Symptoms associated with teething and response to three treatments, including homeopathic medicine: a multicenter prospective observational study among 190 French pediatricians.

BACKGROUND: Primary tooth eruption in infants is associated with a range of local and systemic symptoms although this remains a subject of much debate. In addition, data are limited on the role of physicians in managing infant teething, and on the benefit of homeopathic treatments. METHODS: We conducted an observational, multicenter, prospective survey evaluating teething symptoms, and symptom course following routine medical management by French pediatricians in 597 infants aged from 3 to 24 months. We also examined the response to treatment with routinely prescribed teething medications; the homeopathic agent, Camilia® and topically applied gingival agents (Delabarre® or Dolodent®). RESULTS: Most infants (96.6%) had buccogingival symptoms and 93.3% had at least one general symptom. Fever (≥38 °C) was reported in 15.2% of infants. For teething, 212 infants were prescribed Camilia®, 172 a gingival solution (Delabarre® or Dolodent®) and 213 received Camilia® along with a gingival agent. Infants prescribed both a homeopathic and a gingival treatment had a significantly higher number of symptoms at presentation compared with those prescribed a single agent. There were no significant differences in symptom course across these three treatment groups. Systemic analgesics/antipyretics were prescribed in 68.8% of cases. Parent satisfaction with medical management and prescribed treatments was high. CONCLUSIONS: Teething is frequently associated with transient local and systemic upset in infants and is a significant concern to parents. Camilia® provides a similar benefit to topical therapy, and is frequently used by pediatricians in France.

Motivations of patients seeking supportive care for cancer from physicians prescribing homeopathic or conventional medicines: results of an observational cross-sectional study.

BACKGROUND & AIMS: The motivations of patients who consult a homeopathic (GP-Ho) or conventional (GP-CM) general practitioner for supportive care during cancer treatment have not been widely studied. We investigated the reasons why cancer patients consult a GP-Ho versus a GP-CM for supportive care and the GPs' motivations for their prescriptions. METHODS: This observational survey was carried out in France between October 2008 and October 2011. GPs across France were randomly selected and asked to recruit four cancer patients each. At inclusion, the sociodemographic and clinical (including psychological) characteristics and medical history of the patients were recorded by the GPs and the patients noted their quality of life (QoL) and anxiety/depression using the Quality of Life Questionnaire-C30 (QLQ-C30) and Hospital Anxiety and Depression Scale (HADS) self-questionnaires. The main motivations of the patients regarding the type of GP consultation and the main reasons for the GPs' prescriptions were recorded. RESULTS: Six hundred and forty four patients were included in the analysis: 399 consulted a GP-CM (n = 112) and 245 a GP-Ho (n = 73). Patients consulting a GP-Ho were more often female [OR = 1.93; 95%CI: 1.11-3.35; p = 0.02], employed in a professional capacity [OR = 6.57; 95%CI: 1.96-21.99; p = 0.002], have a shorter time since cancer diagnosis [OR = 2.19; 95%CI: 1.24-3.87; p = 0.007], have received targeted anticancer therapy [OR = 3.70; 95%CI: 1.67-8.18; p = 0.001] and have a high QLQ-C30 score for constipation [OR = 1.01; 95%CI: 1.00-1.02; p = 0.001]. Patients mainly consulted a GP-Ho to receive overall care (73.5% vs. 64.9%; p = 0.024) and medicines to prevent anticancer treatment-related side-effects (63.7% vs. 41.4%; p < 0.0001). In contrast, patients consulted a GP-CM to receive psychological care (50.1% vs. 40.8%; p = 0.021) and more information regarding the oncologists' strategic decisions (p < 0.0001). There was a significantly greater prescription of psychotropic drugs by GP-CM (53.7% vs. 22.4%, p < 0.0001). CONCLUSIONS: Patients consulting a GP-Ho or GP-CM had different motivations for seeking supportive care. There was a significantly greater prescription of psychotropic drugs by GP-CM.

Open-label observational study of the homeopathic medicine Passiflora Compose for anxiety and sleep disorders.

