4 Efficacy

4 Efficacy

This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.

4.1

A non-randomised comparative study of 154 patients with palmar hyperhidrosis treated by endoscopic thoracic sympathectomy (ETS) or botulinum-toxin A injection reported statistically significant improvements in both groups at 6‑ and 12‑month follow-up, assessed objectively using an iodine starch test and pad glove test (p<0.05). The improvement was significantly higher in the ETS group than the botulinum-toxin A injection group (94% and 30% change on the iodine starch test respectively, p=0.01).

4.2

A case series of 1,700 patients (1,052 [62%] patients with hyperhidrosis, 536 [32%] patients with facial blushing and 112 [7%] patients with combinations of blushing and hyperhidrosis) reported that 85% of patients had a 'satisfactory and lasting effect' from the procedure at a mean follow-up of 15 years (absolute number not reported). A case series of 406 patients with palmar and/or axillary hyperhidrosis reported that 91% (n=239) of patients treated by conventional ETS had dry limbs at a mean follow-up of 17 years.

4.3

The non-randomised comparative study of 154 patients reported a statistically significant higher mean satisfaction score for ETS compared with botulinum-toxin A injection at 12‑month follow-up (4.52 and 3.12, respectively [score range 1 to 5 with 1 being very poor and 5 being excellent], p=0.001). The case series of 1,700 patients reported satisfaction rates of 87% and 67% for palmar and axillary hyperhidrosis respectively (p<0.001). Overall, 75% of patients stated that the procedure had improved their quality of life (absolute numbers not reported).

4.4

A case series of 2,000 patients reported recurrence rates of 0% and 4% for palmar and axillary hyperhidrosis respectively at 1‑year follow-up and 1% and 17% respectively at 5‑year follow-up. A case series of 9,988 patients with palmar hyperhidrosis reported that 'almost all' patients obtained satisfactory relief immediately after ETS; recurrence rates were about 1% at 1‑year follow-up and less than 3% at 3‑year follow-up (absolute numbers not reported).

4.5

The case series of 453 patients with palmar, axillary or facial hyperhidrosis reported that 91% (412 out of 453) had better quality of life 30 days after ETS and 90% (409 out of 453) had better quality of life 5 years after ETS. All patients had poor or very poor quality of life before treatment.

4.6

The specialist advisers stated that key efficacy outcomes were reduction in hyperhidrosis and patient satisfaction.