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PubMed2004

Understanding quality of life in patients with colorectal cancer: comparison of data from a randomised controlled trial, a population based cohort study and the norm reference population.

BACKGROUND AND AIMS: Quality of life (QoL) is an important outcome measure in clinical studies. However, there is little experience with the interpretation of QoL results. METHODS: To guide interpretation of QoL results from a randomised controlled trial (RCT) targeting the effectiveness of the immune modulator G-CSF on postoperative recovery in high risk (ASA III/IV) colorectal cancer patients, we compared RCT data with data from a population based cohort study and norm reference data. QoL was assessed using the European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 and CR38 questionnaires. QoL results were analysed on discharge from hospital and six months postoperatively. RESULTS: Colorectal cancer patients (both from the RCT and the cohort study) showed the greatest differences in QoL scores compared to norm reference data at discharge from hospital. Six months postoperatively, global quality of life and pain approximated norm reference values indicating optimal recovery. However, deficits still appeared in scores for role functioning, physical functioning, social functioning and fatigue. The best improvements (discharge from hospital to six months postoperatively) were seen with respect to physical functioning, fatigue and pain. CONCLUSIONS: For further analysis of RCT data, physical functioning and fatigue scores may be more sensitive than global quality of life to detect differences in treatment effects.

Adult↗
PubMed2000

Effect of population screening and treatment for Helicobacter pylori on dyspepsia and quality of life in the community: a randomised controlled trial. Leeds HELP Study Group.

BACKGROUND: Infection with Helicobacter pylori is the main cause of peptic-ulcer disease. Treatment of this infection might lower the prevalence of dyspepsia in the community and improve quality of life. We investigated this possibility in a double-blind randomised controlled trial. METHODS: Individuals aged 40-49 years were randomly selected from the lists of 36 primary-care centres. A researcher interviewed participants with a validated dyspepsia questionnaire and the psychological general wellbeing index (PGWB). H. pylori status was assessed by the carbon-13-labelled urea breath test. Infected participants were randomly assigned active treatment (omeprazole 20 mg, clarithromycin 250 mg, and tinidazole 500 mg, each twice daily for 7 days) or identical placebo. Participants were followed up at 6 months and 2 years. FINDINGS: Of 32,929 individuals invited, 8455 attended and were eligible; 2324 were positive for H. pylori and were assigned active treatment (1161) or placebo (1163). 1773 (76%) returned at 2 years. Dyspepsia or symptoms of gastro-oesophageal reflux were reported in 247 (28%) of 880 in the treatment group and 291 (33%) of 871 in the placebo group (absolute-risk reduction 5% [95% CI 1-10]). H. pylori treatment had no significant effect on quality of life (mean difference in PGWB score between groups 0.86 [-0.33 to 2.05]). INTERPRETATION: Community screening and treatment for H. pylori produced only a 5% reduction in dyspepsia. This small benefit had no impact on quality of life.

Adult↗
PubMed2003

Stapled versus excision haemorrhoidectomy: long-term follow up of a randomised controlled trial.

Advantages of the stapling procedure for haemorrhoids include reduced postoperative pain and shortened convalescence; however, there are few data with respect to functional and symptomatic outcome. At a dedicated clinic, we reviewed patients between Dec, 2001, and March, 2002, who had taken part in a randomised controlled trial undertaken at the unit in 1999, which compared outcomes after open or stapled haemorrhoidectomy. We noted the presence or absence of haemorrhoid specific symptoms, and assessed overall satisfaction, continence, and quality of life. Rigid sigmoidoscopy and an anorectal examination were also used to examine symptomatic recurrence and disease activity. At minimum follow-up of 33 months since surgery, both techniques seem to be equally effective.

Follow-Up Studies↗
PubMed1988

Randomised controlled trial of recombinant tissue plasminogen activator versus urokinase in the treatment of acute pulmonary embolism.

