Chant 1972.

Study characteristics
Methods	Method of randomisation: consecutive slips drawn from concealed envelopes. Demographic data and a history of phlebitis, thrombosis, injury to legs and presenting symptoms such as visability, aching, itching, cramps, swelling, rashes or ulcers were collected. Patients also examined for presence of oedema, pigmentation, eczema and ulceration. Outcomes: examination by same observer, not blinded as the scars were still visible. Symptoms and signs recorded. Patients classified as improved or given further treatment. Follow up: 6 months, 1, 2 and 3 years. Age, address, occupation, parity and weight also recorded.
Participants	339 patients seen, 115 patients had sclerotherapy (I/CST), 100 patients had surgery, 90 patients were excluded. 5 year follow‐up: 249 patients seen. 125 patients had sclerotherapy (I/CST), 124 patients had surgery. Inclusion criteria: varicose veins. Exclusion criteria: previous treatment (31 patients); excluded for medical and social reasons (27 patients); expressed a preference for treatment; age over 60; minimal varicose veins not warranting treatment. The two groups were similar in terms of age, height, weight, sex. Parity in women was similar. More women in CST were in social class IV and V.
Interventions	1) Surgery. SFJ / SPJ ligation, strip of LSV and ligation of incompetent perforating veins and short saphenous and lateral varicosities. 2) I/CST by Fegan's method. An economic analysis was also performed as part of the trial Cost assessment has been carried out along with this trial based on 1967‐68 costs. Hospital costs: Surgery: hospital costing returns, a work‐study, data from the patients' notes, individual costings. General overheads, eg. laundry, shared equally between all in‐patients. Nursing and medical staff costs particular to varicose vein surgery: 2 hours per patient for nurses; 1 hour per patient for doctors. Average cost of an operation used as a reasonable approximation and other costs such as drugs were assessed from notes. Sclerotherapy: cost of a session estimated from the cost of an outpatient visit. This included medical, nursing, and secretarial costs and amounted to £41.50 per session. Average number of patients seen per session was 31; average number of sessions per patient was 7.3.
Outcomes	93% of those treated were seen at 3 years; 14% in the surgery group and 22% in I/CST group had had further treatment; there was no significant difference between the two treatments. See Table 4 and Table 5 for further details. At 3 years, 90 of 100 patients in surgery group and 110 of 115 patients in sclerotherapy group were seen. 39 of surgery and 28 of sclerotherapy patients received treatment to both legs, but only one leg was chosen at random to be analysed, to reduce any bias. Outcome data was transformed using logit transformation and was analysed for the effect of class, sex, type of treatment and number of legs treated. None of these effects were significant. Complications: 15 surgery and 25 sclerotherapy patients had complications. Numbers weren't specified but mean outpatient attendance increased from 1.0 to 2.2. No deaths but one severe bronchospasm under general anaesthetic due to coronary artery occlusion. 34 patients accepted into trial did not have treatment [26 did not attend for treatment (18 surgery, 8 sclerotherapy) and 8 moved or were medically contraindicated]. The 26 who did not attend were judged to have needed more treatment and were added to the 3 year figures. This gives 31 in the surgical and 32 in the sclerotherapy group who needed further treatment. Waiting list time was similar between the two groups (no data), 2 moved out of the area, 6 excluded for medical reasons not apparent at time of randomisation. These patients were analysed for influence of bias and were found to be slightly but not significantly older than the treated group. 15 patients were not seen in follow up (10 surg and 5 CST). Cost: The final estimate was £44.22 for surgery. The average cost of sclerotherapy per patient was £9.77. Costs to the community: sclerotherapy patients had an average of 6.4 days off with a loss of earnings of £29. Surgical patients had an average of 31.3 days off with a loss of £118. Travelling time: sclerotherapy 30 hours, surgery 100 hours. 5 year follow‐up study results: 40% of those treated by sclerotherapy and 24.2% treated by surgery had further treatment. 37 were re‐treated, (25 in sclerotherapy, and 12 in surgery group). 5 initially treated by sclerotherapy went on to have surgery, the rest had sclerotherapy. 33 were given compression stockings. Authors recommended that patients under 35 years should have sclerotherapy, and those of any age who show no signs of venous insufficency have a similar outcome from either treatment. Also stated that those under 35 with signs of venous insufficency are likely to do better with surgical treatment. 2 patients collapsed during operation: one myocardial infarction (F) and one pulmonary embolism (M). Both recovered and were discharged 9 days later. 91.3% CST and 93.9% surgery were seen at 5 years. 10 in CST and 6 in surgery could not be traced.
Notes	Problems with using data on signs and symptoms (not reproducible) as an objective method and stated that there was no other reliable way.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate