Downloaded from aim.bmj.com on June 5, 2014 - Published by group.bmj.

com

Original paper

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 Jude1,5

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.

242

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 nonsignificant 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 associated 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 development or progression of diabetic peripheral
neuropathy is available.3 Treatment, therefore, 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 capsaicin can lead to a reduction in pain
score, the effectiveness of topical treatments is yet to be determined.5
Acupuncture has been shown to be
effective in treating back pain and shoulder
pain.6 7 There is also some evidence that it
may be beneficial in the management of
peripheral neuropathy and painful neuropathy in diabetes.8–10 However, the evidence to support this use of acupuncture is
deficient because of poor methodology,

Garrow AP, et al. Acupunct Med 2014;32:242–249. doi:10.1136/acupmed-2013-010495

doi:10. The acupuncture treatments were carried out by any one of three trained acupuncturists who were either members of the British Acupuncture Council or the Acupuncture Association of Chartered Physiotherapists.25–2 cm). For example.bmj.19 The depth of needle insertion varied according to point. not having previously received acupuncture treatment for DPN.8 9 17 18 The point location and depth of needle insertion were based on traditional acupuncture methods and good clinical practice. Two of the acupuncturists (BV and LFW) were UK trained with nearly 10 years’ experience of treating patients in the NHS and in private practice. and to derive point and variability estimates to inform future sample size calculations. impaired light touch (10 g monofilament)15 or a vibration perception threshold on either foot >25 V.5–1. de qi and blood stagnation. KI3. SP6. a computer-generated randomised list of numbers was prepared allocating participants to receive either real or sham acupuncture. Garrow AP. with a clinical diagnosis of DPN and taking a prescribed drug for DPN were identified from primary and secondary care patient databases and invited to attend a screening visit held in the recruiting centre of a local district general hospital.13 The objective of this sham-controlled single-blind RCT was to examine the practicality and feasibility of integrating acupuncture into the management of lower limb painful neuropathy in diabetes. She has also been a senior lecturer in traditional Chinese medicine and acupuncture since 2001.com on June 5. The allocation was placed inside sequentially ordered sealed opaque envelopes. The study also considered a range of different outcomes for their suitability for a future definitive clinical trial.com Original paper variability of treatment protocols and small sample sizes. the sham needle. a meta-analysis of 29 acupuncture RCTs in the treatment in chronic pain showed that acupuncture produces small but clinically relevant reductions in pain. being free of foot ulcers at the start of the study and having signs of peripheral sensory neuropathy. but was usually 0. aged between 18 and 80 years. having at least one palpable pedal pulse per foot.bmj. PATIENTS AND METHODS Sixty-five patients with type 1 or type 2 diabetes. A total of five standardised acupuncture points on the foot and lower limb of each leg (total 10) were used in the study. most studies have concentrated on the analgesic properties of acupuncture. Study design Before the recruitment. 243 . To reduce the risk of observer bias. Other inclusion criteria were patients taking a prescribed drug for their neuropathic pain. Acupunct Med 2014. These acupuncture points have also commonly been used in other similar clinical studies.16 Data were collected between July 2008 and March 2010. The study was approved by the north west ethics committee (ref: 08/H1011/16A) and all patients gave written informed consent before taking part in the study.20 In brief.Downloaded from aim. the acupuncture practitioners were discouraged from discussing the treatments or previous results with the patients. ISRCTN Number: 39740785. SP10 and ST36 (figure 1). LR3.Published by group. both the real and sham disposable needles look identical. 2014 . The chosen points are based on traditional Chinese medicine diagnosis for diabetes and neuropathy—that is. The treatment allocation was revealed to the acupuncturists out of sight of the participants to ensure blinding. A series of training sessions were carried out before the start of the study to allow practitioners to become familiar with the sham acupuncture devices and to standardise point location and technique. Weekly afternoon clinics were arranged allowing sufficient time for the collection of study outcome data and for the acupuncture treatments to be completed. et al.5 cun (about 0. which has been validated for use in randomised clinical trials. defined as the absence of any two of sharp/blunt sensations (measured using a NeuroTip)14. Korea).32:242–249.11 12 To date. opened only after enrolment.1136/acupmed-2013-010495 Figure 1 Acupuncture points. The third practitioner (MX) was trained in integrated medicine in China and has worked as a consultant doctor in Western and Chinese medicine. The sham device used in the study was the Park sham device (Dong Bang Acupuncture Inc. kidney deficiency. measured with a neurosthesiometer.

