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

Peckham, Emily; Relton, Clare; Raw, Jackie; Walters, Clare; Thomas, Kate; Smith, Christine; Kapur, Kapil; Said, Elmuhtady

doi:10.1016/j.homp.2014.05.001

Cited by 10 publications

(3 citation statements)

References 16 publications

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“…Such ‘effect size’ seems comparable with, for example, sumatriptan for migraine, fluoxetine for major depressive disorder, and cholinesterase inhibitors for dementia [ 14 ]. Five of the 13 RCTs with minimal risk of bias also showed high reliable evidence [ 18 , 19 , 20 , 21 , 22 ]. Especially for individualized homeopathy, effects on all quality levels according to Cochrane criteria are recognizable, even in the methodologically high-quality studies, when criteria for evidence-based medicine for design, conduction, documentation, and rating of studies in homeopathy are applied, e.g., all high-quality trials on homeopathy are considered for rating [ 4 ].…”

Section: Resultsmentioning

confidence: 99%

Evidence-Based Human Homeopathy and Veterinary Homeopathy. Comment on Bergh et al. A Systematic Review of Complementary and Alternative Veterinary Medicine: “Miscellaneous Therapies”. Animals 2021, 11, 3356

Weiermayer¹,

Frass²,

Peinbauer

et al. 2022

Animals

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(1) Background: Classical (=individualized) homeopathic therapy is based on the individual and not on the indication. (2) Methods: The prerequisite for conducting methodologically high-quality studies on indvidualized homeopathy is that the principles of homeopathy are considered, since the selection of the simile (the individually appropriate homeopathic medicinal product) is decisive for the effectiveness of the homeopathic treatment, because only an application lege artis can be effective for the respective patient. Apart from this, criteria for evidence-based medicine must be considered for design, conduction, documentation, and rating of studies in homeopathy. (3) Results: When criteria for evidence-based medicine for design, conduction, documentation, and rating of studies in homeopathy are considered, effects on all quality levels according to Cochrane criteria are recognizable, especially for individualized homeopathy, even in the methodologically high-quality studies. (4) Conclusions: Based on the following three facts, the discussion of the evidence in human and veterinary homeopathy lays the foundations for a comprehensive presentation of the evidence on homeopathy: (a) homeopathic medicinal products without indication are 100% identical with regard to production, quality, safety, and principles of application, regardless of whether they are used in animals or humans; (b) if the simile principle (Similia similibus curentur, or ‘Let like be cured by like’) is adhered to that classical (=individualized) homeopathic therapy is based on the individual and not on the indication; and (c) if the proof of effectiveness of individualized homeopathy in one or more indications is available, the logical consequence seems to be that it can be concluded that it is effective in other indications. In view of One Health and of the demands of the European Green Deal (Farm2Fork Strategy) and the EU Organic Regulation 2018/848, the application of homeopathy in the sense of integrative veterinary medicine and the integration of complementary medicine including homeopathy at universities seems a necessary consequence and requirement in the interests of the patient, which is already expressed in the American consensus guidelines for an integrative veterinary medicine curriculum and is legally anchored in Switzerland by the Medical Professions Act for university teaching and research.

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Section: Resultsmentioning

confidence: 99%

Evidence-Based Human Homeopathy and Veterinary Homeopathy. Comment on Bergh et al. A Systematic Review of Complementary and Alternative Veterinary Medicine: “Miscellaneous Therapies”. Animals 2021, 11, 3356

Weiermayer¹,

Frass²,

Peinbauer

et al. 2022

Animals

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“…A sample size of 414 evaluable patients will provide 90% power to detect the minimum clinically important between-group difference of 35 points on the IBS-SSS [37], between amitriptyline and placebo at 6 months, assuming a standard deviation of 110 points [38,39] and 5% significance level. This equates to a small to moderate effect size of 0.32.…”

Section: Sample Sizementioning

confidence: 99%

Amitriptyline at low-dose and titrated for irritable bowel syndrome as second-line treatment (The ATLANTIS trial): protocol for a randomised double-blind placebo-controlled trial in primary care

Alderson

Wright-Hughes

Ford

et al. 2022

Trials

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Background Irritable bowel syndrome (IBS) is a common functional bowel disorder that has a considerable impact on patient quality of life and substantial societal and health care resource costs. Current treatments are often ineffective. Tricyclic antidepressants have shown promise in secondary care populations but their effectiveness in a primary care setting remains unclear. Methods ATLANTIS is a randomised, multi-centre, parallel-group, two-arm, double-blind, placebo-controlled trial of low-dose amitriptyline as a second-line treatment for IBS in primary care. Participants will be invited by letter, or recruited opportunistically, from general practices in three regions of England (West Yorkshire, Wessex, and West of England) and screened for eligibility. A total of 518 adult patients with IBS, who are symptomatic despite first-line therapies, will be randomised 1:1 to amitriptyline or identical placebo for 6 months. Treatment will commence at a dose of 10 mg (or one placebo tablet) daily at night, with dose titration up to a maximum of 30 mg at night, depending on side effects and response to treatment. Participant-reported assessments will be conducted at baseline and 3, 6, and 12 months post-randomisation. The primary objective is to determine the effectiveness of amitriptyline, compared with placebo, in improving participant-reported global symptoms of IBS at 6 months (using the IBS Severity Scoring System). Secondary outcomes include relief of IBS symptoms, effect on IBS-associated somatic symptoms (Patient Health Questionnaire-12), anxiety and depression (Hospital Anxiety and Depression Scale), ability to work and participate in other activities (Work and Social Adjustment Scale), acceptability and tolerability of treatment, self-reported health care use, health-related quality of life (EQ-5D-3L), and cost-effectiveness. A nested, qualitative study will explore patient and general practitioner experiences of treatments and trial participation, including acceptability, adherence, unanticipated effects, and implications for wider use of amitriptyline for IBS in primary care. Discussion Determining the clinical and cost-effectiveness of low-dose amitriptyline as a second-line treatment for IBS in primary care will provide robust evidence to inform management decisions. Trial registration ISRCTN ISRCTN48075063 . Registered on 7th June 2019.

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“…4 Peckham at al recruited patients from a local cohort of patients suffering irritable bowel syndrome from primary and secondary care. 5 Randomisation again was somewhat unusual, they used a 4:1:1 randomisation between standard care: homeopathic treatment in addition to standard care: an equivalent number of sessions of supportive listening in additional to standard care. Homeopathic treatment was given by two experienced Members of the Society of Homeopaths.…”

Section: Homeopathyor Supportivelisteningin Addition To Standard Carementioning

confidence: 99%

Malaria in pregnancy and irritable bowel syndrome

Fisher¹

2014

Homeopathy

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

Cited by 10 publications

References 16 publications

Evidence-Based Human Homeopathy and Veterinary Homeopathy. Comment on Bergh et al. A Systematic Review of Complementary and Alternative Veterinary Medicine: “Miscellaneous Therapies”. Animals 2021, 11, 3356

Evidence-Based Human Homeopathy and Veterinary Homeopathy. Comment on Bergh et al. A Systematic Review of Complementary and Alternative Veterinary Medicine: “Miscellaneous Therapies”. Animals 2021, 11, 3356

Amitriptyline at low-dose and titrated for irritable bowel syndrome as second-line treatment (The ATLANTIS trial): protocol for a randomised double-blind placebo-controlled trial in primary care

Malaria in pregnancy and irritable bowel syndrome

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