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Scoping Review

 

Anmerkung der Autorin:

Diese Arbeit wurde im Rahmen des MSc Studiums am NCA erstellt. Auf Grund der Methodik fehlen die in der Praxis angewandten individuellen Behandlungen sowie ergänzende Techniken der TCM.

Des weiteren erhebt diese Arbeit keinen Anspruch auf Vollständigkeit und stellt kein Heilungsversprechen dar.

 

‘What is the evidence for the effectiveness of acupuncture in the treatment of Polycystic Ovary Syndrome (PCOS) in women of reproductive age?’

Jessica Noll, Clinic for TCM, 10779 Berlin

Hp, FABORM, MSc Candidate

 

1. Introduction

Polycystic ovarian syndrome (PCOS) is a common endocrine disorder, related to irregular menstruation and increased androgenic hormones (El Hayek et al., 2016). According to the ‘International evidence-based guideline for the assessment and management of polycystic ovary syndrome 2018’ (Misso et al., 2018) its incidence is in 8-13% of women in reproductive age. Furthermore, this guideline describes psychological, reproductive and metabolic features for PCOS.

    1. Diagnostic criteria 

One common problem in the research of PCOS is the use of different definitions, due to a variety of phenotypes (Balen and Michelmore, 2002). The lack of a uniform definition is also from clinical significance. Depending on the speciality of the doctor, the diagnosis will be made. For instance, a gynaecologist might be more interested in the reproductive aspects of PCOS, while an endocrinologist concentrates on impaired glucose tolerance (IGT). Hence, discrepancy in definition may lead to different treatments (Cussons et al., 2005).

Initially described as ‘amenorrhea associated with bilateral polycystic ovaries’ by Stein and Leventhal in 1935, the diagnostic criteria (DC) were changed and updated various times. Hyperandrogenism and chronic anovulation were  included among the DC since the first conference of PCOS supported by the ‘National Institute of Health’ (NIH) in April 1990 (Azziz, 2006).

Because of the variety of symptoms, in 2003 the ‘Rotterdam Consensus Workshop’ (ROT) revised these criteria (Rotterdam, 2004). The scientists decided to broaden the criteria and included polycystic ovaries, diagnosed via ultrasound. Following the ROT, two out of three symptoms should appear. Hence, hyperandrogenism is not a deciding factor anymore.

Azziz (2006) questioned these criteria because it did not correspond with his observations.

In 2009 Azziz et al. drafted guidelines with the ‘Androgen Excess-PCOS-Society’ (AE-PCOS). The society pointed out the difficulty of providing a definition for a syndrome with different phenotypes and no uniform aetiology. As opposed to ROT, the AE-PCOS considers hyperandrogenism as diagnostic factor.

Table 1: DC (Azziz, 2006, Azziz et al., 2009; Rotterdam, 2004)

NIH

1990

ROT

2003

AE-PCOS

2009

Hyperandrogenism

Hyperandrogenism

Hyperandrogenism

Chronic anovulation

polycystic ovaries

Ovarian Dysfunction

An- or Oligo-Ovulation

 

1.2 Treatment recommendations

Recommendations for the treatment of PCOS depend on the presenting features of the disease as well as the desired result (pregnancy, balanced androgens, etc.). E.g., people with obesity and IGT should modify their lifestyle first and then metformin can be recommended. Fertility issues should be treated primarily with clomiphene citrate (CC), while hyperandrogenism can be improved with oral contraceptives (Leon and Mayrin, 2018).

1.3 Intervention: Acupuncture

The use of complementary and alternative medicine (CAM) in the British population is significant: a survey from Thomas and Coleman (2004) evaluated a 10 per cent use of CAM from British adults.

Traditional Chinese Medicine (TCM) as a medical system based on 2500 years of experience (Noll, 2010). Originally, acupuncture belonged to the field of TCM (Kaptchuk, 2002) and involves the insertion of a needle into the skin. Integration of acupuncture as a relatively safe treatment in conventional care is increasing (Witt et al., 2009), especially in gynaecology (Kang et al., 2011). Furthermore, a review by Franconi et al. (2011) provides evidence of the usefulness of acupuncture to treat  infertility due to PCOS.

