The LUNA procedure has no effect on endometriosis pain

Dr Neil Johnson interviewed by Deborah Bush QSM
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Deborah Bush QSM: Hello, my name is Deborah Bush and I’m the Chief Executive of the New Zealand Endometriosis Foundation. I’m also on the international Advisory Board for Endometriosis Zone and I’m talking this afternoon to Neil Johnson, who is a senior lecturer at the University of Auckland. He’s an Obstetrician/Gynaecologist at National Women’s Hospital in Auckland. He’s an REI sub-specialist with Fertility Plus and he’s also a gynaecologist at the University Specialists. 

Neil, you’ve done a fairly long study. I’ve listened with interest over five years about the double-blinded trial on the LUNA Project.  I noticed while listening that there is already a lot of disparity in the research, and I’d be really interested if you told us this afternoon what the outcome of your trial was, and a little bit about it. 

Neil Johnson MD:  Well, LUNA, as you know Deborah, stands for Laparoscopic Uterine Nerve Ablation, and it’s a very simple technique where you can divide the uterine nerve that seems to carry some pain fibres from the uterus. We were very interested in this because there was a lot of research that had gone on before, which had conflicted in saying whether or not this was effective for either women with endometriosis, or indeed, women with chronic pelvic pain, without any evidence of endometriosis.  

So we recruited, as you said, for five years, to this trial, and we had 123 women who very kindly participated. The summary of the result was that for women with endometriosis, who were in any case undergoing gold standard laparoscopic excision of endometriosis, the LUNA, the laparoscopic uterine nerve ablation really didn’t add anything at all to the surgical removal of endometriosis in terms of the pain outcomes.  

Deborah Bush QSM:  It was interesting findings. I noticed some of the questions that followed on from your presentation indicated, particularly from some of the Australians, that they wished that some of their colleagues would also, as you said quite aptly, put a rocket behind LUNA and send it into orbit. I thought that was quite a nice scenario at the end of your presentation.  

Neil Johnson MD:  I think that there are still some funding incentives to specialists in some parts of the world to continue to offer this. Certainly I think for endometriosis, we were reasonably clear that there’s no evidence that it’s effective in addition to adequate surgery.  

Deborah Bush QSM:  How does it conflict with some of the other research on LUNA in other parts of the world, Neil? 

Neil Johnson, MD:  I think it’s largely been an interpretation of the research that’s been done, because certainly our meta analysis, which we did of all of the other studies prior to the trial, gave us more or less a similar result. We have found no evidence from any of the very good studies, and what we’re talking about would be randomised controlled trials obviously the best of the gold standard way of measuring how effective a treatment is. None of those randomised trials have really shown any evidence that LUNA in its own right is effective for women with endometriosis. 

Now, it’s a slightly different story for women who haven’t got endometriosis, but even for those women the margin of benefit would be likely to be small. But very clearly, for endometriosis, at the moment we have no evidence that it’s beneficial. Nor have any of the other good studies shown that. 

Deborah Bush QSM:  So the benefits for LUNA are for women who don’t have endometriosis? Can you clarify that issue for us? 

Neil Johnson MD:  It’s really if a woman’s main symptomatic component is severe menstrual pain, severe dysmenorrhoea, in the absence of any other type of pain, sexual pain, or non-menstrual pain, or pain related to bowel movements. So if dysmenorrhoea, and severe dysmenorrhoea, is the primary component, if there’s no evidence of endometriosis, sometimes a woman will benefit from a LUNA procedure. But of course, it is an operative procedure, and there’s no guarantee that it will work.  

Deborah Bush QSM:  Well, thank you very much. Are the results going to be posted anywhere or published? 

Neil Johnson MD:  In addition to the Australian Gynaecological Endoscopy Society meeting, which we’re holding at the moment, I’m hoping to present this at the British Congress of Obstetrics and Gynaecology later on this year in Glasgow. We’ve recently just prepared this to be submitted as a paper for an external periodic journal. It should be in print, hopefully later in the year. 

Deborah Bush QSM:  I’m sure there will be a lot of people interested in having a look at that research and it might spark some further debate. I don’t know whether anyone is keen to undergo further study, I think this was really conclusive Neil, and the findings here at National Women’s. So congratulations on the study and thank you very much for talking with us this afternoon. 

Neil Johnson MD:  Thank you very much Deb.

Feedback/Questions:

Comment: 
I determined in 1987 that LUNA added nothing for my patients. It wasn't a randomised controlled trial, just listening and sending out hundreds of questionnaires and tabulating and analysing the results. I found that uterine cramping with menses was the type of pelvic pain least likely to respond to excision of endometriosis, and LUNA (which had recently been developed specifically to try to treat uterine cramps) didn't seem to emerge as very helpful. 

It was at that time that I began to review the literature on surgical relief of uterine cramps and was impressed
that presacral neurectomy had a much longer track record (since 1899), made more sense anatomically, and had better support even then in the literature.  I resolved to begin to offer presacral neurectomy to my patients who had severe/debilitating painful cramps with menses. I did my first laparoscopic presacral neurectomy in 1988 and after a few years and a few more hundreds of questionnaires, I was able to show that PSN added a layer of pain relief beyond what excision alone accomplished, because now uterine cramping had a chance of responding to something done specifically for that symptom. A recent Italian study confirmd with an RCT that PSN works (Zullo F, Palomba S, Zupi E, Russo T, Morelli M, Cappiello F, Mastrantonio P.Effectiveness of
presacral neurectomy in women with severe dysmenorrhea caused by endometriosis who were treated with laparoscopic conservative surgery: a 1-year prospective randomised double-blind controlled trial. Am J Obstet Gynecol. 2003 Jul;189(1):5-10.) I have also seen symptoms suggestive of interstitial cystitis improve following PSN. 

I've done over 400 laparoscopic PSNs and the worst that I can say about the procedure is that it doesn't always work. Perhaps some of what women interpret as uterine cramping is due to something else. For example, I've frequently heard from women with previous hysterectomy/oophorectomy, and who also have persistent
endometriosis, that they feel just like the cramping they had when the uterus was in place. Some of the nerves that are cut carry the sensation of bladder fullness, and a rare patient may feel a different sensation when the
bladder is full. They don't leak urine, don't get more infections, and they void normally. However, through questionnaire follow-up, it is clear that most women have no change in sensation of bladder fullness. Some of the nerves that are cut go to the sigmoid colon and slow it down, so following a PSN, the "brake" is released so women can have a reduced sense of constipation. They're not incontinent of stool, don't have diarrhoea, and most women actually don't have any cognizance of a change of bowel function. Laparoscopic presacral neurectomy is a very simple, low-risk procedure, when carried out by an experienced surgeon. 

David Redwine, MD