Identifying Best Practice Diagnosis & Management ofMale Infertility in AyurvedaProgramme:                  MSc Ayurvedic M...
AcknowledgementsThis paper acknowledges the support, guidance, and encouragement of the followingpeople.The study would no...
AbstractThis study explored the contemporary ayurvedic treatment of male infertility to identifybest practice diagnosis an...
Table of Contents1     INTRODUCTION & STUDY AIMS ..................................................................... 12 ...
Table of FiguresTable   1 - Aetiology and Distribution (%) of Male Infertility ....................................... 5Ta...
1   Introduction & Study AimsMale infertility is becoming a major concern both in developed and developing countries.In Eu...
A new student of ayurveda must rely solely on acquired clinical experience andobservational learning of successful treatme...
2     Literature Review2.1    What is the problem?What is the prevalence of male sub fertility in the world today?Infertil...
developed and developing countries, and there are few treatment options available asthe cause is largely unknown.2.2   Wha...
Mouzon and         Nygren,   2006).   However, ICSI does    not address    the underlyingpathophysiology behind either mal...
Little is known about the pathophysiology of idiopathic male infertility as theintroduction of ICSI removed any incentive ...
Whilst varicocele is seen in 12% of sub fertile patients it is also observed in men whohave no fertility problems, and as ...
Based on this body of knowledge, antioxidant supplementation is being investigated asone rational therapy. In this respect...
Seminal MorbiditiesCaraka defines the primary cause for impotency as resulting from seminal morbidities.He indicates that ...
These various types of derangement are classified as 8 types of seminal morbiditiesidentified in table 2:Table 2 - 8 Types...
Clearly both these classical descriptions can encompass the various known pathologiesassociated with male infertility such...
Fertility depends on more than semen produced in the testes. It also depends on thecirculating gonadotropic (luteinising a...
In this respect, Suśruta indicates shodana is applied to seminal disorders according tothe specific doshic involvement. Th...
o   Śukra pravartana (increasing flow) refers to increasing the fluidity and volume of    semen. It is the coordinating fu...
The śukra śodana group indicated for sperm purification is listed in table 4:Table 4 - Caraka Śukra Śodana Herbs - Sperm P...
Sanskrit                     Latin                           Common Name                         Name                     ...
Table 9 - Suśruta Vallī Pañcamūla Herbs - Seminal Disorders Sanskrit                     Latin                           C...
So how do the herb recommendations of Caraka and Suśruta compare?The same herbs are represented by both classical authors ...
What do the remaining classical authors, Aṣṭāñga, Mādhava Nidānam, andBhāvaprakāśā contribute?The remaining classical auth...
there is so much natural variation in semen parameters over time.        Nor would theseclinical trials be known to be ind...
Withania somnifera was found to directly increase spermatogenesis in immature rats byexerting a testosterone like effect w...
Hygrophila auriculata indicated for both sperm production and purification has beenshown to have potent antioxidant potent...
explain its therapeutic effect (Tilak, Adhikari and Devasagayam, 2004). A further animalstudy has shown its ability to red...
defence (Bhatnagar et al., 2005). It has also shown significant ability to reduced serumcholesterol, triglycerides, LDL (l...
Nardostachys jatamansi has been clinically employed for its anti-ischemic, antioxidant,anticonvulsant, and neuroprotective...
total number of normal-motile sperm cells among the different BMI groups. Menpresenting with a BMI greater than 25 have fe...
measure patient outcomes would exceed time constraints. Sadly there is little ayurvedicresearch literature published in ac...
Recognising these limitations, this research approach was employed to qualitativelyinvestigate case histories regarding pa...
treatment rather than desired protocol. Patient records were then identified as having atleast 3 semen samples over a mini...
The first phase involved the transcribing and codifying of both data sets. The datacodification involved some data transfo...
erythrocytes, epithelial cells, micro-organisms, sperm agglutination, concentration,count, motility and morphology. Data f...
3.5 Data AnalysisThe primary aim of this research was to drive out what constituted best practiceayurvedic diagnosis and t...
Prior to conducting the interview, an extensive review of the classical literature forpharmacopoeia associated semen quali...
Sample distribution was investigated using the one sample Kolmogorov-Smirnov testand changes between baseline and post-tre...
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Identifying Best Practice Diagnosis & Management of Male Infertility in Ayurveda
Programme: MSc Ayurvedic Medicine Module: MSc Dissertation
Chris Gribble BSc. PG Dip Ayurveda

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  1. 1. Identifying Best Practice Diagnosis & Management ofMale Infertility in AyurvedaProgramme: MSc Ayurvedic MedicineModule: MSc Dissertation IPH4095Student Name: Chris Gribble BSc. PG Dip AyurvedaStudent Number: M00047552Supervisor: Dr Joshi M.D. Ph.D. (Ayurveda)Submission Date: Friday 4th May, 2007Abbreviations (Citations – Classical Authors)Classical Authors Book SectionsAH Aṣṭāñga hrdayam Ci cikitsasthanaBP Bhāvaprakāśā Ni nidanasthanaCS Caraka saṁhitā Su sutrasthanaSH Suśruta saṁhitā Uk uttara khaṇḍaSS Sārṇgadhara saṁhitāReference ExamplesCS Ci 2/4:5-6Refers to Caraka saṁhitā, cikitsasthana, 2nd chapter, 4th quarter: verses 5-6CS Su 17:63-72Refers to Caraka saṁhitā, sutrasthana, 17th chapter: verses 63-72© Chris St. Clair Gribble
  2. 2. AcknowledgementsThis paper acknowledges the support, guidance, and encouragement of the followingpeople.The study would not have been possible without the generosity of Dr. B. S Prasad whoallowed me to investigate the treatment of his patients, and was willing to share hisexpertise in such an open, honest and inspiring fashion.Thanks also to the Director of SDM College of Ayurveda & Teaching Hospital, DrPrasanna Rao, who allowed the study to take place, and ensured I got the support Ineeded. Thanks also to all the staff and interns at SDM College of Ayurveda & TeachingHospital, who assisted me in collecting and interpreting the case history data.And big thank you to my dear friends, Alison Packer, who provided me with a conduciveenvironment to write up the thesis and the sustenance to keep me going, and DeniseNaniche who provided me advice on statistical analysis.And finally a very big thank you to Dr Joshi, my academic supervisor, who has providedme continual support and encouragement in the pursuit of my ayurvedic studies.© Chris St. Clair Gribble
  3. 3. AbstractThis study explored the contemporary ayurvedic treatment of male infertility to identifybest practice diagnosis and a preferred list of medications. It also investigatedalternative treatment options for pathologies associated with male infertility. This workprovides newly qualified ayurvedic professionals a contemporary practice guideline toexplore in their own clinics, and makes recommendations for the research communitywith respect to exploring the effectiveness of the treatment strategies explored.The approach employed a retrospective case series analysis of 31 cases for patientstreated by a recognised expert. Qualitative analysis identified 46 preferred medicinescategorized against ayurvedic semen quality parameters which appear to havediagnostic value. Reference values are provided to enable their derivation fromallopathic semen data. The qualitative analysis has also identified ayurvedic options forvaricocele (grades 1-3). A further 6 herbs have been identified that warrantinvestigation, and this investigation recommends that future effectiveness studiesinclude radical purification therapies to identify the most beneficial treatment approach.The quantitative analysis of patient outcomes suggests that the treatment strategiesused improved semen quality of the patients. The sample population showed astatistically significant improvement in sperm count (P=0.025, 24.8%) and motility(P=0.002, 134.5%), but a non-significant improvement in morphology (P=0.248,17.0%). In relation to individual cases, this represented attainment of normal values for14.3% of cases, and an improvement in a further 42.9%.This study has not been able to investigate idiopathic male infertility or demonstrate theeffectiveness of the preferred medicines against their identified pathologies. This was aretrospective study constrained by its methodology, the available data, and a smallsample size. However, the evidence does suggest a positive improvement in response totreatment modality for the population as a whole. It has also provided valuableinformation to help in the design of future effectiveness studies and clinical audits.© Chris St. Clair Gribble
  4. 4. Table of Contents1 INTRODUCTION & STUDY AIMS ..................................................................... 12 LITERATURE REVIEW ................................................................................... 3 2.1 WHAT IS THE PROBLEM? .............................................................................. 3 2.2 WHAT ARE THE IMPLICATIONS OF THE PROBLEM?.................................................. 4 2.3 WHAT IS KNOWN ABOUT THE PROBLEM? ............................................................ 5 2.4 WHAT IS THE ALLOPATHIC RESPONSE TO MALE SUB FERTILITY? ................................. 7 2.5 WHAT IS THE AYURVEDIC RESPONSE TO MALE SUB FERTILITY? .................................. 8 2.6 WHAT IS THE RESEARCH QUESTION AND THE VALUE OF THIS STUDY? ........................ 263 METHODOLOGY ......................................................................................... 27 3.1 RESEARCH APPROACH, DESIGN & SETTING ......................................................... 27 3.2 ETHICAL APPROVAL .................................................................................... 28 3.3 SAMPLING APPROACH .................................................................................. 28 3.4 DATA COLLECTION ..................................................................................... 29 3.5 DATA ANALYSIS ........................................................................................ 32 3.6 CONSTRAINTS & LIMITATIONS ........................................................................ 344 RESULTS .................................................................................................. 34 4.1 SAMPLE DEMOGRAPHICS .............................................................................. 35 4.2 PRESCRIBED MEDICINES .............................................................................. 40 4.3 PREFERRED MEDICINES ................................................................................ 