BACKGROUND: Anxiety and sleep disorders (SDS) are frequently treated with psychotropic drugs. Health authorities in France have been advised to improve access to alternative treatments such as homeopathic medicines. Our aim was to describe the socio-demographic characteristics and clinical progression of patients prescribed homeopathic medicine Passiflora Compose (PC) for anxiety and/or SDS. MATERIAL AND METHODS: This was an open-label, observational study. Randomly selected general practitioners (GPs) known to prescribe homeopathic medicines recruited consecutive patients (≥18-years) prescribed PC. The following data were recorded at inclusion by the GP: socio-demographic data and anxiety severity (Hamilton anxiety rating scale or HAM-A); and by the patients: level of anxiety (STAI Spielberger self-assessment questionnaire) and SDS (Jenkins sleep scale or JSS). Anxiety and SDS were reassessed after 4 weeks of treatment using the same scales. RESULTS: A total of 639 patients (mean age: 46.3 ± 17.5 years; 78.6% female) were recruited by 98 GPs. Anxiety was present in 85.4% (HAM-A) and 93.3% (Spielberger State) at inclusion (mean scores: 17.8 ± 8.91 and 54.59 ± 11.69, respectively) and SDS was present in 74.0% (mean score: 15.24 ± 5.28). A total of 401 (62.7%) patients received PC alone and 167 (26.1%) PC + psychotropics. After 4 weeks, mean anxiety scores decreased by more than 7, 12 and 6 points (HAM-A, Spielberger State and Trait respectively), and SDS score by more than 4 points (JSS). CONCLUSION: Anxiety and/or SDS improved significantly in patients included on this study. PC could be an alternative to the use of psychotropic drugs for first intention treatment of anxiety and SDS. Further studies are needed to confirm those results.

Management of the early symptoms of influenza-like illnesses and ear, nose and throat (ENT) disorders by pharmacists.

BACKGROUND: Pharmacists play a key role in primary healthcare, but the characteristics of patients who consult a pharmacist directly rather than going to their general practitioner (GP) are unknown. Our aim was to describe the socio-demographic and clinical characteristics of patients who seek direct therapeutic advice from a pharmacist for influenza-like illness (ILI) or ear, nose and throat (ENT) disorders, the types of medicines dispensed and patient satisfaction with the advice received. METHODS: This prospective, observational study was carried out on a random sample of French pharmacies between November 2010 and March 2011. Patients (≥12-years) with early symptoms of ILI or ENT disorders (<36 h duration) who received treatment were included. Socio-demographic data, symptom severity and disease impact on daily activities and sleep were recorded at inclusion. Symptom evolution and patient satisfaction were assessed after 3 days of treatment. RESULTS: 573 patients (mean age: 42.5 ± 16.2 years; 61.9% female) were recruited by 133 pharmacies. Two-thirds of patients (63.2%) visited the pharmacy early (<24 h) after symptom onset. The most common symptoms were runny nose (56.4%), sore throat (54.6%) and cough (49.0%). Patients were given 2.6 ± 1.2 medications; 98.4% of patients received allopathic (usually paracetamol, 33.5%) and 25.3% homeopathic (Oscillococcinum, 56.6%) treatment, usually combined with allopathy. Compliance was good and 77.2% of patients continued treatment for 3 days. Most symptoms improved significantly after 3 days and quality of life was enhanced. 85.9% of patients were satisfied with the advice received. CONCLUSIONS: Seeking a pharmacist's advice for the management of ILI and ENT disorders has several public health benefits. The clinical improvement and high patient satisfaction observed validate the role of the pharmacist as a health professional of first resort.

China rubra for side-effects of quinine: a prospective, randomised study in pregnant women with malaria in Cotonou, Benin.

BACKGROUND: In endemic areas, gestational malaria is responsible for low birth weight and maternal anaemia. Quinine is the reference treatment for acute malaria in pregnant women, irrespective of term. However, quinine administration is associated with various side-effects. We evaluated the impact of the homeopathic medicine China rubra 7CH on the side-effects of quinine used as treatment for acute malaria in pregnant women in Cotonou, Benin. METHODS: This prospective, comparative, randomised study was carried out between June and December 2007 in the Saint Jean-Baptiste Medical Centre, Cotonou. Women were included if they were >3 months pregnant and had a clinical diagnosis of malaria confirmed by a positive thick blood smear. The study population was divided into two groups: (i) patients who presented between the 1st and 15th of each month and who received China rubra 7CH plus quinine (China group); and (ii) patients who presented from the 16th to the end of each month and who received treatment with quinine only (Standard group). The aim was to compare the frequency of side-effects of quinine in the two groups until day 6 after the start of treatment. Neither the patients nor the care givers were blinded to study treatment. Statistical comparison of the two groups was carried out with an alpha risk fixed at 5%. RESULTS: 211 women were recruited: 105 received quinine plus China rubra 7CH (China group) and 106 received quinine only (Standard group). A decrease in proportion of patients presenting with side-effects was observed in the China group from day 0 to day 6 of follow-up (53.9%-23.3%) whereas the proportion of patients with side-effects in the Standard group did not change significantly (85.9% on day 0 vs. 82.5% on day 6). Ninety-six (72.4%) patients in the China group and 103 (97.2%) in the Standard group reported at least one side-effect during follow-up (p < 0.0001). The most frequently reported side-effects were tinnitus, dizziness and asthenia. CONCLUSIONS: This preliminary study shows the interest of China rubra 7CH in limiting the side-effects of quinine used for the treatment of acute malaria in pregnant women.