The effect of intravenous recombinant human tissue-type plasminogen activator (rt-PA) was compared with that of urokinase in 45 patients with angiographically documented pulmonary embolism (PE) in a randomised controlled trial. The two principal end-points were clot lysis at 2 h, as assessed by angiography, and pulmonary reperfusion at 24 h, as assessed by perfusion lung scanning. All patients received the full dose of rt-PA but urokinase infusions were terminated prematurely (on average after 18 h) in 9 patients because of allergy in 1 and uncontrollable bleeding in 8. By 2 h, 82% of rt-PA-treated patients showed clot lysis, compared with 48% of urokinase-treated patients (p = 0.008; 95% CI for the difference = 10-58%). Improvement in lung scan reperfusion at 24 h was identical in the two treatment groups. The reduction in fibrinogen did not differ significantly between the rt-PA and urokinase groups (45% vs 39% at 2 h and 34% vs 40% at 24 h). The results indicate that in the dose regimens employed, rt-PA acts more rapidly and is safer than urokinase in the treatment of acute PE.

Acute Disease↗
PubMedDate not supplied

Randomised controlled trial of magnetic-resonance pelvimetry in breech presentation at term.

BACKGROUND: Pelvimetry is widely used in women with breech presentation at term to select those for whom planned vaginal delivery is appropriate. However, its clinical value has never been established. We evaluated pelvimetry in a randomised controlled trial. The main outcome measures were the elective and emergency caesarean-section rates and the early condition of the neonate. METHODS: Magnetic-resonance (MR) pelvimetry was done on 235 women. The women were then randomly assigned to two groups--for the study group (n = 118), the pelvimetry results were reported to the responsible obstetricians, who used them as the basis for decisions on whether to schedule elective caesarean or trial of labour; for the control group (n = 117), the pelvimetry results were not disclosed until 8 weeks post partum, and decisions about obstetric management were made on the basis of clinical factors only. FINDINGS: 35 women (15 [13%] study group, 20 [17%] control group) had abnormalities on pelvimetry. The overall caesarean-section rates did not differ significantly between the study and control groups (50 [42%] vs 59 [50%], p = 0.24) but the emergency caesarean-section rate was significantly lower in the study group than in the control group (22 [19%] vs 41 [35%], p = 0.0052). The mean 1 min Apgar scores in the study and control groups were 8.1 and 8.0 (p = 0.93) and the mean 3 min scores 9.5 and 9.4, respectively (p = 0.28). There were no significant differences in the early neonatal outcome for infants born vaginally, by emergency caesarean section, or by elective caesarean section in the two groups, except for a significantly lower Apgar score in the six infants born vaginally to control-group women who had pelvic abnormalities. INTERPRETATION: The use of MR pelvimetry in breech presentation at term did not significantly reduce the overall caesarean-section rate. However, it allowed better selection of the delivery route, with a significantly lower emergency caesarean-section rate. Neonatal outcome was not compromised by use of the pelvimetry data.

Apgar Score↗
PubMed2006

Fish oil in various doses or flax oil in pregnancy and timing of spontaneous delivery: a randomised controlled trial.

OBJECTIVES: To test the earlier suggested hypothesis that intake of long-chain n-3 fatty acids from fish oil may delay the timing of spontaneous delivery and to test if alpha-linolenic acid, provided as flax oil capsules, shows the same effect. DESIGN: Randomised controlled trial including women reporting low dietary fish intake. The women were allocated in the proportions of 1:1:1:1:1:1:2 into six treatment groups and a control group, respectively, from week 17-27 of gestation. The treatment groups received fish oil, in various doses, or flax oil, and the control group did not receive any treatment. SETTING: The Danish National Birth Cohort. SAMPLE: A total of 3098 women allocated into six treatment groups and one control group. METHODS: The six intervention groups were offered fish oil capsules in doses of 0.1, 0.3, 0.7, 1.4 and 2.8 g of eicosapentaenoic acid and docosahexaenoic acid per day or 2.2 g of alpha-linolenic acid (ALA) per day from week 17-27 of gestation until delivery. MAIN OUTCOME MEASURES: Timing of spontaneous delivery. RESULTS: No differences in timing of spontaneous delivery was detected in the fish oil groups or the flax oil group, compared with the control group. The difference in timing of spontaneous delivery in the group receiving the highest fish oil dose compared with the control group was 0.8 days (95% CI: -2.3 to 1.0). Only a minority of the women in the intervention groups took capsules until delivery. CONCLUSION: Possible explanations for these findings include no true effect of n-3 fatty acids on spontaneous delivery or a quick-acting effect not detectable in this trial.

