GaPP2 NEWS - 'Common pelvic pain drug is ineffective, large UK study finds'
Long-standing (chronic) pelvic pain affects >1 million UK women, but there is a lack of proven treatments. If no underlying cause is found, the pain is much more difficult to treat. Gabapentin, used to treat other chronic pain conditions, is being increasingly prescribed. There is no evidence to show whether gabapentin is effective for chronic pelvic pain, so we conducted a clinical trial, called GaPP2.
What did we do?
We involved 306 women with chronic pelvic pain, where no cause had been found, and randomly assigned them to take gabapentin or placebo for 16 weeks. We collected information on pain, physical and emotional wellbeing at the beginning and end of the study. Women scored their pain from 0-10 by text message.
What did we find?
Gabapentin did not reduce pain and did not improve any other aspects of the women's life, as compared with placebo. Side effects were more comon with gabapentin than placebo.
What does this mean?
Women with no obvious cause for their chronic pelvic pain should be made aware that gabapentin will not relieve their pain and may give them unpleasant side effects. More research is needed to see if physiotherapy or talking therapies can help instead. Women who are currently taking gabapentin and wish to stop should be aware that they need to gradually reduce their dose, in the same way that they had to increase it when they started taking it.
The results of the GAPP2 trial were published in the Lancet on 25 September 2020 and can be found in full at the link below:
https://authors.elsevier.com/sd/article/S0140-6736(20)31693-7
The trial is also summarised in a short YouTube video, which you will find below:
Study details:
Full Title: A multi-centre randomised controlled trial of the efficacy and mechanism of action of gabapentin for the management of chronic pelvic pain in women
Short Title:
GaPP2
Aims of the study:
Chronic pelvic pain affects over 1 million women in the UK. It is the reason for 20% of gynaecological consultations and it causes a 45% reduction in work productivity. For women who have no cause for their pain, finding an effective treatment can be problematic and there are no proven treatments available. The main aim of the study is to see if gabapentin will reduce pain in women with long-term pelvic pain and therefore increase their quality of life.
Study design:
A double blind randomised controlled trial.
Sample size:
300 participants to recruit over 21 months. (306 participants were recruited over 41 months)
Study Duration:
All patients in the main study will be followed up for 12 weeks.
Timeframes:
NIHR EME start date 01 March 2015. End date 31 Jan 2019. The last participant was recruited 15th March and the end of study is expected to take place mid-July 2019.