All patients were provided with a patient information sheet which informed them that they were taking part in a randomised trial in which they could be treated with real acupuncture or an inactive treatment that looked like real acupuncture. the number of adverse events and losses to follow-up. 0.1136/acupmed-2013-010495 . The instrument was developed specifically for use in studies of complementary medicine24 and collects information on symptoms considered by the patient to be important. which produces three subscale scores: physical health score.7 considered large effects.23 The instrument contains questions pertaining to five neuropathic sensory disturbance domains and two sensory examination items. Last observation carried forward was used to replace missing values. analyses of covariance were carried out. Sleep quality was assessed using the Sleep Problem Scale (SPS). 2014 .com on June 5. doi:10. a primary outcome measure and a formal power calculation were not required. The proportions in each group showing at least a 25% improvement in LANSS and VAS pain scores were also compared.22 Although originally developed as a screening instrument. a consultant in diabetes.Published by group. the needles remained in place for 30 min and both real and sham needles were manipulated after 15 min.bmj. to determine whether the event was related to the acupuncture treatment.4 considered small effects.26 At each study visit. the LANSS has been used as an outcome measure in previous neuropathic pain RCTs. is blunt and slides into the handle rather than penetrating the skin when the needle is tapped.29 244 Adverse event reporting At the beginning of each study visit.com Original paper however. We did not ask patients whether they felt de qi to avoid the risk of patients in the placebo group becoming unblinded to their treatment allocation.30 Group differences between the means are presented together with their 95% CIs.19 The intervention consisted of a total of 10 weekly sessions during which diabetes and blood pressure management continued as normal.Downloaded from aim. including those taken for DPN. SPS and SF-36 were completed at the baseline visit. The analyses were conducted on an ‘intention-to-treat’ basis.7 considered moderate and >0. The primary Garrow AP.32:242–249. the LANSS pain scale. a mental health score and a bodily pain score (BPS). a short standardised measure of sleep disturbance. Lower limb pain intensity was measured on a 100 mm Visual Analogue Scale (VAS). week 5 and week 10. As outcome values were likely to be strongly correlated with baseline values. For each of the outcome measures.25 General health status was measured using the 36-item Short Form 36 Health Survey (SF-36). a sliding plastic tube is adhered to each of the acupuncture points to mask the allocation of needles from the patients. Baseline characteristics are presented using means and SDs and categorical data are presented as proportions. Before needling. Outcome measures Power calculation and sample size As this was a feasibility study.31 RESULTS Study sample All patients were enrolled into the study within the 18-month target recruitment period. Assessments of neuropathic pain were carried out using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale. Although the main focus of this study was to examine the benefits of acupuncture for the treatment of DPN. an effect size estimate comparing real and sham acupuncture groups was calculated as the difference between the 10-week mean values divided by the pooled SD. χ2 Tests were performed on categorical data and t tests on continuous variables. a power calculation was not required. They were also informed that they would not be told which treatment they had received until all study visits had been completed. The protocol permitted changes in medication as required. which is in keeping with normal acupuncture practice. Any adverse events were recorded on the case report forms and reported to the principal investigator (EBJ) and the research and development department according to the hospital’s standard operating procedures. and the Measure Yourself Medical Outcome Profile (MYMOP) was used to measure changes in health over time.4–0. As this was a feasibility study. Our target sample of 60 people was based on the recommendations of Lancaster et al. The maximum score on the LANSS scale is 24. In addition. there is now some evidence and growing interest in the potential benefits of acupuncture in the management of hypertension. patients were provided with a telephone number to report any concerns they had about the study. et al. all patients had their blood pressure taken before and after treatment and completed a copy of the MYMOP and a VAS for pain.27 28 As resting blood pressure is routinely measured in the diabetic clinic.21 After insertion. Acupunct Med 2014. Outcomes selected for this study were based on measures used in previous studies of DPN. with values ≤0. All patients with suspected adverse events received a referral appointment with the study principal investigator. Statistical analysis We considered the availability and willingness of patients to be recruited. systolic and diastolic blood pressures were recorded before each acupuncture treatment. with scores >12 indicating that neuropathic mechanisms are likely to be contributing to patients’ pain. In addition.bmj. patients were asked if they had had any side effects as a result of the acupuncture treatment.

