The increasing burden of chronic diseases presents not only challenges to the knowledge and expertise of the professional medical community, but also highlights the need to improve the quality and relevance of clinical research in this domain. Many patients now turn to complementary and integrative medicine (CIM) to treat their chronic illnesses; however, there is very little evidence to guide their decision-making in usual care. The following research recommendations were derived from a CIM Stakeholder Symposium on Comparative Effectiveness Research (CER): (1) CER studies should be made a priority in this field; (2) stakeholders should be engaged at every stage of the research; (3) CER study designs should highlight effectiveness over efficacy; (4) research questions should be well defined to enable the selection of an appropriate CER study design; (5) the CIM community should cultivate widely shared understandings, discourse, tools, and technologies to support the use and validity of CER methods; (6) Effectiveness Guidance Documents on methodological standards should be developed to shape future CER studies. CER is an emerging field and its development and impact must be reflected in future research strategies within CIM. This stakeholder symposium was a first step in providing systematic guidance for future CER in this field.

Background

Hypercholesterolemia is an important key contributory factor for ischemic heart disease and is associated with age, high blood pressure, a family history of hypercholesterolemia, and diabetes. Chinese herbal medicines have been used for a long time as lipid-lowering agents.

Objectives

To assess the effects of Chinese herbal medicines on hypercholesterolemia.

Search strategy

We searched the following databases: The Cochrane Library (issue 8, 2010), MEDLINE (until July 2010), EMBASE (until July 2010), Chinese BioMedical Database (until July 2010), Traditional Chinese Medical Literature Analysis and Retrieval System (until July 2010), China National Knowledge Infrastructure (until July 2010), Chinese VIP Information (until July 2010), Chinese Academic Conference Papers Database and Chinese Dissertation Database (until July 2010), and Allied and Complementary Medicine Database (until July 2010).

Selection criteria

We considered randomized controlled clinical trials in hypercholesterolemic participants comparing Chinese herbal medicines with placebo, no treatment, and pharmacological or non-pharmacological interventions.

Data collection and analysis

Two review authors independently extracted data and assessed the risk of bias. We resolved any disagreements with this assessment through discussion and a decision was achieved based by consensus. We assessed trials for the risk of bias against key criteria: random sequence generation, allocation concealment, blinding of participants, incomplete outcome data, selective outcome reporting and other sources of bias.

Main results

We included 22 randomized trials (2130 participants). The mean treatment duration was 2.3 ± 1.3 months (ranging from one to six months). Twenty trials were conducted in China and 18 trials were published in Chinese. Overall, the risk of bias of included trials was high or unclear. Five different herbal medicines were evaluated in the included trials, which compared herbs with conventional medicine in six comparisons (20 trials), or placebo (two trials). There were no outcome data in any of the trials on cardiovascular events and death from any cause. One trial each reported well-being (no significant differences) and economic costs. No serious adverse events were observed. Xuezhikang was the most commonly used herbal formula investigated. A significant effect on total cholesterol (two trial, 254 participants) was shown in favor of Xuezhikang when compared with inositol nicotinate (mean difference (MD) −0.90 mmol/L, 95% confidence interval (CI) −1.13 to −0.68) .

Authors’ conclusions

Some herbal medicines may have cholesterol-lowering effects. Our findings have to be interpreted with caution due to high or unclear risk of bias of the included trials.

Background

Placebo groups are used in randomised clinical trials (RCTs) to control for placebo effects, which can be large. Participants in trials can misunderstand written information particularly regarding technical aspects of trial design such as randomisation; the adequacy of written information about placebos has not been explored. We aimed to identify what participants in major RCTs in the UK are told about placebos and their effects.

Methods and Findings

We conducted a content analysis of 45 Participant Information Leaflets (PILs) using quantitative and qualitative methodologies. PILs were obtained from trials on a major registry of current UK clinical trials (the UKCRN database). Eligible leaflets were received from 44 non-commercial trials but only 1 commercial trial. The main limitation is the low response rate (13.5%), but characteristics of included trials were broadly representative of all non-commercial trials on the database. 84% of PILs were for trials with 50∶50 randomisation ratios yet in almost every comparison the target treatments were prioritized over the placebos. Placebos were referred to significantly less frequently than target treatments (7 vs. 27 mentions, p<001) and were significantly less likely than target treatments to be described as triggering either beneficial effects (1 vs. 45, p<001) or adverse effects (4 vs. 39, p<001). 8 PILs (18%) explicitly stated that the placebo treatment was either undesirable or ineffective.

