Acupuncture for analgesia in the emergency department: a multicentre, randomised, equivalence and non-inferiority trial.

OBJECTIVES: This study aimed to assess analgesia provided by acupuncture, alone or in combination with pharmacotherapy, to patients presenting to emergency departments with acute low back pain, migraine or ankle sprain. DESIGN: A pragmatic, multicentre, randomised, assessor-blinded, equivalence and non-inferiority trial of analgesia, comparing acupuncture alone, acupuncture plus pharmacotherapy, and pharmacotherapy alone for alleviating pain in the emergency department. Setting, participants: Patients presenting to emergency departments in one of four tertiary hospitals in Melbourne with acute low back pain, migraine, or ankle sprain, and with a pain score on a 10-point verbal numerical rating scale (VNRS) of at least 4. MAIN OUTCOME MEASURES: The primary outcome measure was pain at one hour (T1). Clinically relevant pain relief was defined as achieving a VNRS score below 4, and statistically relevant pain relief as a reduction in VNRS score of greater than 2 units. RESULTS: 1964 patients were assessed between January 2010 and December 2011; 528 patients with acute low back pain (270 patients), migraine (92) or ankle sprain (166) were randomised to acupuncture alone (177 patients), acupuncture plus pharmacotherapy (178) or pharmacotherapy alone (173). Equivalence and non-inferiority of treatment groups was found overall and for the low back pain and ankle sprain groups in both intention-to-treat and per protocol (PP) analyses, except in the PP equivalence testing of the ankle sprain group. 15.6% of patients had clinically relevant pain relief and 36.9% had statistically relevant pain relief at T1; there were no between-group differences. CONCLUSION: The effectiveness of acupuncture in providing acute analgesia for patients with back pain and ankle sprain was comparable with that of pharmacotherapy. Acupuncture is a safe and acceptable form of analgesia, but none of the examined therapies provided optimal acute analgesia. More effective options are needed. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12609000989246.

A Pharmacological Review of Bioactive Constituents of Paeonia lactiflora Pallas and Paeonia veitchii Lynch.

The roots of two peony species, Paeonia lactiflora Pallas and Paeonia veitchii Lynch are routinely referred to as either chishao () or baishao (). This paper reviews the botanical origins and traditional medicinal usage of each species, as well as pharmacological like activity of their constituents. A search of herbal pharmacological encyclopaedia, PubChem and PubMed databases identified their known constituents. The biological data for these constituents were evaluated and classified according to pharmacological-like activity, with emphasis on compounds of greatest concentration and bioavailability. It was found that P. lactiflora and P. veitchii have some common compounds; however, their phytochemical bioavailability varies. Furthermore, a larger number of compounds have been identified in P. lactiflora. These have greater potential for antiinflammatory, antiviral, antibacterial and antioxidant therapeutic activity compared with P. veitchii. However, evidence indicates both species are similarly indicated for antiviral and glycaemic activity. Major compounds of each are classified as flavonoids, hydrolysable tannins (polyphenols) and monoterpene glycosides. The evidence suggests both species, when administered in entire botanical form, have an excellent safety profile; however, constituent toxicity risk evidence is limited, requiring further investigation. Although experiments show many compounds have biological activity, further investigation of their therapeutic potential is needed. Copyright © 2016 John Wiley & Sons, Ltd.

Add-on effect of PSORI-CM01 to topical calcipotriol for moderate psoriasis vulgaris: A multi-center, randomized, double-blind pilot study.

