Oscillococcinum® for upper respiratory tract infections and exacerbations in COPD: an observational, prospective study (OXITUNIS).

BACKGROUND: Upper respiratory tract infections (URTIs) are a major cause of exacerbations in patients with chronic obstructive pulmonary disease (COPD). We assessed the effectiveness of Oscillococcinum® in the protection from URTIs in patients with COPD who had been vaccinated against influenza infection over the 2018-2019 winter season. METHODS: Patients (n=106; mean ± standard deviation age: 66.0 ± 10.3 years; 89.6% men) were randomized into two groups: group V received influenza vaccination only and group OV received influenza vaccination plus Oscillococcinum® (one oral dose per week from inclusion in the study until the end of follow-up, with a maximum of 6 months follow-up over the winter season). The primary endpoint was the incidence rate of URTIs (number of URTIs/1000 patient-treatment exposure days) during follow-up compared between the two groups. RESULTS: There was no significant difference in any of the demographic characteristics, baseline COPD, or clinical data between the two treatment groups (OV and V). The URTI incidence rate was significantly higher in group V than in group OV (2.9 versus 1.2 episodes/1000 treatment days, difference OV-V = -1.7; p=0.0312). There was a significant delay in occurrence of an URTI episode in the OV group versus the V group (mean ± standard error: 48.7 ± 3.0 versus 67.0 ± 2.8 days, respectively; p=0.0158). Limitations to this study include its small population size and the self-recording by patients of the number and duration of URTIs and exacerbations. CONCLUSION: Oscillococcinum may decrease the incidence rate and delay the appearance of URTIs in patients with COPD.

Management of Anxiety and Depressive Disorders in Patients ≥ 65 Years of Age by Homeopath General Practitioners versus Conventional General Practitioners, with Overview of the EPI3-LASER Study Results.

BACKGROUND: The increasing use of psychotropic drugs to treat anxiety and depressive disorders (ADDs) is concerning. According to the study, 'Etude Pharmacoépidémiologique de l'Impact de Santé Publique des modes de prise en charge pour 3 groupes de pathologies' (EPI3)-LASER, adult ADD patients who consult a general practitioner prescribing homeopathic medicines (GP-Ho) report less psychotropic drug use and are marginally more likely to experience clinical improvement than those receiving conventional care. We determined whether these observations also apply to patients ≥ 65 years old in the EPI3 cohort. METHODS: The EPI3-LASER study, conducted in France between March 2007 and July 2008, was a nationwide, observational survey of the three most common reasons for primary care consultation, including ADD, and the impact of the GPs' prescribing preferences: homeopathy (GP-Ho), conventional medicines (GP-CM) or mixed prescriptions (GP-Mx). This sub-analysis included 110 patients ≥ 65 years old with ADD from the EPI3 cohort who consulted either a GP-CM or GP-Ho. Socio-demographic and medical data and details of any medications prescribed were collected at inclusion. Information regarding the patients' functional status (Hospital Anxiety and Depression Scale [HADS)]) was obtained via a telephone interview 72 hours after inclusion, and at 1, 3 and 12 months post-inclusion. Medication use and outcome were determined over the 12-month period. Differences between the GP-CM and GP-Ho groups were assessed by multivariate logistic regression analysis. RESULTS: One hundred and ten patients were recruited and 87 (79.1%) with ADD (HADS ≥ 9) at the 72-hour interview were evaluated (age range: 65-93 years, 82.8% female). Patients who consulted a GP-Ho were more likely (odds ratio [OR] = 10.38, 95% confidence interval [CI]: 1.33-81.07) to have clinical improvement (HADS < 9) after 12 months than those in the GP-CM group. Patients who consulted a GP-Ho reported less psychotropic drug use (OR = 22.31 [95% CI: 2.20-226.31]) and benzodiazepine use (OR = 60.63 [95% CI: 5.75-639.5]) than GP-CM patients. CONCLUSIONS: Management of ADD patients aged ≥ 65 years by GP-Ho appears to have a real public health interest in terms of effectiveness and lower psychotropic drug use.

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.