Stimulation of the needle can be done manually or electrically with electro-acupuncture (EA). Johansson and Stener-Victorin (2013) have reported that an effect of acupuncture in PCOS is feasible because nervous pathways are activated.

1.4 Relevance for medicine

It is important to research PCOS, because the overhead costs for PCOS are tremendous and the quality of life of patients with PCOS is reduced (El Hayek, 2016). The associated morbidities, e.g. infertility, complications in pregnancy, IGT, cardiovascular disease, are huge in number and long-term (Fauser et al., 2012). With up to 70% undiagnosed women (Misso et al., 2018) and continuous amended guidelines, more information about PCOS is needed. Furthermore, only 2 systematic reviews (SRs) about acupuncture for PCOS are available via the COCHRANE Library. Both show limited evidence for the effectiveness of acupuncture in reproductive outcome (Jo et al., 2017) and ovulatory disorders (Lim et al., 2016).

Available SRs are commonly based on just one or two DCs (Jo, Lee and Lee, 2017; Luo et al., 2018). Recently, an SR was published by Jo, Lee and Lee (2017), only including Rotterdam criteria. Also, this SR evaluated research only until 2016. Due to the increasing importance of PCOS, a more up to date review would be appropriate. A broad search for the Medical Subheading (MeSh)-Term ‘ovarian syndrome, polycystic’ in PubMed, limited to 2017/01/01 – 2018/12/31 resulted in more than 1000 published papers (appendix 1).

1.5 Aims and objectives

In the context of the heterogeneity of the DC and the importance for actual research, this scoping review (ScR) aims to provide a broader and actual approach to evaluate the effectiveness of acupuncture for women suffering from PCOS. First, the quality of methodology will be assessed, second, the results will be presented in a narrative synthesis, and finally, a discussion about the findings and a conclusion with recommendations for further research will complete this review.

2. Methods

To answer the RQ in a suitable way, an ScR was conducted. ScRs evaluate the existing literature in a field of interest (Peters et al., 2015). The broader approach of an ScR compared to an SR (Malley, Arksey and O'Malle, 2005) is especially suitable for the different DC. In general ScRs do not concentrate on a stated RQ, nor do they assess the quality (Malley, Arksey and O'Malle, 2005). But the use of ScRs is rising, despite there being neither an existing definition nor a standardized process (Pham et al., 2014). Therefore, this review provides a broader definition of the DC and a less extensive search, while critically appraising the included studies.

2.1 Search strategy

As first step a limited search has been conducted. Three relevant databases addressing the clinical management have been selected:

  1. PubMed

PubMed is a freely-available database, providing a comprehensive overview about Medical Subheadings (MeSH)- and PCOS-related terms. Also, PubMed is generally accepted as an important database for biomedical literature (Madhavan ,n.d.) and is most often used by medical professionals (Greenhalgh, 2014); it is an appropriate database for an RQ in the medical field.

  1. Cochrane

The Cochrane Library is a freely-available collection of databases, covering

a wide range for the research of healthcare treatments (Chapman, 2009). The importance of the Cochrane Collaboration for CAM is increasing. Therefore, a topic list with categorizations of CAM has been developed for Cochrane reviews (Wieland, Manheimer and Berman, 2011).

  1. AMED

The  Allied and Complementary Medicine Database (AMED) is a database which is providing a classification of articles related to medicine into broad sub-groups, e.g. acupuncture or homeopathy. The aim of  AMED is to covers information, which is not provided by other databases (Roberts, 1995). ). For instance, a comprehensive SR from 2018 does not include AMED (Luo et al., 2018). Furthermore, the relevance of AMED for CAM is significant (Boehm et al., 2010

Through the Northern College of Acupuncture (NCA), access is available.

Multiple synonyms for PCOS have been used to search in the ‘title/ abstract’ field. Synonyms were identified through MeSH- terms, manual research in books and articles and discussions with experts. For instance, the disease is also referred as hyperandrogenic anovulation due to the symptoms associated with PCOS, also known as Stein-Leventhal-Syndrome.

