Placebo devices as effective control methods in acupuncture clinical trials : a systematic review

While the use of acupuncture has been recognised by the World Health Organisation, its efficacy for many of the common clinical conditions is still undergoing validation through randomised controlled trials (RCTs). A credible placebo control for such RCTs to enable meaningful evaluation of its efficacy is to be established. While several non-penetrating acupuncture placebo devices, namely the Streitberger, the Park and the Takakura Devices, have been developed and used in RCTs, their suitability as inert placebo controls needs to be rigorously determined. This article systematically reviews these devices as placebo interventions. Electronic searches were conducted on four English and two Chinese databases from their inceptions to July 2014; hand searches of relevant references were also conducted. RCTs, in English or Chinese language, comparing acupuncture with one of the aforementioned devices as the control intervention on human participants with any clinical condition and evaluating clinically related outcomes were included. Thirty-six studies were included for qualitative analysis while 14 were in the meta-analysis. The meta-analysis does not support the notion of either the Streitberger or the Park Device being inert control interventions while none of the studies involving the Takakura Device was included in the meta-analysis. Sixteen studies reported the occurrence of adverse events, with no significant difference between verum and placebo acupuncture. Author-reported blinding credibility showed that participant blinding was successful in most cases; however, when blinding index was calculated, only one study, which utilised the Park Device, seemed to have an ideal blinding scenario. Although the blinding index could not be calculated for the Takakura Device, it was the only device reported to enable practitioner blinding. There are limitations with each of the placebo devices and more rigorous studies are needed to further evaluate their effects and blinding credibility

The feasibility and effects of Qigong intervention (mind-body exercise) in cancer patients with insomnia : a pilot qualitative study

Background: Up to 80% of cancer patients experience insomnia that significantly affects their quality of life. This pilot qualitative study investigated the feasibility and effects of a 3-week Qigong (mind-body exercise) intervention with a 1-week follow-up in cancer patients experiencing insomnia. Methods: Cancer patients with insomnia who had completed radiotherapy or chemotherapy treatment and/or were at least 8weeks post-cancer-related surgery were recruited. Primary outcomes were feasibility outcomes, which included recruitment, retention, attendance, completion of assessment, adverse events and participant feedback via a questionnaire and focus group/individual interview. Secondary outcomes on insomnia severity and sleep quality were measured using the Insomnia Severity Index (ISI) and the Pittsburgh Sleep Quality Index (PSQI) at baseline, mid, post-intervention and follow-up. Results: Seven participants were recruited and two withdrew from the study. The participant retention rate was 71.4% with an overall attendance rate of more than 84% and participants were able to complete all required assessments. An adverse event relating to the worsening of existing musculoskeletal condition was reported. Qualitative analysis of participant feedback identified 4 emerging themes: (1) experience from Qigong intervention; (2) class preferences; (3) barriers to participation; and (4) recommendation for improvement. Participants reported increased relaxation, improved sleep and energy level, better upper body flexibility and reduced stress. Both ISI and PSQI scores improved significantly (P<.05). Conclusion: This study demonstrated that it is feasible to employ the current clinical trial design using Qigong intervention on insomnia in cancer patients. Preliminary data suggest that the intervention may improve sleep outcomes, however, these findings need to be confirmed by future robust randomized controlled trials

Atopic dermatitis and chinese medicine

Atopic dermatitis (AD) is said to be the most common skin disease among children, which impacts severely on daily life. The etiology has yet to be fully elucidated and current western medicine managements are targeted at symptomatic relief, some of which have unfavorable side effects. According to the traditional Chinese medicine (TCM), AD is said to be related to a congenitally weak constitution, leading to the attack or generation of pathogenic factors. Chinese herbal medicine (CHM) is usually individualized for each and every patient; however, in hope of increasing the scientific evidence of its efficacy and safety in the treatment of AD, several clinical trials have been conducted using non-individualized CHM. This chapter reviews the findings of clinical and laboratory studies of 4 CHM formulae: Zemaphyte, Pentaherbs Capsule, Hochu-ekki-to, and Xiao Feng San. In clinical studies, Zemaphyte had conflicting results, Pentaherb Capsule and Hochu-ekki-to showed no significant difference in disease severity but found improvement in secondary outcomes, and Xiao Feng San had positive results. All in-vitro studies found potential pharmacological effects that may be beneficial in the management of AD. However, aside from evidence still being deemed insufficient, there were one or more flaws in the clinical study designs, leading to concerns of the credibility of the results. The main concerns identified with studies included the general quality of studies, the suitability of the using a scientific, randomized, control methodology for TCM studies, the lack of pharmacological data of CHM, and the lack of assurance regarding the safety of the intervention. Currently, the treatment of AD with TCM is still highly based on historical and empirical evidence; and as the complete pathophysiology of AD remains unknown, it may be difficult to determine which biochemical and pharmacological properties are required in the CHM to allow it to be deemed a potential pharmacotherapy