45 4.4 INDICATIVE TREATMENT RESPONSE .................................................................. 50 4.5 RESULTS SUMMARY .................................................................................... 545 DISCUSSION ............................................................................................ 546 CONCLUSION ............................................................................................ 647 REFERENCES ............................................................................................ 668 APPENDICES ............................................................................................. 73 8.1 BHĀVAPRAKĀŚĀ HERBS, FORMULATIONS, AND DIETETIC SUPPLEMENTS ........................ 73 8.2 SPEMAN (HIMALAYA COMMERCIAL FORMULA) ...................................................... 85 8.3 LITERATURE SEARCH STRATEGY ...................................................................... 85 8.4 MIDDLESEX UNIVERSITY ETHICAL APPROVAL ....................................................... 86 8.5 SDM HOSPITAL STUDY APPROVAL ................................................................... 87 8.6 DATA COLLECTION TEMPLATE - SEMEN ANALYSIS.................................................. 88 8.7 ALLOPATHIC SEMEN QUALITY REFERENCE DATA.................................................... 89 8.8 DATA TRANSFORMATION RULES ...................................................................... 89 8.9 AYURVEDIC SEMEN QUALITY REFERENCE DATA (SDM HOSPITAL) ............................... 90 8.10 DAŚAMŪLA HERBS ................................................................................... 91 8.11 PHYSICAL EXAMINATION (MALE INFERTILITY) ................................................... 91 8.12 CASE HISTORY TAKING (INFERTILITY)............................................................ 92 8.13 SYSTEMIC AYURVEDIC DIAGNOSTIC PARAMETERS (DIGESTIVE IMBALANCE) ................ 93 8.14 SYSTEMIC AYURVEDIC DIAGNOSTIC PARAMETERS (CHANNEL IMBALANCE) .................. 94 8.15 SYSTEMIC AYURVEDIC DIAGNOSTIC PARAMETERS (TISSUE IMBALANCE)..................... 95 8.16 MUSTĀDYA YĀPANĀ ENEMA......................................................................... 96 8.17 TRADITIONAL CHINESE MEDICINE (MALE INFERTILITY) ........................................ 97 8.18 GLOSSARY (AYURVEDIC TERMS) ................................................................. 100© Chris St. Clair Gribble
  5. 5. Table of FiguresTable 1 - Aetiology and Distribution (%) of Male Infertility ....................................... 5Table 2 - 8 Types of Seminal Morbidity ............................................................... 10Table 3 - Caraka Śukra Janana Herbs - Sperm Increasing ...................................... 14Table 4 - Caraka Śukra Śodana Herbs - Sperm Purification ..................................... 15Table 5 - Caraka Jīvana Herbs - Age Related Impotence ........................................ 15Table 6 - Caraka Vayasthapan Herbs - Seminal Dimunition..................................... 15Table 7 - Suśruta Muṣkadhī Herbs - Seminal Disorders .......................................... 16Table 8 - Suśruta Kaṇṭakī Pañcamūla Herbs - Seminal Disorders ............................. 16Table 9 - Suśruta Vallī Pañcamūla Herbs - Seminal Disorders.................................. 17Table 10 - Suśruta Āmalakyādi Herbs - Vrsha (Aphrodisiac) ................................... 17Table 11 - Suśruta Kākolyādi Herbs - Vrsha (Aphrodisiac) ...................................... 17Table 12 - Comparison of Caraka & Suśruta Herb Groups ....................................... 18Table 13 - Sārṇgadhara - Male Infertility Herbs .................................................... 18Table 14 - Allopathic Semen Quality Characteristics .............................................. 31Table 15 - Guiding Questions for the Consultant Interview ..................................... 32Table 16 - Allopathic Semen Quality Classification (Baseline) .................................. 35Table 17 - Allopathic Diagnosis Classification (Baseline) ......................................... 37Table 18 - % Allopathic Diagnosis Classification (Baseline) ..................................... 38Table 19 - Ayurvedic Diagnostic Parameters (Baseline) .......................................... 39Table 20 - % Types of Prescription ..................................................................... 40Table 21 - Number Prescribed Medicines - Vata Seminal Morbidity ........................... 41Table 22 - Number Prescribed Medicines - Non Vata Seminal Morbidity .................... 42Table 23 - Number Prescribed Medicines - Specific Clinical Action ............................ 43Table 24 - Number Prescribed Medicines - Common Fertility Related Pathologies ....... 44Table 25 - Medicines with Multiple Applications ..................................................... 45Table 26 - Preferred Medicines - Vata Seminal Morbidity ........................................ 46Table 27 - Preferred Medicines - Non Vata Seminal Morbidity .................................. 47Table 28 - Preferred Medicines - Non Vata Seminal Morbidity (Continued) ................. 48Table 29 - Preferred Medicines - Common Associated Pathologies ............................ 49Table 30 - Preferred Medicines - Common Associated Pathologies (Continued)........... 50Table 31 - Changes in Semen Count, Motility, and Morphology (End State) ............... 51Table 32 - % Change in Allopathic Semen Classification (End State) ........................ 52Figure 1 - % Distribution - Allopathic Semen Characteristics (Baseline) .................... 36Figure 2 - % Allopathic Diagnosis Classification (Baseline)...................................... 38Figure 3 - % Distribution of Ayurvedic Diagnostic Parameters (Baseline) .................. 40Figure 4 - % Type of Prescription ....................................................................... 41Figure 5 - % of Medicines with Multiple Applications .............................................. 45Figure 6 - Mean Change for Sperm Count, Motility, & Morphology (End State) ........... 52Figure 7 - Change in Ayurvedic Semen Parameters (End State)............................... 53© Chris St. Clair Gribble
  6. 6. 1 Introduction & Study AimsMale infertility is becoming a major concern both in developed and developing countries.In Europe 25% of couples do not achieve pregnancy within 1 year with 15% of thesepatients seeking medical treatment for their infertility (Dohle et al., 2005). In the past,the main focus of clinical investigation was the female partner. However, research hasshown that the male is solely responsible in 20% of cases and contributory in another30-40% (Thonneau et al., 1991). Further, over 50% of infertile males are classified ashaving idiopathic male infertility as there is no known cause for their reduced semenquality (De Kretser and Baker, 1999).As the pathology behind idiopathic male infertility is largely unknown there are fewtreatment options available. The few options that do exist i.e. assisted fertility are bothexpensive and invasive, move the problem from the male to the female, and are notreadily extensible to developing nations where medical resources are limited (Vayena,Rowe and Griffin, 2002). There are also emerging concerns for the health of IVFoffspring who have been shown to suffer more serious illness and hospitalisation thancontrols (Bonduelle et al., 2005).Given that allopathic medicine has limited treatment options for idiopathic maleinfertility, alternative systems of medicine warrant investigation. Ayurveda is theindigenous medical science of India that has been in continual practice for over 5000years. This field of medicine is recognised by the World Health Organisation (WHO) as amajor contributor to world health (World Health Organization, 2002).Ayurveda has a branch of medicine, vājīkaraṇa, that specifically addresses maleinfertility and all aspects of healthy reproduction. Śukra kashaya, or seminal diminution,is well described across most classical ayurvedic texts, and there is an extensive rangeof herbs and formulations provided.Although ayurveda provides a well described treatment option and extensivepharmacopoeia to treat the infertile male, there is little contemporary literature orclinical research to substantiate the effectiveness of the treatment approach or identifypreferred medicines or treatment approaches.© Chris St. Clair Gribble 1
  7. 7. A new student of ayurveda must rely solely on acquired clinical experience andobservational learning of successful treatment modalities. Observing best practice inthe UK is limited. Ayurveda in the West is still in its infancy, with limited residentexpertise, few patients seeking treatment and a limited subset of the pharmacopoeiaand treatment techniques that would be available in India & Sri Lanka.This situation presents several research questions and associated study aims:o To understand and document what constitutes best practice ayurvedic diagnosis of male infertilityo Identify the preferred ayurvedic herbs and formulations used to treat male sub- fertilityo Investigate if there are alternative ayurvedic options to treating common pathologies associated with male sub-fertilityo Explore the effectiveness of the ayurvedic treatment of male infertilityThis study retrospectively investigates the treatment of 31 male infertility cases, treatedat SDM College of Ayurveda & Teaching Hospital India, under the care of Dr. B. SPrasad, one of the few ayurvedic consultants specialising in male infertility treatment.This venue provided a rich environment to investigate best practice ayurvedic clinicaldiagnosis and treatment of the disease.The main value of the study will be in providing newly qualified ayurvedic professionalsa contemporary practice guideline for the diagnosis and treatment of male infertility. Italso makes recommendations for the research community regarding standards forevidence based medicine, and identifies herbs of therapeutic use that do not appear tohave been researched in the West.This paper first reviews the literature to more fully understand the implications of maleinfertility, to understand the contemporary theories behind its pathophysiology, and tooutline the treatment approach as prescribed by classical ayurveda. The literature isthen searched for any evidence to substantiate the use of the ayurvedic pharmacopoeia.Within this framework, the remaining sections explore the clinical setting and outline themethodology used to analyze the selected cases. The results of this analysis are thendiscussed in respect of the specified research aims and the contemporary literature.© Chris St. Clair Gribble 2