Conclusions

PILs from recent high quality clinical trials emphasise the benefits and adverse effects of the target treatment, while largely ignoring the possible effects of the placebo. Thus they provide incomplete and at times inaccurate information about placebos. Trial participants should be more fully informed about the health changes that they might experience from a placebo. To do otherwise jeopardises informed consent and is inconsistent with not only the science of placebos but also the fundamental rationale underpinning placebo controlled trials.

Objectives. To assess whether any benefits from adjunctive homeopathic intervention in patients with RA are due to the homeopathic consultation, homeopathic remedies or both.

Methods. Exploratory double-blind, randomized placebo-controlled trial conducted from January 2008 to July 2008, in patients with active stable RA receiving conventional therapy. Eighty-three participants from three secondary care UK outpatient clinics were randomized to 24 weeks of treatment with either homeopathic consultation (further randomized to individualized homeopathy, complex homeopathy or placebo) or non-homeopathic consultation (further randomized to complex homeopathy or placebo). Co-primary outcomes: ACR 20% improvement (ACR20) criteria and patient monthly global assessment (GA). Secondary outcomes: 28-joint DAS (DAS-28), tender and swollen joint count, disease severity, pain, weekly patient and physician GA and pain, and inflammatory markers.

Results. Fifty-six completed treatment phase. No significant differences were observed for either primary outcome. There was no clear effect due to remedy type. Receiving a homeopathic consultation significantly improved DAS-28 [mean difference 0.623; 95% CI 0.1860, 1.060; P = 0.005; effect size (ES) 0.70], swollen joint count (mean difference 3.04; 95% CI 1.055, 5.030; P = 0.003; ES 0.83), current pain (mean difference 9.12; 95% CI 0.521, 17.718; P = 0.038; ES 0.48), weekly pain (mean difference 6.017; 95% CI 0.140, 11.894; P = 0.045; ES 0.30), weekly patient GA (mean difference 6.260; 95% CI 0.411, 12.169; P = 0.036; ES 0.31) and negative mood (mean difference − 4.497; 95% CI −8.071, −0.923; P = 0.015; ES 0.90).

Conclusion. Homeopathic consultations but not homeopathic remedies are associated with clinically relevant benefits for patients with active but relatively stable RA.

Trial registration. Current controlled trials, http://www.controlled-trials.com/, ISRCTN09712705.

Objective An economic evaluation of therapeutic massage, exercise, and lessons in the Alexander technique for treating persistent back pain.

Design Cost consequences study and cost effectiveness analysis at 12 month follow-up of a factorial randomised controlled trial.

Participants 579 patients with chronic or recurrent low back pain recruited from primary care.

Interventions Normal care (control), massage, and six or 24 lessons in the Alexander technique. Half of each group were randomised to a prescription for exercise from a doctor plus behavioural counselling from a nurse.

Main outcome measures Costs to the NHS and to participants. Comparison of costs with Roland-Morris disability score (number of activities impaired by pain), days in pain, and quality adjusted life years (QALYs). Comparison of NHS costs with QALY gain, using incremental cost effectiveness ratios and cost effectiveness acceptability curves.

Results Intervention costs ranged from £30 for exercise prescription to £596 for 24 lessons in Alexander technique plus exercise. Cost of health services ranged from £50 for 24 lessons in Alexander technique to £124 for exercise. Incremental cost effectiveness analysis of single therapies showed that exercise offered best value (£61 per point on disability score, £9 per additional pain-free day, £2847 per QALY gain). For two-stage therapy, six lessons in Alexander technique combined with exercise was the best value (additional £64 per point on disability score, £43 per additional pain-free day, £5332 per QALY gain).

Conclusions An exercise prescription and six lessons in Alexander technique alone were both more than 85% likely to be cost effective at values above £20 000 per QALY, but the Alexander technique performed better than exercise on the full range of outcomes. A combination of six lessons in Alexander technique lessons followed by exercise was the most effective and cost effective option.

