INTRODUCTION
Over the past decade our understanding of the pathogenesis as well as diagnosis and treatment for polycystic ovarian syndrome (PCOS) has improved dramatically, both in Western medicine and in TCM. While the quality of Western clinical studies has been high, and the research into causes and pathophysiology has burgeoned, treatment outcomes are still quite poor, specifically in terms of infertility. In addition, recent estimates of the incidence of PCOS is the community have doubled compared with those accepted only a few years ago, and they are only expected to increase over the coming years. (NHMRC, 2015)
Despite the overall low quality of evidence for Chinese herbal medicines (CHM) in the treatment of infertility in these women, the effectiveness of CHM for infertility from all causes (of which PCOS is a major component) is estimated to be around 2-fold compared with Western drug treatments. (Ried, 2015) However, at best this still means that less than half of women so affected can be helped. In light of these facts, clear and frank communication with patients is required, and a flexible approach that includes openness to all forms of treatment is most likely to provide the best chance of a successful outcome.
PCOS IN WESTERN MEDICINE
Polycystic ovarian syndrome (PCOS) may affect up to 21% of women of reproductive age, as it has been estimated that 70% of women so affected remain undiagnosed. (NHMRC, 2015) The disorder is characterised by ovulation dysfunction (oligo-ovulation or anovulation), androgen excess and multiple cysts on the ovaries. Clinical presentations vary considerably, and the presence of only two out of these three features is required for a diagnosis. PCOS is the most common cause of anovulatory infertility, and once pregnant, these women have higher risks of pregnancy-related diabetes and pregnancy complications. PCOS is also associated with peripheral insulin resistance and hyperinsulinemia. Such women are often obese, and this tends to exacerbate both of these abnormalities. In addition, elevated insulin levels may augment the action of gonadotropins on ovarian function as well as increase androgenicity through various pathways. (Lucidi & Casey, 2017; Rosenfield & Ehrmann, 2016; Pojas et al., 2014) Moreover, as POCOS is more prevalent in obese women, the rising rates of obesity in Western and Westernised cultures will likely cause a rise in the incidence and severity of PCOS over time. (NHMRC, 2015)
Pathophysiology
The precise mechanism for anovulation and elevated androgen levels is at present unknown, although they are hypothesised to be due to one or more of the following: altered luteinising hormone (LH) action, insulin resistance and a predisposition to hyperandrogenism. However, due to the heterogenous nature of this condition, it is very likely that the underlying pathophysiology may differ from one patient to another.
One of the proposed mechanisms leading to high androgen levels together with anovulation is the increased secretion of luteinizing hormone (LH) by the pituitary gland, together with normal to low levels of follicle stimulating hormone (FSH) and estradiol. The increased action of LH on the ovarian theca cells leads to an increased production of androgens. Because of the decreased level of follicle-stimulating hormone (FSH) relative to LH, the ovarian granulosa cells are unable to convert the androgens to estrogens (by the process of aromatisation), which leads to decreased estrogen levels and consequent anovulation, while the androgen levels remain elevated. (Lucidi & Casey, 2017)
It has been proposed that insulin resistance with concomitant elevated insulin levels, which may occur in both obese as well as lean patients, exacerbates hyperandrogenism by suppressing the synthesis of sex hormone–binding globulin and increasing the synthesis of androgens by both ovary and adrenals, thereby increasing androgen levels. The androgen excess then leads to irregular menses and the physical manifestations of hyperandrogenism, such as hirsutism. (Rosenfield & Ehrmann, 2016; Pojas et al., 2014)
Recent studies have highlighted the role of innate ovarian hyper-responsiveness to hormonal stimulation, termed functional ovarian hyperandrogenism (FOH), in the pathogenesis of PCOS. This appears to occur in most, but not all women with PCOS, who have elevated androgen levels, due to dysregulation of androgen secretion by the ovaries. (Rosenfield & Ehrmann, 2016)
Clinical presentation and diagnosis