  8. 8. 2 Literature Review2.1 What is the problem?What is the prevalence of male sub fertility in the world today?Infertility is becoming a major concern both in developed and developing countries. It iscommonly accepted that infertility affects more than 80 million people worldwide, with 1in 10 couples experiencing either primary or secondary infertility. Infertility rates varyenormously among countries from less than 5% to greater than 30%. The highest ratesoccur in the developing countries, where there are few resources that could supportassisted fertility programs, and where there is often the highest cultural pressure on thefemale partner to conceive a child (Vayena, Rowe and Peterson, 2002).In Europe, 25% of couples do not achieve pregnancy within 1 year, with 15% of thesepatients seeking medical treatment for infertility (Dohle et al., 2005). Research hasshown that the male is implicated in over 50% of presenting cases (Thonneau et al.,1991).As women delay parenting, there is a corresponding decline in their ability to conceive.A woman in her 20’s has a 74% chance of conception. After the age of 31, her fertilityfalls 3.5% per year representing a 21.5% chance of conception by age 45 (Zaadstra etal., 1991). A man’s semen quality also declines with age. A systematic reviewinvestigating the effects of paternal age on semen quality showed decreases in semenvolume (3%-22%), motility (3%-37%), and morphology (4%-18%) comparing 30 yearolds to 50 year olds (Kidd, Eskenazi and Wyrobek, 2001). In addition, studies haveshown that in some countries and cities there is a decline in sperm count, whilst otherareas remain unaffected (Becker and Berhane, 1997). A decline in semen quality, eitherthrough age or geographical decline, further exacerbates a female’s reduced fecunditythrough delayed parenting. Consequently more men are now presenting with male sub-fertility.For those men presenting with male infertility, about 60% exhibit associated pathologiesknown to affect their semen quality. However, the remaining 40% are classified ashaving idiopathic male infertility where there is no known cause for their reduced semenquality (De Kretser and Baker, 1999). Idiopathic male infertility is prevalent both in© Chris St. Clair Gribble 3
  9. 9. developed and developing countries, and there are few treatment options available asthe cause is largely unknown.2.2 What are the implications of the problem?What are the main implications to male sub-fertility?The main response to male factor infertility has been in the field of assisted fertilitytechnology (ART). In vitro fertilization (IVF) was first introduced in 1978 to alleviatefemale factor infertility, and almost 2 million babies have been born through thistechnique. When IVF was applied in couples with male infertility the expectedfertilisation rate reduced significantly, and in 1992 the intracytoplasmic sperm injection(ICSI) was developed to introduce a single sperm directly into the oocyte (Oehningerand Kruger, 2006, p393).As a technique to address male factor infertility, ICSI moves the problem from the maleto the female partner who has to undergo an IVF procedure which is both invasive andexpensive. Even with vast improvements in technique, the success rate of IVF or ICSIremains less than 30%, and with such a low success rate it is doubtful the expensecould be justified in developing countries (Vayena et al., 2002).An emerging area of concern is the risk to the health of the offspring conceived usingART techniques. A systematic review of 25 studies between 1978 and 2002, involvingboth matched and unmatched cohorts, showed a significant increased risk of pregnancycomplications. For single births there was a significant increased risk of pre-termdelivery, low birth weight, small for gestational age, caesarean section, admission toneonatal intensive care, and perinatal mortality (Jackson, Gibson, Wu and Croughan,2004). Further, a multi-centre cohort study of the physical health of 5 year oldsconceived after IVF and ICSI show increased odds of congenital malformations of 2.77for ICSI and 1.8 for IVF children. These children were also more likely to have suffereda significant childhood illness, had a surgical operation, or required medical therapyinvolving hospitalisation (Bonduelle et al., 2005). The higher rate in ICSI was partlyattributable to an excess of male urogenital problems.Consequently, using ICSI for male factor infertility is not without its risks. And the risk isincreasing in Europe, as it is becoming apparent that conventional IVF is being replacedby ICSI, even when sperm parameters are normal (Andersen, Gianaroli, Felberbaum, de© Chris St. Clair Gribble 4
  10. 10. Mouzon and Nygren, 2006). However, ICSI does not address the underlyingpathophysiology behind either male factor infertility or sub fertility. Nor is the techniquea cost effective therapy for developing nations whose scarce medical resources mustaddress more primary health care needs (Andersen et al., 2006).2.3 What is known about the problem?How is male infertility classified, and what is known about the underlyingcause?Male factor infertility is classified according to the underlying causative physiopathology.Reduced male fertility can be the result of congenital and acquired urogenitalabnormalities, infections of the genital tract, increased scrotal temperature (varicocele),endocrine disturbances, genetic abnormalities and immunological factors.The aetiology and distribution (%) of male infertility among 7,057 men is summarised intable 1 below (Dohle et al., 2005).Table 1 - Aetiology and Distribution (%) of Male Infertility Aetiology (%) Sexual factors 1.7 Urogenital infection 6.6 Congenital anomalies 2.1 Acquired factors 2.6 Varicocele 12.3 Endocrine disturbances 0.6 Immunological factors 3.1 Other abnormalities 3.0 Idiopathic abnormal semen (OAT syndrome) i.e. no known cause 75.1From reviewing these statistics, varicocele, OAT syndrome and infection are the mainareas of clinical significance. This study also shows the highest proportion of cases(75.1%) have no known cause for their reduced semen parameters (idiopathic maleinfertility). The semen analysis of this group reveals a decreased number ofspermatozoa (oligozoospermia), decreased motility (asthenozoospermia) and manyabnormal forms on morphological examination (teratozoospermia). Usually, theseabnormalities present together and are described as the oligo-astheno-teratozoospermia(OAT) syndrome. These men present with no previous history associated with fertilityproblems and have normal findings on physical examination and endocrine laboratorytesting (Dohle et al., 2005).© Chris St. Clair Gribble 5
  11. 11. Little is known about the pathophysiology of idiopathic male infertility as theintroduction of ICSI removed any incentive to investigate the cause. However, recentstudies have shown that the spermatozoa of sub-fertile males exhibit both an impairedcapacity for fertilization and higher rates of damage to both mitochondrial and nucleargenomes. More significant is the finding that these higher rates of DNA damage arenegatively affecting both pregnancy and the health of the offspring. DNA damage hasbeen shown to reduce rates of fertilization, exhibit impaired pre-implantation embryodevelopment, increase rates of early pregnancy loss, and high rates of morbidity in theoffspring including dominant genetic disease, infertility and cancer (Oehninger andKruger, 2006, p257).In response to mounting health concerns, there is now a growing body of researchinvestigating possible mechanisms behind idiopathic male infertility. Male sub-infertilitymay be the result of several factors, such as chronic stress, endocrine disruption due toenvironmental pollution, reactive oxygen species (ROS) induced oxidative stress, andgenetic abnormalities. However, the dominant theory is that oxidative stress is theprimary cause of both defective sperm function and DNA damage in the spermatozoa(Henkel et al., 2005).The human spermatozoon is rich in unsaturated fatty acids which are susceptible to ROSchain reactions leading to a rapid loss of membrane dependent functions. Thelipoperoxidative potential of spermatozoa is closely correlated to impaired spermmotility and sperm-oocyte penetration (Aitken, Harkiss and Buckingham, 1993).Elevated levels of oxidative DNA damage have been observed in the spermatozoa ofinfertile men compared to fertile controls (Henkel et al., 2003). In studies of clinicallycharacterized samples, high levels of oxidative stress have been found in groups ofpatients exhibiting oligozoospermia, varicocele and unexplained infertility. The 2 mainsources of oxidative stress in the ejaculate are leukocytes, mostly neutrophils, and thedefective spermatozoa themselves. It is postulated that spermatozoa with highlipoperoxidative potential reflect defects in the underlying spermatogenesis process(Oehninger and Kruger, 2006, p261). The point at which the spermatozoa are exposedto the leukocytes reflects the resultant oxidative damage. Early exposure in the retetestes or epididymis is likely to have a deleterious effect. Later exposure is likely to beprotected by the powerful anti-oxidants in the seminal plasma (Aitken, West andBuckingham, 1994).© Chris St. Clair Gribble 6
  12. 12. Whilst varicocele is seen in 12% of sub fertile patients it is also observed in men whohave no fertility problems, and as such there is no conclusive evidence that varicocele isa major cause of infertility (Vernet, Rigaudiere, Ghyselinck, Dufaure and Drevet, 1996).However, it has also been shown that increased oxidative stress is present in theejaculate of varicocele patients (Agarwal, Prabakaran and Allamaneni, 2006).Natural protection against lipid peroxidation includes membrane associated antioxidantssuch as hydrophobic vitamin E, radical scavenging molecules such as vitamin C, uricacid, tryptophan and taurine, and mitochondrial and cytosolic antioxidant enzymes suchas superoxide dismutase. The detoxification of lipid peroxides occurs by glutathioneperoxidase within the presence of phospholipase A2 (Suleiman, Ali, Zaki, El-Malik andNasr, 1996). In addition, there are extracellular antioxidants present in the malereproductive tract such as glutathione peroxidase 5, and extremely large quantities ofsuperoxide dismutase (SOD) in the epididymal and seminal plasma (Vernet et al.,1996).Differences in patient susceptibility are thought to arise from individual variations in themolecular composition of the plasma membrane, the degree of ROS exposure during thespermatozoa life history, and level of protection afforded by free radical scavengers,chain breaking antioxidants, and ROS metabolising enzymes.2.4 What is the allopathic response to male sub fertility?So what is the allopathic treatment response to male sub fertility, and what arethe limitations?ICSI has been the main response which, as outlined, is invasive, expensive, and movesthe problem to the female partner. Emerging heath concerns for children born of IVFand ICSI have renewed interest to treat the underlying cause and not just circumventthe problem.Clearly, recent research has associated oxidative stress with defective sperm function,especially with respect to OAT syndrome, infection and varicocele. The researchsuggests that the origins of oxidative stress include leukocytic infiltration, excess freeradical generation from the spermatozoa, and defects in the antioxidant protectionprovided to cells.© Chris St. Clair Gribble 7
