Journal of Alternative Complementary & Integrative Medicine Category: Medicine Type: Review Article

Selecting an Herbal Formulation that is Effective against Hyper-Sensitivity to Cold: A Retrospective Study over 12 Years

Tetsuya Isobe1*
1 International Oriental Medical Center, Kamishidami, Moriyama, Nagoya, Aichi, Japan

*Corresponding Author(s):
Tetsuya Isobe
International Oriental Medical Center, Kamishidami, Moriyama, Nagoya, Aichi, Japan
Email:iso12-7@blue.ocn.ne.jp

Received Date: Jan 18, 2025
Accepted Date: Jan 28, 2025
Published Date: Feb 04, 2025

Abstract

Background: Numerous studies have reported that “hyper-sensitivity to cold (HSC)” is alleviated by treatment with herbal formulations. In Japan, instant preparations known as Kampo extracts are widely used based on the cold symptoms. However, there is no established Kampo formulations most appropriated to use for various types of HSC. 

Subjects and Methods: Subjects were 757 female patients complaining of “HSC” who received herbal treatment using Kampo Extracts. The patient was asked about areas that were cold and the specific oriental examinations were performed. During the initial visit, the patient was prescribed the first formulation for 1 month. During a return visit a month later, the patient was asked mitigation level of her sensitivity to cold. If HSC was not mitigated at all, the herbal formulation was switched and the second formulation was prescribed. In this study, effectiveness of treatment was determined by asking patients about their level of satisfaction after taking the herbal formulation. Patients whose level of satisfaction with an herbal formulation prescribed was 60% or higher were deemed to be responders, and the percentage of responders was defined as the effective rate of the formulation. 

Results: Effective rate against coldness of the lower body was, in descending order, 76.5% for Keishi-bukuryo-gan > 72.1% for Hachimi-jio-gan > 68.2% for Gosha-jinki-gan > 61.5% for Toki -shakuyaku-san > 47.9% for Ryo-kyo-jutsu-kan-to. Effective rate against general coldness was, in descending order, 77.2% for Shimbu-to > 72.7% for Toki-shakuyaku-san. Effective rate against coldness of the ends of the extremities was, in descending order, 71.4% for Toki-shakuyaku-san > 69.8% for Toki-shigyaku-ka-goshuyu-shokyo-to > 60.0% for Shimbu-to. Effective rate against coldness of the toes was, in descending order, 70.0% for Toki-shakuyaku-san > 66.7% for Keishi-bukuryo-gan > 62.5% for Toki-shigyaku-ka-goshuyu-shokyo-to > 47.6 % for Ryo-kyo-jutsu-kan-to.

Conclusion: Based on the current results, the following formulations should be prescribed for HSC as a first choice. For coldness of the lower body, if there are signs of a “kidney deficiency,” Hachimi-jio-gan or Gosha-jinki-gan should be prescribed. If there are no signs of a “kidney deficiency,” Keishi-bukuryo-gan should be prescribed. For general coldness, Shimbu-to should be prescribed. For coldness of the ends of the extremities, Toki-shigyaku-ka-goshuyu-shokyo-to should be prescribed. For coldness of the toes, Keishi-bukuryo-gan should be prescribed. When above formulations were invalid, Toki-shakuyaku-san should be prescribed.

Keywords

Coldness; Herbal formulation; Kampo extract; Sensitivity to cold; Toki-shakuyaku-san

Introduction

Patients suffering from Hyper-Sensitivity to Cold (HSC) are often encountered in routine practice. In Japan, most patients who are seen for coldness are seen during the winter months, but many patients also come to the hospital in the summer complaining of coldness caused by air conditioning. There is no established definition for “HSC,” but Kampo medicine has put forward criteria for “HSC” [1-5]. Studies have reported that about 20% of men and 50-80% of women are “HSC,” and the complaint is common among women [6]. 

