Use of complementary and alternative medicine and quality of life: changes at the end of life

The purpose of this study was to compare the physical, psychological and social dimensions associated with quality-of-life outcomes over the last year of life, between advanced cancer users and nonusers of complementary and alternative medicine. One hundred and eleven patients were identified through Queensland Cancer Registry records, and followed up every four to six weeks until close to death using standardized protocols. Outcome measures were symptom burden, psychological distress, subjective wellbeing, satisfaction with conventional medicine and need for control over treatment decisions. At the initial interview, 36 (32%) participants had used complementary/ alternative medicine the previous week; mainly vitamins, minerals and tonics and herbal remedies. Among all participants, 53 (48%) used at least one form of complementary/ alternative medicine over the study period. Only six (11%) visited alternative practitioners on a regular basis. Overall, complementary/ alternative medicine users reported higher levels of anxiety and pain, less satisfaction with conventional medicine and lower need for control over treatment decisions compared with nonusers. These differences tend to change as death approaches. A more rigorous assessment of complementary/ alternative medicine use, psychological distress, pain and subjective wellbeing among patients with advanced cancer is needed in the clinical setting.

The other side of the coin: safety of complementary and alternative medicine

Most consumers consider complementary and alternative medicine (CAM) products inherently safe. The growing simultaneous use of CAM products and pharmaceutical drugs by Australian consumers increases the risk of CAM-drug interactions. The Therapeutic Goods Administration (TGA) has a two-tier, risk-based regulatory system for therapeutic goods - CAM products are regulated as low risk products and are assessed for quality and safety; and sponsors of products must hold the evidence for any claim of efficacy made about them. Adverse reactions to CAM products can be classified as intrinsic (innate to the product), or extrinsic (where the risk is not related to the product itself, but results from the failure of good manufacturing practice). Adverse reactions to CAM practices can be classified as risks of commission (which includes removal of medical therapy) and risks of omission (which includes failure to refer when appropriate). While few systematic studies of adverse events with CAM exist, and under-reporting is likely, most CAM products and practices do not appear to present a high risk; their safety needs to be put into the perspective of wider safety issues. A priority for research is to rigorously define the risks associated with both CAM products and practices so that their potential impact on public health can be assessed.

The continuing use of complementary and alternative medicine in South Australia: costs and beliefs in 2004

Objective: To survey the use, cost, beliefs and quality of life of users of complementary and alternative medicine (CAM). Design: A representative population survey conducted in 2004 with longitudinal comparison to similar 1993 and 2000 surveys. Participants: 3015 South Australian respondents over the age of 15 years (71.7% participation). Results: In 2004, CAMs were used by 52.2% of the population. Greatest use was in women aged 25-34 years, with higher income and education levels. CAM therapists had been visited by 26.5% of the population. In those with children, 29.9% administered CAMs to them and 17.5% of the children had visited CAM therapists. The total extrapolated cost in Australia of CAMs and CAM therapists in 2004 was AUD$1.8 billion, which was a decrease from AUD$2.3 billion in 2000. CAMs were used mostly to maintain general health. The users of CAM had lower quality-of-life scores than non-users. Among CAM users, 49.7% used conventional medicines on the same day and 57.2% did not report the use of CAMs to their doctor. About half of the respondents assumed that CAMs were independently tested by a government agency; of these, 74.8% believed they were tested for quality and safety, 21.8% for what they claimed, and 17.9% for efficacy. Conclusions: Australians continue to use high levels of CAMs and CAM therapists. The public is often unaware that CAMs are not tested by the Therapeutic Goods Administration for efficacy or safety.

The relationship between subjective appetite sensations, markers of inflammation and appetite in dialysis patients

Background: Poor appetite is a marker of morbidity and mortality in hemodialysis patients, making it an important area for research. Visual analog scales (VAS) can capture a range of subjective sensations related to appetite (such as hunger, desire to eat or fullness), but have not been commonly used to measure appetite in dialysis patients. The aim of this study was to explore the association between retrospective ratings of appetite using VAS and a range of clinical variables as well as biomarkers of appetite in hemodialysis patients.----- Methods: 28 hemodialysis patients (mean age 61±17y, 50% male, median dialysis vintage 19.5(4-101) months) rated their appetite using VAS for hunger, fullness and desire to eat and a 5-point categorical scale measuring general appetite. Blood levels of the appetite peptides leptin, ghrelin and peptide YY were also measured.----- Results: Hunger ratings measured by VAS were significantly (p<0.05) correlated with a range of clinical, nutritional and inflammatory markers: age (r=-0.376), co-morbidities, (r=-0.380) PG-SGA score (r=-0.451), weight (r=-0.375), fat-free mass (r=-0.435), C-Reactive Protein (CRP) (r=-0.383) and Intercellular adhesion molecule (sICAM-1) (r=-0.387). There was a consistent relationship between VAS and appetite on a 5-point categorical scale for questions of hunger, and a similar trend for desire to eat, but not for fullness. Neither method of measuring subjective appetite correlated with appetite peptides.----- Conclusions: Retrospective ratings of hunger on a VAS are associated with a range of clinical variables and further studies are warranted to support their use as a method of measuring appetite in dialysis patients.