LANNS. suggesting that it is a safe treatment. make the initial contact with the patients and send out the patient information sheets.0) 75 (9.3) 4.com Original paper care medical staff and administrators supported the project and readily agreed to identify potentially suitable patients from the databases.1) Male (%) 71 67 Type 2 diabetes (%) 95 96 Diabetes duration years (mean. In contrast. which was considered unrelated to the study. No Table 1 Baseline characteristics of patients randomised into groups who received real or sham acupuncture treatment Characteristics Sham (n=21) Active (n=24) Age (mean. Sham group participants also showed improvements in VAS score. Garrow AP.5) *Light touch sensation assessed using a 10 g monofilament. The patients who received active acupuncture were slightly older and also had higher levels of sensorimotor impairment. IQR) 13 (7–20) 12 (6–16) MYMOP (mean. SD) 131 (19. et al. In the active acupuncture group. ‡Vibration perception assessed using a neurothesiometer. One person in the sham group stopped taking their medication owing to low blood pressure.4%) in the group receiving active treatment showed at least a 25% improvement in VAS pain intensity score compared with four of 31 (12. SD) 63 (10. The baseline demographic and clinical characteristics are displayed in table 1. Leeds Assessment of Neuropathic Symptoms and Signs. MYMOP.7) (mean.Downloaded from aim. resting blood pressure and SPS but these were much smaller than those found in the active treatment group. Six of 24 (25%) patients in the active acupuncture group showed at least a 25% improvement compared with four of 21 (19%) in the sham group.bmj. The largest change seen in the sham group was a 6. IQR) 70 (50–80) 78 (70–90) LANNS pain scale (median. we were unable to determine whether these differences influenced the results of the study.4 (1. SD) 78 (10. The study was carried out on a fairly typical sample of patients with long-term DPN who might be found in primary and secondary care. Acupuncture was also well tolerated by patients with few if any side effects.8) 68 (11.2) 137 (14.4) White British (%) 81 100 Married (%) 76 79 Retired (%) 52 63 At least one palpable pedal pulse on either 100 100 foot (%) Bilateral impaired sharp/blunt sensation (%)* 89 96 Bilateral impaired light touch sensation (%)† 30 29 Vibration perception threshold (VPT) (right) 27 (8. Blood Pressure.1) 33 (10. doi:10. those in the sham group showed a 7. Two patients in the group receiving active acupuncture had their blood pressure medication stopped owing to low blood pressure and two patients had their medication dose increased. resulting in 59 being enrolled into the study. SPS and diastolic blood pressure. Thirteen of 28 (46.2 (7. three adverse events were reported resulting in patients withdrawing from the study. the LANSS score improved by an average of 2.32:242–249. Bias resulting from inadequacies in blinding could lead to exaggerated 245 .Published by group. Because of the small numbers. In the sham group. Patients in the active acupuncture group showed a 16% improvement in LANSS score after acupuncture. Overall.2) 12.3) Diastolic BP (mean.9%) in the sham treatment group. In the group receiving active treatment. 2014 . Adverse events In total. related to a chronic heart condition. and another withdrew as she felt that the acupuncture exacerbated her leg pain. SD)‡ VAS pain score (median. Of the 65 patients considered eligible.0 (9. Forty-five (76%) patients completed a baseline and final assessment: 24 (53%) received active acupuncture and 21 (47%) sham acupuncture treatment.bmj. Visual Analogue Scale. one participant withdrew because she developed a localised swelling in her leg. IQR) 15 (10–19) 14 (9–19) Sleep Problem Scale (median. DISCUSSION This is one of very few studies that have investigated the role of acupuncture in the management of lower limb DPN. improvements over 10 weeks were found for VAS pain intensity. †Impaired sharp blunt sensation assessed using a NeuroTip. BP. the non-completion rate was in line with expectation but found to be higher amongst those allocated to receive sham treatment. In the analysis of covariance. Improvements were also seen for SF-36 physical component and BPS and systolic blood pressure. one participant developed chest pains while undergoing acupuncture treatment. A total of four patients in the active group and 10 patients in the sham group failed to complete the study (figure 2). six refused.3 unit improvement in SF-36 BPS (table 2). Acupunct Med 2014.32 This study has provided a model of how acupuncture can be easily incorporated into the routine management of people with DPN.1 points more in the treatment group than the sham group which would be considered as a moderate treatment effect (table 3). SD) 4.2) Systolic BP (mean. MYMOP score. VAS. None of the patients changed their neuropathic pain medication during the 10-week study period.2% deterioration in LANSS symptoms (table 2).1136/acupmed-2013-010495 incidents of infections associated with the administration of acupuncture were seen or reported.com on June 5. Measure Yourself Medical Outcome Profile. This report follows STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) guidelines. SD) 11.1 (1.

