The efficacy of Hamamelis 30 in the management of varicose veins and its complications using revised venous clinical severity score tool and peripheral venous Doppler study

INTRODUCTION

Varicose veins are defined as dilated, tortuous, subcutaneous veins 3 mm in diameter when measured in the upright position with demonstrable reflux. They are a common global health problem found in all ages and both sexes. The prevalence is known to increase with age and due to standing/walking <4 h/day and excessive lifting.^[1] Although patients may be asymptomatic, aching pain, discomfort, pruritus, and muscle cramps frequently occur. Complications such as edema, eczema, lipodermatosclerosis, ulceration, phlebitis, and bleeding are common. The basic element in the treatment of chronic venous disease is compression therapy.^[2] The cost of investigations and treatment is very high. In the Indian scenario, varicose veins are very common among the lower socio-economic class and the condition can even compel people to change their occupation.^[3] Hamamelis virginiana, taken internally or externally, is a popular remedy for treating varicose veins, phlebitis, and inflamed veins.^[4] The leaves and bark of the North American witch hazel H. virginiana may be used to produce an astringent, also referred to as witch hazel, and is used medicinally.^[5] Hamamelis has been known to improve microcirculation, capillary flow, vascular tone, and to strengthen the connective tissue of the perivascular amorphous substrate and avoid the complications of varicose veins.^[6] The striking features of this remedy are venous congestion, bleeding, distension of veins, and soreness and dark blue purple appearance of the skin, especially of the lower limbs with ulcers that bleed black blood.^[7]

A venous Doppler ultrasound is a diagnostic test used to check the circulation in the large veins of the extremities leg or arms and shows the blockage in the veins by a blood clot or “thrombus” formation. The revised venous clinical severity score (VCSS) is the American Venous Forum’s modification of the clinical score of the Clinical, Etiologic, Anatomic, and Pathophysiologic (CEAP) classification of chronic venous disease. It was designed to be a quantifiable measure of disease severity and is sufficiently dynamic to measure change in response to treatment. The revised VCSS coupled with the clinical CEAP classification provides a standard clinical language to report and compare differing approaches to cardiovascular disease management.^[8] The 2-year recurrence rate of varicose veins after radiofrequency treatment is 14%; after vein stripping, it is 21%. Moreover, no treatment can prevent the occurrence of new lesions.^[9]

Hamamelis, when used as a specific remedy for varicose veins, has a record of producing results in a cost-effective manner, without having to resort to surgery. In a developing country like India, where patients cannot afford surgery, homoeopathic medicines are simple, safe, and cost effective. This study aimed to establish the therapeutic utility and efficacy of Hamamelis in the 30^th centesimal potency (30C) in the management of varicose veins and their complications. Considering the above limitations of the conventional system, the present study focused on evidence-based observations, using the validated VCSS tool and peripheral venous Doppler to understand the role of homoeopathy in varicose veins.

MATERIALS AND METHODS

This was a prospective experimental case study with no control group taken to prevent ethical pitfalls regarding patients not on any treatment. The subjects for the study were selected using purposive sampling, from the patients who reported to the Outpatient Department of Father Muller Homoeopathic Medical College and Hospital, Deralakatte, Karnataka. A total of 60 subjects who fulfilled the inclusion criteria were initially enrolled for the study for 2 years.

RESULTS

In our study, the VCSS tool was useful to study the changes in the clinical scores; we could efficiently validate the changes in the clinical presentation and the evolving remedy responses. Koyano and Sakaguchi studied the VCSS and found good correlation among all severity scores, especially among CEAP scores and VCSS.^[10] In our study of patients with varicose veins the number percentage of male patients were 44% and the number percentage of females were 56% [Figure 1] the number of patients with right leg involvement was 10 and number of patients with left leg was 7 and the number of patients with bilateral involvement was 15 [Figure 2]. We assessed the score severity distribution before and after treatment; most cases improved [Figure 3]. The VCSS showed marked improvement; the left leg improved in 20 patients and remained the same in 5 [Figure 4], while the right leg improved in 16 patients and remained the same in 6. In the left leg, the pre-and post-treatment mean score was 6.32 ± 5.32 and post score was 3.91 ± 2.47, respectively [Table 1]. From the doppler study out of the 22 patients with right leg involvement, only 5 improved and the remainig 17 remained same and in the left leg out of 25 patients with left leg involvement, 7 improved and 18 remained same [Figure 5]. The mean change in the score was 2.41 ± 3.83, indicating 38.13% improvement, which is statistically highly significant (P = 0.008). In the right leg, the pre- and post-treatment mean score was 4.84 ± 2.59 and 3.04 ± 2.23, respectively [Table 2]. The mean change was 1.80 ± 1.66 indicating a 37.19% improvement, which is statistically highly significant (P = 0.000) 5.53 ± 4.1 and 3.45 ± 2.36, respectively. The cumulative pre- and post-treatment score was 5.53 ± 4.15 and 3.45 ± 2.36, respectively [Table 3]. The mean change was 2.09 ± 2.87, indicating a 37.69% improvement (P = 0.000) [Table 4].

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Figure 1:

Distribution of cases according to sex.

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Figure 2:

Distribution of cases according to the limb involvement.

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Figure 3:

Severity distribution–venous clinical severity score (before and after).

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Figure 4:

Venous clinical severity score outcome.

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Figure 5:

Doppler outcome.

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DISCUSSION

Out of 60 patients enlisted and selected for the study, 32 completed the study [Table 5]. Among these 32, 18 (56%) were men and 14 (44%) were women [Figure 1]. This is in accordance with a study from the UK wherein 60% or patients with varicose veins were men, although women more often present themselves for treatment.^[11]

Most patients had lesions in both legs. In our study, the right leg was affected in ten patients, the left in seven, and both legs were affected in 15 patients [Figure 2]. However, Shenoy reported a higher occurrence of left leg involvement.^[12] A research study by Joseph et al. states that veins on the left side were more involved than on the right.^[13]

The selection of Hamamelis as the choice of remedy is supported by mentions in homoeopathic literature. A recent study by Hooda and Tripathi on the role of homoeopathic remedies in varicose veins states that Hamamelis is an essential remedy for varicose veins and venous ulcers.^[14] Devi and Aathi also reported the use of Hamamelis ×3 every 3 hours when the veins are affected.^[15]

While surgery minimizes varicose veins, it is not a fool proof answer. Michaels et al. state that varicose veins may reoccur due to neovascularization, even after thorough surgery, or they may develop elsewhere in the leg.^[16]

The most likely reason for no improvements seen on the Doppler study was the short duration of treatment and short interval between successive scans.

CONCLUSION

From the present study, we can conclude that Hamamelis is an effective remedy for the treatment of varicose veins and its complications, based on the significant improvement in the VCSS after treatment. However, there was no change or improvement in the Doppler study reports, most likely due to the short duration of the study. In future, studies with larger patient groups and longer follow-up duration are required to produce more in-depth and useful data.