Acupuncture in diabetic peripheral neuropathy-protocol for the randomized, multicenter ACUDPN trial.

BACKGROUND: Acupuncture is used to treat patients with diabetic peripheral neuropathy; however, the evidence is unclear. We present the design and methodology of the ACUDPN (ACUpuncture in Diabetic Peripheral Neuropathy) trial, which investigates the effectiveness of acupuncture for the treatment of diabetic peripheral neuropathy (DPN) symptoms. The aim of this study is to investigate whether acupuncture is effective for the treatment of DPN symptoms. METHODS: This study is a two-armed, randomized, controlled, parallel group, open-label, confirmatory, multicenter trial (8-week intervention period plus 16 weeks of follow-up). Physicians in outpatient units in Germany who specialize in acupuncture treatment will treat 110 diabetes type II patients with clinical symptoms of peripheral neuropathy in the feet and legs with signs of neuropathy according to nerve conduction testing. The patients will be randomized in a 1:1 ratio to one of the following two groups: (a) semi-standardized acupuncture plus routine care or (b) routine care alone. Acupuncture will consist of 12 treatments per patient over 8 weeks. The primary outcome will be the overall DPN-related complaints in the extremities after 8 weeks as measured by the Visual Analog Scale (VAS). Further outcome measures will include DPN-related pain, the Neuropathic Pain Symptom Inventory (NPSI), Diabetic Peripheral Neuropathic Pain Impact (DPNPI) scores, and nerve conduction parameters of the sural nerve at weeks 8, 16, and 24. DISCUSSION: The results of this trial will be available in 2021 and will help clarify whether acupuncture can be considered effective for the treatment of DPN with regard to the subdimensions of the neuropathic clinical picture. TRIAL REGISTRATION: ClinicalTrials.gov NCT03755960 . Registered on 11 August 2018.

Physician and treatment characteristics in a randomised multicentre trial of acupuncture in patients with osteoarthritis of the knee.

OBJECTIVE: The aim of this paper is to describe the treatment and physician characteristics in a randomised trial of acupuncture for osteoarthritis of the knee. DESIGN: Three-armed, randomised, controlled multicentre trial with 1-year follow-up. SETTING: Twenty-eight outpatient centres in Germany. INTERVENTIONS: A total of 294 patients with osteoarthritis of the knee were randomised to 12 sessions of semi-standardised acupuncture (at least 6 local and 2 distant points needled per affected knee from a selection of predefined points, but individual choice of additional body or ear acupuncture points possible), 12 sessions of minimal acupuncture (superficial needling of at least 8 of 10 predefined, bilateral, distant non-acupuncture points) or a waiting list control (2 months no acupuncture). OUTCOME: Participating trial physicians and interventions. RESULTS: Forty-seven physicians specialised in acupuncture (mean age 43+/-8 years, 26 females) provided study interventions in 28 outpatient centres in Germany. The median duration of acupuncture training completed by participating physicians was 350 h (range 140-2508). The total number of needles used was 17.4+/-4.8 in the acupuncture group compared to 12.9+/-3.3 in the minimal acupuncture group. In total, 39 physicians (83%) stated that they would have treated patients in either a similar or in exactly the same way outside of the trial, whereas 7 (15%) stated that they would have treated patients differently (1 missing). CONCLUSIONS: Our documentation of the trial interventions shows that semi-standardised acupuncture strategy represents an acceptable compromise for efficacy studies. However, a substantial minority of participating trial physicians stated that they would have treated patients differently outside of the trial.

Acupuncture in patients with osteoarthritis of the knee: a randomised trial.

BACKGROUND: Acupuncture is widely used by patients with chronic pain although there is little evidence of its effectiveness. We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with osteoarthritis of the knee. METHODS: Patients with chronic osteoarthritis of the knee (Kellgren grade < or =2) were randomly assigned to acupuncture (n=150), minimal acupuncture (superficial needling at non-acupuncture points; n=76), or a waiting list control (n=74). Specialised physicians, in 28 outpatient centres, administered acupuncture and minimal acupuncture in 12 sessions over 8 weeks. Patients completed standard questionnaires at baseline and after 8 weeks, 26 weeks, and 52 weeks. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index at the end of week 8 (adjusted for baseline score). All main analyses were by intention to treat. RESULTS: 294 patients were enrolled from March 6, 2002, to January 17, 2003; eight patients were lost to follow-up after randomisation, but were included in the final analysis. The mean baseline-adjusted WOMAC index at week 8 was 26.9 (SE 1.4) in the acupuncture group, 35.8 (1.9) in the minimal acupuncture group, and 49.6 (2.0) in the waiting list group (treatment difference acupuncture vs minimal acupuncture -8.8, [95% CI -13.5 to -4.2], p=0.0002; acupuncture vs waiting list -22.7 [-27.5 to -17.9], p<0.0001). After 52 weeks the difference between the acupuncture and minimal acupuncture groups was no longer significant (p=0.08). INTERPRETATION: After 8 weeks of treatment, pain and joint function are improved more with acupuncture than with minimal acupuncture or no acupuncture in patients with osteoarthritis of the knee. However, this benefit decreases over time.

[Standardized acupuncture therapy in patients with ocular hypertension or glaucoma--results of a prospective observation study]. / Standardisierte Akupunkturtherapie bei Patienten mit okulärer Hypertension oder Glaukom--Ergebnisse einer prospektiven Beobachtungsstudie.