Most, but not all, patients have a polycystic ovarian morphology, due to incomplete maturation of multiple follicles over time. This may be detected on ultrasound. Symptoms generally begin shortly after menarche and are slowly progressive. The main clinical features of PCOS are:
- Amenorrhea or oligomenorrhea due to anovulation (i.e. absent or irregular ovulation)
- Infertility (due to anovulation) or subfertility (due to intermittent ovulation)
- Hirsutism, acne and/or male pattern hair loss (due to hyperandrogenism)
- Obesity, diabetes or metabolic syndrome (due to insulin resistance)
- Obstructive sleep apnea
(Williams, Mortada, Porter, 2016; Lucidi & Casey, 2017)
PCOS is generally diagnosed according to the Rotterdam criteria, i.e. the presence of two of the following: androgen excess, ovulatory dysfunction, or polycystic ovaries; together with the exclusion of other diagnoses that could result in hyperandrogenism or ovulatory dysfunction. (Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group, 2004)
Treatment options
Lifestyle modifications (i.e. calorie restricted diet, exercise and weight loss) are considered first-line treatment. Weight loss alone has been shown to improve symptoms and enhance fertility. In women with persistent anovulation, hirsutism and menstrual irregularity, various pharmacological agents may be prescribed. First-line medical therapy usually consists of an oral contraceptive to induce regular menses. (Williams, et al., 2016; NHMRC, 2015)
As the major abnormality in PCOS is the failure of regular ovulation, and hence regular periods, patients are at risk of developing dysfunctional bleeding and endometrial hyperplasia due to unopposed estrogen exposure, and there is a 2.7-fold increased risk for developing endometrial cancer. In women who do not wish to become pregnant, oral contraceptives help to reduce the risk of endometrial hyperplasia and cancer, as well as reduce circulating androgens. (Dumesic & Lobo, 2013)
Treatment of infertility
If pregnancy is desired, treatments are aimed at inducing ovulation. As with the former group of women, weight control is a critical first step. Pharmaceutical interventions include either clomiphene or letrozole. Clomiphene triggers the pituitary gland to secrete an increased amount of FSH and LH, which stimulates the growth of the ovarian follicle and thus initiates ovulation. Letrozole is an aromatase inhibitor, which suppresses estrogen production, thus stimulating the pituitary to produce increased amounts of FSH and LH. Until quite recently metformin was believed to enhance fertility in these patients; however, a recent Cochrane review found that it does not. (Tang et al., 2012) This drug is now used to prevent the development of diabetes and cardiovascular disease by improving insulin sensitivity in patients not wanting to become pregnant. (Williams, et al, 2016; Lucidi & Casey, 2017) Around 45 – 50% of women treated pharmaceutically will resume ovulation within five or six cycles. However, full term pregnancy rates are low: up to19% with clomiphene; and up to 27.5% with letrozole. (Legro, et al., 2014) A more recent study comparing the two drugs, administered over a maximum of four cycles, found that these was no statistically significant difference between them (although the numbers favoured letrozole), with a full-term pregnancy rate of 20% in the letrozole group. (Ghahiri et al., 2016) If these are unsuccessful, administration of gonadotrophins or laparoscopic ovarian surgery may be offered as second-line therapy. (NHMRC, 2015; Williams, et al., 2016; Lucidi & Casey, 2017) In many cases the achievement of full-term pregnancy may require IVF. (Heijnen et al., 2006; Moll et al., 2007)
Clinical trial data vary widely in terms of efficacy at various stages. First-line pharmaceutical management (i.e. administration of one or more of clomiphene, letrozole or metformin) may give results in the following ranges:
- Ovulation rates: 62 – 82%
- Pregnancy rates: 9 – 58%
- Remaining pregnant after the first trimester: 65 – 71% (out of the women who became pregnant)
- Miscarriage rates: 1 – 23% (out of the women who became pregnant)
- Full term pregnancy: 19 – 27.5%
(Kar, 2013; Ghahiri et al., 2016)
The statistics provided in some of the studies can be quite bewildering, as the percentages given for the various outcomes do not always refer to the number of women who started off in a particular arm of the study. In addition, women who undergo Western medical treatment will be offered gonadotrophins, ovarian surgery and/or IVF if the initial treatment is unsuccessful, which will increase their overall chances of full-term pregnancy. To give a clearer picture of the likely outcomes for first-line pharmaceutical treatment alone, the most recent study cited above showed the following results in the group treated with letrozole (n = 50):
