{"paper_id":"a5f65540-e10b-4cc8-bdfc-1ff6918a8ca0","body_text":"ORIGINAL ARTICLE\nS. Lalchandani Æ A. Baxter Æ K. Phillips\nIs helium thermal coagulator therapy for the treatment of women\nwith minimal to moderate endometriosis cost-effective?\nA prospective randomised controlled trial\nAccepted: 3 May 2005 / Published online: 17 August 2005\n/C211Springer-Verlag Berlin / Heidelberg 2005\nAbstract This study compared the cost and time in-\nvolved of helium thermal coagulator (HTC) treatment\nwith medical therapy using gonadotrophin-releasing\nhormone analogues in women with minimal to moderate\nendometriosis. In a prospective randomised controlled\ntrial, 35 women with history of pain were, upon confir-\nmation of minimal to moderate endometriosis at diag-\nnostic laparoscopy, randomised to immediate surgical or\nmedical treatment. They were asked to complete ana-\nlogue pain score sheets, and their symptoms were re-\nviewed before treatment and at 3, 6, and 12 months after\ntreatment. The cost of the medical or surgical treatment\nwas evaluated from the time of diagnosis to the time of\ncure or symptom relief. The average cost per Helica\nprobe is £111.81 with the machine on free loan, and the\ntotal cost of a 6-month course of injectable Zoladex with\nadd-back therapy is £811.92. The costs involved in the\ntwo treatment modalities were analysed using the\nMann–Whitney test; a p-value <0.05 was considered\nsignificant. In the medical group, three women out of 18\nwere symptom-free, 11 required surgical treatment of\nendometriosis, one had a laparoscopically-assisted\nvaginal hysterectomy, and three became pregnant before\ntheir final reviews. In the surgical group, nine women\nwere symptom-free at the end of 12 months, four re-\nquired Zoladex therapy, one required oral contraceptive\npills, and three required repeat surgical treatment. The\naverage cost per patient in the surgical arm was £323.29\nand in the medical arm was £918.12 ( p<0.0001). Mean\noperating times in the surgical and medical arms were\n32.35 min and 20.83 min, respectively. This suggests that\nwhen facilities and expertise are available, it is better to\nsee and treat mild to moderate endometriosis. There\nwere no surgical complications in our series. Surgical\ntreatment with HTC therapy is safe and is a cheaper and\nmore effective therapy. This is the first study that has\nlooked at the cost-effectiveness of HTC therapy in\nmanaging mild to moderate endometriosis.\nKeywords Endometriosis Æ Helium thermal\ncoagulator Æ Cost-effectiveness\nIntroduction\nEndometriosis, characterised histologically by the pres-\nence and growth of endometrial glands and stroma\noutside the uterine cavity, is a chronic recurring disease\ncommonly encountered in women of reproductive age\n[1]. It is found in 71% of laparoscopies for pelvic pain\nand in 84% of cases in which pain and infertility are\ncomplaints [ 2]. Its frequent occurrence seen at laparos-\ncopy in asymptomatic women has led to the suggestion\nthat this may be a normal physiological process that\nbecomes a disease only when the patient is symptomatic\n[3]. However, once symptomatic, it can be an extremely\ndebilitating condition, causing chronic pelvic pain,\ndysmenorrhoea, dyspareunia, and infertility, and its\nmanagement is often frustrating for both the patient and\nthe gynaecologist [4]. The diagnosis of endometriosis can\nbe elusive and confirmed only by visualisation, i.e. lap-\naroscopy, which is considered to be the gold standard\nfor diagnosing the disease [ 5]. Treatment for the condi-\ntion is either medical or surgical.\nS. Lalchandani ( &)\nDepartment of Obstetrics and Gynaecology,\nSt. Munchin’s Regional Maternity Hospital,\nEnnis Road, Limerick, Republic of Ireland\nE-mail: savitalal5555@yahoo.com\nTel.: +353-61-483148\nFax: +353-61-482731\nA. Baxter\nDepartment of Obstetrics and Gynaecology,\nJessop Hospital for Women, Leavy Greave Road,\nSheffield, South Yorkshire, S3 7RE, UK\nE-mail: Ted.Baxter@sth.nhs.uk\nK. Phillips\nDepartment of Obstetrics and Gynaecology,\nCastle Hill Hospital, Castle Road, Cottingham,\nEast Yorkshire, HU16 5JQ, UK\nE-mail: Kevin.Phillips@hey.nhs.uk\nGynecol Surg (2005) 2: 255–258\nDOI 10.1007/s10397-005-0123-7\n\nSeveral medical strategies are available for treating\nendometriosis. These include combined oral contracep-\ntive pills, progestogens, Danazol, gestrinone, and\ngonadotrophin-releasing hormone analogue (GnRH-a)\nwith or without add-back therapy. Of these, the two\nmain drugs used are GnRH-a and, until recently,\nDanazol. Both have been shown to decrease symptoms\nwhen compared with placebo [ 6, 7]. A large Cochrane\nmetaanalysis of 26 randomised controlled trials con-\nfirmed GnRH-a to be effective in relieving pain [ 8, 9].