Effectiveness of recruitment in clinical trials: an analysis of methods used in a trial for irritable bowel syndrome patients.

A successful clinical trial is dependent on recruitment. Between December 2003 and February 2006, our team successfully enrolled 289 participants in a large, single-center, randomized placebo-controlled trial (RCT) studying the impact of the patient-doctor relationship and acupuncture on irritable bowel syndrome (IBS) patients. This paper reports on the effectiveness of standard recruitment methods such as physician referral, newspaper advertisements, fliers, audio and video media (radio and television commercials) as well as relatively new methods not previously extensively reported on such as internet ads, ads in mass-transit vehicles and movie theater previews.

The effect of Gua Sha treatment on the microcirculation of surface tissue: a pilot study in healthy subjects.

Context: Gua Sha, therapeutic surface frictioning that intentionally raises transitory petechiae and ecchymosis, is a traditional East Asian healing technique also known as cao gio, coining, scraping, and spooning. There are case reports in Western literature but no studies on the physiological effects of Gua Sha.

Objective: To study the microcirculatory effects of Gua Sha on the skin and subcutis in humans to elucidate physiological mechanisms responsible for the clinically observed pain-relieving effect of this treatment

Design: Laser Doppler imaging (LDI) was used to make sequential measurements of the microcirculation of surface tissue before and after Gua Sha treatment in 11 healthy subjects.

Sham acupuncture devices--practical advice for researchers.

Several validated sham acupuncture devices have recently become available. While some debate exists on whether such needles are the best placebo control for an RCT of acupuncture, practical advice based on research experience is missing from the literature. This paper shares our concrete experience using the most commonly used such sham needle (the 'Streitberger needle' and its paired verum needle) in a large RCT (n=135) which included a two-week run-in period.

Two styles of acupuncture for treating painful diabetic neuropathy--a pilot randomised control trial.

In a pilot study, we evaluated the clinical and mechanistic effects of two styles of acupuncture, Traditional Chinese Medicine (TCM) and Japanese acupuncture, for the treatment of painful diabetic neuropathy. Out of seven patients enrolled, three received Traditional Chinese acupuncture while four received Japanese style acupuncture. Treatments were delivered once a week for 10 weeks.

A meta-analysis of the placebo response in complementary and alternative medicine trials of irritable bowel syndrome.

Among patients with irritable bowel syndrome (IBS) enrolled in clinical trials of conventional medical therapy, the placebo response rate is high. IBS patients also frequently use complementary and alternative medicine (CAM), which may act through an 'enhanced placebo effect'. The purpose of this study was to estimate the magnitude of the placebo response rate in CAM trials for IBS and to identify factors that influence this response.

The relationship between social factors and attitudes toward conventional and CAM practitioners.

Context: The research results on the relationship between social factors and attitudes toward complementary and alternative medicines (CAMs) and conventional practitioners are equivocal. Some researchers theorize a relationship between social factors and attitudes toward providers, with CAM being more attractive to socially and economically marginalized groups.

Objectives: To evaluate the relationships between selected sociodemographic factors and attitudes toward CAMs in the general US population.

Experiences of acupuncturists in a placebo-controlled, randomized clinical trial.

Background: This paper describes the experiences of 8 licensed acupuncturists in a placebo-controlled randomized clinical trial (RCT). This information is important to the design and conduct of high-quality trials.

Methods: We conducted a RCT (N=135) with a 2-week placebo run-in followed by 4 weeks of twice-weekly treatments comparing genuine to sham acupuncture (using the Streitberger placebo needle) in the treatment of arm pain caused by repetitive use.

Correlated change in upper limb function and motor cortex activation after verum and sham acupuncture in patients with chronic stroke.

Background: Acupuncture may improve motor function in patients with chronic hemiparetic stroke, yet the neural mechanisms underlying such an effect are unknown. As part of a sham-controlled, randomized clinical trial testing the efficacy of a 10-week acupuncture protocol in patients with chronic hemiparetic stroke, we examined the relationship between changes in function of the affected upper limb and brain activation using functional magnetic resonance imaging (fMRI).

Methods: Seven (7) chronic hemiparetic stroke patients underwent fMRI and testing of function of the affected upper limb (spasticity and range-of-motion) before and after a 10-week period of verum (N=4) or sham (N=3) acupuncture.

Acupuncture trials and informed consent.

Participants are often not informed by investigators who conduct randomised, placebo-controlled acupuncture trials that they may receive a sham acupuncture intervention. Instead, they are told that one or more forms of acupuncture are being compared in the study. This deceptive disclosure practice lacks a compelling methodological rationale and violates the ethical requirement to obtain informed consent.

Developing a research strategy for acupuncture.

This strategic overview revisits some of the basic assumptions that relate to the clinical evaluation of acupuncture. We look at the evidence available to estimate both the specific and nonspecific effect size of acupuncture (efficacy and effectiveness) and consider the placebo within acupuncture trials, as well as the value of both placebo controlled trials and pragmatic acupuncture studies. We argue for an augmented, mixed methodology that integrates basic mechanism studies, including modern imaging techniques such as functional magnetic resonance, quantitative and qualitative research, as well as safety and health economic data to obtain a more rigorous understanding of acupuncture.

The association between psychopathology and placebo analgesia in patients with discogenic low back pain.

Background: Chronic low back pain patients have a high rate of psychopathology, comprised mainly of depression, anxiety, and high levels of neuroticism. We previously found that psychopathology is associated with increased placebo analgesia in this patient group.