Observed improvements in the active acupuncture group.bmj. The study included only 59 participants and therefore some of the results may be susceptible to type II errors —that is. 2014 . participants were asked whether they thought they had received active or sham treatment. treatment effects. Our findings showing small to moderate treatment effects of active acupuncture are comparable with randomised studies of headache and low back pain. however.Published by group. Forty per cent in the active acupuncture group thought they had received sham treatment and 42% in the sham group thought they received real treatment. which shows only small changes in eight of the nine outcome measures in the sham group between baseline and 10 weeks.32:242–249. which showed a small six-unit improvement over 10 weeks.com Original paper Figure 2 Flow chart of patients through the trial. over 90% of patients had loss of sharp/blunt and light touch sensation in their lower limbs (table 1).1136/acupmed-2013-010495 . suggest that acupuncture may have a role in the treatment of some of the unpleasant symptoms associated with DPN.36 In this study. This result may occur because the BPS items relate to general pain changes in the Garrow AP. et al. results which suggest that the sham treatment was relatively therapeutically inactive.Downloaded from aim. therefore. These data suggest that our results were not unduly biased owing to any blinding effects. but not in the sham group.bmj. The exception to this was the SF-36 BPS.33 In a post hoc analysis 3 months after their final treatment. Evidence for this is provided in table 2. the sample size was too small for the observed differences between groups to appear statistically significant. doi:10.34 35 246 The results are also consistent with the findings of a recent systematic review of the analgesic effects of acupuncture in chronic pain. that the study patients would have been able to differentiate between real or sham needles. Acupunct Med 2014.com on June 5. it is unlikely.13 It has previously been suggested that nonpenetrating sham needles could cause some level of sensory stimulation when the needles are tapped and rotated and therefore stimulate the acupuncture points.