  13. 13. Based on this body of knowledge, antioxidant supplementation is being investigated asone rational therapy. In this respect a limited number of antioxidants (glutathione,lycopene, vitamin E) and sperm vitalizers (carnitine, CoQ10) have been shown to havesome therapeutic benefit (Kumar, Gautam and Gupta, 2006).But is oxidative stress actually cause or effect? More research is required to understandthe underlying causes behind excess ROS production in spermatozoa, defects inspermatogenesis, and why antioxidant protection mechanisms are compromised insome individuals. Antioxidant supplementation could be considered palliative, and adeeper understanding of the pathophysiology is needed in order to develop rationalapproaches towards prevention as well as treatment.Also little is understood of other major systems of medicine in terms of their owndefinition of the underlying pathophysiology, and treatment options available. Ayurvedicmedicine has a well described response to male sub-fertility. An integratedunderstanding across both allopathic and indigenous medicine may shed more light asto the causes of male sub-fertility, and provide a wider spectrum of therapeutic options.2.5 What is the Ayurvedic response to male sub fertility?What are the Ayurvedic causes of male sub-fertility?Ayurveda has a well documented disease called klaibya which means impotence orinfertility. The Sanskrit term literally translates as “all things which make a manincapable of copulation”.The classical description of this disease and its treatment starts with Caraka and is thenaugmented by the clinical experience of Suśruta, Aṣṭāñga Hridaya, Mādhava Nidānam,Sārṇgadhara and Bhāvaprakāśa, in chronological order.Caraka says that a patient who suffers from a reduction of semen suffers fromweakness, dryness of mouth, pallor, lassitude, exertion, impotency, and non -ejaculation of semen (Sharma, 2004, CS Su 17:63-72). This definition can be seen toencompass both functional and non functional impotence.Caraka provides two levels of klaibya classification. One specifically relates to seminalmorbidities and the other to various categories of impotence.© Chris St. Clair Gribble 8
  14. 14. Seminal MorbiditiesCaraka defines the primary cause for impotency as resulting from seminal morbidities.He indicates that any type of seminal morbidity can result in infertility. Thesemorbidities are said to relate to one of 14 factors that vitiate one or more bio-energies(vata, pitta or kapha), reach the seminal channels, and vitiate the semen. 1. Excessive sexual indulgence 8. Sex with non passionate women 2. Excessive physical exercise 9. Old age, worry, grief, low confidence 3. Intake of unwholesome food 10.Injury by instruments, alkalis (kṣāra) or 4. Untimely intercourse cauterization (agnikarma) 5. Sex other than through female genital 11.Fear, anger, and black magic tract 12.Emaciation from disease 6. Abstinence from sexual rapport during 13.Suppression of natural urges the appropriate time 14.Injury or vitiation of the tissue elements 7. Intake of foods excessively ununctous, bitter, astringent, saline, sour and hotHealthy or pure semen is defined as thick, sweet unctuous, without putrid smell, heavyslimy, non-irritating, white or transparent like a crystal, and in large quantity (Sharma,2004, CS Ci 2/4:50)o Semen vitiated by vata is frothy, ununctuous, thin and ejaculated with pain and small quantity. This type of semen is indicated to inhibit conception.o Semen vitiated by pitta is blue or yellow in colour, excessively hot and putrid in smell. There is also a burning sensation on ejaculation.o Semen obstructed by kapha is exceedingly slimy in character.o Semen mixed with blood results from excessive intercourse, ulcers, or injuryo Semen which is knotty (granthi) and sinks in water (avasādi) results from aggravated vata obstructing the semen through suppression of sex. This semen is ejaculated with difficulty.© Chris St. Clair Gribble 9
  15. 15. These various types of derangement are classified as 8 types of seminal morbiditiesidentified in table 2:Table 2 - 8 Types of Seminal Morbidity Ayurvedic Category English Translation Phenila Frothy semen Tanu Thin semen Rūkṣa Ununctous semen Vivarṇa Discoloured semen Pūti Semen with putrid smell Piccilla Slimy semen Anya-dhātu-saṁṣṣṭa Semen mixed with other tissue elements Avasādi Semen sinking in waterImpotenceCaraka next outlines the general symptoms of impotence as dyspnoea, perspiration,frustration, and lack of erection. However, his description also includes a systematicdescription of 4 major types depending on its chief causative factor.1. Bījopaghātaja klaibya is impotence caused by seminal diminution2. Dhvajabhaṅgaja klaibya is impotence caused by a non erectile phallus3. Jarāja klaibya is impotence caused by old age4. Śukra-kṣayaja klaibya is impotence caused by excessive loss of semen through sexual intercourse or masturbationThere is no substantive variation in the disease cause or its classification between theclassical authors. The most recent author, Bhāvaprakāśa (Murthy, 2001, BP Uk 1:2-10),defines seven types of male infertility:1. Psychological impotence2. Dietary impotence i.e. excessive pungent, sour, salty foods3. Excessive sex, loss of semen, or vilification therapy leading to non erection4. Abstinence5. Major diseases of the penis6. Rupture of semen channels resulting in non erection which was considered incurable7. Congenital or genetic impotence which was also considered incurable© Chris St. Clair Gribble 10
  16. 16. Clearly both these classical descriptions can encompass the various known pathologiesassociated with male infertility such as UTI, varicocele, hormonal dysfunction, testicularfailure, cryptorchidism, and karyotype disorders (Turek, 2005). More interestinglyayurveda recognizes diet and various behaviours and lifestyle factors as causes for maleinfertility.What is the Ayurvedic view of the underlying pathology of male sub-fertility?Clearly the classical authors have described two main areas of male sub-fertility alongwith their associated causes. They have described defects in the semen and seminalfluid which are treated by addressing the underlying energetic imbalance visible in theresultant pathology. They have also described a disorder of reduced seminal tissue asone of the 80 vata disorders.In ayurveda, health is defined as homeostatic balance of mind, bio-energies, digestionincluding metabolism, tissue formation, body channels both gross and minute, wasteproducts and immunity. Ayurveda considers disease not as a sudden onset, but as aprocess evolving in 6 sequential stages, causing functional and physiological imbalanceof these same factors.The body bio-energies are in continual flux trying to maintain homeostasis against bothendogenous factors arising from diet and lifestyle, and exogenous factors arising fromchanges in the environment. Disease arises when the body’s capability to maintainhomeostasis is exceeded for a sustained period of time.In ayurvedic physiology, Caraka says that the seminal fluid is derived from the bonemarrow. This bone marrow when heated produces an oily bi-product from which semenis produced. This semen is secreted through the pores of the bone marrow and pervadesthe whole body, eventually collecting in the testes (Sharma, 2004, CH Ci 15/32).In a similar fashion, Suśruta describes 7 anatomical layers, kala, each successivelydeeper within the body. The seventh kala is śukradharakala and is a unique concept. Itis said that śukra is spread all over the body just as fat is contained within milk. Hencesemen is present everywhere, not just in the seminal vesicles as identified in allopathicanatomy (Murthy, 2004, SH Sa 4:21-23).© Chris St. Clair Gribble 11
  17. 17. Fertility depends on more than semen produced in the testes. It also depends on thecirculating gonadotropic (luteinising and follicle stimulating) hormones which stimulatethe testes to produce testosterone that governs spermatogenesis, bone marrowdevelopment, and secondary sex characteristics. At puberty the red bone marrow isconverted to yellow fatty bone marrow which is a significant source of cholesterol, andcholesterol is the substrate for testosterone. In this sense the classical description ofśukra pervading the body may have some basis in modern endocrinology (Rao, 2005,p294).What constitutes best practice classical Ayurvedic treatment of male sub-fertility?Ayurveda has been in continual practice for over 5000 years. To answer the question asto what constitutes best practice treatment one has to answer several questions.o What has been classically defined as the optimal treatment for the disease?o What new formulations have been developed and how effective are they?o What evidence based clinical studies exist to guide treatment?o Is there any scientific evidence to support the ayurvedic therapeutics?Classical TreatmentThe basic principle of ayurvedic treatment is to assist the body to heal itself. Thetherapeutic principles of repletion and depletion both consist of a radical expulsion ofimbalanced energies and bio toxins (shodana) followed by conservation treatment(shamana).Shodana serves to expel the excess dosha (vata, pitta and kapha) out of the body usingone or more of 5 purification techniques called panca karma. Shamana or pacificationtreatment then balances the system through medicine, diet and lifestyle to restorehomeostasis and eliminate the disease (Singe, 2005).The classical texts define shodana as a pre-requisite for any shamana treatment ineither disease management or heath promotion. The saying goes that a dirty cloth mustbe cleaned before dye is applied. For any medicine to have its full effect, the bodyshould be suitably purified, and this therapy would constitute best practice.© Chris St. Clair Gribble 12
  18. 18. In this respect, Suśruta indicates shodana is applied to seminal disorders according tothe specific doshic involvement. This particularly applies to the easily curable disordersvitiated by a single dosha.Suśruta in his chapter on anuvasana-uttaravasti says that the use of 18 medicatedenemas (alternating 9 oil and 9 decoction enemas) cure all disorders of semen. The firstoil enema lubricates the urinary bladder and groins, the second mitigates vata in thehead, the third bestows strength and colour, the fourth, fifth, sixth and seventh, eighthand ninth lubricate plasma, blood, muscle, fat, bone and bone marrow tissues insuccession so that by the 18th enema all semen disorders are cured (Murthy, 2004, SHCi 37:71-74).He also specifically indicates that in all seminal disorders, each therapeutic action shouldbe followed by urethral injections (uttara-basti). This therapy is mentioned for bothvitiated semen and premature ejaculation (Murthy, 2004, SH Ci 37:125-126).Understanding what constitutes best practice herbs or dietetic supplements for malesub-fertility is more complex.Several ayurvedic terms pertaining to male sub-fertility and sexual dysfunction are usedin the classical literature. The terms are often used in their broadest sense, so it can bedifficult to understand the target action or morbidity for which a particular herb hasbeen indicated. A working definition is provided here, so as to enable correlation to anallopathic understanding of male sub-fertility.The following terms relate to the production of sperm and seminal fluid at the level ofthe testes and ancillary organs:o Vrsha (aphrodisiacs) promotes the quality of sperm and seminal fluid through the correct functioning of the body and mind. Vrsha is the metabolic strength contained in the blood, the quality of its resultant tissue, and strength of orgasmic control that leads to this high quality sperm and seminal fluid.o Śukrajanna (sperm promoting) refers of actual spermatogenesis and the development of the spermatozoa. Substances which are sukrajanna increase sperm count.© Chris St. Clair Gribble 13