Aging, lack of exercise, lack of sleep, poor diet (a lack of vitamins, minerals, and iron), mental stress, pressure on the body from shoes or underwear, and an autonomic nervous system disorder (sympathetic hyperactivity) have been noted as causes of “HSC” [7,8]. In Oriental medicine, a “kidney deficiency” “blood stasis,” “water retention” and a “deficient constitution” are considered to be causes of “HSC.” It has been reported that some of the Japanese women with HSC have genetic factors [9]. 

Pathologies aggravated by “coldness” are a stiff neck, lower back pain, stomach pain, diarrhea, frequent urination, allergic rhinitis, and dysmenorrhea. Conditions triggered by “coldness” are frostbite, cystitis, connective tissue disorders, ischemic heart disease, the common cold, and influenza [10-13]. 

There is as of yet no established treatment for HSC in either Modern or Traditional medicine. Methods of preventing “HSC” include avoiding excessive intake of foods that cool the body, not wearing light clothing. It has been reported that mild cycle exercise mitigates HSC [14-16]. Treating “HSC” with modern medicine is difficult, and recommended lifestyle habits include actively consuming foods that warm the body, soaking in the bathtub instead of taking a shower, and regular moderate exercise. Numerous studies have reported that “HSC” is alleviated by treatment with herbal formulations [17-24]. In Japan, instant preparations known as Kampo extracts, in which large amounts of constituent herbs are decocted in advance and then dried and powdered, are widely used based on the cold symptoms [25,26]. However, there is no established Kampo formulations most appropriated to use for various types of HSC. Based on the author’s experience prescribing Kampo extracts to patients with “HSC” in routine practice, selecting the optimal Kampo extract for each patient is difficult. The aim of the current work is to determine how to select the optimal herbal formulation for each patient by compiling data on Kampo treatment using the dialectic, which is a method of diagnosis in Oriental medicine.

Subjects and Methods

Subjects were 757 female patients complaining of “HSC” who were seen by this Center’s Department of Oriental Medicine and who received herbal treatment using Kampo Extracts from TSUMURA. from May 2011 to March 2024. A breakdown of the affected area was general coldness in 101 patients, coldness of the ends of the extremities in 295, coldness of the lower body in 308 and coldness of toe in 53. Patients who did not stayed at end of the study were eliminated from the subject in this study. 

The patient was asked about areas that were cold and an examination of the tongue, the abdomen, and the pulse were performed. The examination of the tongue mainly checked for teeth indentations on the tongue (suggesting water retention) and sublingual vein distention or a purple tongue (suggesting “blood stasis”). The examination of the pulse checked for general term for various kinds of feeble and weak pulses (suggesting “deficient constitution”). The examination of the abdomen checked for para-umbilical tenderness and resistance and resistance and sharp tenderness in the left iliac region (suggesting “blood stasis”) or weakness of the lower abdominal region (suggesting a “kidney deficiency”) or feeble and weak pulse (suggesting a “cold constitution”). 

During the initial visit, the patient was prescribed the first formulation, which was 7.5 g of extract formulation a day in 3 packets taken throughout the day, for 1 month. During a return visit a month later, the patient was asked mitigation of her sensitivity to cold. If HSC was not mitigated at all, the herbal formulation was switched and the second formulation was prescribed. If HSC was still not sufficiently mitigated, the dose was increased to 10 g a day in 2 packets taken twice a day, and the patient was prescribed the formulation for 1 month. Similar procedures were followed during the subsequent visit. If a change was required, the patient was prescribed the third formulation in 2 packets taken 3 times a day. The patient was asked about the final effectiveness of the treatment and her level of satisfaction with the treatment. 

The specific Kampo formulation prescribed was based on findings from the examination of the tongue, the abdomen, and the pulse. 

Shimbu-to was selected as the first formulation to prescribe for general sensitivity to cold. If this was inefficacious, Toki-shakuyaku-san was prescribed as the second formulation. Toki-shigyaku-ka-goshuyu-shokyo-to was selected as the first formulation to prescribe for coldness of the ends of the extremities, and Toki-shakuyaku-san or Shimbu-to was prescribed as the second formulation. 

