Double-Blind, Randomized, Placebo-Controlled Trial of Individualized Homeopathic Medicines in Atopic Dermatitis in Adults: A Replication Trial with 6 Months' Follow-up.

BACKGROUND: Atopic dermatitis (AD) is a chronic relapsing and remitting inflammatory skin disease that can have a significant impact on quality of life. During the last four decades, a rising trend in AD has been observed in India. Homeopathic medicines are claimed to be beneficial in AD; however, convincing research evidence has been lacking. We compared the efficacy of individualized homeopathic medicines (IHMs) against placebos in the treatment of AD. METHODS: In this double-blind, randomized, placebo-controlled trial of 6 months' duration (n = 60), adult patients were randomized to receive either IHMs (n = 30) or identical-looking placebos (n = 30). All participants received concomitant conventional care, which included the application of olive oil and maintaining local hygiene. The primary outcome measure was disease severity using the Patient-Oriented Scoring of Atopic Dermatitis (PO-SCORAD) scale; secondary outcomes were the Atopic Dermatitis Burden Scale for Adults (ADBSA) and Dermatological Life Quality Index (DLQI) - all were measured at baseline and every month, up to 6 months. Group differences were calculated on the intention-to-treat sample. RESULTS: After 6 months of intervention, inter-group differences became statistically significant on PO-SCORAD, the primary outcome (-18.1; 95% confidence interval, -24.0 to -12.2), favoring IHMs against placebos (F 1, 52 = 14.735; p <0.001; two-way repeated measures analysis of variance). Inter-group differences for the secondary outcomes favored homeopathy, but were overall statistically non-significant (ADBSA: F 1, 52 = 0.019; p = 0.891; DLQI: F 1, 52 = 0.692; p = 0.409). CONCLUSION: IHMs performed significantly better than placebos in reducing the severity of AD in adults, though the medicines had no overall significant impact on AD burden or DLQI.

Evaluation of Individualized Homeopathic Treatment in Patients With Irritable Bowel Syndrome: A Pilot Study.

BACKGROUND: Some studies have suggested the efficacy of homeopathic treatment for irritable bowel syndrome (IBS). OBJECTIVE: The aim of this pilot study was to evaluate the efficacy of individualized homeopathic treatment in patients with IBS. METHODS: The study was carried out at the National Homeopathic Hospital of the Secretary of Health, Mexico City, Mexico and included 41 patients: 3 men and 38 women, mean age 54 ± 14.89 years, diagnosed with IBS as defined by the Rome IV Diagnostic criteria. Single individualized medicine was prescribed for each patient, taking into account all presenting symptoms, clinical history, and personality via repertorization using RADAR Homeopathic Software (archibel, Isnes, Belgium). The homeopathic drugs were used at fifty-millesimal (LM) potency per the Mexican Homeopathic Pharmacopoeia starting with 0/1 and increasing every month (0/2, 0/3, 0/6). Severity scales were applied at the beginning of treatment and every month for 4 months of treatment. The evaluation was based on comparing symptom severity scales during treatment. RESULTS: The results demonstrated that 100% of patients showed some improvement and 63% showed major improvement or were cured. The study showed a significant decrease in severity of symptom scores 3 months after treatment, with the pain score showing a decrease 1 month after treatment. The results highlight the importance of individualized medicine regimens using LM potency, although the early decrease in pain observed could also be due to the fact that Lycopodium clavatum and Nux vomica were the main homeopathic medicine prescribed, and these medicines contain many types of alkaloids, which have shown significant analgesic effects on pain caused by physical and chemical stimulation. CONCLUSION: This pilot study suggests that individualized homeopathic treatment using LM potencies benefits patients with IBS.

Clinical Characteristics and Remedy Profiles of Patients with COVID-19: A Retrospective Cohort Study.

