In a prospective double-blind trial twelve malnourished patients with lung cancer were randomised to receive either placebo or hydrazine sulphate (60 mg three times daily) for 30 days. Fasting lysine flux was determined by a primed 4-hour continuous infusion of 14C-lysine before and after one month of hydrazine treatment. Baseline plasma lysine flux was 2580 (SD 580) mumol/h for the placebo group and 2510 (440) mumol/h for the hydrazine group. After one month the placebo group showed a slight rise to 2920 (450) mumol/h (p = 0.08) and the hydrazine group showed a significant fall to 1840 (750) mumol/h (p less than 0.05); serum albumin fell in the placebo group and was unchanged in the hydrazine group. Administration of hydrazine sulphate to reduce aminoacid flux may favourably influence the metabolic abnormalities in cancer cachexia.

In a controlled trial to ascertain whether ultrasound given weekly in conjunction with a standard treatment for chronic leg ulcers improves the rate of healing 56 patients were randomised to standard treatment (paste impregnated bandage and a self-adhesive elastic bandage) and 52 to standard treatment plus pulsed ultrasound given weekly. After 12 weeks the proportion of ulcers healed was 20% greater in the ultrasound than in the control group.

The potential of a starch-derived glucose polymer (molecular weight 16,800) as an osmotic agent for peritoneal dialysis was evaluated. A dialysate isosmotic to uraemic serum (302 [SEM 1.3] mOsm/kg) containing 5% glucose polymer (9.4 mmol/l) was compared with hypertonic (332 [1.0] mOsm/kg) 1.36% glucose (76 mmol/l) solution for ultrafiltration, solute transport, and carbohydrate absorption over 6 h and 12 h peritoneal dialysis exchanges. Glucose polymer solution produced substantially greater net ultrafiltration than glucose, while maintaining stable dialysate osmolality throughout the exchanges. At 6 h and 12 h, 14.4% and 28.1% of glucose polymer had been absorbed, compared with 61.5% and 83.0% of glucose; thus, glucose polymer provided less than 50% of the calorie load of the glucose dialysate per unit volume of ultrafiltrate. There was a 7-9-fold increase in serum maltose with glucose polymer. This high-molecular-weight glucose polymer produced sustained ultrafiltration even when dialysate osmolality remained within the physiological range, by a mechanism resembling "colloid" osmosis. It is a safe and effective osmotic agent but its long-term effects need further study.

71 leukaemic patients having HLA-matched bone-marrow transplants (BMT) were randomised to receive whole marrow (group A) or marrow depleted of T cells by treatment with monoclonal antibodies (anti CD4-CD5-CD8, group B; anti CD2-CD5-CD7, group C) plus complement. All patients received cyclophosphamide and total body irradiation before transplantation and cyclosporin after BMT. Marrow treatment removed 97% of T cells (median) in group B and 99% in group C. Although both serious and mild graft-versus-host disease (GVHD) were reduced in T-cell depleted patients, graft failure and relapse were increased. Graft failure was caused by GVHD and transplant complications in the controls and by rejection and relapse in the T-cell depleted groups; relapse-free survival did not differ between the groups. Without better control of host immunity and of the residual leukaemia T-cell depletion of the marrow, BMT should not be pursued in standard-risk patients.

In a trial that began in 1978, 1312 evaluable patients under 80 years of age who either had negative axillary nodes or were postmenopausal with positive axillary nodes were randomised to receive adjuvant tamoxifen 20 mg daily for 5 years, or tamoxifen for the treatment of first relapse. Estimates of oestrogen receptor (ER) content of primary tumour specimens were made in 57%. There has been a highly significant delay in relapse in the adjuvant arm of the trial. This benefit supersedes that from tamoxifen given as treatment for recurrent disease in control-arm patients (93% received this) so that benefit from adjuvant tamoxifen was maintained in the overall survival comparisons. This improvement seems to be independent of nodal and menopausal status. It does not differ significantly with ER level, although the greatest benefit in disease-free survival is in patients with levels of 100 fmol/mg protein or more.