\nHowever, long-term follow-up studies show a high\nrecurrence rate following medical treatment [ 10, 11].\nSurgical treatment for endometriosis is now usually\nperformed laparoscopically. By this minimally invasive\nmethod, the endometriotic lesions are either excised or\nablated using laser, monopolar, or bipolar diathermy or\nnewer methods such as helium thermal coagulator\n(HTC) therapy.\nAlthough both medical and surgical therapy have been\nshown to satisfactorily treat endometriosis, no published\nstudies have compared the cost or the operating time\ninvolved in the two treatment modalities, considering\nthat a diagnostic laparoscopy will be involved in making\na diagnosis before commencing medical therapy. Direct\nand indirect medical costs associated with this condition\nare estimated to be more than $3 billion in the United\nStates annually before factoring in the costs of diagnostic\ntesting [12]. Thus, it is important to make an appropriate\nchoice for an optimal treatment.\nMethods\nAll women presenting to the gynaecology outpatient\nclinic with a history of pelvic pain, dysmenorrhoea, dy-\nspareunia, and dyschesia suggestive of endometriosis or\nwho had previously been diagnosed as having the disease\nwere asked to enter the trial. All women who were less\nthan 16 years of age, pregnant, or subfertile were ex-\ncluded from the study. Power studies were performed\nprior to the study, and 25 patients were required in each\narm. However, only one in three women who were asked\nto enter the trial agreed because two in three wished to\nhave surgical therapy if they were diagnosed with endo-\nmetriosis. A total of 35 women between September 1999\nand March 2001 were recruited for this study.\nAll the women with suspected endometriosis were\nsubjected to a diagnostic laparoscopy as a day-case\nprocedure, and any endometriosis found was staged\naccording to the American Fertility Society classification\n[13]. Randomisation into either HTC or GnRH-a ther-\napy was done at the time of diagnostic laparoscopy. All\nwomen were given visual analogue pain scores preop-\neratively and 3, 6, and 12 months postoperatively, and\ntheir symptoms were taken into consideration. Women\nin the surgical arm had either ablation or excision of all\nendometriotic lesions with HTC therapy. Women who\nhad diagnostic laparoscopy had only a proper staging of\nthe disease.\nAll women in the medical arm were given six injec-\ntions of GnRH-a with add-back hormone replacement\ntherapy (HRT) every 28 days. These women were seen\nin the outpatient clinic 3, 6, and 12 months after the end\nof treatment.\nMechanism of action of HTC therapy and GnRH-a\nHTC generator\nAn HTC generator is a device capable of producing low\noperating powers. It has a high-output impedance circuit\nthat limits the flow of energy. It operates at power levels\nlower than 5 W but still produces a satisfactory caute-\nrising effect. Combining helium within the Helica gen-\nerator produces an ionised plasma beam/corona-type\nflame at very low levels of energy. The energy is deliv-\nered to the target tissue via a probe. The discharged\nbeam has a high molecular temperature typically of the\norder of 800 /C176C; the beam takes place within the plasma\nprovided by the flowing inert gas (helium). The power\nemission can be regulated to emit levels from 1 to 33 W.\nFor coagulation purposes only, the discharged plasma\non 4-s bursts will achieve a maximum level of tissue\npenetration of 1.1 mm. In our trial, the same coagulat-\ning probe was also used for cutting (energy can be\nconcentrated by the probe with tension on the tissues).\nHowever, we are aware that the company has manu-\nfactured probes with a coagulating and cutting compo-\nnent in the same probe.\nOur hospital negotiated with the company to have\nthe machine on loan and buy more than 10 probes per\nmonth. Various financial arrangements can be made\nwith the company. In the free loan option, the machine\nis free, and the average cost per probe is £111.81. In the\nmachine purchase option, the machine costs £17,192,\nand the average cost per probe is £63.63. One probe is\nused per patient.