OBJECTIVE: The aim of the study was to identify indicated homeopathic remedies based on the clinical characteristics of coronavirus disease 2019 (COVID-19) patients in India. METHODS: In this retrospective, cohort study, confirmed COVID-19 patients admitted at a COVID Health Centre in New Delhi between April 29 and June 17, 2020 were given conventional and homeopathic treatment. Patients were grouped into mild, moderate or severe categories of disease. Their symptomatologic profiles were analyzed to identify indicated homeopathic medicines. RESULTS: A total of 196 COVID-19 patients were admitted. One hundred and seventy-eight patients had mild symptoms; eighteen patients had moderate symptoms; no patients with severe symptoms were included as they were referred to tertiary care centers with ventilatory support. The mean age of patients with mild symptoms was significantly lower (38.6 years; standard deviation or SD ± 15.8) compared with patients in the moderate category (66.0 years; SD ± 9.09). The most important symptoms identified were fever (43.4%), cough (47.4%), sore throat (29.6%), headache (18.4%), myalgia (17.9%), fatigue (16.8%), chest discomfort (13.8%), chills (12.6%), shortness of breath (11.2%) and loss of taste (10.2%). Twenty-eight homeopathic medicines were prescribed, the most frequently indicated being Bryonia alba (33.3%), Arsenicum album (18.1%), Pulsatilla nigricans (13.8%), Nux vomica (8%), Rhus toxicodendron (7.2%) and Gelsemium sempervirens (5.8%), in 30C potency. CONCLUSION: Data from the current study reveal that Arsenicum album, Bryonia alba, Pulsatilla nigricans, Nux vomica, Rhus toxicodendron and Gelsemium sempervirens are the most frequently indicated homeopathic medicines. A randomized controlled clinical trial based on this finding is the next step.

Homeopathic Clinical Features of 18 Patients in COVID-19 Outbreaks in Hong Kong.

BACKGROUND: Hong Kong is geographically located in the province of Guangdong which, after Hubei, has been the region of China second-most affected by the COVID-19 pandemic. Compared to the pathognomonic symptoms of the named disease, homeopathic symptoms are always more helpful for homeopathic prescriptions. AIM: This study reports and summarizes the homeopathic symptoms observed in 18 confirmed/suspected epidemiologically related cases in cluster outbreaks of COVID-19 in Hong Kong in early 2020. METHODS: Homeopathic symptoms from this case series were collected from 18 consecutive patients who, in addition to their concurrent conventional treatment or traditional Chinese medicine, actively sought help from homeopathy as an adjunctive measure for symptomatic relief from COVID-19. Cases were categorized according to outbreak clusters, focusing mainly on the homeopathic symptoms. In the analysis, frequency of all homeopathic medicines, common rubrics in all the cases, common rubrics in each of the top-ranked remedies, and differentiating symptoms for each top-ranked remedy were determined. RESULTS: Homeopathic symptoms of 18 cases, each identified as mild and belonging to one of six separate clusters, are reported. Eighteen common symptoms screened out of 79 selected rubrics constituted two sets of homeopathic symptom pictures: Bryonia alba (n = 4) and Gelsemium sempervirens (n = 12). Eight and seven differentiating features, respectively, were identified for Bryonia alba and Gelsemium sempervirens. CONCLUSION: The common symptoms of 18 mild COVID-19 cases constituted two sets of homeopathic symptom pictures, indicating Bryonia alba or Gelsemium sempervirens; they were indicated in 4 and 12 cases, respectively, out of the 18 in total.

Efficacy of a Homeopathic Medicine of Capsicum frutescens L. (Solanaceae) in the Treatment of Hot Flashes in Menopausal Women: A Phase-2 Randomized Controlled Trial.

BACKGROUND: Hot flashes are common in women during menopause, and are an important cause of discomfort, increasing the number of medical appointments. Hormone replacement therapy is an effective treatment, but it can bring undesirable consequences. Alternative treatments exist but they are not universally accepted or effective. The ingestion of malagueta peppers (popular name for fruits of Capsicum frutescens L., Solanaceae) causes sensations similar to those experienced by women during hot flashes. Using the homeopathic law of similars (let like be cured by like), we hypothesized that a homeopathic remedy made of malagueta peppers can be effective in alleviating menopausal hot flashes. We named this remedy Malagueta. METHODS: This randomized, placebo-controlled, double-blind, phase-2 clinical trial was designed to test the hypothesis that, in menopausal women, the homeopathic medicine Malagueta (30 CH), compared with placebo, will significantly reduce the intensity of hot flashes, after 4 weeks of treatment. The primary outcome was the intensity of hot flashes, measured by the Measure Yourself Medical Outcome Profile (MYMOP) instrument. A total of 40 women were enrolled in the study, 20 in each group. RESULTS: The effect of Malagueta on the primary outcome, the intensity of hot flashes, assessed by MYMOP, was superior to that of placebo over the 4 weeks of treatment, with worsening in both groups after treatment was interrupted (after week 4, p < 0.001 in ordinal logistic regression). The odds ratio for treatment response (reduction of at least three MYMOP categories) was 2.78 (95% confidence interval, 0.77 to 10.05). Treatment with Malagueta, compared with placebo, also reduced the intensity of the secondary symptoms (p = 0.001) and improved level of activity (p = 0.025) and well-being (p = 0.008). CONCLUSION: The homeopathic medicine of Capsicum frutescens (Malagueta) was superior to placebo in reducing the intensity of hot flashes in menopausal women after 4 weeks of treatment.

