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Factors that influence the applicability of sham needle in acupuncture trials: two randomized, single-blind, crossover trials with acupuncture-experienced subjects.

OBJECTIVES: In recent years the retractable type of sham needle has been anticipated to be a possible solution for masking patients in acupuncture research. However, this needle has been intended mainly for acupuncture-naïve subjects. The authors' goal in this study was to assess the validity of the retractable type of sham needle. METHODS: The authors conducted two randomized, single-blind, crossover trials with acupuncture-experienced subjects. Different acupuncture points were used in each trial (a LI-4 trial and a BL-23 trial). The subjects received two sessions of different stimulations in each trial. A Park Sham Needle was used in one session, a genuine acupuncture needle in the other. RESULTS: In the LI-4 trial, all of the 21 subjects (100%) felt penetration with the genuine needle, but only 7 of the 20 subjects (35%) felt a similar sensation with the sham needle (P=0.0002). Fifteen of the 21 subjects (71%) felt a dull sensation with the genuine needle, but only 4 of the 20 subjects (20%) felt a similar sensation with the sham needle (P=0.01). In the BL-23 trial, 14 of the 20 subjects (70%) felt penetration with the genuine needle and 10 of the 20 subjects (50%) felt "penetration" with the sham needle (P=0.39). Eight of the 20 subjects (40%) felt a dull sensation with the genuine needle and 2 of the 20 subjects (10%) did with the sham needle (P=0.109). CONCLUSIONS: Potential factors that influence the applicability of "placebo" needling include not only inter-tester variability but also the patient's knowledge and experience of acupuncture, acupuncture point selection, the visual impact of needling, and so on.

Acupuncture Therapy↗

Randomised trial of acupuncture compared with conventional massage and "sham" laser acupuncture for treatment of chronic neck pain.

OBJECTIVES: To compare the efficacy of acupuncture and conventional massage for the treatment of chronic neck pain. DESIGN: Prospective, randomised, placebo controlled trial. SETTING: Three outpatient departments in Germany. PARTICIPANTS: 177 patients aged 18-85 years with chronic neck pain. INTERVENTIONS: Patients were randomly allocated to five treatments over three weeks with acupuncture (56), massage (60), or "sham" laser acupuncture (61). MAIN OUTCOME MEASURES PRIMARY OUTCOME MEASURE: maximum pain related to motion (visual analogue scale) irrespective of direction of movement one week after treatment. SECONDARY OUTCOME MEASURES: range of motion (3D ultrasound real time motion analyser), pain related to movement in six directions (visual analogue scale), pressure pain threshold (pressure algometer), changes of spontaneous pain, motion related pain, global complaints (seven point scale), and quality of life (SF-36). Assessments were performed before, during, and one week and three months after treatment. Patients' beliefs in treatment were assessed. RESULTS: One week after five treatments the acupuncture group showed a significantly greater improvement in motion related pain compared with massage (difference 24.22 (95% confidence interval 16.5 to 31.9), P=0.0052) but not compared with sham laser (17.28 (10.0 to 24.6), P=0.327). Differences between acupuncture and massage or sham laser were greater in the subgroup who had had pain for longer than five years (n=75) and in patients with myofascial pain syndrome (n=129). The acupuncture group had the best results in most secondary outcome measures. There were no differences in patients' beliefs in treatment. CONCLUSIONS: Acupuncture is an effective short term treatment for patients with chronic neck pain, but there is only limited evidence for long term effects after five treatments.

Acupuncture Analgesia↗

Comparison of the effectiveness between manual acupuncture and electro-acupuncture on patients with tennis elbow.

This is a single-blinded randomized controlled trial to compare the relative effectiveness between manual acupuncture (MA) and electro-acupuncture (EA) on the patients with chronic tennis elbow. Twenty patients recruited in the study were first introduced into control group for 2 weeks waiting period. Then, they were randomly assigned into either MA or EA group for acupuncture treatment. The acupuncture points of GB34 and ST38 were used in both treatment groups. In the MA group, the needle was retained for 20 minutes after the Deqi sensation obtained. In the EA group, electrical stimulation with 4 pulses/second frequency was applied and treatment lasted for 20 minutes. After 6 treatments within 2 weeks duration, significant differences were observed between groups favoring the electro-acupuncture in relation to pain relief (Pain visual analogue scale) and pain free hand grip strength (PFG). This study showed that electro-acupuncture is superior to manual acupuncture in treating patients with tennis elbow.