Background

Complementary and alternative medicine (CAM) is popular with patients, yet how patients use CAM in relation to orthodox medicine (OM) is poorly understood.

Aim

To explore how patients integrate CAM and OM when self-managing chronic illness.

Design of study

Qualitative analysis of interviews.

Method

Semi-structured interviews were conducted with individuals attending private CAM practices in the UK, who had had a chronic benign condition for 12 months and were using CAM alongside OM for more than 3 months. Patients were selected to create a maximum variation sample. The interviews were analysed using framework analysis.

Results

Thirty five patient interviews were conducted and seven categories of use were identified: using CAM to facilitate OM use; using OM to support long-term CAM use; using CAM to reduce OM; using CAM to avoid OM; using CAM to replace OM; maximising relief using both CAM and OM; and returning to OM. Participants described initiating CAM use following a perceived lack of suitable orthodox treatment. Participants rejecting OM for a specific condition never totally rejected OM in favour of CAM.

Conclusion

Patients utilise CAM and OM in identifiably different ways, individualising and integrating both approaches to manage their chronic conditions. To support patients and prevent potential adverse interactions, open dialogue between patients, OM practitioners, and CAM practitioners must be improved.

Magnetoencephalography (MEG) enables non-invasive recording of neuronal activity, with reconstruction methods providing estimates of underlying brain source locations and oscillatory dynamics from externally recorded neuromagnetic fields. The aim of our study was to use MEG to determine the effect of manual acupuncture on neuronal oscillatory dynamics. A major problem in MEG investigations of manual acupuncture is the absence of onset times for each needle manipulation. Given that beamforming (spatial filtering) analysis is not dependent upon stimulus-driven responses being phase-locked to stimulus onset, we postulated that beamforming could reveal source locations and induced changes in neuronal activity during manual acupuncture. In a beamformer analysis, a two-minute period of manual acupuncture needle manipulation delivered to the ipsilateral right LI-4 (Hegu) acupoint was contrasted with a two-minute baseline period. We considered oscillatory power changes in the theta (4–8 Hz), alpha (8–13 Hz), beta (13–30 Hz), and gamma (30–100 Hz) frequency bands. We found significant decreases in beta band power in the contralateral primary somatosensory cortex and superior frontal gyrus (SFG). In the ipsilateral cerebral hemisphere, we found significant power decreases in beta and gamma frequency bands in only the SFG. No significant power modulations were found in theta and alpha bands. Our results indicate that beamforming is a useful analytical tool to reconstruct underlying neuronal activity associated with manual acupuncture. Our main finding was of beta power decreases in primary somatosensory cortex and SFG, which opens up a line of future investigation regarding whether this contributes toward an underlying mechanism of acupuncture.

Aim

To investigate the factors predicting adolescent visits to practitioners of complementary and alternative medicine (CAM).

Methods

A longitudinal cohort study conducted in an adolescent total population in Central Norway (The Nord-Trøndelag Health Studies (HUNT)). In Young-HUNT 1, all inhabitants aged 13 to 19 years (N = 8944, 89% response rate) were invited to participate, and the youngest group (13 to 15 year olds) was surveyed again 4 years later (Young-HUNT 2, N = 2429, 82% response rate). The participants completed a comprehensive questionnaire on health and life style which included a question regarding visits to a CAM practitioner in the last 12 months.

Results

One in eleven (8.7%, 95%CI 7.6-9.8%) had visited a CAM practitioner, an increase of 26% in 4 years (1.8% points). The final multivariable analysis predicted increased odds of an adolescent becoming a CAM visitor four years later (p<0.05) if she or he had previously visited a CAM practitioner (adjOR 3.4), had musculoskeletal pain (adjOR 1.5), had migraine (adjOR 2.3), used asthma medicines (adjOR 1.8) or suffered from another disease lasting more than three months (adjOR 2.1). Being male predicted reduced odds of visiting a CAM practitioner in the future (adjOR 0.6).

Conclusion

We can conclude from this study that future visits to a CAM practitioner are predicted by both predisposing factors (being female, having visited a CAM practitioner previously) and medical need factors (having had musculoskeletal pain, migraine, used asthma medicines or experienced another disease lasting more than three months). None of the specific variables associated with CAM visits were predictive for CAM visits four years later.

Complementary and Alternative Medicine (CAM) is widely available in the UK and used frequently by the public, but there is little high quality research to sustain its continued use and potential integration into the NHS. There is, therefore, a need to develop rigorous research in this area. One essential way forward is to train and develop more CAM researchers so that we can enhance academic capacity and provide the evidence upon which to base strategic healthcare decisions. This UK survey identified 80 research active postgraduates registered for MPhils/PhDs in 21 universities and were either current students or had completed their postgraduate degree during the recent UK Research Assessment Exercise (RAE) 2001–2008. The single largest postgraduate degree funder was the university where the students registered (26/80). Thirty-two projects involved randomized controlled trials and 33 used qualitative research methods. The UK RAE also indicates a significant growth of postdoctoral and tenured research activity over this period (in 2001 there were three full time equivalents; in 2008 there were 15.5) with a considerable improvement in research quality. This mapping exercise suggests that considerable effort is currently being invested in developing UK CAM research capacity and thus inform decision making in this area. However, in comparative international terms UK funding is very limited. As in the USA and Australia, a centralized and strategic approach by the National Institute of Health Research to this currently uncoordinated and underfunded activity may benefit CAM research in the UK.

Background

The aim of this study was to compare patients' experiences of public and private sector healthcare, using acupuncture as an example. In the UK, acupuncture is popular with patients, is recommended in official guidelines for low back pain, and is available in both the private sector and the public sector (NHS). Consumerism was used as a theoretical framework to explore patients' experiences.

Methods

Semi-structured face-to-face interviews were conducted in 2007-8 with a purposive sample of 27 patients who had recently used acupuncture for painful conditions in the private sector and/or in the NHS. Inductive thematic analysis was used to develop themes that summarised the bulk of the data and provided insights into consumerism in NHS- and private practice-based acupuncture.

Results

Five main themes were identified: value for money and willingness to pay; free and fair access; individualised holistic care: feeling cared for; consequences of choice: empowerment and vulnerability; and "just added extras": physical environment. Patients who had received acupuncture in the private sector constructed detailed accounts of the benefits of private care. Patients who had not received acupuncture in the private sector expected minimal differences from NHS care, and those differences were seen as not integral to treatment. The private sector facilitated consumerist behaviour to a greater extent than did the NHS, but private consumers appeared to base their decisions on unreliable and incomplete information.

Conclusions

Patients used and experienced acupuncture differently in the NHS compared to the private sector. Eight different faces of consumerist behaviour were identified, but six were dominant: consumer as chooser, consumer as pragmatist, consumer as patient, consumer as earnest explorer, consumer as victim, and consumer as citizen. The decision to use acupuncture in either the private sector or the NHS was rarely well-informed: NHS and private patients both had misconceptions about acupuncture in the other sector. Future research should evaluate whether the differences we identified in patients' experiences across private and public healthcare are common, whether they translate into significant differences in clinical outcomes, and whether similar faces of consumerism characterise patients' experiences of other interventions in the private and public sectors.

Background

Qualitative studies of participants' experiences in randomised clinical trials (RCTs) suggest that the psychosocial context of treatment in RCTs may be quite different to the psychosocial context of treatment in usual practice. This is important, as the psychosocial context of treatment is known to influence patient outcomes in chronic illness. Few studies have directly compared the psychosocial context of treatment across RCTs and usual practice. In this study, we explored differences in psychosocial context between RCT and usual practice settings, using acupuncture as our model.

Methods

We undertook a secondary analysis of existing qualitative interviews with 54 patients. 27 were drawn from a study of western and traditional acupuncture in usual practice (for a range of painful conditions). 27 were drawn from a qualitative study nested in an RCT of western acupuncture for osteoarthritis of the hip or knee. We used qualitative analysis software to facilitate an inductive thematic analysis in which we identified three main themes.

Results

In usual practice, starting acupuncture was more likely to be embedded in an active and ongoing search for pain relief, whereas in the RCT starting acupuncture was opportunistic. Usual practice patients reported few uncertainties and these had minimal consequences for them. In the RCT, patients experienced considerable uncertainties about their treatment and its effectiveness, and were particularly concerned about whether they were receiving real (or fake) acupuncture. Patients stopped acupuncture only at the end of the fixed course of treatment in the RCT, which was similar to those receiving acupuncture in the public sector National Health Service (NHS). In comparison, private sector patients re-evaluated and re-negotiated treatments particularly when starting to use acupuncture.

Conclusions

Differences in psychosocial context between RCTs and usual practice could reduce the impact of acupuncture in RCT settings and/or lead to under-reporting of benefit by patients in trials. New trial designs that ensure participants' experiences are similar to usual practice should minimise differences in psychosocial context and help attenuate these potentially confounding effects.

Abstract

Background

Traditional Chinese Medicine (TCM) is popular for treatment of fibromyalgia (FM) although there is a lack of comprehensive evaluation of current clinical evidence for TCM's therapeutic effect and safety.

Objective

To review systematically the beneficial and harmful effects of TCM therapies for FM.

Methods

We searched six English and Chinese electronic databases for randomized clinical trials (RCTs) on TCM for treatment of FM. Two authors extracted data and assessed the trial quality independently. RevMan 5 software was used for data analyses with an effect estimate presented as mean difference (MD) with a 95% confidence interval (CI).

Results

Twenty-five RCTs were identified with 1516 participants for this review. Seven trials (28%) were evaluated as having a low risk of bias and the remaining trials were identified as being as unclear or having a high risk of bias. Overall, ten trials were eligible for the meta-analysis, and data from remaining 15 trials were synthesized qualitatively. Acupuncture reduced the number of tender points (MD, –3.21; 95% CI –4.23 to –2.11; p < 0.00001, I2 = 0%), and pain scores compared with conventional medications (MD, –1.78; 95% CI, –2.24 to –1.32; p < 0.00001; I2 = 0%). Acupuncture showed no significant effect, with a random-effect model, compared with sham acupuncture (MD, –0.55; 95% CI, –1.35–0.24; p = 0.17; I2 = 69%), on pain reduction. A combination of acupuncture and cupping therapy was better than conventional medications for reducing pain (MD, –1.66; 95% CI, –2.14 to –1.19; p < 0.00001; I2 = 0%), and for improving depression scores with related to FM (MD, –4.92; 95% CI, –6.49 to –3.34; p < 0.00001; I2 = 32%). Other individual trials demonstrated positive effects of Chinese herbal medicine on pain reduction compared with conventional medications. There were no serious adverse effects reported that were related to TCM therapies in these trials.

Conclusions

TCM therapies appear to be effective for treating FM. However, further large, rigorously designed trials are warranted because of insufficient methodological rigor in the included trials.

Dimethyl sulphoxide and methylsulfonylmethane are two related nutritional supplements used for symptomatic relief of osteoarthritis (OA). We conducted a meta-analysis to evaluate their efficacy in reducing pain associated with OA. Randomized or quasi-randomized controlled trials (RCTs), identified by systematic electronic searches, citation tracking and searches of clinical trial registries, assessing these supplements in osteoarthritis of any joint were considered for inclusion. Meta-analysis, based on difference in mean pain related outcomes between treatment and comparator groups, was carried out based on a random effect model. Seven potential trials were identified of which three RCTs, two DMSO and one MSM (total N = 326 patients) were eligible for inclusion. All three trials were considered high methodological quality. A significant degree of heterogeneity (χ2 = 6.28, P = .043) was revealed. Two studies demonstrated statistically significant (but not clinically relevant) reduction in pain compared with controls; with one showing no group difference. The meta-analysis confirmed a non significant reduction of pain on visual analogue scale of 6.34 mm (SE = 3.49, 95% CI, −0.49, 13.17). The overall effect size of 1.82 was neither statistically nor clinically significant. Current evidence suggests DMSO and MSM are not clinically effective in the reduction of pain in the treatment of OA. No definitive conclusions can currently be drawn from the data due to the mixed findings and the use of inadequate dosing periods.