Quantitative and Qualitative Pathogenetic Indices for Review of Data Derived from Homeopathic Pathogenetic Trials.

INTRODUCTION: Analysis of data derived from homeopathic pathogenetic trials (HPTs, homeopathic drug provings) has been a challenge. Most parts of the homeopathic pharmacopeia were sourced from Hahnemann's Materia Medica Pura (1825-1833), TF Allen's Encyclopedia (1874) and Constantine Hering's Materia Medica (1879-1891), well before randomised controlled trials were in use. As a result, such studies and their outcomes harbour a large risk of inclusion of unreliable symptoms. AIMS AND OBJECTIVE: The main purpose of this article is to introduce Quantitative and Qualitative Pathogenetic Indices to improve the method of analysis of symptoms. MATERIALS AND METHODS: The data from HPTs for human immunodeficiency virus nosode, hepatitis C nosode, capsaicin alkaloids (capsaicin and dihydrocapsaicin) and hydroquinone (HQ) were extracted and analysed in terms of novel Qualitative and Quantitative Pathogenetic Indices. Taken into the consideration were the qualitative aspect of a symptom (i.e. its intensity), and the quantitative aspect by calculating the number of symptoms per volunteer per day. The pathogenetic effects and data evaluation indices were calculated for each HPT. A comparison was made of symptoms of verum versus placebo provers in terms of their quantity and quality. RESULTS: Four HPTs involving 81 volunteers (56 on verum and 25 on placebo) generated 555 symptoms or pathogenetic effects (excluding run-in phase symptoms), of which 448 (81%) were reported by volunteers who were in the verum arm, and 107 (19%) were reported by volunteers on placebo. The overall mean incidence of pathogenetic effects for the four HPTs was thus 8 per verum prover and 4.28 per placebo prover. The corresponding mean Quantitative Pathogenetic Index was 0.23 symptoms per volunteer per day for the verum arm and 0.12 symptoms per volunteer per day for the placebo arm. The overall mean incidence of pathogenetic effects in the run-in phase was less. The overall mean Qualitative Pathogenetic Index (number of symptoms, of a given intensity, per volunteer per day) for the verum arm was 0.09 versus 0.05 for the placebo arm. CONCLUSION: The symptoms exhibited by volunteers in the verum arm were more numerous and more intense than those in the placebo arm. An innovative and logical method of reporting of symptoms and analysis has been introduced by the use of these pathogenetic indices, which can be used in future as measurement tools for analysis of data from HPTs.

Hay fever & homeopathy: a case series evaluation.

BACKGROUND: Seasonal allergic rhinitis (hay fever) is common and can considerably reduce the quality of life of sufferers. Despite the wide everyday application and promising results with homeopathy, scientific evidence of its effectiveness for most ailments is scarce. AIM: The assessment of the clinical effectiveness of homeopathic remedies in the alleviation of hay fever symptoms in a typical clinical setting. METHODS: We performed a clinical observational study of eight patients in the treatment of hay fever symptoms over a two-year period (2012 and 2013) using Measure Yourself Medical Outcome Profile (MYMOP) self-evaluation questionnaires at baseline and again after two weeks and four weeks of homeopathic treatment. The individualized prescription - either a single remedy or multiple remedies - was based on the totality of each patient's symptoms. RESULTS: The average MYMOP scores for the eyes, nose, activity and wellbeing had improved significantly after two and four weeks of homeopathic treatment. The overall average MYMOP profile score at baseline was 3.83 (standard deviation, SD, 0.78). After 14 and 28 days of treatment the average score had fallen to 1.14 (SD, 0.36; P<0.001) and 1.06 (SD, 0.25; P<0.001) respectively. CONCLUSIONS: Individualized homeopathic treatment was associated with significant alleviation of hay fever symptoms, enabling the reduction in use of conventional treatment. The results presented in this study can be considered as a step towards a pilot pragmatic study that would use more robust outcome measures and include a larger number of patients prescribed a single or a multiple homeopathic prescription on an individualized basis.

