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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.
Homeopathy is delivered across Mexico via public and private healthcare systems to treat menopausal symptoms and depression, among many others diseases. Homeopathy is based on the 'principle of similars'. Highly diluted preparations of substances that cause symptoms in healthy individuals are used to stimulate healing in patients who have similar symptoms when ill [25]. Individualized homeopathic treatment (IHT) consists of a prescription of an individually selected homeopathic remedy based on the totality of symptoms ascertained after a complete clinical examination of the patient [26]. Nowadays, homeopathic medicines are produced by a standardized methodology. Homeopathic medicines in Centesimal (C) potencies are produced through sequential agitated dilutions. A drop of a parent substance is diluted in 99 drops of ethanol followed by agitation of the solution (1 C). This procedure is repeated in consecutive agitated dilutions (2 C, 3 C, 4 C, and so on).
Adler et al conducted a RCT of individualized homeopathic Q-potencies for moderate to severe depression and found that IHT was non-inferior to fluoxetine, but because of ethical reasons the study did not include a placebo group [37]. Most importantly, although mood symptoms are one of the most common complaints during transition to menopause, to date, there is a lack of RCTs of homeopathic treatment for depression in women at this stage.
C-potencies were provided by Laboratorio Similia (Mexico City) and were manufactured according to Mexican Homeopathic Pharmacopoeia and Hahnemann's methodology. Homeopathic medicines are produced through sequential agitated dilutions in Decimal (D), Centesimal (C) or Quinquagintamillesimal (Q or LM) potencies. C-potencies are prepared by diluting a drop of a parent substance in 99 drops of ethanol followed by agitation of the solution (1 C). Then one drop of this solution is diluted in 99 drops of ethanol followed by agitation of the solution (2 C). This procedure is repeated in consecutive agitated dilutions (3 C, 4 C, and so on). In the HOMDEP-MENOP study each individualized homeopathic remedy was prescribed in C-potencies.
Higher initial potencies were tried, only 30 C and 200 C were prescribed. The factors that influenced the selection of the potency included: clarity of mental symptoms, patient's vitality and sensitivity, nature and kingdom (source) of medicine, chronicity, presence of any pathological disorder. As previously stated, in an IHT the homeopathic doctor selects a remedy based on the specific and most important symptoms the patient has. This individualized prescription also includes the selection of the appropriate potency based on the factors mentioned. Thus, the prescription is individualized in the selection of the remedy and in the appropriate potency required by the patient.
In the HOMDEP-MENOP study, a single dose of the individualized homeopathic remedy selected was dissolved in a 60 ml bottle of 30% alcohol-distilled water. Patients received 10 drops PO two times per day following agitation plus fluoxetine-dummy loaded prescribed PO daily. A double-dummy technique with matching placebos for each active treatment was applied, thus both placebos seemed identical to their corresponding verum formulations. Follow-up visits were at weeks 4 and 6 after the first clinical interview.
In case of IHT, if the participant underwent a severe 'homeopathic aggravation' (temporary intensification of symptoms before a condition improves), the homeopathic medicine was interrupted and the reaction was lessened by using frequent doses of the same remedy in lower potency. If the participant experimented the appearance of new symptoms different from those which prescription was based, the homeopathic medicine was interrupted, a full homeopathic case-taking was taken again with a new individualized remedy prescription, and these symptoms were reported as adverse events.
Only one patient taking fluoxetine had increased anxiety and insomnia, so it was necessary to interrupt the medication and prescribe an IHT. This reaction did not threaten patient's life. This was the only case that the pharmacist told the homeopathic doctor the medication the patient was taken (fluoxetine). Then it was necessary to prescribed an IHT and the patient did not continue in the previously allocated intervention. In the rest of participants, all the adverse events were very mild and tolerable and medication was not interrupted. In the IHT group, 11.4% felt a mild homeopathic aggravation followed by clinical improvement. It was not necessary to stop study medication.
Some RCTs had failed to prove antidepressants efficacy, but other reports and meta-analysis had already shown that fluoxetine improves depression with a drug-placebo difference of 3 points in HRSD considered as a criterion of clinical significance [22]. Our results showed a fluoxetine-placebo difference of 3.2 points. In case of homeopathy, this is the first RCT of IHT in peri- and posmenopausal women with moderate to severe depression using C-potencies with three treatment groups. Previously, Adler et al reported improvement in depression in outpatient patients with moderate to severe depression using individualized homeopathic Q-potencies. They conducted a non-inferiority trial comparing homeopathy with fluoxetine, but a placebo group was not included due to ethical reasons [37]. The HOMDEP-MENOP study included a three arm design, so the placebo group allowed to rule out the placebo effect.
Although individual prescriptions are necessary in classical homeopathy, they have been considered as an obstacle for a double-blind trial in homeopathy [37]. Adler et al stated that 'a study design in which the selection of a suitable, individualized homeopathic medicine occurs during the double-blind randomized phase evaluates not only the efficacy of homeopathy, but also the efficiency of the homeopath in selecting and managing that medicine' [37]. The HOMDEP-MENOP study confirmed the efficacy of 'individualized homeopathic treatment' as a whole, that is, an individualized prescription means selecting an individualized remedy in the appropriate potency. One medicine for each patient was prescribed depending on the symptoms she experienced at the moment of the history case. Many homeopathic RCTs had failed when the same medicine was prescribed for all participants, due to individual differences in symptoms, so although an individualized prescription evaluates the efficiency of the homeopath in selecting the medicine, it can also contribute to resolve a methodological obstacle in homeopathic clinical trials in classical homeopathy.
With respect to climacteric complaints, results from GS score showed that IHT is effective for improving symptoms of women at this stage. Despite the main objective of this study was to prove efficacy of IHT for depression, other climacteric symptoms which are frequently associated with this condition were evaluated. Many observational studies have confirmed the effectiveness of homeopathic treatment for climacteric women [26]. The effectiveness gap remains for women with menopausal symptoms, so it has been necessary to conduct well-designed RCTs. Few RCTs have evaluated the use of homeopathy for menopause, and have failed to demonstrate its efficacy because a single homeopathic medicine for a whole population was prescribed and, as it was previously discussed, that is not the gold standard of homeopathic care, or sample size was too small to obtain meaningful results [26]. Thompson proposed that pragmatic trials in homeopathy could be conducted for menopausal symptoms. Anyway, it might be difficult to elucidate if there is an improvement because of homeopathic medicines effectiveness or due to the whole package of care [26]. be457b7860
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