Statistics from Altmetric.com
Papers on osteoarthritis
Case series (n=3).
The chimpanzee colony at Michale E Keeling Center for Comparative Medicine and Research, Bastrop, Texas, USA is ageing, showing an increase in osteoarthritis (OA). The authors hypothesised that acupuncture could benefit these non-human primates.
Three chimpanzees aged 40–45 years with at least 3 years history of OA were successfully trained by using positive reinforcement techniques (since repeated sedation was impractical) to voluntarily participate in acupuncture treatments for stifle OA. Training was aimed at sitting stationary for 10 min against the cage mesh and becoming desensitised to needles. ST34, ST35 and ST36 were used weekly, attaching dental floss to the needles to avoid losing them if the animals moved. Two animals were trained to have bilateral treatment. Any existing non-steroidal anti-inflammatory medication continued unchanged.
A mobility scoring system was used by three to five observers to assess locomotion on a scale of eight descriptors every 3 months. Observers knew which chimps would receive acupuncture but were blinded to the actual timing of the course of treatment.
The two chimpanzees S and J (figure 1) with the most severe OA showed significant (p<0.05) improvement in mobility after acupuncture treatments. Chimp Y was less severely affected and showed no change. Acupuncture therapy resulted in improved mobility and the training sessions also served as enrichment for the animals, as demonstrated by their voluntary participation in the training and treatment sessions.
Acupuncture proved effective, and all statistical tests were one-tailed (!). See also Image of Acupuncture in this issue.
De qi in knee OA
Three-arm study (n=30) of acupuncture for OA of the knee.
Patients with OA of the knee were randomly assigned to receive either ‘high-dose’ acupuncture (six needles per treatment), ‘low-dose’ acupuncture (two needles per treatment) or sham (six Streitberger needles at non-traditional points, just below the knee). Both high- and low-dose acupuncture treatments involved 24 stimulations per session. The de qi response was measured by the Massachusetts General Hospital Acupuncture Sensation Scale (MASS) and the clinical response was measured by the Knee Injury and OA Outcome Score (KOOS).
Patients treated with real acupuncture reported greater improvements in pain (p=0.025), function in daily living (p=0.039) and function in sport (p=0.049) compared with sham acupuncture (see figure 2); there were no such differences between high- and low-dose acupuncture (p=0.612, 1.0 and 1.0, respectively). Soreness, aching, deep pressure, sharp and dull pain were the most often reported de qi sensations, which were reported equally reliably in the high-dose and low-dose groups. De qi sensations were less pronounced in the sham group; however, 90% of subjects (including all the sham group) thought they had treatment with penetrating needles, and there was no significant correlation between de qi experience and clinical outcomes. The authors concluded that the MASS measures de qi reliably.
This was a very small study with complex analyses, and it is not quite clear what the actual aim was. The study size would not allow either validation of the MASS or detection of a correlation between de qi experience and clinical outcomes. Furthermore, there already is a body of evidence with regard to efficacy of acupuncture for knee OA.
Acupuncture with exercise therapy
Sham controlled RCT without electroacupuncture (n=214).
This RCT was run at three physical therapy centres from 2001 to 2006 in 214 patients with at least 6 months chronic knee pain and x-ray confirmed Kellgren scores of 2 or 3. All patients undertook a standardised exercise-based programme which was as vigorous as they could tolerate, including range-of motion exercises, muscle strengthening and aerobic conditioning (bike and or treadmill). Duration increased from 10 to 20–30 min over the course.
Patients received 12 sessions of acupuncture or sham directly following exercise over 6–12 weeks. Acupuncture was performed at nine points according to the traditional Chinese Bi syndrome: GB34, SP9, ST35, Xiyan locally and BL60, GB39, SP6 and KI3 distally. In the real acupuncture group stimulation was brief at the beginning and end, and de qi was not sought. The sham group had Streitberger non-penetrating needles at the same points with no stimulation.
The primary outcome was the proportion of patients with an improvement of at least 36% in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score at 12 weeks.
One hundred and eighty-one patients provided 12-week data (dropout rate 15%). The WOMAC response rate was no different between true acupuncture (31.6%) and Streitberger needle (30.3%, p=0.5, figure 3). A positive expectation of relief from acupuncture was associated with improvement, with an adjusted OR of 2.14 (95% CI 1.13 to 4.10). Higher baseline 6 min walking distance also predicted a better response and heavier patients (body mass index >35) responded better to acupuncture than to sham (although this was a post hoc comparison).
