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The sample size was calculated via the effective rate based on the FS-14. In some previous acupuncture studies for CFS, researchers adopted the FS-14 score as one of the primary endpoints. The FS-14 score was applied with the formula:
Acupuncture as a therapeutic intervention is widely practiced in the United States. The general theory of acupuncture is based on the premise that there are patterns of energy flow (Qi) through the body that are essential for health. Disruptions of this flow are believed to be responsible for disease. Acupuncture may correct imbalances of flow at identifiable points close to the skin. Findings from basic research have begun to elucidate the mechanisms of action of acupuncture, including the release of opioids and other peptides in the central nervous system and the periphery and changes in neuroendocrine function.
While there have been many studies of its potential usefulness, the vast majority of papers studying acupuncture in the biomedical literature consist of case reports, case series, or intervention studies. One of the difficulties with drawing conclusions from the existing literature is that the term acupuncture is used to describe a variety of treatments that differ in many important aspects according to level of effect (e.g., local, segmental, generalized) and type of acupuncture treatment (e.g., manual versus electrical acupuncture). Many of these studies provide equivocal results because of design, sample size, and other factors. The issue is further complicated by inherent difficulties in the use of appropriate controls, such as placebos and sham acupuncture groups, and by absence of studies comparing acupuncture with conventional biomedical treatments. Some factors needing investigation include frequency, number, and duration of treatments, depth of puncture, number of acupuncture points used, combination with other therapies, sample size, setting, blinding factors, and needle size. Be that as it may, promising results have emerged on the efficacy of acupuncture in adult post-operative and chemotherapy nausea and vomiting and in postoperative dental pain.
In a multi-center, randomized controlled trial, Thomas et al (2005) examined whether patients with persistent non-specific LBP, when offered access to traditional acupuncture care alongside conventional primary care, gained more long-term relief from pain than those offered conventional care only, for equal or less cost. Safety and acceptability of acupuncture care to patients, and the heterogeneity of outcomes were also tested. Patients in the experimental arm were offered the option of referral to the acupuncture service comprising 6 acupuncturists. The control group received usual care from their general practitioner (GP). Eligible patients were randomised in a ratio of 2:1 to the offer of acupuncture to allow between-acupuncturist effects to be tested. Patients were 18 to 65 years of age with non-specific LBP of 4 to 52 weeks' duration, and were assessed as suitable for primary care management by their general practitioner. The trial protocol allowed up to 10 individualized acupuncture treatments per patient. The acupuncturist determined the content and the number of treatments according to patient need. Main outcome measures included the Short Form 36 (SF-36) Bodily Pain dimension (range of 0 to 100 points), assessed at baseline, and 3, 12 and 24 months. Cost-utility analysis was conducted at 24 months using the EuroQoL 5 Dimensions (EQ-5D) and a preference-based single index measure derived from the SF-36 (SF-6D). Secondary outcomes included the McGill Present Pain Index (PPI), Oswestry Pain Disability Index (ODI), all other SF-36 dimensions, medication use, pain-free months in the past year, worry about back pain, satisfaction with care received, as well as safety and acceptability of acupuncture care. A total of 159 patients were in the acupuncture offer arm and 80 in the usual care arm. All 159 patients randomized to the offer of acupuncture care chose to receive acupuncture treatment, and received an average of 8 acupuncture treatments within the trial. These investigators found that traditional acupuncture care delivered in a primary care setting was safe and acceptable to patients with non-specific LBP. Acupuncture care and usual care were both associated with clinically significant improvement at 12- and 24-month follow-up. Acupuncture care was significantly more effective in reducing bodily pain than usual care at 24-month follow-up. No benefits relating to function or disability were identified. They concluded that GP referral to a service providing traditional acupuncture care offers a cost-effective intervention for reducing LBP over a 2-year period.
A randomized controlled study by Smith et al (2008) found acupuncture to be ineffective at inducing labor. Women who were scheduled for a post-term induction with a singleton pregnancy and cephalic presentation were eligible for the study. Subjects received 2 acupuncture or sham acupuncture sessions over a 2-day period before the planned medical/pharmacological induction. The principal primary outcomes related to the need for induction methods and time from the administration of the intervention to delivery. A total of 364 women were randomly assigned to the trial (treatment n = 181 and control n = 183). Subjects did not differ in their need for induction methods between groups: prostaglandin induction: relative risk (RR) 1.20, 95 % CI: 0.96 to 1.51, p = 0.11; artificial rupture of membranes only: RR 0.93, 95 % CI: 0.72 to 1.20, p = 0.57; oxytocin only: RR 0.89, 95 % CI: 0.60 to 1.32, p = 0.55; artificial rupture of membranes plus oxytocin: RR 0.87, 95 % CI: 0.57 to 1.33, p = 0.52; prostaglandins, artificial rupture of membranes, and oxytocin: RR 0.84, 95 % CI: 0.37 to 1.91, p = 0.68. The median time from acupuncture todelivery was 68.6 hours (interquartile range of 53.9 to 79.5) compared with 65 hours (interquartile range of 49.3 to 76.3) for women in the control group. The authors concluded that 2 sessions of manual acupuncture, using local and distal acupuncture points, administered 2 days before a scheduled induction of labor did not reduce the need for induction methods or the duration of labor for women with a post-term pregnancy.
