Pelargonium sidoides root extract for the treatment of acute cough due to lower respiratory tract infection in adults: a feasibility double-blind, placebo-controlled randomised trial.

BACKGROUND: Pelargonium sidoides DC (Geraniaceae) root extract, EPs®7630 or "Kaloba®", is a widely used herbal remedy for respiratory infections, with some evidence of effectiveness for acute bronchitis. However, it is not yet widely recommended by medical professionals in the UK. There is a need to undertake appropriately designed randomised trials to test its use as an alternative to antibiotics. The aim was to assess the feasibility of conducting a double-blind randomised controlled trial of Pelargonium sidoides root extract for treatment of acute bronchitis in UK primary care, investigating intervention compliance, patient preference for dosage form and acceptability of patient diaries. STUDY DESIGN: Feasibility double-blind randomised placebo-controlled clinical trial. METHODS: We aimed to recruit 160 patients with cough (≤ 21 days) caused by acute bronchitis from UK general practices. Practices were cluster-randomised to liquid or tablet preparations and patients were individually randomised to Kaloba® or placebo. We followed participants up for 28 days through self-reported patient diaries with telephone support and reviewed medical records at one month. Outcomes included recruitment, withdrawal, safety, reconsultation and symptom diary completion rates. We also assessed treatment adherence, antibiotic prescribing and consumption, mean symptom severity (at days 2-4 after randomisation) and time to symptom resolution. We interviewed 29 patients and 11 health professionals to identify barriers and facilitators to running such a randomised trial. RESULTS: Of 543 patients screened, 261 were eligible, of whom 134 (51%) were recruited and 103 (77%) returned a completed diary. Overall, 41% (41/100) of patients took antibiotics (Kaloba® liquid group: 48% [15/31]; placebo liquid group: 23% [6/26]; Kaloba® tablet group: 48% [9/21]; placebo tablet group: 50% [11/22]). Most patients adhered to the study medication (median 19 out of 21 doses taken in week 1, IQR 18-21 - all arms combined). There were no serious adverse events relating to treatment. Most patients interviewed found study recruitment to be straightforward, but some found the diary too complex. CONCLUSIONS: It was feasible and acceptable to recruit patients from UK primary care to a double-blind placebo-controlled trial of herbal medicine (Kaloba®) for the treatment of acute bronchitis, with good retention and low data attrition. TRIAL REGISTRATION: HATRIC was registered on the ISRCTN registry ( ISRCTN17672884 ) on 16 August 2018, retrospectively registered. The record can be found at http://www.isrctn.com/ISRCTN17672884 .

Herbal medicine for acute bronchitis: A qualitative interview study of patients' and health professionals' views.

BACKGROUND: Antibiotics are widely prescribed for acute bronchitis in the UK. Herbal medicine could be used instead to provide symptom relief. AIM: To explore the views of patients and health professionals on using herbal medicine for acute bronchitis instead of antibiotics. DESIGN AND SETTING: This was a nested qualitative study, conducted alongside a feasibility randomised clinical trial which ran from July 2018 to May 2019 in 20 GP practices in Wessex, UK. METHOD: We conducted telephone semi-structured interviews with patients and with health professionals. The interview data were transcribed and analysed thematically. RESULTS: Overall, 40 interviews were conducted with 29 patients, six GPs and five nurses. While some patients believed antibiotics are more effective, most were aware of resistance and were keen to try an alternative, including herbal medicine. Several patients believed herbals would be "less intrusive" than antibiotics, whereas a few disliked the taste or experienced side-effects after taking a herbal. Professionals were concerned about potential interactions with conventional medicines. Many patients trusted herbals because of their long history of use, while some did not understand them. Availability of herbals without a prescription enables patients to use them for self-care, but their cost was a barrier for some. Many patients were willing to take a herbal if advised by their GP. Most GPs were happy to recommend a herbal, if endorsed by evidence-based guidelines. CONCLUSION: Many patients and health professionals would consider using herbal medicine for acute bronchitis, if based on trustworthy advice and evidence-based guidelines respectively.

Mindfulness for the self-management of fatigue, anxiety, and depression in women with metastatic breast cancer: a mixed methods feasibility study.

The impact of living with metastatic breast cancer (MBC) is considerable and psychosocial support can be beneficial. Mindfulness-based stress reduction (MBSR) can help self-management of anxiety, depression, quality of life (QoL), and fatigue and has been evaluated in early-stage breast cancer but not MBC. This study investigated the acceptability and feasibility of providing MBSR for women with MBC and of introducing MBSR into a National Health Service (NHS) setting. A mixed methods convergent design was used. Eligible women with MBC, an Eastern Cooperative Oncology Group (ECOG) score of 0 to 2, stable disease, and life expectancy of at least 6 months were invited to attend (by their oncologist) an 8-week MBSR course. Qualitative interviews with patients, a focus group, and interview with NHS staff were held to explore acceptability and feasibility of MBSR. Questionnaires at baseline, during (weeks 4, 8), and after (weeks 16, 24) the course measured fatigue, anxiety and depression, mindfulness, disease-specific QoL, and generic preference based QoL. Of 100 women approached, 20 joined the study. One woman dropped out prior to the intervention due to illness progression. Nineteen women took part in 3 MBSR courses. Recruitment to 2 of the 3 courses was slow. Commitment to 8 weeks was a reason for non-participation, and proved challenging to participants during the course. Participants found the course acceptable and reported many cumulative and ongoing benefits. These included feeling less reactive to emotional distress and more accepting of the disruption to life that occurs with living with MBC. There was high attendance, completion of course sessions, adherence to home practice, excellent follow-up rates, and high questionnaire return rates. MBSR was acceptable to MBC patients, who perceived benefits such as improved anxiety and QoL; but the MBSR course requires a considerable time commitment. There is scope to tailor the intervention so that it is less intensive.