As recruitment was slow, an interim analysis was performed and the trial was deemed futile and stopped before the intended sample size of 169 had been reached. The tactile stimulation of the Streitberger needle, which can be quite marked, proved as effective as the kind of manual acupuncture provided here—brief stimulation and no de qi. It seems likely that patients who are receiving high quality exercise therapy need the extra stimulation provided by electroacupuncture to show any additional improvement.
Comparison of physical treatments for knee OA pain.
A systematic review was performed with network meta-analysis, which included both direct comparisons between treatments and control and indirect comparisons between two treatments that had been tested against a common control. Sham acupuncture was considered separately from placebos.
One hundred and fourteen trials (covering 22 treatments and 9709 patients) were included. Most trials studied short-term effects and many were classed as being of poor quality with a high risk of bias commonly associated with lack of blinding (which was sometimes impossible to achieve). End of treatment results showed that eight interventions (interferential therapy, acupuncture, transcutaneous electrical nerve stimulation (TENS), pulsed electrical stimulation, balneotherapy, aerobic exercise, sham acupuncture and muscle-strengthening exercise) produced a statistically significant reduction in pain compared with standard care.
Using only the better quality studies shown in figure 4, most trials were of acupuncture (11 trials) or muscle-strengthening exercise (9); both interventions were statistically significantly better than standard care. Acupuncture was statistically significantly better than muscle-strengthening exercise (standardised mean difference (SMD) 0.49, 95% credible interval 0.00–0.98).
Acupuncture is clearly ‘top of the pile’ when it comes to physical treatment of OA pain. This paper was published at the same time as the National Institute for Health and Care Excellence (NICE) draft guideline on OA, which recommends muscle strengthening and aerobic exercise and weight loss for pain but does not recommend acupuncture. This failure to recommend acupuncture was because the difference between acupuncture and sham acupuncture is small.
Insomnia in dementia patients
Within-subject (crossover) study (n=22).
Nineteen elderly subjects with dementia living at home in Hong Kong were followed through a control period and an acupuncture treatment period, each lasting 6 weeks. Twelve sessions of acupuncture were given, using HT7, GV20, EX-HN9 (Anmian II), EX-HN3 (Yintang), ST36 and SP6. Subjects were accompanied by carers throughout. Outcome measures were sleep quality and cognitive function assessed by carers, and sleep parameters recorded by wrist actigraphy. Assessments immediately before and after the control and treatment periods were compared (ie, changes over time in each period).
Nineteen out of 22 subjects completed the study. Actigraphy showed that the subjects gained significantly more total sleep time (figure 5) as well as resting time in the treatment period than in the control period (p<0.05). Improvement in sleep efficiency showed a non-significant trend. Improvement in cognitive function was not statistically significant.
Within-subject (‘pre–post’) studies have considerable power (ie, they need fewer subjects than parallel arm studies). Actigraphy is an objective evaluation, reducing or even eliminating the usual measurement bias in unblinded studies. However, this does not exclude the possibility of a placebo effect—both via the carer and directly in the patient—since dementia patients do show placebo responses. It is a little difficult to understand why they recorded change over time for the control period, which was a steady state.
Open-label three-armed RCT (n=755).
Seven hundred and fifty-five patients with depression (Beck Depression Inventory (BDI-II) score ≥20) were identified from GP databases. Patients were randomised to one of three arms in a ratio of 2:2:1 to 12 weekly sessions of acupuncture (n=302), 12 weekly sessions of counselling (n=302) and usual care alone (n=151). Acupuncture treatment was customised within an agreed TCM framework. The primary outcome was the difference in mean Patient Health Questionnaire (PHQ-9) scores at 3 months. Analysis was by intention-to-treat.
PHQ-9 data, shown in figure 6, were available for 614 patients at 3 months and 572 patients at 12 months. Compared with usual care, there was a statistically significant reduction in mean PHQ-9 depression scores at 3 months for acupuncture (−2.46, 95% CI −3.72 to −1.21) and counselling (−1.73, 95% CI −3.00 to −0.45); and over 12 months for acupuncture (−1.55, 95% CI −2.41 to −0.70) and counselling (−1.50, 95% CI −2.43 to −0.58). Differences between acupuncture and counselling were not significant.
The economic evaluation will be interesting and is to be published separately.
Allergic rhinitis: cost-effectiveness
Economic analysis of RCT (n=422).
The ACUSAR trial1 showed that acupuncture provides superior symptom relief from seasonal allergic rhinitis (SAR) compared with standard rescue medication (RM) consisting of an oral antihistamine with additional use of corticosteroids when required. This paper reports measures of health economic analyses of costs and health-related quality of life (QOL).
