Appendix Studies of the Efficacy of Acupuncture *

Transcription

1 Appendix Studies of the Efficacy of Acupuncture * Study Study Description Main Results Researchers Conclusions Lee A, Fan LT. Stimulation of wrist acupuncture point P6 for preventing nausea and vomiting. Cochrane Database Syst Rev. April 15, 2009: (2); CD Ezzo JM, Richardson MA, Vickers A, et al. Acupuncture point stimulation for chemotherapyinduced nausea or vomiting. Cochrane Database Syst Rev 2006;2:CD Manheimer E, Zhang G, Udoff L, et al. Effects of acupuncture on rates of pregnancy and live birth among women undergoing in vitro fertilization: systematic review and meta-analysis. BMJ Mar 8;336(7643): Epub 2008 Feb 7. Review. Update of a Cochrane review (2004) of 40 randomized trials (n = 4,858) evaluating P6 acupoint stimulation compared with sham treatment or drug therapy for the prevention of post-operative nausea and vomiting (PONV). Systematic review of 11 randomized trials of acupoint stimulation by any method (n = 1,247) for acute and delayed chemotherapy-induced nausea and vomiting (CNV) in cancer patients. All trials pooled used concomitant pharmacologic antiemetics, and all, except electroacupuncture trials, used state-of-the-art antiemetics; some compared different types of stimulation, and some used sham controls. Systematic review of seven randomized controlled trials (n = 1,366) that compared needle acupuncture administered within one day of embryo transfer with sham acupuncture or no adjuvant treatment, with reported outcomes of at least one of clinical pregnancy, ongoing pregnancy, or live birth. Compared with sham treatment P6 acupoint stimulation significantly reduced nausea, vomiting, and the need for rescue antiemetics both in adults and children. There was no identifiable difference between invasive vs. non-invasive methods. Acupuncture-point stimulation of all methods combined reduced the incidence of acute vomiting but not acute or delayed nausea severity compared to control suggesting a biologic effect. Electroacupuncture was the most effective intervention; noninvasive electrostimulation (i.e., TENS) did not seem to have an effect as augmentation to anti-emetics; acupressure self-administered appeared to have a protective effect for acute nausea. Complementing the embryo transfer process with acupuncture was associated with significant and clinically relevant improvements in clinical pregnancy, ongoing pregnancy, and live birth P6 acupoint stimulation prevented PONV. There was no reliable evidence for differences in risks of PONV after P6 acupoint stimulation compared to antiemetic drugs. The side effects associated with P6 acupoint stimulation were minor. Electroacupuncture has demonstrated benefit for chemotherapy-induced acute vomiting. Studies combining electroacupuncture with state-ofthe-art antiemetics and in patients with refractory symptoms are needed to determine clinical relevance. Current preliminary evidence suggests that acupuncture given with embryo transfer improves rates of pregnancy and live birth among women undergoing in vitro fertilization.

2 Kwon YD, Pittler MH, Ernst E. Acupuncture for peripheral joint osteoarthritis: a systematic review and meta-analysis. Rheumatology (Oxford). 2006;45(11): White A, Foster NE, Cummings M, Barlas P. Acupuncture treatment for chronic knee pain: a systematic review. Rheumatology.(Oxford). 2007; 46: Manheimer E, Linde K, Lao L, Bouter LM, Berman BM. Metaanalysis: Acupuncture for osteoarthritis of the knee. Ann Intern Med. 2007;146: Davis MA, Kononowech RW, Rolin SA, Spierings EL. Acupuncture for tension-type headache: a meta-analysis of randomized, controlled trials. J Pain. 2008;9: Systematic review of 18 RCTs of acupuncture for patients with peripheral joint OA assessing needle acupuncture with or without electrical stimulation compared to sham or another intervention for pain control. Systematic review and metaanalysis of RCT s of acupuncture for pain and function in patients with chronic knee pain. Meta-analysis of 11 RCTs (n = 2,821) longer than 6 weeks in duration that compared needle acupuncture with a sham, usual care, or waiting list control group for patients with knee osteoarthritis. Systematic review and metaanalysis of 8 RCTs of acupuncture (n = 896) for the treatment of tension-type headache; the data from five studies were pooled for the analysis. Data were assessed at 2 time points: during treatment and at long-term follow-up (20-25 weeks). The meta-analysis of homogeneous data showed a significant effect of manual acupuncture compared with sham acupuncture in the treatment of pain due to peripheral join OA. Compared to sham five studies (n = 1,334) acupuncture was superior both pain and function in both the short and long term. Acupuncture was also significantly superior to no additional intervention. Compared with patients in waiting list control groups, patients who received acupuncture reported clinically relevant short-term improvements in pain and function, as well as clinically relevant short- and long-term improvements compared with patients in usual care control groups. Compared with a sham control, the improvements were not clinically relevant. During treatment, the acupuncture group averaged 8.95 headache days per month compared with 10.5 in the sham group. At longterm follow-up, the acupuncture group reported an average of 8.21 headache days per month compared with 9.54 in the sham group. Sham-controlled RCTs suggest specific effects of acupuncture for pain control in patients with peripheral joint OA. Acupuncture that meets criteria for adequate treatment is significantly superior to sham acupuncture and to no additional intervention in improving pain and function in patients with chronic knee pain. Sham-controlled trials show clinically irrelevant short-term benefits of acupuncture for treating knee osteoarthritis probably due to the variability of acupuncture and sham protocols, patient samples, and settings. Waiting list-controlled trials suggest clinically relevant benefits, but these may be due to non-specific factors. Acupuncture compared with sham for tension-type headache has limited efficacy for the reduction of headache frequency. There exists a lack of standardization of acupuncture point selection and treatment course among randomized, controlled trials. More research is needed to investigate the treatment of specific tensiontype headache subtypes.