BACKGROUND: Mild-moderate psoriasis vulgaris is a common dermatological autoimmune condition with limited conventional therapeutic options. Safe and effective adjunct therapies to topical non-steroidal antipsoriatic therapy are needed. The oral Chinese herbal medicine (CHM) formula PSORI-CM01 has been evidenced potential antipsoriatic pharmacological activity. This article reports a pilot study which was designed as a double-blinded, placebo-controlled randomized controlled trial (RCT) evaluating the effects of PSORI-CM01 when added to topical calcipotriol cream. METHODS: People with moderate psoriasis vulgaris were randomized to receive oral PSORI-CM01 or placebo administered for 12 weeks in combination with calcipotriol. The primary clinical outcome was the change of psoriasis area severity index (PASI) score at week 12 and week 24. Secondary clinical outcomes were PASI75, PASI50, relapse rate, change in body surface area, dermatology life quality index and Skindex29, and adverse events (AEs). Participants' satisfaction and willingness to repeat were also assessed. RESULTS: The pilot study was conducted in Australia and China, 29 participants were randomized with 26 completed the treatment and follow-up. Participants' baseline basic characteristics were comparable. No between-group statistical significance was found on pre-defined clinical outcome measures, although there seemed a trend of treatment effects favoring the combination of PSORI-CM01 with calcipotriol. Frequency and severity of AEs were similar between two groups, with no severe AEs reported. CONCLUSIONS: The design and duration of the study appears feasible. A proper powered RCT with slight adjustments in the methods is needed to reveal the add-on effects of oral CHM PSORI-CM01. The experience and results from this pilot study will contribute to the refine of objectives and design of a future study, and assist the sample size calculation for the full-scale RCT.

Acupuncture for Acne Vulgaris: A Systematic Review and Meta-Analysis.

PURPOSE: To conduct a systematic review and meta-analysis to determine the current best available evidence of the efficacy and safety of acupuncture and related therapies for acne vulgaris. METHODS: Eleven English and Chinese databases were searched to identify randomized controlled trials (RCTs) of acne vulgaris compared to pharmacotherapies, no treatment, and sham or placebo acupuncture. Methodological quality was assessed using Cochrane Collaboration's risk of bias tool. Meta-analysis was conducted using RevMan software. RESULTS: Twelve RCTs were included in the qualitative review and 10 RCTs were included in meta-analysis. Methodological quality of trials was generally low. The chance of achieving ≥30% change in lesion count in the acupuncture group was no different to the pharmacotherapy group (RR: 1.07 [95% CI 0.98, 1.17]; I2 = 8%) and ≥50% change in lesion count in the acupuncture group was not statistically different to the pharmacotherapy group (RR: 1.07 [95% CI 0.98, 1.17]; I2 = 50%). CONCLUSIONS: While caution should be exercised due to quality of the included studies, acupuncture and auricular acupressure were not statistically different to guideline recommended treatments but were with fewer side effects and may be a treatment option. Future trials should address the methodological weaknesses and meet standard reporting requirements stipulated in STRICTA.

Oral Chinese herbal medicine versus placebo for psoriasis vulgaris: A systematic review.

OBJECTIVES: Psoriasis is a chronic inflammatory skin disorder and the efficacy and safety of Chinese herbal medicine (CHM) treatments is unclear. This review evaluates oral CHM for psoriasis vulgaris clinical trial evidence. DESIGN: The Cochrane Library, PubMed, EMBASE, CINAHL, AMED, CBM, CNKI, CQVIP and Wanfang databases were searched from inception to June 2015. Randomised controlled trials (RCTs) of oral CHM compared to placebo data were included and analysed using Review Manager 5.2. RESULTS: Seven studies were included, no study utilised identical CHM intervention. Four studies data were subgrouped (decoction or capsule/pill) and pooled in meta-analysis to evaluate treatment effective rate for PASI60 or above (RR: 2.74 [0.92, 8.21] I2 = 65%). Another five studies were subgrouped and evaluated for PASI score change, (MD -7.00 [-10.74, -3.27] I2 = 98%). Only one study presented Dermatology Life Quality Index data, which favoured CHM (MD: -4.08 [-7.56, -0.60]). Two studies presented data on psoriasis-related inflammatory cell-signalling protein tumour necrosis factor-a (TNF-a) (MD: -4.92 [-5.31, -4.53]). No serious adverse events were reported. CONCLUSION: While CHMs appear to be safe and may have benefit for psoriasis, variation between CHM interventions, outcome measures and the quality of included studies limit the conclusions of this review. Further rigorous RCTs utilising reliable, validated symptom and QoL outcome measures are recommended.

