Safety of SinEcch™ Demonstrated in 3-Year Clinical Study

SinEcch™ was used in a 3-year Post Marketing Surveillance (PMS) Study in South Korea, which was required for SinEcch™ to receive permanent approval by the South Korean FDA. The purpose of this study was to establish the safety and efficacy of SinEcch™.1

Many variables within the patient population had to be taken into consideration when assessing the possibility of adverse effects from using SinEcch™: 650 patients were involved in this study over the course of the 3-year period – 410 were women and 240 were men. The age range of these patients was 15 to over 65 years. 57 kinds of surgery were performed in 19 institutions including university hospitals, general hospitals, and plastic surgery clinics. 62% of the patients took concomitant medications.

All adverse effects observed during the Study were recorded regardless of whether they could be associated with SinEcch™ or not, including those that may have occurred after the SinEcch™ dosing regimen had been completed.

The PMS Report states, “Statistical analysis method of Chi-square test or Fisher’s Exact test was used. The analysis item was adjusted according to the contents of survey material and survey condition, and presence of statistical significance. In order to surmise factors that affect adverse event expression rate, logistic regression analysis was performed, and other surveying items were analyzed using suitable statistical methods. During final report, all of the adverse events investigated during re-examination period were analyzed and 95% confidence interval was proposed” (p. 16).

After taking all factors into consideration and analyzing the results, no adverse effects were attributed to SinEcch™ (Table 11), demonstrating that SinEcch™ is safe as well as effective to use for recovering from surgery.


1 SINECCH Capsule PMS (Post Marketing Surveillance) Report, WooilPharm Co., Ltd., Seoul, Rep. of South Korea, June 14, 2013

SinEcch™ Now Has Four Clinical Studies in Post-Surgical Recovery!

SinEcch™ is statistically significant in the reduction of post-operative swelling and bruising following rhinoplasty and liposuction, and in the reduction of bruising following facelift. These results have been proven in four clinical research studies:

  • Through a Post Marketing Surveillance Study in South Korea, SinEcch™ was found to be safe and effective in 100% of patients.
  • In a rhinoplasty study conducted at Case Western Reserve University, SinEcch™ compared favorably to steroids in the reduction of post-surgical swelling and bruising.
  • In a UCSF double-blind, placebo controlled, random assignment, prospective, institution review board (IRB) approved study, SinEcch™ demonstrated greater reductions in post-operative bruising following facelift with statistically significant results.
  • In a double-blind, placebo controlled, random assignment, prospective, institution review board (IRB) approved lateral thigh liposuction study, SinEcch™ demonstrated statistically significant reductions of post-operative bruising and swelling compared to placebo.

SinEcch™’s unique dosing program distinguishes itself as THE homeopathic Arnica regimen for promoting post-operative recovery.

Please read about our four clinical studies below.

Safety and Efficacy of SinEcch™ in a 3-year Post Marketing Surveillance Study

To evaluate its safety and efficacy in reducing bruising and swelling after plastic surgery, SinEcch™ underwent a 3-year Post Marketing Surveillance (PMS) Study conducted by WooilPharm in South Korea from April 2010 to December 2012 – a requirement for receiving permanent approval as a prescription drug in South Korea.

The PMS Study determined that SinEcch™ is “a very effective drug for reducing bruising and swelling” with no reported cases of side effects.1 Based on these results, the Korean FDA concluded that SinEcch™ is safe and effective for reducing post-operative bruising and swelling following plastic surgery.

PMS Study Methods Summary

Purpose: Evaluate the safety and effectiveness of SinEcch™ as a post-op medication to reduce bruising and swelling following plastic surgery.

Research Institutions: The Study was conducted in 19 health care institutions including university hospitals, general hospitals, and plastic surgery clinics.

Survey Population: 650 plastic surgery patients were involved. The patient population included men and women whose ages ranged from 15 to over 65 years. 57 kinds of surgeries were performed. 62% of the patients took concomitant medications; of these, 28% used antibiotics and 19% used anti-inflammatory analgesics.

PMS Report Summary

Within 8 days following the surgical procedure, a comprehensive evaluation ranked each patient’s bruising and swelling as being either “improved,” “unchanged,” or “aggravated.” The PMS Study found that 100% of the 650 patients saw improvement in their swelling and bruising after using SinEcch™ (Tables 8-10). 75% saw very good or excellent improvement with their bruising, with 32% having no bruising (Table 8). 72% saw very good or excellent improvement with their swelling, with 18% having no swelling (Table 9). No adverse effects were reported.


1 SINECCH Capsule PMS (Post Marketing Surveillance) Report, WooilPharm Co., Ltd., Seoul, Rep. of South Korea, June 14, 2013

When assessing the role of concomitant medications in the recovery progress, the p-values indicating the effectiveness of SinEcch™ for reducing bruising and swelling were 0.002 and 0.028 respectively (Tables 16 and 17).

