Role of acupuncture in the management of diabetic painful neuropathy (DPN): a pilot RCT Adam P Garrow, 1,2 Mei Xing, 1,3 Joanne Vere, 1 Barbara Verrall, 1 LiFen Wang, 1,4 Edward B Jude 1,5 1 Tameside Hospital NHS Foundation Trust, Diabetes Centre, Tameside General Hospital, Ashton-Under-Lyne, Greater Manchester, UK 2 The University of Manchester, School of Nursing, Midwifery and Social Work, Manchester, Greater Manchester, UK 3 The University of Salford, School of Health Sciences, Salford, UK 4 Christie Hospital NHS Trust, Manchester, Greater Manchester, UK 5 School of Clinical and Laboratory Sciences, The University of Manchester, Manchester, Greater Manchester, UK Correspondence to Dr Edward Bernard Jude, Tameside Hospital NHS Foundation Trust, Diabetes Centre, Tameside General Hospital, Ashton-Under-Lyne, Greater Manchester OL6 9RW, UK; edward.jude@tgh.nhs.uk Received 17 November 2013 Revised 7 February 2014 Accepted 10 February 2014 Published Online First 21 March 2014 To cite: Garrow AP, Xing M, Vere J, et al. Acupunct Med 2014;32:242–249. ABSTRACT Aims To examine the role of acupuncture in the treatment of diabetic painful neuropathy (DPN) using a single-blind, placebo-controlled RCT and to collect data that would be required in a future definitive study of the efficacy of acupuncture in DPN. Methods 45 patients were allocated to receive a 10-week course either of real (53%) or sham (47%) acupuncture. Five standardised acupuncture points on the lower limb of each leg were used in the study: LR3, KI3, SP6, SP10 and ST36. Outcome measures included the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale, lower limb pain (Visual Analogue Scale, VAS); Sleep Problem Scale (SPS); Measure Yourself Medical Outcome Profile (MYMOP); 36-item Short Form 36 Health Survey and resting blood pressure (BP). Results Over the 10-week treatment period, small improvements were seen in VAS -15 (-26 to -3.5), MYMOP -0.89 (-1.4 to -0.3), SPS -2.5 (-4.2 to -0.82) and resting diastolic BP -5.2 (-10.4 to -0.14) in the true acupuncture group. In contrast, there was little change in those receiving sham acupuncture. A moderate treatment effect in favour of active acupuncture was detected in MYMOP scores -0.66 (-0.96 to -0.35) but non- significant effect sizes in LANSS Pain Scale -0.37 (-2.2 to 1.4), resting diastolic BP -0.50 (-3.0 to 1.99) and the SPS -0.51 (-2.2 to 1.16). Conclusions We have demonstrated the practicality and feasibility of acupuncture as an additional treatment for people with DPN. The treatment was well tolerated with no appreciable side effects. Larger randomised trials are needed to confirm the clinical and cost-effectiveness of acupuncture in the treatment of DPN. Trial registration number ISRCTN number: 39740785. INTRODUCTION Diabetic painful neuropathy (DPN) is a distressing and disabling complication of diabetes mellitus. A recent study showed that nearly one-third of patients with type 2 diabetes have DPN. 1 The causes of this condition are not yet fully understood, but age, duration of diabetes and diabetes control have all been shown to be asso- ciated with DPN. 1 Typical symptoms include nocturnal burning or shooting pains in the legs and feet, indicating impairment or damage to small nerve fibres. Symptoms often persist for years and are associated with disrupted sleeping patterns and a poor quality of life. 2 No treatment that can reverse the develop- ment or progression of diabetic peripheral neuropathy is available. 3 Treatment, there- fore, relies on the use of medication to manage the pain. The most commonly prescribed drugs for DPN are tricyclic antidepressants and anticonvulsants. Clinical trials have shown these drugs to be effective in controlling the pain but they have important side effects, including dizziness and nausea. Up to two-thirds of patients may have at least one side effect from taking these drugs, of which 15% will be serious enough for them to stop taking the drugs, leaving them with no effective treatment. 4 A number of other, non-pharmacological treatments have been tried, including the application of topical capsaicin and opsite film dressing. Although there is some evidence that cap- saicin can lead to a reduction in pain score, the effectiveness of topical treat- ments is yet to be determined. 5 Acupuncture has been shown to be effective in treating back pain and shoulder pain. 67 There is also some evidence that it may be beneficial in the management of peripheral neuropathy and painful neur- opathy in diabetes. 8–10 However, the evi- dence to support this use of acupuncture is deficient because of poor methodology, Original paper 242 Garrow AP, et al. Acupunct Med 2014;32:242–249. doi:10.1136/acupmed-2013-010495