Individualized Homeopathic Treatment and Fluoxetine for Moderate to Severe Depression

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Individualized Homeopathic Treatment and Fluoxetine for Moderate to Severe Depression (shorthand as HOMDEP-MENOP Study since the original name is stupidly long) is the definitive proof that homeopathy works and even works better than standard medicine – if you think proof is in the form of convoluted protocols that show mixed results and little reproducibility. It's a trial that compares homeopathic medication (individualized homeopathic treatment to be precise) with placebo and standard medication (fluoxetine) with placebo and then comparing the results between homeopathic medicine and placebo and then concluding homeopathy works (compared to placebo, not fluoxetine). This trial treats women undergoing depressing during the their perimenopausal period, when their menstrual cycle become irregular. The study is not poorly designed. It contains many controls: a sample created from random selection, double-blinded, placebo-controlled trial with an okay sample size of 133 women, diagnosed according to the standard DSM-IV criteria. The statistical analysis used is the ANOVA with Bonferroni post-hoc test. It seems to have everything and no doubt this has probably softened some attitudes on homeopathy. It, however, is far from conclusive and shows mixed results at best.

The paper was later retracted in April 23, 2020 for questionable study design, including insufficient controls and lack of methodology of diagnoses made in the study and lack of sufficiently detailed documentation to help with reproducibility of the trial.

Methodology

According to the study, antidepressant medications have history of only a modest benefit, so why not try homeopathy?

The study was performed in a public research hospital in Mexico City that has an outpatient treatment of homeopathy. A sample size of 133 women 40 to 65 years old diagnosed with major depression (moderate to severe symptoms) according to DSM-IV were enrolled and randomly selected, from a screening of 530 women. Some controlled attributes include no prior treatment, homeopathic or standard; no psychotherapy, no drugs taken affecting estrogen function, no other psychiatric disorders, and no substance abuse. The women were then split into three groups, IHT (individualized homeopathic treatment) plus fluoxetine dummy-loaded, fluoxetine (20 mg) plus IHT dummy-loaded, and fluoxetine placebo plus IHT placebo. In IHT, homeopathic doses of 30C (10⁻⁶⁰ dilution) and 200C (10⁻⁴⁰⁰ dilution) were prescribed. In the three groups, 44 women got IHT, 46 fluoxetine, and 43 placebo. The sample size is not very impressive.

Women, as part of the individualized treatment, were evaluated using Samuel Hahnemann's (the father of homeopathy) methodology by a certified medical doctor who has 18-years experience with homeopathy with knowledge on classical homeopathy. Right, a methodology that is incredibly old and probably outdated and a "certified" doctor that specializes in pseudoscience determines how the individualized treatment will go. A hierarchy of depression symptoms are laid out: mental, general and physical, and those with "the most characteristic and clear mental symptoms" are chosen for individualized treatment.

Conclusion

The study concludes that homeopathy and fluoxetine are safe and effective medicine as antidepressants compared to placebo. Despite what some homeopathic proponents say (check the archived Twitter posts embedded in the page), the authors state explicitly that this trial was not designed to compare effectiveness of IHT with the standard fluoxetine. Despite this, however, this study suggests that IHT is a possibly proven treatment that can be a cheap and effective alternative for low-income populations, a health-care option for poor women in Mexico.

There are some limitations including no differences in the BDI score (another standard instrument for measuring depression) compared to the HRSD score. The women reported several factors that can possibly influence the results of the study: 53% reported a history of depression, 73% reported domestic violence (emotional, physical or economic), 36% reported a history of sexual abuse in infancy, and 53% had marital dissatisfaction.

Flaws

Lack of convincing literature that demonstrates efficacy of homeopathy

Even if this is a well-designed positive trial, the evidence for homeopathy hasn't been very convincing. It's even described below by the study authors:

More homeopathic research is needed specially in the menopausal time period where there is a lack of well-designed RCTs. At moment, although homeopathy is frequently prescribed for psychiatric conditions, the need for more high-quality RCTs has been identified. Meta-analyses and systematic reviews have drawn mixed conclusions as to whether homeopathy is more effective than placebo in general medicine

How does this work?

One of the biggest problems in this trial is that, while it gives a little history of what is believed to make homeopathy work, it fails to mention that homeopathy violates basic rules of chemistry, including dilutions so intense that it straddles beyond Avogadro's number and into "nothing of the original substance is left". Even if the trial didn't have any problems, there is an issue on trying to explain how homeopathy is able to achieve any results despite violating major rules. Furthermore, the trial assumes that homeopathy does have some sort of effect. A trial can be terminated early if the patient experienced "homeopathic aggravation", (defined as "temporary intensification of symptoms before a condition improves"), which is simply assumed it exists despite having scant documentation outside of pro-homeopathy websites. When this "homeopathic aggravation" occurs, the solution is to give frequent doses of the same remedy but with lower potency (in homeopathic terms, this means they treated the allergy with a more saturated dose).