Shimbu-to was selected for a “deficiency and cold pattern.” If coldness of the lower body and weakness of the lower abdominal region were noted, Hachimi-jio-gan was selected as the first formulation to prescribe. If it was inefficacious, the formulation was switched to Gosha-jinki-gan. If weakness of the lower abdominal region was not noted, Ryo-kyo-jutsu-kan-to was selected as the first formulation to prescribe. If this was inefficacious, the formulation was switched to Keishi-bukuryo-gan or Toki-shakuyaku-san. If both “blood stasis” and “water retention” were noted, the formulation was switched to Keishi-bukuryo-gan; if those signs were absent, the formulation was switched to Toki-shakuyaku-san. Either Ryo-kyo-jutsu-kan-to or Toki-shigyaku-ka-goshuyu-shokyo-to was the first formulation prescribed for coldness of the toes, and Toki- shakuyaku-san was the second formulation prescribed. 

In this study, effectiveness of treatment was determined by asking patients about their level of satisfaction after taking the herbal formulation [27-29]. Patients whose level of satisfaction with an herbal formulation prescribed for HSC was 60% or higher were deemed to be responders, and the percentage of responders was defined as the effective rate of the formulation. The rationale for this definition is that patients were randomly selected to ask about their level of satisfaction once they finished taking the formulation, and at the same time, they rated their distressing symptoms on a 6-point scale ((1) disappeared, (2) mostly disappeared, (3) considerably alleviated, (4) alleviated, (5) slightly alleviated, and (6) signs of alleviation seemed to appear). The relationship between rated alleviation of symptoms and the level of satisfaction was examined, and results revealed a close correlation between alleviation of symptoms rated as (1)-(2) and a level of satisfaction of 90-100% at 85.9% (152/177) , alleviation of symptoms rated as (2)-(3) and a level of satisfaction of 80-90% at 83.2% (119/143), alleviation of symptoms rated as (3)- (4) and a level of satisfaction of 70-80% at 93.8% (75/80), alleviation of symptoms rated as  (4)(5) and a level of satisfaction of 60-70% at 89.9% (62/69), alleviation of symptoms rated as  (5)-(6) and a level of satisfaction of 50-60% at 85.7% (12/14). The average level of satisfaction among responders was defined as the efficacy of the formulation. 

Patient data were strictly managed at the facility with patients indicated by only their medical chart number so that individuals could not be identified. Verbal informed consent was obtained from the patients prior to conducting this study. This study began once it was approved by the ethical review board of this facility. There are no conflicts of interests in this study. 

The average ages of responders and non-responders to each formulation were statistically compared using a t-test with a significance level of .05.

Results

The efficacy and effective rate of each formulation in each cold area are shown in table 1. 

 

Coldness of the lower body

General coldness

 

 

Ryo-kyo-jutsu-kan-to

Toki-shakuyaku-san

Keishi-bukuryo-gan

Hachimi-jio-gan

Gosha-jinki-gan

Shimbu-to

Toki-shakuyaku-san

 

Effective rate

47.9% (41/86)

61.5% (16/26)

76.5% (26/34)

72.1% (101/140)

68.2% (15/22)

77.2% (71/92)

72.7% (8/11)

 
 

Efficacy

80.4

80.3

83.3

80.5

81.3

80.7

80.6

 

 

 

 

 

 

 

 

 

 

 

Coldness of the ends of the extremities

Coldness of the toes

 

 

Toki-shigyaku-ka-goshuyu-shokyo-to

Shimbu-to

Toki-shakuyaku-san

Ryo-kyo-jutsu-kan-to

Toki-shigyaku-ka-goshuyu-shokyo-to

Toki-shakuyaku-san

Keishi-bukuryo-gan

 

Effective rate

69.8% (169/242)

60.0% (15/25)

71.4% (20/28)

47.6% (10/21)

62.5% (10/16)

70.0% (7/10)

66.7% (4/6)

 
 

Efficacy

77.7

76.8

81.8

82.5

87.5

72.9

77.5

 

Table 1: Efficacy and effective rate by formulation for each area that was cold. 

