Background Exercise may improve fatigue in multiple myeloma survivors, but trial evidence is limited, and exercise may be perceived as risky in this older patient group with osteolytic bone destruction. Methods In this Phase 2 Zelen trial, multiple myeloma survivors who had completed treatment at least 6 weeks ago, or were on maintenance only, were enrolled in a cohort study and randomly assigned to usual care or a 6-month exercise programme of tailored aerobic and resistance training. Outcome assessors and usual care participants were masked. The primary outcome was the FACIT-F fatigue score with higher scores denoting less fatigue. Results During 2014–2016, 131 participants were randomised 3:1 to intervention ( n = 89) or usual care ( n = 42) to allow for patients declining allocation to the exercise arm. There was no difference between groups in fatigue at 3 months (between-group mean difference: 1.6 [95% CI: −1.1–4.3]) or 6 months (0.3 [95% CI: −2.6–3.1]). Muscle strength improved at 3 months (8.4 kg [95% CI: 0.5–16.3]) and 6 months (10.8 kg [95% CI: 1.2–20.5]). Using per-protocol analysis, cardiovascular fitness improved at 3 months (+1.2 ml/kg/min [95% CI: 0.3–3.7]). In participants with clinical fatigue ( n = 17), there was a trend towards less fatigue with exercise over 6 months (6.3 [95% CI: −0.6–13.3]). There were no serious adverse events. Conclusions Exercise appeared safe and improved muscle strength and cardiovascular fitness, but benefits in fatigue appeared limited to participants with clinical fatigue at baseline. Future studies should focus on patients with clinical fatigue. Clinical trial registration The study was registered with ISRCTN (38480455) and is completed.
Aloe vera (AV) is suggested to be beneficial in treating irritable bowel syndrome (IBS) symptoms, but no scientific trials exist to confirm this. We aim to assess the efficacy of AV on IBS in refractory secondary care patients. Patients with IBS were randomised to receive AV or matching placebo for a month. Symptoms were assessed at baseline, 1 and 3 months. Fifty-eight patients randomised, 49 completed the protocol to 1 month and 41 to 3 months. Eleven of thirty-one (35%) AV patients, and 6 of 27 (22%) placebo patients responded at 1 month (p = 0.763). Diarrhoea predominant patients showed a trend towards a response to treatment at 1 month (10/23 V 2/14, p = 0.07). There was no evidence that AV benefits patients with IBS. However, we could not rule out the possibility that improvement occurred in patients with diarrhoea or alternating IBS whilst taking AV. Further investigations are warranted in patients with diarrhoea predominant IBS, in a less complex group of patients.
Background and purposeHaving epilepsy requires individuals to learn about self‐management. So far, trials of self‐management courses have not included in‐depth qualitative evaluations of how the learning method influences participants’ perceptions and behaviour. We aimed to interview participants who had attended a course, as part of a randomized controlled trial, to examine: (i) their perceptions of what they valued and negative aspects of the intervention, and (ii) whether and in what ways they continued to make use of the training.MethodsTwenty participants were selected within 6 months of undertaking a course from the larger randomized controlled trial conducted in England. Semi‐structured interviews were based on a topic guide.ResultsParticipants’ characteristics were representative of the clinical and demographic characteristics of the trial group. Their mean age was 44 years, half were male, and three‐quarters had had epilepsy for over 10 years and had experienced one or more seizures in the previous month. Participants valued the opportunity to meet ‘people like them’. Structured learning methods encouraged them to share and compare feelings and experience. Specific benefits included: overcoming the sense of ‘being alone’ and improving self‐acceptance through meeting people with similar experience. Over half reported that this, and comparison of attitudes and experience, helped them to improve their confidence to talk openly, and make changes in health behaviours.ConclusionsPeople feel socially isolated in long‐term poorly controlled epilepsy. They gain confidence and self‐acceptance from interactive groups. Expert‐facilitated courses that encourage experiential learning can help people learn from each other, and this may enhance self‐efficacy and behaviour change.
Aim: This study aimed to assess physician preferences for later lines (third to fifth) of therapy in patients with relapsed/refractory multiple myeloma (RRMM) in the USA. Materials & methods: Factors relevant to physicians' treatment preferences for RRMM were identified from a literature search and refined in a qualitative phase. Preferences were quantitatively assessed using a discrete choice experiment. Physicians (n = 227) made choices regarding treatment scenarios for RRMM. Results: Efficacy had the highest mean relative importance, with overall survival valued as most important when making treatment decisions for patients with RRMM. Reduced incidences of keratopathy and thrombocytopenia had similar relative importance in later-line treatment. Conclusion: Greater understanding of physicians' criteria for clinical decision-making may help inform wider adoption of new treatments.
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