- Ovulation: 36 (= 72%)
- Pregnancy: 29 (= 58%)
- Pregnant after 3 months: 15 (= 30% of the total group of women taking letrazole and about 52% of women who became pregnant)
- Miscarriages: 5 (= 17% of the women who became pregnant)
- Full term pregnancy: 10 (= 20% of the total group)
(Ghahiri et al., 2016)
Pregnancy is accompanied by almost double the risk of complications (i.e. gestational diabetes, pregnancy-induced hypertension, pre-eclampsia, small for gestational age or large for gestational age, and pre-term delivery). However, there is no increased risk of neonatal complications compared to normal. (Sterling et al., 2016; Kollmann et al., 2015; Doherty et al., 2015; Kjerulff et al., 2011)
While younger patients who are not desiring pregnancy generally seek treatment for menstrual irregularity, hirsutism and acne, older patients seek treatment when they wish to conceive. Based on the limited data available, TCM treatments for achieving full-term pregnancy are likely to be at least as effective as Western pharmaceutical treatments, and a combined approach may provide the best outcomes. (Zhou et al, 2016)
PCOS in contemporary TCM
Although there are traditional gynecological disease categories, under which women with PCOS may have been included, i.e. absent periods, scanty periods, infertility, abdominal mass, (Maciocia, 1998, p.808) there is no diagnosis of PCOS in TCM. Therefore, attempts to diagnose and classify this disorder according to TCM fall within the domain of Integrative Medicine, as Western techniques are required for the disorder to be diagnosed. This then introduces a time-sensitive factor into our knowledge regarding a traditional approach to PCOS. Rather than acquiring expertise through a deeper understanding of the classical literature, we need to follow the development of empirical knowledge, through experimentation and the correlation of clinical experience, in much the same way as Western medicine advances its knowledge. The following review of various approaches to PCOS in the herbal medicine traditions of China, as well as Japan, illustrates this point, and we should be mindful that gynecology text books and other literature published 10 or more years ago will therefore contain a more rudimentary level of knowledge regarding PCOS than more recent publications.
Pathophysiology and approaches to treatment
The earlier literature discusses PCOS in terms of constitutional Kidney Yang deficiency as the sole underlying pathodynamic factor. Subsequent disruption to the metabolism of Fluids leads to the development of Phlegm-Damp, which manifests in the characteristic ovarian changes. In addition, the amenorrhea or oligomenorrhea may be explained in terms of Blood stasis. (Dharmananda, 1997; Yu, 1998, pp.59-61; Maciocia, 1998, pp.808-812) In a clinical trial conducted at the Shanghai Medical University Obstetrics and Gynecology Hospital, 133 patients with PCOS were treated with a formula to tonify the Kidney Yang, resolve Phlegm and invigorate the Blood (to dispel stasis). The outcome was that 82.7% of the women resumed ovulation, and of the 76 women who complained of infertility, 36 became pregnant (47%). (Yu, 1998)
Subsequent expositions on the pathogenesis and diagnosis of PCOS in TCM include Kidney Yin deficiency as a possible underlying factor. (Yu, 2001; Maciocia, 2004; Lewis, 2008) A study carried out by Dr. Ling Zijun at the Jiangxi Province No. 2 People’s Hospital, used the method of artificially regulating the menstrual cycle with four consecutive formulas, with a different one taken each week over the monthly cycle. The aims of the weekly treatments were as follows: first week – stimulating the follicles; second week – inducing ovulation; third week – stimulating the corpus luteum; fourth week – regulating the menses. This cycle was repeated for as many months as necessary (up to three years in one case) to obtain normal menstruation and fertility. Two different sets of four formulas were utilized in this study: one set to treat patients with Kidney Yang deficiency, and an alternative set for patients with Kidney Yin deficiency. According to Dr. Ling, 24 of the 27 women (over 88%) became pregnant. (Dharmananda, 1997).