Effective rate against coldness of the lower body was, in descending order, 76.5% for Keishi-bukuryo-gan > 72.1% for Hachimi-jio-gan > 68.2% for Gosha-jinki-gan > 61.5% for Toki -shakuyaku-san > 47.9% for Ryo-kyo-jutsu-kan-to. Efficacy against coldness of the lower body was, in descending order, 83.3 for Keishi-bukuryo-gan > 81.3 for Gosha-jinki-gan > 80.5 for Hachimi-jio-gan > 80.4 for Ryo-kyo-jutsu -kan-to > 80.3 for Toki-shakuyaku-san. 

Effective rate against general coldness was, in descending order, 77.2% for Shimbu-to > 72.7% for Toki-shakuyaku-san. Efficacy against general coldness was, in descending order, 80.6 for Shimbu-to > 80.5 for Toki- shakuyaku-san. 

Effective rate against coldness of the ends of the extremities was, in descending order, 71.4% for Toki-shakuyaku-san > 69.8% for Toki-shigyaku-ka-goshuyu-shokyo-to > 60.0% for Shimbu-to. Efficacy against coldness of the ends of the extremities was, in descending order, 81.8 for Toki-shakuyaku-san > 77.7 for Toki-shigyaku-ka-goshuyu-shokyo-to. > 76.8 for Shimbu-to. 

Effective rate against coldness of the toes was, in descending order, 70.0% for Toki-shakuyaku-san > 66.7% for Keishi-bukuryo-gan > 62.5% for Toki-shigyaku-ka-goshuyu-shokyo-to > 47.6 % for Ryo-kyo-jutsu-kan-to. Efficacy against coldness of the toes was, in descending order, 87.5 for Toki-shigyaku-ka-goshuyu-shokyo-to > 82.5 for Ryo-kyo-jutsu-kan-to > 77.5 for Keishi- bukuryo-gan > 72.9 Toki-shakuyaku-san. 

The incidence of signs of “water retention,” “blood stasis,” “kidney deficiency,” and “deficient constitution.” by efficacious formulation is shown in table 2. 

 

 

 

 

 

 

 

 

 

 

Coldness of the lower body

General coldness

 

 

Ryo-kyo-jutsu-kan-to

Toki-shakuyaku-san

Keishi-bukuryo-gan

Hachimi-jio-gan

Gosha-jinki-gan

Shimbu-to

Toki-shakuyaku-san

 

Water Retention

40.00%

50.00%

60.00%

42.60%

72.70%

40.00%

33.30%

 
 

Blood Stasis

36.70%

65.00%

83.30%

36.10%

29.10%

66.70%

50.00%

 
 

Kidney Deficiency

16.70%

0%

0%

60.00%

60.00%

25.00%

0%

 
 

Deficient Constitution

46.70%

41.70%

33.30%

44.40%

27.30%

40.00%

50.00%

 
 

 

 

 

 

 

 

 

 

 

 

 Coldness of the ends of the extremities

Coldness of the toes

 

 

Toki-shigyaku-ka-goshuyu-shokyo-to

Simbu-to

Toki-shakuyaku-san

Ryo-kyo-jutsu-kan-to

Toki-shigyaku-ka-goshuyu-shokyo-to

Toki-shakuyaku-san

Keishi-bukuryo-gan

 

Water Retention

42.60%

33.30%

87.50%

50.00%

20.00%

75.00%

33%

 
 

Blood Stasis

57.10%

56.00%

37.50%

50.00%

28.60%

25.00%

66.70%

 
 

Kidney Deficiency

0%

0.00%

0%

0%

0%

0%

0%

 
 

Deficient Constitution

62.30%

50.00%

25.00%

75.00%

40%

0%

0%

 
 

Table 2: The incidence of signs of “water retention,” “blood stasis,” “kidney deficiency,” and “deficient constitution.” by efficacious formulation. 

