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.

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.

Efficacy of individualized homeopathic medicines in irritable bowel syndrome: A double-blind randomized, placebo-controlled trial.

CONTEXT: Gastrointestinal ailments are some of the common conditions treated in homeopathy; yet only a few trials have explored the effects of individualized homeopathic medicines (IHMs) for irritable bowel syndrome (IBS). OBJECTIVE: To explore the efficacy of IHMs in treatment of IBS. DESIGN: Double-blind, randomized, placebo-controlled trial. SETTING: Outpatient departments of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, India. PATIENTS: Sixty patients suffering from IBS; randomized to receive either IHMs (n = 30) or identical-looking placebo (n = 30). INTERVENTIONS: IHMs or placebo in the mutual context of concomitant care in terms of dietary advice, yoga, meditation and exercises. MAIN OUTCOME MEASURES: Primary - IBS quality of life (IBS-QOL) questionnaire; secondary -IBS severity scoring system (IBS-SSS) and EQ-5D-5L scores; all measured at baseline and every month, up to 3 months. RESULTS: Group differences and effect sizes (Cohen's d) were calculated on intention-to-treat (ITT) sample. Groups were comparable at baseline. Recruitment, retention and attrition rates were 64.5%, 91.7% and 8.3% respectively. Group differences in IBS-QOL total scores, IBS-SSS, EQ-5D-5L scores favored IHMs against placebo overall and at all the time points (all P < 0.001). Pulsatilla nigricans (n = 4, 6.7%) and Thuja occidentalis (n = 4, 6.7%) were the most frequently prescribed medicines. Barring some minor events unrelated to interventions, no harms or serious adverse events were recorded in either of the groups. Thus, IHMs acted significantly better than placebos in the treatment of IBS. Independent replications are warranted. [Trial registration: CTRI/2019/10/021632].

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.

INTERVENTIONS FOR THE TREATMENT OF IRRITABLE BOWEL SYNDROME: A REVIEW OF COCHRANE SYSTEMATIC REVIEWS.

BACKGROUND: Irritable bowel syndrome (IBS) is a complex gastrointestinal disorder, whose understanding is relatively uncertain, and the treatment guidance decision still represents a challenge. OBJECTIVE: To identify and critically appraise systematic reviews (SRs) published in the Cochrane Database of SRs (CDSR) on the effects of interventions (pharmacological and non-pharmacological) for the treatment of IBS. METHODS: The search was conducted at the Cochrane Library in May 2020. The methodological quality of the SRs was evaluated by the AMSTAR-2 tool. RESULTS: Eight SRs with moderate to high quality were included, which addressed the treatments: (a) pharmacological: volume agents, antispasmodics, antidepressants and tegaserod; and (b) non-pharmacological: homeopathy, acupuncture, phytotherapy, biofeedback, psychological interventions and hypnotherapy. The results were favorable to antispasmodic drugs and antidepressants regarding the improvement of clinical symptoms. There was no difference between volume agents or tegaserod when compared to placebo. Acupuncture and homeopathy showed a little improvement in symptoms compared to placebo, but the certainty of this evidence was considered low to very low. Psychological interventions seem to improve the overall assessment of the patient and relief symptoms such as abdominal pain. However, there was no long-term follow-up of these patients. The results of the other treatments were considered uncertain due to the high risk of bias. CONCLUSION: Considering the low quality of the studies included in the SRs, pharmacological treatment with antispasmodics and antidepressants seems to be beneficial for patients with IBS. Among non-pharmacological interventions, psychological interventions seem to be beneficial. However, further clinical trials are recommended with greater methodological rigor to prove these findings.

An open-label randomized pragmatic non-inferiority pilot trial to compare the effectiveness of Dysentery compound with individualized homeopathic medicines in irritable bowel syndrome.

Background Irritable Bowel Syndrome (IBS) is a prevalent gastro-intestinal disorder characterized by recurrent abdominal pain, bloating, altered bowel function and myriad of gastro-intestinal symptoms. Dysentery compound (DC), a 'bowel nosode', is one of the homeopathic medicines to treat IBS, but remained under-researched. We hypothesized that DC would be non-inferior to individualized homeopathy (IH) in treatment of IBS. Method An open, randomized (1:1), parallel arms, pragmatic, non-inferiority, pilot trial was conducted to compare the effectiveness of DC with IH medicines in 60 IBS patients. IBS Quality of Life (IBS-QOL) questionnaire was used as the outcome measure; assessed at baseline and after 3 months. Comparative analysis was carried out on the primary outcome to detect non-inferiority by one-tailed t test at alpha=5% with a prefixed margin (Δ) of 1.0 based on assumption. Results Six subjects dropped out. Groups were comparable at baseline (all p>0.01). Though intra-group changes were higher favoring IH over DC, group differences were statistically non-significant (all p>0.01). Non-inferiority was not demonstrated by DC against IH over 3 months (mean difference= -3.3, SE=5.2, lower 95% confidence limit -11.9, t= -0.453, p=0.674). No adverse events were reported from either group. Conclusion Non-inferiority of DC against IH in treatment of IBS was not demonstrated though it appeared as safe; still, being a pilot trial, no definite conclusion could be drawn. Further exploration of both efficacy and effectiveness of either of the therapies is necessary by adequately powered trials and independent replications. Trial registration: CTRI/2017/05/008480; UTN: U1111-1196-1004.

Case Study of Homeopathic Bowel Nosode Remedies for Dysbiotic Japanese Patients.