In addition, Liver Fire that has developed from Liver constraint (generally from emotional strain), may be an important part of the pathogenesis, leading on the one hand to irregular or absent periods, and on the other to the development of cystic changes in the ovaries. (Yu, 2017; Dharmananda, 1997) Physicians at the Long Hua Hospital in Shanghai found that a large proportion of patients with PCOS manifested Liver Fire as the main syndrome pattern, and these women were treated with a variant of Long Dan Xie Gan Tang (Gentiana Formula). In this trial, 9 out of 21 women (i.e. over 42%) treated according to this method became pregnant. (Dharmananda, 1997)
A recent consensus document on the diagnosis and classification of PCOS in integrated traditional Chinese and Western medicine describes a triad of pathogenetic factors in PCOS: Kidney deficiency (either Kidney Yang deficiency or Kidney Yin deficiency), Phlegm and Blood stasis, with each having an exacerbating effect on the other two. The authors relate the various pathophysiological features (according to Western medicine) to these TCM patterns, proposing that patients with Kidney Yang deficiency are characterised mostly by hyperandrogenism, while patients with Kidney Yin deficiency tend to exhibit both hyperandrogenism and hyperinsulinemia. In addition, it is noted that Qi stagnation within the Liver that develops into Liver Fire may also be a contributing factor to the various pathological changes found in women with PCOS. (Yu et al., 2017)
Overall, there are various approaches to the application of herbal medicines in PCOS. On the one hand, a single herbal formula is prescribed, primarily addressing either Kidney Yang deficiency, Kidney Yin deficiency or Liver Fire – generally including herbal ingredients to resolve Phlegm, dispel Blood stasis and soften the mass. On the other hand, four different consecutive formulas may be prescribed in order to artificially regulate the menstrual cycle, and these are aimed at either warm-tonifying the Kidney Yang or nourishing the Kidney Yin, depending on the TCM diagnosis of the underlying pattern. The results appear to be up to around 80% in terms of promoting ovulation, and around 40 – 50% for pregnancy. The treatment period may need to be prolonged in some cases.
Japanese studies using the Western medical paradigm
A Japanese study involving 64 anovulatory women with PCOS demonstrated significant efficacy, in terms of improved endocrine status and ovulation induction, using the formula Wen Jing Tang (Danggui & Evodia Formula), regardless of the Kampo differential diagnosis. In this study, the women were diagnosed according to Kampo (i.e. eight-principle pattern identification) and given matched herbal preparations: either Dang Gui Shao Yao San (Dang Gui & Paeonia Formula) (n=43) or Gui Zhi Fu Ling Wan (Cinnamon & Hoelen Combination) (n=21). Out of these, 54 failed to ovulate after 8 weeks and there was no change in plasma LH levels. This group was selected to either continue with the same treatment as previously (n=27) or take Wen Jing Tang (WJT) (n=27). After 8 weeks, in women taking WJT, plasma LH levels decreased by around 50%, and plasma estradiol levels increased up to 50% (depending on the previous formula taken). The ovulation rate in the group taking WJT was significantly higher (59.3%) than in those with continued use of the same preparation (7.4%). (Ushiroyama et al., 2006).
Three Japanese studies on the effects of Shao Yao Gan Cao Tang (Peony & Licorice Combination) from the late 1980’s and early 1990’s, provided low-grade evidence that this formula may have an effect on lowering testosterone and increasing estradiol, possibly through increasing aromatase activity. In addition, administration of this formula was shown to reduce the LH/FSH ratio, most likely by its action on catecholamines. (Yaginuma et al., 1982; Takahashi et al., 1988; Takahshi & Kitai, 1994) However, the effects on both the surrogate outcomes (i.e. serum estradiol/testosterone ratio and LH/FSH ratio) and the real outcome, (i.e. full-term pregnancy) are rather weak compared to other herbal medicines or Western pharmaceutical treatments. (Kunihoko et al., 2011; Chen et al., 2010; Takahshi & Kitai, 1994) Furthermore, the Japanese variant of this formula, with equal amounts of licorice root and peony root, carries a significant risk of inducing hypokalemia and hypertension at normal dosage levels (Kinoshita et al., 2009), due to the effects of licorice root. (Walker & Edwards, 1994) This makes it a poor choice for use in women with PCOS, who have a higher than normal risk of hypertension in pregnancy. It is interesting to note that these preliminary studies have not been followed up with more rigorous clinical trials, and most of the subsequent research has been focused on the treatment of muscular spasms and associated pain. (Yumiko et al., 2016, Takao et al., 2016)
Pathogenesis and diagnosis
According to our current understanding of PCOS, there are four main pathodynamic factors:
- Kidney deficiency
- Phlegm-Damp
- Blood stasis
- Liver constraint, Qi stagnation with Heat or Fire.
When several of these factors are present, they may interact to perpetuate or exacerbate the condition. Thus, the variable manifestations of this disorder may be accounted for by the relative predominance of one or more of the above factors. For example, a woman diagnosed with PCOS who is lean and shows no marked ovarian changes on ultrasound would be deemed to manifest very little Phlegm-Damp. On the other hand, a patient with a florid complexion, facial acne, infrequent periods, severe PMS before menstruation, emotional volatility and a deep red tongue would be diagnosed with predominant Liver Fire.