8) Results are shown as mean (SD) or mean (95% CI).7 (16.8 to 17.Published by group.3) 6.14) 4. As our results suggested improvements in a variety of troublesome symptoms.8) 10-Week follow-up 75 (9.3 (19.3) 33.6) −1.4) Resting systolic BP Baseline 132 (17.2 to −0.2 (−4.0) 10-Week follow-up 31.5 to 2.1 (9.4) −2.8 to 8.6) 138 (14.0) 0.4 to −0.3 to 5.3 to 1.8) −0.67 (−2.6 (−0.3) Change score (95% CI) 1.5) 7 (−4 to 19) MYMOP scores Baseline 4.1 to 1. Acupunct Med 2014.2) −0. LANNS. previous month and therefore BPS is likely to reflect the episodic nature of chronic musculoskeletal pain commonly found in people of this age.7 (13.5) Change score (95% CI) −0.0) 14.3) 0.2 (−10.3 (6.2) 1. et al.1) −0.2) −5.8 (−7. doi:10. however. 247 .4) −0.05) Change score (95% CI) −0.2 to 0.6 (7.9 (20.4 (−7.4 (1.6 (−2.9) −2.8 to 5.3) 10-Week follow-up 33.1136/acupmed-2013-010495 This study has shown that acupuncture can be successfully incorporated into the management of patients with DPN.8 to 10.0) 3. they do support the inclusion of blood pressure as an outcome in future acupuncture studies.6 (8.5 to 1.85 (0.com on June 5.9) −2.4 to −0.7 to 15.7) 1.5 (−4.1) 12.2 (−5.bmj.4 (−6.1 to 7.1 (12.2) VAS scores Baseline 67 (19) 73 (24) 6 (−5 to −17) 10-Week follow-up 62 (23) 58 (26) −4 (−17 to 9) Change score (95% CI) −5 (−11 to 1.5) 2.82) 2.6 (−2.2) 6.7) 2.2 (1.7) −1.3 to 11.com Original paper Table 2 Changes in outcomes between baseline and 10-weeks group differences (mean and SD) Outcome measures Sham Active Difference (95% CI) LANNS scores Baseline 15.4 to −0. in future studies we would recommend the adoption of additional measures to reduce the non-attendance rate.7 (12.4) 10.7) 133.7 to 3.4) 70 (10.7) Change score (95% CI) −0.4 to −0.5 (10.4 10-Week follow-up 35.6) 10-Week follow-up 16.1 to 22.77) Change score (95% CI) −0. SF-36.2 (20.1 (−1.7 to 10.2 (7.89 (−1. were reported in the findings of a systematic review of 11 studies.7 to 1.7) 75 (9.42 (−3.2 (6.37 Our results also suggest that the 10-week course of acupuncture may lead to a 5 mm Hg reduction in diastolic blood pressure.6 to 10. Visual Analogue Scale.1 (−1. Although the attendance was in line with expectations. VAS.1 (−3.bmj.2 (1.8 (14.8 (6. such as the use of reminder texts and telephone calls.4 to 4.2) 13.4) Sleep Problem Scale Baseline 13.4 to 1.42) −0. 2014 .8) 31.7 (−1.9 (−4.6) 10-Week follow-up 13.9 to 0.Downloaded from aim.5) SF-36 mental component score Baseline 36.9) 37.71) 10-Week follow-up 4. Blood Pressure.6 (−6. future studies should collect information on the different signs and symptoms associated with DPN rather than concentrating on detecting unit reductions in pain intensity.5) −5.5 (−5.8) SF-36 bodily pain score Baseline 27.7 to 3.8 to 8.19) Change score (95% CI) −0.3 (6.6) 39.7 (−6. Similar results.43 to 0.4) Resting diastolic BP Baseline 77 (8.5 (−5.4) 9. Garrow AP. The evidence for the efficacy of acupuncture in controlling blood pressure is controversial and inconclusive.7 (27.5 (−3.7 to 17.1) 3. BP.2 (−10.2) 4.7 (0.9 (9.2 (−10.2) 0.74) −5.2 (7.2) −2.5 to 2.3 (−4.97 (−4.4) 40. MYMOP.2 (14.7 (−6.3) −0.0 to 2.2) SF-36 physical component score Baseline 32.58 to 0.4 (−12.1) Change score (95% CI) −2.1) −15 (−26 to −3.7) −3.03 (−0.3 (−4.1 to 9.6 to 1.2) 2. Measure Yourself Medical Outcome Profile.4) Change score (95% CI) 6. Leeds Assessment of Neuropathic Symptoms and Signs.7) 1.2 (7.5 to 1.3) 4.8 (−1.2 to 5.1) 10-Week follow-up 131.06 (−2.3 (1.1 to 0. Short Form 36.07 (−0.1 to 5.32:242–249.1 (−5.5 to 2.9) 40.003 (−0.16 (−5.1 (−2.38 Although our results should be treated with caution.

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