BACKGROUND: Glaucoma is one of the most frequent causes of blindness worldwide. The main risk factor for this optic nerve disease is high individual intraocular pressure. OBJECTIVE: The aim of this observational study was to investigate the effect of acupuncture therapy on individual internal eye pressure in glaucoma and ocular hypertension patients. MATERIAL AND METHODS: 18 patients (11 female; age 38-75 years) with a diagnosis of glaucoma (n = 3) or ocular hypertension (n = 15) were included in this study. Patients received one session of a standardized acupuncture treatment (acupuncture points Liv 3, Li 4, Gb 37). Target parameters were the change in intraocular pressure and the compatibility of treatment. Measurements of intraocular pressure were carried out 15 min before, 15 min after, and 24 h after acupuncture. RESULTS: Compared with the mean intraocular pressure in both eyes before treatment (21.94 +/- 2.4 mm Hg), patients showed a significant decrease 15 min after treatment (-2.67 +/- 1.34 mm Hg) as well as 24 h after treatment (-2.5 +/- 2.13 mm Hg). There was no significant difference between the mean intraocular pressure at 15 min after treatment and at 24 h after treatment. No adverse events were observed. CONCLUSION: The results of this study indicate that acupuncture therapy may be a valid treatment option for glaucoma and ocular hypertension patients. Additional and, if possible, randomized studies investigating the effectiveness of acupuncture in the treatment of the above-mentioned conditions still need to be conducted.

Acupuncture Randomized Trials (ART) in patients with chronic low back pain and osteoarthritis of the knee - design and protocols.

BACKGROUND: We report on the study design and protocols of two randomized controlled trials (Acupuncture Randomized Trials = ART) that investigate the efficacy of acupuncture in the treatment of chronic low back pain and osteoarthritis of the knee, respectively. OBJECTIVE: To investigate whether acupuncture is more efficacious than (a) no treatment or (b) minimal acupuncture in the treatment of low back pain and osteoarthritis. DESIGN: Two randomized, controlled, multicenter trials with three treatment arms and a total follow-up time of 52 weeks. SETTING: 30 practitioners and outpatient units in Germany specialized in acupuncture treatment. PATIENTS: 300 patients will be included in each study. In the low back pain trial, patients will be included according to clinical diagnosis. In the osteoarthritis pain trial, patients will be included according to the American College of Rheumatology criteria. INTERVENTIONS: Patients are randomly assigned to receive either (1) semi-standardized acupuncture (150 patients), (2) minimal acupuncture at non-acupuncture points (75 patients), or (3) no treatment for two months followed by semi-standardized acupuncture (75 patients, waiting list control). Acupuncture treatment consists of 12 sessions per patient over a period of 8 weeks. MAIN OUTCOME MEASURE: The main outcome measure is the difference between baseline and the end of the 8-week treatment period in the following parameters: pain intensity as measured by a visual analogue scale (VAS; 0-100 mm) in the low back pain trial and by the Western Ontario and McMaster Universities Osteoarthritis Score (WOMAC) in the osteoarthritis trial. OUTLOOK: The results of these two studies (available in 2004) will provide health care providers and policy makers with the information needed to make scientifically sound assessments of acupuncture therapy.

MMPI personality profiles in patients with primary headache syndromes.

The role of psychological factors in the course of primary headache syndromes is still controversial. Using the Minnesota Multiphasic Personality Inventory (MMPI) we investigated the personality profiles of 434 headache patients (160 migraineurs, 95 with tension type headache, 30 with cluster headache and 149 with combination headache) in accordance with the IHS criteria. In the first three MMPI scales (hypochondria, depression, hysteria) there was a slight increase in T mean values to over 60, but still in the range of two standard deviations of the normal population. There were no statistically significant differences between the four headache groups and between patients with and without analgesic abuse. It was impossible to distinguish headache groups on the basis of their personality profiles by means of reclassification with discriminant analysis. In a cluster analysis, patients with cluster headache showed the highest number (20%) of abnormalities, but also the highest percentage (13%) of completely normal results. Our findings--a cross section analysis of personality profiles--contradict many other MMPI-based studies.

Acupuncture and Chinese herbal medicine in the treatment of patients with seasonal allergic rhinitis: a randomized-controlled clinical trial.

BACKGROUND: Patients with allergic rhinitis (AR) increasingly use complementary medicine. The aim of this study was to determine whether traditional Chinese therapy is efficacious in patients suffering from seasonal AR. METHODS: Fifty-two patients between the ages of 20 and 58 who had typical symptoms of seasonal AR were assigned randomly and in a blinded fashion to (i) an active treatment group which received a semi-standardized treatment of acupuncture and Chinese herbal medicine, and (ii) a control group which received acupuncture applied to non-acupuncture points in addition to a non-specific Chinese herbal formula. All patients received acupuncture treatment once per week and the respective Chinese herbal formula as a decoction three times daily for a total of 6 weeks. Assessments were performed before, during, and 1 week after treatment. The change in severity of hay fever symptoms was the primary outcome measured on a visual analogue scale (VAS). RESULTS: Compared with patients in the control group, patients in the active treatment group showed a significant after-treatment improvement on the VAS (P = 0.006) and Rhinitis Quality of Life Questionnaire (P = 0.015). Improvement on the Global Assessment of Change Scale was noted in 85% of active treatment group participants vs 40% in the control group (P = 0.048). No differences between the two groups could be detected with the Allergic Rhinitis Symptom Questionnaire. Both treatments were well-tolerated. CONCLUSIONS: The results of this study suggest that traditional Chinese therapy may be an efficacious and safe treatment option for patients with seasonal AR.