NHR Apr-Sept 2019: Original Research: An open-label randomized pilot trial to study the effectiveness of Allium sativum mother tincture (Ø) in comparison with individualized homoeopathic medicines in treatment of dyslipidemia

An open-label randomized pilot trial to study the effectiveness of Allium sativum mother tincture (Ø) in comparison with individualized homoeopathic medicines in treatment of dyslipidemia


Navin Prakash Ray*1, Usha Uchat2, Rajib Purkait3

  1. Former Postgraduate Trainee, of Homoeopathic Materia Medica, National Institute of Homoeopathy, Govt. of India
  2. Reader, Dept. of Homoeopathic Materia Medica, National Institute of Homoeopathy, Govt. of India
  3. Former Postgraduate Trainee, of Homoeopathic Pharmacy, National Institute of Homoeopathy, Govt. of India

*Correspondence: navin.bhms@gmail.com


ABSTRACT

Background: Dyslipidemia is an important arising issue for the health of the community of India. There is no permanent cure of dyslipidemia in modern medicine; they offer only temporary relief. In this regard, homoeopathy may play a very important role. Treatment in Homoeopathy is mainly based on individualization of the case and selecting the similar medicines i.e. individualized homoeopathic medicine. But it can also be treated with a pre-decided medicine like Allium sativum mother tincture. So for showing which one is more effective in treating the cases of dyslipidemia, a comparative study of these two different approaches are much needed.

Methods: An open-label, randomized, pilot clinical trial was conducted to know the effectiveness of Allium sativum mother tincture (Ø) in comparison with individualized homoeopathic (IH) medicines in the treatment of dyslipidemia. Forty individuals aged between 35 and 60 years and of both sexes were included after being diagnosed as having dyslipidemia and fulfilled the inclusion and exclusion criteria. Follow ups were taken after one month for at least 6 visits.

Result: Patients were randomized into two groups – one group received IH and the other group received Allium sativum Ø. Statistical analysis of findings showed that lipid profiles were improved markedly in the IH group, whereas, Allium sativum Ø could not produce any remarkable effect. Total Cholesterol, Triglycerides, and LDL were reduced after 6 month in IH patients and no marked improvement was shown regarding HDL and VLDL. Unpaired t-test showed significant group differences (P ≤ 0.05) after 6 month of treatment favoring IH against Allium sativum Ø in all lipid parameters except VLDL and HDL.

Conclusion: IH was more effective than Allium sativum Ø in dyslipidemia. However, owing to inadequate sample size, no definite conclusion can be arrived at. Further rigorous controlled trials with larger sample size are warranted.

Keywords: Hyperlipidemia, Dyslipidemia, Individualized homoeopathic medicine, Allium sativum, Mother tincture (Ø), Cholesterol, Triglyceride, HDL, LDL, VLDL.


 INTRODUCTION

One of the consequences of unhealthy lifestyle and improper food habits is dyslipidemia. But very limited information exists regarding the changing time trends in lipid levels and the prevalence of dyslipidemia in Indian subjects1.

During 1980s, the term hyperlipidemia was included in medical science which referred to the conditions with excess lipids in the blood. Further, it was referred as hyperlipoproteinemia which means condition with abnormally elevated levels of lipoproteins in the blood. The term “Dyslipidemia” was introduced in 2006, denoting derangements of one or more of the lipoproteins in blood, such as Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL‑C), and/or Triglycerides (TGL), or low levels of High Density Lipoprotein Cholesterol (HDLC) alone2. Correlation of high level of serum total cholesterol and high level of LDL-cholesterol, as a main risk factor for CAD is well established3.

The W.H.O. has estimated that dyslipidemia is associated with more than 50% of cases of IHD (ischemic heart disease) worldwide and more than 4 million deaths annually4. With epidemiological transition, lack in physical activity and an increase in the stress causes dyslipidemia and CAD (coronary artery disease). According to World Health Report 2002, cardiovascular diseases will be the largest cause of death and disability by 2020 in India; the contributing factors are increasing hypertension, dyslipidemia, diabetes, overweight or obesity, physical inactivity, and using tobacco5.