With coldness of the lower body, the incidence of signs of “water retention” was, in descending order, 72.7% for Gosha-jinki-gan > 60.0% for Keishi- bukuryo-gan > 50.0% for Toki-shakuyaku-san > 42.6% for Hachimi-jio-gan > 40.0% for Ryo-kyo-jutsu-kan-to. The incidence of signs of “blood stasis” was, in descending order, 83.3% for Keishi-bukuryo-gan > 65.0% for Toki-shakuyaku-san > 36.7% for Ryo-kyo-jutsu-kan-to > 36.1% for Hachimi-jio-gan > 29.1% for Gosha-jinki-gan. The incidence of signs of a “kidney deficiency” was, in descending order, 60.0% for Hachimi-jio-gan = 60.0% for Gosha-jinki-gan > 16.7% for Ryo-jutsu-kan-to > 0% for Toki-shakuyaku-san and Keishi-bukuryo-gan. The incidence of signs of “deficient constitution” was, in descending order, 46.7% for Ryo-kyo-jutsu-kan-to > 44.4% for Hachimi-jio-gan > 41.7% for Toki-shakuyaku-san > 33.3% Keishi-bukuryo-gan > 27.3% for Gosha-jinki-gan. 

With general coldness, the incidence of signs of “water retention” was, in descending order, 40.0% for Shimbu-to > 33.3% for Toki-shakuyaku-san. The incidence of signs of “blood stasis” was, in descending order, 66.7% for Shimbu-to > 50.0% for Toki-shakuyaku-san. The incidence of signs of a “kidney deficiency” was, in descending order, 25.0% for Shimbu-to > 0% for Toki-shakuyaku-san. The incidence of signs of “deficient constitution” was, in descending order, 50% for Toki-shakuyaku-san > 40% for Shimbu-to. 

With coldness of the ends of the extremities, the incidence of signs of “water retention” was, in descending order, 87.5% for Toki-shakuyaku-san > 42.6% for Toki-shigyaku-ka-goshuyu-shokyo-to > 33.3% for Shimbu-to. The incidence of signs of “blood stasis” was, in descending order, 57.1% for Toki-shigyaku-ka-goshuyu-shokyo-to > 56.0 for Shimbu-to > 37.5% for Toki-shakuyaku-san. The incidence of signs of a “kidney deficiency” was, in descending order, The incidence of signs of a “kidney deficiency” was 0% for all 3 formulations. The incidence of signs of “deficient constitution” was, in descending order, 62.3% for Toki-shigyaku-ka-goshuyu-shokyo-to > 50% Shimbu-to > 25% for Toki-shakuyaku-san. 

With coldness of the toes, the incidence of signs of “water retention” was, in descending order, 75.0% for Toki-shakuyaku-san > 50.0% for Ryo-kyo-jutsu -kan-to > 33.0% for Keishi-bukuryo-gan > 20.0% for Toki-shigyaku-ka-goshuyu-shokyo-to. The incidence of signs of “blood stasis” was, in descending order, 66.7% for Keishi-bukuryo-gan > 50.0% for Ryo-kyo-jutsu-kan-to > 28.6% for Toki-shigyaku-ka-goshuyu-shokyo-to > 25.0% for Toki-shakuyaku-san. The incidence of signs of a “kidney deficiency” was 0% for all 4 formulations. The incidence of signs of “deficient constitution” was, in descending order, 75% for Ryo-kyo-jutsu-kan-to > 40% for Toki-shigyaku-ka-goshuyu-shokyo-to > 0% for Keishi-bukuryo-gan = 0% for Toki-shakuyaku-san. 