Homeopathic medicine for acute cough in upper respiratory tract infections and acute bronchitis: a randomized, double-blind, placebo-controlled trial.

Cough is a frequent symptom associated to upper respiratory tract infections (URTIs) and, although being self-limiting, it might deeply affect the quality of life. Homeopathic products are often employed by patients to treat cough, but the evidence on their efficacy is scarce. Thus, we tested the efficacy of a homeopathic syrup in treating cough arising from URTIs with a randomized, double blind, placebo controlled clinical trial. Patients were treated with either the homeopathic syrup or a placebo for a week, and recorded cough severity in a diary by means of a verbal category-descriptive score for two weeks. Sputum viscosity was assessed with a viscosimeter before and after 4 days of treatment; patients were also asked to provide a subjective evaluation of viscosity. Eighty patients were randomized to receive placebo (n = 40) or the homeopathic syrup (n = 40). All patients completed the study. In each group cough scores decreased over time, however, after 4 and 7 days of treatment, cough severity was significantly lower in the homeopathic group than in the placebo one (p < 0.001 and p = 0.023, respectively). Sputum was collected from 53 patients: in both groups its viscosity significantly decreased after 4 days of treatment (p < 0.001); however, viscosity was significantly lower in the homeopathic group (p = 0.018). Instead, the subjective evaluation did not significantly differ between the two groups (p = 0.059). No adverse events related to any treatment were reported. We concluded that the homeopathic syrup employed in the study was able to effectively reduce cough severity and sputum viscosity, thereby representing a valid remedy for the management of acute cough induced by URTIs.

Adherence to medical treatment in inflammatory bowel disease patients.

AIM: Inflammatory bowel diseases (IBD) are a group of chronic intestinal conditions characterized by unpredictable course, with periods of flare-ups and remissions suggesting poor adherence to medical therapy. On the other hand adherence is one of the most common reason of failure in the treatment of chronic disease. METHODS: We have analyzed IBD patients' questionnaires, sent by IBD Society of Emilia-Romagna Region (Italy). The anonymous questionnaire included sex, age, qualification, management, disease duration, disease associated, previous surgery, use of homeopathy and self-medication and possible psychological support. We classified patients based on IBD type: Crohn's disease (CD) and ulcerative colitis (UC). RESULTS: A total of 559 IBD patients were analysed (50.1% female), 52.8% were affected by CD. Patients were followed by gastroenterologist in 84.7% of cases. 17.4% of patient reported non-adherence to medical therapy; univariate analysis showed that non-adherence was more frequent in young females followed-up by general practitioners, no difference was found in educational status or type of IBD. Factors independently associated with greater adherence to medical therapy were age (OR=2.039) and follow-up by gastroenterologist (OR=3.025). CONCLUSION: Non-adherence should be taken into account in IBD patients and especially in young female. Gastroenterologists have a major role in promoting education.

Interim results of a randomised controlled trial of homeopathic treatment for irritable bowel syndrome.

Irritable bowel syndrome (IBS) is a chronic condition for which there is no consensus on the optimum treatment. Gastroenterology problems are some of the most common conditions treated by homeopaths, yet few trials have explored the effectiveness of individualised homeopathic treatment for IBS. A three-armed trial was conducted which compared: usual care, homeopathic treatment plus usual care and supportive listening plus usual care. The primary outcome was change in irritable bowel symptom severity score between baseline and 26 weeks, calculated using ANCOVA. An interim ANCOVA adjusted for baseline IBS severity, age and employment status found no statistically significant difference between the three arms. However, a post-hoc test comparing homeopathic treatment plus usual care to usual care alone found a statistically significant difference in favour of homeopathic treatment. In addition, 62.5 percent of patients in the homeopathic treatment arm (compared to 25.0 percent of those in the usual care arm), achieved a clinically relevant change in irritable bowel symptom severity score, which indicates a promising effect for homeopathic treatment, though these results should be interpreted with caution due to the low number of participants in the study.

Observational study of Arctium lappa in the treatment of acne vulgaris.

