Clinical trial: predictive factors for response to gut-directed hypnotherapy for refractory irritable bowel syndrome, a post hoc analysis.

BACKGROUND: Gut-directed hypnotherapy is effective for patients with irritable bowel syndrome (IBS). Despite its considerable evidence base, gut-directed hypnotherapy is not widely available and remains a limited resource. This emphasises the need to select patients who are most likely to benefit. AIM: To determine whether baseline patient characteristics were predictive of response to gut-directed hypnotherapy in patients with IBS METHODS: We conducted a secondary analysis of outcomes of 448 patients with refractory Rome III IBS who participated in a randomised study confirming non-inferiority of 6 compared to 12 sessions of gut-directed hypnotherapy. We compared baseline patient characteristics, including age, sex, IBS subtype, quality of life and IBS-Symptom Severity Scale (IBS-SSS), non-colonic symptom score and Hospital Anxiety and Depression (HAD) score between responders and non-responders. We defined response as ≥50-point decrease in IBS-SSS or ≥30% reduction in pain severity scores. RESULTS: Overall, 76.3% achieved ≥50-point decrease in IBS-SSS. Responders had a higher baseline non-colonic symptom score (p = 0.005). Those who achieved ≥30% improvement in abdominal pain scores (59.8%) had higher baseline IBS-SSS (p = 0.03), and lower baseline HAD-depression score (p = 0.012). Fifty-four patients (12%) dropped out of gut-directed hypnotherapy. Compared to completers, dropouts had higher baseline HAD-anxiety score (p = 0.034). CONCLUSIONS: These data suggest that patients with a higher burden of gastrointestinal and extraintestinal symptoms are most likely to benefit from gut-specific behavioural intervention for refractory IBS. Clinical assessment of gastrointestinal, somatic and psychological symptom profiles may play a role in selecting patients for gut-directed hypnotherapy.

SKYPE HYPNOTHERAPY FOR IRRITABLE BOWEL SYNDROME: Effectiveness and Comparison with Face-to-Face Treatment.

Gut-focused hypnotherapy is an effective treatment for irritable bowel syndrome but is not widely available. This study assessed whether providing hypnotherapy by Skype might partially overcome this problem. Using a 50-point or more reduction in the IBS Symptom Severity Score as the primary outcome measure, 65% of subjects responded to Skype hypnotherapy with all other outcomes significantly improving. The primary outcome figure for face-to-face hypnotherapy was 76%. When other outcome scores for Skype and face-to-face treatment were compared, the mean changes were these: symptom severity (-94.1 vs. -129.2), noncolonic score (-52.3 vs. -64.8), quality of life (+56.4 vs. +66.2), anxiety (-3.3 vs. -3.0), depression (-1.7 vs. -2.5), and a 30% or more pain reduction (44% vs. 62%). Skype hypnotherapy is effective but slightly less so than face-to-face treatment. However, many patients would have been unable to access treatment without the Skype option.

Electrical stimulation disrupts biofilms in a human wound model and reveals the potential for monitoring treatment response with volatile biomarkers.

Management of biofilm infections relies on time-consuming laboratory techniques and monitoring treatment by subjective clinical evaluations. Due to these limitations, there is a need to explore alternative strategies. The aims of this study were to assess the feasibility of using volatile organic compound (VOC) biomarkers to monitor treatment response and measure anti-biofilm efficacy of electrical stimulation (ES) in vitro and in human cutaneous wound biofilm models. Staphylococcus aureus (MSSA) and Pseudomonas aeruginosa (PA) biofilms were exposed to ES, ciprofloxacin, or both, with efficacy assessed and quantified by fluorescence staining, enumeration, metabolic assays, and biomass quantification; VOCs were measured by gas chromatography-mass spectrometry. In vitro MSSA and PA and ex vivo PA biofilms exposed to ES showed significantly reduced bacterial viability, metabolic activity, and biomass compared to controls (p < 0.05). There was significant variation in the relative abundance of VOCs in in vitro MSSA and PA and in ex vivo PA biofilms exposed to ES and antibiotic (p < 0.05). 2-methyl-1-propanol was associated with MSSA viability (R = 0.93, p < 0.05), biomass (R = 0.97, p < 0.05), and metabolic activity (R = 0.93, p < 0.05) and 3-methyl-1-butanol was associated with PA biomass (R = 0.93, p < 0.05). We showed that ES and VOC biomarkers are possible options for alternative nonpharmacological antimicrobial management of biofilms and noninvasive monitoring of wound infection treatment responses, respectively.