Efficacy of acupuncture in the management of atopic dermatitis : a systematic review

Summary Atopic dermatitis (AD) has a high negative impact on quality of life. Acupuncture has antipruritic actions and may assist in treatment of AD; however, the current state of evidence for this remains unknown. We aimed to evaluate the efficacy of acupuncture against placebo/sham acupuncture in the management of AD. Electronic searches were conducted on a number of databases, from their inception until November 2013. Studies comparing the effects of acupuncture with those of placebo/sham acupuncture on severity of disease or symptoms/signs of AD were included. We did not find any studies that were eligible to be included in this systematic review. Among the excluded studies, there were two studies that evaluated the antipruritic effects of acupuncture and one study that evaluated the effects of acupuncture on IgE-mediated allergy. However, there were no randomized controlled trials evaluating the effects of acupuncture on AD as a disease. This finding therefore provides an indication of the current state of evidence of acupuncture in the management of AD, and highlights the research gap that exists, in that there is a lack of gold-standard studies (i.e. RCTs) to support valid conclusions. There is currently no evidence of the effects of acupuncture in the management of AD, and no evidence-based recommendations or conclusions can be made from this review. Several studies indicated that acupuncture may have a role in reducing itch or regulating IgE-mediated allergy, both of which are major characteristics of AD. However, there were no RCTs evaluating the effects of acupuncture on AD as a disease. There is therefore an urgent need for rigorously designed RCTs to assess the efficacy of acupuncture in the management of AD. Click here for the corresponding questions to this CME article

Chinese herbal medicine for atopic dermatitis : a systematic review

Background: Atopic dermatitis (AD) is a chronic, itching skin disease, and conventional therapies offer inadequate symptom management. Patients with AD are increasingly turning to Chinese medicine. Objective: We systematically evaluated the clinical evidence of the efficacy and safety of oral Chinese herbal medicine for AD. Methods: Searches were conducted on major electronic databases using the following key words: "randomized controlled trials," "atopic dermatitis," "traditional Chinese medicine," "traditional East Asian medicine," "herbal medicine," "Chinese herbal drugs," "medicinal plants," "phytotherapy," "Kampo medicine," and "Korean traditional medicine." The results were screened to include English/Chinese randomized controlled trials. A metaanalysis was conducted on suitable outcome measures. Results: Seven randomized controlled trials were included (1 comparing Chinese herbal medicine and Western medicine with Western medicine alone; 6 comparing Chinese herbal medicine with placebo). Combined Chinese herbal medicine with Western medicine was superior to Western medicine alone. Three placebo controlled trials showed significant treatment efficacy and 2 showed significantly reduced concurrent therapy with Chinese herbal medicine. No abnormalities in safety profile or severe adverse events were reported. Limitations: A metaanalysis of all included studies could not be conducted because of study heterogeneity. Conclusions: Chinese herbal medicine significantly improved symptom severity of AD and was reported as well tolerated. However, the poor quality of studies did not allow for valid conclusions to support its tolerability and routine use. Additional studies addressing the methodologic issues are warranted to determine the therapeutic benefit of Chinese herbal medicine for AD

Acupuncture performed around the time of embryo transfer : a systematic review and meta-analysis

This was a systematic review and meta-analysis to examine the efficacy, effectiveness and safety of acupuncture as an adjunct to embryo transfer compared with controls to improve reproductive outcomes. The primary outcome was clinical pregnancy. Twenty trials and 5130 women were included in the review. The meta-analysis found increased pregnancies (risk ratio [RR] 1.32, 95% confidence interval [CI] 1.07–1.62, 12 trials, 2230 women), live births (RR 1.30, 95% CI 1.00–1.68, 9 trials, 1980 women) and reduced miscarriage (RR 1.43, 95% CI 1.03–1.98, 10 trials, 2042 women) when acupuncture was compared with no adjunctive control. There was significant heterogeneity, but no significant differences between acupuncture and sham controls. Acupuncture may have a significant effect on clinical pregnancy rates, independent of comparator group, when used in women who have had multiple previous IVF cycles, or where there was a low baseline pregnancy rate. The findings suggest acupuncture may be effective when compared with no adjunctive treatment with increased clinical pregnancies, but is not an efficacious treatment when compared with sham controls, although non-specific effects may be active in both acupuncture and sham controls. Future research examining the effects of acupuncture for women with poorer IVF outcomes is warranted

Evaluation of the efficacy and safety of a Chinese herbal formula (RCM-106) for atopic dermatitis : study protocol for a randomised, double-blind, placebo-controlled trial in children