Research into the homeopathic consultation has largely focused on patients' experiences, although the practitioner is a crucial component of the therapeutic context and may have an important part in optimizing health outcomes. Therefore the aim of this qualitative research was to gain an in-depth understanding of homeopathic practitioners' perceptions and experiences of the consultation. Medical and non-medical homeopaths were sampled from the registers of the Faculty and Society of Homeopaths. Two phases of data collection were employed. Phase 1 used in depth face-to-face interviews enabling the development of an initial model of the homeopathic consultation. Phase 2 involved observations of homeopathic consultations and practitioner reflective diaries in order to confirm, refute, or enlarge the model. Using the constant comparative method of grounded theory five main categories emerged, exploring the journey, finding the level, responding therapeutically, understanding self, and connecting, forming a model entitled “a theoretical model of a UK classical homeopathic consultation” which describes how homeopaths view and enact the consultation process. This study suggests that the process of identifying and prescribing the remedy is embedded in the consultation, highlighting the interconnectedness of the whole homeopathic consultation and aspects of the consultation that are unique and specific to homeopathy.

Background

The purpose of clinical trials of acupuncture is to help clinicians and patients make decisions about treatment. Yet this is not straightforward: some trials report acupuncture to be superior to sham (placebo) acupuncture while others show evidence that acupuncture is superior to usual care but not sham, and still others conclude that acupuncture is no better than usual care. Meta-analyses of these trials tend to come to somewhat indeterminate conclusions. This appears to be because, until recently, acupuncture research was dominated by small trials of questionable quality. The Acupuncture Trialists' Collaboration, a group of trialists, statisticians and other researchers, was established to synthesize patient-level data from several recently published large, high-quality trials.

Methods

There are three distinct phases to the Acupuncture Trialists Collaboration: a systematic review to identify eligible studies; collation and harmonization of raw data; statistical analysis. To be eligible, trials must have unambiguous allocation concealment. Eligible pain conditions are osteoarthritis; chronic headache (tension or migraine headache); shoulder pain; and non-specific back or neck pain. Once received, patient-level data will undergo quality checks and the results of prior publications will be replicated. The primary analysis will be to determine the effect size of acupuncture. Each trial will be evaluated by analysis of covariance with the principal endpoint as the dependent variable and, as covariates, the baseline score for the principal endpoint and the variables used to stratify randomization. The effect size for acupuncture from each trial - that is, the coefficient and standard error from the analysis of covariance - will then be entered into a meta-analysis. We will compute effect sizes separately for comparisons of acupuncture with sham acupuncture, and acupuncture with no acupuncture control for each pain condition. Other analyses will investigate the impact of different sham techniques, styles of acupuncture or frequency and duration of treatment sessions.

Discussion

Individual patient data meta-analysis of high-quality trials will provide the most reliable basis for treatment decisions about acupuncture. Above all, however, we hope that our approach can serve as a model for future studies in acupuncture and other complementary therapies.

Background

Augmenting validated paper versions of existing outcome measures with an equivalent online version may offer substantial research advantages (cost, rapidity and reliability). However, equivalence of online and paper questionnaires cannot be assumed, nor can acceptability to respondents. The aim was to test whether online and written versions of the Roland Morris Disability Questionnaire (RMDQ), a standard measure of functional disability in back pain, are equivalent at both group and individual levels to establish whether they can be used interchangeably.

Methods

This is a within-participants equivalence study. 167 participants with back pain fully completed both the paper and online versions of the RMDQ in random order. Participants were recruited from a chiropractic clinic and patient support groups in Southern England. Limits of equivalence were pre-defined as 0.5 RMDQ points, the Bland-Altman range was calculated, and participants' comments were examined using content analysis.

Results

The mean score difference was 0.03 (SD = 1.43), with the 95% Confidence Interval falling entirely within our limits of equivalence (-0.19 to 0.25). The Bland-Altman range was -2.77 to 2.83 RMDQ points. Participants identified unique advantages and disadvantages associated with each version of the RMDQ.

Conclusions

The group and individual level data suggest that online and paper versions of the RMDQ are equivalent and can be used interchangeably. The Bland-Altman range appears to reflect the known measurement properties of the RMDQ. Furthermore, participants' comments confirmed the potential value to be had from offering them the choice of completing the RMDQ online or on paper.