A breakdown of the incidence of signs of “blood stasis” in responders in this study are “sublingual vein distention”: “para-umbilical tenderness and resistance”: “resistance and sharp tenderness in the left iliac region” was respectively 28.7%, 59.8, 11.5 % in proportion. 

The average ages of responders and non-responders by formulation are shown in table 3. There were no significant differences in the average ages of responders and non-responders for any of the formulations, regardless of the cold area affected. 

The number of Kampo extract’s package needed to be evaluated final effectiveness in the responders are also shown in table 3. If rounded off, 4 packages are indispensable for each formulation except for Toki-shakuyaku-san (5 packages) in General cold, Shimbu-to (5 packages) in Coldness of the ends of the extremities and Keishi-bukuryo-gan (3 packages) in Coldness of the toes. 

 

Coldness of the lower body

General coldness

 

Ryo-kyo-jutsu-kan-to

Toki-shakuyaku-san

Keishi-bukuryo-gan

Hachimi-jio-gan

Gosha-jinki-gan

Shimbu-to

Toki-shakuyaku-san

Mean ages of Responders

44.8

47.1

50

48.5

47.7

43.6

42.3

Mean ages of Non-responders

43.7

49.2

47.1

48.2

49.3

45.3

46

P value between ages

0.32

0.23

0.19

0.45

0.41

0.26

0.18

Mean No. of Extract's packes in Responders

3.8

4.4

3.6

3.8

4.2

3.9

5.3

 

 

 

 

 

 

 

 

 

Coldness of the ends of the extremities

Coldness of the toes

 

Toki-shigyaku-ka-goshuyu-shokyo-to

Shimbu-to

Toki-shakuyaku-san

Ryo-kyo-jutsu-kan-to

Toki-shigyaku-ka-goshuyu-shokyo-to

Toki-shakuyaku-san

Keishi-bukuryo-gan

Mean ages of Responders

41.8

39.6

41.1

43

41.3

45

39

Mean ages of Non-responders

42.1

44.1

39.5

40.7

35.8

51

53

P value between ages

0.42

0.23

0.41

0.31

0.16

0.07

0.15

Mean No. of Extract's packes in Responders

3.7

4.6

4.1

3.5

3.5

3.6

3.3

Table 3: Average age of responders and non-responders to each formulation. The number of Kampo extract’s package needed to be evaluated final effectiveness in the responders.

Discussion

A high level of efficacy (the level of satisfaction among responders) of about 80% was obtained with all of the formulations used for HSC except for Toki-shakuyaku-san (approximately 70%) for Coldness of the toes. 

As shown in table 1, the top 2 formulations with the highest effective rate against coldness of the lower body were Keishi-bukuryo-gan and Hachimi-jio-gan. Keishi-bukuryo-gan is a diuretic that alleviates “blood stasis” while Hachimi-jio-gan is a “kidney tonifying agent.” As shown in table 2, Keishi-bukuryo-gan resulted in the highest incidence of signs of “blood stasis” in case of no “kidney deficiency”, and Hachimi-jio-gan resulted in the highest incidence of signs of a “kidney deficiency,” so Hachimi-jio-gan should be the first formulation prescribed to patients with signs of a “kidney deficiency” and Keishi-bukuryo-gan should be the first formulation prescribed to patients with signs of “blood stasis”. Like Hachimi-jio-gan, Gosha-jinki-gan is also a “kidney tonifying agent.” As shown in table 2, Gosha-jinki-gan resulted in also the highest incidence of signs of a “kidney deficiency” and a higher incidence of signs of “water retention” than Hachimi-jio-gan, so Gosha-jinki-gan should be the formulation of choice over Hachimi-jio-gan when there are marked signs of “water retention” in addition to incidence of signs of “kidney deficiency.” 

As shown in table 2, Shimbu-to which was prescribed to a large number of patients was the formulation that was most efficacious against general coldness in effective rate, and have a highest incidence of both signs of “water retention” and “blood stasis.” So, Simbu-to should be the first formulation prescribed to patients with general coldness. 