Biomarkers↗
PubMed1992

Randomised controlled trial of breast shells and Hoffman's exercises for inverted and non-protractile nipples.

OBJECTIVE: To determine the value of recommending breast shells or Hoffman's exercises, or both, to pregnant women with inverted or non-protractile nipples who intend to breast feed. DESIGN: Randomised controlled trial with a two treatment by two level factorial design. SETTING: Antenatal clinics in a district general hospital and the community. SUBJECTS: 96 nulliparous women recruited between 25 and 35 completed weeks in a singleton pregnancy with at least one inverted or non-protractile nipple. MAIN OUTCOME MEASURES: Anatomical change of nipples, judged blindly before first breast feeding, and success of breast feeding reported by postal questionnaire six weeks postnatally. RESULTS: Sustained improvement in nipple anatomy was more common in the untreated groups but the differences were not significant (52% (25/48) shells v 60% (29/48) no shells; difference -8% (95% confidence interval -28% to 11%) and 54% (26/48) exercises v 58% (28/48) no exercises; -4% (-24% to 16%)). 24 (50%) women not recommended shells and 14 (29%) recommended shells (21%; 40% to 2%) were breast feeding six weeks after delivery (p = 0.05), reflecting more women recommended shells both deciding to bottle feed before delivery and discontinuing breast feeding. The same number of women in exercise and no exercise groups were successfully breast feeding (0%; -20% to 20%). 13% of women approached about the trial (and planning to breast feed) did not attempt breast feeding. CONCLUSIONS: Recommending nipple preparation with breast shells may reduce the chances of successful breast feeding. While there is no clear evidence that the treatments offered are effective antenatal nipple examination should be abandoned.

Adolescent↗
PubMed2003

Randomised controlled trial of the onset of analgesic efficacy of dexketoprofen and diclofenac in lower limb injury.

OBJECTIVE: To assess the time of onset and difference in analgesic efficacy of oral dexketoprofen compared with oral diclofenac in patients with acute lower limb injury. DESIGN: A prospective, double blind, randomised controlled trial. INTERVENTIONS: Patients who fitted the study criteria were given either 25 mg oral dexketoprofen trometamol or 50 mg sodium diclofenac immediately after triage; baseline and 15 minute pain scores were then recorded for one hour. RESULTS: 122 patients were studied (diclofenac = 57 and dexketoprofen = 65). There were no significant differences in age, sex, type of injury, or baseline pain scores between the two groups. The differences in group mean pain scores between diclofenac and dexketoprofen at 15, 30, 45, and 60 minutes were; 0.53 (95% confidence intervals -0.03 to 1.09), 0.70 (0.16 to 1.24), 0.89 (0.32 to 1.47), and 0.83 (0.21 to 1.45). Odds ratios for a decrease in pain score of at least 1 from baseline (on the 11 point scale) when given dexketoprofen rather than diclofenac at 15, 30, 45, and 60 minutes were; 2.66 (1.19 to 5.98), 3.52 (1.60 to 7.73), 4.48 (1.72 to 11.65), and 5.54 (1.90 to 16.15). Corresponding odds ratios for a decrease in pain score of >/=2 were; 6.88 (1.48 to 32.0), 3.79 (1.59 to 9.01), 5.19 (2.29 to 11.78), and 5.87 (2.68 to 12.88). CONCLUSIONS: Dexketoprofen trometamol is an effective and rapidly acting analgesic for the treatment of acute musculoskeletal injuries.