Abstract

Objectives

Existing studies on the use of complementary and alternative medicine (CAM) have produced diverse results regarding the types and prevalence of CAM use due, in part, to variations in the measurement of CAM modalities. A questionnaire that can be adapted for use in a variety of populations will improve CAM utilization measurement. The purposes of this article are to (1) articulate the need for such a common questionnaire; (2) describe the process of questionnaire development; (3) present a model questionnaire with core questions; and (4) suggest standard techniques for adapting the questionnaire to different languages and populations.

Methods

An international workshop sponsored by the National Research Center in Complementary and Alternative Medicine (NAFKAM) of the University of Tromsø, Norway, brought CAM researchers and practitioners together to design an international CAM questionnaire (I-CAM-Q). Existing questionnaires were critiqued, and working groups drafted content for a new questionnaire. A smaller working group completed, tested, and revised this self-administered questionnaire.

Results

The questionnaire that was developed contains four sections concerned with visits to health care providers, complementary treatments received from physicians, use of herbal medicine and dietary supplements, and self-help practices. A priori–specified practitioners, therapies, supplements, and practices are included, as well as places for researcher-specified and respondent-specified additions. Core questions are designed to elicit frequency of use, purpose (treatment of acute or chronic conditions, and health maintenance), and satisfaction. A penultimate version underwent pretesting with “think-aloud” techniques to identify problems related to meaning and format. The final questionnaire is presented, with suggestions for testing and translating.

Conclusions

Once validated in English and non-English speaking populations, the I-CAM-Q will provide an opportunity for researchers to gather comparable data in studies conducted in different populations. Such data will increase knowledge about the epidemiology of CAM use and provide the foundation for evidence-based comparisons at an international level.

Background

Most traditional Chinese herbal formulas consist of at least four herbs. Four-Agents-Decoction (Si Wu Tang) is a documented eight hundred year old formula containing four herbs and has been widely used to relieve menstrual discomfort in Taiwan. However, no specific effect had been systematically evaluated. We applied Western methodology to assess its effectiveness and safety for primary dysmenorrhoea and to evaluate the compliance and feasibility for a future trial.

Methodology/Principal Findings

A randomised, double-blind, placebo-controlled, pilot clinical trial was conducted in an ad hoc clinic setting at a teaching hospital in Taipei, Taiwan. Seventy-eight primary dysmenorrheic young women were enrolled after 326 women with self-reported menstrual discomfort in the Taipei metropolitan area of Taiwan were screened by a questionnaire and subsequently diagnosed by two gynaecologists concurrently with pelvic ultrasonography. A dosage of 15 odorless capsules daily for five days starting from the onset of bleeding or pain was administered. Participants were followed with two to four cycles for an initial washout interval, one to two baseline cycles, three to four treatment cycles, and three follow-up cycles. Study outcome was pain intensity measured by using unmarked horizontal visual analog pain scale in an online daily diary submitted directly by the participants for 5 days starting from the onset of bleeding or pain of each menstrual cycle. Overall-pain was the average pain intensity among days in pain and peak-pain was the maximal single-day pain intensity. At the end of treatment, both the overall-pain and peak-pain decreased in the Four-Agents-Decoction (Si Wu Tang) group and increased in the placebo group; however, the differences between the two groups were not statistically significant. The trends persisted to follow-up phase. Statistically significant differences in both peak-pain and overall-pain appeared in the first follow-up cycle, at which the reduced peak-pain in the Four-Agents-Decoction (Si Wu Tang) group did not differ significantly by treatment length. However, the reduced peak-pain did differ profoundly among women treated for four menstrual cycles (2.69 (2.06) cm, mean (standard deviation), for the 20 women with Four-Agents-Decoction and 4.68 (3.16) for the 22 women with placebo, p = .020.) There was no difference in adverse symptoms between the Four-Agents-Decoction (Si Wu Tang) and placebo groups.

