Well here I am again for another exciting update :-)

My plan was to write an update about every week, and keep up a daily routine of exercise, Movicol, Vitamins, Anoheal, Yoghurt and hot baths. After about three weeks of this I definitely began to see some good improvement, but after about five weeks of intense exercise I essentially was so worn out I came down with the worst case of flu I've ever experienced. I literally looked like death and was in bed for a week!

Anyhow I somehow kept up with the Anoheal and things seemed to be going well. After two months I stopped using it - probably around the end of May. I then went nearly four months of everything seemingly back to normal - that was until around a week ago.

I wasn't aware of any major trauma down there, but basically things started to feel uncomfortable again. I'd had diarrhoea a couple of times, and possibly a more solid that usual poop but nothing that I thought was a problem.

I tried using Anoheal again (I still had some in the fridge), but reacted badly to it (maybe because it had expired?, I dunno). So here I am again :-( I really thought I had beaten this thing, but seemingly not.

Things aren't *quite* so bad this time, but it's the second relapse I've had, although this time I seem to have lasted longer which is something I guess.

Not entirely sure what the answer is. My GP doesn't seem to know what to do, but has given me a repeat prescription of Anoheal. I think my plan is going to be to get a new tube of Anoheal and get back to exercising, hot baths, and multivitamins - in particular vitamin C. Whatever I was doing before seemed to do the trick after only about three weeks. Although this time I'm planning on using the movicol for longer. I'm also taking the exercise a bit easier. I'll also book an appointment with my consultant.

Hopefully things will improve! Finger crossed. Does anyone know how long Anoheal continues to work after stopping using it? I guess I am worried that my "success" is just the Anoheal, and then it kind of wears off after a few months...?

It really helps to get things down on paper with this problem (at least for me), and it helps that others can relate.

Wishing everyone success in their struggles, and stay positive :-)

- LemonMan

Hello all,

As I seem to have experienced a repeat of my anal fissure, I wanted to know a bit more about Diltiazem cream (or Anoheal in the UK) and to fully understand the drug and if recurrence was normal. I also wanted to know if the supply I had in the fridge was still okay, or if I should get some more. Basically I wanted to know the full ins and outs of the drug, so went away and did some research. I feel better informed now, so thought I would share my conclusions with everyone here. The usual caveats apply in that I am not a Doctor or anything, and this is only my own conclusions. Anyhow hope it's useful to someone out there.

Apologies if there are any typos. Feel free to disagree with my findings ;-) Apologies if someone else has posted something similar elsewhere.

Anoheal (Topical diltiazem) - Questions and Answers

Questions

1. How does it work?
2. How should it be used?
3. How long should you use it?
4. When will I see improvements?
5. What is the shelf life?
6. What are the side effects?
7. What is the success rate?

Answers in short:

Anoheal works by relaxing the anal sphincter and increasing the amount of blood to help with the healing process. It's applied to the anus as a topical cream. It should be used for at least 8 weeks, with some trials testing for 12. You should see some significant improvement after around 3 weeks of usage. The product should be usable for at least 3 months if stored in the fridge. A small number of people experience headaches (up to 5%) and some (up to 15%) experience anal itching, although this may be controllable with a barrier cream

The long version:

1. How does it work?

Anoheal (Topical diltiazem) is an unlicensed (in the UK) topical treatment for anal fissures. The term unlicensed simply means the manufactures have not yet provided statistical clinical evidence that the product works and is safe[1]. However a number of trials have been conducted and the empirical evidence highly suggests the product meets this criteria[2]. As of 2012 Anoheal was at phase 3 of testing[11] – phase 4 being the licensed product[12]. However in 2014 it appears development of the product was discontinued[14] although there is no issue obtaining the product via the NHS on prescription.

Diltiazem is a calcium channel blocker and vasodilator[3][15]. The surface lining of blood vessels contain calcium receptors which regulate the contraction and relaxation of the blood cell. A calcium channel blocker blocks calcium from entering the cell and causes the cell to relax[4]. A Vasodilator is an agent that widens the blood vessels causing increased blood flow[5].