Acute Disease↗
PubMed1994

Randomised controlled trial evaluating cardiovascular screening and intervention in general practice: principal results of British family heart study. Family Heart Study Group.

OBJECTIVE: To measure the change in cardiovascular risk factors achievable in families over one year by a cardiovascular screening and lifestyle intervention in general practice. DESIGN: Randomised controlled trial in 26 general practices in 13 towns in Britain. SUBJECTS: 12,472 men aged 40-59 and their partners (7460 men and 5012 women) identified by household. INTERVENTION: Nurse led programme using a family centred approach with follow up according to degree of risk. MAIN OUTCOME MEASURES: After one year the pairs of practices were compared for differences in (a) total coronary (Dundee) risk score and (b) cigarette smoking, weight, blood pressure, and random blood cholesterol and glucose concentrations. RESULTS: In men the overall reduction in coronary risk score was 16% (95% confidence interval 11% to 21%) in the intervention practices at one year. This was partitioned between systolic pressure (7%), smoking (5%), and cholesterol concentration (4%). The reduction for women was similar. For both sexes reported cigarette smoking at one year was lower by about 4%, systolic pressure by 7 mm Hg, diastolic pressure by 3 mm Hg, weight by 1 kg, and cholesterol concentration by 0.1 mmol/l, but there was no shift in glucose concentration. Weight, blood pressure, and cholesterol concentration showed the greatest difference at the top of the distribution. If maintained long term the differences in risk factors achieved would mean only a 12% reduction in risk of coronary events. CONCLUSIONS: As most general practices are not using such an intensive programme the changes in coronary risk factors achieved by the voluntary health promotion package for primary care are likely to be even smaller. The government's screening policy cannot be justified by these results.

Adult↗
PubMed2002

A randomised controlled trial of written information: the effect on parental non-concordance with occlusion therapy.

BACKGROUND/AIMS: It is well documented that non-concordance with occlusion therapy is both substantial and a major factor leading to treatment failure. Parental understanding in previous work has been found to be poor in key areas such as the critical period and effect of age on prognosis. Research in other areas of medicine has shown that the level of understanding can have a direct effect on the level of concordance. The aims of this study were to assess the ability of educational material in the form of a leaflet, to improve parental understanding of amblyopia and occlusion, and subsequently increase concordance. METHODS: Parents of children aged between 1 and 7 years receiving a minimum of 1 hour of occlusion for amblyopia were recruited. A randomised controlled trial was undertaken where, on inclusion, the patients were randomised into a leaflet group, whose parents were issued with written educational material, and a control group whose parents did not receive the written information. Patients were paired and matched for age (<2 years difference) and amount of prescribed occlusion (no more than 1 hour difference). Concordance was monitored by a parental diary and knowledge and parental reasons for non-concordance were assessed by a questionnaire. Concordance was analysed by means of a concordance index and by calculating the proportion of non-concordant parents by setting a threshold of concordance at 80%. RESULTS: Parental knowledge was significantly greater in the leaflet group (88% had complete knowledge) compared to the control group (49% had complete knowledge) (p <0.001). There were also differences between the groups in the area of the treatment regimen, with errors only occurring in the control group (three patients occluded the incorrect eye), but this did not reach statistical significance. Concordance was significantly greater in the leaflet group (mean concordance index 0.85) compared to the non-leaflet group (mean concordance index (0.71) (p <0.001). Comparison of the proportion of non-concordant parents was also statistically different (p <0.005) at 0.23 (95% CI 0.13 to 0.35) for the leaflet group compared to 0.54 (95% CI 0.41 to 0.67) for the control group. CONCLUSION: A large proportion of patients would benefit by increasing parental knowledge in key areas such as the critical period, importance of occlusion, and potential negative consequences of not treating amblyopia. Written information is a simple, inexpensive, easy to implement, yet effective method of improving parental understanding and subsequent concordance.