Toki-shakuyaku-san was the formulation that was most efficacious against coldness of the ends of the extremities, but few patients were prescribed this formulation. Toki-shigyaku-ka-goshuyu-shokyo-to which was prescribed to a large number of patients has a highest incidence of signs of “blood stasis” and was the second most efficacious formulation in effective rate, so Toki-shigyaku-ka-goshuyu-shokyo-to should be the formulation of first choice under current circumstances. That said, Toki-shakuyaku-san resulted in the highest incidence of signs of “water retention,” as shown in table 2, and it far outpaced the other formulations, so Toki-shakuyaku-san should probably be the first formulation prescribed to patients with marked signs of “water retention.” 

All of the formulations used to treat coldness of the toes in the current study were prescribed to a small number of patients, so this condition should be examined further by increasing the number of patients receiving a given formulation. Nonetheless, under current circumstances effective rate was, in descending order, Keishi-bukuryo-gan > Toki-shigyaku-ka-goshuyu-shokyo-to > Toki-shakuyaku-san > Ryo-kyo-jutsu-kan-to, as shown in table 1. As shown in table 2, Toki-shakuyaku-san resulted in the highest incidence of signs of “water retention”, while Keishi-bukuryo-gan resulted in the highest incidence of signs of “blood stasis” Thus, prescribing Toki-shakuyaku-san to the patients with “water retention”, and Keishi-bukuryo-gan to the patients with “blood stasis” is presumably a safe approach under current circumstances. 

Ryo-kyo-jutsu-kan-to which was prescribed to a large number of patients with coldness of the lower body was not as efficacious as expected. However, in the various types of coldness except coldness of toe, this formulation resulted in the highest incidence of signs of “deficient constitution” as shown in table 2. 

Along with Toki-shakuyaku-san, Keishi-bukuryo-gan resulted in a high incidence of signs of “water retention” and a high incidence of signs of “blood stasis,” against coldness of the lower body as shown in table 2, so Keishi-bukuryo-gan can be prescribed in place of Toki-shakuyaku-san to patients with signs of both “water retention” and “blood stasis.” 

Whether the formulation selected is valid or not can be estimated in one month after taking 3 packets of Kampo extracts (in case of extracts from TSUMURA) per day. However, it was found in this study that 4 packets of extracts need to obtain sufficient therapeutic effect for HSC.

Conclusion

Based on the current results, the following formulations should be prescribed for HSC first or second depending on the area where coldness is felt. 

For coldness of the lower body, if there are signs of a “kidney deficiency,” Hachimi-jio-gan or Gosha-jinki-gan should be prescribed. In case that there are signs of both “kidney deficiency” and “water retention”, Gosha-jinki-gan should be prescribed. If there are no signs of a “kidney deficiency,” Keishi-bukuryo-gan should be prescribed. When above formulations were invalid, Toki-shakuyaku-san should be prescribed. 

For general coldness, Shimbu-to should be prescribed. When this formulation was invalid, Toki-shakuyaku-san should be prescribed. 

For coldness of the ends of the extremities, Toki-shigyaku-ka-goshuyu-shokyo-to should be prescribed. When this formulation was invalid, Toki-shakuyaku-san should be prescribed. 

For coldness of the toes, Keishi-bukuryo-gan should be prescribed to the patients with a sign of “blood stasis”, and Toki-shakuyaku-san should be prescribed to the patients with a sign of “water retention”. When both formulations were invalid, Ryo-kyo-jutsu-kan-to should be prescribed. 

Toki-shakuyaku-san can be the second formulation prescribed for all forms of coldness except those involving a “kidney deficiency,” so this formulation may be a panacea for “HSC.”

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Citation: Isobe T (2025) Selecting an Herbal Formulation that is Effective against Hyper-Sensitivity to Cold: A Retrospective Study over 12 Years. J Altern Complement Integr Med 11: 546.

Copyright: © 2025  Tetsuya Isobe, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


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