In a randomised, double-blind, controlled study of the effect of prednisolone on the development of post-herpetic neuralgia 78 patients with herpes zoster whose pain and exanthema had been present for less than 96 h were given 800 mg acyclovir five times daily for 7 days and prednisolone in a total dose of 575 mg, starting with 40 mg daily in the first week and tapering off over the next 2 weeks. 18 (23%) of the patients had post-herpetic neuralgia at 6 months after the acute zoster, 9 (24.3%) having received prednisolone and 9 (22.5%) placebo. The 95% CI for the difference between the placebo and prednisolone groups in the proportion of patients having pain at 6 months was minus 17% to plus 20%. Prednisolone, however, relieved pain for the first 3 days. The 1-2 week interval between admission and reappearance of pain and development of triggered pain seems to be the time needed to establish neuralgia. Once established, the type and intensity of pain remained largely unaltered.

81 patients with chronic low back pain (average duration 10 years) were randomised to two treatment groups. 40 received an empirically devised regimen of forceful spinal manipulation and injections of a dextrose-glycerine-phenol ("proliferant") solution into soft-tissue structures, as part of a programme to decrease pain and disability. The other 41 patients received parallel treatment in which the main differences were less extensive initial local anaesthesia and manipulation, and substitution of saline for proliferant. Neither patients nor assessors knew which treatment had been given. When assessed by disability scores the experimental group had greater improvement than the control group at one (p less than 0.001), three (p less than 0.004), and six (p less than 0.001) months from the end of treatment; at six months an improvement of more than 50% was recorded in 35 of the experimental group versus 16 of the control group and the numbers free from disability were 15 and 4, respectively (p less than 0.003). Visual analogue pain scores and pain diagrams likewise showed significant advantages for the experimental regimen.

46 male chronic hepatitis B virus (HBV) carriers with active viral replication were randomised, with stratification for histology and sexual preference, to receive six months' lymphoblastoid interferon or no therapy. After nine to eighteen months' follow-up, HBeAg was no longer detectable and anti-HBe was present in 6 of the 23 treated patients. HBsAg was not detectable in 5 of these patients and 3 had anti-HBs. All of the controls remained positive for HBeAg and HBsAg. Seroconversion from HBeAg to anti-HBe was preceded in all cases by a pronounced increase in serum aspartate aminotransferase levels of more than ten times the upper limit of normal at eight to twelve weeks; this response was exclusively associated with interferon therapy. These results suggest that loss of HBsAg and a hepatitis-like illness in the third month of therapy are direct effects of interferon treatment.

Lipoprotein mass concentrations were measured by analytical ultracentrifugation in a subset of 57 hypercholesterolaemic male participants in the National Heart, Lung, and Blood Institute Type II Coronary Intervention Study. 2-year changes in levels of intermediate-density lipoproteins (IDL) of flotation rate 12-20 were strongly predictive of progression of coronary artery disease at 5 years. Changes in serum mass concentrations of low-density lipoproteins (LDL; flotation rate 0-12), very-low-density lipoproteins (VLDL; flotation rate 20-400), high-density lipoproteins (HDL), and the HDL2 and HDL3 subfractions did not differ significantly between men with and without definite progression of coronary artery disease. The relation of IDL mass to disease progression remained significant (p less than 0.05) after adjustment for group assignment to cholestyramine treatment or placebo and was only slightly reduced (p less than or equal to 0.06) by adjustment for changes in LDL mass concentrations. Changes in IDL mass and ratios of HDL-cholesterol to total-cholesterol or LDL-cholesterol were inversely correlated and had a similar ability to predict progression. The findings are consistent with earlier evidence that IDL are directly involved in the development of coronary artery disease and suggest that ratios of HDL-cholesterol to total-cholesterol or LDL-cholesterol may be indicators of coronary disease risk partly owing to relations with IDL metabolism.

Patients with biliary obstruction due to malignant disease, and judged unfit for open operation, were randomised to have a biliary stent inserted either endoscopically via the papilla of Vater or percutaneously. Analysis after 75 patients had been entered showed that the endoscopic method had a significantly higher success rate for relief of jaundice (81% versus 61%, p = 0.017) and a significantly lower 30-day mortality (15% versus 33%, p = 0.016). The higher mortality after percutaneous stents was due to complications associated with liver puncture (haemorrhage and bile leaks). When stenting is indicated in elderly and frail patients the endoscopic method should be tried first.