The prevalence of elevated total cholesterol was highest in the WHO Region of Europe (54% for both sexes), followed by the WHO Region of the Americas (48% for both sexes). The WHO African Region and the WHO South East Asian Region showed the lowest percentages (22.6% for AFR and 29.0% for SEAR)6. One of the various causes of dyslipidemia is obesity.

A study was conducted in 2015 in Pune at Dr. D. Y. Patil Vidhyapith for comparison of dyslipidemia among the normal-BMI and high-BMI group of people of rural Tamil Nadu shows TC, LDL, VLDL TGLs are comparatively high in the person with high BMI than in normal BMI7.

A study done in 2011 on dyslipidemia in type 2 diabetes mellitus patients in Nnewi South-East Nigeria shows the serum lipid abnormalities in type 2 diabetic patients, as seen by the medical unit of the Nnamdi Azikiwe University Teaching Hospital. Nnewi were examined with the aim of determining the type of lipoprotein disorders associated with these patients8.

Effect of Homoeopathic drug in any case is based primarily on the Law of Similia considering the totality of symptoms of the case with special attention to the individualization of peculiar uncommon characteristic symptoms, which are applied for treating homoeopathically in all cases9.

An observational study was done by CCRH on lipoproteinemia, wherein 322 patients were given individualized homoeopathic treatment, out of which 290 patients were improved. Lycopodium clavatum, Calcarea carbonica, Pulsatilla, Rhus tox, Sulphur, and Nux vomica were found useful in treatment. Not only pathological parameters were improved, but also associated symptoms of patients were improved3.

Hippocrates was the first to write of the constitutional nature of the human organism10. Hahnemann had given immense value to constitution. He had used the word constitution at least 16 times in chronic disease. The individualized treatment is classical way of treatment of cases, as recommended by many of our stalwarts.

On the other hand, there are literatures and evidences available which suggest a role of Allium sativum Ø as a specific medicine in lowering the elevated lipid levels. Thus this study aimed the comparison of the two completely different lines of treatment i.e. IH treatment and pre-decided medicine Allium sativum Ø in the condition of dyslipidemia.

Large number of patients of dyslipidemia of different age groups, of both sexes, belonging to different religions, from different areas visits the Outdoor Patient Department (OPD) of National Institute of Homoeopathy (NIH) seeking homoeopathic treatment. Adequate investigation facilities are also available at NIH for the patients. So a comparative study between Allium sativum and IH was found to be feasible here. It has provided a practical evidence of the theoretical knowledge. The different approaches for the treatment of dyslipidemia instigated the basis of this study.

METHODS

Trial design: This open label, randomized prospective, exploratory, pilot, pragmatic, two parallel arms clinical trial was conducted at the Homoeopathic Materia Medica OPD of NIH. Institutional Ethical Committee (IEC) approved the protocol [Ref. no. 5023/NIH/PG/Ethical comm. 2009/vol.III/ 1944(A/S); dated March 27, 2017]. The trial protocol (unpublished) and full dissertation was submitted as the postgraduate thesis of the corresponding author to The West Bengal University of Health Sciences.

Participants: Individuals aged between 35 – 60 years of both sexes and of all religion were included after being clinically diagnosed as having dyslipidemia and by fulfilling other inclusion and exclusion criteria which includes the patients willing to participate in the study by giving written informed consent. Exclusion criteria were the patient suffering from any life threatening disease, any medical emergency, patient already taking other medicine, pregnant and lactating women.

