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SUMMARY Twenty four men with insulin dependent diabetes and different degrees of autonomic neuropathy were studied to establish the response of the QT interval to various heart rates. Nine men with autonomic neuropathy had a longer QT interval than 13 healthy individuals and 15 patients who had diabetes without, or with only mild, autonomic neuropathy. Those with autono.mic neuropathy also had a proportionally greater lengthening of the QT interval for a given increase in RR interval.The results of this study suggest a basis for the finding that sudden death is more common in patients with diabetic autonomic neuropathy.An association between an abnormal QT interval and sudden cardiac death has been found in various diseases.'2 The influence of autonomic tone on the QT period is also widely accepted, although the mechanisms underlying the shortening or lengthening of this period are still not clear."4In the late 1970s several reports noted the high incidence of sudden death in diabetic patients who had severe autonomc neuropathy."6 In some cases death was attributed to cardiorespiratory arrest, but in the overwhelming majority the cause of death was not identified.This prompted us to investigate changes in QT interval during static (quiet lying, sitting, and standing) and dynamic (Valsalva manoeuvre) conditions in groups of diabetic patients with different degrees of autonomic neuropathy. Patients and methodsThe diabetic patients (men aged (mean (SD)) 42 (12)

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Aims/hypothesisThe aim was to evaluate the efficacy and safety of transcutaneous frequency-modulated electromagnetic neural stimulation (frequency rhythmic electrical modulation system, FREMS) as a treatment for symptomatic peripheral neuropathy in patients with diabetes mellitus.MethodsThis was a double-blind, randomised, multicentre, parallel-group study of three series, each of ten treatment sessions of FREMS or placebo administered within 3 weeks, 3 months apart, with an overall follow-up of about 51 weeks. The primary endpoint was the change in nerve conduction velocity (NCV) of deep peroneal, tibial and sural nerves. Secondary endpoints included the effects of treatment on pain, tactile, thermal and vibration sensations. Patients eligible to participate were aged 18–75 years with diabetes for ≥1 year, HbA1c <11.0% (97 mmol/mol), with symptomatic diabetic polyneuropathy at the lower extremities (i.e. abnormal amplitude, latency or NCV of either tibial, deep peroneal or sural nerve, but with an evocable potential and measurable NCV of the sural nerve), a Michigan Diabetes Neuropathy Score ≥7 and on a stable dose of medications for diabetic neuropathy in the month prior to enrolment. Data were collected in an outpatient setting. Participants were allocated to the FREMS or placebo arm (1:1 ratio) according to a sequence generated by a computer random number generator, without block or stratification factors. Investigators digitised patients’ date of birth and site number into an interactive voice recording system to obtain the assigned treatment. Participants, investigators conducting the trial, or people assessing the outcomes were blinded to group assignment.ResultsPatients (n = 110) with symptomatic neuropathy were randomised to FREMS (n = 54) or placebo (n = 56). In the intention-to-treat population (50 FREMS, 51 placebo), changes in NCV of the three examined nerves were not different between FREMS and placebo (deep peroneal [means ± SE]: 0.74 ± 0.71 vs 0.06 ± 1.38 m/s; tibial: 2.08 ± 0.84 vs 0.61 ± 0.43 m/s; and sural: 0.80 ± 1.08 vs −0.91 ± 1.13 m/s; FREMS vs placebo, respectively). FREMS induced a significant reduction in day and night pain as measured by a visual analogue scale immediately after each treatment session, although this beneficial effect was no longer measurable 3 months after treatment. Compared with the placebo group, in the FREMS group the cold sensation threshold was significantly improved, while non-significant differences were observed in the vibration and warm sensation thresholds. No relevant side effects were recorded during the study.Conclusions/interpretationFREMS proved to be a safe treatment for symptomatic diabetic neuropathy, with immediate, although transient, reduction in pain, and no effect on NCV.Trial registrationClinicalTrials.gov NCT01628627FundingThe clinical trial was sponsored by Lorenz Biotech (Medolla, Italy), lately Lorenz Lifetech (Ozzano dell’Emilia, Italy).Electronic supplementary materialThe online version of this article (doi:10.1007/s00125-012-2795-7) conta...

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