\nGnRH-a therapy\nGnRH-a acts continuously on the GnRH receptors,\nresulting in the downregulation and desensitisation of\nthe pituitary gonadotroph. This results in the chronic\nsuppression of gonadotrophin secretion, luteinising\nhormone, and follicle-stimulating hormone and the\ncessation of ovarian activity and, consequently, a de-\ncrease in circulating oestradiol levels, creating a\npseudomenopausal state. This causes predictable side\neffects, namely those symptoms experienced by women\nat menopause. The other problem associated with a 6-\nmonth course of GnRH-a is a reduction in vertebral\nbone mineral density (BMD) of approximately 3–4%.\nThis concern has therefore limited its use to a 6-month\nduration [ 8, 9]. In a multicentre randomised double-\nblinded trial using a 12-month course of GnRH alone,\nwomen experienced a BMD loss in the lumber spine of\n3.2% at 6 months and 6.3% at 12 months and com-\n256\n\nplained of hot flashes, which were dramatically sup-\npressed in the add-back HRT groups, whereas women\nreceiving add-back HRT for 12 months had a signifi-\ncantly negligible (<1%) BMD loss [ 14].\nMain outcome measures and statistics\nThe main outcome measures were the costs and oper-\nating times involved in the two treatment modalities.\nAnalysis of costs was performed using the Mann–\nWhitney test. Analysis was undertaken using the Sta-\ntistics Package for Social Sciences (SPSS) for Windows.\nA p-value <0.05 was considered significant.\nResults\nA total of 35 women were included in the study. Eigh-\nteen women received medical and 17 received surgical\ntreatment of endometriosis. Their mean age was\n32.8 years (range 20–45 years), and mean parity was 1\n(range 1–3). The mean revised American Fertility Soci-\nety scores were 5 (range 2–12) for the medical group and\n6 (range 2–12) for the surgical group.\nAll 35 women underwent diagnostic laparoscopy\nbefore being randomised into the two treatment\nmodalities. Therefore, the basic cost incurred for diag-\nnostic laparoscopy was the same for all patients. There\nwere no surgical complications reported in this series.\nAll of the women were reviewed at 3, 6, and\n12 months following their treatment. In the medical\ngroup, three women out of 18 were symptom-free (17%),\n11 required surgical treatment of endometriosis, one had\na laparoscopically-assisted vaginal hysterectomy, and\nthree became pregnant before their final reviews.\nIn the surgical group, nine women out of 17 were\nsymptom-free at the end of 12 months (53%), four\nrequired Zoladex therapy, one required oral contracep-\ntive pills, and three required repeat surgical treatment.\nThe costs involved were significantly higher in the\nmedical group (Tables 1, 2; Mann–Whitney test p-value\nof 0.0001).\nAn extra 11.5 min was required to surgically treat\nmild to moderate endometriosis in 17 patients who were\nallocated to the surgical group (Table 3).\nAnalysis of the pain scores (using the Wilcoxon\nnonparametric test) and of the success rates of the two\ntreatment modalities (using the chi-square test) will be\ndiscussed in our second paper comparing the effective-\nness of medical versus surgical treatment.\nDiscussion\nWomen with endometriosis have a symptom complex of\npelvic pain, dysmenorrhoea, dyspareunia, and dyschezia,\nwhich can cause profound ill health and reduced quality\nof life. Various studies have looked at different medical\nand surgical treatment options. Additional complexity\nhas been added to the healthcare decision-making pro-\ncess by the socioeconomic constraints of the industry and\nby a population that is increasingly educated about\nhealthcare. As a result, decisions balanced on the basis of\noutcomes and economic realities are needed. This mod-\nelling of surgical versus medical treatment costs for\nchronic pelvic pain and endometriosis factors in the large\nnumber of women with chronic pelvic pain, direct and\nindirect costs of the condition, and the clinical benefits,\nprojected costs, and savings of the therapies. This process\nof calculation becomes an aid for decision-making in the\ncurrent healthcare system [ 15].\nThere has been debate about 3- versus 6-month\nGnRH-a therapy. Heinrichs and Henzl have suggested\nthat GnRH-a administration for 3 months is a cost-\neffective approach. In their series, reduction in endo-\nmetriosis symptoms and signs was similar at the end of 3\nand 6 months [ 16]. Notably, various side effects are\nassociated with GnRH-a therapy.