Following a tear in the lining of the anal sphincter the body attempts to repair the wound. In order to grow new tissue the a process called Angiogenesis is required. This is a process where new blood vessels form from pre-existing vessels [6]. The increased tone (pressure) of the sphincter, compared to other parts of the body, inhibit this process. The use of diltiazem reduces sphincter tone and increases blood flow allowing the repair process to be more effective[7].

2. How should it be used?

Diltiazem (Anoheal) cream is applied to the opening, and “just inside” the anus twice a day (morning and evening) in the location of the fissure. The usual recommended amount is 2.5cm of cream[7], although other recommendations refer to a “pea-size” as sufficient[8]. It is normally recommended a stool softener is used in conjunction with the product to reduce trauma during bowel movements.

3. How long should I use it?

The normal recommended usage period is 8 weeks[9], although recommendations vary between 6 and 12 weeks[10]. It is important to continue to use the product for the prescribed period of time. Patients sometimes stop using the treatment after symptoms improve only to relapse due to insufficient healing[9].

4. When will I see improvements?

A study comparing a placebo with diltiazem at 4% and 2% strengths showed a significant pain redcution for both strengths at week three[16]. My own personal experience was a relief from pain after about the same period.


5. What is the shelf life?

Most references point to a normal recommended expiry (after opening) of 4 weeks with refrigerated use. However a recent article[13] suggests a much more conservative “in-use stability” of 4 weeks at 25ºC (room temperature) and 6 months if stored below 25ºC. If stored for 4-7 days above 25ºC the product can be returned to the refrigerator with no change to the shelf life (6 months).

A recent supply obtained personally on the NHS in May 2016 had an expiry date of November 2018! The usage guide advised to keep the medicine refrigerated and to not use past the expiry date. In conclusion a 6 month shelf life seems reasonable. In my summary above, I have suggested 3 months.

All references advise to avoid freezing, and to destroy post expiry.

What are the side effects?

The main side effect are headaches (1-5%) and anal itching (5-15%)[18]. My personal experience included a mild headache upon first using the product which did not repeat. I also experienced anal itching but have been able to control this with products such as Savalon.


What is the success rate?

Numerous clinical trials have been performed. A summary of some of them are as follows:

All trials using 2% diltiazem

Nelson 2012, 200 adults, 6-8 weeks, 18-58 years. 80% healing, 12.5% recurrence[17]

Sanei 2009, 102 adults, 12 weeks, 17-61 years. 67.7% healing, recurrence not reported[17]

Abd Elhady 2009, 160 adults, 8 weeks, 17-70 years, 80% healing, 65% recurrence[17]

Samin 2012, 134 adults, 12 weeks, mean age 46+/- 16, 43% healing, 17.6% recurrence[17]

Suvarna 2012, 200 adults, 6 weeks, 18-65 years, 69% healing, 10% recurrence[17]


References:

[1] https://www.nice.org.uk/advice/esuom3/ifp/chapter/Licensing-medicines
[2] https://www.nice.org.uk/advice/esuom3/ifp/chapter/Summary-of-possible-benefits-and-harms
[3] https://www.nice.org.uk/advice/esuom3/chapter/Key-points-from-the-evidence
[4] https://www.bhf.org.uk/research-projects/investigations-into-calciumsensing-receptor-mechanisms-in-the-vasculature
[5] https://www.drugs.com/drug-class/vasodilators.html
[6] https://en.wikipedia.org/wiki/Angiogenesis
[7] http://www.stmarksfoundation.org/uploads/docs/patientinformationleaflets/PIL%20Diltiazem.pdf
[8] http://cambridgebowelclinic.co.uk/Conditions/Anal-Fissure
[9] http://www.oxfordpelvicfloor.co.uk/PDFs/rectogesicanoheal.pdf
[10] https://www.nice.org.uk/advice/esuom3/chapter/Overview-for-healthcare-professionals
[11] http://www.biospace.com/News/ventrus-biosciences-inc-unveils-positive-results/260088/source=TopBreaking
[12] http://www.nhs.uk/conditions/medicinesinfo/Pages/Safetyissues.aspx
[13] https://www.sps.nhs.uk/medicines/diltiazem/
[14] http://adisinsight.springer.com/drugs/800019493
[15] https://pubchem.ncbi.nlm.nih.gov/compound/diltiazem#section=Top
[16] http://www.biospace.com/News/ventrus-biosciences-inc-unveils-positive-results/260088/source=TopBreaking
[17] https://www.nice.org.uk/advice/esuom3/chapter/Evidence-review-efficacy
[18] https://www.nice.org.uk/advice/esuom3/chapter/Evidence-review-safety