Effectiveness of homeopathic medicine associated with allopathic medicine in the outpatient management of influenza-like illnesses or ear, nose, and throat disorders by pharmacists.

BACKGROUND: Pharmacists play an increasing role in advising on treatment for minor illnesses such as influenza-like illness (ILI) or ear, nose, and throat (ENT) disorders. However, the profile of patients consulting pharmacists with these illnesses, the types of over-the-counter (OTC) medicines recommended by pharmacists, and the effectiveness of these treatments have not been studied. OBJECTIVES: To describe the sociodemographic and clinical characteristics of patients recommended allopathic and/or homeopathic medicines for ILI or ENT disorders by pharmacists in France and to investigate the effectiveness of these treatments. METHODS: A prospective, observational, multicenter study was carried out in randomly selected pharmacies across the 8 IDREM medical regions of France. Pharmacies that agreed to participate recruited male or female patients who responded to the following inclusion criteria: age ≥ 12 years presenting with the first symptoms of an ILI or ENT disorder that were present for less than 36 hours prior to the pharmacy visit. All medicines recorded in the study were recommended by the pharmacists. The following data were recorded at inclusion and after 3 days of treatment: the intensity of 13 symptoms, global symptom score, and disease impact on daily activities and sleep. Two groups of patients were compared: those recommended allopathic medicine only (AT group) and those recommended homeopathic medicine with or without allopathic medicine (HAT group). The number and severity of symptoms, change in global symptom score, and disease impact on daily activities and sleep were compared in the 2 treatment groups after 3 days of treatment. Independent predictors of recommendations for homeopathic medicine were identified by multi-factorial logistic regression analysis. RESULTS: A total of 242 pharmacies out of 4,809 (5.0%) contacted agreed to participate in the study, and 133 (2.8%) included at least 1 patient; 573 patients were analyzed (mean age: 42.5 ± 16.2 years; 61.9% female). Of these, 428 received allopathic medicines only (74.7%; AT group), and 145 (25.3%) received homeopathic medicines (HAT group) alone (9/145, 1.6%) or associated with allopathy (136/145, 23.7%). At inclusion, HAT patients were significantly younger (39.6 ± 14.8 vs. 43.4 ± 16.1 years; P less than 0.05), had a higher mean number of symptoms (5.2 ± 2.5 vs. 4.4 ± 2.5; P less than 0.01), and more severe symptoms (mean global symptom score: 24.3 ± 5.5 vs. 22.3 ± 5.8; P = 0.0019) than AT patients. After 3 days, the improvement in symptoms and disease impact on daily activities and sleep was comparable in both groups of patients. CONCLUSIONS: Patients recommended homeopathic medicine by pharmacists were younger and had more severe symptoms than those recommended allopathic medicine. After 3 days of treatment, clinical improvement was comparable in both treatment groups. Pharmacists have an important role to play in the effective management of ILI and ENT disorders.

Representations of influenza and influenza-like illness in the community--a qualitative study.