Intervention: The patients are divided into two groups on the basis of randomization chart. One is IH group and other is Allium sativum group. A written informed patient consent was taken from every enrolled patient as per the Informed Patient Consent Form. All the selected patients were properly examined and diagnosis was done clinically and on the basis of laboratory investigations and reports. Proper analysis and evaluation of each case was done by using Kent’s method and then the totality of symptoms of each case was searched out and cases were repertorised with the help of “Kent’s repertory” using RADAR 10 software. Final selection of the similimum was done after consulting standard Materia Medica. The medicines were given in IH group in fifty millesimal potencies. The dose and repetition was strictly maintained as per the homoeopathic principles. The other group received Allium sativum Ø 10 drops twice daily. The medicines were dispensed from the dispensary of National Institute of Homoeopathy. Proper counseling was done as per the requirement after case perceiving. Hygienic and general measures were advised to every patient. Each patient was followed up at an interval of more or less one month. Each case was followed up for at least 6 visits before the assessment of the outcome. Outcome measures were assessed by laboratory investigations and reports after 6 months. The result before the treatment and after was analyzed from statistical point of view and suitable inferences were drawn.

Control: Control was planned as administering individualized homoeopathic medicines in fifty millesimal potencies and in individualized dosage, as decided appropriate to the case or condition. Duration of treatment was 6 months. On each occasion, single individualized medicine was prescribed considering symptom totality, clinical history details, constitutional traits, miasmatic features; repertorization as and when required consultation with Materia Medica, and agreement among the three prescribing homoeopaths. Individualized dose was used based on the three homoeopaths’ “judgment of susceptibility and agreement”. Subsequent prescriptions were produced in accord with Kent’s observations and Hering’s law. Two of the prescribers possessed masters’ degree in homoeopathy and had been practicing “classical homoeopathy” for more than 20 years. The corresponding author was a postgraduate trainee at NIH with 2 years of experience. All the homoeopaths involved were affiliated with respective state councils.

Outcomes: Blood lipid profile – Total Cholesterol, Triglyceride, LDL, HDL, and VLDL, measured at baseline and after 6 months of therapy.

Sample size: Formal effect size calculation was not possible on account of absence of any open randomized trial on dyslipidemia comparing effectiveness of Allium sativum with individualized homoeopathic medicine (IH). As the designed trial was equivalence or non-inferior in type, and Allium sativum was considered as one of the recommended homoeopathic medicines for the said condition, we presumed very small difference and small effect size in favor of either of the therapies and considered both the therapeutic options as equally effective (H0). Hence assuming a small effect size (d) of 0.1, and fixing α at 0.01, power (1 – β) = 80% (minimum recommended) and allocation ratio of 1.1, in order to identify a significant difference between two independent means of muscle strength grading scores (primary outcome measure) of the two groups by unpaired t test (two tailed), we would have required 3142 patients, i.e. 1571 in each arm. However, keeping in mind the exploratory nature of the trial, feasibility issues, and time constraints, we targeted to achieve 46 patients, i.e. 23 in each arm. Given β/α ratio of 4, effect size of 0.1 and sample size of 23 in each arm, post hoc analysis revealed a compromised power (1-β) = 22%. The final analysis was restricted on the protocol compliant sample (n=40) only; thus further compromising the study power up to 21.7%. This indicated the need for cautious interpretation while extrapolating the results to general population. So, the total number of patients was 40, 20 in each group.

Randomization: Intervention (EA) or comparator (IH) was implemented as per the random number chart created by using the random number generator at StatTrek. The chart was generated using 4 blocks of size restricted to 10 (4 × 10 = 40) plus another block of size 6 to maintain alike allocation between groups and 1:1 ratio easily; thus the same numbers of patients were randomized to either code 1 or 2, either of intervention or control. Randomization was done by computer chart method.

Blinding: The prescribing homoeopaths and the patients – both were aware (i.e. open label) of the generated allocation codes all through the study. Allocated codes were maintained till the end of the trial. This open list of random numbers with allocated codes was made available with the pharmacist, and he was instructed for dispensing of either Allium sativum Ø or IH to the patients according to the chart.

Statistical methods: Statistical analysis of the patients’ data during the study was done. As the data collected through laboratory investigations was quantitative in nature, sample size was 40 and same sample was divided into two groups on the basis of randomized chart into IH group and Allium sativum Ø group. At first distribution of baseline outcome measure between two groups was evaluated before treatment, so unpaired t-test was used. Then intra-group changes over 6 months was evaluated so, paired t-test was used. And lastly group difference over 6 month treatment was evaluated with help of unpaired t-test. Apart from the basic statistical methods of tabulation, graphical representations were done. After completion of study the result was represented by using different statistical methods after proper analysis of result.