Conclusion/significance

Four-Agents-Decoction (Si Wu Tang) therapy in this pilot post-market clinical trial, while meeting the standards of conventional medicine, showed no statistically significant difference in reducing menstrual pain intensity of primary dysmenorrhoea at the end of treatment. Its use, with our dosage regimen and treatment length, was not associated with adverse reactions. The finding of statistically significant pain-reducing effect in the first follow-up cycle was unexpected and warrants further study. A larger similar trial among primary dysmenorrheic young women with longer treatment phase and multiple batched study products can determine the definitive efficacy of this historically documented formula.

Trial Registration

Controlled-Trials.com ISRCTN23374750

Background

The aim of this study was to assess the effectiveness of homeopathy compared to conventional treatment in acute respiratory and ear complaints in a primary care setting.

Methods

The study was designed as an international, multi-centre, comparative cohort study of non-randomised design. Patients, presenting themselves with at least one chief complaint: acute (≤ 7 days) runny nose, sore throat, ear pain, sinus pain or cough, were recruited at 57 primary care practices in Austria (8), Germany (8), the Netherlands (7), Russia (6), Spain (6), Ukraine (4), United Kingdom (10) and the USA (8) and given either homeopathic or conventional treatment. Therapy outcome was measured by using the response rate, defined as the proportion of patients experiencing 'complete recovery' or 'major improvement' in each treatment group. The primary outcome criterion was the response rate after 14 days of therapy.

Results

Data of 1,577 patients were evaluated in the full analysis set of which 857 received homeopathic (H) and 720 conventional (C) treatment. The majority of patients in both groups reported their outcome after 14 days of treatment as complete recovery or major improvement (H: 86.9%; C: 86.0%; p = 0.0003 for non-inferiority testing). In the per-protocol set (H: 576 and C: 540 patients) similar results were obtained (H: 87.7%; C: 86.9%; p = 0.0019). Further subgroup analysis of the full analysis set showed no differences of response rates after 14 days in children (H: 88.5%; C: 84.5%) and adults (H: 85.6%; C: 86.6%). The unadjusted odds ratio (OR) of the primary outcome criterion was 1.40 (0.89–2.22) in children and 0.92 (0.63–1.34) in adults. Adjustments for demographic differences at baseline did not significantly alter the OR. The response rates after 7 and 28 days also showed no significant differences between both treatment groups. However, onset of improvement within the first 7 days after treatment was significantly faster upon homeopathic treatment both in children (p = 0.0488) and adults (p = 0.0001). Adverse drug reactions occurred more frequently in adults of the conventional group than in the homeopathic group (C: 7.6%; H: 3.1%, p = 0.0032), whereas in children the occurrence of adverse drug reactions was not significantly different (H: 2.0%; C: 2.4%, p = 0.7838).

Conclusion

In primary care, homeopathic treatment for acute respiratory and ear complaints was not inferior to conventional treatment.

Background

To explore the strengths and weaknesses of conventional biomedical research strategies and methods as applied to complementary and alternative medicine (CAM), and to suggest a new research framework for assessing these treatment modalities.

Discussion

There appears to be a gap between published studies showing little or no efficacy of CAM, and reports of substantial clinical benefit from patients and CAM practitioners. This "gap" might be partially due to the current focus on placebo-controlled randomized trials, which are appropriately designed to answer questions about the efficacy and safety of pharmaceutical agents. In an attempt to fit this assessment strategy, complex CAM treatment approaches have been dissected into standardized and often simplified treatment methods, and outcomes have been limited.

Unlike conventional medicine, CAM has no regulatory or financial gatekeeper controlling their therapeutic "agents" before they are marketed. Treatments may thus be in widespread use before researchers know of their existence. In addition, the treatments are often provided as an integrated 'whole system' of care, without careful consideration of the safety issue.

We propose a five-phase strategy for assessing CAM built on the acknowledgement of the inherent, unique aspects of CAM treatments and their regulatory status in most Western countries. These phases comprise:

1. Context, paradigms, philosophical understanding and utilization

2. Safety status

3. Comparative effectiveness.

4. Component efficacy

5. Biological mechanisms.

Summary

Using the proposed strategy will generate evidence relevant to clinical practice, while acknowledging the absence of regulatory and financial gatekeepers for CAM. It will also emphasize the important but subtle differences between CAM and conventional medical practice.