BACKGROUND: There is little information regarding lay-people's representations of influenza and influenza-like illness in their day-to-day lives. An insight into these views may aid our understanding of community attitudes regarding official recommendations for its prevention. METHODS: This was a qualitative research. Semi-structured face-to-face interviews were conducted with 40 French participants from the community, and from five different locations. Questions elicited the participants' representations of onset of flu and influenza-like illness, as well as their views on what can/should be done to deal with symptoms and their personal experience with flu and flu-like symptoms. RESULTS: Thematic content analyses allowed us to identify five main themes: the presence of a clear continuum between influenza-like illness and flu; a description of flu as a very contagious disease; flu as being benign, except in "frail people", which the respondents never considered themselves to be; interruption of daily activities, which could be considered pathognomonic for influenza for most subjects; self-medication as the main current practice, and requests for healthcare mainly to confirm an auto-diagnosis. CONCLUSIONS: There was a large homogeneity in the representation of flu. There was also a gap between people's representations (i.e., a continuum from having a "cold" to having "influenza") and scientific knowledge (i.e., a distinction between "true" influenza and influenza-like illnesses based on the existence of a confirmatory virological diagnosis). This gap raises issues for current campaigns for flu prevention, as these may not be congruent with the representation of flu being responsible for interrupting daily activities while also being seen as a non-severe disease, as well as the perception that flu is only a risk to "frail people" though no participants considered themselves to be "frail".

Homeopathic treatment of premenstrual syndrome: a case series.

OBJECTIVE: Observational, prospective study to describe the homeopathic management of premenstrual syndrome (PMS) by a group of French physicians. METHOD: Women with PMS for >3 months were prescribed individualized homeopathic treatment. The intensity of 10 clinical symptoms of PMS was scored individually at inclusion and at a 3-6 month follow-up visit: absent = 0, mild = 1, moderate = 2, severe = 3. Total symptom score (range: 0-30) was calculated and compared for each patient at inclusion and at follow-up. PMS impact on daily activities (quality of life, QoL) was compared at inclusion and follow-up as: none, mild, moderate, severe, very severe. RESULTS: Twenty-three women were prescribed homeopathic treatment only (mean age: 39.7 years). Folliculinum (87%) was the most frequently prescribed homeopathic medicine followed by Lachesis mutus (52.2%). The most common PMS symptoms (moderate or severe) at inclusion were: irritability, aggression and tension (87%), mastodynia (78.2%) and weight gain and abdominal bloating (73.9%); and the most common symptoms at follow-up were: irritability, aggression and tension (39.1%), weight gain and abdominal bloating (26.1%) and mastodynia (17.4%). Mean global score for symptom intensity was 13.7 at inclusion and 6.3 at follow-up. The mean decrease in score (7.4) was statistically significant (p < 0.0001). Twenty-one women reported that their QoL also improved significantly (91.3%; p < 0.0001). CONCLUSIONS: Homeopathic treatment was well tolerated and seemed to have a positive impact on PMS symptoms. Folliculinum was the most frequent homeopathic medicine prescribed. There appears to be scope for a properly designed, randomized, placebo-controlled trial to investigate the efficacy of individual homeopathic medicines in PMS.

Homeopathic treatment of migraine in children: results of a prospective, multicenter, observational study.

OBJECTIVES: The study objective was to evaluate the effectiveness of homeopathic medicines for the prevention and treatment of migraine in children. DESIGN: This was an observational, prospective, open, nonrandomized, noncomparative, multicenter study. SETTING/LOCATION: The study was conducted in 12 countries worldwide. SUBJECTS: Fifty-nine (59) physicians trained in the prescription of homeopathic medicines and 168 children, aged 5-15 years, with definite or probable migraine diagnosed using International Headache Society 2004 criteria were the subjects in this study. INTERVENTIONS: Physicians were given complete freedom in terms of treatment prescription; thus, prescriptions were individualized for each patient. OUTCOME MEASURES: The frequency, intensity, and duration of migraine attacks in the 3 months prior to inclusion were compared with those during the 3-month follow-up period. Pertinent data were collected using questionnaires completed by the doctor and the patient or his/her parent/guardian. The secondary outcome measure was the impact of homeopathic medicines on education, measured as absence from school. RESULTS: The frequency, severity, and duration of migraine attacks decreased significantly during the 3-month follow-up period (all p<0.001). Preventive treatment during this time consisted of homeopathic medicines in 98% of cases (mean=2.6 medicines/patient). Children spent significantly less time off school during follow-up than before inclusion (2.0 versus 5.5 days, respectively; p<0.001). The most common preventive medicines used were Ignatia amara (25%; mainly 9C), Lycopodium clavatum (22%), Natrum muriaticum (21%), Gelsemium (20%), and Pulsatilla (12%; mainly 15C). Homeopathy alone was used for the treatment of migraine attacks in 38% of cases. The most commonly used medicines were Belladonna (32%; mainly 9C), Ignatia amara (11%; mainly 15C), Iris versicolor (10%; mainly 9C), Kalium phosphoricum (10%; mainly 9C), and Gelsemium (9%; mainly 15C and 30C). CONCLUSIONS: The results of this study demonstrate the interest of homeopathic medicines for the prevention and treatment of migraine attacks in children. A significant decrease in the frequency, severity, and duration of migraine attacks was observed and, consequently, reduced absenteeism from school.