RESULTS

Study flow: As per pre-specified inclusion and exclusion criteria, 40 patients suffering from dyslipidemia were screened and were enrolled into the trial. Following that, baseline socio-demographic and outcome data were obtained and were randomized to either individualized homoeopathic (IH) medicine group (n=20) or Allium sativum mother tincture group (MT) (n=20). After 6 month of intervention, outcome data were recorded again (Fig. 1).

Fig. 1 Study flow diagram

Recruitment: The study continued for 15 months, started in April 2017 and continued till June 2018.

Baseline data: Distribution of socio-demographics feature including age, gender, residence, religion, socioeconomic status were similar between the IH and MT group ensuring comparability of the two groups. Distribution of the outcome measure at baseline was also similar between the two groups with no significant differences (all P > 0.01). It implied that the groups were comparable at the baseline. (Table 1)

Table 1: Distribution of baseline outcome measure between IH group and Allium satium Ø group

Outcome Measure IH (N=20)

Mean ± SD

Allium Sativum (Ø) (N=20)

Mean ± SD

P value
T. Cholesterol 225.7 ± 40.9 231 ± 45.8 0.7019
Triglyceride 215.5 ± 58.9 225.9 ± 88.3 0.6626
LDL 140.4 ± 25.3 141.4 ± 41.4 0.9243
VLDL 41.7 ± 8.6 44.7 ± 13.9 0.4312
HDL 47.4 ± 9.4 46.06 ± 13.2 0.6965
LDL : HDL 3.03 ± 0.6 3.13 ± 0.8 0.680
T. Ch : HDL 4.87 ± 0.98 5.21 ± 0.92 0.2642

 

Outcomes and estimation:

  • Within group changes over 6 month: All the outcomes in IH groups showed statistically significant improvement in the lipids profile except VLDL (Table 2). Outcomes in MT group showed no significant change in the lipid profile. (Table 3).
  • Group differences over 6 months: Though intra-group changes were significant except in VLDL and HDL, IH has significant advantages over MT over the MT group. (Table 4).
  • There was no significant difference in the level of T. Cholesterol between two groups [IH 225.7(SD 40.9) vs. Allium sativum Ø 231.05 (SD 45.8), mean difference± SE-5.3 ± 13.743, 95% CI 33.12 to 22.52, t= 0.3856, p= 0.7019, unpaired t-test]
  • There was no significant difference in the level of Triglycerides between two groups [IH 215.5(SD 58.9) vs. Allium sativum Ø 225.9 (SD 88.3), mean difference± SE-10.45 ± 23.76, 95% CI -58.55 to 37.65, t= 0.4398, p= 06626, unpaired t-test]
  • There was no significant difference in the level of LDL between two groups [IH 140.4 (SD 25.3) vs. Allium sativum Ø 141.49 (SD 41.46), mean difference± SE 2.210 ± 12.345, 95% CI 22.78 to 27.20, t= 0.1790, p= 0.8589, unpaired t-test]
  • There was no significant difference in the level of VLDL between two groups [IH 41.7 (SD 8.6) vs. Allium sativum Ø 44.7 (SD 13.9), mean difference± SE-2.925 ± 3.676, 95% CI 10.367 to 4.517, t= 0.7957, p= 0.4312, unpaired t-test]
  • There was no significant difference in the level of HDL between two groups [IH 47.4 (SD 9.4) vs. Allium sativum Ø 46.06 (SD 13.2), mean difference± SE1.43 ± 3.63, 95% CI -5.935 to 8.795, t= 0.3931, p= 0.6965, unpaired t-test ]
  • There was no significant difference in the level of LDL : HDL between two groups [IH 3.039 (SD 0.68) vs. Allium sativum Ø 3.138 (SD 0.808), mean difference± SE-0.0985 ± 0.237, 95% CI -0.5782 to 0.3812, t= 0.0.4157, p= 0.680, unpaired t-test]
  • There was no significant difference in the level of T. Ch : HDL between two groups [IH 4.87 (SD 0.98) vs. Allium sativum Ø 5.21 (SD 0.92), mean difference± SE-0.342 ± 0.302, 95% CI -0.9529 to 0.2689, t= 1.1332, p= 0.2642, unpaired t-test]