INTRODUCTION: Arctium lappa (Lappa) is used in traditional Western and Chinese medicine for acne. It is mentioned in homeopathic literature for acne, but its effect has not previously been evaluated. OBJECTIVE: To determine the effectiveness of homeopathic medicine Lappa in treatment of acne vulgaris. METHODS: An uncontrolled observational interventional study was conducted on human subjects who fulfilled the inclusion criteria and gave written informed consent. Lappa was prescribed in potencies starting from 6c rising to 1M as required, over a period of 6 months. Objective assessment was change in acne lesion counts supplemented with Global Acne Grading System (GAGS) and subjective assessment by using Acne-Specific Quality of Life questionnaire (Acne-QoL). RESULTS: Out of 34 human subjects, 32 completed the follow-up. Statistical significant results were seen in lesion counts, GAGS and Acne-QoL score (p value <0.001). CONCLUSION: Lappa has shown positive effects in the treatment of acne especially of inflammatory type. Further controlled, randomized studies with larger sample size are desirable. Trial is registered at ClinicalTrials.gov Identifier: NCT01040390.

Evaluating the association between opium abuse, blood lead levels, and the complexity of coronary artery disease.

Opium abuse and exposure to heavy metals elevate the risk of coronary artery disease (CAD). Therefore, we aimed to determine the association between opium abuse and blood lead levels (BLLs) and the CAD complexity. We evaluated patients with acute coronary symptoms who underwent coronary angiography, and those with >50% stenosis in at least one of the coronary arteries were included. Furthermore, Synergy between PCI with Taxus and Cardiac Surgery I (SYNTAX I) score and BLLs were measured. Based on the opium abuse, 95 patients were subdivided into opium (45) and control (50) groups. Differences in demographics and CAD risk factors were insignificant between the two groups. The median BLLs were remarkably higher in the opium group than in controls (36 (35.7) and 20.5 µg/dL (11.45), respectively, p = 0.003). We also revealed no significant differences in SYNTAX score between the two groups (15.0 (9.0) and 17.5 (14.0), respectively, p = 0.28). Additionally, we found no significant correlation between BLLs and the SYNTAX scores (p = 0.277 and r = -0.113). Opium abuse was associated with high BLLs. Neither opium abuse nor high BLLs were correlated with the complexity of CAD. Further studies are warranted to establish better the relationship between opium abuse, BLLs, and CAD.

The comparison of spontaneous breathing and muscle paralysis in two different severities of experimental lung injury.

OBJECTIVES: The benefits of spontaneous breathing over muscle paralysis have been proven mainly in mild lung injury; no one has yet evaluated the effects of spontaneous breathing in severe lung injury. We investigated the effects of spontaneous breathing in two different severities of lung injury compared with muscle paralysis. DESIGN: Prospective, randomized, animal study. SETTING: University animal research laboratory. SUBJECTS: Twenty-eight New Zealand white rabbits. INTERVENTIONS: Rabbits were randomly divided into the mild lung injury (surfactant depletion) group or severe lung injury (surfactant depletion followed by injurious mechanical ventilation) group and ventilated with 4-hr low tidal volume ventilation with spontaneous breathing or without spontaneous breathing (prevented by a neuromuscular blocking agent). Inspiratory pressure was adjusted to control tidal volume to 5-7 mL/kg, maintaining a plateau pressure less than 30 cm H2O. Dynamic CT was used to evaluate changes in lung aeration and the regional distribution of tidal volume. MEASUREMENTS AND RESULTS: In mild lung injury, spontaneous breathing improved oxygenation and lung aeration by redistribution of tidal volume to dependent lung regions. However, in severe lung injury, spontaneous breathing caused a significant increase in atelectasis with cyclic collapse. Because of the severity of lung injury, this group had higher plateau pressure and more excessive spontaneous breathing effort, resulting in the highest transpulmonary pressure and the highest driving pressure. Although no improvements in lung aeration were observed, muscle paralysis with severe lung injury resulted in better oxygenation, more even tidal ventilation, and less histological lung injury. CONCLUSIONS: In animals with mild lung injury, spontaneous breathing was beneficial to lung recruitment; however, in animals with severe lung injury, spontaneous breathing could worsen lung injury, and muscle paralysis might be more protective for injured lungs by preventing injuriously high transpulmonary pressure and high driving pressure.

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.

The Manitoba Inflammatory Bowel Disease Cohort Study: a prospective longitudinal evaluation of the use of complementary and alternative medicine services and products.