3 Sun Y, Gan TJ. Acupuncture for the management of chronic headache: A systematic review. Anesth Analg. 2008;107: Linde K, Allais G, Brinkhaus B, Manheimer E, Vickers A, White AR. 2009, Acupuncture for tension-type headache. Cochrane Database of Systematic Reviews. 2009, no. 1:CD Trinh K, Graham N, Gross A, et al. Acupuncture for neck disorders. Spine. 2007;32: Furlan AD, van Tulder MW, Cherkin D, et al. Acupuncture and dry-needling for low back pain: An updated systematic review within the framework of the Cochrane Collaboration. Spine. 2005;30: Sytematic review and metaanalysis of 31 trials (n = 3,916) of acupuncture for treatment of chronic headache compared to sham acupuncture, medication, and other nonpharmacological treatments. Update of Cochrane review published in 2001, this includes 11 RCTs (n = 2,317) comparing acupuncture to sham acupuncture or another intervention in patients with episodic or chronic tensiontype headache. Cochrane systematic review of acupuncture for individuals with neck pain. No trials of acute neck pain were found; 10 trails (n = 661) for chronic neck pain were included. Updated Cochrane Review, of 35 RCTs of acupuncture (n = 2,861) that involved needling or dryneedling for adults with nonspecific acute/subacute or chronic low back pain. The combined response rate in the acupuncture group was significantly higher compared with sham acupuncture either at the early or late follow-up. Acupuncture was also superior to medication therapy for headache intensity, frequency physical function, and response rate. Small but statistically significant benefits of acupuncture over sham were found for response as well as for several other outcomes. For chronic mechanical neck disorders, acupuncture was moderately more effective for pain relief than some types of sham controls, measured immediately post-treatment. For chronic neck disorders with radicular symptoms, acupuncture was moderately more effective than a wait-list control at short-term follow-up. For chronic low back pain, acupuncture is more effective for pain relief and functional improvement than no treatment or sham treatment immediately after treatment and in the short-term. Regarding acute low back the data are insufficient. Needling acupuncture is superior to sham acupuncture and medication therapy in improving headache intensity, frequency, and response rate. Acupuncture could be a valuable non-pharmacological tool in patients with frequent episodic or chronic tension-type headaches. Acupuncture is moderately more effective in relieving chronic neck pain at the end of treatment compared to sham, compared to wait list controls, and compared to inactive treatments; the last is maintained at short-term followup. The data suggest that acupuncture and dry-needling may be useful adjuncts to other therapies for chronic low back pain. Higher quality trials in this area are still needed.

4 Manheimer E, White A, Berman B, Forys K, Ernst E. Meta-analysis: Acupuncture for low back pain. Ann Intern Med. 2005;142: Madsen MV, Gotzsche PC, Hrobjartsson A. Acupuncture treatment for pain: Systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups BMJ;338:a3115. Meta-analysis of 22 (n = 789) RCTs comparing needle acupuncture with sham acupuncture, other sham treatments, no additional treatment, or another active treatment for patients with low back pain. Systematic review and metaanalysis of 13 three armed randomized clinical trials. (n = 3,025 patients) involving a variety of pain conditions to evaluate the analgesic effect of acupuncture and placebo acupuncture. For short-term relief of chronic pain, acupuncture is significantly more effective than sham treatment and no additional treatment. A small not statistically significant difference was found between acupuncture and placebo acupuncture; a moderate difference was found between placebo acupuncture, and no acupuncture; large trials reported both small and large effects of placebo. Acupuncture effectively relieves chronic low back pain. No evidence suggests that acupuncture is more effective than other active therapies. A small analgesic effect of acupuncture was found, which may not be clinically relevant. Fu LW, Longhurst JC. Electroacupuncture modulates vlpag release of GABA through presynaptic cannabinoid CB1 receptors. J Appl Physiol. 2009; 106: Epub 2009 Apr 9. Zhang RX, Li A, Liu B, et al. Electroacupuncture attenuates bone cancer pain and inhibits spinal interleukin-1 beta expression in a rat model. Anesth Analg. 2007;105: Garrido-Suárez BB, Garrido G, Márquez L, et al. Pre-emptive anti- Animal study to evaluate whether electroacupuncture (EC) modulates the release of GABA and Glu in the vlpag,. by using HPLC to assess samples collected with microdialysis probes inserted unilaterally into the vlpag of intact anesthetized rats. Evaluation of the effect of electroacupuncture (EA) on cancer-induced hyperalgesia and expression of interleukin-1beta (IL-1beta), upregulation of which is related to the maintenance of persistent pain, in a rat model of bone cancer pain. To determine the thermal antihyperalgesic effect of EA (10 Hz, Twenty-eight min. of EA (2 Hz, 2-4 ma, 0.5 ms) at the P5-6 acupoints reduced the release of GABA by 39% during EA and by 44% 15 min after EA. Thirty-five minutes after EA, GABA concentrations returned to pre-ea levels. In contrast, sham EA did not change the vlpag GABA concentration. EA significantly (P <.05) attenuated hyperalgesia, and inhibited the upregulation of IL- 1beta and its mrna compared to the sham control. The EA pre-treatment showed a thermal anti-hyperalgesic effect in EA modulates the sympathoexcitatory reflex responses by decreasing the release of GABA, but not Glu, in the vlpag, most likely through a presynaptic CB(1) receptor mechanism. EA seems to alleviate bone cancer pain, at least in part by suppressing IL-1beta expression. The results support the clinical use of EA in the treatment of cancer pain. These data constitute the first report that suggested the