Acupuncture↗

Relationship between acupuncture-induced immunity and the regulation of central neurotransmitter system in rabbits--II. Effect of the endogenous opioid peptides on the regulation of acupuncture-induced immune reaction.

By injecting Naloxone, the T-lymphocyte transformation was reduced markedly. When the Naloxone plus electro-acupuncture were used together, it was not reduced but was still lower than it was when only electro-acupuncture was used. This explained why Naloxone could reverse the function by which electro-acupuncture promoted the T-lymphocyte transformation, and the endogenous opioid in the brain promoted the immune reaction. Through promoting the release of the endogenous opioid in the brain, electro-acupuncture raised the T-lymphocyte transformation function. Using electro-acupuncture when naloxone antagonized morphine, the T-lymphocyte transformation function was still promoted markedly. The mechanism could be that electro-acupuncture excited the function of the endogenous opioid system in the brain. In acupuncture immune reaction, the relationship between the endogenous opioid and catecholaminergic systems was explored.

Acupuncture Therapy↗

Acupuncture in an outpatient clinic in China: a comparison with the use of acupuncture in North America.

BACKGROUND: The National Institutes of Health Consensus Panel on Acupuncture has listed as a priority the study comparing indications and patterns of use of acupuncture in different countries. METHODS: I visited an outpatient acupuncture clinic in China and reviewed the clinical files. A MEDLINE search was done to compare the use of acupuncture in North America and China. RESULTS: The most common disorder treated in the clinic was musculoskeletal pain. Less common indications included stroke rehabilitation, Bell's palsy, cholelithiasis, tinnitus, insomnia, migraine, and visceral pain. In North America, acupuncture is primarily for pain relief. Other uses include stroke rehabilitation, various emetic problems, migraine, and various addictions. CONCLUSIONS: Acupuncture is most frequently used in China and North America for pain relief. Other common indications include peripheral nerve palsy, peripheral nerve neuralgia, stroke rehabilitation, psychoemotional disorders, migraine, visceral pain, emesis, asthma, and tinnitus. Acupuncture for cholelithiasis in China but not in the United States suggests a novel use of this modality.

Acupuncture Therapy↗

[Effect of skull acupuncture and scalp acupuncture on serum vascular endothelial growth factor in the patient of acute cerebral infarction].

OBJECTIVE: To investigate effect of skull suture acupuncture (skull acupuncture) and scalp acupuncture on serum vascular endothelial growth factor (VEGF) in the patient of acute cerebral infarction (CI). METHODS: Twenty cases of CI were treated with skull suture acupuncture at coronal suture, sagittal suture, lambdoid suture, etc. combined with medication (group B), group C (n=20) with scalp acupuncture at contralateral Dingnie Qian-xiexian (MS 6) and Dingnie Houxiexian (MS 7) plus medication, and group A (n=20) with medication. Changes of serum VEGF contents were investigated in the three groups. RESULTS: After treatment, the serum VEGF content did not significantly change in group A (P > 0.05), and significantly increased in group B and group C (P < 0.01, P < 0.05), with significant difference as group B and C compared with that of group A (P < 0.05), and with no significant difference between group B and group C (P > 0.05). CONCLUSION: Skull suture acupuncture combined with medication and scalp acupuncture plus medication have a similar effect on serum VEGF in the patient of acute cerebral infarction.

Acupuncture Therapy↗

[Considerations of the placebo problem in acupuncture. Reflections on usefulness, ethical justification, standardization and differentiated use of placebos in acupuncture].