Economic impact of homeopathic practice in general medicine in France.

Health authorities are constantly searching for new ways to stabilise health expenditures. To explore this issue, we compared the costs generated by different types of medical practice in French general medicine: i.e. conventional (CM-GP), homeopathic (Ho-GP), or mixed (Mx-GP).Data from a previous cross-sectional study, EPI3 La-Ser, were used. Three types of cost were analysed: (i) consultation cost (ii) prescription cost and (iii) total cost (consultation + prescription). Each was evaluated as: (i) the cost to Social Security (ii) the remaining cost (to the patient and/or supplementary health insurance); and (iii) health expenditure (combination of the two costs).With regard to Social Security, treatment by Ho-GPs was less costly (42.00 vs 65.25 for CM-GPs, 35 % less). Medical prescriptions were two-times more expensive for CM-GPs patients (48.68 vs 25.62 ). For the supplementary health insurance and/or patient out-of-pocket costs, treatment by CM-GPs was less expensive due to the lower consultation costs (6.19 vs 11.20 for Ho-GPs) whereas the prescription cost was comparable between the Ho-GPs and the CM-GPs patients (15.87 vs 15.24 respectively) . The health expenditure cost was 20 % less for patients consulting Ho-GPs compared to CM-GPs (68.93 vs 86.63 , respectively). The lower cost of medical prescriptions for Ho-GPs patients compared to CM-GPs patients (41.67 vs 63.72 ) was offset by the higher consultation costs (27.08 vs 22.68 respectively). Ho-GPs prescribed fewer psychotropic drugs, antibiotics and non-steroidal anti-inflammatory drugs.In conclusions management of patients by homeopathic GPs may be less expensive from a global perspective and may represent an important interest to public health.

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.

Physician practicing preferences for conventional or homeopathic medicines in elderly subjects with musculoskeletal disorders in the EPI3-MSD cohort.

BACKGROUND: Musculoskeletal pain is common in elderly persons. Analgesic use is high in the elderly and may involve unacceptable risk in individuals with chronic pain. Our aim was to compare the socio-demographic characteristics of elderly subjects with musculoskeletal disorders (MSD) and to assess medication use and clinical evolution of musculoskeletal pain according to physician prescribing preference: homeopathy (Ho) group, conventional medicine (CM) group, or mixed prescription (MX) group. METHODS: The EPI3 study was a 1 year observational survey carried out among general practitioners in France between March 2007 and July 2008. This sub-analysis was carried out on elderly subjects aged ≥70 years from the original EPI3 cohort. Socio-demographic data were collected at inclusion using a self-administered patient questionnaire and medical data were recorded for each patient. Quality of life was measured using the Short Form-12 questionnaire. Patients completed a structured telephone interview on their functional status (evaluated with the QuickDash questionnaire, EIFEL scale or Lequesne index) within 72 hours of inclusion. This telephone interview was repeated at 1, 3, and 12 months. Drug exposure was also assessed during these interviews. RESULTS: 146 patients (mean age ± standard deviation: 75.8±4.8 years) were analyzed (80.1% female, 74.7% MSD of the spine or lower limbs, 64.4% chronic MSD). Patients in the CM and MX groups were 3.7 times or 2.5 times more likely (odds ratio [OR] =3.71, 95% confidence interval [CI]: 1.12-12.30; OR =2.52, 95% CI: 1.05-6.05; respectively) to have used non-steroidal anti-inflammatory drugs (NSAIDs) than those in the Ho group. In contrast, analgesic use was comparable in the three groups (OR =1.06 [CM versus Ho], 95% CI: 0.09-12.11; OR =0.34 [MX versus Ho], 95% CI: 0.07-1.57). Overall functional score evolution was similar in the three groups over time (P=0.16). CONCLUSION: NSAID use was significantly higher in elderly MSD patients consulting a conventional practice general practitioner. In contrast, analgesic use and MSD evolution were similar in the three groups. Consulting a homeopathic physician for MSD management does not appear to represent a loss of therapeutic opportunity, and decreases the use of NSAIDs.

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.

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.