Table 2: Intra-group changes over 6 months in IH group

Outcome Measure Baseline

M ± Sd

After 6 Month

M ± Sd

P Value
T. Cholesterol 225.7 ±40.9 170.8 ±27.5 0.001
Triglycerides 215.5 ±58.9 171.1 ±42.5 0.001
LDL 140.4 ±25.3 99.8 ±20.6 0.001
VLDL 41.7 ±8.6 43.8 ±6.4 0.1316
HDL 47.4 ±9.4 51.05 ±6.4 0.0493
LDL : HDL 3.03 ±0.68 2.03 ±0.51 0.001
T. Ch : HDL 4.8 ±0.98 3.37 ±0.6 0.001
  • After 6 month of treatment the level of T. Cholesterol was reduced from 225.7 (SD40.9) to 170.8 (SD27.5), reduction was statistically significant [mean reduction ± SE 54.95±5.031, 95% CI 44.42 to 65.48, t=10.923, P = 0.001, paired t-test.]
  • After 6 month of treatment the level of Triglyceride was reduced from 215.5 (SD 58.9) to 171.1 (SD 42.5), reduction was statistically significant [mean reduction ± SE 44.42±5.733, 95% CI 32.42 to 56.42, t=7.7487, P = 0.001, paired t-test.]
  • After 6 month of treatment the level of LDL was reduced from 140.4 (SD 25.3) to 99.8 (SD 20.6), reduction was statistically significant [mean reduction ± SE 40.65±3.726, 95% CI 32.85 to 48.45, t=10.908, P = 0.001, paired t-test.]
  • After 6 month of treatment the level of VLDL was reduced from 41.7 (SD 8.6) to 43.8 (SD 6.4), reduction was statistically not significant [mean reduction ± SE -2.015 ±1.279, 95% CI -4.69 to0.661, t=1.5759, P = 0.1316, paired t-test.]
  • After 6 month of treatment the level of HDL was reduced from 47.4 (SD 9.4) to 51.05 (SD 6.4), reduction was statistically significant [mean reduction ± SE 3.56±1.695, 95% CI -7.109 to 0.011, t=2.0997, P = 0.0493, paired t-test.
  • After 6 month of treatment the level of LDL:HDL was reduced from 3.03 (SD 0.68) to 2.03 (SD 0.51), reduction was statistically significant [mean reduction ± SE 1.0085±0.148, 95% CI 0.6997 to 1.3173, t=6.8361, P = 0.001, paired t-test.]
  • After 6 month of treatment the level of T.Ch:HDL was reduced from 4.8 (SD0.98) to 3.37 (SD 0.607), reduction was statistically significant [mean reduction ± SE 1.4965±0.175, 95% CI 1.1364 to 1.8626, t=8.5557, P = 0.001, paired t-test.]

 

Table no. 3: Intra-group changes over 6 months in Allium sativum Ø group

Outcome Measure Baseline

M ± Sd

After 6 Month

M ± Sd

P Value
T. Cholesterol 231.05 ± 45.85 230.55 ± 50.40 0.9297
Triglycerides 225.9 ± 88.38 221.05 ± 73.33 0.6704
LDL 141.49 ± 41.46 144 ± 37.37 0.7071
VLDL 44.7 ± 13.9 47.8 ± 13.9 0.2522
HDL 46.06 ± 13.25 47.8 ± 11.57 0.2747
LDL : HDL 3.13 ± 0.808 3.11 ± 0.96 0.8847
T. Ch : HDL 5.21 ± 0.92 4.96 ± 1.23 0.3468

 