Amblyopia↗
PubMed2002

Improving uptake of influenza vaccination among older people: a randomised controlled trial.

BACKGROUND: The uptake of influenza vaccination among older people is suboptimal. Contact with a doctor or nurse is associated with older people deciding to accept influenza vaccination. AIM: To compare different forms of approach in improving uptake of influenza vaccination among patients aged 75 years and over in primary care. DESIGN OF STUDY: Randomised controlled trial. SETTING: One large rural general practice serving the town and surrounding area of Melton Mowbray, Leicestershire. METHOD: All 2,052 patients aged 75 years and over, registered with the practice and not living in nursing/residential homes or sheltered accommodation, were included in the study. One-third of patients were randomised to receive an offer of influenza vaccination as part of an over-75 health check administered by a practice nurse in the patient's home, and two-thirds of patients were randomised to receive a personal letter of invitation to attend an influenza vaccination clinic held at the surgery. The main outcome measure was uptake of influenza vaccination. RESULTS: Six hundred and eighty patients were randomised to the health check arm of the trial and 1,372 were randomised to receive a personal letter. Of those randomised to the health check arm, 468 received the health check from the nurse. Overall, the difference in influenza vaccination uptake was 6.4% (95% confidence interval [CI] = 2.2% to 10.4%) with 67.9% (n = 932) of those who were sent a personal letter actually receiving the vaccine, compared with 74.3% (n = 505) of those offered a combined health check and influenza vaccination (P = 0.003). CONCLUSION: Combining home-based over- 75 health checks with influenza vaccination can improve uptake among older patients. However this intervention is likely to be costly and its effect on influenza vaccination rates is modest. The difference in uptake is greater among those who do not routinely comeforwardfor vaccination and a more viable option may be to target these patients.

Aged↗
PubMed2003

Age-related macular degeneration and nutritional supplementation: a review of randomised controlled trials.

Age-related macular degeneration (AMD) is the leading cause of severe vision loss in the developed world. The lack of effective treatment modalities, coupled with evidence supporting an oxidative pathogenesis, has increased interest in the potential preventative role of nutritional supplementation. This article reviews seven randomised controlled trials (RCTs) that have investigated the role of nutritional supplementation in AMD. Three of these trials reported a positive effect of nutritional supplementation on AMD; the Age-related eye study (AREDS), the Lutein Antioxidant Supplementation Trial (LAST), and the oral zinc trial by Newsome et al. (1988). However, the oral zinc trial by Newsome et al. (1988) was unlikely to detect any difference between treatments smaller than 72%, and the AREDS results were based on a subgroup of their study population. Lutein was considered for the AREDS formulation, but was not commercially available at that time. The findings of the LAST support a possible therapeutic role of lutein in AMD.

Antioxidants↗
PubMed2006

Communicating population health statistics through graphs: a randomised controlled trial of graph design interventions.

BACKGROUND: Australian epidemiologists have recognised that lay readers have difficulty understanding statistical graphs in reports on population health. This study aimed to provide evidence for graph design improvements that increase comprehension by non-experts. METHODS: This was a double-blind, randomised, controlled trial of graph-design interventions, conducted as a postal survey. Control and intervention participants were randomly selected from telephone directories of health system employees. Eligible participants were on duty at the listed location during the study period. Controls received a booklet of 12 graphs from original publications, and intervention participants received a booklet of the same graphs with design modifications. A questionnaire with 39 interpretation tasks was included with the booklet. Interventions were assessed using the ratio of the prevalence of correct responses given by the intervention group to those given by the control group for each task. RESULTS: The response rate from 543 eligible participants (261 intervention and 282 control) was 67%. The prevalence of correct answers in the control group ranged from 13% for a task requiring knowledge of an acronym to 97% for a task identifying the largest category in a pie chart. Interventions producing the greatest improvement in comprehension were: changing a pie chart to a bar graph (3.6-fold increase in correct point reading), changing the y axis of a graph so that the upward direction represented an increase (2.9-fold increase in correct judgement of trend direction), a footnote to explain an acronym (2.5-fold increase in knowledge of the acronym), and matching the y axis range of two adjacent graphs (two-fold increase in correct comparison of the relative difference in prevalence between two population subgroups). CONCLUSION: Profound population health messages can be lost through use of overly technical language and unfamiliar statistical measures. In our study, most participants did not understand age standardisation and confidence intervals. Inventive approaches are required to address this problem.