A review of the pharmacobiotic regulation of gastrointestinal inflammation by probiotics, commensal bacteria and prebiotics.

The idea that microbes induce disease has steered medical research toward the discovery of antibacterial products for the prevention and treatment of microbial infections. The twentieth century saw increasing dependency on antimicrobials as mainline therapy accentuating the notion that bacterial interactions with humans were to be avoided or desirably controlled. The last two decades, though, have seen a refocusing of thinking and research effort directed towards elucidating the critical inter-relationships between the gut microbiome and its host that control health/wellness or disease. This research has redefined the interactions between gut microbes and vertebrates, now recognizing that the microbial active cohort and its mammalian host have shared co-evolutionary metabolic interactions that span millennia. Microbial interactions in the gastrointestinal tract provide the necessary cues for the development of regulated pro- and anti-inflammatory signals that promotes immunological tolerance, metabolic regulation and other factors which may then control local and extra-intestinal inflammation. Pharmacobiotics, using nutritional and functional food additives to regulate the gut microbiome, will be an exciting growth area of therapeutics, developing alongside an increased scientific understanding of gut-microbiome symbiosis in health and disease.

S-allylmercaptocysteine reduces carbon tetrachloride-induced hepatic oxidative stress and necroinflammation via nuclear factor kappa B-dependent pathways in mice.

Purpose To study the protective effects and underlying molecular mechanisms of SAMC on carbon tetrachloride (CCl4)-induced acute hepatotoxicity in the mouse model. Methods Mice were intraperitoneally injected with CCl4 (50 μl/kg; single dose) to induce acute hepatotoxicity with or without a 2-h pre-treatment of SAMC intraperitoneal injection (200 mg/kg; single dose). After 8 h, the blood serum and liver samples of mice were collected and subjected to measurements of histological and molecular parameters of hepatotoxicity. Results SAMC reduced CCl4-triggered cellular necrosis and inflammation in the liver under histological analysis. Since co-treatment of SAMC and CCl4 enhanced the expressions of antioxidant enzymes, reduced the nitric oxide (NO)-dependent oxidative stress, and inhibited lipid peroxidation induced by CCl4. SAMC played an essential antioxidative role during CCl4-induced hepatotoxicity. Administration of SAMC also ameliorated hepatic inflammation induced by CCl4 via inhibiting the activity of NF-κB subunits p50 and p65, thus reducing the expressions of pro-inflammatory cytokines, mediators, and chemokines, as well as promoting pro-regenerative factors at both transcriptional and translational levels. Conclusions Our results indicate that SAMC mitigates cellular damage, oxidative stress, and inflammation in CCl4-induced acute hepatotoxicity mouse model through regulation of NF-κB. Garlic or garlic derivatives may therefore be a potential food supplement in the prevention of liver damage.

The use of hypnosis in labor and delivery : a preliminary study

Self-hypnosis was taught to 87 obstetric patients (HYP) and was not taught to 56 other patients (CNTRL), all delivered by the same family physician, in order to determine whether the use of self-hypnosis by low-risk obstetric patients leads to fewer technologic interventions during their deliveries or greater satisfaction of parturients with their delivery experience or both. The outcomes of the deliveries of these two groups were compared, and the HYP group was compared to 352 low-risk patients delivered by other family physicians at the same hospital (WCH). Questionnaires were mailed postpartum to 156 patients, all delivered by the same family physician, to determine satisfaction with delivery using the Labor and Delivery Satisfaction Index (LADSI). The hypnosis group showed a significant reduction in the number of epidurals (11.4% less than CNTRL and 17.9% less than WCH, p < 0.05) and the use of intravenous lines (18.5% less for both, p < 0.05). The number of episiotomies was significantly less in the HYP group compared to WCH (15.9%, p < 0.05) and 11.5% less when compared to CNTRL. The tear rate was not statistically different. Combined use of the intervention triad (epidural–forceps–episiotomy) was less for HYP than for CNTRL (15.8% less) and WCH (10.2% less, p < 0.05). More deliveries were done in the labor room with HYP than CNTRL (21%, p < 0.05). The second stage was shortened by 10 min (HYP vs CNTRL). Overall satisfaction of HYP and CNTRL patients was similar and generally favorable.

