Cliff Da Costa

Effect of acupuncture in the treatment of seasonal allergic rhinitis: a randomized controlled clinical trial.

The clinical efficacy and safety of acupuncture in the treatment of Seasonal Allergic Rhinitis (SAR) was evaluated by employing a two-phase crossover single-blind clinical trial. Thirty subjects were randomly assigned to two groups with 17 and 13 subjects respectively and treated with real or sham acupuncture (three times per week) for four consecutive weeks and then a crossover for treatments for a further four weeks without a washout period. The administration of real acupuncture treatment was guided by a syndrome differentiation according to Chinese Medicine Theory. Subjects were assessed by various criteria before, during and after the treatments. Outcome measures included subjective symptom scores using a five-point scale (FPS), relief medication scores (RMS) and adverse effect records. Twenty-six (26) subjects completed the study. There was a significant improvement in FPS (nasal and non-nasal symptoms) between the two types of acupuncture treatments. No significant differences were shown in RMS between the real acupuncture treatment group and the sham acupuncture treatment group. No side effects were observed for both groups. The results indicate that acupuncture is an effective and safe alternative treatment for the management of SAR.

Ear acupressure for smoking cessation: a randomised controlled trial.

This study investigated the efficacy and safety of ear acupressure (EAP) as a stand-alone intervention for smoking cessation and the feasibility of this study design. Adult smokers were randomised to receive EAP specific for smoking cessation (SSEAP) or a nonspecific EAP (NSEAP) intervention which is not typically used for smoking cessation. Participants received 8 weekly treatments and were requested to press the five pellets taped to one ear at least three times daily. Participants were followed up for three months. Primary outcome measures were a 7-day point-prevalence cessation rate confirmed by exhaled carbon monoxide and relief of nicotine withdrawal symptoms (NWS). Intention-to-treat analysis was applied. Forty-three adult smokers were randomly assigned to SSEAP (n = 20) or NSEAP (n = 23) groups. The dropout rate was high with 19 participants completing the treatments and 12 remaining at followup. One participant from the SSEAP group had confirmed cessation at week 8 and end of followup (5%), but there was no difference between groups for confirmed cessation or NWS. Adverse events were few and minor.

The effect of electroacupuncture on opioid-like medication consumption by chronic pain patients: a pilot randomized controlled clinical trial.

Opioid‐like medications (OLM) are commonly used by patients with various types of chronic pain, but their long‐term benefit is questionable. Electroacupuncture (EA) has been previously shown beneficial in reducing post‐operative acute OLM consumption. In this pilot randomized controlled trial, the effect of EA on OLM usage and associated side effects in chronic pain patients was evaluated. After a two‐week baseline assessment, participants using OLM for their non‐malignant chronic pain were randomly assigned to receive either real EA (REA, n=17) or sham EA (SEA, n=18) treatment twice weekly for 6 weeks before entering a 12‐week follow‐up. Pain, OLM consumption and their side effects were recorded daily. Participants also completed the McGill Pain Questionnaire (MPQ), SF‐36 and Beck Depression Inventory (BDI) at baseline, and at the 5th, 8th, 12th, 16th and 20th week. Nine participants withdrew during the treatment period with another three during the follow‐up period. Intention to treat analysis was applied. At the end of treatment period, reductions of OLM consumption in REA and SEA were 39% and 25%, respectively (p=0.056), but this effect did not last more than 8 weeks after treatment. There was no difference between the two groups with respect to reduction of side effects and pain and the improvement of depression and quality of life. In conclusion, REA demonstrates promising short‐term reduction of OLM for participants with chronic non‐malignant pain, but such effect needs to be confirmed by trials with adequate sample sizes.

Assessing Quality of Case Series Studies: Development and Validation of an Instrument by Herbal Medicine CAM Researchers

OBJECTIVES When higher level of evidence is absent, findings of case series studies can be used to generate hypotheses for further research. However, to date, there has been no established instrument for determining their quality. This study was to develop and validate an instrument to assess the quality of case series studies on herbal medicines. DESIGN A draft instrument was developed based on items generated by judges. Raters (including judges), consisting of herbal medicine researchers, herbal medicine practitioners, and other professionals, used the draft instrument to assess the quality of sample case series reports. The number of quality assessment items was then reduced as much as possible in the instrument while maintaining its reliability and validity. Content and construct validity, and inter-rater agreement of the instrument were used as the main outcome measures. RESULTS Seven (7) judges from different backgrounds independently generated 68 nonredundant items for inclusion in the initial draft instrument. The content validity of these items was assessed by all judges for consensus using a seven-point scale, and a 24-item second-draft instrument was derived. The wording and sequence of these items were further revised and then used by 20 raters (including seven judges) to assess the quality of 35 case series reports. A 13-item instrument was finally developed. All raters, including the judges, demonstrated a high level of consistency on quality of the reports by using this instrument, despite their different backgrounds. CONCLUSIONS High-level consistency can be achieved by using this instrument to assess the quality of case series studies. This instrument may facilitate the improvement of reporting quality of case series studies.

Acupuncture analgesia for temporal summation of experimental pain: A randomised controlled study

Background: Temporal summation of pain, a phenomenon of the central nervous system (CNS), represents enhanced painful sensation or reduced pain threshold upon repeated stimulation. This pain model has been used to evaluate the analgesic effect of various medications on the CNS.

Low back pain risk factors in a large rural Australian Aboriginal community. An opportunity for managing co-morbidities?