28 different acupuncture placebos were found in 28 controlled studies, making a comparison of the results impossible. The following differentiation of acupuncture placebos is proposed: 1.a) Real placebos without intrinsic effect, 1.b) Pseudoplacebos with intrinsic effect, 2.a) Placebos without damage of physical integrity (not incisive), 2.b) Placebos with damage of physical integrity (incisive), for example the usual method of placebo-acupuncture-needling outside the known acupuncture points with or without additional stimulation. Painful pseudoplacebos with damage of the physical integrity should only be used in short-term trials on experimentally induced pain in healthy volunteers. For therapeutic studies with really sick persons, only real placebos, painless and without damage of the physical integrity, should be used, e.g. mock-TENS or laser. In order to prevent the patient from knowing the group determination, a third group with another correct treatment is essential, e.g. correct acupuncture, mock-TENS and real TENS or laser. A genuine acupuncture placebo is as unthinkable as placebo-surgery. Since single- or double-blind trials cannot be correctly carried out in acupuncture therapy it appears desirable to replace them by follow-up studies.

Acupuncture Therapy↗

Clinical research on acupuncture. Part 1. What have reviews of the efficacy and safety of acupuncture told us so far?

UNLABELLED: OVERVIEW AND METHODS: This paper discusses those medical conditions in which clinical trials of acupuncture have been conducted, and where meta-analyses or systematic reviews have been published. It focuses on the general conclusions of these reviews by further examining official reviews conducted in the United States, United Kingdom, Europe, and Canada each of which examined available systematic reviews. While all reviews agree that the methodological rigor of acupuncture clinical trials has generally been poor and that higher quality clinical trials are necessary, this has not completely hampered the interpretation of the results of these clinical trials. In some conditions the evidence of efficacy has clearly reached a sufficient critical mass from enough well-designed studies to draw clear conclusions; for the rest, the evidence is difficult to clearly interpret. This paper also examines conclusions from the same international reviews on the safety and adverse effects of acupuncture. Here, conclusions are more easily drawn and there is good agreement about the safety of acupuncture. RESULTS AND CONCLUSIONS: General international agreement has emerged that acupuncture appears to be effective for postoperative dental pain, postoperative nausea and vomiting, and chemotherapy-related nausea and vomiting. For migraine, low-back pain, and temporomandibular disorders the results are considered positive by some and difficult to interpret by others. For a number of conditions such as fibromyalgia, osteoarthritis of the knee, and tennis elbow the evidence is considered promising, but more and better quality research is needed. For conditions such as chronic pain, neck pain, asthma, and drug addiction the evidence is considered inconclusive and difficult to interpret. For smoking cessation, tinnitus, and weight loss the evidence is usually regarded as negative. Reviews have concluded that while not free from serious adverse events, they are rare and that acupuncture is a relatively safe procedure.

Acupuncture Therapy↗

Acupuncture in angina pectoris: does acupuncture have a specific effect?

To overcome the methodological problems of blinding the patients and the acupuncturist in acupuncture trials, 33 patients with stable angina pectoris, who were randomized to either genuine or sham acupuncture, received electroacupuncture by another acupuncturist, and the change in skin temperature was recorded. It was found that the change in skin temperature correlated significantly with the degree of improvement following both genuine and sham acupuncture. Fourteen patients with no decrease in skin temperature exhibited a significantly better response to acupuncture than 19 patients who showed a decrease in skin temperature (G II). In the former group, there was a 15% median improvement in exercise tolerance (G II 0%), a 67% improvement in anginal attack rate (G II 38%), and an 84% improvement in nitroglycerine consumption (G II 50%). A significant correlation was found between the duration of disease and the effect of acupuncture. It is concluded that both genuine and sham acupuncture have a specific effect on some angina pectoris patients in addition to the effect of pharmacological therapy.

Acupuncture Therapy↗

Differences in acupuncture point SP-10 and non-acupuncture point following subcutaneous injection of Tc-99m pertechnetate.