Conclusion

SinEcch™ was found to be both safe and effective by the Korean FDA to reduce post-surgical bruising and swelling, as all patients saw improvement and over 72% saw very good or excellent results. Regardless of whether concomitant medications were used or not, SinEcch™ was shown to be statistically significant in the reduction of bruising and swelling.

SinEcch™ Compared to Steroids Following Rhinoplasty

A Clinical Research Study at Case Western Reserve University compared SinEcch™ to steroids and a control group in the reduction of swelling and bruising following rhinoplasty.1

In this institution review board2 approved, prospective, clinical trial, 48 patients, whose ages ranged from 15 to 65 years, underwent first time nose surgery using the surgical technique of cutting the nasal bone in the performance of nasal surgery. These patients were randomized into three groups:

  • Group A = SINECCH GROUP. The SinEcch™ Group took SinEcch™ three times a day for 4 days
  • Group P = STEROID GROUP. The Steroid Group received 10 mg of dexamethasone administered intravenously during the operation. After the operation, the regimen was changed to a 6-day oral tapering dose of methylprednisone
  • Group C = CONTROL GROUP. The Control Group received neither SinEcch™ nor steroids

For comparison, digital photos were taken on post-op day 2 and day 8. Three impartial plastic surgeons were blinded to the nature of the study treatment and were asked to rate:

  1. The total area of bruising (scale of 0-5)
  2. The intensity of bruising (scale of 0-4)
  3. The severity of swelling (scale of 0-3)

Each of these three aspects were to be observed and rated on post-operative days 2 and 8.


1 “A Randomized, Controlled Comparison between Arnica and Steroids in the Management of Postrhinoplasty Ecchymosis and Edema”, Ali Totonchi, M.D., Bahman Guyuron, M.D., Plastic and Reconstructive Surgery, Volume 120, Number 1, July 2007, pgs. 271-274. “Disclosure: The authors have no financial interest or commercial affiliation with any product, device, or drug mentioned in this article” p. 274.
2 The institutional review board serves as an objective third party and an oversight committee, governed by Federal Regulations with the purpose of protecting and managing risk to human participants involved in research. This is to ensure that only ethical and scientifically valid research is conducted.

Study Results

SinEcch™ performed favorably compared to steroids for reducing swelling. On post-op day 2, both the SinEcch™ group and the steroid group were highly statistically significant with less swelling than the control group (p<0.0001).3

On post-op day 8, SinEcch™ had a significantly smaller area of bruising and a lower intensity of bruising than both steroids and the control group (Table 2). SinEcch™’s rating for the area of bruising was 1.42, compared to 2.17 for the control group and 2.73 for the steroid group (p<0.05). Likewise, SinEcch™ scored a 0.92 for the intensity of bruising, while the control group received a 1.02 and the steroid group a 1.85 (p<0.01).4

Conclusion

Both the SinEcch™ group and the steroid group were highly statistically significant in reducing post-operative swelling compared to the control group. In addition, SinEcch™ achieved significantly better results compared to steroids and the control group for reducing bruising following rhinoplasty.


3 The probability of this result happening by chance (the p-value) was analyzed and found to be less than 0.0001 — that is, it was less than 1 chance in 10,000. It is extremely unlikely that this result was simply by chance.
4 The probability of these results happening by chance (the p-value) was analyzed. For the area of bruising, the probability that improvement was by chance was less than 0.05 — that is, it was less than 5 chances in 100. For the intensity of bruising, the probability that improvement was by chance was less than 0.01, or less than 1 chance in 100. It is highly unlikely that these results were simply by chance.
Clinical Research Study of SinEcchTM in the Reduction of Bruising After Facelift

In an institutional review board-approved,1 randomized, prospective, double-blind, placebo-controlled trial conducted by Drs. Maas, Seeley, Denton and Ahn through the University of California, San Francisco, SinEcch™ was compared to placebo for the reduction of bruising following facelift.2 This study had two main goals:

1. The researchers sought to develop an objective method of quantifying the amount of post-operative bruising. They employed the use of Adobe Photoshop to objectively measure the coloring and area of the patients’ bruising following surgery. Because the analysis is based on fixed color spectrums and area measurements, all subjectivity is removed.

2. The researchers used this objective method to quantify the degree of bruising of post-operative facelift in patients given either homeopathic Arnica montana in the SinEcch™ protocol, or placebo, thereby being able to conclude whether Arnica is effective in reducing bruising.

Dr. Corey Maas and his Fellows performed all surgeries; the same surgical procedure was used for all patients. The patients were women with an average age of 58 years. Photos were taken on post-op days 1, 5, 7, and 10. An analysis of the color and areas of the patients’ bruising on each of these four days was conducted.