  • After 6 month of treatment the level of T. Cholesterol was reduced from 231.05 (SD 45.85) to 230.55 (SD 50.4), reduction was statistically not significant [mean reduction ± SE 0.50±5.59, 95% CI 11.20 to 12.20, t=0.0894, P=0.9297, paired t-test.]
  • After 6 month of treatment the level of Triglyceride was reduced from 225.9 (SD 88.38) to 221.05 (SD 73.33), reduction was statistically not significant [mean reduction ± SE 4.925±11.393, 95% CI -18.921 to 28.771, t=0.4323, P =0.6704, paired t-test.]
  • After 6 month of treatment the level of LDL was reduced from 141.49 (SD 41.46) to 144 (SD 37.37), reduction was statistically not significant [mean reduction ± SE -2.510±.6.580, 95% CI -16.282 to 11.262, t=0.3815, P = 0.7071, paired t-test.]
  • After 6 month of treatment the level of VLDL was reduced from 44.7 (SD 13.9) to 47.8 (SD 13.9), reduction was statistically not significant [mean reduction ± SE -3.1140±2.659, 95% CI -8.705 to 2.425, t=1.1809, P = 0.2522, paired t-test.]
  • After 6 month of treatment the level of HDL was reduced from 46.06 (SD 13.25) to 47.8 (SD 11.57), reduction was statistically not significant [mean reduction ± SE -1.740±1.547, 95% CI -4.978 to 1.498, t=1.1248, P = 0.2747, paired t-test.]
  • After 6 month of treatment the level of LDL:HDL was reduced from 3.13 (SD 0.808) to 3.114 (SD 0.9612), reduction was statistically not significant [mean reduction ± SE 0.024±0.163, 95% CI 0.3178 to 0.3658, t=0.1470, P = 0.8847, paired t-test.]
  • After 6 month of treatment the level of T. Ch:HDL was reduced from 5.21 (SD 0.92) to 4.964 (SD 1.23), reduction was statistically not significant [mean reduction ± SE 0.2495±0.259, 95% CI 0.2919 to 0.7909, t=0.9646, P = 0.3468, paired t-test.]

 

Table 4: Inter-group difference over 6 months of treatment

 

Lipids Mean Difference

± SE

t – Score P Value
T. Cholesterol – 54.4 ± 7.5 7.2402 < 0.001
Triglycerides -37.2 ± 12.4 3.0039 < 0.005
LDL -43.1 ± 7.5 5.7077 < 0.001
VLDL -1.1 ± 2.9 0.3818 = 0.7051
HDL 1.8 ± 2.2 0.793 = 0.4327
LDL : HDL -1.03 ± 0.2 4.6916 < 0.001
T. Ch : HDL -1.1 ± 0.3 3.4208 < 0.005

 

 

The statistical inference of group difference over 6 month treatment:

 

  • The mean difference (±SD) of T. Cholesterol between two groups were -54.4±7.5, t score = 7.2402, P value < 0.001, unpaired t-test.
  • The mean   difference (±SD) of Triglycerides between two groups were       -37.2±12.4, t score = 3.0039, P value < 0.005, unpaired t-test.
  • The mean difference (±SD) of LDL between two groups were -43.16±7.5, t score = 5.7077, P value < 0.001, unpaired t-test.
  • The mean difference (±SD) of VLDL between two groups were -1.12±2.95, t score = 0.3818, P value = 0.7051, unpaired t-test.
  • The mean difference (±SD) of HDL between two groups were 1.82±2.95, t score = 0.793, P value = 0.4327, unpaired-t test.
  • The mean difference (±SD) of LDL: HDL between two groups were -1.032±0.22, t score = 4.6916, P value < 0.001, unpaired t-test.
  • The mean difference (±SD) of T. Ch: HDL between two groups were -1.1485 ±0.33, t score = 3.4208, P value <0.005, unpaired t-test.