There is a lack of reliable evidence for acpuncture treatment of Parkinson's disease. Lam and co-workers (2008) evaluated the safety and effectiveness of acupuncture therapy (monotherapy or adjuvant therapy), compared with placebo, conventional interventions, or no treatment in treating patients with idiopathic Parkinson's disease (IPD). All RCTs of any duration comparing monotherapy and adjuvant acupuncture therapy with placebo or no intervention were included. Data were abstracted independently by 2 investigators onto standardized forms, and disagreements were resolved by discussion. A total of 10 trials were included, each using a different set of acupoints and manipulation of needles. None of them reported the concealment of allocation. Only 2 studies mentioned the number of dropouts; 2 used a non-blind method while others did not mention their blinding methods. Nine studies claimed a statistically significant positive effect from acupuncture as compared with their control; only 1 indicated that there were no statistically significant differences for all variables measured. Only 2 studies described details about adverse events. The authors concluded that there is evidence indicating the potential effectiveness of acupuncture for treating IPD. However, results were limited by the methodological flaws, unknowns in concealment of allocation, number of dropouts, and blinding methods in the studies. They stated that large, well-designed, placebo-controlled RCTs with rigorous methods of randomization and adequately concealed allocation, as well as intention-to-treat data analysis are needed to ascertain the clinical value of acupuncture in the treatment of IPD.
In a randomized, patient-assessor blinded, sham-acupuncture, controlled trial, Shin et al (2010) assessed the safety and effectiveness of acupuncture for ocular symptoms, tear film stability and tear secretion in dry eye patients. A total of 42 subjects with defined moderate to severe dry eye underwent acupuncture treatment 3 times a week for 3 weeks. Seventeen standard points (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8 on the left for men and right for women) with "de qi" manipulation for the verum acupuncture group and seventeen sham points of shallow penetration without other manipulation for the sham group were applied during the acupuncture treatment. Differences were measured using the ocular surface disease index (OSDI), the VAS of ocular discomfort, the tear film break-up time (TFBUT) and the Schimer I test with anesthesia. In addition, adverse events were recorded. There were no statistically significant differences between results on the OSDI, VAS, TFBUT or Schimer I tests from baseline between the verum and sham acupuncture groups. However, results from the within-group analysis showed that the OSDI and VAS in both groups and the TFBUT in the verum acupuncture group were significantly improved after 3 weeks of treatment. No adverse events were reported during this trial. The authors concluded that both types of acupuncture improved signs and symptoms in dry-eye patients after a 4-week treatment. However, verum acupuncture did not result in better outcomes than sham acupuncture.
Zhu and colleagues (2013) examined the safety and effectiveness of acupuncture for pain in endometriosis. These investigators searched the Cochrane Menstrual Disorders and Subfertility Group (MSDG) Specialized Register of controlled trials, Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE, CINAHL, AMED, PsycINFO, CNKI and TCMDS (from inception to 2010) and reference lists of retrieved articles. Randomized single or double-blind controlled trials enrolling women of reproductive age with a laparoscopically confirmed diagnosis of endometriosis and comparing acupuncture (body, scalp or auricular) to either placebo or sham, no treatment, conventional therapies or Chinese herbal medicine were selected for analysis. Three authors independently assessed risk of bias and extracted data; they contacted study authors for additional information. Meta-analyses were not performed as only 1 study was included. The primary outcome measure was decrease in pain from endometriosis. Secondary outcome measures included improvement in quality of life scores, pregnancy rate, adverse effects and rate of endometriosis recurrence. A total of 24 studies were identified that involved acupuncture for endometriosis; however only 1 trial, enrolling 67 participants, met all the inclusion criteria. The single included trial defined pain scores and cure rates according to the Guideline for Clinical Research on New Chinese Medicine. Dysmenorrhea scores were lower in the acupuncture group (mean difference -4.81 points, 95 % CI: -6.25 to -3.37, p 2ff7e9595c
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