5 hyperalgesic effect of electroacupuncture in carrageenan-induced inflammation: Role of nitric oxide. Brain Res Bull. 2009;79: Epub 2009 May 3. Kaptchuk TJ, Stason WB, Davis RB, Legedza AR, Schnyer RN, Kerr CE, Stone DA, Nam BH, Kirsch I, Goldman RH..Sham device v inert pill: randomised controlled trial of two placebo treatments. BMJ Feb 18;332(7538): Dhond RP, Kettner N, Napadow V. Do the neural correlates of acupuncture and placebo effects differ? Pain. 2007;128(1-2):8-12. Epub 2007 Jan 30. Review. Harris RE, Zubieta JK, Scott DJ, Napadow V, Gracely RH, Clauw DJ. Traditional Chinese 3 ma) and its combination with L- NAME as nitric oxide synthase (NOS) inhibitor in carrageenaninduced hyperalgesia in rats. Single blind RCT to investigate whether a sham device (a validated sham acupuncture needle) has a greater placebo effect than an inert pill in patients with persistent arm pain. This RCT was created from the two week placebo run-in periods for two nested trials that compared acupuncture and amitriptyline with their respective placebo controls. Comparison of participants who remained on placebo continued beyond the run-in period to the end of the study. Review of neuroimaging studies of acupuncture to investigate differences between the specific and non-specific (i.e., placebo effects of acupuncture). To evaluate whether activation of the opiod receptors is different in acupuncture and sham correspondence with plasmatic increase of NO metabolites. L- NAME pre-administration decreased significantly the plasmatic concentrations of NO(2and suppressed the antihyperalgesic effect of EA. The combination of EA with ketamine enhanced the anti-hyperalgesic effect. Pain decreased during the two week placebo run-in period in both the sham device and placebo pill groups, but changes were not different between the groups. Changes in severity scores for arm symptoms and grip strength were similar between groups, but arm function and pain improved more in the placebo pill group. Longitudinal regression analyses showed significantly greater downward slopes per week on the 10 point arm pain scale in the sham device group than in the placebo pill group Although controversy regarding appropriate control methodology (e.g., sham acupuncture) continues, data suggest that modulation of certain limbic brain networks may differentiate between specific and placebo components of acupuncture. Although acupuncture and sham acupuncture elicited a similar amount of pain relief, their effects participation, at least in part, of the L-arginine-NOS-NO-GMPc pathway activation in antihyperalgesic effect of EA in carrageenan-induced inflammation model. The sham device (acupuncture sham needle) had greater effects than the placebo pill on self reported pain and severity of symptoms over the entire course of treatment but not during the two week placebo run in. Data suggest that modulation of certain limbic brain networks may differentiate between specific and placebo components of acupuncture. These data suggest that although the clinical effects of acupuncture and sham acupuncture may be

6 acupuncture and placebo (sham) acupuncture are differentiated by their effects on mu-opioid receptors (MORs). Neuroimage. 2009;47: Epub 2009 Jun 6. acupuncture. Patients with fibromyalgia, (n = 20) underwent opioid positron emission tomography (PET), prior to and following nine acupuncture or sham acupuncture treatments. on opioid receptors were markedly different. Sham acupuncture evoked the release of endogenous opioids, a mechanism involved in the placebo effect, whereas acupuncture increased the opioid receptor binding strength. Furthermore, following acupuncture, patients with greater increases in receptor binding had greater reductions in pain. similar, their underlying mechanisms are not. * The studies described in this Appendix are discussed in the February 2009 letter to the editor by Schnyer, Harris, and MacPherson, who also prepared the Appendix.