Introduction: Atopic dermatitis is a chronic, inflammatory skin rash that greatly affects quality of life. The current therapies are inadequate in managing atopic dermatitis and often have associated adverse effects or drug tolerance development. Chinese medicine is expected to have promising prospects in the management of atopic dermatitis and recent studies have shown encouraging results. This study aims to evaluate the efficacy and safety of a newly formulated Chinese herbal formula, RMIT Chinese Medicine-106 (RCM-106), in the management of moderate-to-severe atopic dermatitis in children aged 6-18 years. Methods: The study is a randomised, double-blind, placebo-controlled, parallel-armed clinical trial. Participant, investigator and assessors will remain blinded to the treatment assignment until after the study has been completed. After a 2-week run-in period, 90 participants will be randomised, using block randomised sequences generated by computer, to receive either RCM-106 or matching placebo capsules, twice daily, for a treatment period of 8 weeks and followed up for 4 weeks. Primary outcome measures include the evaluation of disease severity and extent using two validated scoring instruments-Scoring Atopic Dermatitis (SCORAD) and Patient-Oriented Scoring Atopic Dermatitis (PO-SCORAD). Secondary outcome measures include the evaluation of quality of life using the Children's Dermatology Life Quality Index (CDLQI); occurrence of adverse events and total usage of other therapies as recorded in the participants' daily diary and laboratory studies which include eosinophil count, total IgE, full blood count and liver and kidney function tests. Intention-to-treat analysis will be applied to all data analyses. Ethics and dissemination: This trial has received human ethics approval from the Human Research Ethics Committee (HREC) of RMIT University (Project number 15/12). The study findings will be published in peerreviewed journals and presented at the national and international conferences

Acupuncture versus antidepressants in the management of postpartum depression : a systematic review

Background: Antidepressants for postnatal depression may not be acceptable to women and so many may seek alternative therapies. Aim: To evaluate the effectiveness and safety of acupuncture for postnatal depression compared with antidepressant treatment. Methods: A literature search was conducted in English, Chinese, Japanese and Korean databases. Details of the trials were extracted and analysed. Findings Of the 1592 studies reviewed, three met the inclusion criteria for quantitative analysis.Two studies reported no significant differences between acupuncture and fluoxetine for depression, while the third reported significant improvements. Conclusions: Acupuncture in postpartum depression was at least as effective as fluoxetine hydrochloride, supporting the notion that acupuncture may be a safe and effective option

Systematic review of acupuncture placebo devices with a focus on the credibility of blinding of healthy participants and/or acupuncturists

Background: An ideal placebo design in clinical research should resemble the intervention under investigation to facilitate blinding, yet remain clinically inert. With regard to physical interventions such as acupuncture, a true placebo device has not been developed and validated. Since 1998, researchers have designed several placebo acupuncture devices (PADs). The three most widely used PADs are the Streitberger, the Park and the Takakura device. Aim: This review focuses on evaluating studies of these devices, in the context of credibility of blinding (COB), assessment of penetrating pain or sensation, and de qi sensation. Methods: Electronic database searches were conducted in four English and two Chinese databases from their inception until November 2016. All studies included in the review were conducted on healthy participants and compared verum manual acupuncture with any of the aforementioned PADs with respect to one or more of the above three outcomes related to blinding effect. Results: The synthesised analyses of the 15 included studies showed that the Streitberger and Park placebo devices may not blind participants successfully when tested at a sensitive acupuncture point (LI4). In terms of penetrating sensation, there were significant differences between these two placebo devices and verum acupuncture when applied at this point. The Takakura device was the only PAD that had the potential to blind the acupuncturist. However, the blinding analyses of all outcome measures were inconsistent. Conclusion: Overall, there were insufficient data to confirm the blinding effects of these skin-contact PADs as each device was associated with limitations that warrant further design improvements

Chinese herbal medicine for mild cognitive impairment : a systematic review and meta-analysis of cognitive outcomes

Mild cognitive impairment (MCI) is a condition that may be prodromal to the development of dementia. There remain, as yet, no approved pharmaceutical interventions for MCI. Chinese herbal medicines (CHMs) have a long history of use for cognitive impairments and some plant ingredients have shown neuroprotective actions in experimental studies. This review assesses the current clinical evidence from controlled clinical trials for the effects of CHMs on cognitive outcomes as measured by Mini-mental state examination (MMSE) or Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog). Fifty one studies (4026 participants) were included. These compared CHM with placebo, supportive care, pharmaceutical treatment or combined CHM with a pharmaceutical in an integrative setting. For the eight randomised controlled trials (RCTs) of comparisons with placebo, MMSE was significantly higher in the CHM groups (MD 1.56 [0.78, 2.34] I2 = 85%, n = 503), similarly for eight RCTs of comparisons with supportive care (MD 1.77 [1.33, 2.21] I2 = 0%, n = 555). Benefits were also evident in comparisons with some pharmaceuticals and with integrative treatment. The small size of most studies and methodological weaknesses mean that these results should be interpreted with caution. Further studies employing rigorous methods are required to investigate the potential benefits of these CHMs for MCI