  19. 19. o Śukra pravartana (increasing flow) refers to increasing the fluidity and volume of semen. It is the coordinating function that eases expulsion of the seminal fluid.o Śukra shodana refers to sperm purification, and is thought to improve semen quality with respect to both morphology and counto Śukrala is a broad term thought to encompass vrsha, śukra jannana, and śukra pravartana.The following term relates to local pelvic controls as governed by the endocrine system,blood supply, and the central nervous system.o Vajikaraka refers to the reproductive capacity and would encompass functional capacity and sexual arousal at the level of the brain. Functional impotence would be addressed by substances that are vajikaraka.Three classical authors, Caraka, Suśruta and Sārṇgadhara provide the greatest clarityregarding an indication of a herb with respect to its target action.What herbs does Caraka recommend to improve the reproductive capacity ofthe healthy male?Caraka specifically identifies 2 herb groups classified as sperm purifying (śukrashodana) or sperm producing (śukra Jarana) that have particular relevance for idiopathicmale infertility (Sharma, 2004, CH Su 4:9-20).The śukra janana group indicated for increasing semen is listed in tables 3 and 4:Table 3 - Caraka Śukra Janana Herbs - Sperm Increasing Sanskrit Latin Common Name Name Name Jaṭāmāṁṣī Nardostachys jatamansi Spikenard Jīvantī Leptadenia reticulata None Kākolī Roscoea procera Kakoli Kṣīra-kākolī Lilium polphyllum White lilly Kuliṅgā (guṇjā) Abrus precatorius Wild Liquorice Root Māṣaparṅī Teramnus labialis Rabbit vine Medā Polygonatum verticillatum Whorled Solomons seal Mudgaparṇī Phaseolus trilobus Wild gram Śatāvarī Asparagus racemosus Wild asparagus Vidārīkañda Pueraria tuberosa Indian kudju© Chris St. Clair Gribble 14
  20. 20. The śukra śodana group indicated for sperm purification is listed in table 4:Table 4 - Caraka Śukra Śodana Herbs - Sperm Purification Sanskrit Latin Common Name Name Name Elavāluka Prunus cerasus Dwarf cherry Ikṣu Saccharum officinarum Sugar cane Kadamba (gum) Anthocephalus chinensis Wild Cinchona Kāsa Saccharum spontaneum Thatch grass Kaṭphala Myrica nagi Bay berry Kokilākṣa (alkalies) Hygrophila auriculata Ribbed gourd Kuṣṭha Saussurea lappa Costus root Samudraphena Sepia officinalis Calcium carbonate Uśīra Vetiveria zizanioides Vetiver grass Vasuka Indigofera enneaphylla NoneCaraka also mentions two other herb groups as useful in treating male sub-fertility(Sharma, 2004, CH Su 4:9-20).The jīvana group taken in milk is vrsha, indicated for men up to 70 years of age, and islisted in table 5:Table 5 - Caraka Jīvana Herbs - Age Related Impotence Sanskrit Latin Common Name Name Name Jīvaka Microstylis wallichii Orchid species Jīvantī Leptadenia reticulata None Kākolī Roscoea procera Kakoli Kṣīra-kākolī Lilium polphyllum White lilly Mahāmedā Polygonatum cirrhifolium King’s Solomons seal Māṣaparṅī Teramnus labialis Rabbit vine Medā Polygonatum verticillatum Whorled Solomons seal Mudgaparṇī Phaseolus trilobus Wild gram ṛddhi Habenaria edgewothii None ṛṣabhaka Microstylis muscifera None Vṛddhi Habenaria latiabris NoneThe vayasthapan group is indicated (Sharma, 2004, CH Ci 30:202-203) for seminaldiminution and is listed in table 6:Table 6 - Caraka Vayasthapan Herbs - Seminal Dimunition Sanskrit Latin Common Name Name Name Āmalakī, Emblica officinalis Indian gooseberry Aparājita Clitoria ternatea Butterfly pea Guḍūcī Tinospora cordifolia Moonseed© Chris St. Clair Gribble 15
  21. 21. Sanskrit Latin Common Name Name Name Harītakī Terminalia chebula Chebulic myrobalan Jīvantī Leptadenia reticulata Jivanti Maṇḍūkaparṇī Centella asiatica Indian pennywort Punarnavā Boerhavia diffusa Hog weed, horse purslane Rāsnā Pluchea lanceolata English plantain Śālaparṇī Desmodium gangeticum Salpan Śatāvarī Asparagus racemosus Wild asparagusWhat herbs does the Suśruta recommend to improve the reproductive capacityof the healthy male?Suśruta outlines 3 groups as useful in treating seminal disorders, and 2 groups as beingvrsha or aphrodisiac (Murthy, 2004, SH Su 38).The muṣkadhī group is indicated for seminal disorders whose herbs are listed in table 7:Table 7 - Suśruta Muṣkadhī Herbs - Seminal Disorders Sanskrit Latin Common Name Name Name Citraka Plumbago zeylanica Leadwort Dhava Anogeissus latifolia Dhaora Kuṭaja Holarrhena antidysenterica Kurchi Madana Randia dumetorum Emetic nut Mokṣa (white) Schrebera swietenoides Mokha (alkaline substance) Palāśa Butea frondosa Bastard teak Śimśapa Dalbergia sissoo Indian rosewood Sñuhi Euphorbia nerrifolia Milk hedge Triphalā Embilica officinalis Indian gooseberry Terminalia chebula Chebulic myrobalan Terminalia bellirica Belleric myrobalanKaṇṭakī pañcamūla group is also indicated for seminal disorders. These herbs are listedin table 8:Table 8 - Suśruta Kaṇṭakī Pañcamūla Herbs - Seminal Disorders Sanskrit Latin Common Name Name Name Himsrā Capparis sepiaria Indian caper Jhiṇṭi Barleria prionitis Porcupine flower Karamarda Carissa carandas Star fruit Śatāvarī Asparagus racemosus Wild asparagus Svadaṅṣṭrā Tribulus terrestris Small caltropVallī pañcamūla group is also indicated for seminal disorders and is listed in table 9:© Chris St. Clair Gribble 16
  22. 22. Table 9 - Suśruta Vallī Pañcamūla Herbs - Seminal Disorders Sanskrit Latin Common Name Name Name Guḍūcī Tinospora cordifolia Heart leaved, moonseed Kṛṣṇa sārivā Cryptolepis buchanani Sarsaparilla Meṣaśrñgi Gymnema sylvestre Rams horn Rajanī (species haridrā) Curcuma Longa Turmeric Vidāri Pueraria tuberosa Indian kudjuĀmalakyādi group is indicated as vrsha (aphrodisiac) and is listed in table 10:Table 10 - Suśruta Āmalakyādi Herbs - Vrsha (Aphrodisiac) Sanskrit Latin Common Name Name Name Āmalakī Emblica officinalis gaertn Indian gooseberry Citraka Plumbago zeylanica Leadwort Harītakī Terminalia chebula Chebulic myrobalan Pippalī Piper longum Long pepperkākolyādi group is also indicated as vrsha (aphrodisiac) and is listed in table 11:Table 11 - Suśruta Kākolyādi Herbs - Vrsha (Aphrodisiac) Sanskrit Latin Common Name Name Name Drākṣā Vitis vinifera Grape Guḍūcī Tinospora cordifolia Heart leaved, moonseed Jīvantī Leptadenia reticulata Jivanti Jīvantī Leptadenia reticulata Jivanti Kākolī Roscoea procera Kakoli Karkaṭa-śṛngī Rhus succedanea Scarlet rhus Kṣīra-kākolī Lilium polphyllum White lily Mahāmedā Polygonatum cirrhifolium King’s Solomons seal Māṣaparṅī Teramnus labialis Rabbit vine Medā Polygonatum verticillatum Whorled Solomons seal Mugdha-parṇī Phaseolus trilobus Wild bean Padmaka Prunus cerasoides Himalayan wild cherry Prapauṇḍarīka Cassia absus Pigs senna ṛddhi Habenaria edgewothii None Vamśa Bambusa arundinacea Thorny bamboo Vidārīkañda Pueraria tuberosa Indian kudju Vṛddhi Habenaria latiabris None Yaṣṭimadhu Glycyrrhiza glabra LiquoriceSuśruta indicates that vājīkaraṇa remedies are of three kinds; those that producesemen, those that secrete semen, and those that have both effects. He provides severalremedies (Murthy, 2004, SH Ci 26:15-38), but does not delineate which remedies havewhich effect.© Chris St. Clair Gribble 17
  23. 23. So how do the herb recommendations of Caraka and Suśruta compare?The same herbs are represented by both classical authors according to different systemsof classification. Caraka classified herbs based on pharmacological action, and Suśrutagrouped them by similarity of substance.Table 12 - Comparison of Caraka & Suśruta Herb Groups Caraka Suśruta Jīvaniya Kākolyādi Śukra janana Kākolyādi Śukra śodana Vallī pañcamūla Kaṇṭakī pañcamūla Vayasthapan Kākolyādi, vidarikandadiGogte (2000, p71) notes there is a remarkable similarity between the two methods ofclassification. The correlation of these groups is outlined in table 12.What herbs does the sārṇgadhara saṁhitā recommend to improve thereproductive capacity of the healthy male?This treatise, although not comprehensive, is known for its detail concerningpharmaceutics (Murthy, 2003, p19). Here the ayurvedic terms are defined veryspecifically with respect to action. Theses herbs are listed in table 13:Table 13 - Sārṇgadhara - Male Infertility Herbs Vājikara (aphrodisiacs: increase sexual desire) Nāgabalā Grewia hirsuta Bombay presidency Kapikacchu bīja Mucuna pruriens Velvet bean śukrala (semenogogues: increases quantity of semen) Aśvagandhā Withania somnifera Winter cherry Musali Asparagus adscendens White musli Śarkarā kṣira Saccharum officinarum Sugar cane Śatāvarī kṣira Asparagus racemosus Wild asparagus Māṣa Phaseolus mungo Black lentil śukrala (and also help in ejaculation) Bhalātaka- phalamajjā Semecarpus anacardium Marking nut Āmalaki Emblica officinalis Emblic myrobalan śukrala (ejaculation and premature ejaculation) Bhatī phala (helps expel semen) Solanum indicum Indian nightshade Jātīphala (with hold ejaculation) Myristica fragans Nutmeg Haritakī (dries it up) Terminalia chebula Chebulic myrobalan© Chris St. Clair Gribble 18
  24. 24. What do the remaining classical authors, Aṣṭāñga, Mādhava Nidānam, andBhāvaprakāśā contribute?The remaining classical authors all build on the initial contribution of Caraka andSushruta. Aṣṭāñga combines both their recommendations, and adds a few additionalherbs such as kapikacchu. Mādhava nidānam does not address the disease at all.However, perhaps the most comprehensive list of both herbs and formulations isprovided by Bhāvaprakāśā who is the most recent of the classical authors.As Bhāvaprakāśā is considered to provide the most comprehensive overview, asummary of his recommended herbs, formulations and dietary supplements to treatmale sub-fertility has been included in appendix 1 for reference purposes.What constitutes best practice contemporary Ayurvedic treatment of male sub-fertility?A few ayurvedic pharmaceutical companies have produced multi-herbal formulations totreat male sub-fertility. The formulation ADDYZOA, from Carak Pharmacy, is indicatedfor male sexual dysfunction and OAT syndrome. The Nagarjuna pharmacy producesCOUNT PLUS GRANULES indicated as a general formula for male infertility andassociated problems. However, none of these companies provide any clinical evidence tosupport the use of their formulations.Only the Himalaya pharmacy, which produces Speman indicated for Oligospermia,provides any visibility regarding the clinical effectiveness of their formulation. Speman isa poly-herbal formulation comprising of powders of Orchis mascula, Asteracanthalongifolia, Lactuca scariola, Mucuna pruriens and extracts of Argyreia speciosa, Tribulusterrestris, Leptadenia reticulata, Parmelia perlata, enriched with gold ash (appendix 2).There are several recent clinical studies that investigate its effect on sub-fertile maleswith respect to semen parameters and gonadotropic index. However, most of thesestudies can be discounted on methodological grounds.All these studies were simple before and after open evaluation studies with no controlgroup or randomisation. With no control group there is less confidence that a change isa result of the intervention, and hence would be excluded for best practice clinicalevidence as defined by the Cochrane Collaboration (2007). This is especially true where© Chris St. Clair Gribble 19