Electrical stimulation increases blood flow and haemoglobin levels in acute cutaneous wounds without affecting wound closure time: evidenced by non-invasive assessment of temporal biopsy wounds in human volunteers.

Recent studies highlighted the beneficial effects of a novel electrical stimulation waveform, the degenerate wave (DW), on skin fibroblasts and symptomatic skin scarring. However, no study to date has investigated the role of DW on acute cutaneous wounds. Therefore, we evaluated this in a trial using a temporal punch biopsy model. Twenty healthy volunteers had a biopsy performed on day 0 (left arm) and day 14 (right arm). On day 14, DW was applied. Participants were randomised into two groups. Objective non-invasive assessments were performed on days 0, 7, 14, 60 and 90 using spectrophotometric intracutaneous analysis and full-field laser perfusion imaging. There were statistically significant increases in mean flux on day 14 (P = 0.027) in the post-DW arm. Haemoglobin levels increased on day 7 for the post-DW arm compared to without DW (P = 0.088). Differences in melanin levels were higher post-DW on the left arm between randomised groups on day 90 (P = 0.033). Haemoglobin levels in the vascular ring increased significantly from day 7 to 90 (P < 0.001 for post-DW and without DW arms). This study, for the first time, shows that DW increases blood flow and haemoglobin levels in acute healing wounds without affecting wound closure time and may have potential application in enhancing acute cutaneous healing.

A double-blind placebo-controlled randomized trial of Melissa officinalis oil and donepezil for the treatment of agitation in Alzheimer's disease.

BACKGROUND/AIMS: Behavioural and psychological symptoms (BPSD) are frequent in people with Alzheimer's disease and cause considerable stress to patients and their carers. Antipsychotics have been widely used as a first-line treatment, resulting in an estimated 1,800 excess strokes and 1,600 excess deaths in the UK alone. Safe and effective alternatives are urgently needed. Based upon preliminary evidence from clinical trials, aromatherapy with melissa oil may be such an alternative, but initial studies have been modest in size, and adequate blinding has been problematic. Our objective was to assess the efficacy of melissa aromatherapy in the treatment of agitation in people with Alzheimer's disease in an adequately powered and robustly blinded randomized controlled trial comparing it with donepezil, an anticholinesterase drug used with some benefit to treat BPSD. METHODS AND FINDINGS: The study was a double-blind parallel-group placebo-controlled randomized trial across 3 specialist old age psychiatry centres in England. Participants had probable or possible Alzheimer's disease, were resident in a care home, had clinically significant agitation (defined as a score of 39 or above on the Cohen Mansfield Agitation Inventory) and were free of antipsychotics and/or anticholinesterase for at least 2 weeks. Participants were allocated to 1 of 3 groups: placebo medication and active aromatherapy; active medication and placebo aromatherapy or placebo of both. MAIN OUTCOME: The primary outcome measure was reduction in agitation as assessed by the Pittsburgh Agitation Scale (PAS) at 4 weeks. This is an observational scale, and raters were required to wear nose clips to ensure that full blinding was maintained. The PAS, Neuropsychiatric Inventory (NPI; another measure of BPSD) and other outcome measures were completed at baseline, 4-week and 12-week follow-ups. 114 participants were randomized, of whom 94 completed the week 4 assessment and 81 completed the week 12 assessment. Aromatherapy and donepezil were well tolerated. There were no significant differences between aromatherapy, donepezil and placebo at week 4 and week 12, but importantly there were substantial improvements in all 3 groups with an 18% improvement in the PAS and a 37% improvement in the NPI over 12 weeks. CONCLUSION: When assessed using a rigorous design which ensures blinding of treatment arms, there is no evidence that melissa aromatherapy is superior to placebo or donepezil, in the treatment of agitation in people with Alzheimer's disease. However, the sizeable improvement in the placebo group emphasizes the potential non-specific benefits of touch and interaction in the treatment of agitation in people with Alzheimer's disease.

Mood color choice helps to predict response to hypnotherapy in patients with irritable bowel syndrome.