Acupuncture and standard emergency department care for pain and/or nausea and its impact on emergency care delivery: a feasibility study.

OBJECTIVE: To evaluate the feasibility of delivering acupuncture in an emergency department (ED) to patients presenting with pain and/or nausea. METHODS: A feasibility study (with historical controls) undertaken at the Northern Hospital ED in Melbourne, Australia, involving people presenting to ED triage with pain (VAS 0-10) and/or nausea (Morrow Index 1-6) between January and August 2010 (n=400). The acupuncture group comprised 200 patients who received usual medical care and acupuncture; the usual care group comprised 200 patients with retrospective data closely matched from ED electronic health records. RESULTS: Refusal rate was 31%, with 'symptoms under control owing to medical treatment before acupuncture' the most prevalent reason for refusal (n=36); 52.5% of participants responded 'definitely yes' for their willingness to repeat acupuncture, and a further 31.8% responded 'probably yes'. Over half (57%) reported a satisfaction score of 10 for acupuncture treatment. Musculoskeletal conditions were the most common conditions treated n=117 (58.5%), followed by abdominal or flank pain n=49 (24.5%). Adverse events were rare (2%) and mild. Pain and nausea scores reduced from a mean±SD of 7.01±2.02 before acupuncture to 4.72±2.62 after acupuncture and from 2.6±2.19 to 1.42±1.86, respectively. CONCLUSIONS: Acupuncture in the ED appears safe and acceptable for patients with pain and/or nausea. Results suggest combined care may provide effective pain and nausea relief in ED patients. Further high-quality, sufficiently powered randomised studies evaluating the cost-effectiveness and efficacy of the add-on effect of acupuncture are recommended.

Oral granulated Chinese herbal medicine (YXBCM01) plus topical calcipotriol for psoriasis vulgaris: study protocol for a double-blind, randomized placebo controlled trial.

BACKGROUND: Probably related to immune dysfunction, psoriasis vulgaris is a chronic, painful, disfiguring and disabling dermatological disease, carrying an increased risk of serious comorbidities. Current conventional therapies can be costly, show risks of side effects and have limited efficacy, with relapse common on treatment cessation. Chinese herbal medicine is effective in treating psoriasis vulgaris. However, any benefit of adding Chinese herbal medicine to conventional treatments when treating psoriasis vulgaris is yet to be determined. METHODS/DESIGN: This is a pilot randomized, placebo controlled, double-blinded trial. The pilot is primarily to determine the feasibility of undertaking a full size randomized trial. Thirty participants with psoriasis vulgaris and Psoriasis Area Severity Index (PASI) scores ≥ 7 and ≤ 12 will be included. Participants will be randomized (in a 1:1 ratio) to receive oral granulated Chinese herbal medicine YXBCM01 plus topical calcipotriol 0.005% or oral YXBCM01 placebo plus topical calcipotriol 0.005% treatment for 12 weeks, with a 12-week follow-up phase. The Chinese herbal medicine or placebo will be administered orally as dissolvable granules. The primary outcome measure will be PASI change (%) from baseline to the end of treatment phase. Secondary outcomes will include safety, key psoriasis-related cytokine changes (for example, IL12, IL17 and IL 23) during the entire trial and symptom relapse rates at the end of the follow-up phase. DISCUSSION: The study will evaluate the feasibility of a randomized controlled trial investigating combined conventional and Chinese herbal medicine therapy for psoriasis vulgaris. The ingredients of YXBCM01 were selected based on literature, the expert opinion on herbal medicine and pre-clinical evidence, for instance Chinese herbal medicine possesses anti-inflammatory or antiproliferative properties. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12614000493640.