BACKGROUND: The composition of intestinal microbiota is very important in human health. Gastrointestinal disturbances are among the symptoms commonly reported by individuals diagnosed with chronic diseases, such as inflammatory bowel disease, autism, and chronic fatigue syndrome. The effects of probiotics and prebiotics for dysbiosis have been reported in many studies. Bowel nosodes are homeopathic remedies made from human gut microbiota. OBJECTIVE: Bowel nosodes made from the intestinal bacteria of European patients from the 1900s were administered to Japanese patients suffering from gastrointestinal disturbances, such as constipation and diarrhea, to determine their therapeutic efficacy. METHODS: Twenty-eight outpatients from Yoko Clinic (11 males, 17 females; age range, 4-72 years) were enrolled in this study. One nosode remedy was selected for each case. Patients took six pills for 2 days. After a month, the effect of each treatment was evaluated using the Glasgow Homeopathic Hospital Outcome Scale (grade +4 to -4). RESULTS: Patient number of each grade was +4 (N = 2), +3 (N = 4), +2 (N = 7), +1 (N = 3), 0 (N = 7), with no negative grades. Of the 23 patients analyzed, 69.6% showed some type of improvement, and no harmful effects from taking bowel nosodes were observed; 26% of patients showed major improvement or were "cured." CONCLUSION: It is difficult to find correct constitutional remedies as they often require high-level techniques and time. Since there are only 11 main bowel nosode remedies, they are easier to choose from and cheaper to use and develop than classical constitutional remedies. Herein, 69.6% of dysbiotic patients taking bowel nosodes showed improvements, and no harmful effects were reported by any patient. These results suggest that the homeopathic bowel nosodes are a useful method for controlling gastrointestinal disturbances.

Intervenções para o tratamento da síndrome do intestino irritável: revisão de revisões sistemáticas Cochrane / Interventions for the treatment of irritable bowel syndrome: a review of cochrane systematic reviews

ABSTRACT BACKGROUND: Irritable bowel syndrome (IBS) is a complex gastrointestinal disorder, whose understanding is relatively uncertain, and the treatment guidance decision still represents a challenge. OBJECTIVE: To identify and critically appraise systematic reviews (SRs) published in the Cochrane Database of SRs (CDSR) on the effects of interventions (pharmacological and non-pharmacological) for the treatment of IBS. METHODS: The search was conducted at the Cochrane Library in May 2020. The methodological quality of the SRs was evaluated by the AMSTAR-2 tool. RESULTS: Eight SRs with moderate to high quality were included, which addressed the treatments: (a) pharmacological: volume agents, antispasmodics, antidepressants and tegaserod; and (b) non-pharmacological: homeopathy, acupuncture, phytotherapy, biofeedback, psychological interventions and hypnotherapy. The results were favorable to antispasmodic drugs and antidepressants regarding the improvement of clinical symptoms. There was no difference between volume agents or tegaserod when compared to placebo. Acupuncture and homeopathy showed a little improvement in symptoms compared to placebo, but the certainty of this evidence was considered low to very low. Psychological interventions seem to improve the overall assessment of the patient and relief symptoms such as abdominal pain. However, there was no long-term follow-up of these patients. The results of the other treatments were considered uncertain due to the high risk of bias. CONCLUSION: Considering the low quality of the studies included in the SRs, pharmacological treatment with antispasmodics and antidepressants seems to be beneficial for patients with IBS. Among non-pharmacological interventions, psychological interventions seem to be beneficial. However, further clinical trials are recommended with greater methodological rigor to prove these findings.

RESUMO CONTEXTO: A síndrome do intestino irritável (SII) é um distúrbio gastrointestinal complexo, cujo entendimento é relativamente incerto e a decisão de orientação do tratamento ainda representa um desafio. OBJETIVO: Identificar e avaliar criticamente as revisões sistemáticas (RSs) publicadas na base de dados de RSs Cochrane (CDSR) sobre os efeitos das intervenções (farmacológicas e não farmacológicas) para o tratamento da SII. MÉTODOS: A busca foi realizada na Biblioteca Cochrane em maio de 2020. A qualidade metodológica das RSs foi avaliada pela ferramenta AMSTAR-2. RESULTADOS: Foram incluídas oito RSs com qualidade moderada a alta, as quais abordaram os tratamentos: (a) farmacológico - agentes de volume, antiespasmódicos, antidepressivos e o tegaserod; e (b) não farmacológico - homeopatia, acupuntura, fitoterapia, biofeedback, intervenções psicológicas e hipnoterapia. Os resultados foram favoráveis aos medicamentos antiespasmódicos e antidepressivos em relação à melhora dos sintomas clínicos. Não houve diferença entre os agentes de volume ou tegaserod quando comparados ao placebo. Acupuntura e homeopatia apresentaram pequena melhora dos sintomas em comparação ao placebo, porém a qualidade da evidência foi considerada baixa a muito baixa. As intervenções psicológicas parecem melhorar a avaliação global do paciente e alívio de sintomas como dor abdominal. Contudo, não houve acompanhamento desses pacientes a longo prazo. Os resultados dos demais tratamentos foram considerados incertos devido ao alto risco de viés. CONCLUSÃO: Considerando a baixa qualidade dos estudos incluídos nas RSs, o tratamento farmacológico com antiespasmódicos e antidepressivos parece ser benéfico para os pacientes com SII. Entre os não-farmacológicos, as intervenções psicológicas parecem obter benefícios. Entretanto, novos ensaios clínicos são recomendados com maior rigor metodológico para comprovar estes achados.