Medicines used in IH Group:

In this study, medicines were prescribed on the basis of totality of symptoms. Frequently prescribed medicines were Lycopodium, Medorrhinum, Natrum mur, Thyroidinum, Thuja occ, Ignatia etc. It was observed that Lycopodium was indicated for maximum cases (5 out of 20 cases, 25%). Thuja occ was used for 3 cases out of 20 (15%) and Thyroidinum, Medorrhinum and Ignatia was used for 2 (10%) cases for each.

Adverse effect:

No harm, unintended effects, serious adverse events, and homoeopathic aggravation were reported from either group during the study period.

DISCUSSION

The present study entitled as “An open label randomized clinical (pilot) trial to study effectiveness of Allium sativum mother tincture (Ø) in comparison with individualized homoeopathic medicine in the treatment of cases of dyslipidemia” was conducted at National Institute of Homoeopathy, Kolkata. The aim of this study was to compare the treatment done with Allium sativum Ø and IH in the treatment for dyslipidemia.

Empirically selected Allium sativum Ø is significantly less effective to IH in treatment of dyslipidemia, as evidenced from blood lipid profile. However, the trial being underpowered, cautious interpretation is warranted. Further exploration is necessary. One of the major strengths of the study was randomization; i.e. each number had the same chance of being allocated to either of the two arms. It is a “gold standard” for proof of efficacy/effectiveness. The advantages of randomization included equipoise across groups, enhanced internal validity due to homogenous study groups, minimized selection bias, unbiased allocation, generation of two comparable groups, balancing among possible confounders, facilitating simple analysis, and to declare evidently that the difference was because of the treatment. Prospective study design allowed causal inference to be drawn. No placebo control was used; rather all the randomized patients received medicine – either Allium sativum Ø or IH. Hence, ethically the study was less vulnerable. In the study design, we kept provision for pair-wise comparisons using rigorous parametric tests, namely t-test.

The study was the very first of its kind in homoeopathy; hence exploratory in nature. Effect size could not be calculated on account of absence of any study of similar design; hence sample size was based on assumption only. The trial was open; no blinding was used. Thus, patient selection bias, treatment assignment bias, patient evaluation bias, and data analysis bias may have affected the outcomes of the study.

Besides, our analysis was restricted to protocol compliant sample only. Imputation of missing values using appropriate statistical techniques and an intention-to-treat analysis would have generated more proper results than this. Further studies are suggested on similar or more rigorous design with validated clinical scoring system and questionnaire focusing on quality of life issues.

 

CONCLUSION

This prospective, open, randomized, two parallel arms, exploratory, pilot, pragmatic trial was carried out at National Institute of Homoeopathy included 40 patients. Over 6 months of intervention, outcome assessment of the treatment was done by laboratory investigations and reports after 6 months of the treatment shows blood lipid profile improved significantly in the IH groups and there is no significant improvement  in Allium sativum Ø group in dyslipidemia. The overall response of patients after homoeopathic treatment was satisfactory and the study shows that individualized homoeopathic medicine is more effective than Allium sativum Ø in the treatment of dyslipidemia.

However, being an underpowered trial, results should be interpreted cautiously and further research in multi-centric design is required on larger sample size before making any firm recommendations.

Conflict of interest statement: The authors declare that they have no competing interest. The trial was carried out as the post graduate thesis of the corresponding author under the guidance of UU who is permanent teaching faculty of the institute.

Funding:  We receive no funding for the study.

Authors’ contributions: NPR and UU conceived and designed the study. NPR and UU collected the data. RP ran the statistical analysis and interpreted the data. NPR has prepared the manuscript. UU reviewed and approved the final manuscript.

Acknowledgment:  We are thankful to staffs of hospital section and patients for their sincere participation in the study.

 

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Cite this article as: Ray NP, Uchat U, Purkait R.  An open label randomized pilot trial to study the effectiveness of Allium sativum mother tincture (Ø) in comparison with individualized homoeopathic medicines in treatment of dyslipidemia. National Homoeo Recorder 2019;15(2,3):

Download: An open-label randomized pilot trial to study the effectiveness of Allium sativum mother tincture (Ø) in comparison with individualized homoeopathic medicines in treatment of dyslipidemia

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