\nWinkel suggested that medical treatment is cheaper\nand safer than surgical treatment [ 17]. In our study\ngroup, surgical treatment with HTC appeared to be a\nsafer, cheaper, and more effective therapy. There were\nno surgical complications in our series, and patients had\nprompt relief of symptoms without the possible side\neffects of medical treatment. In our series, 12 out of 18\nTable 1 Treatment outcomes in the two groups\nGroup Further\ntreatment\nNumber\nof cases\nCost per\npatient\nMedical None 6 £811.92\nMedical Surgical 11 £923.73\nMedical Hysterectomy 1 £1,493.63\nSurgical None 9 £111.81\nSurgical Medical 4 £923.73\nSurgical Oral contraceptive 1 £123.81\nSurgical Surgical (repeat) 3 £223.62\nTable 2 Cost\nMean total cost per patient ( p<0.0001)\nSurgical arm £323.29\nMedical arm £918.12\nTable 3 Operating time\nMean operating time\nSurgical arm 32.35 min (range 20–50)\nMedical arm\n(diagnostic laparoscopy)\n20.83 min (range 15–35)\nDifference 11.52 min\nCost\nInjectable Zoladex (goserelin) 3.6 mg £122.27\nLivial (tibolone; add-back), 28-pack £13.05\nTotal cost for 6 months £811.92\n257\n\npatients in the medical group underwent subsequent\nsurgical treatment, adding to the cost of already\nexpensive treatment.\nApart from the cost-effectiveness of surgical treat-\nment, another important point shown in our study is\nthat by spending only an extra 11.5 min in the operating\ntheatre, 53% of the patients with minimal to moderate\nendometriosis were successfully treated.\nTo our knowledge, this is the first study that has\nlooked at the cost-effectiveness of HTC therapy in\nmanaging mild to moderate endometriosis.\nAcknowledgements The authors gratefully acknowledge the help of\nMr. Stephen Lindow.\nReferences\n1. Thomas E (1999) The clinician’s view of endometriosis. Int\nJ Gynaecol Obstet 4(Suppl 1):S1–S3\n2. Koninckx PR, Meuleman C, Demeyere S, Lesffre E, Cornillie\nFJ (1991) Suggestive evidence that pelvic endometriosis is a\nprogressive disease, whereas deeply infiltrating endometriosis is\nassociated with pelvic pain. Fertil Steril 55:759–765\n3. Tierney R, Prentice A (2002) The medical management of\nendometriosis. Rev Gynaecol Pract 2:91–98\n4. Brosens IA (1999) Symptomatic endometriosis: focus on\nrecurrent ectopic bleeding as a defining feature of endometri-\nosis and a therapeutic target. Hormonal Ther Obstet Gynaecol\n5:4–11 [Biomedis]\n5. Rice VM (2002) Conventional medical therapies for endome-\ntriosis. Ann N Y Acad Sci 955:343–352\n6. Telimaa S, Puolakka J, Ronnberg L, Kauppila A (1987) Pla-\ncebo-controlled comparison of danazol and high-dose med-\nroxyprogesterone acetate in the treatment of endometriosis.\nGynecol Endocrinol 1(1):13–23\n7. Dlugi AM, Miller JD, Knittle J (1990) Lupron depot (leupro-\nlide acetate for depot suspension) in the treatment of endo-\nmetriosis: a randomized, placebo-controlled, double-blind\nstudy. Lupron Study Group. Fertil Steril 54:419–427\n8. Prentice A, Deary AJ, Goldbeck-Wood S, Farquhar C, Smith\nSK (2000) Gonadotrophin-releasing hormone analogues for\npain associated with endometriosis. Cochrane Database Syst\nRev 2:CD000346\n9. Wright S, Valdes CT, Dunn RC, Franklin RR (1995) Short-\nterm lupron or Danazol therapy for pelvic endometriosis. Fertil\nSteril 63:504–507\n10. Minjarez DA, Chaff WD (2000) Update on the medical treat-\nment of endometriosis. Obstet Gynecol Clin North Am\n7(3):641–651\n11. Wellbery C (1999) Diagnosis and treatment of endometriosis.\nAm Fam Physician 60(6):1753–1762, 1767–1768\n12. Barbieri RL (1997) Primary gonadotropin-releasing hormone\nagonist therapy for suspected endometriosis: a nonsurgical\napproach to the diagnosis and treatment of chronic pelvic pain.\nAm J Manag Care 3(2):285–290\n13. The American Fertility Society (1985) Revised American Fer-\ntility Society classification of endometriosis. Fertil Steril\n43:351–352\n14. Hornstein MD, Surrey ES, Weisberg GW, Casino LA (1998)\nLeuprolide acetate depot and hormonal add-back in endome-\ntriosis: a 12-month study. Lupron Add-Back Study Group.\nObstet Gynecol 91(1):16–24\n15. Winkel CA (1999) Modelling of medical and surgical treatment\ncosts of chronic pelvic pain: new paradigms for making clinical\ndecisions. Am J Manag Care 5(Suppl 5):S276–S290\n16. Heinrichs WL, Henzl MR (1998) Human issues and medical\neconomics of endometriosis. Three versus 6-month GnRH-\nagonist therapy. J Reprod Med 43(Suppl 3):299–308\n17. Winkel CA (2000) A cost-effective approach to the manage-\nment of endometriosis. Curr Opin Obstet Gynaecol 12(4):317–\n320\n258","source_license":"CC0","license_restricted":false}