered with ClinicalTrials.gov (NCT06269107) and is complete. FINDINGS: Of 653 individuals screened between Feb 15 and Aug 6, 2024, 151 did not meet screening criteria and 17 withdrew before initiating treatment; 243 were randomised to IcoSema and 242 to glargine U100. Of the 485 randomly allocated participants, 286 (59%) were male and 199 (41%) were female, and median age was 58 years (range 26-82). For HbA1c, from baseline (9·57% for IcoSema and 9·50% for glargine U100), mean change to week 40 was greater with IcoSema versus glargine U100 (-3·32 vs -2·44 percentage points; estimated treatment difference [ETD] -0·88 percentage points [95% CI -1·12 to -0·63]), confirming superiority of IcoSema (p<0·001). From baseline to week 40, mean bodyweight decreased with IcoSema and increased with glargine U100 (-0·79 vs 3·81 kg; ETD -4·61 kg [95% CI -5·46 to -3·75]), confirming superiority of IcoSema (p<0·001). Rate of combined clinically significant (blood glucose <3·0 mmol/L [<54 mg/dL], confirmed with a blood glucose meter) or severe hypoglycaemia (severe cognitive impairment requiring external assistance for recovery) was statistically significantly lower with IcoSema versus glargine U100 (0·29 vs 0·59 episodes per person-year of exposure; estimated rate ratio 0·56 [95% CI 0·32 to 0·97]; p=0·04). Gastrointestinal disorders were the most frequently reported adverse events with IcoSema. INTERPRETATION: Once-weekly IcoSema demonstrated superior HbA1c reduction and bodyweight change, with lower rates of clinically significant or severe hypoglycaemia, versus glargine U100, suggesting that IcoSema might be an effective once-weekly treatment option for insulin-naive individuals with type 2 diabetes inadequately controlled on oral glucose-lowering medications. FUNDING: Novo Nordisk.

Humans↗

PubMed2026

Efficacy and safety of mitapivat in adults with transfusion-dependent α-thalassaemia or β-thalassaemia (ENERGIZE-T): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial.

BACKGROUND: The absence of disease-modifying therapies for patients with α-thalassaemia and oral disease-modifying therapies for patients with β-thalassaemia has been a substantial unmet need in these patients. We assessed the efficacy and safety of mitapivat, an oral allosteric activator of pyruvate kinase, in adults with transfusion-dependent thalassaemia. METHODS: ENERGIZE-T is a global, double-blind, randomised, placebo-controlled, phase 3 trial, conducted across 19 countries in North America, Europe, Asia-Pacific, South America, and the Middle East. Patients aged 18 years or older with transfusion-dependent α-thalassaemia or β-thalassaemia were randomly allocated (2:1) with a central interactive response technology system, stratified by geographical region and thalassaemia genotype, to receive 100 mg mitapivat or placebo orally twice a day for 48 weeks. The primary endpoint was transfusion reduction response (TRR), defined as a reduction of at least 50% in transfused red blood cell units with a reduction of at least two units in any consecutive 12-week period until week 48 compared with baseline. Efficacy was analysed in the full analysis set, comprising all randomly allocated patients. Type, severity, and relationship of adverse events and serious adverse events were assessed in patients who received at least one dose of study treatment. This study is registered with ClinicalTrials.gov (NCT04770779) and is active but not recruiting. FINDINGS: Between Nov 30, 2021 and May 2, 2023, 305 patients were screened, of whom 258 were randomly allocated (median age 33·5 years [IQR 27·0-44·0]; 136 [53%] female and 122 [47%] male participants). Of 258 patients allocated, 238 (92%) completed the double-blind treatment period. All patients were required to have a safety follow-up approximately 4 weeks after the final dose of study drug, regardless of completion of the double-blind period or continuation into the open-label extension period. In the full analysis set, TRRs occurred in 52 (30%) of 171 patients in the mitapivat group and 11 (13%) of 87 in the placebo group (adjusted difference 18 percentage points [95% CI 8-27]; two-sided p=0·0003). The safety analysis set comprised 172 patients in the mitapivat group (including one patient allocated to the placebo group who received one dose of mitapivat in error) and 85 in the placebo group. Adverse events were reported in 155 (90%) patients treated with mitapivat and 71 (84%) treated with placebo; the most common events with mitapivat were headache, upper respiratory tract infection, initial insomnia, diarrhoea, and fatigue. Serious adverse events were reported in 19 (11%) patients treated with mitapivat and 13 (15%) treated with placebo. Ten (6%) patients who received mitapivat and one (1%) who received placebo discontinued study treatment due to adverse events. No deaths were reported. INTERPRETATION: Mitapivat significantly reduced the transfusion burden and was generally well tolerated, showing a favourable benefit-risk profile. These findings support mitapivat as the first oral disease-modifying therapy for adults with transfusion-dependent α-thalassaemia or β-thalassaemia, providing a new treatment option to reduce transfusion burden in this patient population. FUNDING: Agios Pharmaceuticals, Inc.