Management of influenza-like illness by homeopathic and allopathic general practitioners in France during the 2009-2010 influenza season.

OBJECTIVE: This study was done to determine characteristics and management of patients in France visiting allopathic general practitioners (AGPs) and homeopathic general practitioners (HGPs) for influenza-like illness (ILI). DESIGN: This was a prospective observational study. SETTINGS/LOCATION: It was conducted in metropolitan France during the 2009-2010 influenza season. SUBJECTS: Sixty-five HGPs and 124 AGPs recruited a total of 461 patients with ILI. INTERVENTIONS: Patients were treated for ILI by their GPs. GPs and patients completed questionnaires recording demographic characteristics and patient symptoms when patients were included in the study. Patients reported satisfaction with treatment on day 4. Prescriptions were recorded by the GPs. OUTCOME MEASURES: Outcome measures were patient characteristics, demographics, and symptoms at baseline; medications prescribed by type of physician; and satisfaction with treatment by type of physician and medication. RESULTS: Most AGPs (86%), and most patients visiting them (58%) were men; whereas most HGPs (57%; p<0.0001), and most patients visiting them (56%; p=0.006) were women. Patients visiting AGPs were seen sooner after the appearance of symptoms, and they self-treated more frequently with cough suppressants or expectorants (p=0.0018). Patients visiting HGPs were seen later after the appearance of symptoms and they self-treated with homeopathic medications more frequently (p<0.0001). At enrollment, headaches (p=0.025), cough (p=0.01), muscle/joint pain (p=0.049), chills/shivering (p<0.001), and nasal discharge/congestion (p=0.002) were more common in patients visiting AGPs. Of these patients, 37.1% visiting AGPs were prescribed at least one homeopathic medication, and 59.6% of patients visiting HGPs were prescribed at least one allopathic medication. Patient satisfaction with treatment did not differ between AGPs and HGPs but was highest for patients treated with homeopathic medications only. CONCLUSIONS: In France, homeopathy is widely accepted for the treatment of ILI and does not preclude the use of allopathic medications. However, patients treated with homeopathic medications only are more satisfied with their treatment than other patients.

Method for appraising model validity of randomised controlled trials of homeopathic treatment: multi-rater concordance study.

BACKGROUND: A method for assessing the model validity of randomised controlled trials of homeopathy is needed. To date, only conventional standards for assessing intrinsic bias (internal validity) of trials have been invoked, with little recognition of the special characteristics of homeopathy. We aimed to identify relevant judgmental domains to use in assessing the model validity of homeopathic treatment (MVHT). We define MVHT as the extent to which a homeopathic intervention and the main measure of its outcome, as implemented in a randomised controlled trial (RCT), reflect 'state-of-the-art' homeopathic practice. METHODS: Using an iterative process, an international group of experts developed a set of six judgmental domains, with associated descriptive criteria. The domains address: (I) the rationale for the choice of the particular homeopathic intervention; (II) the homeopathic principles reflected in the intervention; (III) the extent of homeopathic practitioner input; (IV) the nature of the main outcome measure; (V) the capability of the main outcome measure to detect change; (VI) the length of follow-up to the endpoint of the study. Six papers reporting RCTs of homeopathy of varying design were randomly selected from the literature. A standard form was used to record each assessor's independent response per domain, using the optional verdicts 'Yes', 'Unclear', 'No'. Concordance among the eight verdicts per domain, across all six papers, was evaluated using the kappa (κ) statistic. RESULTS: The six judgmental domains enabled MVHT to be assessed with 'fair' to 'almost perfect' concordance in each case. For the six RCTs examined, the method allowed MVHT to be classified overall as 'acceptable' in three, 'unclear' in two, and 'inadequate' in one. CONCLUSION: Future systematic reviews of RCTs in homeopathy should adopt the MVHT method as part of a complete appraisal of trial validity.