HubBLe controlled trial

Challenges

Haemorrhoids are common, affecting as many as 1 in 3 of the population and result in a significant burden to the NHS with over 20,000 haemorrhoidal operations are carried out in England each year. Repeated visits to hospital for therapy represent a significant disruption to the personal and working lives of patients.

Treatment is dictated by the degree of symptoms and the degree of prolapse, and ranges from dietary advice to rubber band ligation (RBL) in the outpatient department, to an operation under anaesthetic.

Although RBL is cheap, it has a high recurrence rate (from 11% to over 50%) and often needs repeating. Failure may require surgical intervention, commonly the traditional "open" haemorrhoidectomy (OH) or a stapled haemorrhoidopexy (SH); both requiring anaesthetic.

OH is associated with considerable post-operative discomfort, and a delay in return to normal activity, but has a low recurrence rate. SH has a slightly higher recurrence rate but potentially shorter recovery.

An alternative treatment is haemorrhoidal artery ligation (HAL), which although also requiring an anaesthetic, evidence suggests a recovery similar to RBL but an effectiveness that approaches the more intensive surgical options.

The aim of this study was to establish the clinical effectiveness and cost effectiveness of haemorrhoidal artery ligation compared with conventional rubber band ligation in the treatment of people with symptomatic prolapsing haemorrhoids (second or third degree).

Research

This was a multi-centre, parallel group randomised controlled trial involving 18 centres throughout England and Scotland.

These participants fell into two basic groups:

1. Patients presenting to the surgical outpatient clinic (SOPC) with symptomatic haemorrhoids where alternative diagnoses had been excluded;
2. Patients with symptoms confirmed due to haemorrhoids who returned to surgical outpatients following one unsuccessful RBL.

After consent, participants were individually randomised to HAL or RBL in equal proportion at all centres.

Data was collected to establish which patients had further treatment for recurrent symptoms or complications following their initial procedure.

Follow-up was conducted at 1 day, 7 days, 21 days, 6 weeks and 12 months post-procedure.

Results

One year after surgery, 49% of the patients had a recurrence of symptoms after RBL compared with 30% of patients undergoing HAL.

About one third of RBL patients whose symptoms persisted underwent a further surgical procedure, many having further RBL and discounting these RBLs led to a minimal difference between treatments.

Most patients initially felt better after surgery, but then relapsed within the year. Symptom scores, quality of life, continence and complications were the same after both procedures.

Those undergoing HAL tended to have more pain but the discomfort was not severe in the majority and resolved by 1-3 weeks after the operation. HAL is much more expensive.

HAL reduced recurrence compared with RBL, but these RBL recurrences can often be treated successfully by simple re-banding.

The RBL procedure (repeated if necessary), therefore, has similar recurrence rates to HAL. HAL is also more painful in the short-term, waiting time is longer, and is more expensive.

Impact

These results may be helpful to patients considering their options for the treatment of haemorrhoids. It provides a more robust figure for the recurrence of haemorrhoids after the two treatments which may help people decide what to choose.

The results may also help clinicians in the choice of treatments for patients. In addition to the recurrence and information on symptoms, it is clear that HAL is not cost-effective and this may influence decisions made by clinicians and save the NHS money.

NICE said the evidence from HubBLE will be reviewed and incorporated when associated guidance for haemorrhoidal artery ligation is being reviewed.

Publications

Brown SR, Tiernan JP, Watson AJM, Biggs K, Shephard N, Wailoo AJ, Bradburn M, Alshreef A & Hind D (2016) Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial. The Lancet.

Comment:

• Bach, S.P. and Fearnhead, N.S., 2016. Does HubBLe spell trouble for HAL?. The Lancet, 388(10042), pp.311-312. DOI: http://dx.doi.org/10.1016/S0140-6736(16)30657-2

Correspondence Articles and Response:

• Giordano, P., 2016. The HubBle trial: a word of caution. The Lancet, 388(10063), pp.2995-2996. http://dx.doi.org/10.1016/S0140-6736(16)32531-4
• Fujita, T., 2016. The HubBle trial: a word of caution. The Lancet, 388(10063), pp.2994-2995. http://dx.doi.org/10.1016/S0140-6736(16)32523-5
• Brown, S.R. and Bradburn, M., 2016. The HubBle trial: a word of caution–Authors' reply. The Lancet, 388(10063), p.2996. http://dx.doi.org/10.1016/S0140-6736(16)32530-2

Brown S, Tiernan J, Biggs K, Hind D, Shephard N, Bradburn M, Wailoo A, Alshreef A, Swaby L, Watson A, Radley S, Jones O, Skaife P, Agarwal A, Giordano P, Lamah M, Cartmell M, Davies J, Faiz O, Nugent K, Clarke A, Macdonald A, Conaghan P, Ziprin P & Makhija R (2016) The HubBle trial: Haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for symptomatic second- and third-degree haemorrhoids: A multicentre randomized controlled trial and health-economic evaluation. Health Technology Assessment, 20(88), 1-180.

Brown, S.R., 2016. Hubble trial: time to stick to basics for treatment of haemorrhoids?. Techniques in Coloproctology, pp.1-3.

Alshreef, A., Wailoo, A.J., Brown, S.R., Tiernan, J.P., Watson, A.J., Biggs, K., Bradburn, M. and Hind, D., 2017. Cost-Effectiveness of Haemorrhoidal Artery Ligation versus Rubber Band Ligation for the Treatment of Grade II–III Haemorrhoids: Analysis Using Evidence from the HubBLe Trial. PharmacoEconomics-Open, pp.1-10.
https://link.springer.com/article/10.1007%2Fs41669-017-0023-6

Tiernan J, Hind D, Watson A, Wailoo AJ, Bradburn M, Shephard N, Biggs K and Brown S Study Protocol. The HubBLe Trial: haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for heamorrhoids. BMC Gastroenterology. 2012, 12:153. DOI: 10.1186/1471-230X-12-153

Project staff

Participating sites

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (project number 10/57/46). The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR or the Department of Health.