Adult↗

PubMed1986

Randomized clinical trials: alternatives to conventional randomization.

The randomized allocation format remains an exceedingly powerful tool for clinical research. Because humans are the subjects in clinical research, this area of scientific study must operate within the limits dictated by such basic principles as individual autonomy, justice, and beneficence. As randomized studies have become more common in clinical research, it has become apparent that there is often need for modification of the basic randomized format or for alternatives. The most widespread modification is the use of sequential analyses to monitor the progress of a trial and ensure early identification of either unanticipated adverse effects or more pronounced differences than expected. Although this modification does not affect the basic randomized allocation format, it does provide a protection that is lacking in the conventional trial and should be utilized whenever feasible. Modifications that do affect the basic structure of the randomized trial include adaptive allocation and pre-randomization. The former is attractive and useful but limited to studies in which results from early enrollees are known before late enrollees are allocated. The greater the linkage between preceding subject results and subsequent assignments, the greater is the protection afforded by such a format. Pre-randomization, more universally applicable than adaptive allocation, suffers from pronounced cross-over potential and has been criticized on ethical grounds, a combination of weaknesses that raises questions of whether pre-randomization truly offers advantages to conventional randomized formats. True alternatives to the randomized format include the self-controlled study and the historical control design. Both possess significant ethical advantages over the simple randomized study. Unfortunately, both are at some methodological disadvantage when the same comparison is made. The self-controlled study is limited to the study of conditions sufficiently stable or recurrent that they permit two or more treatment courses in a single patient. In emergency medicine and critical care, this description fits only a small proportion of the illness spectrum. This design is underutilized in clinical research focused on less severe problems of the type seen in ambulatory and primary-care settings. Such problems can be suitable topics for research by emergency medicine specialists. Historical control studies are eminently applicable in the emergency and critical-care setting.(ABSTRACT TRUNCATED AT 400 WORDS)

Antihypertensive Agents↗

PubMed1988

Controlled clinical trial of complete open surgical drainage and of prednisolone in treatment of tuberculous pericardial effusion in Transkei.

240 patients with active tuberculous pericardial effusion received a 4-drug daily antituberculosis regimen for 6 months and have been studied for 24 months or longer. Those willing were randomly allocated to open pericardial biopsy and complete drainage of pericardial fluid on admission or percutaneous pericardiocentesis as required. All patients were randomly allocated to prednisolone or matching placebo for the first 11 weeks, on a double-blind basis. Complete open drainage on admission abolished the need for pericardiocentesis (p less than 0.01) but did not influence the need for pericardiectomy for subsequent constriction or the risk of death. Among patients who did not have open drainage on admission, 2 (3%) of 76 given prednisolone compared with 10 (14%) of 74 given placebo died of pericarditis (p less than 0.05), 6 (8%) and 9 (12%) respectively required pericardiectomy, 7 (9%) and 17 (23%) repeat pericardiocentesis (p less than 0.05), and 3 (4%) and 7 (9%) open surgical drainage. By 24 months, apart from the 16 who died from pericarditis, all but 3 patients (2%) had a favourable status.