Objective: To better understand this finding in the context of other known predictors of placebo response (such as expectations for relief), we performed a detailed analysis of expectations and other possible covariates.

Sham device v inert pill: randomised controlled trial of two placebo treatments.

Objective: To investigate whether a sham device (a validated sham acupuncture needle) has a greater placebo effect than an inert pill in patients with persistent arm pain.

Design: A single blind randomised controlled trial created from the two week placebo run-in periods for two nested trials that compared acupuncture and amitriptyline with their respective placebo controls. Comparison of participants who remained on placebo continued beyond the run-in period to the end of the study.

Investigating placebo effects in irritable bowel syndrome: a novel research design.

Little is known about placebo effects with scientific precision. Poor methodology has confounded our understanding of the magnitude and even the existence of the placebo effect. Investigating placebo effects presents special research challenges including: the design of appropriate controls for studying placebo effects including separating such effects from natural history and regression to the mean, the need for large sample sizes to capture expected small effects, and the need to understand such potential effects from a patient's perspective.

Brain activity associated with expectancy-enhanced placebo analgesia as measured by functional magnetic resonance imaging.

In this study, a well established expectancy manipulation model was combined with a novel placebo intervention, a validated sham acupuncture needle, to investigate the brain network involved in placebo analgesia. Sixteen subjects completed the experiment. We found that after placebo acupuncture treatment, subjective pain rating reduction (pre minus post) on the placebo-treated side was significantly greater than on the control side.

Development of a Chinese medicine assessment measure: an interdisciplinary approach using the delphi method.

Background: The diagnostic framework and clinical reasoning process in Chinese medicine emphasizes the contextual and qualitative nature of a patient's illness. Chinese medicine assessment data may help interpret clinical outcomes.

Objectives: As part of a study aimed at assessing the validity and improving the inter-rater reliability of the Chinese diagnostic process, a structured assessment instrument was developed for use in clinical trials of acupuncture and other Chinese medical therapies.

Sociodemographic determinants of the utilization of specific types of complementary and alternative medicine: an analysis based on a nationally representative survey sample.

Objectives: To evaluate the relationships between selected sociodemographic factors and the use of particular types of complementary and alternative medicine (CAM) in the general U.S. population.

Acupuncture for upper-extremity rehabilitation in chronic stroke: a randomized sham-controlled study.

Objective: To compare the effects of traditional Chinese acupuncture with sham acupuncture on upper-extremity (UE) function and quality of life (QOL) in patients with chronic hemiparesis from stroke.

Design: A prospective, sham-controlled, randomized controlled trial (RCT).

Setting: Patients recruited through a hospital stroke rehabilitation program.

Systematic review of the effects of ginseng on cardiovascular risk factors.

Objective: To examine the evidence for the efficacy of ginseng (Panax spp.) on cardiovascular risk factors, including blood pressure, lipid profiles, and blood glucose, and to summarize reported cardiovascular adverse events.

Data Sources: We searched MEDLINE, AMED, BIOSIS, CAB, EMBASE, and the Cochrane Controlled Trials databases through July 2005 and performed hand searches of bibliographies.

A randomized, controlled trial of acupuncture for chronic daily headache.

Background: Approximately 4% of adults experience headaches nearly every day. Nonpharmacologic interventions for frequent headaches may be appropriate because medical management alone is often ineffective.

Objective: To assess the efficacy of acupuncture as an adjunct to medical management for chronic daily headache (CDH).

Advancing acupuncture research.

Since the early 1970s, acupuncture has been the subject of multiple animal experiments and randomized clinical trials. Our understanding of acupuncture from both the clinical and mechanistic perspectives has, as a result, grown tremendously. Yet the final word on acupuncture as a therapy remains mixed, largely due to the contradictory nature of the evidence.

The placebo effect in irritable bowel syndrome trials: a meta-analysis.

Background: Despite the apparent high placebo response rate in randomized placebo-controlled trials (RCT) of patients with irritable bowel syndrome (IBS), little is known about the variability and predictors of this response.

Objectives: To describe the magnitude of response in placebo arms of IBS clinical trials and to identify which factors predict the variability of the placebo response.

Methods: We performed a meta-analysis of published, English language, RCT with 20 or more IBS patients who were treated for at least 2 weeks.

Viewpoint: what is the best and most ethical model for the relationship between mainstream and alternative medicine: opposition, integration, or pluralism?

Despite radical improvements in medicine over the past 60 years, patients maintain multiple health care pathways that include high utilization of unconventional treatments. The authors examine three possible relationships between mainstream and alternative medicine: opposition, integration, and pluralism. Opposition, the traditional ethical position that the medical profession must eradicate unconventional medicine for the good of the patient, has withered away.

Can words hurt? Patient-provider interactions during invasive procedures.

Patients are often prepared for procedural discomforts with descriptions of pain or undesirable experiences. This practice is thought to be compassionate and helpful, but there is little data on the effect of such communicative behavior. This study assesses how such descriptions affect patients' pain and anxiety during medical procedures.

Patient expectations in placebo-controlled randomized clinical trials.

Objective: To explore participants' experience in placebo-controlled randomized clinical trials (RCTs) specifically in relationship to their expectations.

Background: Aspects of being in RCTs, such as informed consent, perception of benefit and understanding of randomization, have been examined. In contrast, little is known concerning the formation of patient expectations before and during trials.