BackgroundLow back pain (LBP) is the most prevalent musculo-skeletal condition in rural and remote Australian Aboriginal communities. Smoking, physical inactivity and obesity are also prevalent amongst Indigenous people contributing to lifestyle diseases and concurrently to the high burden of low back pain.ObjectivesThis paper aims to examine the association between LBP and modifiable risk factors in a large rural Indigenous community as a basis for informing a musculo-skeletal and related health promotion program.MethodsA community Advisory Group (CAG) comprising Elders, Aboriginal Health Workers, academics, nurses, a general practitioner and chiropractors assisted in the development of measures to assess self-reported musculo-skeletal conditions including LBP risk factors. The Kempsey survey included a community-based survey administered by Aboriginal Health Workers followed by a clinical assessment conducted by chiropractors.ResultsAge and gender characteristics of this Indigenous sample (n = 189) were comparable to those reported in previous Australian Bureau of Statistics (ABS) studies of the broader Indigenous population. A history of traumatic events was highly prevalent in the community, as were occupational risk factors. Thirty-four percent of participants reported a previous history of LBP. Sporting injuries were associated with multiple musculo-skeletal conditions, including LBP. Those reporting high levels of pain were often overweight or obese and obesity was associated with self-reported low back strain. Common barriers to medical management of LBP included an attitude of being able to cope with pain, poor health, and the lack of affordable and appropriate health care services.Though many of the modifiable risk factors known to be associated with LBP were highly prevalent in this study, none of these were statistically associated with LBP.ConclusionAddressing particular modifiable risk factors associated with LBP such as smoking, physical inactivity and obesity may also present a wider opportunity to prevent and manage the high burden of illness imposed by co-morbidities such as heart disease and type-2 diabetes.

Semi-self-administered ear acupressure for persistent allergic rhinitis: a randomised sham-controlled trial

The Brassicaceae family encompasses numerous species of great agronomic importance, belonging to such genera as Brassica, Raphanus, Sinapis, and Annoracia.1 Raphanus sativus is a perennial plant that belongs to the Brassicaceae family, and it is native to China and Japan. The radish is eaten raw; the bulbs and the leafs are edibles and are used for the preparation of salads in some Mediterranean areas. The R sativus bulb is spherical and red and has white pulp, with a pungent flavor and lobed leafs with irregular edges. The literature reports reactions to Raphanus niger, which is considered a variety of R sativus.

Acupuncture for Frequent Migraine: A Randomized, Patient/Assessor Blinded, Controlled Trial with One-Year Follow-Up.

Objectives. This study aimed to evaluate the efficacy and safety of manual acupuncture as a prophylaxis for frequent migraine. Methods. Fifty frequent migraineurs were randomly allocated to receive 16 sessions of either real acupuncture (RA = 26) or sham acupuncture (SA = 24) during 20 weeks. The primary outcomes were days with migraine over four weeks, duration, and intensity of migraine and the number of responders with more than 50% reduction of migraine days. The secondary outcomes were the relief medication, quality of migraine, quality of life, and pressure pain thresholds. Results. The two groups were comparable at baseline. At the end of the treatment, when compared with the SA group, the RA group reported significant less migraine days (RA: 5.2 ± 5.0; SA: 10.1 ± 7.1; P = 0.008), less severe migraine (RA: 2.18 ± 1.05; SA: 2.93 ± 0.61; P = 0.004), more responders (RA: 19 versus SA: 7), and increased pressure pain thresholds. No other group difference was found. Group differences were maintained at the end of the three-month follow-up, but not at the one-year follow-up. No severe adverse event was reported. Blinding was successful. Discussion. Manual acupuncture was an effective and safe treatment for short-term relief of frequent migraine in adults. Larger trials are 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 Childrens 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 peer-reviewed journals and presented at the national and international conferences. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612001181897. TGA CTN Scheme: Trial number 2012/0713; Protocol number 15/12.

Panax ginseng C.A Meyer root extract for moderate Chronic Obstructive Pulmonary Disease (COPD): study protocol for a randomised controlled trial

BackgroundChronic obstructive pulmonary disease (COPD) impairs quality of life and leads to premature mortality. COPD sufferers experience progressive deterioration of lung function and decreased ability to undertake day-to-day activities. Ginseng has been used for thousands of years in Chinese medicine for respiratory symptoms. Several controlled clinical trials using ginseng for COPD have shown promising clinical effect, however these studies were generally small and with some potential bias, prompting the need for rigorously designed studies.AimThe objective of this study is to evaluate the therapeutic value and safety profile of a standardised root extract of Panax ginseng C.A Meyer (ginseng) for symptomatic relief, with a focus on quality of life (QoL) improvements in individuals with moderate (Stage II) COPD FEV1/FVC < 0.7 and FEV1 50% - 80% predicted.MethodsThis paper describes the design of a randomised, multi-centre, double-blind, placebo controlled, two-armed parallel clinical trial. Two trial sites in Melbourne Australia will proportionately randomise a total of 168 participants to receive either ginseng capsule (100 mg) or matching placebo twice daily for 24 weeks. The primary outcomes will be based on three validated QoL questionnaires, St Georges Respiratory Questionnaire (SGRQ), Short Form Health Survey (SF-36) and the COPD Assessment Test (CAT). Secondary outcomes are based on lung function testing, relief medication usage and exacerbation frequency and severity. Safety endpoints include blood tests and adverse event reporting. Intention-to-treat will be applied to all data analyses.DiscussionFindings from this study may lead to new therapeutic development for chronic respiratory diseases, particularly COPD. This protocol may also guide other investigators to develop quality herbal medicine clinical trials in the future.Trial registrationAustralia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000768099