Forming connections in the homeopathic consultation.

OBJECTIVE: A previous study which explored homeopathic practitioners' in depth understanding and experiences of homeopathic consultations identified "connecting" as a key component of the consultation. This paper reports on "connecting" and its role in the consultation. METHOD: Using a qualitative grounded theory approach data was collected from homeopaths using in-depth interviews, observations of homeopathic consultations and solicited practitioner reflective diaries. Constant comparison assisted code, concept and category formation to form a model of the UK classical homeopathic consultation. RESULTS: "Connecting", describes a complex notion of relationship in the homeopathic consultation consisting of four dimensions, and performs several roles within the consultation that enable practitioners to elicit symptoms, identify expectations, assist with prescribing, help patients engage with homeopathic principles and stimulate healing. CONCLUSION: This study shows the homeopath as an important component of the therapeutic context forming complex relationships and using communication that is skills based and inductively shaped to interpret and respond to each individual patient and their narrative in the consultation. PRACTICE IMPLICATIONS: This study could have implications for teachers, students and practitioners of homeopathy by influencing training needs, and could prove instructive for other clinicians as homeopaths' communication style could be used to augment other consultations.

Homeopathy enables rheumatoid arthritis patients to cope with their chronic ill health: a qualitative study of patient's perceptions of the homeopathic consultation.

OBJECTIVE: The role of the consultation in mediating improved clinical outcomes has been demonstrated in both conventional and complementary medicine but to date no depth study has explored how complementary medical consultations achieve such benefits. This study explored rheumatoid arthritis (RA) patients' perceptions of the homeopathic consultation including any perceived benefit. METHODS: Qualitative study nested within a placebo-controlled multi-centre trial assessing adjunctive homeopathic intervention for RA. In-depth face to face interviews (with 16 participants) were analysed using interpretative phenomenological analysis. RESULTS: RA participants perceived homeopathic consultations helped them cope better through either enabling improved physical health, wellbeing and/or illness management. Four themes associated with improved coping were: receiving emotional support; exploring the illness; exploring self; and gaining advice. Exploring the wider narrative of their illness, enabled participants to address their individual needs and for some, this process of increased awareness changed their perception resulting in the perceived benefits. CONCLUSION: Homeopathic consultations enable RA patient to cope better. PRACTICE IMPLICATIONS: Homeopathic consultations may provide an additional resource for RA patients. Identifying and employing the "active ingredients" that confer benefit may be appropriate for other clinicians to maximise patient benefits from consultations.

A grounded theory study of homeopathic practitioners' perceptions and experiences of the homeopathic consultation.

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.

Patients' and doctors' views on depression severity questionnaires incentivised in UK quality and outcomes framework: qualitative study.

OBJECTIVE: To gain understanding of general practitioners' and patients' opinions of the routine introduction of standardised measures of severity of depression through the UK general practice quality and outcomes framework. DESIGN: Semistructured qualitative interview study, with purposive sampling and constant comparative analysis. PARTICIPANTS: 34 general practitioners and 24 patients. SETTING: 38 general practices in three sites in England: Southampton, Liverpool, and Norfolk. RESULTS: Patients generally favoured the measures of severity for depression, whereas general practitioners were generally cautious about the validity and utility of such measures and sceptical about the motives behind their introduction. Both general practitioners and patients considered that assessments of severity should be seen as one aspect of holistic care. General practitioners considered their practical wisdom and clinical judgment ("phronesis") to be more important than objective assessments and were concerned that the assessments reduced the human element of the consultation. Patients were more positive about the questionnaires, seeing them as an efficient and structured supplement to medical judgment and as evidence that general practitioners were taking their problems seriously through a full assessment. General practitioners and patients were aware of the potential for manipulation of indicators: for economic reasons for doctors and for patients to avoid stigma or achieve desired outcomes. CONCLUSIONS: Despite general practitioners' caution about measures of severity for depression, these may benefit primary care consultations by increasing patients' confidence that general practitioners are correct in their diagnosis and are making systematic efforts to assess and manage their mental health problems. Further education of primary care staff may optimise the use and interpretation of depression questionnaires.

Overseas Chinese students in the UK: patterns and correlates of their use of Western and traditional Chinese medicine.

We explored the correlates of use of TCM and WM by ethnic Chinese students in the UK. A questionnaire assessed key theoretical determinants of health services use. One hundred and seventy ethnic Chinese participants (international students at one university in the South of England) completed this questionnaire (presented in English and Chinese) assessing their demographic characteristics, health status, attitudes towards and use of TCM and WM. Participants were more likely to use WM than TCM when they were in the UK. Different variables predicted use of WM and TCM. The statistical predictors (demographic characteristics, health status, past behaviour, attitudes) explained modest but important proportions of the variance in use of WM (37%) and TCM (29%). In conclusion, this small exploratory study suggests a need for further research on the health care utilisation of this growing body of international students. Improved language support is needed for international students in UK health care settings.