Adult↗
PubMed2000

A randomised controlled trial of lay health workers as direct observers for treatment of tuberculosis.

SETTING: Study conducted in a suburb of Cape Town, South Africa. OBJECTIVE: Comparison of successful tuberculosis treatment outcome rates between self supervision, supervision by lay health worker (LHW), and supervision by clinic nurse. METHODS: Open, randomised, controlled trial with intention-to-treat analysis. RESULTS: All groups (n = 156) achieved similar outcomes (LHW vs. clinic nurse: risk difference 17.2%, 95% confidence interval [CI] -0.1-34.5; LHW vs. self supervision 15%, 95%CI -3.7-33.6). New patients benefit from LHW supervision (LHW vs clinic nurse: risk difference 24.2%, 95%CI 6-42.5, LHW vs. self supervision 39.1%, 95%CI 17.8-60.3) as do female patients (LHW vs. clinic nurse 48.3%, 95%CI 22.8-73.8, LHW vs. self supervision 32.6%, 95%CI 6.4-58.7). CONCLUSIONS: LHW supervision approaches statistically significant superiority, but fails to reach it most likely due to the study's limitation, the small sample size. It is possible that subgroups (new and female patients) do well under LHW supervision. LHW supervision could be offered as one of several supervision options within TB control programmes.

Adult↗
PubMed2001

A randomised controlled trial of delayed antibiotic prescribing as a strategy for managing uncomplicated respiratory tract infection in primary care.

BACKGROUND: Despite evidence that uncomplicated lower respiratory tract infection (cough) does not respond appreciably to antibiotics and that bacterial resistance is increasing, general practitioners (GPs) still prescribe frequently. AIM: To assess delayed antibiotic prescribing as a strategy for reducing the unnecessary use of antibiotics for cough in primary care. DESIGN OF STUDY: Open randomised controlled trial of delayed versus immediate prescribing of antibiotics. SETTING: One hundred and ninety-one adult patients with uncomplicated cough in 22 Scottish practices who would have received antibiotics under the GP's usual practice were randomised to receive either an immediate prescription (92 patients) or a delayed prescription (99 patients). METHOD: Delayed subjects were asked to wait a week before deciding whether to collect their prescription. Outcome measures included symptom duration, prescription uptake, patient satisfaction, patient enablement, and subsequent consultation rates. The 48 GPs who recruited patients were surveyed six months after the trial to see whether they used delayed prescribing as a part of their normal practice. RESULTS: Study and control groups were similar at baseline. Of the subjects in the delayed arm, 55% did not pick up their prescription. Although most patients were satisfied, more patients in the immediate arm were very satisfied with the treatment (P = 0.001) and the consultation (P = 0.03). The patients in the immediate arm were also more enabled (3.3 versus 2.4; P = 0.04), although more of them intended to consult for similar complaints in the future (85% versus 69%, P = 0.02). We were unable to detect any difference in actual consulting behaviour in the follow-up period (mean = 15 months [SD = 5 months]). Subsequently, 68% of GPs used delayed prescribing at least monthly; all gave the prescription to the patient. CONCLUSION: Delayed prescribing is effective at reducing the use of antibiotics for self-limiting cough; however, patients are less satisfied and enabled as a result. Patients may be deterred from consulting rather than becoming enabled.