Adolescent↗

PubMed1992

The pain and discomfort experienced during orthodontic treatment: a randomized controlled clinical trial of two initial aligning arch wires.

A randomized controlled clinical trial was performed to compare the nature, prevalence, intensity, and duration of pain related to the use of a relatively recently developed superelastic arch wire and a more traditional multistranded steel arch wire. Other factors likely to influence the pain experience were also investigated. Forty-three subjects participated in the study, the pain response being assessed by each of the visual analogue scales, the questionnaires, and an analgesic consumption record. In 18 of the 43 subjects a standardized preliminary dental extraction procedure was used as a control. Subsequent to the random allocation of an initial arch wire in 43 patients, 22 of them underwent a second arch wire in the opposing arch, the wire again being determined by random allocation. It was found that the prevalence, intensity, and duration of pain after the insertion of the two types of wire was similar but much greater than in the postextraction control phase. The pain score peaked on the morning after the placement of the arch wire, lasting typically for 5 to 6 days. The pain and discomfort experienced after the insertion of the second arch wire was similar to that of the first, no conditioning response being evident. Overall a diurnal variation was found with a tendency to an increase in pain in the evenings and nights, although this did not greatly affect sleep. The pain response was found to be highly and consistently subjective, not related to the dental arch, crowding, sex, or social class; however, a statistically significant association was found between the age and the pain experienced.

Adolescent↗

PubMed1987

Do serotonin uptake inhibitors decrease smoking? Observations in a group of heavy drinkers.

Serotonin uptake inhibitors have been reported to alter several consummatory and drug self-administration behaviors in rats. These observations suggest important therapeutic applications in humans. While evaluating zimelidine and citalopram effects on ethanol intake, we also assessed smoking behavior. Five male heavy drinkers smoking 29.7 +/- 9.0 (mean +/- SD) cigarettes a day were randomly allocated to receive zimelidine (200 mg/day orally) or placebo in a double-blind crossover study. Another 17 male heavy drinkers smoking 21.1 +/- 14.3 (mean +/- SD) cigarettes a day were randomly allocated to receive citalopram (20 or 40 mg/day orally) or placebo in a double-blind crossover study. In both studies, subjects were not trying to modify their smoking or drinking and received no advice or other treatment to do so. Zimelidine had no effects on the number of cigarettes smoked (F1,4 = 1.80, not significant (NS]. Neither citalopram dose had an effect on smoking (citalopram 20 mg: F1,8 = 0.06, NS; citalopram 40 mg: F1,7 = 0.68, NS). Because intrasubject variation is small, this trial was of sufficient size to exclude with 99.99% confidence the possibility that these drugs decrease smoking behavior by 50%. Since serotonin uptake inhibitors can attenuate ethanol intake in humans, these drugs may have differential effects on consummatory behaviors.

Adult↗

PubMed1989

A controlled trial of 3-month, 4-month, and 6-month regimens of chemotherapy for sputum-smear-negative pulmonary tuberculosis. Results at 5 years. Hong Kong Chest Service/Tuberculosis Research Centre, Madras/British Medical Research Council.

Of 1,710 Chinese patients with radiologically active pulmonary tuberculosis but with sputum negative for acid-fast bacilli on four or more initial microscopic examinations who were studied for 5 yr, 592 (35%) had one or more initial sputum cultures positive for Mycobacterium tuberculosis. These 592 patients were randomly allocated to receive streptomycin, isoniazid, rifampin, and pyrazinamide daily for 4 months or 3 times a week for either 4 or 6 months. The remaining 1,118 patients with all their initial cultures negative were randomly allocated to receive the same four drugs daily for 3 months or 3 times a week for either 3 or 4 months. There were no bacteriologic failures during chemotherapy, and the relapse rates for the 4-month regimens during the 5 yr were 2% in 293 patients with drug-susceptible cultures initially (95% confidence limits, 1 to 5%); 8% in 59 patients with cultures resistant to isoniazid, streptomycin, or both drugs, but susceptible to rifampin initially; and 4% in 325 patients with all their cultures negative initially (95% confidence limits, 1 to 7%). The combined relapse rate for the 3-month regimens was 7% in 709 patients with all their cultures negative initially (95% confidence limits, 5 to 9%). In Hong Kong, 4 months of chemotherapy is now used routinely in the treatment of patients with smear-negative pulmonary tuberculosis, whether their initial sputum cultures are positive or negative.

Adolescent↗

PubMed1989

Influence of maternal diet during lactation and use of formula feeds on development of atopic eczema in high risk infants.

OBJECTIVE: To examine the effects of maternal diet during lactation and the use of formula feeds on the development of atopic eczema in infants at risk. DESIGN: Mothers who planned to breast feed exclusively were randomly allocated to either a restricted diet (avoiding milk and other dairy products, eggs, fish, peanuts, and soybeans) or a diet without restrictions. Mothers who did not plan to breast feed were randomly allocated to using one of three formula feeds. SETTING: Child health centre in Canada. SUBJECTS: 97 Mothers who chose to breast feed and 124 mothers who did not. INTERVENTIONS: Restricted diet for 49 mothers who breast fed. Casein hydrolysate formula, soy milk formula, or cows' milk formula for infants not breast fed. MAIN OUTCOME MEASURE: Development of eczema in babies. RESULTS: Infants were followed up over 18 months and examined for eczema. Eczema was less common and milder in babies who were breast fed and whose mothers were on a restricted diet (11/49 (22%) v 21/48 (48%)). In infants fed casein hydrolysate, soy milk, or cows' milk 9/43 (21%), 26/41 (63%), and 28/40 (70%), respectively, developed atopic eczema. CONCLUSIONS: In families with a history of atopic disease [corrected] mothers who breast feed should avoid common allergenic foods during lactation. If they choose not to breast feed a hydrolysate formula should be used.

Bottle Feeding↗

PubMed1991

Effects of varying recall periods on reported food intakes.

A 32-item food frequency questionnaire was administered with different time periods over which intake frequencies were to be recalled. In replicate Studies 1 and 2, 154 students were randomly allocated to six recall periods, ranging from the "the past 3 days" through to "the past year" and "usual intake". Perceived "oftenness" of intake was estimated on seven-point ratings. In Study 3, 78 students were randomly allocated to five short recall periods, e.g. last weekend, the past 5 days. In addition to rating "oftenness", they estimated their frequencies of intake numerically. In the first two studies, recall period was related to "oftenness" ratings in three ways. Responses for some foods (mainly snacks) were unaffected by recall period; others (mainly staples) were monotonically related to the requested duration of the recall; and, for a third set of foods, periods greater than one month (including "usual intake") yielded equivalent ratings but these were greater frequencies than those associated with shorter recall periods. In Study 3, marked differences were seen between frequency ratings over "average" durations and those over recent periods of similar duration. Correlations between numerical frequency estimates and "oftenness" ratings were high. The implications of the results for uses of food frequency methodology in nutritional epidemiology are discussed.

Adult↗

PubMed1989

Guillotine and dissection tonsillectomy compared.

One hundred children and twenty adults were randomly allocated to guillotine or dissection tonsillectomy operations. The study was prospective and double-blind. In the children, the guillotine technique had demonstrable advantages over the dissection technique in terms of duration of operation, blood loss and post-operative pain. There was no significant morbidity in either group. In the adults, the random allocation of patients into these groups was found to be technically unsatisfactory and this arm of the study was abandoned after twenty patients.

Adolescent↗

PubMed1978

Manchester regional breast study. Preliminary results.