Replication issues (particularly the "individualized" part)

See the main article on this topic: Reproducibility

The use of individualized treatment should already activate suspicion. According to the methodology, "only one remedy [of IHT] was prescribed at a time but it could be changed at every follow-up according to patient's symptoms." This means there can possibly be several different treatments going on at the IHT group since, well, everyone has different needs. While double-blinding was achieved by doctors administering dummy IHT trials, there is a serious problem of replicating this trial. While everyone in the standard trial has received a consistent dose of 20 mg fluoxetine, the IHT group is pretty much allowed to reign free. According to a comment, there are 25 different medicines used in the experimental IHT group.

Although individual prescriptions are necessary in classical homeopathy, they have been considered as an obstacle for a double-blind trial in homeopathy. 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'. 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.

Bolded for emphasis. Hint hint. Somehow, homeopathy works when it's individualized, but it falls apart when it's consistent throughout the board! If individual prescriptions are necessary, it would make homeopathy virtually impossible to study and compare to placebo. Of course, homeopathy is "individualized" because it's holistic and "considers the entire patient" and all that stuff.

Other issues

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.

Patients are chosen with "the most characteristic and clear mental symptoms". There seems to be no definition what this exactly means and no explanation for the hierarchy. What is "the most important symptoms" of the patient? It's likely that depression comes in a spectrum and probably not in a linear one either. How does one measure mental health and then compare it to physical health?

This study used less than the maximum dose for fluoxetine, so it's probably not surprising that fluoxetine at points, such as the Beck Depression Inventory and Greene Climacteric Scale, has shown no difference from placebo.

Author responds to comments

Some of the author comments are… questionable. While it is true that author's personal biases should have no bearing on the results of the study, it calls the study's neutrality into serious question, especially if the study has some flaws to begin with.

The study aimed to evaluate the efficacy of the individualized homeopathic treatment as a whole, an individualized prescription means selecting an individualized remedy according to the patient's symptoms in the appropriate potency needed to heal. That is classical homeopathy. In general terms, homeopathy studies the patient as a whole, taking into account that is a human being that might be physically and mentally ill. This is not magic, is a comprehensive medical approach or holistic care.

This sounds way too close to the typical pro-alt-medicine canards spouted by quacks, and this argument is used not only in homeopathy but the rest of alternative medicine. Oh wait, that reference is invalid as the author thinks David Gorski is a biased source.

It would be more objective to conduct the study in a setting that does not have a business in delivery of homeopathic treatments, but the same thing occurs with many other studies which are conducted in their own settings. Most of the time, medical doctors conduct studies in settings where they work on their own area of expertise, precisely because they are trained in that. Moreover, other medical doctors are employed by the pharmaceutical industry which is frequently involved with funds in many studies.

This is in response to an objection that the study is performed in a hospital that happens to administer homeopathic treatments. The objection that the trial is carried in a hospital that uses homeopathic treatments is probably not a strong point since trials for conventional medicine are done in hospitals that administer conventional medicine, but the author's last sentence seems to bring the author's neutrality into question. It rings too much of the Big Pharma shill conspiracy gambit the alt medicine practitioners often like to trot out because their experiments hardly ever impress Big Pharma enough for Big Pharma to sponsor them apparently.

Homeopathy has always been attacked, but the reality is that its use is widespread and patients seek for homeopathic treatments. Don't you think something that has been attacked for so long and remains has some truth? Although its mechanism of action is still unknown. It is not a war between conventional medicine and homeopathy. If Chris Lee claims homeopathy is magic, he might prove it.

This is an additional sentence in response to the full comment that merely dismisses Chris Lee's claims as "biased". This also sounds like an appeal to antiquity. If homeopathy is still being practiced despite having a lot of tenacious critics, there has to be some truth to it! This comment can also be interpreted as supporting a tenet of integrative medicine, the idea of "integrating" the best of conventional and alternative medicine instead of the two at odds, though reality suggests that it is more of an excuse to sneak woo into more legitimate medicine. The last remark is a bit disingenuous, essentially telling Chris Lee to prove an impossibility.

External links

• The study itself.
• Steve Novella comments a bit on the study.