OBJECTIVE: To determine the prevalence of complementary and alternative medicine (CAM) use over time in a population-based cohort of patients with inflammatory bowel disease (IBD). METHODS: The Manitoba IBD Cohort Study is a longitudinal, population-based study of multiple determinants of health outcomes in an IBD cohort. Participants completed semi-annual surveys, and annual in-person interviews. Enquiries about the use of 12 types of CAM service providers and 13 CAM products, based on items from a national survey, were included at months 0, 12, 30 and 54. RESULTS: Overall, 74% of respondents used a CAM service or product in the 4.5-year period, with approximately 40% using some type of CAM at each time point, and 14% using CAM consistently at every time point. There was a trend for women to use CAM more than men; there was no difference in CAM use between patients with Crohn's disease and those with ulcerative colitis. The most often used CAM services (on average) were massage therapy (30%) and chiropractic (14%), physiotherapy (4%), acupuncture (3.5%) and naturopathy/homeopathy (3.5%). A wide range of CAM products were used, with Lactobacillus acidophilus (8%), fish and other oils (5.5%), glucosamine (4%) and chamomile (3.5%) as the most common. On average, only 18% of consumers used CAM for their IBD, so the majority chose it for other problems. There were no differences in psychological variables between CAM users and non-users. CONCLUSIONS: Those with IBD commonly try CAM, although very few use these approaches regularly over the years. CAM is not usually used by patients with IBD for disease management, but clinicians should be aware that many will test the services and products.

Indian Traditional Treatments for Psoriasis: A Critical Appraisal of Available Evidence Supporting Efficacy.

OBJECTIVE: To examine data from studies supporting the clinical efficacy of medical approaches from India traditional systems of medicines like Ayurveda, Unani, Siddha, and Homeopathy for psoriasis using outcome indicators employed in clinical practice and research. METHODS: Searches were conducted between December 2019 and September 2020 in databases PubMed, Scopus, Web of Science and Ovid Medline using search terms including traditional, complementary, psoriasis, Kushtha, Ayurveda, Siddha, Unani, Homeopathy and clinical. Controlled trials, case series and case reports published from India were included. RESULTS: Data of 17 selected studies were extracted. Treatment efficacy in terms of improvement in Psoriasis Area and Severity Index (PASI) score or/and percentage reduction in score (PASI 50, PASI 75 and PASI 90) or/and patient-reported outcomes using instruments like Dermatology Life Quality Index and Psoriasis Disability Index were noted. All studies reported good improvement as per the study specific outcome. However, study characteristics, including study design, sample size, follow-up period, inclusion and exclusion criteria were heterogeneous, and the choice of outcome measures was not adequate to conclude the effectiveness of intervention. The use of some herbs as common ingredients in several formulations across different systems of medicines were noted in analyzing individual formulation. CONCLUSIONS: Future studies must incorporate a comprehensive study design with specific outcome measures like PASI, PASI 75, PASI 90, quality of life parameters, compliance to medications, adverse reactions, remission period, relapse rate and cost-effectiveness with long term follow-up. The currently available evidence on the roles of these herbs at molecular level in psoriasis is preliminary.

A protocol for a trial of homeopathic treatment for irritable bowel syndrome.

BACKGROUND: Irritable bowel syndrome is a chronic condition with no known cure. Many sufferers seek complementary and alternative medicine including homeopathic treatment. However there is much controversy as to the effectiveness of homeopathic treatment. This three-armed study seeks to explore the effectiveness of individualised homeopathic treatment plus usual care compared to both an attention control plus usual care and usual care alone, for patients with irritable bowel syndrome. METHODS/DESIGN: This is a three-armed pragmatic randomised controlled trial using the cohort multiple randomised trial methodology. Patients are recruited to an irritable bowel syndrome cohort from primary and secondary care using GP databases and consultants lists respectively. From this cohort patients are randomly selected to be offered, 5 sessions of homeopathic treatment plus usual care, 5 sessions of supportive listening plus usual care or usual care alone. The primary clinical outcome is the Irritable Bowel Syndrome Symptom Severity at 26 weeks.From a power calculation, it is estimated that 33 people will be needed for the homeopathic treatment arm and 132 for the usual care arm, to detect a minimal clinical difference at 80 percent power and 5 percent significance allowing for loss to follow up. An unequal group size has been used for reasons of cost. Analysis will be by intention to treat and will compare homeopathic treatment with usual care at 26 weeks as the primary analysis, and homeopathic treatment with supportive listening as an additional analysis. DISCUSSION: This trial has received NHS approval and results are expected in 2013. TRIAL REGISTRATION: Current Controlled Trials ISRCTN90651143.