Adult↗
PubMed2006

Effectiveness of a Minimal Intervention for Stress-related mental disorders with Sick leave (MISS); study protocol of a cluster randomised controlled trial in general practice [ISRCTN43779641].

BACKGROUND: The main aims of this paper are to describe the setting and design of a Minimal Intervention in general practice for Stress-related mental disorders in patients on Sick leave (MISS), as well as to ascertain the study complies with the requirements for a cluster randomised controlled trial (RCT). The potential adverse consequences of sick leave due to Stress-related Mental Disorders (SMDs) are extensive, but often not recognised. Since most people having SMDs with sick leave consult their general practitioner (GP) at an early stage, a tailored intervention given by GPs is justified. We provide a detailed description of the MISS; that is more accurate assessment, education, advice and monitoring to treat SMDs in patients on sick leave. Our hypothesis is that the MISS will be more effective compared to the usual care, in reducing days of sick leave of these patients. METHODS: The design is a pragmatic RCT. Randomisation is at the level of GPs. They received the MISS-training versus no training, in order to compare the MISS vs. usual care at patient level. Enrollment of patients took place after screening in the source population, that comprised 20-60 year old primary care attendees. Inclusion criteria were: moderately elevated distress levels, having a paid job and sick leave for no longer than three months. There is a one year follow up. The primary outcome measure is lasting full return to work. Reduction of SMD- symptoms is one of the secondary outcome measures. Forty-six GPs and 433 patients agreed to participate. DISCUSSION: In our study design, attention is given to the practical application of the requirements for a pragmatic trial. The results of this cluster RCT will add to the evidence about treatment options in general practice for SMDs in patients on sick leave, and might contribute to a new and appropriate guideline. These results will be available at the end of 2006.

Adult↗
PubMed2001

Adjuvant chemoradiotherapy and chemotherapy in resectable pancreatic cancer: a randomised controlled trial.

BACKGROUND: The role of adjuvant treatment in pancreatic cancer remains uncertain. The European Study Group for Pancreatic Cancer (ESPAC) assessed the roles of chemoradiotherapy and chemotherapy in a randomised study. METHODS: After resection, patients were randomly assigned to adjuvant chemoradiotherapy (20 Gy in ten daily fractions over 2 weeks with 500 mg/m(2) fluorouracil intravenously on days 1-3, repeated after 2 weeks) or chemotherapy (intravenous fluorouracil 425 mg/m(2) and folinic acid 20 mg/m(2) daily for 5 days, monthly for 6 months). Clinicians could randomise patients into a two-by-two factorial design (observation, chemoradiotherapy alone, chemotherapy alone, or both) or into one of the main treatment comparisons (chemoradiotherapy versus no chemoradiotherapy or chemotherapy versus no chemotherapy). The primary endpoint was death, and all analyses were by intention to treat. Findings 541 eligible patients with pancreatic ductal adenocarcinoma were randomised: 285 in the two-by-two factorial design (70 chemoradiotherapy, 74 chemotherapy, 72 both, 69 observation); a further 68 patients were randomly assigned chemoradiotherapy or no chemoradiotherapy and 188 chemotherapy or no chemotherapy. Median follow-up of the 227 (42%) patients still alive was 10 months (range 0-62). Overall results showed no benefit for adjuvant chemoradiotherapy (median survival 15.5 months in 175 patients with chemoradiotherapy vs 16.1 months in 178 patients without; hazard ratio 1.18 [95% CI 0.90-1.55], p=0.24). There was evidence of a survival benefit for adjuvant chemotherapy (median survival 19.7 months in 238 patients with chemotherapy vs 14.0 months in 235 patients without; hazard ratio 0.66 [0.52-0.83], p=0.0005). Interpretation This study showed no survival benefit for adjuvant chemoradiotherapy but revealed a potential benefit for adjuvant chemotherapy, justifying further randomised controlled trials of adjuvant chemotherapy in pancreatic cancer.

Adenocarcinoma↗