Oral Chinese herbal medicine combined with pharmacotherapy for psoriasis vulgaris: a systematic review.

Clinically, oral Chinese herbal medicine (CHM) is widely used in the treatment of psoriasis. This review evaluates the effects of oral CHM in combination with pharmacotherapy for psoriasis vulgaris. The Cochrane Library, PubMed, Embase, CINAHL, CNKI, and CQVIP were searched from their inceptions to November 2012. Randomized controlled trials (RCTs) investigating CHM plus pharmacotherapy compared to pharmacotherapy were included. Data were analyzed using Review Manager 5.1.0. Seventeen RCTs were included, conducted in China, and employed a diversity of both herbal medicines and pharmacotherapies. When the meta-analyses were restricted to studies that used a well-known pharmacotherapy as the comparator with 60% or greater clinical improvement in psoriasis as the outcome, five studies used oral acitretin, one used topical calcipotriol, and one used topical clobetasol propionate as control interventions. At the end of treatment, there was a benefit for the pooled result of the five studies that compared CHM plus acitretin with acitretin alone and no serious adverse events were reported. However, none of these studies was blind, so there is considerable risk of bias in this result. In addition, there was inadequate reporting of longer-term results, so it remains unclear whether the reported effect could be maintained or whether the prolonged use of the CHM in conjunction with acitretin would be safe. The main plants used in these studies, Rehmannia glutinosa root, Salvia miltiorrhiza root, and Lithospermum erythrorhizon root, have shown anti-inflammatory and/or antiproliferative effects in experimental studies. These actions may at least partially explain the observed results.

Key considerations for conducting Chinese medicine clinical trials in hospitals.

Conducting clinical trials of Chinese medicines (CM) in hospitals presents challenges for researchers. The success of hospital-based CM clinical trials may be influenced by the protocol design, including the maintenance of CM theory in compliance with scientific rigour and hospital guidelines and justified treatment approaches with results that can translate into clinical practice. Other influences include personnel and resources such as a dedicated team open to CM with an established research culture and the ability to maximise participant recruitment. This article identifies the key challenges and limitations of conducting CM clinical trials in Australian hospitals.

Acupuncture as analgesia for low back pain, ankle sprain and migraine in emergency departments: study protocol for a randomized controlled trial.

BACKGROUND: Pain is the most common reason that patients present to an emergency department (ED) and is often inadequately managed. Evidence suggests that acupuncture is effective for pain relief, yet it is rarely practiced in the ED. The current study aims to assess the efficacy of acupuncture for providing effective analgesia to patients presenting with acute low back pain, migraine and ankle sprain at the EDs of four hospitals in Melbourne, Australia. METHOD: The study is a multi-site, randomized, assessor-blinded, controlled trial of acupuncture analgesia in patients who present to an ED with low back pain, migraine or ankle sprain. Patients will be block randomized to receive either acupuncture alone, acupuncture as an adjunct to pharmacotherapy or pharmacotherapy alone. Acupuncture will be applied according to Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). Pain after one hour, measured using a visual analogue scale (VAS), is the primary outcome. Secondary outcomes measures include the following instruments; the Oswestry low back pain disability questionnaire, 24-hour Migraine Quality of Life questionnaire and Patient's Global Assessment of Ankle Injury Scale. These measures will be recorded at baseline, 1 hour after intervention, each hour until discharge and 48±12 hours of ED discharge. Data will also be collected on the safety and acceptability of acupuncture and health resource utilization. DISCUSSION: The results of this study will determine if acupuncture, alone or as an adjunct to pharmacotherapy provides effective, safe and acceptable pain relief for patients presenting to EDs with acute back pain, migraine or ankle sprain. The results will also identify the impact that acupuncture treatment may have upon health resource utilisation in the ED setting. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000989246.