  25. 25. there is so much natural variation in semen parameters over time. Nor would theseclinical trials be known to be independent or unbiased as funding sources or sponsorshipwas not declared and the papers were co-authored with a Himalaya medical advisor.However, in the absence of virtually any clinical studies of ayurvedic pharmacopoeia formale sub-fertility, these few studies at least provide some indication of effectiveness forthe ayurvedic approach. The only study using well defined measurement protocol andinclusion criteria showed that Speman increased sperm density significantly from 19.41to 26.81 million/ml at 3 months with an improvement showing at 4 weeks. The spermmotility also showed significant gradual improvement from 40.50% to 46.16% after 3months treatment, and sperm morphology improved from 53.38% to 61.62%. Themean testosterone levels increased from 3.85 ng/ml to 6.12ng/ml after 3 months oftreatment with Speman (Singh, Pandey, Sakar and Kulkarni, 2003). The authorsconclude that Speman may be improving sperm density and morphology by influencingtestosterone.Searching the literature for a clinical comparison, a small scale RCT of the powerfulantioxidant Astaxanthin has been shown to have significant improvement on semencount from 36.2 to 48.6 million/ml, motility from 28.5 to 31.9%, and normalmorphology from 9.6 to 11.4%. However, there was no significant change intestosterone levels (Comhaire, El Garem, Mahmoud, Eertmans and Schoonjans, 2005).Speman contains Mucuna pruriens which has been proven to have an anti-lipidperoxidation property (Tripathi and Upadhyay, 2002). As there is mounting evidencethat oxidative stress is the main factor in male sub-fertility, this suggests thatinfluencing testosterone may not be the only factor behind the improved semencharacteristics in the Speman study.Is there any scientific evidence to support the Ayurvedic treatment of male subfertility?A recent publication by Mishra (2004) has found some evidence in support of ayurvedictherapeutics for male infertility. The author discovered no independent human clinicaltrials, but found some evidence from animal models pertaining to several ayurvedicherbs.© Chris St. Clair Gribble 20
  26. 26. Withania somnifera was found to directly increase spermatogenesis in immature rats byexerting a testosterone like effect without raising serum levels of testosterone. Thealkaloids present in Mucuna pruriens were found to increase the number of spermatozoaand weight of testes, seminal vesicles and prostate in the albino rat. Piper longuminduced significant increase in the weight of the reproductive organs, sperm motility,and sperm count in male rats. Tribulus terrestris has been shown to increasetestosterone and spermatogenesis in male rams. An extract of this herb, Protodioscinhas been shown to improve sexual behaviour parameters in albino rats. Trichopuszeylanicus and Vanda tessellate have both been shown to stimulate sexual behaviour inmale mice. Zingiber officinale plant extracts show significant improvement in spermcount and motility.With so few studies available, a broader review of the literature was conducted lookingfor association with oxidative stress as the theoretical cause behind OAT syndrome andalso for research on male infertility, fertility agents, and hyperlipidemia. A search acrossPUBMED, AMED, Google Scholar, and the Medknow collection of Indian Medical Journalsfor 94 herbs classically prescribed for male sub-fertility has provided some indicativeevidence in support of their use. (Please refer to appendix 3 for the search keywordsemployed).A high proportion of the fertility related herbs have been evidenced as having apowerful antioxidant potential. These herbs appear to be working at the levelof spermatogenesis.The sweet fruit of Semecarpus anacardium is indicated for sperm purification andincreasing seminal flow. A study has shown an alcoholic extract of pericarp showedsignificant protection against FeSO4 induced lipid peroxidation (Tripathi and Singh,2001). However, unless the medicine is adequately purified it is considered extremelytoxic which might explain some animal studies which show that ethanolic extract causesa reduction in the number of primary spermatocytes, secondary spermatocytes andspermatids causing spermatogenic arrest in albino rats (Sharma, Verma and Dixit,2003).Mucuna pruriens is indicated when semen is depleted, and to improve virility. An alcoholextract of the seeds has an anti-lipid peroxidation property, which is mediated throughthe removal of superoxides and hydroxyl radicals (Tripathi and Upadhyay, 2002).© Chris St. Clair Gribble 21
  27. 27. Hygrophila auriculata indicated for both sperm production and purification has beenshown to have potent antioxidant potential (Vijayakumar et al., 2006).Asparagus racemosus indicated for both sperm production and purification has shownevidence of increased antioxidant defence; that is, enzymes superoxide dismutase,catalase, and ascorbic acid increased significantly, whereas a significant decrease in lipidperoxidation was observed (Bhatnagar, Sisodia and Bhatnagar, 2005). A further studyhas shown potent antioxidant properties in vitro in mitochondrial membranes of ratlivers (Kamat, Boloor, Devasagayam and Venkatachalam, 2000).Cissus quadrangularis indicated for sterility has shown both antioxidant andantimicrobial activity (Murthy, Vanitha, Swamy and Ravishankar, 2003).Curculigo orchioides used to increase semen has been shown to have immunostimulant,hepaprotective, and potent antioxidative activities (Wu et al., 2005). This herb is alsoused in Traditional Chinese Medicine (TCM).Euryale ferox indicated to increase semen and prevent premature ejaculation contains asignificant antioxidant activity (Lee, Ju and Kim, 2002).Suśruta mentions the poly herbal formula triphala in relation to male infertility andsperm purification. Research has found that all three constituents of triphala are activeand they exhibit slightly different activities under different conditions. In particular,Emblica officinalis shows greater efficiency in lipid peroxidation and plasmid DNA assay,while Terminalia chebula has greater radical scavenging activity. Thus their combinationis expected to be more efficient due to the combined activity of the individualcomponents (Naik et al., 2005). A separate study of Terminalia chebulais foundadditional evidence of its role in preventing oxidative damage in living systems (Lee etal., 2005).Anogeissus latifolia indicated for sperm purification has been shown to have potentantioxidant activity (Govindarajan et al., 2004).Plumbago zeylanica is indicated for sperm purification. It has been found that one of itsactive ingredients, plumbagin, has significant antioxidant abilities that may possibly© Chris St. Clair Gribble 22
  28. 28. explain its therapeutic effect (Tilak, Adhikari and Devasagayam, 2004). A further animalstudy has shown its ability to reduce oxidative stress in albino mice (Sivakumar andDevaraj, 2006).Vitis vinifera is indicated for semen purification. Procyanidins, an extract from Vitisvinifera, is believed to exert antioxidant protection sparing liposoluble vitamin E andreducing DNA oxidative damage (Simonetti, Ciappellano, Gardana, Bramati and Pietta,2002).Myrica nagi, indicated for sperm purification, is an effective chemopreventive agent inthe skin and capable of ameliorating cumene hydroperoxide-induced cutaneousoxidative stress and toxicity (Alam, Iqbal, Saleem, Ahmed and Sultana, 2000).Sugarcane juice, indicated for semen purification, has a phenolic extract that has showna protective effect against in vivo MeHgCl intoxication and potent inhibition of ex vivolipoperoxidation (Almeida, Novoa, Linares, Lajolo and Genovese, 2006).The beta-vetivenene, beta-vetivone, and alpha-vetivone constituents isolated fromVetiveria zizanioides, indicated for semen purification, have shown strong antioxidantactivity (Kim, Chen, Wang, Chung and Jin, 2005).Extract of Prunus cerasus indicated for sperm purification was found to have strongantioxidant activity (Wang, Nair, Strasburg, Booren and Gray, 1999).Some fertility related herbs have been shown to have antioxidant potential andbe effective in reducing hyperlipemia. High lipid content and obesity is nowconsidered a factor in reduced fertility.Emblica officinalis is indicated for increasing semen. The polyphenol fraction has beenshown to scavenge superoxide and hydroxyl radicals and inhibit lipid peroxidation invitro. It has also be shown to be useful in hypercholesterolemia and lipid peroxidation incholesterol-fed rats (Rajeshkumar, Pillai and Kuttan, 2003).Withania somnifera indicated for both sperm production and purification has shown cellcycle disruption and anti-angiogenic activity, which may be a critical mediator for itsanti-cancer action (Mathur et al., 2006). It is known to exhibit increased antioxidant© Chris St. Clair Gribble 23
  29. 29. defence (Bhatnagar et al., 2005). It has also shown significant ability to reduced serumcholesterol, triglycerides, LDL (low density lipoproteins) and VLDL (very low densitylipoproteins) in human trials (Andallu and Radhika, 2000).Glycyrrhiza glabra used as a sperm purifier was found to protect microsomalmembranes, as evident from a reduction in lipid peroxidation, and also protects plasmidDNA from radiation-induced strand breaks (Shetty, Satav and Nair, 2002). The herb hasalso been shown to be hypocholesterolaemic (Visavadiya and Narasimhacharya, 2006).The herb has also shown hypocholesterolaemic action (Sitohy, Massry, Saadany andLabib, 1991).Most research on Tinospora cordifolia reflects its clinical use in Ayurveda, supporting itshypoglycaemic and hypolipidaemic action (Stanely and Menon, 2003). More recentresearch also point to its Nitric Oxide Scavenging capacity (Jagetia and Baliga, 2004)and maintenance of antioxidant status of cells which is suggestive of achemopreventive efficacy of T. cordifolia against chemotoxicity, including carcinogenicity(Singh, Banerjee, Kumar, Raveesha and Rao, 2006).Some fertility related herbs appear to be working more at a gonadotropic levelor at the level of the brain.An aqueous extract of Centella asiatica, as a longevity promoter, has been foundeffective in preventing cognitive deficits, as well as oxidative stress (Kumar and Gupta,2003).Pueraria tuberosa has been indicated for sperm purification and increasing semen count.Some research points to its estrogenic potential (Shukla, Mathur and Prakash, 1989);other research suggests ethanolic and butanolic extracts evoke a significant anti-fertilitywhilst the aqueous extract does not show any significant anti-fertility activity in thethree animal species tested. This may indicate that this herb is acting at the level ofhormonal control (Prakash, Saxena, Shukla and Mathur, 1985).Piperine, the active ingredient in Piper longum Linn has been shown to have animmunomodulatory and antitumor capability increasing WBC count (Sunila and Kuttan,2004). It has been found to exert a significant increase in reproductive organ weights,sperm motility and sperm count (Shah, Al-Shareef, Ageel and Qureshi, 1998).© Chris St. Clair Gribble 24