What a crap week. I've been a bit depressed this week. I'm trying to keep a outward smile for friends and family, but inside I'm down. It's difficult to be positive all the time and somehow I feel I must have done something wrong to deserve this. It's an illogical thought process, but when you are down you don't think logically. I have been keeping it from my wife this time, but found a moment to tell her. She was reassuring, but I don't think anyone can really understand this who hasn't been through it.

From my previous post you may see I've been researching Anoheal. The main questions I had were, how long it lasts in the fridge and when I sould see some improvement.

When I first got my fissure (following severe constipation) I thought I was healed within only a couple of weeks, and stopped using it. Two months later I was back to square one. I then used it again, but this time thought I must have a chronic fissure and was worried if it would still work. It itched the second time, but I worked out a way to control the itching using Canestan (I've now moved to Savalon) after about three to four weeks I had some definite improvement and kept on using it for the full 8 weeks. Four months or so later I had another relapse.

I'm now on week one of the treatment again, and I'm scared again that the treatment won't work. I've therefore been doing a lot of research into diltiazem (see previous post) to understand what I should expect and see what other people have experienced. Knowledge is power so they say, and it has helped a bit understanding it more. I am now hoping for improvement over the next couple of weeks.

The consultant I saw (an excellent man in Harley Street) told me I had a “very obvious fissure”. I am hoping to see some improvement and then go back to see him (costs a bomb mind you). The fissure is frustrating in that I can feel it, but no matter what set-up of mirrors I arrange I just can't see it. It's also at the top (an anterior fissure) which is very rare in men (about 1% of fissures) and wonder if this complicates the healing process more.

Anyhow, next steps. I plan to do some work on understanding wound healing and in particular if using vitamin C (or anything else) has been clinically proven to help. I want to understand if exercise helps too and can be proven. It seems madness that these fissures don't heal themselves – why does the body seemingly act against itself?

I've been exercising and applying the cream, but I need a spreadsheet to track my progress, so that is next on my list. I did that last time. I'm also planning a 12 week healing regime this time. But really I am counting on seeing some improvement in the next two weeks to lift my spirits.

Well that's me this week.

Best, LemonMan

Hi LM, sorry to hear your suffering again,
This has to be one of the most mentally draining conditions I have ever had, even my IBD doesn't effect me like this fissure does and the weeks I spent in splints and recovering from an accident pale in comparison. I agree that only people who have experienced the agony of unrelenting spasms can understand.
You have a good doctor and are otherwise healthy so you should heal...have you thought of transdermal vit c and transdermal mag as I can't take enough internally to help it would go straight through me lol
Also you could research calcium fluoride/sulphate and silica cell salts I do take these and can feel them helping but they are either lactose fructose or alcohol based all of which aggravate my IBD....at the end sometimes we just have to accept that our body may need help and that 20 years ago LIS was the gold standard to help heal fissure.
I wish you a speedy recovery

Thanks for the reply :-) and thanks for the pointers. I definitely will look into these. Having an AF certainly has helped me appreciate and understand human suffering in others more, and appreciated what it means to be healthy. Good luck with your own personal situation too.

Another update. Well so much for my plan. Went to see my CRS and he says that diltiazem wasn't working for me and botox is the next step. I've also now got a thrombose hemerroid to boot. I'm not sure about other's experiences but it's my belief that diltiazem has contributed to my hemmie. It would make sense given diltiazem is a vasodilator (i.e. swells the blood cells).

I've tried diltiazem three times now, so now I've decided to give it up. I was also one of those lucky few who react to it with some pretty difficult to manage itching. For now I want to help the hemmie subside and have switched to Anusol (oh the joy).

So the next step is botox. I guess I will be doing some research into the ins and outs of that. My CRS reckons that about 60% of people who don't respond to diltiazem are fixed with botox, but I'm not entirely sure it's as successful as that based on my initial research. Still, must stay positive!