A new method of radionuclide venography, namely SC-RNV, by subcutaneous injection of Tc-99m pertechnetate at acupuncture points was recently developed in our laboratory. The time-activity curve of SC-RNV can be divided into 3 phases as: the phase of diffusion of radioisotopes through the subcutaneous space, the phase of entrance of radioisotopes into intravascular space to reach a peak concentration and the phase of equilibrium state of radioisotopes in the intravascular space. In this study, we used the 3 phases of SC-RNV to evaluate the absorption of Tc-99m pertechnetate injected subcutaneously in the acupuncture point SP-10 (Xuehai) and in a non-acupuncture point near SP-10. The results revealed that the absorption of Tc-99m pertechnetate via SP-10 was significantly greater than that of non-acupuncture point, evidenced by shorter phase 1, higher peak activity and greater accelerating rate of phase 2. This suggests that the absorption of radioisotopes from acupuncture point is faster and greater than that of non-acupuncture point.

Absorption↗

Studies on the enhanced effect of acupuncture analgesia and acupuncture anesthesia by D-phenylalanine (2nd report)--schedule of administration and clinical effects in low back pain and tooth extraction.

D-phenylalanine (DPA) is known to block the activity of carboxypeptidase, an enzyme which degrades enkephalins, endogenous morphine-like substances. Therefore, it is considered that DPA administered as an inhibiting drug of this degrading enzyme might prolong analgesia induced by acupuncture. 1) Thirty patients suffering from chronic low back pain were treated with acupuncture 30 minutes after the oral administration of 4.0 grams of DPA. The results were: excellent in 7 cases, good in 11, fair in 6 and poor in 6. Cases graded excellent and good were then compared with a placebo group. The effect was increased 26% in the DPA-acupuncture group, which shows no statistically significant difference (P less than 0.1). 2) In 56 patients, tooth extraction was performed under acupuncture anesthesia: 18 had received 4.0 gram of DPA (P.O.) 30 minutes earlier. The results were excellent in 8, good in 6, fair in 3, and poor in 1. The excellent and good cases were compared with 38 placebo group cases. The effect in the DPA-acupuncture anesthesia group was significantly increased by 35% (P less than 0.01). 3) In order to determine the optimum time for the administration of DPA, two schedules of administration were compared. [1] DPA was given on the previous day in three 0.5 gram doses (26 cases). [2] A single 4 gram dose was administered 30 minutes before treatment (30 cases). The results from the "excellent", "good" and "fair" cases showed a 16% increase in effectiveness when DPA was administered the day before, not a statistically significant difference (P less than 0.1), but a clear tendency to increase was observed. The above findings show that DPA has an enhancing effect on acupuncture analgesia and anesthesia in clinical practice.

Acupuncture Analgesia↗

[Action of an enkephalinase blocker on the effect of acupuncture in acupuncture sensitive and resistant rabbits].

In unanaesthetized acupuncture-sensitive rabbit d-phenylalanine injection didn't change the EP in response to tooth pulp electrostimulation, but prolonged the analgetic effect of auriculo-acupuncture stimulation 15 Hz expressed by decreasing of the amplitude of N1P2 component EP. In acupuncture-resistant rabbit d-phenylalanine injection induced analgetic effect which was enhanced and prolonged by auriculo-acupuncture stimulation. It's suggested that the recovery of pain sensibility after acupuncture analgesia is determined by enkephalinase's mechanism activation which is activated permanently in acupuncture-resistant rabbits.

Acupuncture Analgesia↗

[The experimental study of prevention and treatment of the side-effects of chemotherapy with acupuncture (comparison among the effect of acupuncture at different acupoint)].

After an intraperitoneal injection of cyclophosphamide in rats, there was pathologic changes in hemopoietic, immune and visceral function. Acupuncture respectively at Zusanli, Dazhui and Shenshu points could decrease the above mentioned harms in the rats, the effect of acupuncture on hemopoietic function: Dazhui more than or equal to Zusanli, Zusanli more than Shenshu; the effect of acupuncture on immune function: Zusanli more than Dazhui, Dazhui more than or equal to Shenshu; the effect of acupuncture on the function of the liver and the kidney: Shenshu more than or equal to Zusanli, Zusanli more than Dazhui. The effect of acupuncture at all three points, i.e. Zusanli. Dazhui and Shenshu was more than that at any single point due to their coordination. There was no obvious effect when acupuncture at non-acupoints on tail.