  30. 30. Nardostachys jatamansi has been clinically employed for its anti-ischemic, antioxidant,anticonvulsant, and neuroprotective activities. It is also indicated for increasing semen.An ethanol extract significantly improved learning and memory in young mice and alsoreversed their amnesia. The underlying mechanism of action can be attributed to itsantioxidant property. Hence, it is possible this is acting both at the level of the brain anddirectly on spermatogenesis (Joshi and Parle, 2006).Desmodium gangeticum has shown potent antioxidant activity (Govindarajan et al.,2003). This herb also works on the brain, having been shown to be a promisingcandidate for improving memory (Joshi and Parle, 2006).What can the Ayurvedic and allopathic approaches learn from each other?One can speculate that several ayurvedic herbs targeted at male sub-fertility may beworking to reduce oxidative stress and thereby support the allopathic theory ofpathogenesis for OAT syndrome. Also a few ayurvedic herbs indicated for male infertilityshow their main benefits in regulating hyperlipidemia and obesity.Boerhavia diffusa, indicated as a longevity promoter, can induce a significant reductionin serum and tissue cholesterol, free fatty acids, phospholipids, and triglycerides (Pariand Satheesh, 2004a). Another study demonstrates remarkable anti diabetic activityand improvement in antioxidant status (Pari and Satheesh, 2004b).Gymnema sylvestre is indicated for diseases of semen and diabetes. Animal studieshave shown that this herb decreases bodyweight, regulates lipoprotein metabolism andis especially useful in multi-factor obesity syndrome.Lipid status or body weight is not widely considered as part of the diagnostic criteria formale infertility. However, studies have shown that metabolic syndrome X underpinsboth hyperlipidemia and obesity, and the bio-markers for this syndrome are becomingincreasingly prevalent, especially in the young (Eckel, Grundy and Zimmet, 2005).Further oxidative stress has been shown to be an early indictor of metabolic syndromeand obesity (Furukawa et al., 2004). So is there any correlation with hyperlipidemia,obesity and semen quality? A recent study has shown that the BMI index has a directcorrelation with semen quality characteristics. There was a significant difference in the© Chris St. Clair Gribble 25
  31. 31. total number of normal-motile sperm cells among the different BMI groups. Menpresenting with a BMI greater than 25 have fewer chromatin-intact normal-motile spermcells per ejaculate (Kort et al., 2006). Also a high incidence of hyperestrogenemia anddyslipidemia has been shown to be more prevalent in groups of infertile men (Torres,Carrera and Zambrana, 2000).One can speculate that herbs targeting fat metabolism, directly or indirectly, regulateoxidative status which has been hypothesised to affect semen quality. Also thedemographics of metabolic syndrome may go some way to explain the regionalvariations in semen count seen in the developed nations. Both Europe and the US showthe highest decreases in semen quality where obesity is also a significant factor.2.6 What is the research question and the value of this study?Although ayurveda provides a well described treatment option and extensivepharmacopeia to treat the infertile male, there is little contemporary literature or clinicalevidence to substantiate the effectiveness of the treatment approach.A new student of ayurveda must rely solely on acquired clinical experience andobservational learning of successful treatment modalities. Observing best practice inthe UK is limited. Ayurveda in the West is still in its infancy with limited residentexpertise, few patients seeking treatment and a limited subset of the pharmacopoeiaand treatment techniques that would be available in India & Sri Lanka.This situation presents several research questions that need to be addressed:o What constitutes best practice ayurvedic diagnosis of male infertility?o What are the preferred ayurvedic herbs or formulations are used to treat male sub- fertility?o Are there alternative ayurvedic options to treating common pathologies associated with male sub-fertility?o How effective is the ayurvedic treatment of male infertility?An effectiveness study or clinical audit would not be feasible given the constraints oftime, financial resources, and limited access to clinical expertise, even in India. Nor isan exploratory clinical study feasible given the lead times involved. The semen lifecycleis 3 months to maturation, so sample base lining and a minimum number of samples to© Chris St. Clair Gribble 26
  32. 32. measure patient outcomes would exceed time constraints. Sadly there is little ayurvedicresearch literature published in accredited journals.Given these constraints a pragmatic approach was to find a recognised ayurvedic expertin the treatment of male infertility, to randomly select 30 plus male patients who hadcompleted a course of infertility treatment, and conduct a retrospective qualitative casehistory analysis. To provide an indicative measure of effectiveness some quantitativeanalysis was conducted regarding sperm motility, morphology and count as dependentvariables.The main aim of this study was to understand, document and communicate ayurvedicbest practice diagnosis and treatment of male infertility, and identify which herbs orformulations should be explored further for the treatment of male infertility.The main value of the study will be to provide newly qualified ayurvedic professionals acontemporary practice guideline for the diagnosis and treatment of male infertility.3 Methodology3.1 Research Approach, Design & SettingSDM College of Ayurveda & Teaching Hospital, India is one of the few Indian hospitalswith a dedicated department specializing in infertility. This department, containing bothinpatient and outpatient clinics, is run by the consultant physician Dr. B. S Prasad, oneof the few consultants specialising in infertility treatment, and provided the settingwhere this study took place.In medicine, a retrospective case study looks backward in time, using medical recordsand interviews, for a group of patients who have a known disease. The case studyapproach uses a mix of qualitative and quantitative approaches and has long been usedby clinicians as a method for understanding a disease (Bowling, 2002, p404). In thisrespect a case series should not be confused with qualitative research as they are basedon a mix of quantitative and qualitative evidence (Yin, 2003, p14). Others would arguethat the approach lacks rigour as the case records may not reflect the actual data, andthat the data and its interpretation cannot necessarily be verified (Kyburz-Graber,2004).© Chris St. Clair Gribble 27
  33. 33. Recognising these limitations, this research approach was employed to qualitativelyinvestigate case histories regarding patient diagnosis and treatment modality for sub-fertile males who had been under the expert care of a single consultant physician, andto quantitatively assess patient outcome through analysis of semen sample records.This was an exploratory before and after investigation of a single population who hadundergone treatment. There was no control, comparison group or sample stratification.The working hypothesis was that there would be an improvement in semen qualitycharacteristics in response to treatment. It is hoped this study will inform a future largerscale clinical audit to establish agreed practice guidelines with an aim to improve patientoutcomes.3.2 Ethical ApprovalThe study commenced once Ethical approval had been granted from MiddlesexUniversity Health Studies Ethics Sub-committee (appendix 4). This approval wasobtained when written permission to access patient records had been received from thedirector of the SDM hospital (appendix 5).All patient information recorded was kept strictly confidential, and the identity ofpatients protected by using an anonymous patient number at all times.3.3 Sampling ApproachA register of patient semen samples had been provided which held records from May2000 up to the current period of sampling. This register contained semen quality datain line with WHO guidelines (Jeyendran, 2000) on semen analysis, along with 2 otherclassically defined ayurvedic semen quality parameters. (Please refer to the semen datacollection template in appendix 6).From this register it was straightforward to identify patient records that met initialsemen sample inclusion criteria. Best practice suggests that there should be at least 2baseline semen samples separated by at least 1 month (Berman, 2004). This is toestablish an accurate baseline. Natural variation in semen samples are known to varysignificantly in relation to diet, lifestyle and environmental factors (Centola andGinsburg, 1996, p19). However, in all cases, only a single baseline sample had beenrecorded. It was communicated that this had been dictated by the cost of private© Chris St. Clair Gribble 28
  34. 34. treatment rather than desired protocol. Patient records were then identified as having atleast 3 semen samples over a minimum of a 3 month treatment period. As the spermlifecycle is 72 days, this sampling rate and measurement periodicity is in line withaccepted protocol (Oehninger and Kruger, 2006, p161), and thought to provide moreconfidence that a change would have been in response to treatment. This identified 31patient records for initial case history screening.These 31 patient records were retrieved from the administration office and only selectedfor detailed analysis if they met the following inclusion criteria:o A complete diagnosis including associated pathologies was documentedo A complete treatment history including associated dosage was documentedo A single consultant had been responsible for the course of treatmentAnd rejected if they met the following exclusion criteria:o An untreatable pathology has been identified e.g. azoospermia where no response to treatment would have been expectedo Semen analysis records were not fully documentedThis resulted in a convenience sample of 21 patient records for detailed case historyanalysis. The planned strategy to randomly select patient records that met the inclusioncriteria was not possible given the small number of available records that met theinclusion criteria.This overall sampling strategy was designed to ensure the available data reflected bestpractice clinical diagnosis. Such selective screening of patient records was essential tounderstand the treatment prescribed in relation to the underlying diagnosed pathology.3.4 Data CollectionThe research instrument was implemented in 3 phases. All the original paper based casenotes had been recorded mostly in English in a standard structured format with varyingdegrees of legibility. The associated semen samples had been recorded in a log book bypatient number in chronological order. Fortunately, the structured format reflected bestpractice WHO guidelines with respect to both diagnosis and semen characteristics.© Chris St. Clair Gribble 29
