FORMULATION FOR TREATING TOBACCO OR PSYCHOTROPE WITHDRAWAL SYMPTOMS

Abstract

The invention relates to a homoeopathic formulation prepared from the six homoeopathic strains tabacum, Nux vomica, Aurum metallicum, Passiflora incarnata, Agnus castus and Lobelia inflata, said homoeopathic formulation having beneficial effects on persons undergoing smoking or psychotropic drug withdrawal.

Claims

1. A homoeopathic composition comprising: A mother tincture of tabacum, optionally diluted up to a factor of 60C; One mother tincture of Nux vomica, optionally diluted up to a factor of 60C; A mother tincture of Aurum metallicum; A mother tincture of Passiflora incarnata; A mother tincture of Agnus castus; A mother tincture of Lobelia inflata.

2. A homoeopathic composition of claim 1, wherein the mother tincture of tabacum is diluted by a factor of 5D.

3. A homoeopathic composition of claim 1, wherein the mother tincture of Nux vomica is diluted by a factor of 9D.

4. A homoeopathic composition of claim 1, wherein the mother tincture of Aurum metallicum is diluted by a factor of 9D.

5. A homoeopathic composition of claim 1, wherein the mother tincture of Passiflora incarnata is diluted by a factor of 5D.

6. A homoeopathic composition of claim 1, wherein the Agnus castus mother tincture is diluted by a factor of 5D.

7. A homoeopathic composition of claim 1, wherein the mother tincture of Lobelia inflata is diluted by a factor of 6D.

8. A homoeopathic composition according to claim 1, comprising, by equal mass A mother tincture of tabacum, diluted by a factor of 5D; and A mother tincture of Nux vomica, diluted by a factor of 9D; and One mother tincture of Aurum metallicum, diluted by a factor of 9D; and One Passiflora incarnata mother tincture, diluted by a factor of 5D; and One Agnus castus mother tincture, diluted by a factor of 5D; and One mother tincture of Lobelia inflata, diluted by a factor of 6D.

9. A method for the treatment of at least one symptom related to smoking cessation and/or psychotropic drug withdrawal, and/or for a treatment accompanying a person in a smoking or psychotropic drug withdrawal situation comprising the step of: administering a homeopathic composition of claim 1 to a patient in need.

10. The method according to claim 9, wherein the administration of the composition is made subcutaneously.

11. A method for the preparation of a homoeopathic medicinal composition, comprising the following steps: supplying of a mother tincture from each of the following 6 strains: tabacum, Nux vomica, Aurum metallicum, Passiflora incarnata, Agnus castus and Lobelia inflata; mixing the 6 mother tinctures.

12. A method according to claim 11, further comprising a final dilution step with a sodium chloride solution in order to finally obtain a 0.9% isotonic solution, followed by a sterilization step of the composition.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0134] FIG. 1 shows the socio-professional data associated with the patient cohort. FIG. 1A shows the age distribution of the patients in the study, and FIG. 1B shows the distribution of the socio-professional categories of the patients within the cohort.

[0135] FIG. 2 illustrates the success rate by gender of smoking cessation in patients who received a composition according to the invention. By success, it should be understood that the patients reported abstinence from tobacco consumption after administration of the composition according to the invention.

[0136] FIG. 3 is a graph showing the proportion of patients who stopped smoking and those who used tobacco after administration of the formulation, as a function of their stated motivation to stop smoking.

[0137] FIG. 4 is a graph showing the relationship between the duration of abstinence reported by patients after being treated with a composition according to the invention and the duration of this abstinence.

[0138] FIG. 5 is a graph illustrating the abstinence rate of patients according to their estimated dependence according to the Fagerstrom test.

[0139] FIG. 6 is a graphical representation of the time frame in which the effects of the compound on smoking cessation are experienced by patients. The effects are, for example, the phenomenon known as “craving”, sleep or eating disorders, and emotional instability.