Acupuncture Points↗

[A study on factors of acupuncture methods affecting effects through acupuncture treatments for experimental gastric ulcer in rats].

Many factors, such as the selection of acupoints, the interval between acupunctures, the acupuncture time, the manipulation and the specification of acupuncture needles, are capable of affecting curative effects. There were some studies on these factors ago. However each of these studies only related to a single factor. These studies could not reflect the clinical truth, and could not provide accurate overall data for medical staff. In order to solve the above problems, we carried out an animal experiment designed by L9 (3(4)) orthogonal design. The experiment which consisted of 9 acupuncture groups and 3 control ones was carried out in 108 rats, which were suffered from experimental gastric ulcer. In the experiment, the body weight, ulcer area, plasma SOD and LPO of each rat were observed. The results showed that in the acupuncture treatments for experimental gastric ulcer in rats, 10 minutes' electric acupuncture treatment using thinner needles and the method that each rat was treated every other day were the best methods. The reason why the above results came into being was elucidated in this paper.

Acetates↗

The acupuncture point and its connecting central pathway for producing acupuncture analgesia.

Characteristics of the acupuncture point in producing acupuncture analgesia (AA) were examined by the inhibition of noxious responses in the brain stem reticular formation, potentials, and neuronal activity in the dorsal periaqueductal central gray (D-PAG), and analgesia caused by low frequency stimulation of the acupuncture point. As a result, stimulation of the muscle beneath the acupuncture point was found to be effective in producing AA. AA measured by tail flick, vocalization, and writhing tests was abolished by hypophysectomy, and by antiserum of beta-endorphin administered into the 3rd ventricle. The pathway from the D-PAG to the anterior hypothalamus (AA-AH) in the AA afferent pathway from the acupuncture point to the pituitary gland was determined. The lateral hypothalamus, lateral septum, cingulate bundle, dorsal-hippocampus, and habenulo-interpeduncular tract were found, in addition to regions previously found, to belong to the AA afferent pathway. A network of divergence and convergence in their rostral and caudal relations was observed. The AA afferent pathway diverges from the D-PAG, converges to the HP, and then projects to the AA-AH.

Acupuncture Analgesia↗

Standards for reporting interventions in controlled trials of acupuncture: The STRICTA recommendations. STandards for Reporting Interventions in Controlled Trails of Acupuncture.

Acupuncture treatment and control group interventions in parallel-group randomised trials of acupuncture are not always precisely reported. In an attempt to improve standards, an international group of experienced acupuncturists and researchers devised a set of recommendations, designating them STRICTA: STandards for Reporting Interventions in Controlled Trials of Acupuncture. In a further consensus-building round, the editors of several journals helped redraft the recommendations. These follow the Consolidated Standards for Reporting Trials (CONSORT) format, acting as an extension of the CONSORT guidelines for the specific requirements of acupuncture studies. Participating journal editors are publishing the STRICTA recommendations and requesting prospective authors to adhere to them when preparing reports for publication. Other journals are invited to adopt these recommendations. The intended outcome is that interventions in controlled trials of acupuncture will be more adequately reported, thereby facilitating an improvement in critical appraisal, analysis and replication of trials.

Acupuncture Therapy↗

The analgesic efficacy of bee venom acupuncture for knee osteoarthritis: a comparative study with needle acupuncture.

The aim of this investigation was to determine whether bee venom (BV) administered directly into an acupoint was a clinically effective and safe method for relieving the pain of patients with knee osteoarthritis (OA) as compared to traditional needle acupuncture. We evaluated the efficacy of BV acupuncture using both pain relief scores and computerized infrared thermography (IRT) following 4 weeks of BV acupuncture treatment. We observed that a significantly higher proportion of subjects receiving BV acupuncture reported substantial pain relief as compared with those receiving traditional needle acupuncture therapy. Furthermore, the IRT score was significantly improved and paralleled the level of pain relief.

Acupuncture Points↗