Results

Over the course of the ten post-op days, the SinEcch™ group consistently had less bruising than placebo, especially on days 1 and 7 with the placebo group having, respectively, 27% and 41% more bruising (Table 2). Placebo required 50% more time to achieve the same rate of healing as SinEcch™ (on day 9, placebo had the same degree of healing as SinEcch™ did on day 6 (Figure 6)). Overall, the placebo group had 25% more bruising than the SinEcch™ group.

The results were highly statistically significant for post-op day 1 (p=0.005) and day 7 (p<0.001).3

Conclusion

SinEcch™ was conclusively shown to reduce bruising better than placebo following facelift, as it resulted in less bruising throughout the 10 day recovery period, with highly statistically significant differences on days 1 and 7. Overall, placebo had 25% more bruising than SinEcch™, with a dramatic 41% more bruising than SinEcch™ on day 7.


1 The institutional review board serves as an objective third party and an oversight committee, governed by Federal Regulations with the purpose of protecting and managing risk to human participants involved in research. This is to ensure that only ethical and scientifically valid research is conducted.
2 “Effect of Homeopathic Arnica montana on Bruising in Face-Lifts,” by Brook M. Seeley, M.D., et al., Archives of Facial Plastic Surgery, vol. 8, Jan./Feb. 2006, pages 54–59. “Funding/Support: This study was supported in part by a research grant from Alpine Pharmaceuticals, makers of SINECCH” p. 59.
3 The probability of these results happening by chance (the p-value) was analyzed. The probability that the amount of improvement seen on post-op day 1 was by chance was 0.005 — that is, it was 5 chances out of 1,000. The probability that the amount of improvement seen on post-op day 7 was by chance was less than 0.001, or less than 1 chance in 1,000. It is highly unlikely that these results were simply by chance.
Clinical Research Study of SinEcchTM in the Reduction of Bruising and Swelling After Liposuction

Dr. Michael Kulick of San Francisco presented his institutional review board-approved,1 randomized, prospective, double-blind, placebo-controlled trial of SinEcch™ at the Research and Innovative Technology Scientific Session of the American Society of Aesthetic Plastic Surgery (ASAPS) meeting in Las Vegas, April 29, 2002.2

The goal of this study was to determine if positive claims made about Arnica montana would stand up to the demands of a true research study. This lateral thigh liposuction study included 29 women whose ages ranged from 18 to 45 years. Dr. Kulick performed all 29 lateral thigh liposuction surgeries himself.

There was no statistically significant difference in the volume of fat removed (p>0.36). The patients receiving SinEcch™ were younger than the treatment group (mean age 32.6 vs. 37.9) (p<0.02). This age difference was accounted for in the statistical analysis that included a linear mixed-effects model to include treatment group, post-treatment week, and the interaction of the treatment group, time, and patient age. For comparison and evaluation, Dr. Kulick took photographs of the patients from the front, rear, left side, and right side at post-op weeks 1-4.

Dr. Kulick and four other plastic surgeons with experience in liposuction ranked the 29 patients' photo sets from most to least bruising/swelling for post-op weeks 1-4. In addition, the patients were asked to evaluate their bruising and swelling over the first 30 days following surgery using a visual analogue scale (VAS). An independent, blinded statistician performed the analysis of the physicians’ ratings and the patients’ VAS results.

Results

The evaluation by all five surgeons showed greater improvement from SinEcch™ compared to placebo. Data from three of the plastic surgeons showed statistically significant differences in favor of SinEcch™ for reducing bruising and swelling (p<0.006, p<0.003 and p<0.0001).3 The results of the patients’ VAS also showed greater improvement from using SinEcch™ compared to placebo (p<0.02).4

Conclusion

Evaluations made by three surgeons and by the patients showed highly statistically significant differences between SinEcch™ and placebo, with SinEcch™ being definitively better for reducing bruising and swelling following liposuction.


1 The institutional review board serves as an objective third party and an oversight committee, governed by Federal Regulations with the purpose of protecting and managing risk to human participants involved in research. This is to ensure that only ethical and scientifically valid research is conducted.
2 Printed in the Abstract Book of the ASAPS Conference, pages 17–18: "Arnica Montana, Role in Reducing Bruising and Swelling: Fact or Fiction?" Only material presented at Dr. Kulick's talk is reproduced here. The evaluating surgeons have no financial interest in the company that provided the medication (Alpine Pharmaceuticals). Support included patient reimbursement for their recruitment/participation, recruitment of the surgeon evaluators and statistical analysis.
3 The probability of these results happening by chance (the p-value) was analyzed. The probability that the amount of improvement seen by week four was by chance was less than 0.006, 0.003 and 0.0001. That is, it was less than 6 chances in 1,000, less than 3 chances in 1,000, and less than 1 chance in 10,000, respectively. It is extremely unlikely that these results were simply by chance.
4 The probability of these results happening by chance (the p-value) was analyzed and found to be less than 0.02, that is, less than 2 chances in 100. It is very unlikely that these results were simply by chance.