In addition, MeSH-terms for a broader search have been implemented.

Finally, a time limitation for publishing was set for the 1st of April 1990, because of

the first NHI-sponsored conference for PCOS.

The full details of the search strategy are provided in appendix 1.

2.2 Study selection

To provide a framework, the PICO(S) (Population, Intervention, Comparator, Outcome, Study design) method was applied (table 2). PICO helps to concentrate on the research question and to be precise (Schardt et al., 2007). Designed for clinical studies, the PICO-Approach provides a step-by-step guide to limit the scope of a review (Springett and Campbell, 2006).

2.2.1 Population of interest

The population of interest consists of women in reproductive age, defined from the World Health Organisation (WHO) to be within 15-49 years of age. The menstruation cycle of teenage girls is variable and often prolonged (Hillard, 2016). Therefore, adolescents are excluded.

To provide extensive results, the ScR will include the DC of Rotterdam, NIH and AE-PCOS.

Studies, including other aetiologies of hyperandrogenism e.g. hypothyroidism or Cushing-syndrome are excluded.

2.1.2 Intervention

The intervention focused on in this ScR included acupuncture and its variations, such as EA and laser acupuncture (LA, Biomodulation).

EA was implemented in the search strategy as recommended by recognized authorities in the field of TCM (Lyttleton, 2013). Laser acupuncture is increasingly used to treat infertility (Abdel-Salam and Harith, 2015) and has already been analysed in some recent studies (El-Shamy, EL-Kholy and El-Rhaman, 2018).

Since there is little published on acupuncture as the only treatment for PCOS and the first line treatment for ovulation induction is CC (NICE, 2013), the combination of acupuncture and CC is included in this survey.

The use of TCM implies using Chinese herbs. Due to the individual nature of herbal prescriptions, an evaluation is very difficult and herbal medicine treatments are excluded in this ScR.

All other interventions e.g. changes in lifestyle are excluded, to concentrate more on the effectiveness of acupuncture.

2.1.3 Comparison

Reporting on acupuncture in research is complicated due to different styles or number of treatment sessions (MacPherson et al., 2010). The body might response different depending on various factors e.g., intensity and duration of stimulation.

For this reason, more comparators will be considered:

            1. Control-acupuncture: acupuncture-like placebo method

            2. Medication

            3. No treatment

2.1.4 Outcome

PCOS is a set of symptoms, ranging from menstrual disorders to long-term metabolic or cardiovascular complications, to name a few (Broekmans et al., 2006). The WHO categorized PCOS as a group II ovulation disorder (NICE, 2013). Furthermore, the most frequent reason for anovulatory infertility is PCOS (Koivunen et al., 2008). For that reason, this review concentrates on improvement of ovulation as outcome.

An appropriate measurement to measure ovulation is serum progesterone in the mid-luteal-phase, depending on the length of the individual cycle (Misso et al., 2018, NICE 2013). The basal body temperature is not reliable (NICE, 2013) and is excluded, as well as measurement of the luteinizing hormone (LH) peak, since PCOS often implies an excess of LH due to the pathophysiology (Rotterdam, 2004; Kumar and Sait, 2011).

2.1.5 Study design

Quantitative research with experimental study design is an appropriate method to test the effect of an intervention (Shadish, Cook and Campbell, 2002) and to find out about causality between two actions (Celano, 2014).

Moreover, randomized controlled trails (RCTs) are the gold-standard for health research (Jadad, 2004).

Given that acupuncture is a part of CAM in all its complexity, rigorous RCTs are difficult to assess (Baxter et al., 2008) and quasi-experimental studies are therefore also included in this ScR.

Table 2: PICOS

Population of interest

 

Women in reproductive age diagnosed with PCOS

Intervention

Acupuncture

EA

LA

Comparator

Control-acupuncture

Standard care

No treatment

Outcomes of interest

Improvement of ovulation, measured with serum progesterone level

Study design

RCT, quasi-experimental studies

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