1020 patients with early breast cancer were treated between March, 1970, and October, 1975, according to a prospective clinical trial. The results have been recorded after a follow-up of two to seven years. 713 cases of clinical stage-1 cancer were randomly allocated to treatment by simple mastectomy and postoperative radiotherapy, or simple mastectomy alone. There was no statistically significant difference in overall survival or in survival without distant metastases between the two groups. There was a significant reduction in the incidence of local recurrence in those who had received early postoperative radiotherapy compared with those who had not. 307 cases of clinical stage-11 cancer were randomly allocated to treatment by simple mastectomy and postoperative radiotherapy or radical mastectomy alone. There was no statistically significant difference in survival or in the incidence of local recurrence or distant metastases between the two groups.

Adult↗

PubMed1989

[Adjuvant chemotherapy for gastric cancer--the third study. First report: central randomization by telephone method and analysis of patients' background factors].

JFMTC conducted the third adjuvant chemotherapy study for gastric cancer patients after curative surgery from 1982 to 1983. Patients were randomly allocated to one of the three arms by telephone method controlled at the headquarters of the foundation. This method resulted in the marked reduction of ineligible cases (253 cases, 6.0% of 4,236 cases), compared with those in the first study (18.3%). Main reasons of ineligibility were the violation of entry criteria due to the misjudgment of noncancer, duplicate cancers and operative curability. Telephone method for random allocation seems to contribute to the improvement in the data quality of a clinical trial.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1988

Cefamandole and isoxazolyl penicillins in antibiotic prophylaxis of patients undergoing total hip or knee-joint arthroplasty.

In a prospective comparative clinical efficacy and safety study, 58 patients undergoing total hip or knee arthroplasty were randomly allocated to two groups; one received 29 cefamandole intravenously before operation and then 1 g every 6 h parenterally for 3 days and the other received 29 cloxacillin i.v. every 8 h for 1 day and 29 dicloxacillin perorally every 8 h for 2 days. Concentrations of cefamandole and cloxacillin were measured in the serum of all patients and in the synovial fluid of 28 patients. The serum C-reactive protein (CRP) level was measured in 16 randomly allocated patients preoperatively and daily for 8 days. In serum the concentrations of cefamandole and cloxacillin were high. The great variation in cloxacillin concentration can be due in part to its strong affinity for blood proteins. Cefamandole entered the synovial fluid of the knee joint at high concentrations in 5-15 min; similar concentrations of cloxacillin were measured after 16-30 min. Thus, cefamandole seems to be more recommendable as antibiotic prophylaxis in total hip and knee replacements. The CRP level decreased to below 60 mg/l in all 16 patients on the 6th postoperative day.

Aged↗

PubMed1985

Efficacy of clavulanate-potentiated amoxycillin in experimental and clinical skin infections.

The efficacy of clavulanate-potentiated amoxycillin was compared with amoxycillin alone in experimental staphylococcal infection in dogs and in a controlled trial in clinical cases of skin infection in dogs and cats. The experimental infection was produced by subdermal inoculation with beta-lactamase producing (amoxycillin resistant) staphylococci absorbed in cotton dust. This produced discrete, localised lesions with no systemic involvement. In a cross over study, six animals were randomly allocated to treatment with either amoxycillin alone (10 mg/kg, dosed twice daily) or a formulation of clavulanate-potentiated amoxycillin (12.5 mg/kg, of a 1:4 ratio, dosed twice daily). The lesions of the animals treated with clavulanate-potentiated amoxycillin resolved more quickly than those treated with amoxycillin alone. The difference was significant (P less than 0.05) for both lesion diameter and inflammation score after day 6 of treatment. A trial was carried out in clinical cases of skin disease which were randomly allocated to twice daily treatment with either amoxycillin alone (10 or 20 mg/kg), or with clavulanate-potentiated amoxycillin (12.5 or 25 mg/kg of a 1:4 ratio). The required duration of treatment was shorter (P less than 0.5) for the potentiated amoxycillin treatments, and the success rate (judged by cure or substantial improvement) was higher (P less than 0.05) for this group, especially (P less than 0.01) where amoxycillin resistant organisms were isolated. It was concluded that clavulanate-potentiated amoxycillin was an effective treatment of skin infections both under experimental and clinical conditions.

Amoxicillin↗