  35. 35. The first phase involved the transcribing and codifying of both data sets. The datacodification involved some data transformation of the prescription history into astandard format, and translation of any Sanskrit terms into English with the assistanceof attending interns. This also enabled validation of any illegible script.Best practice allopathic reproductive history includes coital history and timing, durationof infertility and prior fertility, childhood illnesses, developmental history, systemicmedical diseases, prior surgeries, sexually transmitted infections, and gonadal toxinexposure (Berman, 2004). Best practice ayurvedic diagnosis additionally includes aqualitative assessment with respect to digestion, tissue formation, body channels, wasteproducts, immunity and mental function in relation to both the seasonal and geographicenvironments. Both sets of data had been recorded with varying degrees of consistencyand completeness. The allopathic criteria regarding the initial physical examination andprevious medical history was well recorded whilst the ayurvedic systemic diagnosticcriteria were poorly recorded if at all. In observing patient diagnosis in the clinicalsetting, it became apparent that there was detailed ayurvedic analysis of the underlyingpathology, qualitatively assessing the systemic variables, and this was implicitlyrepresented in the initial treatment plan, but not explicitly recorded.From the transcribed data, each patient was classified according to one of the clinicalgroupings as defined by Dohle et al. (2005) namely sexual factors, UTI, congenital,acquired, varicocele, endocrine, immunological, abnormality and OAT syndrome.The case histories also included a full treatment history, including both radical shodanapurification and balancing shamana treatment. For each type of treatment prescribedmedicines, dosage, and prescription period, and patient progress had been recorded.From this data, a complete list of pharmacopoeia was extracted across all records, aswell as the primary medicine(s) prescribed for each patient and whether they hadundergone shamana treatment, or both shodana and shamana treatment.The second phase involved extracting the semen quality data for each patient. Thesemen sample log contained semen quality parameters according to accepted protocols(Jeyendran, 2000). This included macroscopic parameters of appearance, coagulationand liquefaction time, odour and colour, viscosity and volume. The log also containeddata for the microscopic parameters of non-sperm cellular elements, leukocytes,© Chris St. Clair Gribble 30
  36. 36. erythrocytes, epithelial cells, micro-organisms, sperm agglutination, concentration,count, motility and morphology. Data for the ayurvedic semen quality parameters ofphenila and avasādi were also extracted.Using standard WHO reference values (Rowe, 2000), each semen sample was thenclassified into one of the categories defined in table 14:Table 14 - Allopathic Semen Quality Characteristics Semen Classification Normal semen Normal semen with agglutination (>5%) Antibody coated spermatozoa (> 20% immobilized sperm) Oligozoospermia (less than 20 million spermatozoa per ml) Asthenozoospermia (less than 25% rapid linear progression) Teratozoospermia (less than 40% of sperm of normal morphology)The remaining ayurvedic semen parameters were derived from the extracted valuesaccording to a set of defined reference criteria used at SDM hospital. The referencecriteria were aligned to accepted allopathic clinical values, except for phenila andavasādi which are unique to ayurveda.It should be noted that some data transformation was performed to enable consistentclassification of the sample population, and to understand patient outcome.Quantitative values not recorded (NR) were transposed as null values. Where a rangehad been provided the top end of the range was taken as an absolute value. Qualitativevalues were transposed as normal values when not recorded. These transformationrules were consistent with the other associated data and from having observed therecording process.Hence, the semen sample data was codified according to valid measurement protocolsagainst accepted reference standards. This provided a baseline set of values to measurechange in sperm count, motility and morphology over time. This preliminary dataprovided the basis for the 3rd phase of data extraction, the consultant interview, whichformed the basis of the qualitative data analysis.(Please refer to the appendices 7-9 for the allopathic, ayurvedic reference standards andthe transformation rules applied).© Chris St. Clair Gribble 31
  37. 37. 3.5 Data AnalysisThe primary aim of this research was to drive out what constituted best practiceayurvedic diagnosis and treatment of male sub-fertility.A qualitative analysis took place in the form of a series of informal unstructuredinterviews with the consultant responsible for the patient treatment.The raw data collected in phases 1 and 2 was used to drive the consultant interviews.Time permitting, each case history was to be reviewed against a structured questiontemplate, and responses collected for further analysis. This did not prove possible asaccess to consultant time was limited, and could not support such an in-depth casespecific analysis. A pragmatic solution was agreed whereby a consolidated list ofpharmacopoeia prescribed across the sampled cases was reviewed against a set ofguiding clinical questions as outlined in table 15.Table 15 - Guiding Questions for the Consultant Interview Guiding Questions What constitutes best practice diagnosis of male infertility? How does one clinically diagnose sperm pathology in ayurveda? What are the preferred ayurvedic herbs or formulations used to treat male sub- fertility? What are your preferred herbs to treat the various sperm pathologies? What herbs would you suggest should be investigated further, and for which pathology? Are there alternative ayurvedic options to treating common pathologies associated with male sub-fertility? What other common pathologies associated with male sub-fertility does ayurveda treat and what is your preferred treatment approach? How effective is the ayurvedic treatment of male infertility? What is the general prognosis regarding the various pathologies associated with male sub-fertility?The interview process thus comprised a series of 12 discussions occurring betweenpatient sessions at Dr Prasad’s private clinic each evening for a period of 2 weeks. Thediscussions were not recorded at the request of the consultant.© Chris St. Clair Gribble 32
  38. 38. Prior to conducting the interview, an extensive review of the classical literature forpharmacopoeia associated semen quality had been conducted. Where identified, theLatin names of the herbs had been checked against the medical databases (AMED &PUBMED) for any existing research associated with semen quality. This data informedthe discussion with respect to why specific medicines had been prescribed, andfacilitated a clinical discussion on the ayurvedic view of sub-fertility pathogenesis.This approach yielded a deeper level of information than would have been obtained by asimple survey, and enabled the documentation of the consultant’s view of whatconstituted best practice diagnosis and treatment of male sub-fertility based on hisextensive years of clinical experience.A measure of quantitative analysis on patient semen samples was also conducted. Themain value in the semen records had been the categorisation with respect to semenquality and baseline diagnosis. This was derived from the raw data using acceptedprotocols as already outlined. However, semen samples were also analyzed as to howthey changed over time to provide an indicative measure of therapeutic value. The wordindicative must be stressed as this was a small scale retrospective study with no controlor comparative group. Here the independent variable was considered the “totaltreatment intervention” with dependent variables of sperm count, motility, andmorphology.As there was no control group, no comparison group and too small a sample size toenable statistical power, the quantitative analysis is only indicative and should not begeneralised. The sample represented a mix of varying pathologies so samplestratification did not provide enough cases to assess idiopathic infertility. Also whilst themeasurement parameters used accepted protocols to ensure content validity, therewere concerns regarding measurement reliability. It was noted that there was astandard rotation of interns conducting the semen sample analysis. Although theyworked under the supervision of the consultant, this suggested poor measurementreliability, both between patients and within a set of patients’ semen samples. Internalquality control with respect to semen quality is a common problem of reliability that isoften overlooked (Cooper, Neuwinger, Bahrs and Nieschlag, 1992).© Chris St. Clair Gribble 33
  39. 39. Sample distribution was investigated using the one sample Kolmogorov-Smirnov testand changes between baseline and post-treatment patient outcomes were measuredusing the Wilcoxon Signed Rank test; the statistical package for Social Science (SPSS)was used to generate these values.3.6 Constraints & LimitationsApart from the limitations in methodology and sampling already outlined, there are afew broader constraints that should be made explicit.A preferred treatment strategy cannot be generalised as best practice when:o The sample size was small and in a single setting. However, to conduct a large multiple centre audit was beyond the study scope.o There was little visibility of the true measure of success - couple conception rates for the cases studied.o In-depth case history analysis was constrained as the systemic ayurvedic diagnostic data had not been adequately recorded.o Patient outcome and correct diagnosis could not be adequately verified in the context of a retrospective study.4 ResultsThe sampling strategy had identified 31 case histories. Screening against both theinclusion and exclusion criteria eliminated 11 cases, resulting in 21 cases for furtheranalysis. One case had no associated semen record, 6 cases had less than 3 semensamples, 3 cases had incomplete case notes, and one case was designated asazoospermia. The selected cases and associated semen samples provided a rich data setto investigate the sample demographics, disease classification, prescribed medicines andprovide an indication of treatment response.However, there was one major gap in the data, the ayurvedic systemic diagnostic data,which could have enabled an energetic analysis of both treatment programme and theunderlying pathogenesis in relation to the resultant semen parameters.© Chris St. Clair Gribble 34

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