All direct and indirect costs of SAR were analysed including the cost of medication, outpatient visits, hospital admissions and days off from work. A single acupuncture session was priced at €35 from society's perspective, or €21 as per reimbursement from a third-party payer's perspective. Effectiveness was measured as health-related QOL using the Medical Outcomes Study 36-item Short Form Health Survey which generated figures for quality-adjusted life-years (QALYs). Cost-effectiveness, taking into account these cost and effectiveness measures, was calculated as the relation of between-group differences, the incremental cost-effectiveness ratio (ICER).
Baseline costs were lowest in the RM group at €62 society's perspective, €15.3 third party payer's perspective; followed by real acupuncture at €162.0 society's perspective, €30.9 third party payer's perspective; and then sham acupuncture at €205.5 society's perspective, €18.0 third party payer's perspective. The increased costs of acupuncture were mainly due to a higher number of outpatient visits and more days of work loss in both acupuncture groups.
Effectiveness analysis measured by a raw health state utility showed most improvement for acupuncture at 0.798 (95% CI 0.782 to 0.813), followed by sham acupuncture at 0.770 (95% CI 0.747 to 0.793) and was lowest for RM at 0.768 (95% CI 0.747 to 0.789). QALYs for the real acupuncture group were significantly higher than the RM group (p=0.001), but there was no significant difference between the sham acupuncture and waiting list groups (p=0.40).
Cost-effectiveness measured by ICER for real acupuncture was between €31 241 (95% CI €12 049 to €96 013) and €118 889 (95% CI €55 658 to €378 600) from society's perspective and between €20 807 (95% CI €12 856 to €47 624) and €74 585 (95% CI €45 273 to €195 142) from a third party payer's perspective (figure 7). On the basis of a baseline 8-week treatment period and threshold value of €50 000 per QALY gained, the probability of additional acupuncture being worthwhile is only 1.3% from society's perspective and 22.2% from a third party payer's perspective. A longer comparison period of 16 weeks leads to an increase in the cost-effectiveness probability.
Acupuncture is an effective but not cost-effective treatment for SAR in addition to RM according to this study. It is therefore difficult to justify its routine use, especially since SAR is a self-limiting condition which resolves at the end of the hay fever season. However, possible clinical indications for the use of acupuncture may include perennial rhinitis, which is a chronic disease, and severe cases of SAR where RM gives inadequate relief. Acupuncture may be a reasonable additional treatment for these patients, especially since it avoids the use of corticosteroids and their associated side effects. Further research is needed in these areas.
Induction of labour (two papers)
Four-armed RCT (n=407).
Four hundred and seven pregnant women with normal singleton pregnancies and cephalic presentations were randomised at day 290 of gestation into groups of acupuncture, sweeping, acupuncture and sweeping and controls. The primary objective was to compare the proportion of women going into labour before induction of labour 4 days later.
There were no significant differences in the number of women achieving spontaneous labour before planned induction (figure 8). No difference was demonstrated in a comparison of the combined groups treated with acupuncture with the groups not treated with acupuncture (p=0.76). However, significantly more women went into labour before planned induction (p=0.02) in the combined groups receiving sweeping than in the groups not treated with sweeping.
This study was large enough and good enough to show any effect of acupuncture on induction.
Systematic review and meta-analysis (n=2220) of trials of acupuncture for induction of labour.
The usual Cochrane procedures were used for searches and bias assessment. Primary outcomes reported were the need for caesarean section and serious neonatal morbidity, and among the 25 secondary outcomes were failure to progress and the need for oxytocin induction.
Of the retrieved studies, 14 were included in the analysis and eight were excluded for various reasons (insufficient reporting of randomisation, non-relevant intervention, addressing pain relief in labour, dealing with women already in labour). Only one study was described as being of low risk of bias. There was no significant difference in caesarean section rates between women receiving acupuncture and control interventions (n=361). No serious maternal morbidity was reported in the trials. There were no differences in secondary outcomes either, including any difference in time from intervention to delivery (three trials, n=161, figure 9). Duration of labour was shorter in the usual care group compared with acupuncture. Individual trials reported some benefits (eg, in cervical maturation).
This was an update of an earlier analysis, now including more trials. The authors were concerned with the quality of the studies with regard to risk for bias. Overall, they did not see any evidence for the use of acupuncture. The long list of outcomes was confusing and, of the list of five primary outcomes usually looked at in systematic reviews of interventions in induction of labour, only two were addressed in acupuncture studies. In particular, no study reported on vaginal delivery not achieved in 24 h.