It really helps me to get my thoughts down on paper (so to speak), as one of the main problems is that I really can't find anyone to talk to about it. I'd encourage anyone out there to do the same. My GP pretty much shrugs his shoulders and suggests I get a private consultation. It's not really the way the NHS is supposed to work, but I think he knows the NHS route less than ideal. I think my wife is bored of hearing about it, and doesn't really understand how mentally draining it can be. To be honest I try not to mention it these days because I really don't want to burden her with it.

Still doing the swimming though, and enjoying that. People have said I look more healthy - so that's something positive!

Will update you on what happens re botox and will be interested to hear peoples good and bad experiences with it.

Best - The LemonMan

Hi LM
Have they offered you GTN cream that always an option. I had Botox and was very very sceptical but as my private surgeon refused to do LIS on my fissure until I tried to heal it some more with Botox I didn't have a choice, although he was kind enough to let me have the Botox on the NHS as Botox is very expensive.
Now I really didn't want Botox I left his room crying I had heard horror stories and was dreading it....the first two weeks were not good although the spasms stopped straight away....this might be of interest to you...after the Botox my hems really did swell up and I believe a lot of the pain was from them.
After the first three weeks my pain started to decrease eventually just becoming discomfort I was only getting 20 mins of discomfort after a BM as oppose to 10 hours of agony before the Botox. The Botox did not heal my fissure but it wasn't meant too I have a long deep fissure that would have needed a very long cut for LIS so Botox was just a step.
So from someone who did not want and was sceptical of Botox...I would honestly say give it a go if that is what is advised, it can work and will help even if it's just a bit....but get it on the NHS as Botox shots are exceptionally expensive. LIS is cheaper.
I don't bother even telling my husband anymore as he is completely bored of it now and cannot possibly understand the pain or the stress.
Hope all goes well

Thanks for the reply MPB. I have a doctors appointment on the 31st. At the moment I plan to ask for GTN, but it will kind of depend what happens on the day. At the moment I have stopped taking everything except for Movicol. I think I was quite swollen down there - maybe something to do with the Diltazem and I imagine that's how I ended up with a thrombosed hermerrhoid. At the moment I'm back to looking for that miracle cure :-(

Hi LM
Good luck with the appointment, and please if you find a miracle cure can you please let me know asap lol.
I really reacted to Diltazem and my hems hated it only had it two weeks couldn't cope. GTN was much better for me.
Fingers crossed

Quick update on my situation.

Went to see my GP to see if I can get botox (as recommended by my CRS) on the NHS. My GP said to go ask my CRS if he would do it for me on the NHS, and if not to recommend someone who will. I don't think I'm taking the conventional route somehow with the NHS here, but I have fired off an email to my CRS anyway. Let's see what happens.

I feel I definitely have a chronic fissure now. In the sense it's not a tear as such any more, but has developed into an open sore. That's what it feels like anyway - a constant burning sensation that hurts the longer I sit on it. Standing for a bit gives some relief, but sitting for more then an hour gets really uncomfortable.

I stopped taking Anoheal (Diltiazem) a couple of weeks ago because I developed a small external hemerrhoid, and thought I would try some alternative remedies. I tried coconut oil, and while soothing, didn't really help me. I feel that might help more in the early stages with a fissure for people who want to sooth the initial tear and make passing stools easier.

I've also just bought some Medihoney - which is a sterile version of Manuka Honey. I've been doing some research on this and I can't find any clinical trials that proves it works. However there is some anecdotal evidence that it is particularly good at healing open sores and has anti bacterial properties. I'm thinking this might help with where I am at the moment. Those people who have reported success have usually experienced pain relief within a few days, so I figure it can't hurt to give it a go for a week or so.

Call me stupid, but I wasn't expecting it to be actual honey! I thought "honey" was some sort of synonym for a smoothing cream. Funny. It even has some crystallisation in it that you often see in usual honey jars.

If I get no luck from that, I think I will return to diltiazem and resume my old routine which has worked before. I was thinking of trying GTN ointment, but I've had success with diltiazem and *think* I can control the itching. My GP has been pretty good in prescribing what I want so far, and has told me to call him for this sort of thing which is pretty good at least.

Let's see how the Medihoney goes and maybe in a weeks time I can report a small miracle :-)

LemonMan