As the goal of treatment is to manage the condition by providing symptom relief and to restore fertility, the practitioner needs to be able to discriminate the various syndrome-patterns and prescribe accordingly. Therefore, it is important to be able to link the key symptoms and signs with the corresponding TCM pattern.
Kidney deficiency refers to deficiency of the Kidney Essence, which directly impairs fertility. This may manifest in three ways: deficiency of the Kidney Yin, deficiency of the Kidney Yang, or deficiency of both the Kidney Yin and Yang (referred to simply as deficiency of the Kidney Essence).
Deficiency of the Kidney Yang manifests with signs of Cold and impaired Fluid metabolism, i.e. pale and swollen tongue with a moist coat; cold hands and feet, cold lower abdomen, and intolerance to cold temperatures. In addition, there may also be other more general signs of Kidney Yang deficiency, such as low back pain with a cold sensation, polyuria, nocturia, loss of libido, deep and slow pulse. These patients are more likely to exhibit hyperandrogenism and less likely to have hyperinsulinemia.
Kidney Yin deficiency manifests with signs of Heat and Dryness, i.e. red cheeks or malar flush; constipation; night sweating; hot sensations in the hands, feet and centre of chest, red tongue with a dry and scanty coat. Other signs of Kidney Yin deficiency include: low grade fever or tidal fever or afternoon fever; dry mouth and throat; thirst that is not alleviated by drinking; low back pain. These patients tend to have hyperinsulinemia as well as hyperandrogenism.
Kidney Essence deficiency may manifest with a mixture of signs of Kidney Yang deficiency and Kidney Yin deficiency with neither predominating.
Phlegm-Damp may arise from disordered Fluid metabolism due to Kidney deficiency. Other factors that may contribute include Spleen Qi deficiency and Liver Heat or Liver Fire. This manifests in obesity, cysts on the ovaries, a thick greasy tongue coat and a slippery pulse.
Blood stasis may arise from Kidney deficiency, retained Phlegm-Damp or Liver constraint. The main manifestations are amenorrhea, oligomenorrhea, menstrual blood with clots.
Liver constraint, Qi stagnation with Liver Fire, may arise due to prolonged emotional strain. Such patients are susceptible to anxiety, depression, irritability and anger, as well as premenstrual syndrome. Additional signs include thirst, constipation, headaches and a wiry pulse.
Commonly used formulas
As discussed above, there are various approaches to the treatment of this disorder, and a variety of formulas may be used to address the different TCM patterns that are detected.
Kidney Essence deficiency:
Kidney Yang deficiency:
- Zhuang Yang Yi Jing Wan (Epimedium & Ginseng Formula)
- Fu Gui Ba Wei Wan (Rehmannia Eight Formula) a.k.a. Rehmannia Eight Vitality Formula – with marked signs of Cold
Kidney Yin deficiency:
- Zuo Gui Wan (Left Returning Formula)
- Zhi Bai Ba Wei Wan (Anemarrhena, Phellodendron & Rehmannia Formula) a.k.a. Empty Heat Formula – with marked signs of Heat
Blood stasis with Phlegm-Damp:
- Nei Xiao Luo Li Wan (Prunella & Scrophularia Formula)
- Gui Zhi Fu Ling Wan (Cinnamon & Hoelen Combination) – for women with a delicate or weak constitution
Blood stasis:
Liver Heat or Liver Fire:
- Long Dan Xie Gan Tang (Gentiana Formula) a.k.a. Anti-Inflamm. Formula
- Yin Chen Hao Wan – Jia Wei (Artemisia & Rhubarb Combination) – with milder signs of Heat
Clinical protocols
The clinical syndrome patterns in PCOS may be classified as follows:
- Kidney deficiency with Phlegm-Damp and Blood stasis in the lower Jiao
- Liver Fire with Kidney Essence deficiency and Blood stasis
- Deficiency Cold of the Chong-Ren Channels with Blood stasis
By judiciously applying the formulas listed above, we can have a flexible approach that allows for individual variation as well as observed changes during the course of treatment. Thus, in patients with Kidney deficiency without any clear signs of Yin or Yang deficiency, the formula: Qi Bao Mei Ran Dan (Polygonum & Cuscuta Formula) a.k.a. Hair Growth Formula is the most suitable. In those with Kidney Yang and Essence deficiency the formula: Zhuang Yang Yi Jing Wan (Epimedium & Ginseng Formula) is appropriate. While patients exhibiting Kidney Yang deficiency with marked signs of Cold (e.g. sensitivity to the cold, cold hands and feet) together with disruption of Fluid metabolism (i.e. obesity, polyuria, nocturia, ankle oedema, etc.), would be prescribed the formula Fu Gui Ba Wei Wan (Rehmannia Eight Formula) a.k.a. Rehmannia Eight Vitality Formula.
Kidney Essence deficiency with Blood stasis in the lower Jiao
Key clinical features: Infertility, amenorrhea or irregular periods, no clear signs of Cold or Heat, deep and weak pulse.
P/T: Nourish the Kidney and enrich the Kidney Essence, activate the Blood and dispel stasis
Qi Bao Mei Ran Dan (Polygonum & Cuscuta Formula) a.k.a. Hair Growth Formula
plus
Tao Hong Si Wu Wan (Persica, Carthamus & Dang-gui Combination) a.k.a. Blood Moving 2 Formula
Kidney Yang deficiency with Phlegm-Damp and Blood stasis in the lower Jiao
Key clinical features: Pale and swollen tongue with a moist coat; other signs of Kidney Yang deficiency (e.g. low back pain with a cold sensation; intolerance of cold; the hands, feet and lower abdomen are cold to the touch; polyuria, nocturia; low libido, deep-slow-weak pulse).
P/T: Warm-tonify the Kidney Yang, resolve Phlegm and break up Blood stasis.
Formulas:
Zhuang Yang Yi Jing Wan (Epimedium & Ginseng Formula)
or
Fu Gui Ba Wei Wan (Rehmannia Eight Formula) a.k.a. Rehmannia Eight Vitality Formula – with marked signs of Cold
Plus
Nei Xiao Luo Li Wan (Prunella & Scrophularia Formula)
or
Gui Zhi Fu Ling Wan (Cinnamon & Hoelen Combination) – for women with a delicate or weak constitution.
Kidney Yin deficiency with Phlegm-Damp and Blood stasis in the lower Jiao
Key clinical features: Red tongue with a dry and scanty coat; other signs of Kidney Yin deficiency (e.g. flushed face or red cheeks or malar flush; low grade fever or tidal fever or afternoon fever; dry mouth and throat; thirst that is not alleviated by drinking; low back pain; night sweating; hot sensations in the hands, feet and centre of chest, rapid-thready pulse).
P/T: Nourish the Kidney Yin and clear deficiency Heat, resolve Phlegm and break up Blood stasis.
Formulas:
Zuo Gui Wan (Left Returning Formula)
or
Zhi Bai Ba Wei Wan (Anemarrhena, Phellodendron & Rehmannia Formula), a.k.a. Empty Heat Formula – with marked signs of Heat
Plus
Nei Xiao Luo Li Wan (Prunella & Scrophularia Formula)
or
Gui Zhi Fu Ling Wan (Cinnamon & Hoelen Combination) – for women with a delicate or weak constitution.
Liver Fire with Kidney Essence deficiency and Blood stasis
Key clinical features: Headaches; facial flushing; bitter taste in the mouth; conjunctival congestion; possibly excessive vaginal discharge; red tongue with a thick yellow coat; rapid-full pulse.
P/T: Drain Fire from the Live, clear Damp Heat, activate the Blood to dispel stasis, nourish the Kidney Essence.
Long Dan Xie Gan Tang (Gentiana Formula) a.k.a. Anti-Inflamm Formula
Plus
Nei Xiao Luo Li Wan (Prunella & Scrophularia Formula)
Plus
Qi Bao Mei Ran Dan (Polygonum & Cuscuta Formula) a.k.a. Hair Growth Formula
In patients with milder signs of Heat:
Yin Chen Hao Wan – Jia Wei (Artemisia & Rhubarb Combination)
Plus
Tao Hong Si Wu Wan (Persica, Carthamus & Dang-gui Combination) a.k.a. Blood Moving 2 Formula
Plus
Qi Bao Mei Ran Dan (Polygonum & Cuscuta Formula) a.k.a. Hair Growth Formula
Deficiency Cold of the Chong-Ren Channels with Blood stasis
Key clinical features: Cold lower abdomen with pain and distention, low grade tidal fever, dry mouth and lips, (possibly also: hot hands; dark or purple tongue; thready-choppy pulse).