Indeterminate systematic reviews
Many systematic reviews of acupuncture that are formally ‘rigorous’ are published with positive trends for acupuncture but with no conclusive findings because of ‘poor quality’. There is an argument for less definitive, more exploratory reviews that could evaluate the literature for the most promising treatments and the most responsive patients to guide further research. Four reviews are briefly summarised here, without further comment.
A total of 25 trials involving 1649 participants were included. The methodological quality of the included trials was generally poor. Meta-analysis showed that manual acupuncture had a better effect on global symptom improvement than mecobalamin (RR 1.31, 95% CI 1.21 to 1.42), vitamin B1 and B12 (RR 1.55, 95% CI 1.33 to 1.80) and no treatment (RR 1.56, 95% CI 1.31 to 1.85), and that the combination of manual acupuncture and mecobalamin had a better effect than mecobalamin alone on global symptom improvement (RR 1.56, 95% CI 1.28 to 1.90). Adverse events were not reported in any trials. The asymmetrical funnel plot suggested publication bias.
Despite the number of trials of manual acupuncture for diabetic peripheral neuropathy and their uniformly positive results, no clinically relevant conclusions can be drawn from this review due to the high risks of bias and the possibility of publication bias of the trials. There remains an urgent need for training Chinese researchers in conducting unbiased trials as well as prospectively registering all initiated Chinese trials to avoid publication bias.
Chemotherapy-induced peripheral neuropathy
Only papers in the English language were included, irrespective of study design. Eight relevant papers were identified. One was an experimental study which showed that electroacupuncture suppressed chemotheraphy-induced peripheral neuropathy (CIPN) pain in rats. In addition, there were seven very heterogeneous clinical studies, one controlled randomised study using auricular acupuncture, two randomised controlled studies using somatic acupuncture, and three case series/case reports which suggested a positive effect of acupuncture in CIPN.
Only one controlled randomised study demonstrated that acupuncture may be beneficial for CIPN. All the clinical studies reviewed had important methodological limitations.
Menopausal hot flushes
Eight studies compared acupuncture with sham acupuncture. No significant difference was found between the groups for hot flush frequency, but flushes were significantly less severe in the acupuncture group, with a small effect size (SMD −0.45, 95% CI −0.84 to −0.05, 6 RCTs, 297 women, I2=62%, very low-quality evidence, high heterogeneity). In a post hoc sensitivity analysis excluding studies of women with breast cancer, there was no significant difference between the groups for either outcome.
Three studies compared acupuncture versus hormone therapy. Acupuncture was associated with significantly more frequent hot flushes than hormone therapy, and there was no significant difference between the groups for hot flush severity.
Four studies compared acupuncture with waiting list or no intervention. Traditional acupuncture was significantly more effective in reducing hot flush frequency from baseline (SMD −0.50, 95% CI −0.69 to −0.31, 3 RCTs, 463 women, I2=0%, low-quality evidence), and was also significantly more effective in reducing hot flush severity (SMD −0.54, 95% CI −0.73 to −0.35, 3 RCTs, 463 women, I(2)=0%, low-quality evidence). The effect size was moderate in both cases.
We found insufficient evidence to determine whether acupuncture is effective for controlling menopausal vasomotor symptoms as the evidence was of low or very low quality.
Thirty-five randomised trials involving 2539 patients were included. The methodological quality of the included trials was evaluated as generally low. Two trials reported the effect of acupuncture compared with sham acupuncture in combinations of Western medicine. Acupuncture significantly reduced systolic blood pressure (−7.47 mm Hg, 95% CI 10.43 to −4.5, p<0.00001) and diastolic blood pressure (−4.22 mm Hg, 95% CI 6.26 to −2.18, p<0.0001) and no heterogeneity was detected between studies. However, other studies had substantial heterogeneity due to their poor quality, and their sample sizes were not satisfactory as an equivalence study. Five trials described the adverse effects.
While there is some evidence to suggest the potential effectiveness of acupuncture for hypertension, the results are limited by the methodological flaws of the studies.
Streitberger needle sensation
Sixty healthy volunteers were recruited from students of the School of Acupuncture and Moxibustion, Guangzhou University of Chinese Medicine, all with experience of acupuncture. They were told a new needle was being tested to see if it was more or less painful than the usual one. They were blinded and received both needles (crossover design). There was no difference between the needles in terms of penetration sensation (table 1), visual analogue score ratings or de qi sensation.
The use of the Streitberger needle is credible in a Chinese population with acupuncture experience, but no wonder it is so successful in generating a response in patients.
Competing interests None.
Provenance and peer review Commissioned; internally peer reviewed.
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.