Foot massage and physiological stress in people with dementia : a randomized controlled trial

Background There is increasing interest in using complementary and alternative treatments to manage behavioural and psychological symptoms of dementia such as agitation, aggression and depressed mood. Objective To compare the effect of foot massage (intervention) and quiet presence (control) on agitation and mood in people with dementia. Design A randomised controlled trial using a within-subjects, crossover design. Settings Five long-term care facilities in Brisbane, Australia. The primary outcome was the Cohen-Mansfield Agitation Inventory (CMAI) and the secondary outcome was the Observed Emotion Rating Scale (OERS). The screening and data collection research assistants, families, and care staff were blinded to participant allocation. Participants Participants of the study were 55 long-term care residents aged 74–103 years (mean age 86.5), with moderate to severe dementia and a history of agitated behaviour according to the Pittsburgh Agitation Scale. A computer-program randomised participants to 10-min foot massage (intervention) or quiet presence (control), every weekday for 3 weeks. Results A carry-over effect was identified in the data, and so the data was treated as a parallel groups RCT. The mean total CMAI increased in both groups (reflecting an increase in agitation) with this increase greater in the quiet presence group than the foot massage group (p=0.03). There was a trend towards a difference on OERS General Alertness, with a positive change in alertness for participants in the foot massage group (indicating reduced alertness) and a negative change for participants in the quiet presence group (indicating increased alertness) (F(1,51)=3.88, p=0.05, partial ή2=0.07). Conclusions The findings highlight the need for further research on the specific conditions under which massage might promote relaxation and improve mood for people with dementia. The unfamiliar research assistants and variations in usual activity may have contributed to the increase in agitation and this needs further research.

Lyprinol : is it a useful anti-inflammatory agent?

The New Zealand green lipped mussel preparation Lyprinol is available without a prescription from a supermarket, pharmacy or Web. The Food and Drug Administration have recently warned Lyprinol USA about their extravagant anti-inflammatory claims for Lyprinol appearing on the web. These claims are put to thorough review. Lyprinol does have anti-inflammatory mechanisms, and has anti-inflammatory effects in some animal models of inflammation. Lyprinol may have benefits in dogs with arthritis. There are design problems with the clinical trials of Lyprinol in humans as an anti-inflammatory agent in osteoarthritis and rheumatoid arthritis, making it difficult to give a definite answer to how effective Lyprinol is in these conditions, but any benefit is small. Lyprinol also has a small benefit in atopic allergy. As anti-inflammatory agents, there is little to choose between Lyprinol and fish oil. No adverse effects have been reported with Lyprinol. Thus, although it is difficult to conclude whether Lyprinol does much good, it can be concluded that Lyprinol probably does no major harm.

An explorative qualitative analysis of participants' experience of using kava versus placebo in an RCT. (Clinical report)

Many randomised controlled trials (RCT) have been conducted using Piper methysticum (kava), however no qualitative research exploring the experience of taking kava during a clinical trial has previously been reported. ---------- Patients and methods: A qualitative research component (in the form of semi structured and open ended written questions) was incorporated into an RCT to explore the experiences of those participating in a clinical trial of kava. The written questions were provided to participants at weeks 2 and 3 (after randomisation, after each controlled phase). The researcher and participants were blinded as to whether they were taking kava or placebo. Two open ended questions were posed to elucidate their experiences from taking either kava or placebo. Thematic analysis was undertaken and researcher triangulation employed to ensure analytical rigour. Key themes after the kava phases were a reduction in anxiety and stress, and calming or relaxing mental effects. Other themes related to improvement in sleep and in somatic anxiety symptoms. ---------- Results: Kava use did not cause any serious adverse reactions although a few respondents reported nausea or other gastrointestinal side effects. This represents the first documented qualitative investigation of the experience of taking kava during a clinical trial. The primary themes involved anxiolytic and calming effects, with only a minor theme reflecting side effects. Our exploratory qualitative data was consistent with the significant quantitative results revealed in the study and provides additional support to suggest the trial results did not exclude any important positive or negative effects (at least as experienced by the trial participants).

A pilot randomised trial of Medilixir cream shows some promising results, but control treatment may have been inappropriate

Aim To test the efficacy of Medilixir [cream] against the standard treatment of aqueous cream in the provision of relief from the symptoms of postburn itch. Design RCT with two parallel arms. Setting Professor Stuart Pegg Adult Burns Centre, Royal Brisbane and Women's Hospital, Brisbane, Australia. Participants Fifty-two patients aged between 18 and 80 years, admitted directly to the burns centre between 10 March and 22 July 2008, were able to provide informed consent, and had shown no allergic reaction to a patch test with the study medication, were randomised. Patients admitted from intensive care or high dependency were excluded. Main results Effect estimates and confidence intervals were not reported for any of the outcomes; only group means/proportions and P-values from hypothesis testing were provided. More patients in the intervention group reported itch reduction compared to comparison treatment (91 vs. 82%, P=0.001). Itch recurrence after cream application occurred later in the intervention group compared to the control group (P<0.001). Use of antipruritic medication was significantly greater in the control group (P=0.023). There was no difference in sleep disturbance between groups (not quantified). On average, Medilixir took longer to apply than aqueous cream (157s for Medilixir vs. 139s for aqueous cream; mean difference 17s), but authors noted that the groups did not differ significantly (CI for mean difference and P-values were not reported).