P/T: Warm the uterus and dispel Cold, nourish and activate the Blood, dispel Blood stasis.
Wen Jing Tang (Danggui & Evodia Formula)
Plus
Tao Hong Si Wu Wan (Persica, Carthamus & Dang-gui Combination) a.k.a. Blood Moving 2 Formula
Protocols for acne and hirsutism
Acne:
Plus
Long Dan Xie Gan Tang (Gentiana Formula) a.k.a. Anti-Inflamm. Formula – with marked signs of Heat
or
Yin Chen Hao Wan – Jia Wei (Artemisia & Rhubarb Combination) – with milder signs of Heat
Hirsutism:
Tao Hong Si Wu Wan (Persica, Carthamus & Dang-gui Combination) a.k.a. Blood Moving 2 Formula
CONCLUDING REMARKS
In terms of the most important outcomes, i.e. full-term pregnancy and healthy delivery, the best available evidence suggests that TCM herbal treatment may be at least as effective as Western pharmaceutical management; and possibly up to twice as successful. (Ried, 2015) However, the TCM evidence is of poor quality, so we need to be cautious, as well as optimistic, in our discussions with patients. A recent systematic review on Chinese herbal medicines for sub-fertile women with PCOS was inconclusive, due to the low quality of the evidence available (Zhou et al, 2016), suggesting that Chinese herbal treatments may be no more successful than Western pharmaceutical treatments. However, it should be noted that all the various pharmacological interventions have significant down-sides (Ong et al., 2017; Williams, et al., 2016), unlike the herbal medicines that may be used for the same purposes. Moreover, there is a growing body of evidence validating the efficacy of Chinese herbs in correcting the various abnormalities associated with PCOS. ‘Current research demonstrates that the compounds isolated from herbs have shown beneficial effects for PCOS and when combined in an herbal formula can target both reproductive and metabolic defects simultaneously…. One advantage of herbal medicine, especially Chinese herbal medicine, is that multiple herbs are combined in a formula and can therefore have multiple targets while still remaining low risk with minimal side-effects.’ (Ong, et al., 2017)
Based on recent studies, the outcomes from Western pharmaceutical interventions have improved steadily over the past ten years, together with improved study design and reporting. However, translating this evidence into information that may be easily understood by patients is not always easy, both for the reasons discussed above, as well as the fact that the frequency rates (e.g. for ovulation or pregnancy) have quite a large margin of error (e.g. in studies with 50 or less women in each group, a difference in the order of 10% between pregnancy rates is not deemed to be statistically significant). Thus, it is not possible to provide precise figures for the expected results of treatment. Based on the most recent study cited above, (Ghahiri et al., 2016) we may tell our patients that Western pharmaceutical treatment, continued over four to six cycles, could be expected to give the following outcomes:
‘Your chances of resuming regular menstruation (with ovulation) are very good, up to around 70%.
If you begin having periods the chances of becoming pregnant are also very good, up to around 80%.
However, your chance of losing the pregnancy within the first trimester are quite high, almost 50%.
If your pregnancy continues past the first trimester, your chances of going to full term and giving birth are around two out of three.
Unfortunately, you are at greater risk of complications during pregnancy (e.g. diabetes, hypertension, pre-eclampsia) and labor (e.g. preterm birth, requirement for Caesarian section), which are almost twice that of women who do not have PCOS. However, the risks for your new born are no higher than normal.’
As already stated, based on best available evidence, treatment with TCM is likely to provide similar outcomes to pharmaceutical management, and most likely with fewer adverse effects. Therefore, a similar conversation to the one in the previous paragraph may be warranted, in discussing the option of TCM herbal treatments with your patient. Unfortunately, the TCM clinical studies (and summaries of such studies) available to date are still inadequate. While ovulation rates, which are generally high, along with pregnancy rates are generally given, full-term pregnancy rates are not reported. (Zhou et al, 2016) It is also possible that the risks to the mother during pregnancy and labor would be similar in women treated with TCM. Again, there is a complete lack of evidence in this regard. Thus, the services of an obstetrician are crucial, and the best course of action would be for the TCM practitioner to work together with the patient’s gynecologist and obstetrician, with all parties sharing information freely.
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