BACKGROUND: Approximately two thirds of patients with irritable bowel syndrome (IBS) respond well to hypnotherapy. However, it is time consuming as well as expensive to provide and therefore a way of predicting outcome would be extremely useful. The use of imagery and color form an integral part of the hypnotherapeutic process and we have hypothesised that investigating color and how it relates to mood might help to predict response to treatment. In order to undertake this study we have previously developed and validated a method of presenting colors to individuals for research purposes called the Manchester Color Wheel (MCW). Using this instrument we have been able to classify colors into positive, neutral and negative shades and this study aimed to assess their predictive role in hypnotherapy. METHODS: 156 consecutive IBS patients (aged 14-74, mean 42.0 years, 127 (81%) females, 29 (19%) males) were studied. Before treatment, each patient was asked to relate their mood to a color on the MCW as well as completing the IBS Symptom Severity Score, the Hospital Anxiety and Depression (HAD) Scale, the Non-colonic Symptom Scale, the Quality of Life Scale and the Tellegen Absorption Scale (TAS) which is a measure of hypnotisability. Following hypnotherapy all these measures were repeated with the exception of the TAS. RESULTS: For patients with a positive mood color the odds of responding to hypnotherapy were nine times higher than that of those choosing either a neutral or negative color or no color at all (odds ratio: 8.889; p = 0.042). Furthermore, a high TAS score and the presence of HAD anxiety also had good predictive value (odds ratio: 4.024; p = 0.092, 3.917; p < 0.001 respectively) with these markers and a positive mood color being independent of each other. In addition, these factors could be combined to give an even stronger prediction of outcome. Twice as many responders (63, 77.8%) had a positive mood color or were anxious or had a high TAS score compared with 32 (42.7%) without these factors (p < 0.001). CONCLUSION: A positive mood color, especially when combined with HAD anxiety and a high TAS score, predict a good response to hypnotherapy.

Using art to help understand the imagery of irritable bowel syndrome and its response to hypnotherapy.

A medical artist asked 109 patients if they had an image of their IBS pre- and posthypnotherapy, making precise watercolor paintings of any images described. Results were related to treatment outcome, symptoms, anxiety, depression, and absorption (hypnotizability); 49% of patients had an image, and a wide variety were recorded and painted. Imagery was significantly associated with gender (p < .05), anxiety (p < .05), noncolonic symptomatology (p < .05), and absorption (p = .001); 57.8% of responders compared with 35.5% of nonresponders to hypnotherapy had an image of their disease (p < .05) before treatment, and color images were associated with better outcomes (p = .05) than monochrome ones. All images changed in responders, often becoming more nonspecific in nature. Inquiring about IBS imagery helps to identify potential responders and nonresponders to hypnotherapy and may also provide insights into how patients think about their illness.

Long-term improvement in functional dyspepsia using hypnotherapy.

BACKGROUND & AIMS: We have shown hypnotherapy (HT) to be effective in irritable bowel syndrome, with long-term improvements in symptomatology and quality of life (QOL). This study aimed to assess the efficacy of HT in functional dyspepsia (FD). METHODS: A total of 126 FD patients were randomized to HT, supportive therapy plus placebo medication, or medical treatment for 16 weeks. Percentage change in symptomatology from baseline was assessed after the 16-week treatment phase (short-term) and after 56 weeks (long-term) with 26 HT, 24 supportive therapy, and 29 medical treatment patients completing all phases of the study. QOL was measured as a secondary outcome. RESULTS: Short-term symptom scores improved more in the HT group (median, 59%) than in the supportive (41%; P = 0.01) or medical treatment (33%; P = 0.057) groups. HT also benefited QOL (42%) compared with either supportive therapy (10% [P < 0.001]) or medical treatment (11% [P < 0.001]). Long-term, HT significantly improved symptoms (73%) compared with supportive therapy (34% [P < 0.02]) or medical treatment (43% [P < 0.01]). QOL improved significantly more with HT (44%) than with medical treatment (20% [P < 0.001]). QOL did improve in the supportive therapy (43%) group, but 5 of these patients commenced taking antidepressants during follow-up. A total of 90% of the patients in the medical treatment group and 82% of the patients in the supportive therapy group commenced medication during follow-up, whereas none in the HT group did so (P < 0.001). Those in the HT group visited their general practitioner or gastroenterologist significantly less (median, 1) than did those in the supportive therapy (median, 4) and medical treatment (median, 4) groups during follow-up (P < 0.001). CONCLUSIONS: HT is highly effective in the long-term management of FD. Furthermore, the dramatic reduction in medication use and consultation rate provide major economic advantages.