Monitoring improvement in health during homeopathic intervention. Development of an assessment tool based on Hering's Law of Cure: the Hering's Law Assessment Tool (HELAT).

INTRODUCTION: Hering's 'Law of Cure' is considered important in homeopathy and thought to predict a positive outcome to treatment. No formal outcome measures are currently available to monitor response to homeopathic treatment on the basis of these assumptions. We describe a simple assessment tool, the Hering's Law Assessment Tool (HELAT) to identify and differentiate patient responses to homeopathic treatment as corresponding to Hering's Law from other symptomatic responses. We describe the development of the tool and assess its face, content and predictive validity. METHOD: The HELAT was initially developed through literature review, discussion between homeopaths and clinical experience. In phase one, the tool was reviewed by three experienced homeopaths to assess face and content validity. In phase two, we tested its predictive validity by hypothesizing that the HELAT total score may predict changes in a clinical response (using standard validated rheumatological outcome, the American College of Rheumatology (ACR)20%) in 32 patients with rheumatoid arthritis receiving homeopathic intervention over 24 weeks as part of a clinical trial. RESULTS: The HELAT was piloted and changed to improve face and content validity and the final version was then employed for phase two as a predictor of outcome. HELAT total score predicted patient's clinical response (ACR20) [B = 1.142, SE = 0.462, P = 0.013] which was independent of practitioner assessing the patients treatment response [B = 1.04, SE = 1.01, P = 0.302]. CONCLUSION: The initial data suggests that the HELAT may hold promise for a potential clinical and research outcome measure in homeopathy. Further work is now needed to formally assess its reliability and validity for potential use in clinical practice and trials.

Individualized homeopathy in a group of Egyptian asthmatic children.

OBJECTIVES: To evaluate homeopathy as an adjunctive treatment for bronchial asthma in children. METHODS: In a prospective observational longitudinal study the effects of individualised homeopathic medicines were assessed in 30 children with asthma as an adjunct to conventional treatment. The main outcome measures were frequency of attacks, use of medication, night awakening and spirometry at baseline and at follow-up till 6 months. RESULTS: There were clinically relevant and statistically significant changes in those measuring severity, indicating relative improvements after 3 months and absolute improvements after 6 months of treatment by homeopathic medicines. CONCLUSIONS: This study provides evidence that homeopathic medicines, as prescribed by experienced homeopathic practitioners, improve severity of asthma in children. Controlled studies should be conducted.

Homeopathic medicines substantially reduce the need for clotting factor concentrates in haemophilia patients: results of a blinded placebo controlled cross over trial.

BACKGROUND: Modern management of haemophilia patients is expensive: 90% of expenditure is on clotting factor concentrates. Any intervention which reduces the need for clotting factor concentrates in these patients without compromising the quality of life is of interest. AIMS AND OBJECTIVES: To investigate the effectiveness of individualised homeopathic medicines in reducing the requirement of factor concentrates in haemophilia patients. MATERIALS AND METHODS: In a single blind placebo controlled cross over trial 28 consecutive persons with haemophilia (PWH) with severe (24) or moderately severe (4) disease received standard management with placebo homeopathy for 1 year and active homeopathic treatment in the subsequent year with the same conventional management. There was no wash out period. They received standard managements for any acute emergency during the study period. Development of inhibitor during the study period was a withdrawal criterion. Sample size for the trial was calculated as 24 PWH. Transfusion requirements, bleeding scores, pain scores were evaluated blind by independent experts. Homeopathic medicines were selected by experienced homeopathic physicians depending on clinical condition of the patient. Chi-squared and paired t tests were used in statistical analysis. RESULTS: 28 patients were recruited. Homeopathic medicines improved frequency of bleeding, extent of bleeding, blood products consumed and pain scores (P<0.0001). There was also significant improvement in well being. Plasma levels of clotting factors did not change. No patients developed inhibitors during the study there were no dropouts. CONCLUSION: Individualised homeopathic medicines may have an important supportive role in the management of PWH, where blood products and factor concentrates are not easily available. Larger, perhaps multicentric trials are warranted.