EXPERIMENTAL RESULTS

[0140] Within psychiatric clinics specialising in particular in the analysis, monitoring and treatment of addictions, a certain number of patients have been monitored in the context of smoking cessation support with the administration of a formulation according to the invention. Under the coordination of psychiatrists, tobaccologists and addictologists, an independent, multicentre, real-life clinical study is currently being carried out to assess the impact of the formulation on smoking abstinence; this study provides for the follow-up of patients over a period of 24 months; the results presented here cover a period of approximately 18 months. A total of seven physicians were involved in the implementation and monitoring of the treatment.

[0141] The participants were given, at one time, two subcutaneous injections of 1 ml each of the homoeopathic formulation comprising the following compounds in equal masses: [0142] A mother tincture of tabacum, diluted by a factor of 5D; and

[0143] A mother tincture of Nux vomica, diluted by a factor of 9D; and

[0144] One mother tincture of Aurum metallicum, diluted by a factor of 9D; and

[0145] One Passiflora incarnata mother tincture, diluted by a factor of 5D; and

[0146] One Agnus castus mother tincture, diluted by a factor of 5D; and

[0147] One mother tincture of Lobelia inflata, diluted by a factor of 6D.

[0148] Over the course of the study (approximately 18 months), of the patients treated with a formulation according to the invention, 778 subjects gave their agreement in principle to participate in this study. At the time of the post-treatment contact, 554 of them responded, thus constituting the cohort for the study of the effects of the formulation on smoking cessation.

[0149] The cohort is 45% female (n=248), and therefore 55% male (n=306). The age and socio-professional category of the subjects were noted. The graphs in FIG. 1A and FIG. 1B illustrate these two data items for the entire cohort.

Results:

[0150] Of the 554 subjects in the study, the reported abstinence from smoking after receiving a subcutaneous injection of the homoeopathic formulation was 85.7% (see graph in FIG. 2). This rate of declared abstinence seems to be independent of the patient's age and socio-professional category. The gender of the patient also seems to have no impact on withdrawal, as women and men report abstinence in similar proportions (86.3% and 85.3% respectively; see FIG. 2). In other words, only about 15% of patients report a recurrence of their smoking within the first few months of treatment.

[0151] The study also shows that cessation is particularly satisfactory for people who reported having a moderate to strong motivation to quit smoking, since people who reported being moderately motivated to quit do not resume smoking in satisfactory proportions (see graph in FIG. 3). The satisfaction score for the medical consultation is very high among patients who have quit smoking, exceeding 8.2/10, supporting the importance that patients place on treatment in helping them quit smoking.

[0152] It is also important to note that no patient has reported any side effects following the injection of the formulation. On the contrary, some treatments known in the prior art for smoking cessation are accompanied by mild to severe side effects.

[0153] The number of patients who have stopped smoking is thus higher than 85%, much higher than the usual success rates of prior art cessation strategies, but in addition, the long-term result is also satisfactory, since 66% of the patients declared that they had not used tobacco 6 months after receiving the treatment and, for more than 33% of them, after one year. These data items are illustrated in FIG. 4. These withdrawal rates are higher than the rates usually observed in therapies known in the prior art, with a very high tolerance threshold. This recurrence rate is lower than the results generally observed in patients using other means of withdrawal (other formulations of traditional medicine, homoeopathic medicine or via alternative medicines such as hypnosis or acupuncture). For example, treatment with varenicline (marketed under the brand name Champix® in Europe) results in abstinence at 12 months of 14% to 22% depending on the study. However, varenicline has serious side effects and is under increased surveillance by the French National Agency for the Safety of Medicines and Health Products, whereas the patients in this study reported no drug-related side effects.

[0154] Another point to mention concerns the results observed in patients with a high level of dependency. People with a high or very high dependence according to the Fagerstrom test carried out before treatment show a significant rate of abstinence after treatment: more than 83% of patients who stopped smoking had a high or very high dependence level, and only 40% of people with a high or very high dependence score resumed smoking after treatment (see FIG. 5).

[0155] The effects of withdrawal following an injection are relatively rapid, with effects felt within hours of the treatment session in about 60% of patients, and even immediate effects in about 20% of cases (see FIG. 6).

[0156] The effects were estimated by means of individual questionnaires whose answers were collected in writing or by telephone by the team in charge of this study.